bellco formula 2000 user manual

IB5331228ENG Rev. 01

Formula Formula plus Formula 2000 Formula 2000 plus

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USER MANUAL

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ENG - Ed. 11/09 IB5331228ENG rev.01 Index - i of vii

INDEX

Expressions used in the manual iii Glossary Iv

Section 1

1.1 INTRODUCTION (Ed. 11/09) 1.2 WARNINGS, CAUTIONS AND SAFETY NOTES (Ed. 11/09)

Section 2

2.1 DESCRIPTION OF MACHINE AND COMPONENTS – STANDARD NON-THERAPY MODELS (Ed. 11/09) 2.2 DESCRIPTION OF MACHINE AND COMPONENTS – STANDARD THERAPY MODEL (Ed. 11/09) 2.3 DESCRIPTION OF MACHINE AND COMPONENTS – OPTIONS AND ACCESSORIES (Ed. 11/09) 2.4 FORMULA DOMUS (HOME CARE SYSTEM) - VERSION FOR HOME HAEMODIALYSIS (Ed. 11/09) 2.5 OPERATOR INTERFACE (Ed. 06/09) 2.6 CONFIGURATION (Ed. 06/09) 2.7 DISPOSABLE MATERIALS AND ACCESSORIES (Ed. 06/09) 2.8 TECHNICAL CHARACTERISTICS (Ed. 11/09)

Section 3

3.1 START-UP, TEST, RINSE (Ed. 06/09) 3.2 DIALYSIS FLUID PREPARATION (Ed. 06/09) 3.3 PREPARATION OF TREATMENT (Ed. 06/09) 3.4 HEPARIN (Ed. 06/09) 3.5 INITIATING DIALYSIS AND TREATMENT PROCESS (Ed. 06/09) 3.6 DISCONNECTING PATIENT (Ed. 06/09) Section 4

4.1 DOUBLE NEEDLE HAEMODIALYSIS – DN (Ed. 11/09) 4.2 SINGLE NEEDLE/SINGLE PUMP HAEMODIALYSIS – SNsp (Ed. 11/09) 4.3 SINGLE NEEDLE/DOUBLE PUMP HAEMODIALYSIS – SNdp (Ed. 11/09) Section 5

5.1 ONLINE HAEMODIAFILTRATION (HDF PRE, HDF POST ) (Ed. 11/09) Section 6

6.1 OPERATION DURING HAEMODIAFILTRATION WITH INFUSION OF DIALYSIS FLUID (PHF PRE, PHF POST) (Ed. 06/09)

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Section 7

7.1 HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE REINFUSION (HFR) (Ed. 06/09)

Section 8

8.1 PROFILES (ed. 12/07) 8.2 PROFILER (Ed. 06/09) 8.3 FORMULA PLUS SENSORS (Ed. 11/09) 8.4 OTHER FUNCTIONS (Ed. 12/07)

Section 9

9.1 DISINFECTION/CLEANING (Ed. 11/09) 9.2 WEEKLY DISINFECTION/CLEANING (Ed. 05/08) 9.3 PERIODIC CLEANING AND MAINTENANCE (Ed. 06/09) 9.4 MANAGEMENT OF ULTRAFILTERS AND MULTIPURE FILTER (Ed. 05/08) 9.5 DISINFECTION/CLEANING PROCEDURE FOR FORMULA MACHINE USED IN ON-LINE HAEMODIAFILTRATION TREATMENT (Ed. 12/07)

Section 10

10.1 ALARMS AND WARNINGS - GENERAL (Ed. 06/09) 10.2 ALARMS AND WARNINGS - DIALYSATE SECTION (Ed. 06/09) 10.3 ALARMS AND WARNINGS - BLOOD SECTION (Ed. 06/09)

Section 11

11.1 PROBLEM SOLVING (Ed. 06/09)

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EXPRESSIONS USED IN THE MANUAL WARNING Warns the operator not to take any particular action or carry out a procedure able to cause potential risks which, if ignored, may produce serious injury to the patient and/or the user.

CAUTION Refers to operating procedures and conditions which, if not applied, may have adverse effects on the patient or the machine.

NOTE Refers to important operating procedures and conditions.

This manual constitutes an integral and essential part of the machine. The manufacturer reserves the right to perform any eventual modifications to the user manual and the equipment without notice obligation. Should typographic mistakes or errors of other kind be noticed, the corrections will be included in the next versions/editions of the manual. Reserved property - Forbidden reproduction without the prior written permission of the manufacturer – The manufacturer protects its rights on the drawings and the images to law terms.

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GLOSSARY

These terms are defined as they apply to haemodialysis and to the formula® single patient delivery system. The definitions are not intended to be comprehensive. DN Identifies double needle dialysis.

SNsp Identifies single needle dialysis with a single pump.

SNdp

Identifies single needle dialysis with double pump.

HDF This refers to standard haemodiafiltration treatment (replacement solution is a sterile solution supplied in bags).

HDF OnLine This refers to the following on-line haemodiafiltration treatments (replacement solution is an ultrapure solution generated for ultrafiltration from dialysis solution prepared by the machine): HDF PRE, HDF POST, MID-HDF

HDF PRE This refers to pre-dilution on-line haemodiafiltration treatment with High-Flux standard dialysers (see Disposable materials chapter)

HDF POST This refers to post-dilution on-line haemodiafiltration treatment with High-Flux standard dialysers (see Disposable materials chapter)

MID-HDF This refers to mid-dilution on-line haemodiafiltration treatment with OLPure dialysers (see Disposable materials chapter).

PHF This refers to on-line haemodiafiltration treatments PHF PRE and PHF POST carried out using PHF double chamber dialysers (see Disposable materials chapter). (Replacement solution is an ultrapure solution generated for ultrafiltration from the dialysis solution prepared by the machine)

PHF PRE This refers to pre-dilution on-line haemodiafiltration treatment with PHF dual-chamber dialysers (see Disposable materials chapter).

PHF POST This refers to post-dilution on-line haemodiafiltration treatment with PHF dual-chamber dialysers (see Disposable materials chapter).

HFR Refers to haemodiafiltration treatment with endogenous reinfusion of ultrafiltrate.

Class I equipment

EN 60601-1 classification. Equipment in which protection against electrical shock does not rely on basic insulation only, but which includes an additional safety precaution in that means are provided for the connection of the equipment to the protective earth conductor in the fixed wiring of the installation in such a way that accessible metal parts can not become live in the event of a failure of the basic insulation.

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Applied part Type B

Applied part in conformity with the requirements specified in EN 60601-1, which provides a degree of protection against electrical risks with particular reference to permissible leakage currents.

Applied part Type BF

Applied part in conformity with the requirements specified in EN 60601-1, which provides a higher degree of protection against electrical risks with respect to that provided by applied parts type B.

By-pass Device to deviate dialysis fluid away from the dialyser to the drain.

Dialysis fluid Solution which is intended to exchange solutes and/or water with blood during haemodialysis. It is also defined as dialysing solution or dialysis fluid.

Electroclamp Device to automatically clamp the blood lines, i.e. in case of an alarm.

Arterial phase or arterial cycle (AP)

In single needle, it indicates the phase in which blood is drawn from the patient with the pump running and the clamp closed.

Venous phase or venous cycle (VP)

In single needle, it indicates the phase in which blood is returned to the patient with the pump stopped and the clamp open.

Arterial pressure The pressure measured in the extracorporeal circuit between the patient and the arterial blood pump.

Switching pressure Pressure used to define when the venous phase ends and the arterial

phase starts and to indicate possible problems arising during such phases.

Ultrafiltration pressure Pressure measured on the dialysate at dialyser outlet before the UF

pump. Transmembrane pressure The hydrostatic pressure difference inside the dialyser across the

membrane from the blood to the dialysate side.

Venous pressure The pressure measured in the extracorporeal circuit between the outlet of the dialyser and the return to the patient.

Stroke Blood volume moved during the cycle in Single Needle .

Single needle, single pump treatment

Emergency treatment carried out in the event of vascular access problems using a single drawing point, a Y line and a single blood pump.

Ultrafiltration The process of fluid removal from the patient’s blood across the dialyser.

Isolated ultrafiltration Ultrafiltration without dialysing fluid. Fluid removal is carried out without changing the solute composition of the blood.

Accessory MDD 93/42 classification. An article which, whilst not being a device, is intended specifically by its manufacturer to be used together with a device to enable it to be

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used in accordance with the use of the device intended by the manufacturer of the device.

Maintenance Any operation for maintaining the efficiency of the machine. Also, from the "maintenance" menu, the user can access rinsing, descaling, disinfection and ultrafilter and bacterial microfilter control functions.

Rinsing Physical process that uses water to remove deposits eventually present in the fluid pathway.

Descaling Process that removes inorganic deposits commonly left by the saline solutions circulating in the fluid pathway of the dialysis machine.

Disinfection Chemical or physical process which has effect on living micro-organisms, but with possibility of survival of some vegetative forms (spores).

Disinfection/cleaning In both the instructions for use and on the user interface, this term indicates a generic machine “cleaning” process which may consist of disinfection, descaling or rinsing.

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ENG – Ed. 11/09 chap. 1.1 - Introduction - 1 of 14

1.1 INTRODUCTION1.1 INTRODUCTION1.1 INTRODUCTION1.1 INTRODUCTION

GENERALGENERALGENERALGENERAL

NAMENAMENAMENAME

formula For convenience, if not otherwise specified, the name formula will be used to indicate the models formula, formula 2000, formula plus, formula 2000 plus, and formula Therapy.

INTENDED USEINTENDED USEINTENDED USEINTENDED USE

Haemodialysis and haemodiafiltration delivery system for the acetate or bicarbonate dialysis treatment of patients suffering from chronic renal failure. It may be used both in hospitals and at home.

CAUTIONCAUTIONCAUTIONCAUTION Information and assistance given to the patient during dialytic tInformation and assistance given to the patient during dialytic tInformation and assistance given to the patient during dialytic tInformation and assistance given to the patient during dialytic therapy in home herapy in home herapy in home herapy in home dialysis must take place under the management and supervision of the dialysis must take place under the management and supervision of the dialysis must take place under the management and supervision of the dialysis must take place under the management and supervision of the physicphysicphysicphysician prescribing the treatment. Tian prescribing the treatment. Tian prescribing the treatment. Tian prescribing the treatment. The manufacturer does not undertake any he manufacturer does not undertake any he manufacturer does not undertake any he manufacturer does not undertake any responsibility for teaching the patient how to use responsibility for teaching the patient how to use responsibility for teaching the patient how to use responsibility for teaching the patient how to use formula. Responsibility lies Responsibility lies Responsibility lies Responsibility lies exclusively wiexclusively wiexclusively wiexclusively with the physician in charge.th the physician in charge.th the physician in charge.th the physician in charge.

LIMITATION OF USELIMITATION OF USELIMITATION OF USELIMITATION OF USE

The formula delivery system is not designed, commercialised or intended for use different from that specified. Furthermore, it must not be used outside the specifications and operating values indicated by the manufacturer. The formula delivery system is not designed to dialyse infants.

COLLATERAL EFFECTSCOLLATERAL EFFECTSCOLLATERAL EFFECTSCOLLATERAL EFFECTS

Dialysis therapy may cause hypotension, nausea, vomiting and cramping in some patients.

CONTRAINDICATIONSCONTRAINDICATIONSCONTRAINDICATIONSCONTRAINDICATIONS

Hyperpotassemia (only with haemodialysis concentrates containing potassium) Hypopotassemia (only with haemodialysis concentrates not containing potassium) Uncontrollable coagulation anomalies.

2 of 14 - chap. 1.1 - Introduction ENG – Ed. 11/09

HAEMODIALYSISHAEMODIALYSISHAEMODIALYSISHAEMODIALYSIS

Haemodialysis Haemodialysis Haemodialysis Haemodialysis is a method of blood purification that is able to eliminate the toxic substances and excess water that accumulate in the body in the event of renal failure. Haemodialysis consists of the treatment of a patient’s blood by extracorporeal circulation, through a device made up of semi-permeable capillary fibres (dialyser) and a solution with an electrolytic content similar to plasma water which runs outside the fibres. The porosity of the membrane of which the fibres are made up allows water molecules and low molecular weight solutes to travel from the blood compartment to the dialysis fluid compartment, while the larger solutes such as protein and blood cells remain inside the blood compartment. Solutes are typically transported through the membrane via two different mechanisms: diffusion and convection

HAEMODIAFILTRATION HAEMODIAFILTRATION HAEMODIAFILTRATION HAEMODIAFILTRATION

HaemodiafiltratioHaemodiafiltratioHaemodiafiltratioHaemodiafiltrationnnn is a haemodialysis technique that uses a dialyser, both for its diffusive properties and for its high convection capacity, with a plasma water removal that exceeds the weight loss rate, thus necessitating reinfusion with a physiological solution. The infusion methods, filter types and physiological solution used distinguish certain haemodiafiltration methods implemented into the formula machine. This manual gives descriptions on:

o Standard haemodiafiltrationStandard haemodiafiltrationStandard haemodiafiltrationStandard haemodiafiltration, for treatments in which the replacement solution consists of a sterile solution supplied in bags. Standard haemodiafiltration implemented into the formula machine is indicated by the letters HDFHDFHDFHDF.

o On line haemodiafiltrationOn line haemodiafiltrationOn line haemodiafiltrationOn line haemodiafiltration, for treatments in which the replacement solution consists of an ultrapure solution derived by ultrafiltration from dialysis solution prepared by the machine. HDF Online treatments available on the formula machine are indicated by the letters: HDF PREHDF PREHDF PREHDF PRE, HDF POSTHDF POSTHDF POSTHDF POST, MIDMIDMIDMID----HDFHDFHDFHDF, PHF PREPHF PREPHF PREPHF PRE, PHF POSTPHF POSTPHF POSTPHF POST.

o Haemodiafiltration with endogenous reinfHaemodiafiltration with endogenous reinfHaemodiafiltration with endogenous reinfHaemodiafiltration with endogenous reinfusionusionusionusion, for treatments in which the replacement solution consists of an ultrapure solution derived by ultrafiltration from plasma water from the patient. Haemodiafiltration treatment with endogenous reinfusion implemented into the formula machine is indicated by the letters HFRHFRHFRHFR.

Refer to the relevant chapters for descriptions and use of the aforementioned methods. See the table in this chapter, below, for the availability of treatments according to the formula model used.


HAEMODIAFILTRATION HAEMODIAFILTRATION HAEMODIAFILTRATION HAEMODIAFILTRATION ---- INDICAT INDICAT INDICAT INDICATIONSIONSIONSIONS

Haemodiafiltration treatments are indicated for patients who have haemodynamic stability problems and when molecules of medium- to high molecular weight have to be removed.

ONONONON----LINE HAEMODIAFILTRATION LINE HAEMODIAFILTRATION LINE HAEMODIAFILTRATION LINE HAEMODIAFILTRATION –––– CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS

Online haemodiafiltration treatments (HDF PRE, HDF POST, PHF PRE, PHF POST, MID-HDF) are not recommended in areas where the quality of water entering the machine is not under strict control by the dialysis centre and does not conform to the regulations in force.

WARNINGWARNINGWARNINGWARNING • Chemical substChemical substChemical substChemical substances potentially toxic for infusion, present in the deionised ances potentially toxic for infusion, present in the deionised ances potentially toxic for infusion, present in the deionised ances potentially toxic for infusion, present in the deionised

water distribution network or in concentrate solutions are not detectable by water distribution network or in concentrate solutions are not detectable by water distribution network or in concentrate solutions are not detectable by water distribution network or in concentrate solutions are not detectable by formula.

• It is the responsibility of the dialysis centre to use water suitable for It is the responsibility of the dialysis centre to use water suitable for It is the responsibility of the dialysis centre to use water suitable for It is the responsibility of the dialysis centre to use water suitable for infusion.infusion.infusion.infusion.

• To avoid potentially dTo avoid potentially dTo avoid potentially dTo avoid potentially dangerous situations, carefully read the directions on angerous situations, carefully read the directions on angerous situations, carefully read the directions on angerous situations, carefully read the directions on the device packaging. the device packaging. the device packaging. the device packaging.

• Check that the device packaging, which ensures their sterility, is not Check that the device packaging, which ensures their sterility, is not Check that the device packaging, which ensures their sterility, is not Check that the device packaging, which ensures their sterility, is not damaged and that the sterilization validity date has not expired.damaged and that the sterilization validity date has not expired.damaged and that the sterilization validity date has not expired.damaged and that the sterilization validity date has not expired.

• Always ensure that disposable devices are Always ensure that disposable devices are Always ensure that disposable devices are Always ensure that disposable devices are installed properly using aseptic installed properly using aseptic installed properly using aseptic installed properly using aseptic techniques.techniques.techniques.techniques.

• Only use not pyrogenic concentrate solutions, qualitatively in compliance Only use not pyrogenic concentrate solutions, qualitatively in compliance Only use not pyrogenic concentrate solutions, qualitatively in compliance Only use not pyrogenic concentrate solutions, qualitatively in compliance with the monographs of the European Pharmacopoeia.with the monographs of the European Pharmacopoeia.with the monographs of the European Pharmacopoeia.with the monographs of the European Pharmacopoeia.

• The concentrate solutions to be used for preparation of dialysis fluid must The concentrate solutions to be used for preparation of dialysis fluid must The concentrate solutions to be used for preparation of dialysis fluid must The concentrate solutions to be used for preparation of dialysis fluid must be intactbe intactbe intactbe intact, opened only at the moment of use. Once opened, they must be , opened only at the moment of use. Once opened, they must be , opened only at the moment of use. Once opened, they must be , opened only at the moment of use. Once opened, they must be used for one treatment only within 24 hours.used for one treatment only within 24 hours.used for one treatment only within 24 hours.used for one treatment only within 24 hours.

• Before starting an onBefore starting an onBefore starting an onBefore starting an on----line haemodiafiltration session, take a dialysis fluid line haemodiafiltration session, take a dialysis fluid line haemodiafiltration session, take a dialysis fluid line haemodiafiltration session, take a dialysis fluid sample and check that it is free from any residual chemical agents.sample and check that it is free from any residual chemical agents.sample and check that it is free from any residual chemical agents.sample and check that it is free from any residual chemical agents.

• BefoBefoBefoBefore and during onre and during onre and during onre and during on----line haemodiafiltration treatment, check the exact line haemodiafiltration treatment, check the exact line haemodiafiltration treatment, check the exact line haemodiafiltration treatment, check the exact mixture of the concentrates with water.mixture of the concentrates with water.mixture of the concentrates with water.mixture of the concentrates with water.

• Always run a disinfection cycle before and after each onAlways run a disinfection cycle before and after each onAlways run a disinfection cycle before and after each onAlways run a disinfection cycle before and after each on----line line line line haemodiafiltration treatment session. The manufacturer declines any haemodiafiltration treatment session. The manufacturer declines any haemodiafiltration treatment session. The manufacturer declines any haemodiafiltration treatment session. The manufacturer declines any responsibility forresponsibility forresponsibility forresponsibility for patient safety in the event of failure to carry out proper patient safety in the event of failure to carry out proper patient safety in the event of failure to carry out proper patient safety in the event of failure to carry out proper disinfection.disinfection.disinfection.disinfection.

• Regularly change the Multipure and Forclean filters to ensure the maximum Regularly change the Multipure and Forclean filters to ensure the maximum Regularly change the Multipure and Forclean filters to ensure the maximum Regularly change the Multipure and Forclean filters to ensure the maximum purification of the liquid used.purification of the liquid used.purification of the liquid used.purification of the liquid used.

• The Qinf value must be selected taking into consideration the dilution The Qinf value must be selected taking into consideration the dilution The Qinf value must be selected taking into consideration the dilution The Qinf value must be selected taking into consideration the dilution modemodemodemode; in POST dilution (PHF POST) in particular, a careful evaluation of the ; in POST dilution (PHF POST) in particular, a careful evaluation of the ; in POST dilution (PHF POST) in particular, a careful evaluation of the ; in POST dilution (PHF POST) in particular, a careful evaluation of the set value is necessary. Refer to the literature and the clinical scene of the set value is necessary. Refer to the literature and the clinical scene of the set value is necessary. Refer to the literature and the clinical scene of the set value is necessary. Refer to the literature and the clinical scene of the patient to avoid potentially dangerous conditions.patient to avoid potentially dangerous conditions.patient to avoid potentially dangerous conditions.patient to avoid potentially dangerous conditions.


HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE REINREINREINREINFUSION (HFR) FUSION (HFR) FUSION (HFR) FUSION (HFR) ---- INDICATIONS INDICATIONS INDICATIONS INDICATIONS

Haemodiafiltration with on-line endogenous reinfusion of ultrafiltrate (HFR) is indicated for patients who may, on the one hand, enjoy the benefits derived from a haemodiafiltration technique (cardiovascular stability, efficiency of removal of molecules of medium- to high molecular weight) and, on the other hand, save nutritional and hormonal components. This technique is hence indicated for elderly patients and patients at risk of developing a malnutrition picture of both Type I (from reduced protein-calorie intake) and Type II (on the basis of chronic inflammation).

HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE HAEMODIAFILTRATION WITH ENDOGENOUS ULTRAFILTRATE REINFUSION (HFR) REINFUSION (HFR) REINFUSION (HFR) REINFUSION (HFR) ---- CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS

The disposables utilised in HFR treatment, if properly used, do not have contraindications. Nevertheless, the HFR technique with the SELECTA PLUS cartridge (cartridge containing charcoal) is not indicated for patients undergoing a therapy with ACE inhibitors or sartanes (angiotensin II receptor antagonists). The SELECTA PLUS cartridge has been associated with an increase in contact phase activation in patients treated with ACE inhibitors or sartanes. Therefore, it is unadvisable to use the SELECTA PLUS cartridge for such patients or patients who have already shown a certain hypersensitivity. The HFR treatment uses an adsorbent cartridge to regenerate the ultrafiltrate and hence adsorption can also occur in the case of medication. This adsorption may directly or indirectly cause side effects, particularly in sensitive patients.


MMMMAIN FEATURES AIN FEATURES AIN FEATURES AIN FEATURES

The formula dialysis system is produced in the following models: • formula (single pump) • formula 2000 (double pump) • formula plus (single pump) • formula 2000 plus (double pump) • formula Therapy (double pump) The basic model, formula, is equipped with a single pump and can be used to carry out standard dialysis treatment (double needle haemodialysis) and emergency treatment (single needle haemodialysis). In comparison to the basic model, formula 2000 is equipped with a second pump for infusion in the haemodiafiltration treatments and some sensors necessary for monitoring the infusion circuit. formula plus/ formula 2000 plus are “enriched” with innovative and advanced sensors (conductivity sensor, hematocrit measuring sensor, heart rate meter, ultrafilter recognition sensor, sphygmomanometer) able to control the progress of dialysis and its dose, monitor the patient and prevent any complications from arising. formula Therapy introduces, based on the formula 2000 plus, a double filtration of the dialysis solution, in order to produce a replacement solution in on-line haemodiafiltration treatments. The formula dialysis system is able to operate in different treatment modes, subdivided according to the preparation of the dialysis solution and to extracorporeal circulation and the treatment of infusion solutions. As regards the preparation of dialysis solution:

• treatments with acetate concentrate • treatments with liquid bicarbonate concentrate • treatments with bicarbonate concentrate powder • treatments with acetate-free concentrate (Lympha)

As regards the extracorporeal circulation system and the treatment of infusion solutions:

• Double Needle Haemodialysis • Single Needle Haemodialysis with single pump (SNsp) • Sequential haemodialysis with isolated ultrafiltration • Haemodiafiltration (HDF) with scale accessory • Haemodialysis with extracorporeal circulation with single needle/double pump

(SNdp) • Haemodiafiltration with endogenous ultrafiltrate reinfusion (HFR) • On-line Haemodiafiltration with the infusion of dialysis fluid (PHF PRE, PHF

POST, HDF PRE, HDF POST, MID-HDF).


TABLE OF TREATMENTS/MODELS TABLE OF TREATMENTS/MODELS TABLE OF TREATMENTS/MODELS TABLE OF TREATMENTS/MODELS

X indicates that the treatment shown at the start of the row can be carried out using the model indicated at the top of the column. formula formula plus formula

2000: formula 2000 plus

formula Therapy

DN X X X X X SNsp X X X X X SNdp X X X HDF X X HFR X X X PHF PRE X X X PHF POST X X X HDF PRE X HDF POST X MID-HDF X Additionally, formula is manufactured into a configuration specifically suited for use in the home environment as the display, keyboard and flow regulators can be positioned at various heights from the floor with variable inclinations. formula has an electronic multiprocessor architecture composed of control and protection microprocessors which control functioning of all the actuators/detectors/transducers, and a Personal Computer which supervises all the operating functions and facilitates operator/machine interaction making the management approach to dialysis immediate and safe. The PC architecture of formula allows using high-level software; the operator can communicate with the machine in a flexible and simple manner. Guide messages on the display make all the operating functions easy for the operator to understand. The significant data to manage the dialysis session are highlighted on one single display page on the operator interface, both in numeric terms and with ideograms to facilitate reading. The hydraulic circuit has been optimised in volume, and is rigorously singlerigorously singlerigorously singlerigorously single----passpasspasspass in any operating state. For ultrafiltration control a Coriolis flowmeter is used, able to measure the mass of fluids which flow through the circuit without interrupting dialysis. Ultrafiltration accuracy is independent of UF pressure. Use of the Multipure antibacterial filter, placed on the water inlet of the machine, and of the ultrafilter for endotoxin removal, placed on the dialysate inlet, allows preparing a dialysing solution of high microbiological quality, and improves biocompatibility of the haemodialytic treatment administered by formula. The hydraulic circuit is completely disinfectable. Short, automatic, high-flow rinsing cycles guarantee removal by mechanical means of any salt or biofilm deposits before disinfection.


The vertical structure (monolithic type) of formula makes the external surfaces easy to clean, and thanks to the side panels which can be opened and rotated by 180º, access to the internal components is improved thus facilitating maintenance/repair operations. formula has four rotating wheels of which the front two can be locked individually, allowing safe transport and positioning in any operating environment. formula optimises the consumption of: • electric energyelectric energyelectric energyelectric energy: it is equipped with a high-efficiency heat exchanger which allows

increasing the inlet water temperature by conduction, recovering part of the heat emitted by the dialysis fluid running to the drain with the consequent reduction in machine energy requirements.

• concentraconcentraconcentraconcentratestestestes: both during the patient waiting phase and during dialysis with isolated ultrafiltration, formula reduces the dialysis fluid flow to a minimum level.

• feedwater:feedwater:feedwater:feedwater: in all standby phases during rinsing, formula reduces the inlet water flow to a minimum.

SAFETY PHILOSOPHY SAFETY PHILOSOPHY SAFETY PHILOSOPHY SAFETY PHILOSOPHY

formula has a multiprocessor architecture and guarantees the safety of the patient even in single fault condition (first failure proof IEC 513). The self-tests, run automatically when switching on and at the beginning of each dialysis session, allow checking proper functioning of the components. Any failure recognized during the tests prevents starting of the treatment. The operator interface is structured in such a way that the operator has to confirm any commands twice and thus ensures that the actual intended action is carried out. formula immediately transmits every alarm condition to the operator giving him a visual, optical and acoustic warning: • visual: messages and/or ideograms on screen in bright red • optical: red flashing light located at the highest point of the I.V. pole • acoustic: warning signal of different intensity according to a scale of priorities. Direct access keys allow the operator to manage the alarm condition. formula combines technological innovations with tradition, maintaining a rapidly accessible potentiometer knob for blood pump control: any critical condition can be controlled by simply setting the blood flow to zero by turning the knob. formula is equipped with non-invasive measuring transducers, free of stasis points and not subject to contamination because the dialysing fluid flows across them at high speed. The transducers are fitted with auto-diagnostic systems which check functioning before each treatment and do not require any particular calibration except in the maintenance phase. formula warns the operator of some faults which may affect the efficiency of the dialysis treatment: • dialysate flow lower than an adequate threshold • incorrect connection between patient and machine


• presence of electrically conductive substances in the machine's water system which could produce unsuitable conductivity levels for the set treatment

• incorrect completion of the disinfection programs.


SYMBOLS ON THE MACHINESYMBOLS ON THE MACHINESYMBOLS ON THE MACHINESYMBOLS ON THE MACHINE

The following symbols are found on the machine or the identification tag:

Applied part TYPE B (ref. EN 60601-1

Applied part TYPE BF (ref. EN 60601-1)

Defibrillation-proof type BF applied part (ref. EN 60601-1)

IPX1IPX1IPX1IPX1

Protection against dripping water with vertical drop

Year of manufacture

Alternate current power supply

Off (not powered)

On (powered)

WARNING. Consult the manual.

Protection ground

Equipotentiality

DRAIN

Water inlet

Remote alarm


Socket for auxiliary keyboard

Connectors for serial ports

Conformity with Directive 93/42/EEC relative to Medical Devices. Notifying body: TÜV SÜD Product Service - Munich (Germany)

Connector for Pulsar

Connector for Hemox

This symbol indicates the compulsory separation of electrical and electronic equipment for disposal (see Disposal).

MANUFACTURER RESPONSIBILITYMANUFACTURER RESPONSIBILITYMANUFACTURER RESPONSIBILITYMANUFACTURER RESPONSIBILITY

The manufacturer is responsible for the safety, reliability and proper functioning of formula only if the electrical system of the dialysis room is in conformity with the regulations in force, if the machine is used in accordance with the instructions in the user manual and if any maintenance operation is carried out by authorized technical staff. Proper functioning of formula is guaranteed only if the machine is used and maintained in accordance with the instructions supplied by the manufacturer. The manufacturer declines any liability following incorrect or improper use of the machine, as well as in case of errors on the part of the Haemodialysis Centre staff. All maintenance and repair procedures and periodic inspections must be carried out exclusively by qualified technicians authorised by the manufacturer in accordance with the specifications in the technical manual. BELLCO is a company whose quality system is certified in accordance with EN ISO 13485: 2003. formula has been designed and manufactured in compliance with National, European and International regulations applicable to the safety of electro-medical equipment: EN 60601EN 60601EN 60601EN 60601----1 1 1 1

Medical electrical equipment. Part 1: General requirements for safety

EN 60601EN 60601EN 60601EN 60601----1111----2222

Medical electrical equipment. Part 1: General requirements for safety - Collateral standards: Electromagnetic compatibility – Requirements and tests


EN EN EN EN 60601606016060160601----1111----4 4 4 4

Medical electrical equipment. Part 1: General requirements for safety. 4. Collateral standard: Programmable electrical medical systems

EN 60601EN 60601EN 60601EN 60601----2222----16161616

Medical electrical equipment. Part 2-16: Particular requirements for the safety of haemodialysis, haemofiltration and haemodiafiltration equipment

EN 60601EN 60601EN 60601EN 60601----2222----30303030

Medical electrical equipment. Part 2: Particular requirements for safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment.

EN EN EN EN ISO 14971ISO 14971ISO 14971ISO 14971 Medical devices Application of risk management to medical devices (ISO 14971:2000)

formula carries the CE marking in compliance with the European Directive 93/42/EEC of 14 June 1993 relative to Medical Devices. Notifying Body: TÜV SÜD Product Service - Munich (D), number 0123.

The CE marking printed in this manual is valid only if the machine related to it carries the same marking. Contact the manufacturer (or your local representative) for additional information.

To contTo contTo contTo contact Afteract Afteract Afteract After----Sales Service:Sales Service:Sales Service:Sales Service:

ph: ++39 0535 29271 (Italy)

ph: ++39 0535 29402 (International)

Fax: ++39 0535 29400

e-mail: [email protected] Local Representative Local Representative Local Representative Local Representative


EQUIPMENT DISPOSALEQUIPMENT DISPOSALEQUIPMENT DISPOSALEQUIPMENT DISPOSAL

IMPORTANT IMPORTANT IMPORTANT IMPORTANT The guidelines herein indicated are addressed only to the Member States which The guidelines herein indicated are addressed only to the Member States which The guidelines herein indicated are addressed only to the Member States which The guidelines herein indicated are addressed only to the Member States which accepted Directive 2002/96/EC of 27 January 2003 on Waste Electrical and accepted Directive 2002/96/EC of 27 January 2003 on Waste Electrical and accepted Directive 2002/96/EC of 27 January 2003 on Waste Electrical and accepted Directive 2002/96/EC of 27 January 2003 on Waste Electrical and ElElElElectronic Equipment (WEEE). ectronic Equipment (WEEE). ectronic Equipment (WEEE). ectronic Equipment (WEEE). These measures comply with the European These measures comply with the European These measures comply with the European These measures comply with the European Directive and the national laws transposing the Directive in the Member States.Directive and the national laws transposing the Directive in the Member States.Directive and the national laws transposing the Directive in the Member States.Directive and the national laws transposing the Directive in the Member States. In order to safeguard, protect and improve the quality of the environment as well as the human health, at the end of its lifetime the dialysis equipment must be treated as special waste and must be collected separately, in compliance with the current national regulations. Illicit disposal of WEEE (Waste Electrical and Electronic Equipment) is punished with pecuniary endorsements. The manufacturer shall be responsible for the take-back and disposal of the equipment and undertakes to treat it according to the modalities of reuse, recycling, treatment and other forms of recovery of the WEEE as foreseen by the law. At the time of purchase of a new equipment, the customer may demand the manufacturer the take-back and disposal of the historical WEEE (placed on the marked before 13 August 2005), as long as the new equipment is of equivalent type (meeting the criteria of equivalence indicated in the Directive 2002/96/EC), In compliance with the Directive 2002/96/EC, the equipment to be disposed of must be delivered to the manufacturer opportunely disinfected and accompanied by a declaration which states that the equipment is NOT infected. The disinfection and the declaration (signed by a person officially designed ) must be executed by the hospital. The manufacturer will not take back equipment from the hospital which have not been previously disinfected and are not accompanied by declarations adequately edited and signed.


PRODUCT CODEPRODUCT CODEPRODUCT CODEPRODUCT CODE

The product code, described below, is a 9-character alphanumerical code:

I B F X M X 7 0 0 The first two charactersfirst two charactersfirst two charactersfirst two characters (IB) are identical for all equipment and identify the product. The third character (alphabetic)third character (alphabetic)third character (alphabetic)third character (alphabetic) identifies the machine: F:F:F:F: formula or formula 2000 The fourth fourth fourth fourth and fifth characters fifth characters fifth characters fifth characters (alphanumeric)))) identify the model: XM:XM:XM:XM: formula (single pump) XB:XB:XB:XB: formula 2000 (double pump) PM:PM:PM:PM: formula Plus (single pump) PB:PB:PB:PB: formula 2000 Plus (double pump) TB:TB:TB:TB: formula Therapy (double pump)

The sixth character sixth character sixth character sixth character (alphanumeric) identifies the version: X: standard system DDDD: formula Domus (Home Care System) The seventh character seventh character seventh character seventh character (numeric) indicates the pre-set voltage. 2222: 110 Vac 3333: 115 Vac 4444: 120 Vac 6666: 220 Vac 7777: 230 Vac 8888: 240 Vac The eighth and ninth characters eighth and ninth characters eighth and ninth characters eighth and ninth characters (numeric) are digits included between 00 and 99. They identify the option devices mounted on the machine. Formula Formula Formula Formula , Formula Plus, , Formula Plus, , Formula Plus, , Formula Plus, Formula 2000 Formula 2000 Formula 2000 Formula 2000 and Formand Formand Formand Formula 2000 Plus ula 2000 Plus ula 2000 Plus ula 2000 Plus models models models models

CODECODECODECODE SphygmoSphygmoSphygmoSphygmo Double Double Double Double clampclampclampclamp

PerforatedPerforatedPerforatedPerforated ccccartridgeartridgeartridgeartridge

00000000 01010101 xxxx 02020202 xxxx 03030303 xxxx 10 10 10 10 xxxx xxxx 20202020 xxxx xxxx 30 30 30 30 xxxx xxxx 40 40 40 40 xxxx xxxx xxxx


Formula Therapy modelFormula Therapy modelFormula Therapy modelFormula Therapy model

CODECODECODECODE SphygmoSphygmoSphygmoSphygmo NatriumNatriumNatriumNatrium Double Double Double Double clampclampclampclamp

Perforated Perforated Perforated Perforated ccccartridge artridge artridge artridge

00000000 xxxx xxxx

01010101 xxxx xxxx xxxx

02020202 xxxx xxxx xxxx

30 30 30 30 xxxx xxxx xxxx xxxx

ENG – Ed. 11/09 chap. 1.2 – Warnings, Cautions and Safety notes - 1 of 4

1. 2 WARNINGS, CAUTIONS AND SAFETY NOTES1. 2 WARNINGS, CAUTIONS AND SAFETY NOTES1. 2 WARNINGS, CAUTIONS AND SAFETY NOTES1. 2 WARNINGS, CAUTIONS AND SAFETY NOTES

WARNINGSWARNINGSWARNINGSWARNINGS

Carefully read the instructions contained in this manual before starting the Carefully read the instructions contained in this manual before starting the Carefully read the instructions contained in this manual before starting the Carefully read the instructions contained in this manual before starting the machine for the first time. Nonmachine for the first time. Nonmachine for the first time. Nonmachine for the first time. Non----conform use, application of procedures conform use, application of procedures conform use, application of procedures conform use, application of procedures different from those indicated, or the use of accessordifferent from those indicated, or the use of accessordifferent from those indicated, or the use of accessordifferent from those indicated, or the use of accessory devices not provided for y devices not provided for y devices not provided for y devices not provided for may present a risk to the patient and/or the machine.may present a risk to the patient and/or the machine.may present a risk to the patient and/or the machine.may present a risk to the patient and/or the machine.

Haemodialysis treatments must be carried out under supervision of the Haemodialysis treatments must be carried out under supervision of the Haemodialysis treatments must be carried out under supervision of the Haemodialysis treatments must be carried out under supervision of the medical staff responsible for administration of the treatment.medical staff responsible for administration of the treatment.medical staff responsible for administration of the treatment.medical staff responsible for administration of the treatment.

formula may only be used by persons who may only be used by persons who may only be used by persons who may only be used by persons who have acquired adequate knowledge have acquired adequate knowledge have acquired adequate knowledge have acquired adequate knowledge of haemodialysis and who have been suitably trained for proper use of the of haemodialysis and who have been suitably trained for proper use of the of haemodialysis and who have been suitably trained for proper use of the of haemodialysis and who have been suitably trained for proper use of the machine and the risks connected with such use.machine and the risks connected with such use.machine and the risks connected with such use.machine and the risks connected with such use. Check the quality of the haemodialysis water used so that when mixed with the Check the quality of the haemodialysis water used so that when mixed with the Check the quality of the haemodialysis water used so that when mixed with the Check the quality of the haemodialysis water used so that when mixed with the concentrates, no potenconcentrates, no potenconcentrates, no potenconcentrates, no potentially dangerous conditions for the patient are created.tially dangerous conditions for the patient are created.tially dangerous conditions for the patient are created.tially dangerous conditions for the patient are created. The operator must pay careful attention to all the alarm conditions and follow The operator must pay careful attention to all the alarm conditions and follow The operator must pay careful attention to all the alarm conditions and follow The operator must pay careful attention to all the alarm conditions and follow the instructions, the warnings and the notes contained in this manual. the instructions, the warnings and the notes contained in this manual. the instructions, the warnings and the notes contained in this manual. the instructions, the warnings and the notes contained in this manual. If If If If formula does not function as described in th does not function as described in th does not function as described in th does not function as described in the manual, it must not be used e manual, it must not be used e manual, it must not be used e manual, it must not be used until its operating conditions have been restored.until its operating conditions have been restored.until its operating conditions have been restored.until its operating conditions have been restored. There are no parts of the machine which may be repaired by the operator. There are no parts of the machine which may be repaired by the operator. There are no parts of the machine which may be repaired by the operator. There are no parts of the machine which may be repaired by the operator. Periodic maintenance is to be carried out every 3000 hours of operation or Periodic maintenance is to be carried out every 3000 hours of operation or Periodic maintenance is to be carried out every 3000 hours of operation or Periodic maintenance is to be carried out every 3000 hours of operation or every 12 months.every 12 months.every 12 months.every 12 months. The machThe machThe machThe machines are not disinfected before shipment. Always carry out a ines are not disinfected before shipment. Always carry out a ines are not disinfected before shipment. Always carry out a ines are not disinfected before shipment. Always carry out a disinfection cycle after installation, before use.disinfection cycle after installation, before use.disinfection cycle after installation, before use.disinfection cycle after installation, before use. The blood circuits must be sterile and pyrogenThe blood circuits must be sterile and pyrogenThe blood circuits must be sterile and pyrogenThe blood circuits must be sterile and pyrogen----free. Check that the packaging free. Check that the packaging free. Check that the packaging free. Check that the packaging is undamaged and open it using aseptic techniques. To prevent anyis undamaged and open it using aseptic techniques. To prevent anyis undamaged and open it using aseptic techniques. To prevent anyis undamaged and open it using aseptic techniques. To prevent any possibility possibility possibility possibility of contamination, the sterile sets must be used immediately.of contamination, the sterile sets must be used immediately.of contamination, the sterile sets must be used immediately.of contamination, the sterile sets must be used immediately. Once the disposable material is installed, check there are no bends or kinks in Once the disposable material is installed, check there are no bends or kinks in Once the disposable material is installed, check there are no bends or kinks in Once the disposable material is installed, check there are no bends or kinks in the lines.the lines.the lines.the lines. Disposable material should be treated as special waste and disposed of Disposable material should be treated as special waste and disposed of Disposable material should be treated as special waste and disposed of Disposable material should be treated as special waste and disposed of according to statuaccording to statuaccording to statuaccording to statutory laws and regulations. Do not retory laws and regulations. Do not retory laws and regulations. Do not retory laws and regulations. Do not re----sterilize. When handling sterilize. When handling sterilize. When handling sterilize. When handling disposable material, adopt the necessary and adequate precautions to prevent disposable material, adopt the necessary and adequate precautions to prevent disposable material, adopt the necessary and adequate precautions to prevent disposable material, adopt the necessary and adequate precautions to prevent any exposure to or transmission of infecting agents, HIV and hepatitis viruses.any exposure to or transmission of infecting agents, HIV and hepatitis viruses.any exposure to or transmission of infecting agents, HIV and hepatitis viruses.any exposure to or transmission of infecting agents, HIV and hepatitis viruses. When the machine is no longer going tWhen the machine is no longer going tWhen the machine is no longer going tWhen the machine is no longer going to be used, it must also be treated as o be used, it must also be treated as o be used, it must also be treated as o be used, it must also be treated as special refuse and disposed of according to statutory laws and regulations.special refuse and disposed of according to statutory laws and regulations.special refuse and disposed of according to statutory laws and regulations.special refuse and disposed of according to statutory laws and regulations.

2 of 4 - chap. 1.2 – Warnings, Cautions and Safety notes ENG – Ed. 11/09

The temperature of the liquid circulating in the tubes during the heat The temperature of the liquid circulating in the tubes during the heat The temperature of the liquid circulating in the tubes during the heat The temperature of the liquid circulating in the tubes during the heat disinfection cycles is extremely high. Do not touch the tubes and the disinfection cycles is extremely high. Do not touch the tubes and the disinfection cycles is extremely high. Do not touch the tubes and the disinfection cycles is extremely high. Do not touch the tubes and the connectors until the disinfection cycle has ended.connectors until the disinfection cycle has ended.connectors until the disinfection cycle has ended.connectors until the disinfection cycle has ended. During dialysis pay careful attention to inverse ultrafiltration (signalled by a During dialysis pay careful attention to inverse ultrafiltration (signalled by a During dialysis pay careful attention to inverse ultrafiltration (signalled by a During dialysis pay careful attention to inverse ultrafiltration (signalled by a specific alarm), as this situation can be dangerous for the patient. specific alarm), as this situation can be dangerous for the patient. specific alarm), as this situation can be dangerous for the patient. specific alarm), as this situation can be dangerous for the patient. Accurately Accurately Accurately Accurately verify the patientverify the patientverify the patientverify the patient’’’’s weight.s weight.s weight.s weight. During dialysDuring dialysDuring dialysDuring dialysis pay careful attention to eventual leakage of fluids from the is pay careful attention to eventual leakage of fluids from the is pay careful attention to eventual leakage of fluids from the is pay careful attention to eventual leakage of fluids from the equipment, as this situation can be dangerous for the patient. equipment, as this situation can be dangerous for the patient. equipment, as this situation can be dangerous for the patient. equipment, as this situation can be dangerous for the patient. Accurately verify Accurately verify Accurately verify Accurately verify the patientthe patientthe patientthe patient’’’’s weight.s weight.s weight.s weight.

Some of the alarms can be disabled by pressing the Some of the alarms can be disabled by pressing the Some of the alarms can be disabled by pressing the Some of the alarms can be disabled by pressing the key to allow the key to allow the key to allow the key to allow the operator to resolvoperator to resolvoperator to resolvoperator to resolve the situations which generated the alarm. The operator e the situations which generated the alarm. The operator e the situations which generated the alarm. The operator e the situations which generated the alarm. The operator must pay very careful attention and is responsible for monitoring the disabled must pay very careful attention and is responsible for monitoring the disabled must pay very careful attention and is responsible for monitoring the disabled must pay very careful attention and is responsible for monitoring the disabled parameters. The repeated silencing of alarms due to an unknown cause can be parameters. The repeated silencing of alarms due to an unknown cause can be parameters. The repeated silencing of alarms due to an unknown cause can be parameters. The repeated silencing of alarms due to an unknown cause can be dangerous for the patient.dangerous for the patient.dangerous for the patient.dangerous for the patient.

If the I If the I If the I If the I....VVVV.... po po po pole is fitted with both hooks and scale, in HDF hang the le is fitted with both hooks and scale, in HDF hang the le is fitted with both hooks and scale, in HDF hang the le is fitted with both hooks and scale, in HDF hang the infusion fluid bags only on the scale hooks to prevent weight loss errors.infusion fluid bags only on the scale hooks to prevent weight loss errors.infusion fluid bags only on the scale hooks to prevent weight loss errors.infusion fluid bags only on the scale hooks to prevent weight loss errors. The maximum load that may be applied to the IV pole of The maximum load that may be applied to the IV pole of The maximum load that may be applied to the IV pole of The maximum load that may be applied to the IV pole of formula is 10 kg, is 10 kg, is 10 kg, is 10 kg, while to the Iwhile to the Iwhile to the Iwhile to the I....VVVV.... pole of pole of pole of pole of formula 2000 is 16 kg is 16 kg is 16 kg is 16 kg.... To transport or to move the machine, the IV pole and scale hooks must be To transport or to move the machine, the IV pole and scale hooks must be To transport or to move the machine, the IV pole and scale hooks must be To transport or to move the machine, the IV pole and scale hooks must be unloaded.unloaded.unloaded.unloaded. formula must always be installed by technicians authorised by the must always be installed by technicians authorised by the must always be installed by technicians authorised by the must always be installed by technicians authorised by the manufacturer or by technical staff of the dialysis centre, who are adequately manufacturer or by technical staff of the dialysis centre, who are adequately manufacturer or by technical staff of the dialysis centre, who are adequately manufacturer or by technical staff of the dialysis centre, who are adequately trained and authorised.trained and authorised.trained and authorised.trained and authorised. If not, the manufacturer declines all responsibility If not, the manufacturer declines all responsibility If not, the manufacturer declines all responsibility If not, the manufacturer declines all responsibility regarding safety and reliability of the machine.regarding safety and reliability of the machine.regarding safety and reliability of the machine.regarding safety and reliability of the machine. The electrical system of the haemodialysis rooms must be in conformity with The electrical system of the haemodialysis rooms must be in conformity with The electrical system of the haemodialysis rooms must be in conformity with The electrical system of the haemodialysis rooms must be in conformity with the relevant regulations; therefore, have the earthing and the good conditionthe relevant regulations; therefore, have the earthing and the good conditionthe relevant regulations; therefore, have the earthing and the good conditionthe relevant regulations; therefore, have the earthing and the good condition of the power outlet checked before installing the machine. Specific regulations of the power outlet checked before installing the machine. Specific regulations of the power outlet checked before installing the machine. Specific regulations of the power outlet checked before installing the machine. Specific regulations of different countries, as well as any changes to national regulations, must be of different countries, as well as any changes to national regulations, must be of different countries, as well as any changes to national regulations, must be of different countries, as well as any changes to national regulations, must be taken into account.taken into account.taken into account.taken into account. Ensure compliance with current regulations concerning drainEnsure compliance with current regulations concerning drainEnsure compliance with current regulations concerning drainEnsure compliance with current regulations concerning drain----traps and pointraps and pointraps and pointraps and pointttt----totototo----point distance to the drain.point distance to the drain.point distance to the drain.point distance to the drain. The The The The formula single patient delivery system is a continuous operation machine, single patient delivery system is a continuous operation machine, single patient delivery system is a continuous operation machine, single patient delivery system is a continuous operation machine, and is not suitable for use with inflammable anaesthetic mixtures containing and is not suitable for use with inflammable anaesthetic mixtures containing and is not suitable for use with inflammable anaesthetic mixtures containing and is not suitable for use with inflammable anaesthetic mixtures containing air, oxygen or nitrous oxide.air, oxygen or nitrous oxide.air, oxygen or nitrous oxide.air, oxygen or nitrous oxide.

ENG – Ed. 11/09 chap. 1.2 – Warnings, Cautions and Safety notes - 3 of 4

When connecting the machine to thWhen connecting the machine to thWhen connecting the machine to thWhen connecting the machine to the mains, only use the power cable provided e mains, only use the power cable provided e mains, only use the power cable provided e mains, only use the power cable provided and do not use extensions or adapters for plugs.and do not use extensions or adapters for plugs.and do not use extensions or adapters for plugs.and do not use extensions or adapters for plugs. Do not connect external machines to the auxiliary socketDo not connect external machines to the auxiliary socketDo not connect external machines to the auxiliary socketDo not connect external machines to the auxiliary socket (if present) (if present) (if present) (if present).... The The The The connector for an external keyboard may only be used by technicians or connector for an external keyboard may only be used by technicians or connector for an external keyboard may only be used by technicians or connector for an external keyboard may only be used by technicians or personnel authorispersonnel authorispersonnel authorispersonnel authorised by the manufacturer.ed by the manufacturer.ed by the manufacturer.ed by the manufacturer. The power supply voltage on the mains outlet at the dialysis centre must be The power supply voltage on the mains outlet at the dialysis centre must be The power supply voltage on the mains outlet at the dialysis centre must be The power supply voltage on the mains outlet at the dialysis centre must be identical to that indicated on the machine identification plate.identical to that indicated on the machine identification plate.identical to that indicated on the machine identification plate.identical to that indicated on the machine identification plate. Do not remove labels or written information from the machine panels.Do not remove labels or written information from the machine panels.Do not remove labels or written information from the machine panels.Do not remove labels or written information from the machine panels. Before use, the macBefore use, the macBefore use, the macBefore use, the machine must be configured. The first configuration must be hine must be configured. The first configuration must be hine must be configured. The first configuration must be hine must be configured. The first configuration must be performed only by technicians authorised by the manufacturer.performed only by technicians authorised by the manufacturer.performed only by technicians authorised by the manufacturer.performed only by technicians authorised by the manufacturer.

CAUTIONSCAUTIONSCAUTIONSCAUTIONS

During transport and storage the machine must be kept in its original During transport and storage the machine must be kept in its original During transport and storage the machine must be kept in its original During transport and storage the machine must be kept in its original packaging. Should the period of transport or storage bepackaging. Should the period of transport or storage bepackaging. Should the period of transport or storage bepackaging. Should the period of transport or storage be longer than 15 weeks, longer than 15 weeks, longer than 15 weeks, longer than 15 weeks, refer to the ambient data relative to functioning.refer to the ambient data relative to functioning.refer to the ambient data relative to functioning.refer to the ambient data relative to functioning. When unpacking, check that there are no signs of external damage which may When unpacking, check that there are no signs of external damage which may When unpacking, check that there are no signs of external damage which may When unpacking, check that there are no signs of external damage which may compromise proper functioning of the machine.compromise proper functioning of the machine.compromise proper functioning of the machine.compromise proper functioning of the machine. Take all the necessary precautions so that the machine cannTake all the necessary precautions so that the machine cannTake all the necessary precautions so that the machine cannTake all the necessary precautions so that the machine cannot fall or is not ot fall or is not ot fall or is not ot fall or is not placed in an unstable position during ordinary use or transport. In case of placed in an unstable position during ordinary use or transport. In case of placed in an unstable position during ordinary use or transport. In case of placed in an unstable position during ordinary use or transport. In case of falling or other mechanical stress, have a preventive inspection carried out by falling or other mechanical stress, have a preventive inspection carried out by falling or other mechanical stress, have a preventive inspection carried out by falling or other mechanical stress, have a preventive inspection carried out by qualified technicians.qualified technicians.qualified technicians.qualified technicians. On all models, before moving the machine, the IV pole hookOn all models, before moving the machine, the IV pole hookOn all models, before moving the machine, the IV pole hookOn all models, before moving the machine, the IV pole hooks, scale hooks and s, scale hooks and s, scale hooks and s, scale hooks and concentrate bag concentrate bag concentrate bag concentrate bag holderholderholderholder must be completely unloaded. must be completely unloaded. must be completely unloaded. must be completely unloaded. On DOMUS versions, the instrument table must also completely empty before On DOMUS versions, the instrument table must also completely empty before On DOMUS versions, the instrument table must also completely empty before On DOMUS versions, the instrument table must also completely empty before moving the machine.moving the machine.moving the machine.moving the machine. Do not step on the containerDo not step on the containerDo not step on the containerDo not step on the container----tray base.tray base.tray base.tray base. Use the bag hook only for the physiological soluUse the bag hook only for the physiological soluUse the bag hook only for the physiological soluUse the bag hook only for the physiological solution bags.tion bags.tion bags.tion bags. Use of mobile telephones near Use of mobile telephones near Use of mobile telephones near Use of mobile telephones near formula or other devices emitting or other devices emitting or other devices emitting or other devices emitting electromagnetic waves may cause bad functioning of the machine.electromagnetic waves may cause bad functioning of the machine.electromagnetic waves may cause bad functioning of the machine.electromagnetic waves may cause bad functioning of the machine. After each dialysis disinfect the concentrate intake tubes.After each dialysis disinfect the concentrate intake tubes.After each dialysis disinfect the concentrate intake tubes.After each dialysis disinfect the concentrate intake tubes. Do not exchange the concentrate with the disinfectant Do not exchange the concentrate with the disinfectant Do not exchange the concentrate with the disinfectant Do not exchange the concentrate with the disinfectant tubes and with those of tubes and with those of tubes and with those of tubes and with those of other dialysis machines.other dialysis machines.other dialysis machines.other dialysis machines.

4 of 4 - chap. 1.2 – Warnings, Cautions and Safety notes ENG – Ed. 11/09

NOTESNOTESNOTESNOTES

This manual provides the necessary instructions for safe and proper This manual provides the necessary instructions for safe and proper This manual provides the necessary instructions for safe and proper This manual provides the necessary instructions for safe and proper functioning of functioning of functioning of functioning of formula.... It must not be understood as guide for administration It must not be understood as guide for administration It must not be understood as guide for administration It must not be understood as guide for administration of dialytic therapy. of dialytic therapy. of dialytic therapy. of dialytic therapy. Keep this manual in a readiKeep this manual in a readiKeep this manual in a readiKeep this manual in a readily accessible place for rapid consultation by both ly accessible place for rapid consultation by both ly accessible place for rapid consultation by both ly accessible place for rapid consultation by both the operator and the authorised maintenance technician.the operator and the authorised maintenance technician.the operator and the authorised maintenance technician.the operator and the authorised maintenance technician. The operator must regularly clean the machine. Refer to the chapter “Cleaning The operator must regularly clean the machine. Refer to the chapter “Cleaning The operator must regularly clean the machine. Refer to the chapter “Cleaning The operator must regularly clean the machine. Refer to the chapter “Cleaning and Maintenance”. Before carrying out any cleaning or preventive maintand Maintenance”. Before carrying out any cleaning or preventive maintand Maintenance”. Before carrying out any cleaning or preventive maintand Maintenance”. Before carrying out any cleaning or preventive maintenance enance enance enance operation, make sure that the machine is off. operation, make sure that the machine is off. operation, make sure that the machine is off. operation, make sure that the machine is off. The The The The formula technical manual is handed out following a specific course on the technical manual is handed out following a specific course on the technical manual is handed out following a specific course on the technical manual is handed out following a specific course on the machine, or is available on request for authorized technical staff.machine, or is available on request for authorized technical staff.machine, or is available on request for authorized technical staff.machine, or is available on request for authorized technical staff.

NOTES FOR USING THE SCALE FORMULA 2000NOTES FOR USING THE SCALE FORMULA 2000NOTES FOR USING THE SCALE FORMULA 2000NOTES FOR USING THE SCALE FORMULA 2000

The FORMULA The FORMULA The FORMULA The FORMULA 2000 SCALE accessory may be used only on 2000 SCALE accessory may be used only on 2000 SCALE accessory may be used only on 2000 SCALE accessory may be used only on formula 2000 andandandand formula 2000 plus models in standard and domus versions; installation must be models in standard and domus versions; installation must be models in standard and domus versions; installation must be models in standard and domus versions; installation must be carried out by a qualified technician authorised by the manufacturer.carried out by a qualified technician authorised by the manufacturer.carried out by a qualified technician authorised by the manufacturer.carried out by a qualified technician authorised by the manufacturer. The FORMULA 2000 SCALE accessory does not come The FORMULA 2000 SCALE accessory does not come The FORMULA 2000 SCALE accessory does not come The FORMULA 2000 SCALE accessory does not come as standard with as standard with as standard with as standard with compatible models.compatible models.compatible models.compatible models. The FORMULA 2000 SCALE accessory is required only for HDF treatment; it is The FORMULA 2000 SCALE accessory is required only for HDF treatment; it is The FORMULA 2000 SCALE accessory is required only for HDF treatment; it is The FORMULA 2000 SCALE accessory is required only for HDF treatment; it is not required for any of the other treatments. not required for any of the other treatments. not required for any of the other treatments. not required for any of the other treatments.

ENG – Ed. 11/09 chap. 2.1 - Description of machine and components - 1 of 6

2.1 DESCRIPTION OF MACHINE AND COMPONENTS 2.1 DESCRIPTION OF MACHINE AND COMPONENTS 2.1 DESCRIPTION OF MACHINE AND COMPONENTS 2.1 DESCRIPTION OF MACHINE AND COMPONENTS ––––

STANDARD STANDARD STANDARD STANDARD NONNONNONNON----THERAPY MODELS THERAPY MODELS THERAPY MODELS THERAPY MODELS

FRONT VIEWFRONT VIEWFRONT VIEWFRONT VIEW

26

25

24

8

22

4

5 9

6

23

10

7

3

1

2

2 of 6 - chap. 2.1 – Description of machine and components ENG – Ed. 11/09

FRONT PANEL: DESCRIPTION FRONT PANEL: DESCRIPTION FRONT PANEL: DESCRIPTION FRONT PANEL: DESCRIPTION

1111

Pivoting wheelsPivoting wheelsPivoting wheelsPivoting wheels

To easily move the machine. The front wheels are fitted with a braking system. It is recommended to lock the wheels during treatment.

2222

Container baseContainer baseContainer baseContainer base To house the containers of the concentrate solutions and chemicals used for disinfection/cleaning.

3333 Disinfectant connector (yellow)Disinfectant connector (yellow)Disinfectant connector (yellow)Disinfectant connector (yellow)

4444 Acetate/acid concentrate connector (white/red)Acetate/acid concentrate connector (white/red)Acetate/acid concentrate connector (white/red)Acetate/acid concentrate connector (white/red)

5555 Bicarbonate cBicarbonate cBicarbonate cBicarbonate concentrate connector (blue)oncentrate connector (blue)oncentrate connector (blue)oncentrate connector (blue)

6666 Powder bicarbonate cartridge supportsPowder bicarbonate cartridge supportsPowder bicarbonate cartridge supportsPowder bicarbonate cartridge supports Allow the use of the powder bicarbonate cartridge.

7777 Powder bicarbonate cartridge connectorPowder bicarbonate cartridge connectorPowder bicarbonate cartridge connectorPowder bicarbonate cartridge connector

8888 Dialyser fluid outlet connector (red) Dialyser fluid outlet connector (red) Dialyser fluid outlet connector (red) Dialyser fluid outlet connector (red)

To connect the dialysis fluid tube to the dialyser outlet.

9999 Dialyser inlet connector for dialysis fluid (blue)Dialyser inlet connector for dialysis fluid (blue)Dialyser inlet connector for dialysis fluid (blue)Dialyser inlet connector for dialysis fluid (blue) To connect the dialysis fluid tube to the dialyser inlet.

10101010 Dialysis fluid drawing connectorDialysis fluid drawing connectorDialysis fluid drawing connectorDialysis fluid drawing connector

11111111

Electric safety Electric safety Electric safety Electric safety clampclampclampclamp To close the blood line interrupting the blood flow to the patient during an alarm condition.

12121212 Air detectorAir detectorAir detectorAir detector

To detect foam or air bubbles in the venous line. Ultrasound device.

13131313 Blood detectorBlood detectorBlood detectorBlood detector

To detect presence of the line and blood in the arterial line. Infrared-ray device.

14141414

Heparin pumpHeparin pumpHeparin pumpHeparin pump

To administer heparin. 20, 30 and 50 cc syringes can be used. The syringe capacity is set by the operator, while the internal diameter is fixed by the technician during configuration. When the blood pump stops, also the heparin pump interrupts infusion.

15151515

Heparin syringe positioniHeparin syringe positioniHeparin syringe positioniHeparin syringe positioning keysng keysng keysng keys To push the heparin syringe plunger up or down or to automatically load the pump segments.

16161616

Arterial pump flow regulatorArterial pump flow regulatorArterial pump flow regulatorArterial pump flow regulator To change the blood flow. Turn the knob clockwise to increase flow, anticlockwise to decrease it. Set to zero to stop the pump.


33

32

34

12

31

30

18

20

19

14

13

11

31b

27

17

16

29

28

15

21

23b


17171717

Arterial pumpArterial pumpArterial pumpArterial pump

To move blood through the extracorporeal circuit. The pump stops when the cover is opened. In case of power failure, the pump may be manually moved by turning the cranking handle.

18181818 Level Level Level Level detectordetectordetectordetector Optical device to measure the level in the venous chamber.

19191919 LuerLuerLuerLuer----lock connector to measure the arterial pressure (redlock connector to measure the arterial pressure (redlock connector to measure the arterial pressure (redlock connector to measure the arterial pressure (red))))

20202020 LuerLuerLuerLuer----lock connector to measure the venous pressure (blue)lock connector to measure the venous pressure (blue)lock connector to measure the venous pressure (blue)lock connector to measure the venous pressure (blue)

21212121 Clips to fix the blood linesClips to fix the blood linesClips to fix the blood linesClips to fix the blood lines

22222222 DisplayDisplayDisplayDisplay

Colour display.

23232323 I.V. poleI.V. poleI.V. poleI.V. pole

23b23b23b23b I.V. pole hooksI.V. pole hooksI.V. pole hooksI.V. pole hooks

24242424 Expansion chamber supportExpansion chamber supportExpansion chamber supportExpansion chamber support

25252525

Scale Formula 2000 (optional) Scale Formula 2000 (optional) Scale Formula 2000 (optional) Scale Formula 2000 (optional)

To be used only in haemodiafiltration (HDF) for bags containing infusion liquid.

Maximum load: 16 Kg.

26262626 Alarm lamp (red)Alarm lamp (red)Alarm lamp (red)Alarm lamp (red) To indicate an alarm or warning condition by flashing.

27272727

Fixing clipsFixing clipsFixing clipsFixing clips To fix the switching chamber in Single Needle with Double Pump (SNdp) or the infusion chamber.

28282828

Blood/infusion/ultrafiltration pump (formula 2000)Blood/infusion/ultrafiltration pump (formula 2000)Blood/infusion/ultrafiltration pump (formula 2000)Blood/infusion/ultrafiltration pump (formula 2000) To move blood in single needle with double pump. In haemodiafiltration treatments it permits the handling of infusion liquid. The pump stops when the cover is opened. In case of power failure, the pump may be manually moved by turning the cranking handle. The pump is bidirectional.

29292929

Infusion/ultrafiltration pump flow regulator (formula 2000)Infusion/ultrafiltration pump flow regulator (formula 2000)Infusion/ultrafiltration pump flow regulator (formula 2000)Infusion/ultrafiltration pump flow regulator (formula 2000) To change the infusion/ultrafiltration flow. Turn the knob clockwise to increase flow, anticlockwise to decrease it. Set to zero to stop the pump.

30303030 End Infusion detector (formula 2000)End Infusion detector (formula 2000)End Infusion detector (formula 2000)End Infusion detector (formula 2000) Ultrasound device which detects the absence of infusion liquid during haemodiafiltration treatments.

31313131 LuerLuerLuerLuer----lock connector for infusion pressure measurement lock connector for infusion pressure measurement lock connector for infusion pressure measurement lock connector for infusion pressure measurement (formula 200(formula 200(formula 200(formula 2000)0)0)0)

31b31b31b31b Blood leakage detector (formula 2000)Blood leakage detector (formula 2000)Blood leakage detector (formula 2000)Blood leakage detector (formula 2000)

32323232 Natrium (formula plus) (accessory)Natrium (formula plus) (accessory)Natrium (formula plus) (accessory)Natrium (formula plus) (accessory)

33333333 Hemox (formula plus) (accessory)Hemox (formula plus) (accessory)Hemox (formula plus) (accessory)Hemox (formula plus) (accessory)

34343434 Additional pressure transducers: Additional pressure transducers: Additional pressure transducers: Additional pressure transducers: - formula 2000: luer-lock connectors for prefilter arterial pressure transducers

and haemofilter ultrafiltration (in HFR) / auxiliary pressure (other treatments) . - formula:::: luer-lock connector for the prefilter arterial pressure transducer.


REAR PANELREAR PANELREAR PANELREAR PANEL

Fig. 5Fig. 5Fig. 5Fig. 5

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REAR PANEL: DESCRIPTIONREAR PANEL: DESCRIPTIONREAR PANEL: DESCRIPTIONREAR PANEL: DESCRIPTION

1111 Cooling fansCooling fansCooling fansCooling fans

2222 Main switchMain switchMain switchMain switch

3333 Hour counterHour counterHour counterHour counter

4444 Acoustic warning indicatorAcoustic warning indicatorAcoustic warning indicatorAcoustic warning indicator

5555 Battery labelBattery labelBattery labelBattery label Only present on machines equipped with battery.

6666 Identification plateIdentification plateIdentification plateIdentification plate Indicates the serial number and the mains voltage (V).

7777 Connector for external keyboard Connector for external keyboard Connector for external keyboard Connector for external keyboard Only for technicians authorised by the manufacturer.

8888 Connector for heart rate meter Connector for heart rate meter Connector for heart rate meter Connector for heart rate meter ---- Pulsar Pulsar Pulsar Pulsar

9999 Connector for hematocrit and oxygen saturation measuring system Connector for hematocrit and oxygen saturation measuring system Connector for hematocrit and oxygen saturation measuring system Connector for hematocrit and oxygen saturation measuring system ---- HemoxHemoxHemoxHemox

10101010 Connector for serial communication RS 2Connector for serial communication RS 2Connector for serial communication RS 2Connector for serial communication RS 232 C 32 C 32 C 32 C Available for connecting data acquisition systems with formula protocol.

11111111 Tube winding supportsTube winding supportsTube winding supportsTube winding supports To be used to wind the inlet and drain tubes.

12121212 Cable winding supportsCable winding supportsCable winding supportsCable winding supports To be used to wind the power cable.

13131313 Forclean support and protection coveForclean support and protection coveForclean support and protection coveForclean support and protection coverrrr Ultrafilter for dialysis fluid. The protection cover is purposely arranged to avoid contact with the ultrafilter connecting tubes.

Pay extreme attention because the temperature of the liquid Pay extreme attention because the temperature of the liquid Pay extreme attention because the temperature of the liquid Pay extreme attention because the temperature of the liquid circulating in the tubes during certain disinfection/cleaningcirculating in the tubes during certain disinfection/cleaningcirculating in the tubes during certain disinfection/cleaningcirculating in the tubes during certain disinfection/cleaning cycles is cycles is cycles is cycles is very high.very high.very high.very high.

14141414 Multipure filter support Multipure filter support Multipure filter support Multipure filter support Water inlet antibacterial filter.

15151515 Auxiliary socket for external machine power supplyAuxiliary socket for external machine power supplyAuxiliary socket for external machine power supplyAuxiliary socket for external machine power supply (if present) (if present) (if present) (if present) To connect external machines or accessories. At present, no connection is available. Do not remove the cap from its housing.

16161616 Power cablePower cablePower cablePower cable To be connected to the mains; it must be inserted in a suitable wall socket.

17171717 Drain connectorDrain connectorDrain connectorDrain connector

18181818 Water inlet connectorWater inlet connectorWater inlet connectorWater inlet connector

19191919 Sphygmomanometer Sphygmomanometer Sphygmomanometer Sphygmomanometer ---- Sphygmo Sphygmo Sphygmo Sphygmo

20202020 Equipotentiality (if present)Equipotentiality (if present)Equipotentiality (if present)Equipotentiality (if present)


2.2 DESCRIPTION OF MACHINE AND COMPONENTS 2.2 DESCRIPTION OF MACHINE AND COMPONENTS 2.2 DESCRIPTION OF MACHINE AND COMPONENTS 2.2 DESCRIPTION OF MACHINE AND COMPONENTS ––––

THERAPY MODELTHERAPY MODELTHERAPY MODELTHERAPY MODEL,,,, STANDARDSTANDARDSTANDARDSTANDARD VERSION VERSION VERSION VERSION


26

24

8

22

4

5 9

6

23

10

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23b


FRONT PANEL: DESCRIPTION FRONT PANEL: DESCRIPTION FRONT PANEL: DESCRIPTION FRONT PANEL: DESCRIPTION

1111

Pivoting wheelsPivoting wheelsPivoting wheelsPivoting wheels

To easily move the machine. The front wheels are fitted with a braking system. It is recommended to lock the wheels during treatment.

2222

Container baseContainer baseContainer baseContainer base To house the containers of the concentrate solutions and chemicals used for disinfection/cleaning.

3333 Disinfectant connector (yellow)Disinfectant connector (yellow)Disinfectant connector (yellow)Disinfectant connector (yellow)

4444 Acetate/acid concentrate connector (white/red)Acetate/acid concentrate connector (white/red)Acetate/acid concentrate connector (white/red)Acetate/acid concentrate connector (white/red)

5555 Bicarbonate concentrate connector (blue)Bicarbonate concentrate connector (blue)Bicarbonate concentrate connector (blue)Bicarbonate concentrate connector (blue)

6666 Powder bicarbonate cartridge supportsPowder bicarbonate cartridge supportsPowder bicarbonate cartridge supportsPowder bicarbonate cartridge supports Allow the use of the powder bicarbonate cartridge.

7777 Bicarbonate cartridge perforator unitBicarbonate cartridge perforator unitBicarbonate cartridge perforator unitBicarbonate cartridge perforator unit

8888 Dialyser fluid outlet connector (red) Dialyser fluid outlet connector (red) Dialyser fluid outlet connector (red) Dialyser fluid outlet connector (red)

To connect the dialysis fluid tube to the dialyser outlet.

9999 Dialyser inlet connector for dialysis fluid (blue)Dialyser inlet connector for dialysis fluid (blue)Dialyser inlet connector for dialysis fluid (blue)Dialyser inlet connector for dialysis fluid (blue) To connect the dialysis fluid tube to the dialyser inlet.

10101010 Dialysis fluid drawing connectorDialysis fluid drawing connectorDialysis fluid drawing connectorDialysis fluid drawing connector

11111111

Electric safety Electric safety Electric safety Electric safety clampclampclampclamp To close the blood line interrupting the blood flow to the patient during an alarm condition.

12121212 Air detectorAir detectorAir detectorAir detector

To detect foam or air bubbles in the venous line. Ultrasound device.

13131313 Blood detectorBlood detectorBlood detectorBlood detector

To detect presence of the line and blood in the arterial line. Infrared-ray device.

14141414

Heparin pumpHeparin pumpHeparin pumpHeparin pump

To administer heparin. 20, 30 and 50 cc syringes can be used. The syringe capacity is set by the operator, while the internal diameter is fixed by the technician during configuration. When the blood pump stops, also the heparin pump interrupts infusion.

15151515

Heparin syHeparin syHeparin syHeparin syringe positioning keysringe positioning keysringe positioning keysringe positioning keys To push the heparin syringe plunger up or down or to automatically load the pump segments. (see the chapter “PREPARATION OF THE TREATMENT”.

16161616

Arterial pump flow regulatorArterial pump flow regulatorArterial pump flow regulatorArterial pump flow regulator To change the blood flow. Turn the knob clockwise to increase flow, anticlockwise to decrease it. Set to zero to stop the pump. It allows the automatic opening of the clamp (see the chapter “PREPARATION OF THE TREATMENT”).


33

32

34

12

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18

20

19

14

11

31b

27

17

16

29

28

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25

13


17171717

Arterial pumpArterial pumpArterial pumpArterial pump

To move blood through the extracorporeal circuit. The pump stops when the cover is opened. In case of power failure, the pump may be manually moved by turning the cranking handle.

18181818 Level gaugeLevel gaugeLevel gaugeLevel gauge Optical device to measure the level in the venous chamber.

19191919 LuerLuerLuerLuer----lock connector to measure the arterial pressure (red)lock connector to measure the arterial pressure (red)lock connector to measure the arterial pressure (red)lock connector to measure the arterial pressure (red)

20202020 LuerLuerLuerLuer----lock connector to measure the venous pressure (blue)lock connector to measure the venous pressure (blue)lock connector to measure the venous pressure (blue)lock connector to measure the venous pressure (blue)

21212121 Clips to fix the blood lClips to fix the blood lClips to fix the blood lClips to fix the blood linesinesinesines

22222222 DisplayDisplayDisplayDisplay

Colour display.

23232323 I.V. poleI.V. poleI.V. poleI.V. pole

23b23b23b23b I.V. pole hooksI.V. pole hooksI.V. pole hooksI.V. pole hooks

24242424 Expansion chamber supportExpansion chamber supportExpansion chamber supportExpansion chamber support

25252525 Infusion connectorInfusion connectorInfusion connectorInfusion connector Device for connecting infusion line in on-line treatments

WARNING!WARNING!WARNING!WARNING! Opening of the cover must be done only in system ready mode or afteOpening of the cover must be done only in system ready mode or afteOpening of the cover must be done only in system ready mode or afteOpening of the cover must be done only in system ready mode or after r r r having set the priming.having set the priming.having set the priming.having set the priming. Do not under any circumstances open the cover if rinsing or Do not under any circumstances open the cover if rinsing or Do not under any circumstances open the cover if rinsing or Do not under any circumstances open the cover if rinsing or disinfection/cleaning is being performed.disinfection/cleaning is being performed.disinfection/cleaning is being performed.disinfection/cleaning is being performed.

26262626 Alarm lamp (red)Alarm lamp (red)Alarm lamp (red)Alarm lamp (red) To indicate an alarm or warning condition by flashing.

27272727

Fixing clipsFixing clipsFixing clipsFixing clips To fix the switching chamber in Single Needle with Double Pump (SNdp) or the infusion chamber.

28282828

Blood/infusion/ultrafiltration pump Blood/infusion/ultrafiltration pump Blood/infusion/ultrafiltration pump Blood/infusion/ultrafiltration pump To move blood in single needle with double pump. In haemodiafiltration treatments it permits the handling of infusion liquid. The pump stops when the cover is opened. In case of power failure, the pump may be manually moved by turning the cranking handle. The pump is bidirectional.

29292929

Infusion/ultrafiltration pump flow regulator Infusion/ultrafiltration pump flow regulator Infusion/ultrafiltration pump flow regulator Infusion/ultrafiltration pump flow regulator To change the infusion/ultrafiltration flow. Turn the knob clockwise to increase flow, anticlockwise to decrease it. Set to zero to stop the pump.

30303030 EndEndEndEnd----infusion detector infusion detector infusion detector infusion detector Ultrasound device which detects the absence of infusion liquid during haemodiafiltration treatments.

31313131 Pressure transducer Pressure transducer Pressure transducer Pressure transducer

31b31b31b31b Blood leak detectorBlood leak detectorBlood leak detectorBlood leak detector

32323232 NaNaNaNatrium sensortrium sensortrium sensortrium sensor

33333333 Hemox sensor (optional)Hemox sensor (optional)Hemox sensor (optional)Hemox sensor (optional)

34343434 Additional pressure transducers: Additional pressure transducers: Additional pressure transducers: Additional pressure transducers: luer-lock connectors for prefilter arterial pressure transducers and haemofilter ultrafiltration (in HFR) / auxiliary pressure (other treatments) .


REAR PANELREAR PANELREAR PANELREAR PANEL

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REAR PANEL: DESCRIPTIONREAR PANEL: DESCRIPTIONREAR PANEL: DESCRIPTIONREAR PANEL: DESCRIPTION

1111 Cooling fansCooling fansCooling fansCooling fans

2222 Main switchMain switchMain switchMain switch

3333 Hour counterHour counterHour counterHour counter

4444 Acoustic warning indicatorAcoustic warning indicatorAcoustic warning indicatorAcoustic warning indicator

5555 Battery labelBattery labelBattery labelBattery label Only present on machines equipped with battery.

6666 Identification plateIdentification plateIdentification plateIdentification plate Indicates the serial number and the mains voltage (V).

7777 Connector for external keyboardConnector for external keyboardConnector for external keyboardConnector for external keyboard Only for technicians authorised by the manufacturer.

8888 Connector for heart rate meter Connector for heart rate meter Connector for heart rate meter Connector for heart rate meter ---- Pulsar Pulsar Pulsar Pulsar

9999 Connector for hematocrit and oxygen saturation measuring system Connector for hematocrit and oxygen saturation measuring system Connector for hematocrit and oxygen saturation measuring system Connector for hematocrit and oxygen saturation measuring system ---- HemoxHemoxHemoxHemox

10101010 Connector for serial communication RS 232 CConnector for serial communication RS 232 CConnector for serial communication RS 232 CConnector for serial communication RS 232 C Available for connecting data acquisition systems with formula protocol.

11111111 Additional hydraulic protection coverAdditional hydraulic protection coverAdditional hydraulic protection coverAdditional hydraulic protection cover

12121212 Support for Forclean ultrafilters, Forclean ultrafilters and protective Support for Forclean ultrafilters, Forclean ultrafilters and protective Support for Forclean ultrafilters, Forclean ultrafilters and protective Support for Forclean ultrafilters, Forclean ultrafilters and protective covers.covers.covers.covers.

Ultrafilter for dialysis fluid. The protection cover is purposely set-up to avoid contact with the ultrafilter connecting tubes.

Pay careful attention since the temperature of the liquid circulating Pay careful attention since the temperature of the liquid circulating Pay careful attention since the temperature of the liquid circulating Pay careful attention since the temperature of the liquid circulating in the tubes during certain disinfection/descaling cycles is in the tubes during certain disinfection/descaling cycles is in the tubes during certain disinfection/descaling cycles is in the tubes during certain disinfection/descaling cycles is very high.very high.very high.very high.

13131313 Support for Multipure Filter and Multipure FilterSupport for Multipure Filter and Multipure FilterSupport for Multipure Filter and Multipure FilterSupport for Multipure Filter and Multipure Filter Water inlet antibacterial filter.

14141414 Power cablePower cablePower cablePower cable To be connected to the mains; it must be inserted in a suitable wall socket.

15151515 Drain connectorDrain connectorDrain connectorDrain connector

16161616 Water inlet connectorWater inlet connectorWater inlet connectorWater inlet connector

17171717 SphygmomanomeSphygmomanomeSphygmomanomeSphygmomanometer ter ter ter ---- Sphygmo Sphygmo Sphygmo Sphygmo

18181818 Equipotentiality (if present)Equipotentiality (if present)Equipotentiality (if present)Equipotentiality (if present)


2.3 DESCRIPTION OF 2.3 DESCRIPTION OF 2.3 DESCRIPTION OF 2.3 DESCRIPTION OF MACHINEMACHINEMACHINEMACHINE AND COMPONENTS AND COMPONENTS AND COMPONENTS AND COMPONENTS ––––

OPTIONS AND ACCESSORIESOPTIONS AND ACCESSORIESOPTIONS AND ACCESSORIESOPTIONS AND ACCESSORIES

OPTIONS OPTIONS OPTIONS OPTIONS

Single Clamp vs. Double ClampSingle Clamp vs. Double ClampSingle Clamp vs. Double ClampSingle Clamp vs. Double Clamp

SINGLE CLAMPSINGLE CLAMPSINGLE CLAMPSINGLE CLAMP

DOUBLE CLAMPDOUBLE CLAMPDOUBLE CLAMPDOUBLE CLAMP

WARNINGWARNINGWARNINGWARNING Do not introduce the fingers between the clamps during functioning.Do not introduce the fingers between the clamps during functioning.Do not introduce the fingers between the clamps during functioning.Do not introduce the fingers between the clamps during functioning.

ARTERIAL TUBE GUIDE CLIP

ARTERIAL CLAMP

VENOUS CLAMP

VENOUS CLAMP


BIDRY VS. PERBIDRY VS. PERBIDRY VS. PERBIDRY VS. PERFORATION SYSTEMFORATION SYSTEMFORATION SYSTEMFORATION SYSTEM

Bidry CartridgeBidry CartridgeBidry CartridgeBidry Cartridge

PPPPerforation Systemerforation Systemerforation Systemerforation System

NOTENOTENOTENOTE The expression “perforation system” also extends to cases where the powder The expression “perforation system” also extends to cases where the powder The expression “perforation system” also extends to cases where the powder The expression “perforation system” also extends to cases where the powder bicarbonate cartridge used does not require a connection bicarbonate cartridge used does not require a connection bicarbonate cartridge used does not require a connection bicarbonate cartridge used does not require a connection bybybyby perforation. perforation. perforation. perforation. In the machine operator interfaceIn the machine operator interfaceIn the machine operator interfaceIn the machine operator interface the term “bidry” generally refers to the the term “bidry” generally refers to the the term “bidry” generally refers to the the term “bidry” generally refers to the powder bicarbonate cartridge irrespective of the connection system (with powder bicarbonate cartridge irrespective of the connection system (with powder bicarbonate cartridge irrespective of the connection system (with powder bicarbonate cartridge irrespective of the connection system (with hooks or by perforation).hooks or by perforation).hooks or by perforation).hooks or by perforation).

PERFORATION SYSTEM

BIDRY CARTRIDGE SUPPORT HOOKS

BIDRY CARTRIDGE CONNECTOR


IIII.V..V..V..V. POLE SUPPORT POLE SUPPORT POLE SUPPORT POLE SUPPORT

1111 Dialyser holderDialyser holderDialyser holderDialyser holder To hold the dialyser to the IV pole.

2222 Lines fixing clipsLines fixing clipsLines fixing clipsLines fixing clips To hold the blood lines firmly to the dialyser.

3333 Fixing clipFixing clipFixing clipFixing clip To fix the dialyser to the holder

4444 Concentrate bags holderConcentrate bags holderConcentrate bags holderConcentrate bags holder Holding device for positioning of the concentrate bags during treatment.

5555 Bag Bag Bag Bag hookhookhookhook Support device for hanging the bags of physiological solution.

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5


WARNINGWARNINGWARNINGWARNING The concentrate bags holder is suitable for the positioning of two bags, The concentrate bags holder is suitable for the positioning of two bags, The concentrate bags holder is suitable for the positioning of two bags, The concentrate bags holder is suitable for the positioning of two bags, and has a maximum load capacity of 13 kg.and has a maximum load capacity of 13 kg.and has a maximum load capacity of 13 kg.and has a maximum load capacity of 13 kg. To transport or move all formulaTo transport or move all formulaTo transport or move all formulaTo transport or move all formula equipment models, the equipment models, the equipment models, the equipment models, the holder must be left holder must be left holder must be left holder must be left empty.empty.empty.empty.

The holder cannot be installed on the right I.V. pole of the formulaThe holder cannot be installed on the right I.V. pole of the formulaThe holder cannot be installed on the right I.V. pole of the formulaThe holder cannot be installed on the right I.V. pole of the formula Domus Domus Domus Domus version.version.version.version.

The holder cannot be installed at a height aboveThe holder cannot be installed at a height aboveThe holder cannot be installed at a height aboveThe holder cannot be installed at a height above the ultrafiltration/venous the ultrafiltration/venous the ultrafiltration/venous the ultrafiltration/venous pump flow regulator. pump flow regulator. pump flow regulator. pump flow regulator.

WARNINGWARNINGWARNINGWARNING The bag hook has a maximum capacThe bag hook has a maximum capacThe bag hook has a maximum capacThe bag hook has a maximum capacity of 5 kg.ity of 5 kg.ity of 5 kg.ity of 5 kg.


ONBOARD DISINFECTANTONBOARD DISINFECTANTONBOARD DISINFECTANTONBOARD DISINFECTANT

The onboard disinfectant kit has been designed so that the chemical agent can be drawn directly from the container placed at the rear of the machine. The advantages offered by installing the kit are the following: - the container of the chemical agent remains closed and hence no unpleasant fumes

are emitted into the environment - the machine can more easily be moved with the container housed in its rack. The kit can be installed on all formula machines. The kit must be installed by technicians authorised by the manufacturer. The rack can house 5-6-litre containers and has a load-carrying capacity of maximum 15 kg.

WARNINGWARNINGWARNINGWARNING Do not use the container rack in a manner or for uses different from that Do not use the container rack in a manner or for uses different from that Do not use the container rack in a manner or for uses different from that Do not use the container rack in a manner or for uses different from that indicated.indicated.indicated.indicated.

Always check theAlways check theAlways check theAlways check the quantity and the type of chemical agent in the container quantity and the type of chemical agent in the container quantity and the type of chemical agent in the container quantity and the type of chemical agent in the container before starting the disinfection/cleaning.before starting the disinfection/cleaning.before starting the disinfection/cleaning.before starting the disinfection/cleaning.

Do not mix chemical agents with a different composition.Do not mix chemical agents with a different composition.Do not mix chemical agents with a different composition.Do not mix chemical agents with a different composition. For other safety information, consult the chapter concerning disinfection.


INSTRUMENT TABLE INSTRUMENT TABLE INSTRUMENT TABLE INSTRUMENT TABLE

The instrument table has been designed to hold all those devices normally used in the dialysis room, for example, tubes, dialysers, syringes, clamps. The table is divided into two compartments, a deeper one to house the more bulky items, and the other larger but less deep for smaller items. The table can be installed on all the formula

machines. The kit must be installed by technicians authorised by the manufacturer.

CAUTIONCAUTIONCAUTIONCAUTION Small bags can be placed on the table, however, it Small bags can be placed on the table, however, it Small bags can be placed on the table, however, it Small bags can be placed on the table, however, it has a maximum loadhas a maximum loadhas a maximum loadhas a maximum load----carrying capacity of 5 kg.carrying capacity of 5 kg.carrying capacity of 5 kg.carrying capacity of 5 kg. Do not use the Do not use the Do not use the Do not use the tabletabletabletable in a manner or for uses different from that indicated. in a manner or for uses different from that indicated. in a manner or for uses different from that indicated. in a manner or for uses different from that indicated.

During haemodiafiltration do not place the bags containing the infusion fluid During haemodiafiltration do not place the bags containing the infusion fluid During haemodiafiltration do not place the bags containing the infusion fluid During haemodiafiltration do not place the bags containing the infusion fluid on the table.on the table.on the table.on the table.

To transport or move the formulaTo transport or move the formulaTo transport or move the formulaTo transport or move the formula Domus eq Domus eq Domus eq Domus equipment, the instruments table uipment, the instruments table uipment, the instruments table uipment, the instruments table must be left empty.must be left empty.must be left empty.must be left empty. The instrument table must regularly be cleaned with a cloth moistened in a neutral detergent. Use the products indicated in the chapter "Routine Cleaning and Maintenance" of this user manual. The retaining screws can be loosened and the table lifted upwards and removed so that the top cover of the machine can also be cleaned.

ENG – Ed. 11/09 chap. 2.4 - Formula Domus (Home Care System) - 1 of 6

2.4. FORMULA DOMUS (HOME CARE SYSTEM)2.4. FORMULA DOMUS (HOME CARE SYSTEM)2.4. FORMULA DOMUS (HOME CARE SYSTEM)2.4. FORMULA DOMUS (HOME CARE SYSTEM) ---- VERSION FOR VERSION FOR VERSION FOR VERSION FOR

HOME HOME HOME HOME HAEMOHAEMOHAEMOHAEMODIALYSISDIALYSISDIALYSISDIALYSIS

formula Domus Home Care System is particularly suited for use in the home environment as the display, keyboard and flow regulators can be positioned at different heights from the floor with variable inclinations.

WARNINGWARNINGWARNINGWARNING

Carefully read the instructions contained in this user manual before starting Carefully read the instructions contained in this user manual before starting Carefully read the instructions contained in this user manual before starting Carefully read the instructions contained in this user manual before starting the equipment for the first time.the equipment for the first time.the equipment for the first time.the equipment for the first time. NonNonNonNon----conform use, application of procedures conform use, application of procedures conform use, application of procedures conform use, application of procedures different from those indicated, or the use of accessory devicesdifferent from those indicated, or the use of accessory devicesdifferent from those indicated, or the use of accessory devicesdifferent from those indicated, or the use of accessory devices not provided for not provided for not provided for not provided for may present a risk to the patient and/or the machine.may present a risk to the patient and/or the machine.may present a risk to the patient and/or the machine.may present a risk to the patient and/or the machine.

This chapter includes only specific information related to This chapter includes only specific information related to This chapter includes only specific information related to This chapter includes only specific information related to formula Domus, , , , therefore anything which is not expressly mentioned in this chapter remains therefore anything which is not expressly mentioned in this chapter remains therefore anything which is not expressly mentioned in this chapter remains therefore anything which is not expressly mentioned in this chapter remains unchanged relative to the informaunchanged relative to the informaunchanged relative to the informaunchanged relative to the information contained in the tion contained in the tion contained in the tion contained in the formula user user user user manual. manual. manual. manual.

Information and assistance given to the patient during dialytic therapy in home Information and assistance given to the patient during dialytic therapy in home Information and assistance given to the patient during dialytic therapy in home Information and assistance given to the patient during dialytic therapy in home dialysis must take place under the management and supervision of the dialysis must take place under the management and supervision of the dialysis must take place under the management and supervision of the dialysis must take place under the management and supervision of the physician prescribing the treatment. The manufacturer does not physician prescribing the treatment. The manufacturer does not physician prescribing the treatment. The manufacturer does not physician prescribing the treatment. The manufacturer does not undertake any undertake any undertake any undertake any responsibility for teaching the patient how to use responsibility for teaching the patient how to use responsibility for teaching the patient how to use responsibility for teaching the patient how to use formula. Responsibility lies Responsibility lies Responsibility lies Responsibility lies exclusively with the physician in charge.exclusively with the physician in charge.exclusively with the physician in charge.exclusively with the physician in charge.

2 of 6 – chap. 2.4 - Formula Domus (Home Care System) ENG – Ed. 11/09


1 DisplayDisplayDisplayDisplay Colour display with tilting capability, held by the monitor arm.

2

FunctionsFunctionsFunctionsFunctions Indicate the functions which can be activated depending on the machine operating status. Refer to the description in the dedicated chapter in the user manual.

3 Arterial pump flow regulatorArterial pump flow regulatorArterial pump flow regulatorArterial pump flow regulator To change the blood flow. Turn the knob clockwise to increase flow, anticlockwise to decrease it. Set to zero to stop the pump.

4 Infusion/ultrafiltration pump flow regulator Infusion/ultrafiltration pump flow regulator Infusion/ultrafiltration pump flow regulator Infusion/ultrafiltration pump flow regulator (formula 2000)))) To change the infusion/ultrafiltration flow. Turn the knob clockwise to increase flow, anticlockwise to decrease it. Set to zero to stop the pump.

5 Monitor armMonitor armMonitor armMonitor arm

6 Right side I.V. poleRight side I.V. poleRight side I.V. poleRight side I.V. pole To support the monitor arm.


ADJUSTING THE DISPLAYADJUSTING THE DISPLAYADJUSTING THE DISPLAYADJUSTING THE DISPLAY

To adjust the display to the most comfortable viewing angle, proceed as indicated in fig. 1 for the monitor arm version with locking pin knob and to fig. 2 for the monitor arm version without locking pin knob.

fig.1

(1) (2) (3) (4) (1) (2) (3) (4) (1) (2) (3) (4) (1) (2) (3) (4)

(1) monitor arm

(2) locking pin knob

(3) vertical adjustment clamp

(4) friction system

fig.2

(3) (2) (1 (3) (2) (1 (3) (2) (1 (3) (2) (1) ) ) )

(1) monitor arm

(2) vertical adjustment clamp

(3) friction system

• Loosen the screw of the friction system clamp.

• Loosen the screw of the vertical adjustment clamp.

• Adjust the arm to the most comfortable height. Exert pressure on the clamp not on the arm, in order to prevent jamming while moving up or down.

• Tighten the screw of the vertical adjustment clamp.

• Hold the display with one hand and with the other hand pull the locking pin knob outward.

• Adjust to the height and angle needed, then release the locking pin knob.

• Again holding the display with one hand move it down until the arm locks into place.

• Tighten the screw of the friction system clamp enough to allow the arm to swivel.

• Loosen the screw of the friction system clamp.

• Loosen the screw of the vertical adjustment clamp.

• Adjust the arm to the most comfortable height. Exert pressure on the clamp not on the arm, in order to prevent jamming while moving up or down.

• Tighten the screw of the vertical adjustment clamp.

• Hold the display with one hand and with the other hand pull the arm outward.

• Adjust to the height and angle needed, then release the arm.

• Tighten the screw of the friction system clamp enough to allow the arm to swivel.


WAWAWAWARNINGSRNINGSRNINGSRNINGS

To avoid possible harm to the patient, do not perform monitor adjustment To avoid possible harm to the patient, do not perform monitor adjustment To avoid possible harm to the patient, do not perform monitor adjustment To avoid possible harm to the patient, do not perform monitor adjustment during dialysis treatment, but only when the patient is disconnected from the during dialysis treatment, but only when the patient is disconnected from the during dialysis treatment, but only when the patient is disconnected from the during dialysis treatment, but only when the patient is disconnected from the equipment.equipment.equipment.equipment.

The sole function of the monitor arm is to support the display. Therefore:The sole function of the monitor arm is to support the display. Therefore:The sole function of the monitor arm is to support the display. Therefore:The sole function of the monitor arm is to support the display. Therefore:

• Do not useDo not useDo not useDo not use monitor, arm or cable management tube to support bags or any monitor, arm or cable management tube to support bags or any monitor, arm or cable management tube to support bags or any monitor, arm or cable management tube to support bags or any other object or weight.other object or weight.other object or weight.other object or weight.

• Do not lean on and pull the monitor and/or arm when you get up from the Do not lean on and pull the monitor and/or arm when you get up from the Do not lean on and pull the monitor and/or arm when you get up from the Do not lean on and pull the monitor and/or arm when you get up from the bed or the armchair. bed or the armchair. bed or the armchair. bed or the armchair.

• Never push or pull directly on monitor and/or arm to transport or move the Never push or pull directly on monitor and/or arm to transport or move the Never push or pull directly on monitor and/or arm to transport or move the Never push or pull directly on monitor and/or arm to transport or move the eeeequipment.quipment.quipment.quipment.

The manufacturer does not undertake any responsibility for possible damages The manufacturer does not undertake any responsibility for possible damages The manufacturer does not undertake any responsibility for possible damages The manufacturer does not undertake any responsibility for possible damages when these directions are not followed, such as the machine falling over when when these directions are not followed, such as the machine falling over when when these directions are not followed, such as the machine falling over when when these directions are not followed, such as the machine falling over when leaning on the monitor or arm. leaning on the monitor or arm. leaning on the monitor or arm. leaning on the monitor or arm.

Take care not to spill any liquids above the display.Take care not to spill any liquids above the display.Take care not to spill any liquids above the display.Take care not to spill any liquids above the display.

TakeTakeTakeTake care not to rotate the flow regulators accidentally during dialysis. care not to rotate the flow regulators accidentally during dialysis. care not to rotate the flow regulators accidentally during dialysis. care not to rotate the flow regulators accidentally during dialysis.

Do not install the Do not install the Do not install the Do not install the concentrate concentrate concentrate concentrate bagbagbagbagssss holder on the right IV pole. holder on the right IV pole. holder on the right IV pole. holder on the right IV pole.

To move or transport the home haemodialysis system, proceed as follows To move or transport the home haemodialysis system, proceed as follows To move or transport the home haemodialysis system, proceed as follows To move or transport the home haemodialysis system, proceed as follows (refer to fig. (refer to fig. (refer to fig. (refer to fig. 3333):):):):

• lower the monitor arm along tlower the monitor arm along tlower the monitor arm along tlower the monitor arm along the righthe righthe righthe right----side I.V. pole to the lowest position side I.V. pole to the lowest position side I.V. pole to the lowest position side I.V. pole to the lowest position above surface.above surface.above surface.above surface.

• fold the monitor arm in vertical position.fold the monitor arm in vertical position.fold the monitor arm in vertical position.fold the monitor arm in vertical position. • place the display in front of the machine facing onward.place the display in front of the machine facing onward.place the display in front of the machine facing onward.place the display in front of the machine facing onward. To transport or move the equipment, proceed as follows:To transport or move the equipment, proceed as follows:To transport or move the equipment, proceed as follows:To transport or move the equipment, proceed as follows: • push the machine from the back.push the machine from the back.push the machine from the back.push the machine from the back. • leaveleaveleaveleave the instruments table empty, if there is one the instruments table empty, if there is one the instruments table empty, if there is one the instruments table empty, if there is one.... • unload the IV pole hooks and scaleunload the IV pole hooks and scaleunload the IV pole hooks and scaleunload the IV pole hooks and scale.... • unload the concentrate bags holderunload the concentrate bags holderunload the concentrate bags holderunload the concentrate bags holder....


MONITOR ARM WITH LOCKING PIN KNOB MONITOR ARM WITHOUT LOCKING PIN KNOB

fig.3

ENG – Ed. 06/09 chap. 2.5 – Operator Interface - 1 of 28

2.5 OPERATOR INTERFACE2.5 OPERATOR INTERFACE2.5 OPERATOR INTERFACE2.5 OPERATOR INTERFACE

GENERAL GENERAL GENERAL GENERAL

The operator interface consists of a graphic display, a keyboard to the right of the monitor and a series of keys/icons (below the display) to enable specific functions. It is divided into functional areas in which the operating status is shown, both of the dialysis fluid preparation and of the extracorporeal circuit section. The use of ideograms allows graphically reproducing the progress of the main dialysis variables. The on-line guide makes operation easier for the user; the alarm messages and/or warnings displayed on differentiated colour bars help identify the situation and correct it.

1

2

3

410

56789

11

12 13 14

15

lun 08:00

2 of 28 - chap. 2.5 – Operator Interface ENG – Ed. 06/09

1111 Help on lineHelp on lineHelp on lineHelp on line

2222 Side Side Side Side keyskeyskeyskeys To activate the corresponding functions.

3333 Enter keyEnter keyEnter keyEnter key To confirm the selection made.

4444 Arrow keysArrow keysArrow keysArrow keys To increase or decrease the values of the selected parameters. The horizontal keys act on the horizontal graphic tools, whereas the vertical keys act on the vertical graphic tools.

5555 Key to silence the acoustic warning signal Key to silence the acoustic warning signal Key to silence the acoustic warning signal Key to silence the acoustic warning signal To silence the acoustic tone. The silencing period is 2 min. in dialysis and 5 min. in priming.

6666 Key to temporarily disable the alarms Key to temporarily disable the alarms Key to temporarily disable the alarms Key to temporarily disable the alarms Allows an alarm to be silenced. The silencing period is 2 min. in dialysis and 5 min. in priming.

7777 Key to stop the blood pumps Key to stop the blood pumps Key to stop the blood pumps Key to stop the blood pumps To stop the blood pumps. Consequently, the clamp automatically closes and the min. and max. pressure thresholds are recalculated.

8888 Bypass key Bypass key Bypass key Bypass key To isolate the dialyser from the dialysate circuit. Active during dialysis only.

9999 Keys to regulate the level in the venous drip chamberKeys to regulate the level in the venous drip chamberKeys to regulate the level in the venous drip chamberKeys to regulate the level in the venous drip chamber

10101010

Power keyPower keyPower keyPower key Turns on the monitor when the main switch is in the ON position (“I”). Orange LED = indicates that the machine can be turned on. Green LED = indicates that the machine is powered. Red LED = indicates that the mains power supply has been interrupted. This key may not be used to turn off the machine. Flashing orange LED = the back-up battery is functioning.

11111111

Bar to display operating instructions and alarm messagesBar to display operating instructions and alarm messagesBar to display operating instructions and alarm messagesBar to display operating instructions and alarm messages During the operating phases, it displays the message to the operator. It is normally grey. The bar changes colour depending on the operating conditions. It turns - red if an alarm occurs - orange if a warning occurs

- yellow if the key has been pressed.

12121212 Dialysate section status barDialysate section status barDialysate section status barDialysate section status bar Indicates the machine operating status relative to the dialysate fluid section.

13131313 Blood section status barBlood section status barBlood section status barBlood section status bar Indicates the machine operating status relative to the extracorporeal circuit section.

14141414 Clock/Heparin iconClock/Heparin iconClock/Heparin iconClock/Heparin icon Indicates the day of the week and the time expressed in hours and minutes. In dialysis, it turns into the syringe heparin icon which indicates the status of the heparin program.

15151515 FunctionsFunctionsFunctionsFunctions Indicate the functions which can be activated depending on the machine operating status. To activate, press the corresponding key on the keyboard on the side.


NOTENOTENOTENOTE

The LED next to the keys The LED next to the keys The LED next to the keys The LED next to the keys and and and and indicates: indicates: indicates: indicates:

• LED off = function inactive,LED off = function inactive,LED off = function inactive,LED off = function inactive,

• LED on = function active.LED on = function active.LED on = function active.LED on = function active.

The LED next to the keys The LED next to the keys The LED next to the keys The LED next to the keys and and and and indicates: indicates: indicates: indicates:

• LED off = function inactive,LED off = function inactive,LED off = function inactive,LED off = function inactive,

• LED on permanently = function active,LED on permanently = function active,LED on permanently = function active,LED on permanently = function active,

• LED flashing = function activaLED flashing = function activaLED flashing = function activaLED flashing = function activatatatatable.ble.ble.ble. The interface management philosophy is based on the display of windows connected according to a simplified “tree” structure with a “main menu” and few “submenus” , which show the functions dedicated for that operative condition. This means that some functions may be present or absent in relation to the machine status or the selected menu.

Each function is activated through the key next to the function. During dialysis only one window is displayed in which all the variables concerned are shown.

08:00BICARBONATO- PREP. DIALISI AD

ritorna

ok

ricalcoloincorso

infusioneeparina

capacitàsiringa

BICARBONATO- PREP. DIALISI AD

ritorna

ematico

dialisato

lun 08:00

lun 08:00

BICARBONATO- PREP. DIALISI AD

modificatrattamento

modificaparametri

iniziastacco

Menù principale 1°sottomenù 2°sottomenùMain menu First submenu

Second


ONONONON----LINE HELPLINE HELPLINE HELPLINE HELP

The on-line help aids the operator to solve problems and provides information relating to the machine data. The machine operates regardless of the on-line help window being present. The on-line help is active in any treatment mode, as well as in rinsing and

maintenance. to access on-line help. The on-line help is based on priority criteria, i.e. in relation to the machine state

(alarms/warnings present) or profile activation. When is pressed, the information can be viewed in the order here below indicated:

• Once to view the blood section alarm window • Twice to view the dialysate section alarm window • Three times to view the profile window (if enabled) • Four times to view the on-line help window with the general information.

Failing one or more of the above conditions, the next priority information is displayed. For example, if there are no alarms and the profiles are not enabled, the

key needs to be pressed only once to view the on-line help window with the general information.

The on-line help window remains open for about 30 sec.; it disappears when is pressed again or if 30 sec. have elapsed or if the machine state has changed. In case of alarms or warnings, the on-line help window provides information relating to the active alarm or warning. The information may be on one or more pages. Use

the and keys to move from one page to the previous or next. On-line help cannot be activated if a measurement with the sphygmomanometer (Sphygmo) is in progress.


The on-line help window with general information contains a series of function keys which in their turn activate further data windows:

parameters dialysis

To view the data of the treatment in progress. When the patient is disconnected, the data remains stored until the next treatment, i.e. until the beginning of dialysate preparation and blood line priming for the next treatment.

parameters mainten.

to view information on maintenance: last disinfection/cleaning carried out, weekly programming, Multipure and Forclean filters operating hours.

parameters config.

To view a further menu which allows access to the configuration data.

layout blood lines

Function not active at present.

layout dial. side

Function not active at present.

machine parameters

Function that may be accessed only by technicians authorised by the manufacturer.

return

To return to the previous menu.


GRAPHIC TOOLS AND MOGRAPHIC TOOLS AND MOGRAPHIC TOOLS AND MOGRAPHIC TOOLS AND MODIFICATION OF RELEVADIFICATION OF RELEVADIFICATION OF RELEVADIFICATION OF RELEVANT NT NT NT PARAMETERSPARAMETERSPARAMETERSPARAMETERS

The graphic tools displayed during each machine operating phase are immediate and thus allow the operator to read and monitor the main parameters during the entire treatment and to interpret the alarm conditions. Some parameters can only be set during configuration and cannot be modified by the operator. Other parameters may be modified, even during dialysis, by entering the menu

see/mod.parameters

. Selection and modification procedureSelection and modification procedureSelection and modification procedureSelection and modification procedure The selection and/or modification procedure is similar for all the parameters.

• blood

or dialysate

• Select the desired parameter (e.g.

totalcond.

). The graphic tool is highlighted in light blue to indicate that the parameter may be modified.

• Use the arrow keys below the screen to set the new value. The horizontal keys act on the horizontal graphic tools, whereas the vertical keys act on the vertical graphic tools.

• to confirm and make the settings operative both on the dialysate and blood side.

•

return

to return to the main menu and cancel all changes made: the current settings remain active.

Tool coloursTool coloursTool coloursTool colours The background of the graphic tools can take on different colours according to the machine status or the mode of use of the variable displayed:

• Red colour: the equipment is in a state of alarm due to the value taken by the variable being displayed.

• Orange colour: the variable being displayed is at the limit of the set or acceptable range.

• Green colour: the variable being displayed holds a value that is automatically set by the equipment.

• Light blue colour: the variable being displayed can be modified. • White colour: in all other cases.


DIALYSISDIALYSISDIALYSISDIALYSIS FLUIDFLUIDFLUIDFLUID SECTIONSECTIONSECTIONSECTION

TEMPERATURETEMPERATURETEMPERATURETEMPERATURE

The tool indicates: - the alarm limits for the dialysis fluid temperature (graduated scale) - the current value (mobile index) All the values are expressed in °C.

To modify the temperature value set,

see/mod.parameters

dialysate

otherparameters

temperature

The mobile index indicates the value set, the window indicates the current value.

Press or to obtain the new value (intervals of 0.5°C) and

confirm with .

When the modification has been acquired, the display returns to the main menu.

BICARBONATE CONDUCTIVITYBICARBONATE CONDUCTIVITYBICARBONATE CONDUCTIVITYBICARBONATE CONDUCTIVITY

During dialysis the tool indicates the conductivity read by the partial conductivity probe (first step) (in mS/cm).

To modify the conductivity value set,

see/mod.parameters

dialysate

bic.cond.

CONDBIC 2.4 3.6

3.1

The mobile index shows the value set, the ends of the scale show the min. and max. settable values with reference to the concentrates used (3-5 mS/cm).


Use the or key to obtain the new value and confirm with . When the modification has been acquired, the display returns to the main menu.

TOTAL CONDUCTIVITYTOTAL CONDUCTIVITYTOTAL CONDUCTIVITYTOTAL CONDUCTIVITY

During dialysis the tool indicates the dialysis fluid conductivity read by the probe at the machine outlet (in mS/cm).

To modify the conductivity value set,

see/mod.parameters

dialysate

totalcond.

.

C O N D T O T 1 2 . 1 1 5 . 7

1 4 . 0

The mobile index indicates the value set, the ends of the scale show the min. and max. settable values (mS/cm).

Use the or key to obtain the new value and confirm with . When the modification has been acquired, the display returns to the main menu.

UF/UF/UF/UF/RATERATERATERATE

During dialysis the tool indicates the UF set (set independently or obtained from the ratio between the weight to lose and the treatment time ) (in kg/h) .

To modify the UF value set,

see/mod.parameters

dialysate

ufrate

UF/h0.10 4. 0

1.00

0

The mobile index indicates the value set, the ends of the scale show the min. and max. values set in configuration (kg/h).

Use the or key to obtain the new value and confirm with . During dialysis the instrument becomes orange if: - - the UF setting corresponds to the extreme pre-set values - the UF value does not correspond to the ratio between weight loss and treatment

time settings. When the modification has been acquired, the display returns to the main menu.


PATIENT WEIGHT LOSSPATIENT WEIGHT LOSSPATIENT WEIGHT LOSSPATIENT WEIGHT LOSS

0.00

4.00

1.33

2.67

Peso kg

The graduated scale indicates the weight loss set (or weight to lose), the mobile index displays the weight lost (in kg).

To modify the total weight loss set,

see/mod.parameters

dialysate

weightloss

.

0 . 0 0

1 6 . 0 0

3 . 3 3

6 . 6 6

Peso kg

The graduated scale indicates the max. settable total weight loss (16.0 kg), the mobile index indicates the total weight loss set, the window indicates the current value.

Press the keys or to obtain the new value and then

confirm with . When the modification has been acquired, the display returns to the main menu.

NOTENOTENOTENOTE Check that the UF/h value obtained is coherent with the modified values set.Check that the UF/h value obtained is coherent with the modified values set.Check that the UF/h value obtained is coherent with the modified values set.Check that the UF/h value obtained is coherent with the modified values set.


TREATMENT TIMETREATMENT TIMETREATMENT TIMETREATMENT TIME

4:00 00:00

During dialysis the tool indicates: - the total duration of the treatment (4:00) in hh:mm - the time elapsed from the start of treatment (the circled

tool colors clockwise) or - the countdown time to the end of the treatment (the

circled tool empties counterclockwise) The displayed value depends on the value set in configuration. The treatment time is expressed in hh:mm. The flashing circle indicates that the ultrafiltration program is running. To modify the treatment time set,

see/mod.parameters

dialysate

treat. time

10:00 00:00

The tool indicates: the max. treatment time (10:00) in hh:mm - the time set for the treatment in progress (04:00 hh:mm),

inside the tool, - the treatment time performed or the residual treatment

time (in hh:mm). The displayed value depends on the value set in configuration.

Use the or key to obtain the new value and

confirm with . When the modification has been acquired, the display returns to the main menu.

NOTENOTENOTENOTE It is not possible to set a treatment time less than the time already reached.It is not possible to set a treatment time less than the time already reached.It is not possible to set a treatment time less than the time already reached.It is not possible to set a treatment time less than the time already reached. Check that the UF/h value obtained is coherent with the modified values set.Check that the UF/h value obtained is coherent with the modified values set.Check that the UF/h value obtained is coherent with the modified values set.Check that the UF/h value obtained is coherent with the modified values set.

During dialysis

see/mod.parameters

and

dialysate

to display the totalized treatment time below the tool.

01:00

01:0001:0001:0001:00


ULTRAFILTRATION or TMP PRESSUREULTRAFILTRATION or TMP PRESSUREULTRAFILTRATION or TMP PRESSUREULTRAFILTRATION or TMP PRESSURE

During dialysis the tool indicates the ultrafiltration pressure the ultrafiltration pressure the ultrafiltration pressure the ultrafiltration pressure (P_UF (P_UF (P_UF (P_UF in mmHg) or the transmembrane pressure (TMP ) or the transmembrane pressure (TMP ) or the transmembrane pressure (TMP ) or the transmembrane pressure (TMP in mmHg),),),), depending on the set configuration. The mobile index indicates the current value, the ends of the scale indicate the min. and max. alarm thresholds (fixed during configuration, not modifiable during treatment). The thresholds of the max (H) and min (L) alarms are displayed, as well. These thresholds are automatically calculated on the basis of the average ultrafiltration pressure (or TMP) ± the set range value (settable between 30 and 300 mmHg). To modify this value:

see/mod.parameters

dialysate

otherparameters

range TMP/P_UF

.

Use the or key to obtain the new value and confirm

with .

The transmembrane pressure is obtained from the following relation:

Single NeedleSingle NeedleSingle NeedleSingle Needle:

TMP = (Max Switch. P + Min. Switch. P) /2 – (Pd out + 30 mmHg)

Other treatments:

TMP = Pv – (Pd out + 30 mmHg)

where: VP = venous pressure Pd out = dialysate pressure measured at the dialyser outlet Switch. Pres. = switching pressure in single needle 30 mmHg = load loss of the dialysate compartment. In the event of alarm with bypass: TMP = 0

To recalculate the min. and max. ultrafiltration pressure (or TMP) alarm thresholds,

- 3 0 0

2 0 0

-

P_UF mmHg


see/mod.parameters

see other parameters

recalcul. TMP/P_UF on

.

NOTENOTENOTENOTE The recalculation of the average ultrafiltration pressure (or TMP) is also The recalculation of the average ultrafiltration pressure (or TMP) is also The recalculation of the average ultrafiltration pressure (or TMP) is also The recalculation of the average ultrafiltration pressure (or TMP) is also enabled when:enabled when:enabled when:enabled when: ---- the ultrafiltration time is modified (even by changing the weight loss or the the ultrafiltration time is modified (even by changing the weight loss or the the ultrafiltration time is modified (even by changing the weight loss or the the ultrafiltration time is modified (even by changing the weight loss or the treatment time)treatment time)treatment time)treatment time) ---- isolated ultrafiltration is enabled (or disabled) isolated ultrafiltration is enabled (or disabled) isolated ultrafiltration is enabled (or disabled) isolated ultrafiltration is enabled (or disabled) ---- minimum ultrafiltration is enabled (or disabled) minimum ultrafiltration is enabled (or disabled) minimum ultrafiltration is enabled (or disabled) minimum ultrafiltration is enabled (or disabled) ---- an infusion bolus is enabled (or ends) an infusion bolus is enabled (or ends) an infusion bolus is enabled (or ends) an infusion bolus is enabled (or ends) ---- the TMP (or P_UF) range is modified the TMP (or P_UF) range is modified the TMP (or P_UF) range is modified the TMP (or P_UF) range is modified ---- the infusion flow is modified (in PHF PRE, PHF POST, HDF PRE, HDF POST the infusion flow is modified (in PHF PRE, PHF POST, HDF PRE, HDF POST the infusion flow is modified (in PHF PRE, PHF POST, HDF PRE, HDF POST the infusion flow is modified (in PHF PRE, PHF POST, HDF PRE, HDF POST, , , , MIDMIDMIDMID----HDF, HDF)HDF, HDF)HDF, HDF)HDF, HDF) manually or automatically with variation of the infusion manually or automatically with variation of the infusion manually or automatically with variation of the infusion manually or automatically with variation of the infusion flowflowflowflow....

---- the the the the or or or or or or or or key is pressed. key is pressed. key is pressed. key is pressed.

AVERAGAVERAGAVERAGAVERAGE TMP AND WORKING TMP E TMP AND WORKING TMP E TMP AND WORKING TMP E TMP AND WORKING TMP

If automatic control of the infusion flow is enabled in online-haemodiafiltration, the tool displays the average TMP measured and the working TMP set for automatic control.

The average TMP is obtained from the following relations:

TreatmentTreatmentTreatmentTreatment Formula for TMP calculationFormula for TMP calculationFormula for TMP calculationFormula for TMP calculation

HDF PRE HDF POST MID HDF

( )302

+−+

= doutvfilt P

PPTMP

PHF PRE ( ) ( )30

2+−

+∆−= dout

vefilt PPPP

TMP

PHF POST ( ) ( )302

+−∆++

= doutevfilt P

PPPTMP

where Pfilt indicates the prefilter arterial pressure, Pv the venous pressure, Pdout the dialysate measured at the dialyser outlet and ∆Pe the pressure drop on the blood filter of the dual chamber filter (20 mmHg). To modify the working TMP:

see/mod.parameters

blood

set TMP

.

Press the or keys to set the new value and then confirm with .


DIALYSIS FLUID FLOWDIALYSIS FLUID FLOWDIALYSIS FLUID FLOWDIALYSIS FLUID FLOW The dialysis fluid flow is measured on the haemodialysis water before mixing with the concentrates. Its value, which does not appear on the main page during dialysis, may be displayed and/or modified by activating the following functions:

see/mod.parameters

dialysate

otherparameters

flow

.

Flow

The tool indicates:

• the selectable flows in the boxes (ml/min) • the current flow at the far right (ml/min)

(502) • the set flow (blue box)

Use the or key to obtain the new value and confirm with . The reading of the flow rate just set requires at least 1 min. When the modification has been acquired, the display returns to the main menu.

NOTE NOTE NOTE NOTE Initially, the dialysis fluid is prepared at a minimum flow. Initially, the dialysis fluid is prepared at a minimum flow. Initially, the dialysis fluid is prepared at a minimum flow. Initially, the dialysis fluid is prepared at a minimum flow. As soon as blood is detected, the flow ratAs soon as blood is detected, the flow ratAs soon as blood is detected, the flow ratAs soon as blood is detected, the flow rate automatically adjusts to the set e automatically adjusts to the set e automatically adjusts to the set e automatically adjusts to the set value.value.value.value.

NOTE NOTE NOTE NOTE FFFFor treatments with OnLine Haemodiafiltration:or treatments with OnLine Haemodiafiltration:or treatments with OnLine Haemodiafiltration:or treatments with OnLine Haemodiafiltration: HDF PRE, HDF POST, HDF PRE, HDF POST, HDF PRE, HDF POST, HDF PRE, HDF POST, MIDMIDMIDMID----HDF, PHF PRE, PHF POSTHDF, PHF PRE, PHF POSTHDF, PHF PRE, PHF POSTHDF, PHF PRE, PHF POST.... If the dialysis fluid flow is set at 800 ml/min, the flow that is actually sent to If the dialysis fluid flow is set at 800 ml/min, the flow that is actually sent to If the dialysis fluid flow is set at 800 ml/min, the flow that is actually sent to If the dialysis fluid flow is set at 800 ml/min, the flow that is actually sent to the dialyser does not correthe dialyser does not correthe dialyser does not correthe dialyser does not correspond to the set value, but is equal to the set spond to the set value, but is equal to the set spond to the set value, but is equal to the set spond to the set value, but is equal to the set value minus the infusion flow.value minus the infusion flow.value minus the infusion flow.value minus the infusion flow. If the dialysis fluid flow is set at 500 ml/min and the infusion flow is set at If the dialysis fluid flow is set at 500 ml/min and the infusion flow is set at If the dialysis fluid flow is set at 500 ml/min and the infusion flow is set at If the dialysis fluid flow is set at 500 ml/min and the infusion flow is set at less than 18 kg/hr, the inlet flow to the dialyser coincides with the set value; less than 18 kg/hr, the inlet flow to the dialyser coincides with the set value; less than 18 kg/hr, the inlet flow to the dialyser coincides with the set value; less than 18 kg/hr, the inlet flow to the dialyser coincides with the set value; if, however, theif, however, theif, however, theif, however, the infusion flow exceeds 18 kg/hr, the inlet flow to the dialyser infusion flow exceeds 18 kg/hr, the inlet flow to the dialyser infusion flow exceeds 18 kg/hr, the inlet flow to the dialyser infusion flow exceeds 18 kg/hr, the inlet flow to the dialyser is equal to the maximum value (800 ml/min) minus the infusion flow.is equal to the maximum value (800 ml/min) minus the infusion flow.is equal to the maximum value (800 ml/min) minus the infusion flow.is equal to the maximum value (800 ml/min) minus the infusion flow. If the dialysis fluid flow is set at 300 ml/min, the inlet flow to the dialyser If the dialysis fluid flow is set at 300 ml/min, the inlet flow to the dialyser If the dialysis fluid flow is set at 300 ml/min, the inlet flow to the dialyser If the dialysis fluid flow is set at 300 ml/min, the inlet flow to the dialyser coincides with the set value.coincides with the set value.coincides with the set value.coincides with the set value.

INFUSION BOLINFUSION BOLINFUSION BOLINFUSION BOLUSUSUSUS Boluses of dialysis fluid can be infused at any time in a dialysis session, during haemodiafiltration treatments. To infuse a bolus,

see/mod.parameters

dialysate

otherparameters

Infusion bolus


and set the amount to be infused with the or keys.

The total amount of boluses infused during treatment is displayed on the monitor, on the first page.

NOTENOTENOTENOTE When an infusion bolus is enabled, any Kt/V measurement in progress will be aborted.


BLOODBLOODBLOODBLOOD SECTIONSECTIONSECTIONSECTION

BLOOD FLOWBLOOD FLOWBLOOD FLOWBLOOD FLOW

The graphic tool indicates the blood flow set (settable between 20 and 700 ml/min).

To modify this value, turn the flow regulator - clockwise to increase, - anticlockwise to decrease. In the case of an increase in blood flow or when there is a re-start after the pumps are stopped, the flow is gradually increased (ramp trend) to the set value. To display also the real blood flow,

see/mod.parameters


The graphic tool indicates the set and the real blood flows. The latter may differ from the set flow for the following reasons:

• the machine status does not allow the operator to set the arterial pump flow (i.e. priming phase in HFR).

• the flow is recalculated on the basis of the measured arterial pressure, when pressure is below –100 mmHg.


INFUSION FLOWINFUSION FLOWINFUSION FLOWINFUSION FLOW

Qinf 3.00 kg/h

The graphic tool indicates the infusion flow set (settable

between 0 and 8 l/h in HDF and HFR, between 0 and 21

kg/hr in On Line Haemodiafiltration).

To change the value, turn the blue flow regulator

- clockwise to increase,

- anticlockwise to decrease.

In HFR, the graphic tool displays the UF/infusion flow set

(settable between 0 and 8 L/hr). If automatic control of

the UF/infusion (HFR Evolution) flow is enabled, the tool

background is green and the displayed value is that

automatically set by the machine.

In online haemodiafiltration, if automatic control of the

infusion flow based on the TMP is enabled, the tool

background is green and the value displayed is that set

automatically by the machine.

see/mod.parameters

blood

to display the tool with the maximum and minimum limits of automatic infusion flow setting.

VENOUS PRESSURE VENOUS PRESSURE VENOUS PRESSURE VENOUS PRESSURE

The graduated scale indicates the absolute min. and max. limits (not modifiable by the operatornot modifiable by the operatornot modifiable by the operatornot modifiable by the operator) relative to the out-of-range alarm. For the limit values refer to the Chapter “TECHNICAL CHARACTERISTICS”. The mobile index indicates the actual pressure read in the venous drip chamber (mmHg).


The max. (H) and min. (L) alarm thresholds are displayed in dialysis and in reinfusion only in DN, HDF, HDF PRE, HDF POST, MID-HDF, PHF PRE, PHF POST, HFR. These values are automatically calculated on the basis of the mean venous pressure (Pvm) ± the pressure value set during configuration (between 50 and 150 mmHg).

ARTERIAL PRESSURE ARTERIAL PRESSURE ARTERIAL PRESSURE ARTERIAL PRESSURE

The graduated scale indicates the min. and max. limits relative

to the out-of-range alarm, not modifiable by the operatornot modifiable by the operatornot modifiable by the operatornot modifiable by the operator.... For the limit values refer to the Chapter “TECHNICAL CHARACTERISTICS”. The mobile index indicates the pressure read before the arterial pump (mmHg).

-300

200

-150

The max. (H) and min. (L) alarm thresholds are displayed only only only only during dialysis.during dialysis.during dialysis.during dialysis. These thresholds are automatically calculated on the basis of the mean arterial pressure (PAm) ± the pressure value set during configuration (between 50 and 250 mmHg).

To recalculate the min. and max. alarm thresholds of the venous/arterial pressure,

see/mod.parameters

blood

recalcul. on

.

NOTENOTENOTENOTE Recalculation of the mean arterial and venous pressure is activated also Recalculation of the mean arterial and venous pressure is activated also Recalculation of the mean arterial and venous pressure is activated also Recalculation of the mean arterial and venous pressure is activated also whenwhenwhenwhen ---- the blood flow is modified or the blood flow is modified or the blood flow is modified or the blood flow is modified or ---- an infusion bolus is enabled (or ends) or an infusion bolus is enabled (or ends) or an infusion bolus is enabled (or ends) or an infusion bolus is enabled (or ends) or

---- the the the the or or or or key is pressed. key is pressed. key is pressed. key is pressed.

Pa mmHg


PREFILTER ARTERIAL PRESSURE AND AUXILIARY/TMPH PRESSUREPREFILTER ARTERIAL PRESSURE AND AUXILIARY/TMPH PRESSUREPREFILTER ARTERIAL PRESSURE AND AUXILIARY/TMPH PRESSUREPREFILTER ARTERIAL PRESSURE AND AUXILIARY/TMPH PRESSURE

To display the prefilter arterial pressure and the auxiliary pressure,

see/mod.parameters


The graphic tool indicates the prefilter arterial pressure (left) and the auxiliary pressure (right).

In HFR, the prefilter arterial pressure (Pfilt) and blood filter transmembrane pressure (TMPH) are visualized:

The tool displays the prefilter arterial pressure next to the hemofilter transmembrane pressure. The latter is calculated as difference between the prefilter arterial pressure and the ultrafiltration pressure (before the infusion pump).

SWITCHING PRESSURSWITCHING PRESSURSWITCHING PRESSURSWITCHING PRESSURE (in Single Needle)E (in Single Needle)E (in Single Needle)E (in Single Needle)

The graduated scale gives the min. and max. limits in relation

to the out of range alarm, not modifiable by the operatornot modifiable by the operatornot modifiable by the operatornot modifiable by the operator, which are different depending on whether the equipment is in priming, dialysis or reinfusion. For the limit values refer to the Chapter “TECHNICAL CHARACTERISTICS”. The mobile index indicates the pressure read in the venous drip chamber (mmHg).

The max. and min. alarm thresholds (modifiable by the operator) are displayed only during dialysis in single only during dialysis in single only during dialysis in single only during dialysis in single needle single pump (SNsp).needle single pump (SNsp).needle single pump (SNsp).needle single pump (SNsp).

see/mod.parameters

blood

max switch. p.

or

min switch. p.

Then use or key to obtain the new value and

confirm with . The switching pressure ranges are : max: +200 / +400 mmHg min: +10 / +200 mmHg


END PRIMINGEND PRIMINGEND PRIMINGEND PRIMING The tool indicates the stop priming and end priming values (in litres). Both values are set during configuration of the machine.

End primingEnd primingEnd primingEnd priming = total volume of fluid to use for priming. Stop primingStop primingStop primingStop priming = volume of fluid to be circulated in the blood lines before the pump stops.

0.00 3.00

1.50

2.00End

Priming

- End priming (3.00) is indicated (in litres) on the graduated scale.

- Inside the tool the quantity of physiological solution which still needs to be circulated (2.00) is indicated.

- The mobile index indicates the stop priming value (in litres), obtained from the difference between the end priming and stop priming set. (1.50).

- If the stop priming has not been set, the mobile index is set to 0.

To modify the stop priming and/or end priming values set,

see/mod. parameters

blood

stop priming

or

priming volume

EndPriming

The upper mobile index indicates the stop priming (StopP) value (in l) set. The lower mobile index indicates the end priming (VolP) value (in l) set. The graduated scale indicates the min. (0.00) and max. value (7.00) which can be set (in L).

Use the or keys to obtain the new value and confirm with . When the modification has been acquired, the display returns to the main menu.

NOTENOTENOTENOTE The Stop Priming and/or End Priming values may be modified provided that The Stop Priming and/or End Priming values may be modified provided that The Stop Priming and/or End Priming values may be modified provided that The Stop Priming and/or End Priming values may be modified provided that the new value set is not less than the total remaining physiological solution.the new value set is not less than the total remaining physiological solution.the new value set is not less than the total remaining physiological solution.the new value set is not less than the total remaining physiological solution. The Stop Priming may not be greater than the End Priming value. The Stop Priming may not be greater than the End Priming value. The Stop Priming may not be greater than the End Priming value. The Stop Priming may not be greater than the End Priming value.

NOTENOTENOTENOTE Following a treatment change, if the treatment selected is an online or an Following a treatment change, if the treatment selected is an online or an Following a treatment change, if the treatment selected is an online or an Following a treatment change, if the treatment selected is an online or an HFR treatment, the total priming volume is reset.HFR treatment, the total priming volume is reset.HFR treatment, the total priming volume is reset.HFR treatment, the total priming volume is reset.


BLOOD VOLUMEBLOOD VOLUMEBLOOD VOLUMEBLOOD VOLUME The volume of blood treated, i.e. the volume circulating in the arterial line (in L) is displayed on the second page. To display it,

see/mod. parameters


.

Counting starts only when blood is detected (therefore not in priming).

In Single Needle the volume of treated blood depends on the set stroke volume.

STROKE (ONLY IN SINGLE NEEDLE)STROKE (ONLY IN SINGLE NEEDLE)STROKE (ONLY IN SINGLE NEEDLE)STROKE (ONLY IN SINGLE NEEDLE)

In priming and dialysis it indicates the blood volume circulated during the cycle (ml). The setting range is fixed during configuration: Minimum (10 - 50 ml) Maximum (30 - 100 ml). The operating values can however be modified by the operator provided the allowed range is not exceeded.

To change the set stroke,

see/mod. parameters

blood

stroke

The mobile index indicates the stroke value (in ml) set. The graduated scale indicates the min. (10) and max. value (50) set during configuration (in ml).

Use the or keys to obtain the new value and confirm with . When the modification has been acquired, the display returns to the main menu.


QBM (ONLY IN SINGLE NEEDLE)QBM (ONLY IN SINGLE NEEDLE)QBM (ONLY IN SINGLE NEEDLE)QBM (ONLY IN SINGLE NEEDLE)

Indicates the mean blood flow during the whole cycle (ml/min). Such blood flow is obtained by the following relation :

Qb x art. phase duration. / (art. phase duration. +

ven. phase duration).

In single needle with double pump, the tool has a

green background to indicate that this flow is

regulated by the equipment following an

optimization algorithm.

ARTERIAL PRESSURE DISPLAY IN SINGLEARTERIAL PRESSURE DISPLAY IN SINGLEARTERIAL PRESSURE DISPLAY IN SINGLEARTERIAL PRESSURE DISPLAY IN SINGLE----NEEDLE WITH DOUBLE PUMPNEEDLE WITH DOUBLE PUMPNEEDLE WITH DOUBLE PUMPNEEDLE WITH DOUBLE PUMP

In Single Needle with double pump, if the double clamp is present, the arterial pressure is displayed on the first page in place of the switching pressure.

see/mod. parameters

blood

to view/modify the switching pressure.

see/mod. parameters


to view:

- the real-time measured switching pressure,

- the instantaneous arterial pressure

ARTERIAL PRESSURE DISPLAY IN SINGLE NEEDLE WITH SINGLE PUMPARTERIAL PRESSURE DISPLAY IN SINGLE NEEDLE WITH SINGLE PUMPARTERIAL PRESSURE DISPLAY IN SINGLE NEEDLE WITH SINGLE PUMPARTERIAL PRESSURE DISPLAY IN SINGLE NEEDLE WITH SINGLE PUMP In Single Needle with single pump, if the double clamp is present, the arterial pressure is displayed next to the switching pressure on the first page.

see/mod. parameters


to view the instantaneous pressure with the tool

.

LOWER SWITCHING PRESSURE THRESHOLD (min. switch. p.) (in SINGLE LOWER SWITCHING PRESSURE THRESHOLD (min. switch. p.) (in SINGLE LOWER SWITCHING PRESSURE THRESHOLD (min. switch. p.) (in SINGLE LOWER SWITCHING PRESSURE THRESHOLD (min. switch. p.) (in SINGLE NEEDLE WITH DOUBLE PUMP)NEEDLE WITH DOUBLE PUMP)NEEDLE WITH DOUBLE PUMP)NEEDLE WITH DOUBLE PUMP)

The lower switching pressure threshold makes it possible to manage the blood pressure in the dialyser, to improve its effectiveness using transmembrane pressure. Therefore the min. switching pressure set by the operator is not actually the minimum switching pressure, but the threshold needed for the algorithm to detect when the automatic switching pressure reduction mechanism must stop. The range set is +100 / -100 mmHg. It is advisable to set a value between + 10 and +50 mmHg.


To set the min switch. p. value:

see/mod. parameters

blood

min switch. p.

In Single Needle with double pump the upper switching pressure threshold is automatically set by the machine starting with an initial value of +450mmHg (+200mmHg as long as the dialysate connectors are NOT connected to the dialyser) which is progressively decreased of 20 mmHg each cycle until reaching a value corresponding to the minimum switching pressure + the equivalent pressure of the set stroke. This operation requires a certain number of cycles before reaching normal operation.

UPPER VENOUS PRESSURE THRESHOLD (max ven. p.) in SINGLE NEEDLE WITH UPPER VENOUS PRESSURE THRESHOLD (max ven. p.) in SINGLE NEEDLE WITH UPPER VENOUS PRESSURE THRESHOLD (max ven. p.) in SINGLE NEEDLE WITH UPPER VENOUS PRESSURE THRESHOLD (max ven. p.) in SINGLE NEEDLE WITH DOUBLE PUMPDOUBLE PUMPDOUBLE PUMPDOUBLE PUMP

This is the maximum venous pressure value allowed during treatment. The range set is +100 / +400 mmHg. To set the max venous pressure value:

see/mod. parameters

blood

max switch. p.

ARTERIAL BLOOD FLOW (QbA) AND VENOUS BLOOD FLOW (QbV)ARTERIAL BLOOD FLOW (QbA) AND VENOUS BLOOD FLOW (QbV)ARTERIAL BLOOD FLOW (QbA) AND VENOUS BLOOD FLOW (QbV)ARTERIAL BLOOD FLOW (QbA) AND VENOUS BLOOD FLOW (QbV) In Single Needle Double Pump the arterial flow regulator (red knob) regulates the delivery of both the arterial and venous pumps. Therefore the blue flow regulator is not used. In priming the delivery of the venous pump is equal to 1.1 of the delivery set for the arterial pump (so if QbA is set at 300 ml/min, QbV will be 330 ml/min). In dialysis on the contrary , the delivery of the venous pump can be between 1.1 and 1.5 of the delivery set for the arterial pump. The speed of the venous pump gradually increases until the threshold set for upper venous pressure (max ven. p.) has been reached: this means that the delivery of the venous pump will automatically regulate so that the average blood flow (Qbm) is optimised in conformity with the set max. venous pressure.

The arterial blood flow is displayed on the screen during priming and dialysis: the set range is 20 - 700 ml/min during priming and dialysis 20 - 250 ml/min during rinseback

To display the venous blood flow:

see/mod. parameters


.

The tool indicating the venous blood flow in ml/min is displayed on the right


NOTENOTENOTENOTE The delivery of the venous pump cannot exceed 1.5 times the delivery of the The delivery of the venous pump cannot exceed 1.5 times the delivery of the The delivery of the venous pump cannot exceed 1.5 times the delivery of the The delivery of the venous pump cannot exceed 1.5 times the delivery of the arterial pump and cannot exceed the indicated limits.arterial pump and cannot exceed the indicated limits.arterial pump and cannot exceed the indicated limits.arterial pump and cannot exceed the indicated limits. Data for expected blood flow recirculation in the extracorporeal circuit are available upon request.

EFFICIENCY (in SINGLE NEEDLE)EFFICIENCY (in SINGLE NEEDLE)EFFICIENCY (in SINGLE NEEDLE)EFFICIENCY (in SINGLE NEEDLE) Efficiency is calculated as follows:

efficiency = number of venous pump revs number of arterial pump revs

The range of allowed efficiency values is set during configuration and can be changed during treatment; when this range is exceeded, a warning is generated. To modify the range:

see/mod. parameters

blood

efficiency max

or

see/mod. parameters

blood

efficiency min

or to obtain the new value and then confirm with .

Efficiency is an excellent indication of the negative suction pressure. Because the actual delivery of a pump starts to decrease when the negative suction pressure falls below a certain limit (based on the type of pump and the section), the ratio between the venous pump revs and arterial pump revs provides a good approximate indication of the negative inlet pressure (e.g. setting a minimum efficiency equal to 0.7, the warning is generated for negative suction pressures of approximately -400 mmHg).

Efficiency is displayed on a specific instrument during dialysis

To display it,


see/mod. parameters


.

VOLUME OF LIQUID INFUSEDVOLUME OF LIQUID INFUSEDVOLUME OF LIQUID INFUSEDVOLUME OF LIQUID INFUSED The volume of infused fluid (in kg) in haemodiafiltration treatments (HDR, HFR, OnLine HDF, PHF) is displayed on the second page. To display it,

see/mod. parameters


.

Tool displayed in patient rinseback with ultrapure dialysis fluid. Counting starts when going into rinseback. Tool displayed in the other cases. Counting starts only when blood is detected (therefore not in priming).

SCALE WEIGHTSCALE WEIGHTSCALE WEIGHTSCALE WEIGHT

The graphic tool indicates the weight of the bags hanged

on the scale in HDF (kg).

INFUSION PRESSUREINFUSION PRESSUREINFUSION PRESSUREINFUSION PRESSURE The infusion fluid pressure (in mmHg) during haemodiafiltration treatments is displayed on the second page. To display it,

see/mod. parameters


Pinf mmHg

Qinf ml/min


GRAPHIC PARAMETER DIGRAPHIC PARAMETER DIGRAPHIC PARAMETER DIGRAPHIC PARAMETER DISPLAYSPLAYSPLAYSPLAY

The graphic display of the time trend of the parameters measured is the same for all the sensors. By way of example, the graph displayed with the Natrium sensor on Formula Therapy is explained.

sensors

Applications

cond/temp blood/UF .

Indicated at the bottom right of the screen are the conductivity and temperature data of the blood and the ultrafiltrate read in real-time. The function keys of the menu on the side allow displaying the graph of the time trend of this data.

display BC

to view the blood conductivity graph.

COND/TEMP BLOOD/UF

COND/TEMP BLOOD/UF

COND/TEMP BLOOD/UF


Now

display BT

to display the blood temperature graph, as well.

The graph is the Cartesian type in two dimensions: the time axis (in minutes) is represented horizontally and the selected parameter vertically (e.g. blood temperature and blood conductivity). A maximum of two parameters can be displayed simultaneously, each curve with its own scale. These curves are plotted by points. The red vertical bars identify the beginning and end of dialysis. The graph shows the data of the dialysis in progress or the one just concluded and is reset only when a new dialysis is set. The grid facilitates data reading (the time axis is divided into 60 min. intervals, significant values are indicated on the other axis).

The

zoom

function key allows enlarging the graph displayed, more specifically the graph related to the dialysis time included between the red vertical bars.

Press the and keys to act on the vertical scale and the and keys for the horizontal one.

COND/TEMP BLOOD/UF


SCREENSAVER MODESCREENSAVER MODESCREENSAVER MODESCREENSAVER MODE

Through the screensaver mode, formula® provides the possibility of performing dialysis with the screen blackened so as not to disturb patients undergoing dialysis at night. This mode must be enabled in the Service configuration, where the time is set after which - when there are no alarms and no keys are pressed - the screen is automatically blackened. The screen automatically lights up again • if an alarm occurs, • if any key is pressed • if a flow regulator is adjusted. To enable the screensaver mode:

see/mod. parameters


enable screensaver

. To disable the screensaver mode:

see/mod. parameters


disable screensaver

.

ENG – Ed. 06/09 ch. 2.6 - Configuration - 1 of 12

2.6 CONFIGURATION

Configuration is a phase in the machine installation procedure. It is carried out by technicians authorised by the manufacturer in order to fix the operating parameters in accordance with the hardware characteristics of the machine and the habits of the dialysis centre. These parameters will be displayed as default values during the machine operating phases: some may be modified before and during treatment, others can be modified only by re-executing the configuration. Configuration is divided into three levels of which only one is accessible by the operator/user, while the others are available only to authorized technical staff. The configuration procedure described here below can thus be carried out by the operator/user and customised according to prescriptions given by the responsible physician and the requirements of the dialysis centre. NOTE The configuration menu can be accessed only when the machine is turned on.

HOW TO CARRY OUT CONFIGURATION • Turn on the machine with the main switch.

• Wait until the LED next to the key on the front panel turns orange.

• Press and wait for three white asterisks (***) to appear at the bottom right of the screen.

• In sequence press the keys . If the sequence is not respected, the configuration menu cannot be accessed.

• The parameters are displayed on pages which can only be consulted only in one direction (it is not possible to return to the previous page unless first completing the configuration and then turning the machine off and on again).

• Use the or key to scroll from one parameter to the next; use the or key to modify the parameter selected.

• When the settings have been made, press . The following window appears:

• Again press to confirm and pass to the next page.

• Press to cancel confirmation. • In case of a power failure, the parameters confirmed up to that moment will have been

stored; to set the remaining parameters, the configuration menu must be re-accessed.

WILL YOU CONFIRM DATA?

(ENTER = YES)

2 of 12 – ch. 2.6 - Configuration ENG - Ed. 06/09

Page 1

ALARMS, WARNINGS AND DEFAULT VALUES

RANGE PRE-SET VALUES

Treatments selectable by the user

DN SNsp SNdp

HDF PHF HFR

DN-SNsp - SNdp

specifies the type of treatment that may be used.

Priming volume (l) 1.0 ÷ 7.0 2.0 specifies the total volume that can be utilized for priming.

Stop priming volume (l)

0.0 ÷ 4.0 0.0 specifies the volume of priming fluid that has circulated before the blood pump stops. When set to 0, the pump stop is cancelled and the priming liquid circulates in the blood lines until the priming volume is reached.

3.0 + vol. stop

priming ÷ 7.0 4.0 If HFR Cartridge = SELECTA PLUS

has been set in Service Configuration. Specifies the priming volume automatically set by the machine for HFR Selecta Plus.

Vol. priming HFR (l)

1.3 + vol. stop

priming ÷ 7.0

2.0 If HFR Cartridge = SELECTA or HFR Cartridge = BOTH has been set in Service Configuration. Specifies the priming volume automatically set by the machine for HFR Selecta .

1.0 ÷ (vol.

priming –3.0)

1.0 If HFR Cartridge = SELECTA PLUS has been set in Service Configuration. Specifies the stop priming volume automatically set by the machine for HFR Selecta Plus.

Vol. stop priming HFR (l)

0.7 ÷ (vol.

priming –1.3) 0.7 If HFR Cartridge = SELECTA or

HFR Cartridge = BOTH has been set in Service Configuration. Specifies the stop priming volume automatically set by the machine for HFR Selecta .

Qb priming HFR (ml/min)

0 ÷ 200 200 If HFR Cartridge = SELECTA PLUS has been set in Service Configuration. Specifies the arterial pump flow rate, automatically set by the machine, during HFR Selecta Plus priming.

Qb priming HFR (ml/min)

0 ÷ 200 100 If HFR Cartridge = SELECTA or HFR Cartridge = BOTH has been set in Service Configuration.


Specifies the arterial pump flow rate, automatically set by the machine, during HFR Selecta priming.

Qinf LV (ml/min) 10 ÷ 100 10 specifies the infusion flow rate automatically set in HFR by the machine, when the relative automatic control is active.

Patient’s connecting time (sec)

30 ÷ 180 90 specifies the time elapsing between the detection of blood and the activation of the dialysis alarm limits.

FF Max (%) 1 ÷ 40 22 in HFR specifies the threshold filtration fraction value for the automatic control of the infusion flow.

Additional pump stop during patient’s connection

ON/OFF OFF specifies the additional arterial pump stop as soon as the blood level is detected in the venous drip chamber: ON: pump stop active OFF: pump stop not active

TMPH Max (mmHg) 0 ÷ 400 200 in HFR specifies the max. hemofilter transmembrane pressure for the automatic control of the infusion flow.

Alarm range: PV (mmHg)

50 ÷ 150 120 specifies the venous pressure alarm threshold with respect to its mean value.

Alarm range : PA (mmHg)

50 ÷ 250 150 specifies the arterial pressure alarm threshold with respect to its mean value.

PA alarm: max (mmHg) 100 ÷ 300 200 specifies the maximal arterial pressure alarm value.

PA alarm : min (mmHg) -100 ÷ -350 -300 specifies the minimum arterial pressure alarm value.

Heparin pump normal 20/30/50 30 specifies the capacity of the heparin syringe.

Heparin pump diameter 20 cc (mm)

18.0 ÷ 30.0 20.0 specifies the diameter of the heparin syringe for each of the syringes that may be used.


18.0 ÷ 30.0 23.9


18.0 ÷ 30.0 26.8

Normal heparin pump speed (cc/hr)

0 ÷ 10 0 specifies the heparin pump infusion flow rate.

Normal heparin pump prestop (min)

0 ÷ 120 0 specifies the pre-switching off time of the heparin pump.

Automatic heparin bolus 0 ÷ 25 0.0 specifies the quantity of heparin


(cc) automatically infused as soon as blood is recognized.

Pre-set values refer to the values that have been set prior to storing the machine.

Page 2



UF pressure measurement

neg. UF or TMP

neg. UF Indicates the pressure to be utilized to monitor the correct use of the dialyser.

Min TMP/backfiltration alarm (mmHg)

0 ÷ -300

-60 For double needle or single needle treatments.

Max TMP alarm (mmHg) 200 ÷400

200 For double needle or single needle treatments.

Min TMP alarm/backfiltr. HFLUX (mmHg)

0 ÷ -300

-100 For haemodiafiltration treatments (HDF, PHF, HFR).

Max TMP alarm HFLUX (mmHg)

200 ÷400

300 For haemodiafiltration treatments (HDF, PHF, HFR).

Min. neg. UF alarm (mmHg)

-200 ÷-400 -300 For double needle or single needle treatments.

Max. neg. UF alarm (mmHg)

200 ÷ 400 200 For double needle or single needle treatments.

Neg. UF alarm min HFLUX (mmHg)

-200 ÷-400 -300 For haemodiafiltration treatments (HDF, PHF, HFR).

Neg. UF alarm max HFLUX (mmHg)

200 ÷ 400 200 For haemodiafiltration treatments (HDF, PHF, HFR).

Min settable WLR (kg/hr) 0.1 ÷ 0.5 0.1 Defines the minimum value of hourly ultrafiltration that can be set.

Max. settable WLR (kg/hr) 0.5 ÷4.0

2.5 Defines the maximum value of hourly ultrafiltration that can be set.

Dialyser rinsing UF value (kg/hr)

0.1 ÷ 1.5 0.5 Defines the ultrafiltration rate when rinsing the dialyser.

Acoustic min. UF warning deadened

ON/OFF OFF Defines the time elapsing between an acoustic tone and the following ON = acoustic tone every 2 min. OFF = acoustic tone every 20 sec.


Page 3



Dialysate type (DN/SN) Bic + STD A. Conc/ Bid+STD A. Conc/Acet/

Bic+Lympha/Bid+Lympha

Bic+STD A. Conc

Dialysate type : HDF Bic + STD A. Conc/ Bid+STD A. Conc/Acet/


Bic+STD A. Conc

Dialysate type : PHF Bic + STD A. Conc/ Bid+STD A. Conc/Acet/


Bic+STD A. Conc

Dialysate type : HFR Bic + STD A. Conc/ Bid+STD A. Conc/Acet/


Bic+STD A. Conc

Treatment type DN/SNsp/SNdp/ HDF/ PHF/HFR

DN

Dialysate flow (ml/min)

300/500/800 500

Treatment time (hr:min) 0:00 ÷10:00 0

Total weight (kg) 0 ÷ 10

0

Weight loss (kg/hr) 0.1 ÷ 4.0 * * The range depends on the WRL min.

and max. values defined in page 2.

0.1

Max. systolic pressure (mmHg) 0-300 300

Min. systolic pressure (mmHg) 0-300 0

Max. diastolic pressure (mmHg) 0-200 200

Min. diastolic pressure (mmHg) 0-200 0

Total conductivity (mS/cm)

12.1 ÷ 15.7 14

Bicarbonate conductivity (mS/cm) 2.4 ÷ 3.6 4 ÷6

3.1

Dialysate temperature (°C) 35 ÷39 37.5

Time countdown ON/OFF OFF


Page 4



Water inlet conductivityalarm (mS/cm) 0 = no alarm

0 ÷ 1.0

0.2 defines the conductivity alarm valuereferring to the use of inappropriatehaemodialysis water.

Filter replacement warningtime Forclean (hr) 0 = no filter

0 / 400 200 defines the number of hours afterwhich the filter must be replaced (referto the instructions for use of theForclean filter)

filter replacement warningtime Multipure (hr) 0 = no filter

0 / 600 600 defines the number of hours afterwhich the filter must be replaced (referto the instructions for use of theMultipure filter).

Acoustic alarms inrinseback

ON / OFF ON-OFF

ON

Acoustic alarms in priming ON / OFF ON-OFF

ON

identifies the acoustic tones associatedwith priming and rinseback alarms. ON = alarms active, OFF = alarmsinactive ON-OFF= only some alarms areinactive

Arterial and venous pumpout of range alarm (SNsp / SNdp) (rpm)

3 ÷12 5 defines the single needle rpm out ofrange alarm threshold.

Normal value max. SWITCHING PRESSURE (SNsp) (mmHg)

200 ÷400

250 defines the maximum switchingpressure value programmed in singleneedle single pump mode.

Normal value min. SWITCHING PRESSURE (SNsp) (mmHg)

10 ÷ 200 30 defines the minimum switchingpressure value programmed in singleneedle single pump mode.

Min. STROKE (SNsp/ SNdp) (cc)

10 ÷ 20 10 defines the minimum stroke which canbe set for each cycle in single needlemode.

Max STROKE (SNsp/ SNdp) (cc)

30 ÷ 100 50 defines the maximum stroke which canbe set for each cycle in single needlemode.

STROKE normal value (SNsp/ SNdp) (cc)

10 ÷50 10 defines the STROKE default value insingle needle mode.


Page 5



Max. VENOUS PRESSURE (SNdp) (mmHg)

+100 ÷ +450 + 350 identifies the maximum venous pressure value which can be set in single needle double pump.

Min. SWITCHING PRESSURE (SNdp) (mmHg)

-100 ÷ +100 + 30 identifies the lowest minimum switching pressure value which can be set in single needle double pump.

Max. efficiency (SNdp)

1.1 ÷ 2.0 1.2 identifies the higher value of the efficiency alarm in single needle double pump.

Min. efficiency (SNdp)

0.0 ÷ 0.9 0.7 identifies the lower value of the efficiency alarm in single needle double pump.

Date identifies the date used by the equipment computer (dd, mm, yyyy).

Time identifies the time used by the equipment computer (hh, mm, ss).

Page 6 DISINFECTION/CLEANING

SETTINGS RANGE PRE-SET

VALUES

Disinfection/cleaning icon available in rinsing

ON / OFF ON Indicates the activation of the icon for disinfected/cleaned machine during pre-dialysis rinse.

USER CHEM. FULL disinf. setting Dilution ratio 1:

6 ÷ 30 30 Identifies the dilution ratio for the chemical-full disinfection/cleaning with USER agent.

USER CHEM. FULL disinf. setting Rinsing (min)

23 ÷ 33 33 Identifies the duration of the post-disinfection rinsing for the chemical-full disinfection/cleaning with USER agent.

USER CHEM. FULL disinf. setting Min conductivity (mS/cm)

0.0 ÷ 20.0 20.0 Identifies the conductivity lower value of the DISINFECTION warning for the chemical-full disinfection/cleaning with USER agent.

USER CHEM. FULL disinf. setting Max conductivity (mS/cm)

0.0 ÷ 20.0 0.0 Identifies the conductivity upper value of the DISINFECTION warning for the chemical-full disinfection/cleaning with USER agent.

USER CHEM. STD disinf. setting Dilution ratio 1:

6 ÷ 30 30 Identifies the dilution ratio for the chemical std. disinfection/cleaning with USER agent.

USER CHEM. STD disinf. setting contact (min)

7 ÷ 11 7 Identifies the contact time of the chemical agent in the chemical std. disinfection/cleaning with USER agent.


USER CHEM. STD disinf. setting rinsing (min)

25 ÷ 30 30 Identifies the duration of the post-disinfection/cleaning rinsing for the chemical std. disinfection/cleaning with USER agent.

USER CHEM. STD disinf. setting Min conductivity (mS/cm)

0.0 ÷ 20.0 20.0 Identifies the conductivity lower value of the DISINFECTION warning for the chemical std. disinfection/cleaning with USER agent.

USER CHEM. STD disinf. setting Max conductivity (mS/cm)

0.0 ÷ 20.0 0.0 Identifies the conductivity upper value of the DISINFECTION warning for the chemical std. disinfection/cleaning with USER agent.

USER CHEM. HEAT disinf. setting Dilution ratio 1:

6 ÷ 30 30 Identifies the dilution ratio for the chemical-heat disinfection/cleaning with USER agent.

USER CHEM. HEAT disinf. setting contact (min)

15 ÷ 20 20 Identifies the contact time in the chemical-heat disinfection/cleaning with USER agent.

USER CHEM. HEAT disinf. setting Min conductivity (mS/cm)

0.0 ÷ 20.0 20.0 Identifies the conductivity lower value of the DISINFECTION warning for the chemical-heat disinfection/cleaning with USER agent.

USER CHEM. HEAT disinf. setting Max conductivity (mS/cm)

0.0 ÷ 20.0 0.0 Identifies the conductivity upper value of the DISINFECTION warning for the chemical-heat disinfection/cleaning cycle with USER agent.


Page 7

CHEMICAL STD. DISINFECTION/CLEANING SETTING Contact time

RANGE (min)

Contact time Pre-set value

(min)

Rinse time RANGE (min)

Rinse time Pre-set value (min)

HYPOCHLORITE 7 or 11 7 25 or 30 25 PERESAL 7 or 11 7 25 or 30 25 AMUCHINA 6 or 10 6 25 or 30 25 ACETIC ACID 6 or 10 6 25 or 30 25 TIUTOL 7 or 11 7 25 or 30 25 INSTRUNET 6 or 10 6 25 or 30 25 PURISTERIL 7 or 11 7 25 or 30 25 OXAGAL 6 or 10 6 25 or 30 25 RENAXID 7 or 11 7 25 or 30 25 RANGE Pre-set value Default agent

HYPOCHLORITE, PERESAL, AMUCHINA, ACETIC ACID, TIUTOL, INSTRUNET, PURISTERIL, OXAGAL, RENAXID , USER

AMUCHINA

Page 8

CHEMICAL FULL DISINFECTION/CLEANING SETTING Rinse time

RANGE (min) Rinse time

Pre-set values (min)

HYPOCHLORITE 23 or 33 23 PERESAL 23 or 33 23 AMUCHINA 23 or 33 23 DIALOX 23 or 33 23 TIUTOL 23 or 33 23 INSTRUNET 23 or 33 23 OXAGAL 23 or 33 23 RENAXID 23 or 33 23

RANGE Pre-set value Default agent HYPOCHLORITE, PERESAL, AMUCHINA, DIALOX, TIUTOL,

INSTRUNET, OXAGAL, RENAXID ,USER AMUCHINA

Default dwell time (h: min)

0:00 ÷ 80:00 12:00

Dwell time can be set only for Dialox, Oxagal and centralized disinfection.


Page 9

HEAT DISINFECTION/CLEANING SETTING Contact time

RANGE (min)

Contact time Value

pre-set (min)

Heating time RANGE (min)

Heating time Value

pre-set (min)

Heat

15 or 20 15

Chemical Heat 15 or 20 15

Page 10

WEEKLY DISINFECTION SETTING Types of

disinf./cleaning

Start h : min

Duration (min) Event

Rinsing g : h : min

Shut down g : h : min

Monday absent / type - - - - / N.W. - - - ENABLED DISABLED

Tuesday absent / type - - - - / N.W. - - - ENABLED DISABLED

Wednesday absent / type - - - - / N.W. - - - ENABLED DISABLED

Thursday absent / type - - - - / N.W. - - - ENABLED DISABLED

Friday

absent / type - - - - / N.W. - - - ENABLED DISABLED

Saturday

absent / type - - - - / N.W. - - - ENABLED DISABLED

Sunday absent / type - - - - / N.W. - - - ENABLED DISABLED

Should the set parameters be not congruent with the settings of the previous or next days, the whole line of the table is coloured in red in order to warn the operator about incorrect settings.


Ex: Monday he. wsh.w.i.t 7:00 20 mo 8:00 DISABLED

Tuesday st. DIALOX 18:00 13 we 7:50 DISABLED

Wednesday st. HYPOCHLORITE

8:00 32 - - DISABLED

Saturday he. wsh.w.i.t 2:00 45 su 1:00 su 2:00 Sunday he. dis.w.i.t. 2:00 21 do 3:00 DISABLED

The start of Wednesday disinfection/cleaning is not congruent with the start of the rinsing of the previous day. The beginning of Sunday disinfection/cleaning coincides with the end of Saturday disinfection/cleaning. Remember that between the end of a disinfection/cleaning and the beginning of the next at least 20 minutes must elapse.


Explanations of the abbreviations used for setting the weekly disinfection.

TYPE OF DISINFECTION/CLEANING ABBREVIATION

ABSENT ABSENT Standard chemical disinfection with HYPOCHLORITE st. HYPOCHLORITE

Standard chemical disinfection with AMUCHINA st. AMUCHINA Standard chemical disinfection with PERESAL st. PERESAL Standard chemical disinfection with ACETIC st. ACETIC A. Standard chemical disinfection with TIUTOL st. TIUTOL

Standard chemical disinfection with INSTRUNET st. INSTRUNET Standard chemical disinfection with PURISTERIL st. PURISTERIL

Standard chemical disinfection with OXAGAL st. OXAGAL Standard chemical disinfection with RENAXID st. RENAXID

Standard chemical disinfection with USER disinfectant st. USER Chemical-full disinfection with HYPOCHLORITE fu. HYPOCHLORITE

Chemical-full disinfection with AMUCHINA fu. AMUCHINA Chemical-full disinfection with PERESAL fu. PERESAL Chemical-full disinfection with DIALOX fu. DIALOX Chemical-full disinfection with TIUTOL fu. TIUTOL

Chemical-full disinfection with INSTRUNET fu. INSTRUNET Chemical-full disinfection with OXAGAL fu. OXAGAL Chemical-full disinfection with RENAXID fu. RENAXID

Chemical-full disinfection with USER disinfectant fu. USER Heat disinfection heat

Chemical-heat disinfection with CITRIC ACID ch.he.CITRIC A. Chemical-heat disinfection with USER disinfectant ch.he.USER

Centralized chemical disinfection ce.ch. Centralized heat washing he. wsh.w.i.t.

Centralized heat disinfection he. dis. w.i.t. MACHINE POWER ON POWER ON

Centralized chemical special disinfection ch. w.i.t.sp. Centralized heat washing special h. w.i.t.sp.

Centralized heat special disinfection h.d. w.i.t.sp. For the profile configuration pages, refer to chapter “PROFILES”. When settings have been completed, the following message appears: FORMULA IS READY

TO BE SWITCHED OFF.

ENG – Ed. 06/09 chap. 2.7 – Disposable Materials and Accessories - 1 of 10

2.7 DISPOSABLE MATERIALS AND ACCESSORIES2.7 DISPOSABLE MATERIALS AND ACCESSORIES2.7 DISPOSABLE MATERIALS AND ACCESSORIES2.7 DISPOSABLE MATERIALS AND ACCESSORIES

DIALDIALDIALDIALYYYYZZZZERSERSERSERS

The hollow-fibre dialysers must conform to the harmonized standard EN 1283. Some dialysers that can be used with formula and manufactured by Bellco are listed herein as a reference. Other equivalent dialysers suitable for the intended use, produced by Bellco or having the same functional and mechanical characteristics, can be used.

Low Flux and High Flux Hollow Fibre Dialyser

CodeCodeCodeCode ModelModelModelModel Ster.Ster.Ster.Ster.

PhyltherTM LF 11 G Gamma




PhyltherTM LF 11 SD Steam





2 of 10 - chap. 2.7 - Disposable Materials and Accessories ENG – Ed. 06/09


IBP4247 PhyltherTM HF 11 G Gamma




IBP4246 PhyltherTM HF 11 SD Steam







IBP 4123 BLS512G Gamma



IBP 4127 BLS512SD Steam





OLpur SERIES DIALYZERS for MIDOLpur SERIES DIALYZERS for MIDOLpur SERIES DIALYZERS for MIDOLpur SERIES DIALYZERS for MID----HDFHDFHDFHDF

IB0958079 OLpur MD190 radiation

IB0958105 OLpur MD220 radiation

Manufacturer: Nephros Inc. New York, NY 10032 USA


BLOOD AND INFUSION LINESBLOOD AND INFUSION LINESBLOOD AND INFUSION LINESBLOOD AND INFUSION LINES

The blood and infusion lines to use with formula must have characteristics comparable with the blood lines manufactured by Bellco and specifically dedicated for this dialysis machine. Some codes of the lines manufactured by Bellco and suitable for the use with formula are given herein as a reference. Other equivalent codes produced by Bellco or other devices, with the same functional and mechanical characteristics, from another manufacturer can be used. ETO SterilizationETO SterilizationETO SterilizationETO Sterilization

Arterial line for double needle and single needle (single pump and double pump) for formula and formula 2000.

IB0354410

Venous line for double needle and single needle (single pump) for formula and formula 2000.

IB0432610

Infusion line for HDF for formula 2000. IB0487110

Combipack (arterial and venous line in the same packaging) for formula and formula 2000.

IB0681700

BETA SterilizationBETA SterilizationBETA SterilizationBETA Sterilization

Arterial line for double needle and single needle (single pump and double pump) for formula and formula 2000.

IB0354440

Arterial line for double needle and single needle (single pump and double pump) for formula and formula 2000 with spike for saline bags.

IB0356240

Venous line for double needle and single needle (single pump) for formula, formula 2000 and formula plus.

IB0432640

Venous line for HDF for formula 2000.

IB0432740

Venous line for single needle (double pump) for formula 2000.

IB0432840

Infusion line in HFR for formula 2000.

IB0434020

Infusion line in PHF for formula 2000

IB0434120

Combipack (arterial and venous line in the same packaging) for formula and formula 2000.

IB0691500

Arterial line including Natrium and Hemox for formula plus and formula 2000 plus.

IB0428440

Arterial line including Hemox for formula plus and formula 2000 plus IB0428540

Infusion line including Natrium for formula 2000 plus. IB0434720


formula plus/ formula 2000 plus can however be used with the blood and infusion lines dedicated to formula / formula 2000.

Therapy formula can use the lines dedicated for formula 2000 / formula 2000 plus as far as blood lines (artery and vein), infusion lines for HFR, and Kit for HFR are concerned.

Infusion lines for PHF (PHF PRE, PHF POST) and HDF OnLine (HDF PRE, HDF POST, MID-HDF) are as follows:

Infusion line for PHF for formula Therapy.

IB0434920

Infusion line for HDF ONLINE for formula Therapy.

IB0435020

T-set for dilution IB0560900

KITS FOR SPECIFIC TREATMENTSKITS FOR SPECIFIC TREATMENTSKITS FOR SPECIFIC TREATMENTSKITS FOR SPECIFIC TREATMENTS

Some complete kits for specific treatments available with formula are given herein as a reference, including the different devices composing the kits, manufactured by Bellco.

KIT PHFKIT PHFKIT PHFKIT PHF

KIT PHFKIT PHFKIT PHFKIT PHF including

Arterial line

Venous line

Infusion line

Infusion set

Manometer protection set

PHF dialyser

BL690 BL690 BL690 BL690 –––– IB 0567600 IB 0567600 IB 0567600 IB 0567600 (PHF DIALYSER 0719)

IB 0357040

IB 0432640

IB 0434120

IB 0550920

IB 0556700

IBP 4100

KIT KIT KIT KIT PHFPHFPHFPHF including

Arterial line

Venous line

Infusion line

Infusion set

Manometer protection set

PHF dialyser

BL690 BL690 BL690 BL690 –––– IB 0567610 IB 0567610 IB 0567610 IB 0567610 (PHF DIALYSER 0714)

IB 0357040

IB 0432640

IB 0434120

IB 0550920

IB 0556700

IBP 4105


KIT HFRKIT HFRKIT HFRKIT HFR

KIT HFRKIT HFRKIT HFRKIT HFR including

Arterial line

Venous line

Infusion line

Dialyser SG30 PLUS

Selecta Cartridge

BL640 BL640 BL640 BL640 ---- IB0568822 IB0568822 IB0568822 IB0568822 (DIALYSERDIALYSERDIALYSERDIALYSER SG30 PLUS)

IB 0357040

IB 0432640

IB 0434020

IBP 4117

IBP 1503

KIT HFRKIT HFRKIT HFRKIT HFR including

Arterial line

Venous line

Infusion line

Dialyser SG40 PLUS

Selecta Cartridge

BBBBL640 L640 L640 L640 –––– IB 0568823 IB 0568823 IB 0568823 IB 0568823 (DIALYSER (DIALYSER (DIALYSER (DIALYSER SG40 PLUS))))

IB 0357040

IB 0432640

IB 0434020

IBP 4114

IBP 1503

KIT HFR AEQUILIBRIUMKIT HFR AEQUILIBRIUMKIT HFR AEQUILIBRIUMKIT HFR AEQUILIBRIUM including

Arterial line

Venous line

Infusion line

Dialyser SG30 PLUS

Selecta Cartridge

BL640 BL640 BL640 BL640 ---- IB0568828 IB0568828 IB0568828 IB0568828 (DIALYSERDIALYSERDIALYSERDIALYSER SG30 PLUS)

IB 0357040

IB 0432640

IB 0434720

IBP 4117

IBP 1503

KIT HFRKIT HFRKIT HFRKIT HFR AEQUILIBRIUMAEQUILIBRIUMAEQUILIBRIUMAEQUILIBRIUM including

Arterial line

Venous line

Infusion line

Dialyser SG40 PLUS

Selecta Cartridge

BL640 BL640 BL640 BL640 –––– IB 0568829 IB 0568829 IB 0568829 IB 0568829 (DIALYSER (DIALYSER (DIALYSER (DIALYSER SG40 PLUS))))

IB 0357040

IB 0432640

IB 0434720

IBP 4114

IBP 1503

KIT HFR KIT HFR KIT HFR KIT HFR including

Arterial line

Venous line

Infusion line

Dialyser HFR 13

Selecta Cartridge

BL640 BL640 BL640 BL640 ---- IB0568836 IB0568836 IB0568836 IB0568836 (DIALYSERDIALYSERDIALYSERDIALYSER HFR13)

IB 0357040

IB 0432640

IB 0434020

IBP 4282

IBP 1503

KIT HFR KIT HFR KIT HFR KIT HFR including

Arterial line

Venous line

Infusion line

Dialyser HFR 17

Selecta Cartridge


IB 0357040

IB 0432640

IB 0434020

IBP 4283

IBP 1503


KIT HFR AEQUILIBRIUMKIT HFR AEQUILIBRIUMKIT HFR AEQUILIBRIUMKIT HFR AEQUILIBRIUM including

Arterial line

Venous line

Infusion line

Dialyser HFR 13

Selecta Cartridge


IB 0357040

IB 0432640

IB 0434720

IBP 4282

IBP 1503

KIT HFRKIT HFRKIT HFRKIT HFR AEQUILIBRIUMAEQUILIBRIUMAEQUILIBRIUMAEQUILIBRIUM including

Arterial line

Venous line

Infusion line

Dialyser HFR 17

Selecta Cartridge

BL640 BL640 BL640 BL640 –––– IB 0568839 IB 0568839 IB 0568839 IB 0568839 (DIALYSER (DIALYSER (DIALYSER (DIALYSER HFR 17))))

IB 0357040

IB 0432640

IB 0434720

IBP 4283

IBP 1503

KIT HFR AEQUILIBRIUKIT HFR AEQUILIBRIUKIT HFR AEQUILIBRIUKIT HFR AEQUILIBRIUM HEMOXM HEMOXM HEMOXM HEMOX including

Hemox arterial line

Venous line

Infusion line

Dialyser HFR 13

Selecta Cartridge


IB 0428540

IB 0432640

IB 0434720

IBP 4282

IBP 1503

KIT HFRKIT HFRKIT HFRKIT HFR AEQUILIBRIUM HEMOXAEQUILIBRIUM HEMOXAEQUILIBRIUM HEMOXAEQUILIBRIUM HEMOX including

Hemox arterial line

Venous line

Infusion line

Dialyser HFR 17

Selecta Cartridge

BL640 BL640 BL640 BL640 –––– IB 0568841 IB 0568841 IB 0568841 IB 0568841 (DIALYSER (DIALYSER (DIALYSER (DIALYSER HFR 17))))

IB 0428540

IB 0432640

IB 0434720

IBP 4283

IBP 1503


CONCENTRATES CONCENTRATES CONCENTRATES CONCENTRATES

The concentrate saline solutions are identified by the dilution ratio to which they must be used. For “dilution ratio” it is meant the water quantity which must be added to the concentrate unit. Based on different conductivity configurations (partial conductivity), formula has to be used with appropriate concentrate solutions.

3 mS System3 mS System3 mS System3 mS System Basic solution for bicarbonate dialysis dilution 1:28.57 Acid solution for bicarbonate dialysis dilution 1:35

3 mS System with powder bicarbonate3 mS System with powder bicarbonate3 mS System with powder bicarbonate3 mS System with powder bicarbonate Herein some bicarbonate cartridge types are listed:

BIDRY – Powder bicarbonate cartridge Code BSCART003 from 750 g, - water down to obtain a solution close to saturation at approx. 37°C BIDRY – Powder bicarbonate cartridge Code BSCART009 from 950 g, - water down to obtain a solution close to saturation at approx. 37°C SOLUCART PLUS – powder bicarbonate cartridge Code BSCART002 from 750 g, - water down to obtain a solution close to saturation at approx. 37°C SOLUCART PLUS – powder bicarbonate cartridge Code BSCART018 from 850 g, - water down to obtain a solution close to saturation at approx. 37°C Acid solution for bicarbonate dialysis dilution 1:35 or 1:45 (various formulas) To be used with Bidry or Solucart Plus LYMPHA kit Acetate free (bicarbonate powder cartridge and concentrate acid solution in bag) dilution 1:45 (various formulas)

5 mS Sys5 mS Sys5 mS Sys5 mS System tem tem tem Basic solution for bicarbonate dialysis dilution 1:20.13 Acid solution for bicarbonate dialysis dilution 1:36.83 In configuration mode different dilution ratios can be set. Further details can be given on request.


WATER INLET FILTERWATER INLET FILTERWATER INLET FILTERWATER INLET FILTER

MULTIPUREMULTIPUREMULTIPUREMULTIPURE Code IB5092200

Water inlet for bacterial microfilter.

ACCESSORACCESSORACCESSORACCESSORIIIIESESESES

FORCLEAN PLUSFORCLEAN PLUSFORCLEAN PLUSFORCLEAN PLUS Code IB0958500

Hollow-fibre Medisulfone® ultrafilter for dialysis fluid, ETO sterilized.

FORCLEANFORCLEANFORCLEANFORCLEAN I Code IB0958600

Hollow-fiber Medisulfone® ultrafilter for dialysis fluid, ETO sterilized, equipped with transponder.

SCALE SCALE SCALE SCALE FORMULA 2000 Code IB7097000

Scale for HDF

SPHYGMO SPHYGMO SPHYGMO SPHYGMO FORMULA Code IB7097050

Sphygmomanometer NATRIUM NATRIUM NATRIUM NATRIUM FORMULA Plus Code IB7097060

Blood temperature and conductivity sensor HEMHEMHEMHEMOX OX OX OX FORMULA Plus Code IB7097070

Hematocrit and oxygen saturation measuring system PULSAR PULSAR PULSAR PULSAR FORMULA Plus Code IB7097080

Heart rate meter

ENG – Ed. 11/09 chap. 2.8 – Technical characteristics - 1 of 22

2.8 TECHNICAL CHARACTERISTICS2.8 TECHNICAL CHARACTERISTICS2.8 TECHNICAL CHARACTERISTICS2.8 TECHNICAL CHARACTERISTICS

DIMENSIONS AND WEIGHDIMENSIONS AND WEIGHDIMENSIONS AND WEIGHDIMENSIONS AND WEIGHTTTT

Height, depth, width Standard model

1740 x 755 x 500 mm

Height, depth, width Domus model (with monitor arm)

1740 x 800 x 1000 mm - max.-

Weight (formula) 85 kg Weight (formula 2000) 89 kg Weight (formula plus) 85.5 kg Weight (formula 2000) 89.5 kg Weight (formula Domus) 94 kg Weight (formula 2000 Domus) 98 kg Weight (formula plus Domus) 94.5 kg Weight (formula plus Domus) 98.5 kg Weight (formula Therapy) 91 kg Weight (formula Therapy Domus) 100 kg

MAX. APPLICABLE WEIGMAX. APPLICABLE WEIGMAX. APPLICABLE WEIGMAX. APPLICABLE WEIGHT HT HT HT

I.V. pole hooks 10 Kg Scale hooks 16 kg Bag hooks 5 Kg Instrument table 5 Kg Concentrate bags holder 13 Kg Onboard disinfectant container rack 15 Kg WARNINGWARNINGWARNINGWARNING The maximum load that can be applied tThe maximum load that can be applied tThe maximum load that can be applied tThe maximum load that can be applied to the I.V. pole on the single pump o the I.V. pole on the single pump o the I.V. pole on the single pump o the I.V. pole on the single pump models (formulamodels (formulamodels (formulamodels (formula, formula, formula, formula, formula plus) is 10 kg, and 16 kg for double pump models. plus) is 10 kg, and 16 kg for double pump models. plus) is 10 kg, and 16 kg for double pump models. plus) is 10 kg, and 16 kg for double pump models.

AMBIENT AND STORAGE AMBIENT AND STORAGE AMBIENT AND STORAGE AMBIENT AND STORAGE CONDITIONSCONDITIONSCONDITIONSCONDITIONS

Operation: Temperature +10ºC to +40ºC Relative humidity 0-95% non-condensing Pressure atmospheric

Storage and transport (without liquids) Temperature -19ºC to +70ºC Relative humidity 0-95% non-condensing Pressure atmospheric If the period of transport or storage exceeds 15 weeks, refer to the ambient operating conditions (see above). In case of battery-equipped formula machines, if the transportation and/or storage period exceeds one month, it is recommended to contact After-Sales Service Department for battery removal.

Bellco

2 of 22 - chap. 2.8 - Technical characteristics ENG – Ed. 11/09

HAEMODIALYSISHAEMODIALYSISHAEMODIALYSISHAEMODIALYSIS WATER REQUIREMENTS WATER REQUIREMENTS WATER REQUIREMENTS WATER REQUIREMENTS

The water used for haemodialysis treatments with formula must meet the requirements as specified by the National or European Pharmacopoeia, and the American AAMI standards for haemodialysis systems. In particular, the European Pharmacopoeia and the American AAMI standards suggest the following values: European Pharmacopoeia IV Ed. AAMI European Pharmacopoeia IV Ed. AAMI European Pharmacopoeia IV Ed. AAMI European Pharmacopoeia IV Ed. AAMI WQD,1998WQD,1998WQD,1998WQD,1998

Pollutant

Maximum level suggested Maximum level suggested Maximum level suggested Maximum level suggested

Maximum level suggested Maximum level suggested Maximum level suggested Maximum level suggested

Calcium 2.0 mg/l (0.10 mEq/l) 2 mg/l (0.1 mEq/l)

Magnesium 2.0 mg/l (0.165 mEq/l) 4 mg/l (0.3 mEq/l)

Sodium 50 mg/l (2.17 mEq/l) 70 mg/l (3.0 mEq/l)

Potassium 2.0 mg/l (0.05 mEq/l) 8 mg/l (0.2 mEq/l)

Fluoride 0.20 mg/l 0.2 mg/l

Chlorine 0.10 mg/l 0.5 mg/l

Chloramine 0.1 mg/l

Chloride 50 mg/l

Nitrate (N) 2.0 mg/l 2.0 mg/l

Sulphate 50 mg/l 100.0 mg/l

Copper, Barium and Zinc 0.10 mg/l (Zinc) 0.1 mg/l each

Aluminium 0.010 mg/l 0.01 mg/l

Arsenic, Lead, Silver 0.005 mg/l each

Cadmium 0.001 mg/l

Chromium 0.014 mg/l

Selenium 0.09 mg/l

Ammonium 0.20 mg/l

Heavy metals 0.10 mg/l (Lead)

Mercury 0.001 mg/l 0.0002 mg/l

Endotoxin 0.25 I.U. /ml

Bacterial level 100 CFU /ml 200 CFU /ml

WARNINGWARNINGWARNINGWARNING The user is responsible for evaluating the quality of the water supplied so that when The user is responsible for evaluating the quality of the water supplied so that when The user is responsible for evaluating the quality of the water supplied so that when The user is responsible for evaluating the quality of the water supplied so that when mixed with the concentrates no pmixed with the concentrates no pmixed with the concentrates no pmixed with the concentrates no potentially dangerous conditions for the patient are otentially dangerous conditions for the patient are otentially dangerous conditions for the patient are otentially dangerous conditions for the patient are created.created.created.created.

WATERWATERWATERWATER suitable for dialysis treatments in conformity with AAMI standards or European Pharmacopoeia.

Temperature (min-max) 5ºC ÷ 32ºC If the kit for centralized disinfection/cleaning is installed: 5ºC ÷ 32ºC in dialysis


5ºC ÷ 94ºC in rinsing and disinfection/cleaning

Input pressure (min-max) 0.9 ÷ 4.0 bar

If the kit for centralized disinfection/cleaning is installed: 0.9 ÷ 7.5 bar

Flow (minimum inlet) 1000 ml/min

DRAINDRAINDRAINDRAIN at atmospheric pressure to prevent siphon effects.

Height of drain from ground max 800 mm Flow

60 l/h max.

Temperature • 60 °C max (during chemical-heat descaling) • 15° C (in dialysis) If the kit for centralized disinfection/cleaning is installed: • 94 °C max (during chemical-heat descaling) • 15° C (in dialysis)

ELECTRICAL DATAELECTRICAL DATAELECTRICAL DATAELECTRICAL DATA

Nominal voltage 220V~, 230V~, 240V~ ±10% 110V~, 115V~, 120V~ ±10%

Nominal frequency 50 / 60 Hz (220V~,230V~,240V~) 60 Hz (110V~,115V~,120V~) Average power absorbed during dialysis (Tin water = 17.5°C, Tdialysate = 37.5°C, Troom = 20°C, Dialysate Flow = 800 ml/min)

1.0 kW

Max. absorption 8 A ( 220V~, 230V~, 240V~ ) 16 A ( 110V~, 115V~, 120V~ )

Power cable with Schuko moulded plug

( 220V~, 230V~, 240V~ ) with NEMA 5-20 moulded plug

( 110V~, 115V~, 120V~ )

Bellco


Potential equalization

WARNINGWARNINGWARNINGWARNING For treatment of patients with central For treatment of patients with central For treatment of patients with central For treatment of patients with central venous catheter, it is necessary to: venous catheter, it is necessary to: venous catheter, it is necessary to: venous catheter, it is necessary to: • connect the equipment to a potential connect the equipment to a potential connect the equipment to a potential connect the equipment to a potential

equalizer. equalizer. equalizer. equalizer. • If other devices aIf other devices aIf other devices aIf other devices are connected to the re connected to the re connected to the re connected to the

patient or located in the area that can be patient or located in the area that can be patient or located in the area that can be patient or located in the area that can be reached by the patient, it is necessary to reached by the patient, it is necessary to reached by the patient, it is necessary to reached by the patient, it is necessary to check that all leakage currents of these check that all leakage currents of these check that all leakage currents of these check that all leakage currents of these devices are within the limits for type CF devices are within the limits for type CF devices are within the limits for type CF devices are within the limits for type CF applied paapplied paapplied paapplied parts.rts.rts.rts.

Leakage current to earth

< 0.5 mA

Leakage current to patient < 0.1 mA in conformity with EN 60601-1, CEI EN 60601-1 and IEC 60601-1.

Type of protection against direct and indirect contacts

Class I

Applied part

Type B

Degree of protection against ingress of water

IPX1

Electromagnetic compatibility

In conformity with EN 60601-1-2

Power failure The system is able to maintain the current dialysis parameters in memory for a minimum of 2 minutes.

An acoustic alarm intervenes which cannot be silenced. When the power is restored, the system automatically restarts from the same values.

Battery operation Lead battery 12V 7.2Ah


BLOOD SECTIONBLOOD SECTIONBLOOD SECTIONBLOOD SECTION

BLOOD FLOWBLOOD FLOWBLOOD FLOWBLOOD FLOW in double needle and in haemodiafiltration treatments

20 - 700 ml/min

In single needle (instantaneous) 20 -700 ml/min During rinseback (initial phase) 20 -250 ml/min During rinseback (final phase) 20 -180 ml/min Resolution 10 ml/min Accuracy (*) ± 10 % for inlet pressure above -250 mmHg

and any outlet pressure in the working range

NOTNOTNOTNOTEEEE An alarm is generated when the blood pump stops.An alarm is generated when the blood pump stops.An alarm is generated when the blood pump stops.An alarm is generated when the blood pump stops.

INFUSION FLOW in HDF 0.5 – 8 kg/h in PHF PRE, PHF POST, HDF PRE, HDF POST, MID-HDF

0.5 – 21 kg/h

in HFR 0.5 – 8 l/h Resolution 0.1 l/h Accuracy (*) ± 10 % (*) Accuracy with the blood lines indicated in the Disposable materials chapter.

VENOVENOVENOVENOUS PRESSUREUS PRESSUREUS PRESSUREUS PRESSURE

Type Pressure transducer (part of protective system) Reading -400 to +800 mmHg Resolution 5 mmHg Accuracy ± 20 mmHg, ± 3% of actual value Alarms: - during dialysis (min/max) + 10 mmHg ÷ 450 mmHg - during priming and - In rinseback SNsp and SNdp (min/max)

-150 mmHg ÷ +300 mmHg

- in reinfusion DN, HDF, HDF PRE, HDF POST, MID-HDF, PHF PRE, PHF POST, HFR

-150 mmHg / +450 mmHg

Alarm thresholds (during dialysis and reinfusion DN, HDF, HDF PRE, HDF POST, MID-HDF, PHF PRE, PHF POST, HFR )

50 to 150 mmHg, configurable intervals, calculated with respect to average value.

ARTERIAL PRESSUREARTERIAL PRESSUREARTERIAL PRESSUREARTERIAL PRESSURE

Type Pressure transducer (part of protective system) Reading -400 to +800 mmHg Resolution 5 mmHg

Bellco


Accuracy ± 20 mmHg, ± 3% of actual value Alarms: - during dialysis (max) 100 ÷ 300 mmHg, configurable (min) - 350 ÷ -100 mmHg, configurable - during priming and rinseback (min/max)

- 300 / + 200 mmHg

- in on-line reinfusion (min/max) - 300 / + 700 mmHg Alarm thresholds (during dialysis) 50 to 250 mmHg, configurable intervals,

calculated with respect to average value.

PREPREPREPRE----FILTER ARTERIAL PRESFILTER ARTERIAL PRESFILTER ARTERIAL PRESFILTER ARTERIAL PRESSURE SURE SURE SURE

Reading -400 to +800 mmHg Resolution 5 mmHg Accuracy ± 10 mmHg, ± 3% of actual value Alarms: - during dialysis (min/max) + 20 mmHg / + 770 mmHg - during priming and rinseback (min/max)

Not available

Alarm thresholds (during dialysis) Not available

INFUSION PRESSURE (OINFUSION PRESSURE (OINFUSION PRESSURE (OINFUSION PRESSURE (ONLY IN HFR, HDF PRE,NLY IN HFR, HDF PRE,NLY IN HFR, HDF PRE,NLY IN HFR, HDF PRE, HDF POST, MID HDF POST, MID HDF POST, MID HDF POST, MID----HDF, PHF PRE, PHF HDF, PHF PRE, PHF HDF, PHF PRE, PHF HDF, PHF PRE, PHF POST)POST)POST)POST)

Reading -400 to +800 mmHg Resolution 5 mmHg Accuracy ± 10 mmHg, ± 3% of actual value Alarms: Therapy modelTherapy modelTherapy modelTherapy model - in on-line priming and in on-line rinseback, (HDF PRE, HDF POST, MID-HDF, PHF PRE, PHF POST) (min/max)

-200 mmHg ÷ +770 mmHg

- in priming with bags, rinseback with bags, rinseback with air and during dialysis (min/max)

+ 20 mmHg ÷ +770 mmHg

other modelsother modelsother modelsother models - in on-line priming and during dialysis (min/max)

+20 mmHg / +770 mmHg

- in priming with bags and in on-line rinseback (PHF) (min/max)

-200 mmHg / +770 mmHg

HEMOFILTER ULTRAFILTHEMOFILTER ULTRAFILTHEMOFILTER ULTRAFILTHEMOFILTER ULTRAFILTRATION PRESSURE (ONLRATION PRESSURE (ONLRATION PRESSURE (ONLRATION PRESSURE (ONLY IN HFR)Y IN HFR)Y IN HFR)Y IN HFR)

Reading -400 to +800 mmHg Resolution 5 mmHg Accuracy ± 10 mmHg, ± 3% of actual value


HEMOFILTER TRANSMEMBHEMOFILTER TRANSMEMBHEMOFILTER TRANSMEMBHEMOFILTER TRANSMEMBRANE PRESSURE (ONLY RANE PRESSURE (ONLY RANE PRESSURE (ONLY RANE PRESSURE (ONLY IN HFR)IN HFR)IN HFR)IN HFR)

Hemofilter TMPHemofilter TMPHemofilter TMPHemofilter TMP Pre-filter arterial press. - Hemofilter UF press.

Alarms: - during dialysis (min/max) - 100 to +300 mmHg - during priming and rinseback (min/max)

Not available

Alarm thresholds (during dialysis) Not available

VENOUS SWITCHING PREVENOUS SWITCHING PREVENOUS SWITCHING PREVENOUS SWITCHING PRESSURE IN SINGLESSURE IN SINGLESSURE IN SINGLESSURE IN SINGLE----PUMP SINGLE NEEDLEPUMP SINGLE NEEDLEPUMP SINGLE NEEDLEPUMP SINGLE NEEDLE

Reading -400 to +800 mmHg Setting range: - min +10 ÷ +200 mmHg - max +200 ÷ +400 mmHg Resolution 5 mmHg Accuracy ± 10 mmHg, ± 3% of actual value

VENOUS SWITCHING PREVENOUS SWITCHING PREVENOUS SWITCHING PREVENOUS SWITCHING PRESSURE IN DOUBLESSURE IN DOUBLESSURE IN DOUBLESSURE IN DOUBLE----PUMP SINGLE NEEDLEPUMP SINGLE NEEDLEPUMP SINGLE NEEDLEPUMP SINGLE NEEDLE

Reading -400 to +800 mmHg Setting range: - min -100 ÷ +100 mmHg Resolution 5 mmHg Accuracy ± 10 mmHg, ± 3% of actual value

HEPARIN PUMP (WITH SHEPARIN PUMP (WITH SHEPARIN PUMP (WITH SHEPARIN PUMP (WITH SYRINGE) YRINGE) YRINGE) YRINGE)

Syringe capacity 20, 30, 50 cc

Syringe internal diameter (configurable)

18 - 30 mm (increments of 0.1 mm)

Infusion flow 0.1 -10 ml/h (increments of 0.1 ml/h) Accuracy ± 2% (if internal diameter is correctly set during

configuration) Max operating pressure 900 mmHg

AIRAIRAIRAIR/END INFUSION/END INFUSION/END INFUSION/END INFUSION DETECTOR DETECTOR DETECTOR DETECTOR

Type ultrasound Sensitivity bubbles ≥ 100Ol

BLOOD DETECTOR FOR EBLOOD DETECTOR FOR EBLOOD DETECTOR FOR EBLOOD DETECTOR FOR END PRIMINGND PRIMINGND PRIMINGND PRIMING

Type infrared rays

BLOOD LEAK BLOOD LEAK BLOOD LEAK BLOOD LEAK DETECTOR ON THE BLOODETECTOR ON THE BLOODETECTOR ON THE BLOODETECTOR ON THE BLOOD FILTERD FILTERD FILTERD FILTER

Type optical - green

DRIP CHAMBER LEVEL GDRIP CHAMBER LEVEL GDRIP CHAMBER LEVEL GDRIP CHAMBER LEVEL GAUGEAUGEAUGEAUGE

Type infrared rays

Bellco


DIALYSIS FLUID SECTIONDIALYSIS FLUID SECTIONDIALYSIS FLUID SECTIONDIALYSIS FLUID SECTION

DIALYSIS FLUIDDIALYSIS FLUIDDIALYSIS FLUIDDIALYSIS FLUID

Temperature:Temperature:Temperature:Temperature: Type PT100 (part of protective system) Setting 35ºC to 39ºC (increments of 0.5°C) Reading 25ºC to 50ºC Resolution 0.1°C Accuracy ± 0.5°C Alarms (min/max) 34 / 40ºC Powder bicarbonatePowder bicarbonatePowder bicarbonatePowder bicarbonate cartridge cartridge cartridge cartridge filling pressurefilling pressurefilling pressurefilling pressure (only with kit for filling the powder bicarbonate cartridge under positive pressure)

Max. 2.5 bar Concentrate inlet presConcentrate inlet presConcentrate inlet presConcentrate inlet pressuresuresuresure (only with installed kit for concentrate centralised distribution)

Max. 3 bar

UF PressureUF PressureUF PressureUF Pressure

Type Pressure transducer (part of protective system)

Reading - 625 ÷ +625 mmHg Resolution 5 mmHg Accuracy ± 10 mmHg, ± 3% of actual value Alarms: (configurable) min. -200 ÷ -400 mmHg (increments of 10 mmHg)

max +200 ÷ +400 mmHg (increments of 10 mmHg) Alarm thresholds (during dialysis) 30 to 300 mmHg, configurable intervals, calculated

with respect to average value.

TMPTMPTMPTMP ::::

In double needle, HDF, HFR, PHF In double needle, HDF, HFR, PHF In double needle, HDF, HFR, PHF In double needle, HDF, HFR, PHF PRE, PHF POST, MIDPRE, PHF POST, MIDPRE, PHF POST, MIDPRE, PHF POST, MID----HDF, HDF HDF, HDF HDF, HDF HDF, HDF PRE, HDF POST PRE, HDF POST PRE, HDF POST PRE, HDF POST

VP – (Pdo + 30 mmHg)

In In In In single needlesingle needlesingle needlesingle needle Min switch P. + max switch P. – (Pdo +30 mmHg) 2

where: VP = venous pressure Pdo = dialysate pressure measured at dialyser outlet Switch P. = switching pressure in single needle 30 mmHg = load loss of the dialysate compartment.


Reading within the configured alarm limits Resolution 5 mmHg Alarms: (configurable) min -300 ÷ 0 mmHg (increments of 10 mmHg) max +200 ÷ +400 mmHg (increments of 10 mmHg) Alarm thresholds (during dialysis) from 30 to 300 mmHg, settable intervals,

calculated against the average value.

AVERAGE TMP:AVERAGE TMP:AVERAGE TMP:AVERAGE TMP:

In onIn onIn onIn on----line haemodiafiltration line haemodiafiltration line haemodiafiltration line haemodiafiltration with automatic control of the with automatic control of the with automatic control of the with automatic control of the infusion flow enabledinfusion flow enabledinfusion flow enabledinfusion flow enabled

in HDF PRE, HDF POST, MIDin HDF PRE, HDF POST, MIDin HDF PRE, HDF POST, MIDin HDF PRE, HDF POST, MID----HDFHDFHDFHDF Pfilt + Pv – (Pdo + 30 mmHg) 2

in PHF PREin PHF PREin PHF PREin PHF PRE (Pfilt – 20 mmHg)+ Pv – (Pdo + 30 mmHg) 2

in PHF POSTin PHF POSTin PHF POSTin PHF POST Pfilt + (Pv + 20 mmHg) – (Pdo + 30 mmHg) 2

where: Pv = venous pressure Pdo = dialysate pressure at the dialyser outlet Pfilt = prefilter arterial pressure 30 mmHg = dialysate compartment pressure drop 20 mmHg = blood filter pressure drop

Resolution 5 mmHg

MAXIMUM TMP:MAXIMUM TMP:MAXIMUM TMP:MAXIMUM TMP:

In In In In double needledouble needledouble needledouble needle, , , , HDF, HDF, HDF, HDF, PHF PHF PHF PHF POST, HDF PRE, HDF POST POST, HDF PRE, HDF POST POST, HDF PRE, HDF POST POST, HDF PRE, HDF POST

Pfilt – Pdo

in in in in HFR, HFR, HFR, HFR, PHF PREPHF PREPHF PREPHF PRE (Pfilt – 20 mmHg) – Pdo

in MIDin MIDin MIDin MID----HDFHDFHDFHDF Pfilt + Pv – (Pdo + 30 mmHg) 2

where: Pfilt = prefilter arterial pressure Pdo = dialysate pressure at the dialyser outlet 20 mmHg = blood filter pressure drop

Resolution 5 mmHg Signalling (max. only) +600 mmHg

FLOW RATE:FLOW RATE:FLOW RATE:FLOW RATE:

Setting 300, 500, 800 ml/min Reading 200 to 1000 ml/min Resolution 1 ml/min Accuracy ± 10 %

CONDUCTIVITYCONDUCTIVITYCONDUCTIVITYCONDUCTIVITY

Final solution

Bellco


Type Conductivity sensor (part of protective system) Setting 12.1 ÷ 15.7 mS/cm (increments of 0.1 mS/cm Reading 11.5 ÷ 16.5 mS/cm Resolution 0.1 mS/cm Accuracy: 0.1 mS/cm Alarm limits on value set ± 5% Basic section during bicarbonate dialysis Type Conductivity sensor Setting (3 mS/cm) 2.4 ÷ 3.6 mS/cm (increments of 0.1 mS/cm) Setting (5 mS/cm) 4.0 ÷ 6.0 mS/cm (increments of 0.1 mS/cm) Reading 2 ÷ 8 mS/cm Resolution 0.1 mS/cm Accuracy: 0.1 mS/cm Alarm limits on value set ± 5%

ULTRAFILTRATIONULTRAFILTRATIONULTRAFILTRATIONULTRAFILTRATION

Ultrafiltration control continuous flow single-pass differential flowmeter Accuracy ± 1 g/min, ± 1% of total ultrafiltrate

SCALE (SCALE (SCALE (SCALE (only in HDF with bags):only in HDF with bags):only in HDF with bags):only in HDF with bags):

Accuracy ± 0.3% of total infused fluid

WEIGHT LOSSWEIGHT LOSSWEIGHT LOSSWEIGHT LOSS

Programmable weight loss 0.1 to 4.0 Kg/h Accuracy: - In double needle, single needle, HFR, PHF PRE, PHF POST, HDF PRE, HDF POST, MID-HDF

± 1 g/min ± 1% weight loss

- in HDF with bags ± 1 g/min ± 1% weight loss ± 1.3% of the total infused fluid

BLOOD BLOOD BLOOD BLOOD LEAK DETECTORLEAK DETECTORLEAK DETECTORLEAK DETECTOR

Type infrared ray optical (part of protective system) Sensitivity 0.5 ml/min blood, hematocrit 25 %


DISINFECTION/CLEANINGDISINFECTION/CLEANINGDISINFECTION/CLEANINGDISINFECTION/CLEANING

CHEMICAL DISINFECTIOCHEMICAL DISINFECTIOCHEMICAL DISINFECTIOCHEMICAL DISINFECTION/CLEANING (NOT PRESN/CLEANING (NOT PRESN/CLEANING (NOT PRESN/CLEANING (NOT PRESENT ON THE THERAPY MENT ON THE THERAPY MENT ON THE THERAPY MENT ON THE THERAPY MODEL):ODEL):ODEL):ODEL):

Chemical agents - Hypochlorite >7% - Amuchina - Peresal - Acetic Acid (10%) (descaling agent) - Tiutol - Instrunet - Puristeril - Oxagal - Renaxid - User Agent

Dilution ratio 1:30 Hypochlorite, Peresal, Tiutol, Puristeril , Renaxid 1:6 Amuchina, Acetic Acid, Instrunet, Oxagal 1:6 - 1:30 (settable during configuration), User Agent Contact time settable during configuration Hypochlorite, Peresal,Tiutol, Puristeril , Renaxid = 7 or

11 min. Amuchina, Acetic Acid, Instrunet, Oxagal = 6 or 10 min. Consumption (cc) ∼ 90 (dilution ratio 1:30, contact time 7 min)

∼ 120 (dilution ratio 1:30, contact time 11 min) ∼ 250 (dilution ratio 1:6, contact time 6 min) ∼ 400 (dilution ratio 1:6, contact time 10 min)

Water temperature in circuit 38°C ∼ Dwell time None

Rinsing time settable during configuration - 25 or 30 minutes if contact time is 6/7 min.

- 30 min. if contact time is 10/11 min.

Total duration

32 or 37 or 41 min. for Hypochlorite, Peresal,Tiutol, Puristeril, Renaxid. 31 or 36 or 40 min. for Amuchina, Acetic Acid, Instrunet, Oxagal

Bellco


CHEMICALCHEMICALCHEMICALCHEMICAL----FULL DISINFECTION/CLFULL DISINFECTION/CLFULL DISINFECTION/CLFULL DISINFECTION/CLEANINGEANINGEANINGEANING

Chemical agents Therapy Model: - Amuchina - Oxagal - User Agent Other Models: - Hypochlorite >7% - Amuchina - Peresal - Tiutol - Dialox - Instrunet - Oxagal - Renaxid - User Agent

Dilution ratio 1:30 Hypochlorite, Peresal, Tiutol, Renaxid 1:6 Amuchina, Instrunet, Oxagal, Dialox 1:6 - 1:30 (settable during configuration), User Agent Consumption (cc) ∼ 45 (dilution ratio 1:30)

∼ 166 (dilution ratio 1:6) ∼ 250 (dwelling - dilution ratio 1:6)

Water temperature in circuit 38°C ∼ Intake + contact time (minutes)

Therapy Model: 11 (14 with OXAGAL + dwelling) Other models: 8 (12 with DIALOX/OXAGAL + dwelling)

Dwell time max 80 hours only with DIALOX and OXAGAL

Rinsing time (minutes) settable during configuration Therapy Model: - 23 ÷ 33 (AMUCHINA) - 42 ÷ 52 (OXAGAL) Other Models: - 23 or 33

Total duration (minutes) Therapy Model: - 34 ÷ 44 (AMUCHINA) - 53 ÷ 63 (OXAGAL) - 56 ÷ 66 (OXAGAL + dwelling) Other Models: 31 or 41 (35 or 45 with DIALOX /OXAGAL+ dwell)


COLD DESCALING (PRESCOLD DESCALING (PRESCOLD DESCALING (PRESCOLD DESCALING (PRESENT ONLY ON THE THERENT ONLY ON THE THERENT ONLY ON THE THERENT ONLY ON THE THERAPY MODEL):APY MODEL):APY MODEL):APY MODEL):

Descaling agents Acetic Acid (10%) (descaling agent) User descaling agent

Dilution ratio 1:6 Acetic acid 10% Consumption (cc) ∼ 166 Water temperature in circuit 38°C ∼ Intake + contact time (minutes)

11 (ACETIC A.)

Rinsing time (minutes) settable during configuration 28 ÷ 38 min (ACETIC A.)

Dwell time none Total duration (minutes) 39 ÷ 49 (ACETIC A.)

HOT DESCALING: HOT DESCALING: HOT DESCALING: HOT DESCALING:

Descaling agents Citric acid 12% , descaling agent User descaling agent

Dilution ratio 1:6 Citric acid 12% 1:6 - 1:30 (settable during configuration), User Agent Consumption (cc) ∼ 166 Average temperature in circuit

50°C ∼

Contact time (minutes) Therapy Model: 13 Other Models: 13

Heating time + intake (minutes)

Therapy Model: Phase not foreseen Other Models:_ settable during configuration 15 or 20 min.

Rinsing time (minutes) Therapy Model: 23 ÷ 33 min Other Models: 23

Dwell time None

Total duration (minutes) Therapy Model: 36 ÷ 46 Other Models: 51 or 56

Bellco


HEAT DISINFECTION:HEAT DISINFECTION:HEAT DISINFECTION:HEAT DISINFECTION:

Chemical agents none Average temperature in circuit

85°C ∼

Pre-heating time (minutes) Therapy Model: 8 Other Models: 8

Contact time (minutes) 15 or 20 (settable during configuration) Cooling time (minutes) Therapy Model:

16 Other Models: 15

Total duration (minutes) Therapy Model: 31 or 36 Other Models: 30 or 35

RINSING RINSING RINSING RINSING automatic when turning on and after each dialysis

Water temperature 37.5°C ∼ Flow 750 ml/min Life cycle 3 min.


NATRIUM TECHNICAL NATRIUM TECHNICAL NATRIUM TECHNICAL NATRIUM TECHNICAL CHARACTERISTICSCHARACTERISTICSCHARACTERISTICSCHARACTERISTICS

Temperature (blood and ultrafiltrate):Temperature (blood and ultrafiltrate):Temperature (blood and ultrafiltrate):Temperature (blood and ultrafiltrate): Operating principle Reading

Thermal resistance and thermal conduction 25 – 50 °C

Resolution 0.1°C Accuracy ± 0.5°C Conductivity (blood and ultrafiltConductivity (blood and ultrafiltConductivity (blood and ultrafiltConductivity (blood and ultrafiltrate):rate):rate):rate): Operating principle Reading

Electromagnetic induction 0 – 25 mS/cm

Resolution

0.1 mS/cm

Accuracy ± 0.1 mS/cm Interfacing with disposable The reader interfaces with the disposable

conductivity probe inserted in the blood line. Patient safety

The applied part is galvanically isolated from all live parts of the equipment. The conductivity and temperature measurements do not affect the behaviour of the equipment, except in the Aequilibrium application.

HEMOX TECHNICAL HEMOX TECHNICAL HEMOX TECHNICAL HEMOX TECHNICAL CHARACTERISTICSCHARACTERISTICSCHARACTERISTICSCHARACTERISTICS

OOOOperating principleperating principleperating principleperating principle Optical absorbance at three different wavelengths HematocritHematocritHematocritHematocrit Reading 15 ÷ 50 % Resolution 0.1 % Accuracy ± 5 % Oxygen saturationOxygen saturationOxygen saturationOxygen saturation Reading 40 ÷ 100% Resolution 0.1 % Accuracy ± 5 % Percent volume lossPercent volume lossPercent volume lossPercent volume loss (derived quantit(derived quantit(derived quantit(derived quantity)y)y)y) Resolution 0.1 % Accuracy ± 2.5 % Dimensions Interfacing with disposable

51 x 72 x 45 mm The reader interfaces with the disposable cuvette built in the blood line.

Bellco


Patient safety The device is not an applied part. The hematocrit and oxygen saturation measurements do not affect unit performance.

PULSAR PULSAR PULSAR PULSAR TECHNICAL TECHNICAL TECHNICAL TECHNICAL CHARACTERISTICSCHARACTERISTICSCHARACTERISTICSCHARACTERISTICS

Operating principleOperating principleOperating principleOperating principle

Reading of the pulses emitted by commercial electrocardiographic bands.

Heart rate Heart rate Heart rate Heart rate Operating range 0 – 250 bpm Resolution

1 bpm

Accuracy

± 1 bpm

Patient safety

The chest band is battery-powered and completely isolated from the equipment. The receiver does not constitute a part applied to the patient. The heart rate measurements do not affect the operation of the equipment. The measurement can directly be checked on the wrist clock supplied with the equipment.

LECTOR TECHNICAL CHARACTERISTICS LECTOR TECHNICAL CHARACTERISTICS LECTOR TECHNICAL CHARACTERISTICS LECTOR TECHNICAL CHARACTERISTICS

Operating principleOperating principleOperating principleOperating principle

Transponder system

Reading Wavelength

Ultrafilter recognition code (10 characters) 125 KHz

Patient safety

The system guarantees, if properly configured, recognition of depletion of the ultrafilter eliminating the risk of errors by the operators.


SPHYGMOMANOMETERSPHYGMOMANOMETERSPHYGMOMANOMETERSPHYGMOMANOMETER TECHNICAL TECHNICAL TECHNICAL TECHNICAL CHARACTERISTICSCHARACTERISTICSCHARACTERISTICSCHARACTERISTICS

Operating principle

Oscillometric method

Pressure measurement

Systolic: 40 - 260 mmHg

Diastolic: 20 - 200 mmHg

Heart rate

40 - 200 beats per minute

Accuracy (pressure measurement) ± 3 mmHg between 0 and 300 mmHg in operating conditions between 0° and 50°C.

Accuracy (heart rate) ±2% or ±3 beats per minute whichever is greater

Inflation

automatic

Cuff: suitable for adult patients only

Plus Plus Plus Plus code 4941270 **This cuff is supplied with the sphygmomanometer

Arm circumference 310 - 400 mm

Small Small Small Small code 4941275 Arm circumference 230 - 330 mm

LargeLargeLargeLarge code 4941280 Arm circumference 380 - 500 mm

Patient safety The operating software assures that: - max. cuff inflation time is limited to 50 seconds;

- duration of blood pressure reading is limited to 130 seconds.

Additional redundant safety circuitry oversees normal operation and will override to abort a reading if: - cuff pressure exceeds 300 mmHg at any time;

- the cuff has been inflated for 180 seconds.

Defibrillation-proof type BF applied part (ref. EN 60601-1)

Bellco


Kt/VKt/VKt/VKt/V TECHNICAL CHARACTERISTICS TECHNICAL CHARACTERISTICS TECHNICAL CHARACTERISTICS TECHNICAL CHARACTERISTICS

Operating principle

Conductometric Method

Dialysance Measurement

Max: 700 ml/min.

Resolution 1 ml/min

Accuracy

+ 10%

Alarms Refer to the chapter on alarms


MATERIALSMATERIALSMATERIALSMATERIALS

BODY BODY BODY BODY

BAYDUR and polystyrene, self extinguishing.

MATERIALS IN CONTACTMATERIALS IN CONTACTMATERIALS IN CONTACTMATERIALS IN CONTACT WITH DIALYSIS FLUID WITH DIALYSIS FLUID WITH DIALYSIS FLUID WITH DIALYSIS FLUID

Metallic materials:Metallic materials:Metallic materials:Metallic materials: Stainless steel AISI 316 (UNI X5CrNiMo1712) Titanium grade 5 (6AL4V ASTM B348) Stainless steel UHB 904L/R 840 Stainless steel AISI 302 Stainless steel AISI 316 L(UNI X2CrNiMo1712) Ceramic materials:Ceramic materials:Ceramic materials:Ceramic materials: Pure alumina 99.7% Al2O3 (ceramic)

Plastic materials:Plastic materials:Plastic materials:Plastic materials: Polypropylene PP (Moplen) Polyoxymethylene POM (Delrin) Vinylidene polyfluoride PVDF (Kynar) Polycarbonate PC (Makrolon) Polyetherimide PEI (Ultem) Polytetrafluoroethylene PTFE (virgin Teflon) Polysulfone PSU (Udel) Polyarylether PEEK (Victrex) Polyphenylsulfide PPS (Ryton R4) Glass:Glass:Glass:Glass: Borosilicated glass 3.3 DIN-ISO 3585 (Duran)

Elastomeric materials:Elastomeric materials:Elastomeric materials:Elastomeric materials: Silicone VMQ-FG Silicone VMQ-FG + fabric Fluorosilicone MVSQ Ethylene-propylene-diene EPDM Silicone VMQ-FG (silopren LSR) Silicone VMQ-FG (elastosil LR) Medical silicone, Si (raumed) Silicone, red, SI

Tubes:Tubes:Tubes:Tubes: Polyvinylchloride PVC+fabric (Raufilam) Silicone VMQ-FG Silicone VMQ-FG + fabric Medical silicone, Si (raumed)

Lubricants:Lubricants:Lubricants:Lubricants: Medical silicone spray Ethanol, colourless Threadlockers:Threadlockers:Threadlockers:Threadlockers: Anaerobic adhesive, monocomponent (Sichel 100 M SP)

Bellco


REQUIREMENTS OF THE STANDARD IEC 60601REQUIREMENTS OF THE STANDARD IEC 60601REQUIREMENTS OF THE STANDARD IEC 60601REQUIREMENTS OF THE STANDARD IEC 60601----1111----2:20012:20012:20012:2001

The FORMULA FORMULA FORMULA FORMULA dialysis machine is suitable for use in the specified electromagnetic environment. The purchaser or user of FORMULAFORMULAFORMULAFORMULA should assure that it is used in an electromagnetic environment as described below:

Emissions testEmissions testEmissions testEmissions test ComplianceComplianceComplianceCompliance Electromagnetic EnvironmentElectromagnetic EnvironmentElectromagnetic EnvironmentElectromagnetic Environment

Class B The device FORMULAFORMULAFORMULAFORMULA is suitable for use in domestic establishments and in establishments directly connected to the low voltage power supplies network which supplies buildings used for domestic purposes.

Radiated and conducted RF emissions

CISPR 11

Group 1 The device FORMULAFORMULAFORMULAFORMULA uses RF energy only for its internal function. Therefore, the RF emission is very low and not likely to cause interference in nearby electronic equipment.

Harmonic emissions

EN 61000-3-2

Complies The device FORMULAFORMULAFORMULAFORMULA is suitable for use in establishments directly connected to a public low voltage power supply network.

Voltage fluctuations/ Flicker emissions

EN 61000-3-3

Complies The device FORMULAFORMULAFORMULAFORMULA is suitable for use in establishments directly connected to a public low voltage power supply network.

The FORMULA FORMULA FORMULA FORMULA dialysis machine is suitable for use in the specified electromagnetic environment. The purchaser or user of FORMULAFORMULAFORMULAFORMULA should assure that it is used in an electromagnetic environment as described below:

Immunity testImmunity testImmunity testImmunity test Test levelTest levelTest levelTest level magnetic field EN magnetic field EN magnetic field EN magnetic field EN

60601606016060160601----1111----2222

Compliance Compliance Compliance Compliance levellevellevellevel

Electromagnetic EnvironmentElectromagnetic EnvironmentElectromagnetic EnvironmentElectromagnetic Environment

Electrostatic discharge (ESD) EN 61000-4-2

±6 kV contact ±8 kV air

EN 60601-1-2 Test level

Residential

Radiated RF EN 61000-4-3 Conducted RF EN 61000-4-6

Non-life supporting equipment 3 V/m 80 MHz to 2.5 GHz Non-life supporting equipment 3 V 150 kHz to 80 MHz



Residential

Electrical fast transient/burst EN 61000-4-4

±2 kV for power supply lines ±1 kV for


Residential


input/output lines>3m

Surge EN 61000-4-5

±1 kV differential mode ±2 kV common mode


Residential

Voltage dips, short interruptions and voltage variations on power supply input lines EN 61000-4-11

0% Un for 0.5 cycles 40% Un for 5 cycles 70% Un for 25 cycles 0% Un per 5 s


Residential

Power frequency (50/60 Hz) EN 61000-4-8

3 A/m EN 60601-1-2 Test level

Residential

Recommended Separation Distance for nonRecommended Separation Distance for nonRecommended Separation Distance for nonRecommended Separation Distance for non----LIFE SUPPORTING EQUIPMENTLIFE SUPPORTING EQUIPMENTLIFE SUPPORTING EQUIPMENTLIFE SUPPORTING EQUIPMENT

RF SourceRF SourceRF SourceRF Source Typical Rated Power Typical Rated Power Typical Rated Power Typical Rated Power (W)(W)(W)(W)

DistanceDistanceDistanceDistance (m)(m)(m)(m)

Microcellular phone CT1, CT2, CT3 0,01 0,4

DECT cellular phone, wireless information technology equipment (modem, LAN)

0,25 2

Cellular phone, hand-held (USA) 0,6 3

Cellular phone, hand-held (e.g. GSM and NMT, Europe; DECS 1800)

2 8

6 11

Walkie-talkie (rescue, police, fire, maintenance)

5 9

Cellular phone 16 16

Mobile radio (rescue, police, fire) 100 40

For transmitters using frequencies below 800 MHz, the DISTANCE can be estimated using Equation A:

Pd 4=

For transmitters using frequencies between 800 MHz and 2,5 GHz, the DISTANCE can be estimated using Equation B:

Pd 3,2=

where P is the rated power of the transmitter in Watt (W) according to the transmitter manufacturer.

ENG – Ed. 06/09 chap. 3.1 – Start-up, Test, Rinse - 1 of 4

3.1 START-UP, TEST, RINSE

PRELIMINARY CONDITIONS • The machine must be connected to a haemodialysis water source and the tap must be open. • The power cable must be connected to the mains socket. • The water drain line must be positioned in the drain. • The machine must be off. • The patient must be disconnected from the blood lines and the dialyser. • The consumption materials must be available. NOTE Ensure that the national regulations concerning drain-traps and the point-to-point distance to the drain are respected.

ELECTRICAL AND HYDRAULIC CONNECTION 1. Position the machine in a suitable place and block the wheels. 2. Connect the water inlet tube to the water supply of the dialysis room. 3. Insert the special tube in the drain. The drain must be at atmospheric pressure to prevent

siphon effects (max. height: 800 mm). Check that the tubes are not squashed or occluded. 4. Connect the power cable directly to the mains outlet. 5. Open the haemodialysis water delivery tap. 6. Switch on the main switch on the rear panel of the machine.

7. Wait until the LED next to the key on the front panel comes on (orange). 8. If required, it is possible to enter machine configuration following the instructions given in the

dedicated chapter of this manual.

POWER ON Turn on the machine using the main switch located at the rear.

Wait until the LED next to the key on the front panel comes on (orange).

Press the key . The LED turns green. WARNING Check that the alarm indicator turns on and the acoustic warning indicator emits a signal.

2 of 4 – chap. 3.1 – Start-up, Test, Rinse ENG - Ed. 06/09

After a few seconds the screen comes on, and the formula® logo appears with the software release. In this phase, the equipment performs the initial autodiagnostic tests.

Upon conclusion of the initial tests, a rinsing phase which lasts a few minutes (not modifiable by the operator) starts. Simultaneously the autodiagnostic tests begin on both the dialysis fluid side and the blood side. When the blood tests are successfully completed, WAIT appears on the blood status bar of the

screen. The function key

select priming

appears. At this point it is possible to start installing the blood lines. During the tests the following functions keys are available:

switch off

To switch off the machine.

select priming

To prime the blood lines.

special treatment

To change the haemodiafiltration treatment set in configuration (refer to the chapter " Preparation of Treatment ").

filter management

To replace the Forclean and/or Multipure filters (refer to Chapter “Management of ultrafilters and Multipure filter).

disinfection/ cleaning

To program disinfection, descaling, centralized disinfection/cleaning, programmed disinfection/cleaning.

sensors

To access the sensor menu (see the Chapter “FORMULA PLUS SENSORS”).

A positive outcome of the dialysate tests is indicated by the message SYSTEM READY and the word RINSING on the top left side. The dialysis system is ready to be programmed.

The function key

select dialysis

appears.

ENG – Ed. 06/09 chap. 3.1 – Start-up, Test, Rinse - 3 of 4

The machine reverts to a low-consumption rinsing condition. The rinsing time is indicated by the circular tool on the left of the screen (mm: sec). During the above described phases the following icons may be present on the screen:

or

“Disinfection/cleaning performed icon”: for meaning and management, refer to the “Disinfection/cleaning” chapter.

indicates that a disinfection/cleaning has been programmed. To check the program set, and if necessary to modify it,

disinfection/cleaning

weekly disinf./clean.

indicates that a disinfection/cleaning has not been programmed.

Indicate that the internal battery is installed. Red icon = the battery test did not have a positive outcome and therefore the machine will not be able to operate if there is a power fail.

Green icon = the battery is operating

AUTOMATIC TURNING ON formula® has the possibility to automatically turn on, at the time set by the operator, to run the tests and enter the SYSTEM READY state. This performance has to be set during configuration, i.e. the parameters POWER ON and START TIME are to be set (in the weekly setting page). Automatic turning on can also be set from the keyboard of the display.

•



• Select the desired day.

• In the next menu, set POWER ON in the field TYPE, set the desired time for automatic turning on in the field START TIME.

•

ok to confirm.

Always check that the main switch located at the rear of the machine is in the ON position (I).

4 of 4 – chap. 3.1 – Start-up, Test, Rinse ENG - Ed. 06/09

ENG – Ed. 06/09 chap. 3.2 – Dialysis Fluid Preparation - 1 of 8

3.2 DIALYSIS FLUID PREPARATION3.2 DIALYSIS FLUID PREPARATION3.2 DIALYSIS FLUID PREPARATION3.2 DIALYSIS FLUID PREPARATION

DIALYSATE PREPARATION WITH LIQUID/ POWDER BICARBONATE DIALYSATE PREPARATION WITH LIQUID/ POWDER BICARBONATE DIALYSATE PREPARATION WITH LIQUID/ POWDER BICARBONATE DIALYSATE PREPARATION WITH LIQUID/ POWDER BICARBONATE or ACETATEor ACETATEor ACETATEor ACETATE


It is recommended to use concentrate solutions suitable to the type and It is recommended to use concentrate solutions suitable to the type and It is recommended to use concentrate solutions suitable to the type and It is recommended to use concentrate solutions suitable to the type and duration of the treatment in terms of composition and quantity. Consequently, duration of the treatment in terms of composition and quantity. Consequently, duration of the treatment in terms of composition and quantity. Consequently, duration of the treatment in terms of composition and quantity. Consequently, check the technical specifications of the concentrate solutions in the labels on check the technical specifications of the concentrate solutions in the labels on check the technical specifications of the concentrate solutions in the labels on check the technical specifications of the concentrate solutions in the labels on the containers anthe containers anthe containers anthe containers and/or bags (composition, quantity/volumes, dilution ratio, and d/or bags (composition, quantity/volumes, dilution ratio, and d/or bags (composition, quantity/volumes, dilution ratio, and d/or bags (composition, quantity/volumes, dilution ratio, and so on.).so on.).so on.).so on.).

The most suitable concentrate solution must be determined by the physician The most suitable concentrate solution must be determined by the physician The most suitable concentrate solution must be determined by the physician The most suitable concentrate solution must be determined by the physician responsible for the treatment.responsible for the treatment.responsible for the treatment.responsible for the treatment.

Check that the dialysis system is configured for the type of concentrate used (Check that the dialysis system is configured for the type of concentrate used (Check that the dialysis system is configured for the type of concentrate used (Check that the dialysis system is configured for the type of concentrate used (3 3 3 3 or 5or 5or 5or 5 mS/cm). Use of wrong concentrates represents a risk for the patient.mS/cm). Use of wrong concentrates represents a risk for the patient.mS/cm). Use of wrong concentrates represents a risk for the patient.mS/cm). Use of wrong concentrates represents a risk for the patient.

Do not use concentrate solutions whose container was previously opened or Do not use concentrate solutions whose container was previously opened or Do not use concentrate solutions whose container was previously opened or Do not use concentrate solutions whose container was previously opened or looks damaged.looks damaged.looks damaged.looks damaged.

The sodium bicarbonate powder cartridge makes it possible to prepare the dialysis fluid for dialysis treatment. All formula® models are equipped for the use of a powder bicarbonate cartridge, according to two alternative options: cartridge with luer lock connection (Bidry), or perforated cartridge.


The powder bicarbonate cartridge The powder bicarbonate cartridge The powder bicarbonate cartridge The powder bicarbonate cartridge maymaymaymay only be used with machines set for only be used with machines set for only be used with machines set for only be used with machines set for partial conductivity to 3mS/cm. partial conductivity to 3mS/cm. partial conductivity to 3mS/cm. partial conductivity to 3mS/cm.

Use the powder bicarbonate cartridge only after having carefully read the Use the powder bicarbonate cartridge only after having carefully read the Use the powder bicarbonate cartridge only after having carefully read the Use the powder bicarbonate cartridge only after having carefully read the instructions for use provided with the cartridge.instructions for use provided with the cartridge.instructions for use provided with the cartridge.instructions for use provided with the cartridge.

The powder bicarbonate cartridge must be used with acid concentrate suitable The powder bicarbonate cartridge must be used with acid concentrate suitable The powder bicarbonate cartridge must be used with acid concentrate suitable The powder bicarbonate cartridge must be used with acid concentrate suitable for use with pure sodium bicarbonate solution and appropriate for 1:35 or for use with pure sodium bicarbonate solution and appropriate for 1:35 or for use with pure sodium bicarbonate solution and appropriate for 1:35 or for use with pure sodium bicarbonate solution and appropriate for 1:35 or 1:45 dilution ratios.1:45 dilution ratios.1:45 dilution ratios.1:45 dilution ratios.

Check the expiry date and integrity of the powder bicarbonate cartridge and its Check the expiry date and integrity of the powder bicarbonate cartridge and its Check the expiry date and integrity of the powder bicarbonate cartridge and its Check the expiry date and integrity of the powder bicarbonate cartridge and its proproproprotective wrapping.tective wrapping.tective wrapping.tective wrapping.

Use the powder bicarbonate cartridge only once and for a single treatment. Do Use the powder bicarbonate cartridge only once and for a single treatment. Do Use the powder bicarbonate cartridge only once and for a single treatment. Do Use the powder bicarbonate cartridge only once and for a single treatment. Do not keep it and use for another treatment.not keep it and use for another treatment.not keep it and use for another treatment.not keep it and use for another treatment.

Do not administer dialysis solutions obtained parenterally.Do not administer dialysis solutions obtained parenterally.Do not administer dialysis solutions obtained parenterally.Do not administer dialysis solutions obtained parenterally.

Make sure that the Make sure that the Make sure that the Make sure that the piercingpiercingpiercingpiercing connectors are not unplugged connectors are not unplugged connectors are not unplugged connectors are not unplugged during rinse and during rinse and during rinse and during rinse and disinfection/cleaning modes; if during such phases the disinfection/cleaning modes; if during such phases the disinfection/cleaning modes; if during such phases the disinfection/cleaning modes; if during such phases the piercingpiercingpiercingpiercing connectors are connectors are connectors are connectors are not plugged correctly on the mobile bypass, it is possible to have alarms, a not not plugged correctly on the mobile bypass, it is possible to have alarms, a not not plugged correctly on the mobile bypass, it is possible to have alarms, a not not plugged correctly on the mobile bypass, it is possible to have alarms, a not corrected disinfection/cleaning or an insufficient rinse of the hydraulic circucorrected disinfection/cleaning or an insufficient rinse of the hydraulic circucorrected disinfection/cleaning or an insufficient rinse of the hydraulic circucorrected disinfection/cleaning or an insufficient rinse of the hydraulic circuit.it.it.it.

2 of 8 – chap. 3.2 – Dialysis Fluid Preparation ENG - Ed. 06/09

The upper The upper The upper The upper piercingpiercingpiercingpiercing connector can contain a permanent magnet, therefore it connector can contain a permanent magnet, therefore it connector can contain a permanent magnet, therefore it connector can contain a permanent magnet, therefore it must be handled with caution by individuals with pacemakers. must be handled with caution by individuals with pacemakers. must be handled with caution by individuals with pacemakers. must be handled with caution by individuals with pacemakers.

NOTENOTENOTENOTE

• Check that the quantity of concentrate used is sufficient to complete the Check that the quantity of concentrate used is sufficient to complete the Check that the quantity of concentrate used is sufficient to complete the Check that the quantity of concentrate used is sufficient to complete the therapy, so as to avoid exhaustion of the containers/bags and their therapy, so as to avoid exhaustion of the containers/bags and their therapy, so as to avoid exhaustion of the containers/bags and their therapy, so as to avoid exhaustion of the containers/bags and their consequent replacement during treatment.consequent replacement during treatment.consequent replacement during treatment.consequent replacement during treatment.

• If containers are used, for proper mixing, check that the concentrate If containers are used, for proper mixing, check that the concentrate If containers are used, for proper mixing, check that the concentrate If containers are used, for proper mixing, check that the concentrate aspiration lines are properly inserted in the containers of concentrate saaspiration lines are properly inserted in the containers of concentrate saaspiration lines are properly inserted in the containers of concentrate saaspiration lines are properly inserted in the containers of concentrate saline line line line solutions.solutions.solutions.solutions.

• Check that the powder bicarbonate cartridge Check that the powder bicarbonate cartridge Check that the powder bicarbonate cartridge Check that the powder bicarbonate cartridge connectorconnectorconnectorconnectorssss arararareeee properly properly properly properly positioned on the machine.positioned on the machine.positioned on the machine.positioned on the machine.

• Check that the set conductivity allows reaching the correct composition of Check that the set conductivity allows reaching the correct composition of Check that the set conductivity allows reaching the correct composition of Check that the set conductivity allows reaching the correct composition of the dialysis fluid obtained with the concentrates used.the dialysis fluid obtained with the concentrates used.the dialysis fluid obtained with the concentrates used.the dialysis fluid obtained with the concentrates used.

• Frequently check the level of contaminants in the dialysis liquid. Frequently check the level of contaminants in the dialysis liquid. Frequently check the level of contaminants in the dialysis liquid. Frequently check the level of contaminants in the dialysis liquid.

• If a certain type of concentrate solution is used for the first time, it is If a certain type of concentrate solution is used for the first time, it is If a certain type of concentrate solution is used for the first time, it is If a certain type of concentrate solution is used for the first time, it is suggested to draw a sample of dialysis fluid before the treatment and to suggested to draw a sample of dialysis fluid before the treatment and to suggested to draw a sample of dialysis fluid before the treatment and to suggested to draw a sample of dialysis fluid before the treatment and to check its correct composition.check its correct composition.check its correct composition.check its correct composition.

select dialysis

. The following window will appear.

bicarbonate + conc A STD

or

bicarbonate+ lympha

to set dialysis with liquid bicarbonate or standard acid concentrate or Lympha (acetate-free solution).

acetate

to set an acetate dialysis.


bidry + conc A STD

or

bidry + lympha

to set dialysis with powder bicarbonate or standard acid concentrate or Lympha (acetate-free solution). Select the desired dialysis fluid with the relevant function key. Should two different dialysing fluids be associated to the same function key, press the

key once (e.g.

bicarbonate+ conc A STD

) to select a dialysis fluid type, press twice to select the

alternative dialysis fluid type, (i.e.

bicarbonate+ lympha

).

ok

to confirm.

NOTENOTENOTENOTE

selectdialysis

allows setting the treatment both in the blood and the dialysate allows setting the treatment both in the blood and the dialysate allows setting the treatment both in the blood and the dialysate allows setting the treatment both in the blood and the dialysate compartments.compartments.compartments.compartments.

In all In all In all In all models of the models of the models of the models of the formula device, with the exception of the device, with the exception of the device, with the exception of the device, with the exception of the formula Therapy, priming of the extracorporeal circuit can be performed with the use Therapy, priming of the extracorporeal circuit can be performed with the use Therapy, priming of the extracorporeal circuit can be performed with the use Therapy, priming of the extracorporeal circuit can be performed with the use of bags of physiological solution before/during/after the preparation of the of bags of physiological solution before/during/after the preparation of the of bags of physiological solution before/during/after the preparation of the of bags of physiological solution before/during/after the preparation of the dialysate. dialysate. dialysate. dialysate.

In the In the In the In the formula Therapy model, this is true with the except Therapy model, this is true with the except Therapy model, this is true with the except Therapy model, this is true with the exception of HDF PRE, HDF ion of HDF PRE, HDF ion of HDF PRE, HDF ion of HDF PRE, HDF POST, MIDPOST, MIDPOST, MIDPOST, MID----HDF, PHF PRE, PHF POST treatments, where priming can be HDF, PHF PRE, PHF POST treatments, where priming can be HDF, PHF PRE, PHF POST treatments, where priming can be HDF, PHF PRE, PHF POST treatments, where priming can be performed only after preparing the dialysate. performed only after preparing the dialysate. performed only after preparing the dialysate. performed only after preparing the dialysate.

PARAMETER SETTING PARAMETER SETTING PARAMETER SETTING PARAMETER SETTING

Set the dialysis fluid parameters as described in the chapter Operator Interface – Dialysing Solution Section; the settable parameters are the following: • Bicarbonate Conductivity • Total Conductivity • Temperature • Dialysis Fluid Flow


CONCENTRATE SOLUTIONS CONNECTIONCONCENTRATE SOLUTIONS CONNECTIONCONCENTRATE SOLUTIONS CONNECTIONCONCENTRATE SOLUTIONS CONNECTION

If liquid concentrates in containers are used, open the containers, insert the cannulas and connect the concentrate connectors:

Bicarbonate dialysisBicarbonate dialysisBicarbonate dialysisBicarbonate dialysis: connect the blueblueblueblue connector to the bicarbonatebicarbonatebicarbonatebicarbonate concentrate container, connect the white/redwhite/redwhite/redwhite/red connector to the acidacidacidacid concentrate container.

Acetate dialysisAcetate dialysisAcetate dialysisAcetate dialysis: Connect the white/redwhite/redwhite/redwhite/red connector to the acetateacetateacetateacetate concentrate. If liquid concentrates in bags are used, attach the concentrate connectors to the proper connector and refer to the instruction sheets of the bags.

Bicarbonate dialysis with containersBicarbonate dialysis with containersBicarbonate dialysis with containersBicarbonate dialysis with containers Acetate dialysis with containers Acetate dialysis with containers Acetate dialysis with containers Acetate dialysis with containers

BIC AC

If the powder bicarbonate cartridge is used, proceed with its connection.


BIDRY CARTRIDGE INSTALLATIONBIDRY CARTRIDGE INSTALLATIONBIDRY CARTRIDGE INSTALLATIONBIDRY CARTRIDGE INSTALLATION

• Mount the cartridge on its support hooks with the blue connector at the top right.

• Connect the transparent connector of the cartridge to the Bidry connector of the

machine.

• Insert the other end of the cartridge (blue connector) in the Luer connector on the

block.

• Check that the clamps on the cartridge inlet and outlet lines are open.

• Connect the white/red connector to the acid concentrate.


PERFORATED CARTRIDGE INSTALLATIONPERFORATED CARTRIDGE INSTALLATIONPERFORATED CARTRIDGE INSTALLATIONPERFORATED CARTRIDGE INSTALLATION

• Completely rotate the locking bracket so as to release the upper piercing connector (Fig.1).

• Disconnect the upper piercing connector from the mobile bypass.

• Lift the mobile bypass (Fig.2).

• Place the lower cartridge end into the lower piercing connector.

• Secure the upper piercing connector on the upper cartridge end and insert it into upper clip support (Fig.3).

• Connect the white/red connector to the acid concentrate.

Fig.1

Fig.2

Fig.3


CHANGING THE CONCENTRATE TYPECHANGING THE CONCENTRATE TYPECHANGING THE CONCENTRATE TYPECHANGING THE CONCENTRATE TYPE

To change the concentrate type during the treatment, proceed as follows:

modify treatment

. Select the treatment type (acetate, bicarbonate + standard acid concentrate, bicarbonate + Lympha, bidry + standard acid concentrate, bidry + Lympha ).

ok

. If the dialysate type has been changed, the following dialogue window will appear: Ex:

yes

to confirm.

return

to return to the previous menu.


Connect the concentrate connectors according to the selected treatment (refer Connect the concentrate connectors according to the selected treatment (refer Connect the concentrate connectors according to the selected treatment (refer Connect the concentrate connectors according to the selected treatment (refer to the previous paragraphs).to the previous paragraphs).to the previous paragraphs).to the previous paragraphs).

The CONCENTRATE CONNECTORS alarm indicates that one of the connectors The CONCENTRATE CONNECTORS alarm indicates that one of the connectors The CONCENTRATE CONNECTORS alarm indicates that one of the connectors The CONCENTRATE CONNECTORS alarm indicates that one of the connectors has been wronghas been wronghas been wronghas been wrongly positioned.ly positioned.ly positioned.ly positioned.

The CONCENTRATE ERROR alarm indicates that concentrates different from The CONCENTRATE ERROR alarm indicates that concentrates different from The CONCENTRATE ERROR alarm indicates that concentrates different from The CONCENTRATE ERROR alarm indicates that concentrates different from those selected are being used or air has been aspirated from one of the those selected are being used or air has been aspirated from one of the those selected are being used or air has been aspirated from one of the those selected are being used or air has been aspirated from one of the connectors.connectors.connectors.connectors.

NOTENOTENOTENOTE

If the Profiler application is active, the type of concentrate solution cannot be If the Profiler application is active, the type of concentrate solution cannot be If the Profiler application is active, the type of concentrate solution cannot be If the Profiler application is active, the type of concentrate solution cannot be changed without first disabling the Profiler.changed without first disabling the Profiler.changed without first disabling the Profiler.changed without first disabling the Profiler.

CONNECTION TO THE DIALYSERCONNECTION TO THE DIALYSERCONNECTION TO THE DIALYSERCONNECTION TO THE DIALYSER

• When the led indicator of the key lights up and the BYPASS warning appears, disconnect the blue Hansen connector from the machine and connect it to the dialysis fluid inlet connector of the dialyser.

• Disconnect the red Hansen connector from the machine and connect it to the dialysate outlet connector of the dialyser.

• again to fill the dialyser.

Dialysate: BIDRY+LYMPHA Do you confirm?


• When the message BIC. appears in the top left side. (/BIDRY/ACETATE) + STD A. CONC. (/LYMPHA) – STAND-BY, the dialysate is ready.

• In this phase , provided that blood has not yet been detected, the function DialyserDialyserDialyserDialyser

Rinse onRinse onRinse onRinse on may be activated, which allows performing ultrafiltration to remove any substances, e.g. glycerine, from the dialyser.

•

dialyserrinse on

. The function key turns into

dialyserrinse off

.

Ultrafiltration carried out corresponds to the value set at configuration (default value = 0,5 kg/h).

• This function is temporarily interrupted any time an alarm triggers but restarts as soon as the alarm is cleared. It is automatically disabled when blood has been detected.

NOTENOTENOTENOTE

UltraUltraUltraUltrafiltration carried out during the Dialyser Rinse functionfiltration carried out during the Dialyser Rinse functionfiltration carried out during the Dialyser Rinse functionfiltration carried out during the Dialyser Rinse function d d d does not affect the oes not affect the oes not affect the oes not affect the programmed ultrafiltration during dialysis.programmed ultrafiltration during dialysis.programmed ultrafiltration during dialysis.programmed ultrafiltration during dialysis. • The dialysis fluid flow sets to the programmed value only when blood is detected.

During dialysis fluid preparation, the flow is automatically set to a minimum value.

SETTING THE ULTRAFILTRATION PROGRAMSETTING THE ULTRAFILTRATION PROGRAMSETTING THE ULTRAFILTRATION PROGRAMSETTING THE ULTRAFILTRATION PROGRAM


The dialysis parameters must be adapted to the patient, therefore, the The dialysis parameters must be adapted to the patient, therefore, the The dialysis parameters must be adapted to the patient, therefore, the The dialysis parameters must be adapted to the patient, therefore, the ultrafiltration program must be carried out under supervision of the physician ultrafiltration program must be carried out under supervision of the physician ultrafiltration program must be carried out under supervision of the physician ultrafiltration program must be carried out under supervision of the physician prescribing the treatment.prescribing the treatment.prescribing the treatment.prescribing the treatment. Set the ultrafiltration parameters as described in the chapter Operator Interface – Dialysing Solution Section; the settable parameters are the following: • Weight Loss • Treatment time • Hourly Ultrafiltration • Ultrafiltration/transmembrane pressure thresholds Hourly UF may be set as single parameter or is obtained from the weight loss – treatment time ratio. Refer to the Operator Interface chapter for the individual parameter settings. When the settings have been made, the relevant tool displays the UF/h value.

uf on

.

The function

uf set

appears to indicate that the program has been enabled. The program will start just a few seconds after detecting blood in the arterial line. In case heparin should be administered, follow the instructions in Chapter “Heparin”.

ENG – Ed. 06/09 chap. 3.3 – Preparation of treatment - 1 of 6

3.3 3.3 3.3 3.3 PREPARATIONPREPARATIONPREPARATIONPREPARATION OF OF OF OF THE THE THE THE TREATMENTTREATMENTTREATMENTTREATMENT

TREATMENT SELECTION TREATMENT SELECTION TREATMENT SELECTION TREATMENT SELECTION

In the rinsing phase, the

special treatment

function is enabled, which allows to modify the configured haemodiafiltration (HDF/HDF OnLine, HFR, PHF) treatment already set. On formula2000 machines not configured for haemodiafiltration treatments, the choice of the blood treatments is the following:

double needle

s. needle (s. pump)

s. needle (d. pump)

only if the presence of the second pump has been configured.

If, however, the machine is configured to perform a haemodiafiltration treatment, the combination of the functions keys allows selecting from 4 or more treatment modes:

double needle

s. needle (s. pump)

or

s. needle (d. pump)

hdf

double needle

s. needle (s. pump)

or

s. needle (d. pump)

phf pre

or

phf post

double needle

s. needle (s. pump)

or

s. needle (d. pump)

hfr Selecta

or

hfr Selecta Plus

2 of 6 - chap. 3.3 – Preparation of treatment ENG - Ed. 06/09

or, only for the Therapy model

double needle

s. needle (s. pump)

or

s. needle (d. pump)

mid-hdf

or

hdf pre

or

hdf post

Select the desired treatment with the relevant function key. Should two treatments be associated to the same function key, press the key once (e.g.

s. needle (s. pump)

) to select the treatment, press twice or more to select the alternative

treatment or treatments (i.e.

s. needle (d. pump)

).

return

to cancel and return to the previous menu, or

ok

to confirm selection. NOTENOTENOTENOTE

Press Press Press Press

cancel priming

to cancel priming and return to the rinsing phase. to cancel priming and return to the rinsing phase. to cancel priming and return to the rinsing phase. to cancel priming and return to the rinsing phase.

NOTENOTENOTENOTE

In case oIn case oIn case oIn case of an error in the selection of a haemodiafiltration treatment, you can f an error in the selection of a haemodiafiltration treatment, you can f an error in the selection of a haemodiafiltration treatment, you can f an error in the selection of a haemodiafiltration treatment, you can ––––

only in priming only in priming only in priming only in priming –––– change this selection using change this selection using change this selection using change this selection using

cancel priming

or, if priming can no or, if priming can no or, if priming can no or, if priming can no longer be cancelled using the following procedure:longer be cancelled using the following procedure:longer be cancelled using the following procedure:longer be cancelled using the following procedure:

modify treatment

double needle

ok

modify treatment


mid-hdf

or or or or

hdf pre

or or or or

hdf post

or or or or phf pre

or or or or phf post

hfr Selecta

or or or or

hfr Selecta Plus

ok

The moment the new treatment is confirmed, the totalThe moment the new treatment is confirmed, the totalThe moment the new treatment is confirmed, the totalThe moment the new treatment is confirmed, the totalizedizedizedized priming volume is priming volume is priming volume is priming volume is set to zero.set to zero.set to zero.set to zero.

NOTENOTENOTENOTE

To modify the stop priming or end priming volumes, press To modify the stop priming or end priming volumes, press To modify the stop priming or end priming volumes, press To modify the stop priming or end priming volumes, press

see/mod. parameters

and and and and

blood

and respectively sele and respectively sele and respectively sele and respectively select ct ct ct

stop priming

or or or or

priming volume

.... Refer to chapter on disposable devices for the list of disposable devices to use for the selected treatment.

BLOOD LINE INSTALLATIONBLOOD LINE INSTALLATIONBLOOD LINE INSTALLATIONBLOOD LINE INSTALLATION


• The use of specific blood lines is recommended (sThe use of specific blood lines is recommended (sThe use of specific blood lines is recommended (sThe use of specific blood lines is recommended (see the chapter concerning ee the chapter concerning ee the chapter concerning ee the chapter concerning disposable devices).disposable devices).disposable devices).disposable devices). The alarms and performance can be influenced by the The alarms and performance can be influenced by the The alarms and performance can be influenced by the The alarms and performance can be influenced by the use of inappropriate blood lines, for example, the air detection alarm.use of inappropriate blood lines, for example, the air detection alarm.use of inappropriate blood lines, for example, the air detection alarm.use of inappropriate blood lines, for example, the air detection alarm.

• Use only lines with blood catcher for the connection to the pressure Use only lines with blood catcher for the connection to the pressure Use only lines with blood catcher for the connection to the pressure Use only lines with blood catcher for the connection to the pressure transducers.transducers.transducers.transducers.

• DurDurDurDuring dialysis, if blood or any other fluid comes into contact with the blood ing dialysis, if blood or any other fluid comes into contact with the blood ing dialysis, if blood or any other fluid comes into contact with the blood ing dialysis, if blood or any other fluid comes into contact with the blood catcher, and fluid passage through the membrane is detected or suspected, catcher, and fluid passage through the membrane is detected or suspected, catcher, and fluid passage through the membrane is detected or suspected, catcher, and fluid passage through the membrane is detected or suspected, proceed as follows:proceed as follows:proceed as follows:proceed as follows:

---- replace the line as indicated in the instructions given by the manufacturer; replace the line as indicated in the instructions given by the manufacturer; replace the line as indicated in the instructions given by the manufacturer; replace the line as indicated in the instructions given by the manufacturer; ---- Cont Cont Cont Contact the authorized Afteract the authorized Afteract the authorized Afteract the authorized After----Sales Service to verify and sanitize the internal Sales Service to verify and sanitize the internal Sales Service to verify and sanitize the internal Sales Service to verify and sanitize the internal measurement set;measurement set;measurement set;measurement set; ---- DO NOT USE the machine for further treatments before it has been checked DO NOT USE the machine for further treatments before it has been checked DO NOT USE the machine for further treatments before it has been checked DO NOT USE the machine for further treatments before it has been checked and disinfected.and disinfected.and disinfected.and disinfected.

• To avoid potentially dangerous conditions, carefully read the instructiTo avoid potentially dangerous conditions, carefully read the instructiTo avoid potentially dangerous conditions, carefully read the instructiTo avoid potentially dangerous conditions, carefully read the instructions on ons on ons on ons on the packaging of the blood lines.the packaging of the blood lines.the packaging of the blood lines.the packaging of the blood lines.

• Check that the line packaging, which ensures their sterility, is not damaged Check that the line packaging, which ensures their sterility, is not damaged Check that the line packaging, which ensures their sterility, is not damaged Check that the line packaging, which ensures their sterility, is not damaged and that the sterilization validity date has not expired.and that the sterilization validity date has not expired.and that the sterilization validity date has not expired.and that the sterilization validity date has not expired.

• Ensure that installation is carried out properly using aseptic techniques. Ensure that installation is carried out properly using aseptic techniques. Ensure that installation is carried out properly using aseptic techniques. Ensure that installation is carried out properly using aseptic techniques. General information on several operating procedures is given here below. For the assembly sequence, refer to the chapter on the selected treatment.

After setting up the blood lines,

select priming

to start priming. For the priming sequence, referFor the priming sequence, referFor the priming sequence, referFor the priming sequence, refer to the chapter on the selected treatment to the chapter on the selected treatment to the chapter on the selected treatment to the chapter on the selected treatment.


SEMIAUTOMATIC LOADING OF THE PUMP SEGMENTSEMIAUTOMATIC LOADING OF THE PUMP SEGMENTSEMIAUTOMATIC LOADING OF THE PUMP SEGMENTSEMIAUTOMATIC LOADING OF THE PUMP SEGMENT

Semiautomatic loading of the pump segment makes it easier for the operator to mount the pump segment inside the pump body. Semiautomatic loading of the pump segment must be activated separately for each pump. It can be carried out in Rinsing, Priming and Rinseback modes (when the message EMPTYING appears). Manual operation of the heparin pump plunger can not be done simultaneously with

the pump segment loading. Thus pressing the keys and for positioning the

heparin syringe as well as opening the pump covers, the following functions can be

activated in a mutually exclusive way:

• Automatic operation of the arterial pump: open the cover of the arterial pump and

press . • Automatic operation of the venous pump (or infusion pump): open the cover of the

venous pump (or infusion) and press . • Automatic operation of the heparin pump plunger: close both pump covers and

press or . To carry out the semiautomatic loading of the pump segment: • Open the cover of the pump where the segment is to be mounted. • Position the pump segment in the lower guide-set if it is the arterial pump, in the

left guide-set if it is the venous or infusion pump.

• Press down the key for the arterial pump, instead press for the venous or infusion pump and rotate the pump until completing insertion of the segment.

• If the pump stops rotating (it cannot perform more than one revolution each time), release the key. Then press it again.

NOTENOTENOTENOTE

To avoid To avoid To avoid To avoid crushing injuries be careful not to inadvertently insert your fingers crushing injuries be careful not to inadvertently insert your fingers crushing injuries be careful not to inadvertently insert your fingers crushing injuries be careful not to inadvertently insert your fingers inside the pump while it is rotating.inside the pump while it is rotating.inside the pump while it is rotating.inside the pump while it is rotating.


AUTOMATIC OPENING OF THE CLAMPAUTOMATIC OPENING OF THE CLAMPAUTOMATIC OPENING OF THE CLAMPAUTOMATIC OPENING OF THE CLAMP

To facilitate the installation of the blood lines, an automatic clamp opening procedure may be used (of both clamps in the case of a machine equipped with a double clamp). To open the clamp, • open the cover of the arterial pump, • set the blood pump flow to the max value with the flow regulator. To close the clamp, close the cover of the arterial pump and/or lower the blood pump flow rate. The automatic clamp opening procedure may be activated in all operation phases except during initial blood tests and dialysis.

INSTALLING THE DIALYSERINSTALLING THE DIALYSERINSTALLING THE DIALYSERINSTALLING THE DIALYSER


The use of the dialyzers described in the chapter on singleThe use of the dialyzers described in the chapter on singleThe use of the dialyzers described in the chapter on singleThe use of the dialyzers described in the chapter on single----use devices use devices use devices use devices is is is is recommended. If different dialysers are used, check that the specifications and recommended. If different dialysers are used, check that the specifications and recommended. If different dialysers are used, check that the specifications and recommended. If different dialysers are used, check that the specifications and instructions for use of the dialysers are compatible with use on instructions for use of the dialysers are compatible with use on instructions for use of the dialysers are compatible with use on instructions for use of the dialysers are compatible with use on formula....

The dialyser inlet/outlet connectors must be in conformity with ISO 8637 and The dialyser inlet/outlet connectors must be in conformity with ISO 8637 and The dialyser inlet/outlet connectors must be in conformity with ISO 8637 and The dialyser inlet/outlet connectors must be in conformity with ISO 8637 and EN 1283 standards.EN 1283 standards.EN 1283 standards.EN 1283 standards. Install the dialyser in its support and carefully read the instructions on the packaging related to use of the filter.

MOUNTING THE PRIMING SOLUTION BAGSMOUNTING THE PRIMING SOLUTION BAGSMOUNTING THE PRIMING SOLUTION BAGSMOUNTING THE PRIMING SOLUTION BAGS

Hang the bags containing the physiological solution for priming from the hooks of the stand (max. 10 kg).

Do not hang the bags of priming solution from the scale hooks: use only the Do not hang the bags of priming solution from the scale hooks: use only the Do not hang the bags of priming solution from the scale hooks: use only the Do not hang the bags of priming solution from the scale hooks: use only the relevant support on the I.V. pole.relevant support on the I.V. pole.relevant support on the I.V. pole.relevant support on the I.V. pole.

ENG – Ed. 06/09 chap. 3.4 - Heparin - 1 of 6

3.4 HEPARIN3.4 HEPARIN3.4 HEPARIN3.4 HEPARIN

WARNINGWARNINGWARNINGWARNING Heparin may only be administered under supervision of a physician.Heparin may only be administered under supervision of a physician.Heparin may only be administered under supervision of a physician.Heparin may only be administered under supervision of a physician.

SYRINGE INSTALLATIONSYRINGE INSTALLATIONSYRINGE INSTALLATIONSYRINGE INSTALLATION

1. Prepare a syringe with the required quantity of heparin.

2. Push the syringe plunger to the bottom using the key next to the heparin pump.

3. Mount the syringe in the support.

4. Fix the syringe turning the retaining screw (located in the lower part) clockwise.

5. Connect the syringe to the arterial line.

NOTENOTENOTENOTE Do not unwind the tubing segment of the heparin infusion line.Do not unwind the tubing segment of the heparin infusion line.Do not unwind the tubing segment of the heparin infusion line.Do not unwind the tubing segment of the heparin infusion line.

2 of 6 – chap. 3.4 - Heparin ENG – Ed. 06/09

SSSSYRINGE CAPACITY SETTYRINGE CAPACITY SETTYRINGE CAPACITY SETTYRINGE CAPACITY SETTING/MODIFICATIONING/MODIFICATIONING/MODIFICATIONING/MODIFICATION

This may be carried out both during priming and dialysis:

see/mod.parameters

heparin

syringecapacity

The graphic tool indicates the syringe capacity value currently set (on the right).

Use the or key to set the new value and to confirm.

HEPARIN INFUSION SETHEPARIN INFUSION SETHEPARIN INFUSION SETHEPARIN INFUSION SETTING/MODIFICATIONTING/MODIFICATIONTING/MODIFICATIONTING/MODIFICATION

It may be carried out both during priming and dialysis:

see/mod.parameters

heparin

heparininfusion

The tool indicates the heparin infusion value currently set (on the left).


HEPARIN PREHEPARIN PREHEPARIN PREHEPARIN PRE----STSTSTSTOP SETTING/MODIFICATOP SETTING/MODIFICATOP SETTING/MODIFICATOP SETTING/MODIFICATION ION ION ION

Provision has been made in the machine configuration for a heparin pre-stop value, that is, how long (min) before the end of dialysis the heparin pump interrupts infusion. This value may be modified during both priming and dialysis:

see/mod.parameters

heparin

heparinpre-stop

The tool indicates the pre-stop value currently set (on the left). The max. settable value is 120 minutes.



DISPLAY OF TOTAL HEPDISPLAY OF TOTAL HEPDISPLAY OF TOTAL HEPDISPLAY OF TOTAL HEPARIN INFUSEDARIN INFUSEDARIN INFUSEDARIN INFUSED

In dialysis the total value of the heparin infused can be viewed.

see/mod.parameters

heparin

.

The graphic tool indicates the set heparin infusion on the left, and the total heparin infused on the right.

WARNINGWARNINGWARNINGWARNING The total value of heparin infused only takes the set program into account The total value of heparin infused only takes the set program into account The total value of heparin infused only takes the set program into account The total value of heparin infused only takes the set program into account

and does not consider any heparin infused manually by pressing the and does not consider any heparin infused manually by pressing the and does not consider any heparin infused manually by pressing the and does not consider any heparin infused manually by pressing the and and and and

keys on the front p keys on the front p keys on the front p keys on the front panel.anel.anel.anel.


ACTIVATION OF THE HEACTIVATION OF THE HEACTIVATION OF THE HEACTIVATION OF THE HEPARIN PROGRAMPARIN PROGRAMPARIN PROGRAMPARIN PROGRAM

The heparin program status is clear to the operator by the syringe icon on the right top of the screen. The icon colour is associated to a different meaning.

Indicates that the program has not been previously set. Warning: NO HEPARIN SETTING

grey background

Indicates that the heparin pump is momentarily stopped because of an alarm of the blood side.

white background

Indicates that heparin is being administered.

red background

Indicates that the heparin program was set but not activated.

heparinon

Warning: HEPARIN OFF Also indicates that the pre-stop value has been reached. The heparin pump is off.

green background

Indicates that the heparin user profile is active and that heparin is being administered.

orange background

Indicates that the heparin user profile is active, that heparin is being administered but the infusion value was set to the max. allowed value.

If the heparin program has not been activated, when blood has been detected in the arterial line, the warning NO HEPARIN SETTING appears. This condition is true if the heparin flow rate set in configuration mode is different from 0. Set the heparin infusion value and start the program.

To stop the heparin infusion at any time,

heparinoff

. When the pre-stop time has been reached, if you want to continue infusing, it is necessary to decrease the pre-stop time or increase the dialysis time.

heparinon

.


FILLING THE SYRINGE FILLING THE SYRINGE FILLING THE SYRINGE FILLING THE SYRINGE DURING TREATMENTDURING TREATMENTDURING TREATMENTDURING TREATMENT

1.

heparinoff

.

2. Clamp the heparin infusion line.

3. Unscrew the retaining screw and remove the syringe from the support.

4. Fill the syringe with the required quantity of heparin.

5. Move the plunger to the end of its travel with the key .

6. Mount the syringe as previously described.

7. Remove the clamp from the heparin infusion line.

8.

heparinon

HEPARIN BOLHEPARIN BOLHEPARIN BOLHEPARIN BOLUSESUSESUSESUSES

Two types of heparin boluses can be carried out. At the beginning of the patient connection phase, the machine can deliver a bolus in an amount that can be set during configuration (with the Automatic Heparin Bolus Automatic Heparin Bolus Automatic Heparin Bolus Automatic Heparin Bolus (cc)(cc)(cc)(cc) parameter) and modified during priming. To modify this value:

see/mod. parameters

heparin

.

The

heparin bolus

function key allows the bolus amount to be set, which will then be activated when blood is detected. To enable this function, set and activate the heparin program during priming. Manual boli can be administered during the patient’s connection and dialysis

phases, provided the heparin program is active.

see/mod. parameters

heparin

. The function

heparin bolus

allows to set the size of the bolus which starts after confirmation .


Both these functions are not available if a heparin profile is active .

ENG – Ed. 06/09 chap. 3.5 - Initiating dialysis and treatment process – 1 of 4

3.5 3.5 3.5 3.5 INITIATING INITIATING INITIATING INITIATING DIALYSIS DIALYSIS DIALYSIS DIALYSIS AND AND AND AND TREATMENTTREATMENTTREATMENTTREATMENT PROCESS PROCESS PROCESS PROCESS

PATIENT CONNECTION AND START OF TREATMENTPATIENT CONNECTION AND START OF TREATMENTPATIENT CONNECTION AND START OF TREATMENTPATIENT CONNECTION AND START OF TREATMENT

For patient connection and starting treatment, refer to the chapter on the selected treatment. The following functions keys are available during dialysis:

modifytreatment


If changing the treatment, check that all the parameters are If changing the treatment, check that all the parameters are If changing the treatment, check that all the parameters are If changing the treatment, check that all the parameters are congruent with the treatment selected and modify them if congruent with the treatment selected and modify them if congruent with the treatment selected and modify them if congruent with the treatment selected and modify them if necessarynecessarynecessarynecessary....

see/mod.parameters

Displays and modifies the treatment parameters.

heparinon

Enables the heparin program (see Chapter « Heparin »). The function is available only if the heparin infusion value has been set.

ufoff

Interrupts the UF program in progress, activating a minimum UF of 0.1 kg/h. The treatment time continues to advance.

To restart the UF program, press

ufon

. When the UF program is

reactivated, a window warns the user to check in the

see/mod.parameters

and

dialysate

menu that the ultrafiltration parameters are as desired.

2 of 4 - chap. 3.5 - Initiating dialysis and treatment process ENG - Ed. 06/09

isolated ufon

Activates isolated UF.

sensors

Allows access to the sensor menu and the Kt/V application.

rinseback

Enables the restitution of blood to the patient.

sphygmo measure

Enables sphygmomanometer measurement.

PASSING TO THE SINGLE NEEDLE SINGLE PUMPPASSING TO THE SINGLE NEEDLE SINGLE PUMPPASSING TO THE SINGLE NEEDLE SINGLE PUMPPASSING TO THE SINGLE NEEDLE SINGLE PUMP

During dialysis, it is possible to pass from any treatment mode to Single Needle with single pump.

NOTENOTENOTENOTE

In the Therapy model, if an onIn the Therapy model, if an onIn the Therapy model, if an onIn the Therapy model, if an on----line haemodialine haemodialine haemodialine haemodiafiltration (HDF OnLine, PHF) filtration (HDF OnLine, PHF) filtration (HDF OnLine, PHF) filtration (HDF OnLine, PHF) treatment is being performed, the treatment change to Single Needle does not treatment is being performed, the treatment change to Single Needle does not treatment is being performed, the treatment change to Single Needle does not treatment is being performed, the treatment change to Single Needle does not allow a return to the previous treatment.allow a return to the previous treatment.allow a return to the previous treatment.allow a return to the previous treatment.

Single Needle Dialysis with Single Pump must be considered as an Single Needle Dialysis with Single Pump must be considered as an Single Needle Dialysis with Single Pump must be considered as an Single Needle Dialysis with Single Pump must be considered as an emergency treatment.emergency treatment.emergency treatment.emergency treatment.

•

modifytreatment

s.needle (s.pump)

•

ok

to confirm. • The message DIALYSIS SNsp appears on the top right bar, the blood pump stops

and the alarm message PUMP OFF is displayed. • Disconnect the line for arterial pressure measurement and clamp it. • Set the blood flow to the desired value. • Set the switching pressures and the stroke :

see/mod.parameters

blood

switch p.

and

stroke

• Suggested values: min. switch. p. = 50 mmHg max. switch. p. = 350 –400 mmHg stroke = 20 ml

• to restart the blood pump.

ENG – Ed. 06/09 chap. 3.5 - Initiating dialysis and treatment process – 3 of 4

DIALYSIS WITH ISOLATED UFDIALYSIS WITH ISOLATED UFDIALYSIS WITH ISOLATED UFDIALYSIS WITH ISOLATED UF

Dialysis with isolated UF may be carried out at the beginning, during or at the end of a dialysis session for a maximum time of 60 minutes, provided that the UF program has been activated and no alarms are present.

isolated ufon

. The message BIC. (BIDRY/ACETATE) + STD A. CONC. - ISOLATED appears at the top left of the screen. To set an isolated UF different from the ultrafiltration in progress,

see/mod.parameters

and

dialysate

and then enter the menus UF/HourUF/HourUF/HourUF/Hour or Weight Loss and Treatment TimeWeight Loss and Treatment TimeWeight Loss and Treatment TimeWeight Loss and Treatment Time to modify the parameters and obtain the new isolated UF value. During isolated UF the dialysis fluid flow automatically turns to a minimum value and will be reset to the set value as soon as isolated UF has been completed.

isolated uf off

to at any time stop isolated UF.

Isolated UF is interruptedinterruptedinterruptedinterrupted each time:

• an alarm occurs,

• the keys and have been pressed. Isolated UF is disableddisableddisableddisabled when: • the UF program has ended (message END UF) • an hour of isolated UF has been run.

• the function key

rinseback

has been pressed.

NOTENOTENOTENOTE

If the ultrafiltration parameters If the ultrafiltration parameters If the ultrafiltration parameters If the ultrafiltration parameters have been modified during haemodialysis with have been modified during haemodialysis with have been modified during haemodialysis with have been modified during haemodialysis with isolated UF, when running conventional dialysis the UF value must be checked isolated UF, when running conventional dialysis the UF value must be checked isolated UF, when running conventional dialysis the UF value must be checked isolated UF, when running conventional dialysis the UF value must be checked and modified if necessary, since the machine keeps the ultrafiltration with and modified if necessary, since the machine keeps the ultrafiltration with and modified if necessary, since the machine keeps the ultrafiltration with and modified if necessary, since the machine keeps the ultrafiltration with which isolated UF has been run in memory.which isolated UF has been run in memory.which isolated UF has been run in memory.which isolated UF has been run in memory.

The total duratiThe total duratiThe total duratiThe total duration of the treatment includes the isolated UF time.on of the treatment includes the isolated UF time.on of the treatment includes the isolated UF time.on of the treatment includes the isolated UF time.

Ultrafiltration is not affected by isolated UF.Ultrafiltration is not affected by isolated UF.Ultrafiltration is not affected by isolated UF.Ultrafiltration is not affected by isolated UF.

4 of 4 - chap. 3.5 - Initiating dialysis and treatment process ENG - Ed. 06/09

ULTRAFILTRATION SYSTEM TESTULTRAFILTRATION SYSTEM TESTULTRAFILTRATION SYSTEM TESTULTRAFILTRATION SYSTEM TEST

At 30 minute intervals, the equipment runs a self-test of the ultrafiltration system. While the test is running, the message bar displays the word SELF-TEST.

NOTENOTENOTENOTE

If a haemodiafiltration treatment is being performed, with the exception of If a haemodiafiltration treatment is being performed, with the exception of If a haemodiafiltration treatment is being performed, with the exception of If a haemodiafiltration treatment is being performed, with the exception of HFR, the infusion pump is at rest during the test.HFR, the infusion pump is at rest during the test.HFR, the infusion pump is at rest during the test.HFR, the infusion pump is at rest during the test.

In online haemodiafiltration, before the test the infusion pump gradually In online haemodiafiltration, before the test the infusion pump gradually In online haemodiafiltration, before the test the infusion pump gradually In online haemodiafiltration, before the test the infusion pump gradually decelerates untidecelerates untidecelerates untidecelerates until it stops in correspondence to the test; when exiting the test, l it stops in correspondence to the test; when exiting the test, l it stops in correspondence to the test; when exiting the test, l it stops in correspondence to the test; when exiting the test, the infusion pump gradually accelerates up to the value set.the infusion pump gradually accelerates up to the value set.the infusion pump gradually accelerates up to the value set.the infusion pump gradually accelerates up to the value set.

ENG – Ed. 06/09 chap. 3.6 – Disconnecting patient - 1 of 4

3.6 PATIENT RINSEBACK

PATIENT RINSEBACK WARNING During patient rinseback some machine protections are not active. Check the rinseback procedure with extreme care to prevent passage of air bubbles into the vein. To interrupt the treatment or when the treatment time has ended (the UF END message appears),

rinseback.

A message appears requesting to confirm rinseback.

no to cancel the

operation, or

yes to confirm.

NOTE When rinseback has started, you may not return to dialysis. Rinseback to the patient of the blood in the extracorporeal lines performed without the help of physiological saline solution is termed Rinseback with air (the Technical configuration setting is Rinseback with physiological saline solution = OFF): it is accomplished by disconnecting the arterial line from the patient and leaving the connector in free air. Rinseback to the patient of the blood in the extracorporeal lines performed with the help of physiological saline solution is termed Rinseback with physiological saline solution (the Technical configuration setting is Rinseback with physiological saline solution = ON): it is accomplished by disconnecting the arterial line from the patient and connecting it to a bag of physiological saline solution or, in online treatments, to the infusion line, leaving the connector in free air.

2 of 4 – chap. 3.6 – Disconnecting patient ENG - Ed. 06/09

Rinseback is divided into two phases: • Rinseback I: this consists in the progressive emptying of the blood lines, in sequence: arterial

line, dialyser, venous line to the venous drip chamber; • Rinseback II: this consists of the emptying of the last section of the venous line, beyond the

drip chamber. Passing from phase one to phase two occurs following a different procedure depending on the type of rinseback: Rinseback with air - the arterial line does not contain any more blood (this situation is assessed by the blood

detector) - the drip chamber is emptied or blood mixed with physiological saline solution is presence (this

situation is assessed by the level detector) - air is present in the return line for at least 2 sec (as assessed by the air detector) Rinseback with physiological solution - the arterial line does not contain any more blood (this situation is assessed by the blood

detector) - the drip chamber is emptied or blood mixed with physiological saline solution is presence (this

situation is assessed by the level detector) In the transition dialysis-rinseback, there is a stop of extracorporeal circulation, with an automatic initial reduction of blood flow settable by the operator. Arterial pump rotation is continuous. In the transition from rinseback I to rinseback II, there is a stop of extracorporeal circulation, with a further automatic reduction of blood flow settable by the operator. Rotation of the arterial pump varies according to the type of rinseback: Rinseback with air:

the arterial pump makes a complete turn and then stops; press to restart the pump every time it stops, that is to say after each turn, and complete rinseback. Rinseback with physiological solution: the arterial pump continues its motion continuously. WARNING If you have set rinseback with air, the AIR DETECTED alarm is not active. Therefore carry out patient rinseback with extreme care to prevent passage of air bubbles into the vein. If you have set rinseback with physiological solution (or online rinseback), check with care the quantity of physiological saline solution (or ultrapure dialysis fluid) infused to the patient to prevent weight loss errors. For the operating sequence, refer to the chapter on the selected treatment.

ENG – Ed. 06/09 chap. 3.6 – Disconnecting patient - 3 of 4

The following functions keys are available during patient rinseback:

rinsing

rinsing

and confirm (yes

) to start a few minute rinsing cycle during which the self-diagnostic tests are performed. Then the machine reverts to a low-consumption rinsing condition and waits for operator’s intervention.

early disinf./clean.


and confirm (yes

) to start a short high flux rinsing phase (90 sec. at 800 ml/min) at the end of which only the disinfection/cleaning program is allowed. Dialysis will be enabled only after the self-test phase, at the end of disinfection/cleaning.

dialyser drain on

The function is available when the message EMPTYING appears on the top right bar. Press the key to empty the dialyser again.

bidry drain on

The function is available only in case of bicarbonate cartridge dialysis. Press the key to empty the cartridge. For dialysis with the Bidry cartridge, disconnect the cartridge blue connector and check that the clamps are open. When using a pierceable bicarbonate cartridge, remove the upper piercing connector from the upper clip support and disconnect it from the cartridge.

Keep the cartridge in the lower piercing connector.

bidry drain on

. Wait for the cartridge to empty and then remove it. Re-close the mobile bypass over the lower piercing connector. Re-close the upper piercing connector over the mobile bypass and lock it with the locking bracket.

4 of 4 – chap. 3.6 – Disconnecting patient ENG - Ed. 06/09

ENG – Ed. 11/09 chap. 4.1 – DN Haemodialysis - 1 of 8

4.1 DOUBLE NEEDLE HAEMODIALYSIS4.1 DOUBLE NEEDLE HAEMODIALYSIS4.1 DOUBLE NEEDLE HAEMODIALYSIS4.1 DOUBLE NEEDLE HAEMODIALYSIS ---- DN DN DN DN

Refer to chapter on disposable materials for the list of disposable devices to use for the selected treatment.

BLOOD LINE INSTALLATION BLOOD LINE INSTALLATION BLOOD LINE INSTALLATION BLOOD LINE INSTALLATION

Refer to the chapter Preparation of Treatment for general information.

ARTERARTERARTERARTERIAL LINE ASSEMBLYIAL LINE ASSEMBLYIAL LINE ASSEMBLYIAL LINE ASSEMBLY

• Fix the expansion chamber in the relevant support (1).

• Connect the Luer connector of the blood catcher (if present on the arterial expansion chamber) to the prefilter arterial pressure gauge (1b) (red).

• Open the cover of the arterial pump.

• Lift the folding drive handle of the pump.

• Fix the arterial pump segment inlet in the lower set guide . (For semi-automatic loading of the pump segment, refer to the relevant paragraph in the Treatment preparation chapter).

• Turn the pump anti-clockwise and fit the segment.

• Fasten the other end of the segment in the upper guide set.

• Fold the drive handle back into the pump block and close the cover.

• Accurately insert the arterial line in the blood detector (2) and in the fixing clip (3) next to the electric safety clamp. If the arterial electric safety clamp (double clamp) (3b) is present, insert the arterial line following the instructions described in the paragraph “Automatic opening of the clamp” in the Treatment preparation chapter.

• Connect the Luer-lock connector of the blood catcher (at pump inlet) to the pressure gauge (4) (red).

• Connect the red line connector to the blood inflow connector of the dialyser.

• Fasten the line in the relevant clip on the dialyser holder.

• Fix the line in the relevant clip (5) (red side).

• Connect the heparin syringe (see Chapter “Heparin”)

2 of 8 - chap. 4.1 – DN Haemodialysis ENG - Ed. 11/09

3 b

6 1

4 1

3

1

5 1

2 1

1 b


VENOUS LINE ASSEMBLYVENOUS LINE ASSEMBLYVENOUS LINE ASSEMBLYVENOUS LINE ASSEMBLY

• Insert the venous drip chamber into its support (1), positioning it approximately halfway. The internal filter must remain below the support.

• Insert the venous line into the air detector (2).

• Insert the line into the electric safety clamp pressing the lever downward and accurately position the tube in the fastening clip. (For semi-automatic opening of the clamp, refer to the corresponding paragraph in the chapter Treatment Preparation).

• Attach the blue connector to the blue blood outlet connector of the dialyser.

• Connect the Luer-lock connector of the blood catcher to the venous pressure gauge (4)(blue).


• Fasten the line in the relevant clip (3) (blue side).

• Hang the priming fluid collection bag on the hook of the stand.

1

3

2

4


PRIMING BLOOD LINESPRIMING BLOOD LINESPRIMING BLOOD LINESPRIMING BLOOD LINES

• Start the blood pump ( ).

• Vent air from the venous drip chamber....

• Set the blood pump flow with the flow regulator.

• Fill the arterial expansion chamber up to 1/3 its volume.

• Fill the venous drip chamber up to 2/3 its volume and close it.

• If there are alarms, and . • As soon as the level has been reached in the venous drip chamber, the electric

safety clamp opens and line priming ends. • To change the bag or bottle of physiological solution, stop the blood pump by

pressing . • Once replaced, reactivate the pump.

• The machine stops 0.2 l before the Stop PrimingStop PrimingStop PrimingStop Priming value is reached. (If the stop priming is = 0= 0= 0= 0, the equipment continues to operate).

• If recirculation is desired, connect together the venous and the arterial line.

to continue. • The machine stops again 0.4 litres before the End Priming value is reached and

after every 0.2 litres circulated, until blood is detected in the arterial line. • Dialysate preparation is independent of blood line priming until the dialyser

connectors are connected to the dialyser (see the chapter concerning dialysate preparation).



• to stop the blood pump.

• to bypass the dialyser.

• Connect the arterial line to the patient in accordance with the procedure used at the centre.

• Re-activate the blood pump and completely prime the lines with blood.

• to stop the blood pump again and connect the venous line to the patient.

• and check that the clamps on the pressure measurement lines and the main line are open.

• Regulate the blood flow to the desired value by turning the flow regulator.

• to connect the dialyser to the dialysis fluid.

• As soon as blood in the arterial line is detected, the message CONNECT appears on the top right bar (blood section). Blood circulates to prime the venous blood line and the dialyser. As soon as blood is detected in the venous drip chamber, if the relevant parameter was set in configuration, an additional pump stop is performed; if not, wait until the message DIALYSIS appears. The left status bar will read BIC. (ACETATE/BIDRY) + STD A. CONC. (LYMPHA) - PROG.

• If the heparin program has not been set yet, then the message NO HEPARIN SETTING appears.

• The alarm thresholds of the arterial (Pa) and venous pressure (Pv) automatically switch to the values set for dialysis. The machine automatically sets the max. and min. (H/L) pressure values.

• If the UF program has not activated yet, a pertinent message appears.

• During dialysis the instrument indicating the UF setting becomes orange if:

- the UF setting corresponds to the extreme pre-set values - the UF value does not correspond to the ratio between weight loss and treatment time settings.

• At any time during the dialysis session, it is possible to view and modify the pre-set parameters (temperature, conductivity, dialysis fluid flow, treatment time, UF/hr,

weight loss)

see/mod. parameters

and follow the instructions in the Operator Interface chapter.

• During the dialysis, if

see/mod. parameters

and

dialysate

selected, the total running treatment time is shown beneath the treatment time instrument.

• The volume of treated blood is displayed on the second page of the screen:

see/mod. parameters

and


, refer to the “blood volume” tool, Operator Interface chapter,

• In case of alarms, refer to the dedicated chapter.


PATIENT PATIENT PATIENT PATIENT RRRRINSEBACKINSEBACKINSEBACKINSEBACK

Refer to the Disconnecting Patient chapter for general information.

RINSEBACKRINSEBACKRINSEBACKRINSEBACK with air with air with air with air

• After confirming the Rinseback command, the equipment activates the transition to the Rinseback I phase (see the general chapter on patient rinseback): the blood pump stops (PUMP STOP message), the dialyser is isolated, ultrafiltration is interrupted.

• Disconnect the arterial line from the patient and let it free.

• Reactivate the pump ( ) to start blood rinseback.

• If necessary, adjust the blood flow using the flow regulator.

• The venous and arterial pressure alarms absolute thresholds are set automatically.

• Upon transition to the Rinseback II phase (see the general chapter on patient rinseback), the blood pump stops (PUMP STOP message) and the electric safety clamp is closed.

• to infuse any blood present in the venous line. The arterial pump rotates only one time before coming to a stop.


If rinseback is performed with air, the AIR DETECTED alarm is not active during If rinseback is performed with air, the AIR DETECTED alarm is not active during If rinseback is performed with air, the AIR DETECTED alarm is not active during If rinseback is performed with air, the AIR DETECTED alarm is not active during emptying (emptying (emptying (emptying (Rinseback IIRinseback IIRinseback IIRinseback II). ). ). ). Therefore Therefore Therefore Therefore carry out patient carry out patient carry out patient carry out patient rinsebackrinsebackrinsebackrinseback with extreme with extreme with extreme with extreme care to prevent passage of air bubbles into the vein.care to prevent passage of air bubbles into the vein.care to prevent passage of air bubbles into the vein.care to prevent passage of air bubbles into the vein.

• Set the arterial flow regulator to zero or .

• Disconnect the venous line from the patient.

• Disconnect the blue dialyser connector and insert it in its housing on the machine. The Filter Emptying procedure will be performed automatically.

• Turn the dialyser and wait until it empties out completely.

• Disconnect the red dialyser connector and insert it in its housing on the machine.

• If the perforated cartridge is present, perform the emptying procedure (see the Chapter “PATIENT RINSEBACK”).

• Remove disposable accessories.

• Position the concentrate connectors in their housings on the machine.


RINSEBACK WITH PHYSIOLOGICAL SALINE SOLUTIONRINSEBACK WITH PHYSIOLOGICAL SALINE SOLUTIONRINSEBACK WITH PHYSIOLOGICAL SALINE SOLUTIONRINSEBACK WITH PHYSIOLOGICAL SALINE SOLUTION


In In In In Rinseback with phRinseback with phRinseback with phRinseback with physioysioysioysiological saline solution, check with care the quantity of logical saline solution, check with care the quantity of logical saline solution, check with care the quantity of logical saline solution, check with care the quantity of physiological saline solution infused to the patient to prevent weight loss physiological saline solution infused to the patient to prevent weight loss physiological saline solution infused to the patient to prevent weight loss physiological saline solution infused to the patient to prevent weight loss errors.errors.errors.errors.

• For information on displaying and modifying parameters, refer to the Operator Interface chapter.


• Disconnect the arterial line from the patient and connect the physiological saline solution bag.




• Upon transition to the Rinseback II phase (see the general chapter on patient rinseback), the equipment stops the blood pump (PUMP STOP message) and closes the electric safety clamp.

• to infuse any blood-saline solution in the venous line • The arterial pump performs continuous rotation with a reduced flow. If necessary,

adjust the blood flow using the flow regulator.

• Set the arterial flow regulator to zero or . • Disconnect the venous line from the patient. • Disconnect the blue dialyser connector and insert it in its housing on the machine.

The Filter Emptying procedure will be performed automatically. • Turn the dialyser and wait until it empties out completely. • Disconnect the red dialyser connector and insert it in its housing on the machine. • If the sodium bicarbonate powder cartridge is present, perform the emptying

procedure (see the Chapter “PATIENT RINSEBACK”).



ENG – Ed. 11/09 chap. 4.2 – SNsp Haemodialysis - 1 of 8

4.2 SINGLE NEEDLE SINGLE PUMP HAEMODIALYSIS4.2 SINGLE NEEDLE SINGLE PUMP HAEMODIALYSIS4.2 SINGLE NEEDLE SINGLE PUMP HAEMODIALYSIS4.2 SINGLE NEEDLE SINGLE PUMP HAEMODIALYSIS ---- SNsp SNsp SNsp SNsp




ARTERIAL LINE ASSEMBLYARTERIAL LINE ASSEMBLYARTERIAL LINE ASSEMBLYARTERIAL LINE ASSEMBLY





• Fix the arterial pump segment inlet in the lower set guide . (For semi-automatic loading of the pump segment, refer to the relevant paragraph in the chapter PREPARATION OF TREATMENT).




• Accurately insert the arterial line in the blood detector (2) and in the fixing clip (3) next to the electric safety clamp. If the arterial electric safety clamp (double clamp) (3b) is present, insert the arterial line following the instructions described in the paragraph “Automatic opening of the clamp” in the chapter PREPARATION OF TREATMENT.

• Connect the red connector of the line to the dialyser blood inlet connector.



• Connect the heparin syringe (see Chapter “Heparin”).

2 of 8 - 4.2 – SNsp Haemodialysis ENG - Ed. 11/09

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• Insert the line into the electric safety clamp pressing the lever downward and accurately position the tube in the fastening clip. (For automatic opening of the clamp, refer to the relevant paragraph in the chapter PREPARATION OF TREATMENT).


• Connect the Luer-lock connector of the blood catcher to the venous pressure gauge (4)(blue).


• Fasten the line in the relevant clip (3) (blue side).

• Hang the priming fluid collection bag on the hook of the stand.

1

3

2

4


PRIMING THE BLOOD LINES IN SINGLE NEEDLE WITH SINGLE PRIMING THE BLOOD LINES IN SINGLE NEEDLE WITH SINGLE PRIMING THE BLOOD LINES IN SINGLE NEEDLE WITH SINGLE PRIMING THE BLOOD LINES IN SINGLE NEEDLE WITH SINGLE PUMP (SNsp)PUMP (SNsp)PUMP (SNsp)PUMP (SNsp)

• Start the blood pump ( ). • Vent air from the venous drip chamber.... • Set the blood pump flow with the flow regulator. • Fill the arterial expansion chamber up to 1/3. • Fill the venous drip chamber up to its level (2/3) and close it.

• In case of alarms, press and . • The blood pump goes on running until the level in the venous drip chamber has

been reached, or the first pump cycling has occurred. • To change the bag or bottle of physiological solution, stop the blood pump by

pressing . Once replaced, reactivate the pump. • Suggested values for the switching pressures:

max. switch p.= 350 – 400 mmHg min. switch p. = 50 mmHg • If the alarm “abnormal switching pressure” intervenes after the first pump switching

and the blood lines are still empty, . To prime the blood lines more rapidly, it is suggested to cancel priming, to open the venous drip chamber and to select the treatment again.

NOTENOTENOTENOTE

Priming can be cancelled with Priming can be cancelled with Priming can be cancelled with Priming can be cancelled with

cancel priming

until dialysate preparation has until dialysate preparation has until dialysate preparation has until dialysate preparation has begun.begun.begun.begun.

If dialysate preparation has begun, it is recommended to change treatments, If dialysate preparation has begun, it is recommended to change treatments, If dialysate preparation has begun, it is recommended to change treatments, If dialysate preparation has begun, it is recommended to change treatments, going to Double Needle.going to Double Needle.going to Double Needle.going to Double Needle.

When priming is over, change When priming is over, change When priming is over, change When priming is over, change the treatment again and return to Single Needle the treatment again and return to Single Needle the treatment again and return to Single Needle the treatment again and return to Single Needle Dialysis.Dialysis.Dialysis.Dialysis. • During the entire priming phase, the pump cycling depends on the switching

pressure values set. The stroke is not used. • The machine stops 0.2 l before the Stop PrimingStop PrimingStop PrimingStop Priming value is reached. (If the stop

priming is = 0= 0= 0= 0, the equipment continues to operate). • If recirculation is desired, inter-connect the venous line and the arterial line.

to continue. • The machine stops again 0.4 l before the End primingEnd primingEnd primingEnd priming value is reached and after

every 0.2 litres circulated until blood is detected in the arterial line. • Start dialysis fluid preparation as already described for Double Needle Dialysis. • Set the stroke value (refer to the chapter “Description of the equipment and its

components”). Suggested value: 20 ml/min.







• to stop the blood pump again and connect the venous line to the patient,




• As soon as blood in the arterial line is detected, the message CONNECT appears on the top right bar (blood section). Blood circulates to prime the venous blood line and the dialyser. As soon as blood is detected in the venous drip chamber, if the relevant parameter was set in configuration, an additional pump stop is performed; if not wait until the message DIALYSIS appears. The left status bar will read BIC. (ACETATE/BIDRY) + STD A. CONC. (LYMPHA)- PROG. If the heparin program has not been set yet, then the message NO HEPARIN SETTING appears.

• The absolute thresholds of the arterial (Pa, in the case of double clamp equipment) and venous pressure alarms (Pc) switch automatically to the values set for dialysis. The machine automatically sets the max. and min. (H/L) pressure values.




• At any time during the dialysis session, it is possible to view and modify the pre-set parameters (temperature, conductivity, dialysis fluid flow, treatment time, UF/hr,

weight loss)

see/mod. parameters

and follow the instructions in the Operator Interface chapter.


see/mod. parameters

and

dialysate

are selected, the total running treatment time is shown beneath the treatment time instrument.


see/mod. parameters


and refer to the “blood volume” tool, Operator Interface chapter.



• The alarm thresholds of the switching pressures automatically switch to the values set for the dialysis. Pump cycling depends on the set stroke volume.

• The tool Qbm indicates the mean blood flow given by the following formula:

Qbm = Qb x art. phase duration / ( art. phase duration + ven. phase Qbm = Qb x art. phase duration / ( art. phase duration + ven. phase Qbm = Qb x art. phase duration / ( art. phase duration + ven. phase Qbm = Qb x art. phase duration / ( art. phase duration + ven. phase duration)duration)duration)duration)

PATIENT PATIENT PATIENT PATIENT RINSEBACKRINSEBACKRINSEBACKRINSEBACK


RINSEBACKRINSEBACKRINSEBACKRINSEBACK WITH AIRWITH AIRWITH AIRWITH AIR





• The venous and arterial pressure alarms absolute thresholds are set automatically (if the double clamp is present).

• Upon transition to the Rinseback II phase (see the general chapter on patient rinseback), the blood pump stops (PUMP STOP message) and the electric safety clamp is closed.

• Press to infuse any blood present in the venous line. The arterial pump rotates only one time before coming to a stop.


If rinseback is performed with air, the AIR DETECTED alarm is not active during If rinseback is performed with air, the AIR DETECTED alarm is not active during If rinseback is performed with air, the AIR DETECTED alarm is not active during If rinseback is performed with air, the AIR DETECTED alarm is not active during emptying (emptying (emptying (emptying (Rinseback IIRinseback IIRinseback IIRinseback II). Therefore carry out patient ). Therefore carry out patient ). Therefore carry out patient ). Therefore carry out patient rinsebackrinsebackrinsebackrinseback with extreme with extreme with extreme with extreme care to prevent passage of air bubbles into the care to prevent passage of air bubbles into the care to prevent passage of air bubbles into the care to prevent passage of air bubbles into the vein.vein.vein.vein.






• If the perforation cartridge is present, perform the emptying procedure (see the Chapter “PATIENT RINSEBACK”).




RINSEBACKRINSEBACKRINSEBACKRINSEBACK WITH PHYSIOLOGICAL SALINE SOLUTIONWITH PHYSIOLOGICAL SALINE SOLUTIONWITH PHYSIOLOGICAL SALINE SOLUTIONWITH PHYSIOLOGICAL SALINE SOLUTION


In In In In RinsebackRinsebackRinsebackRinseback with physiological saline solution, check with care the quantity of with physiological saline solution, check with care the quantity of with physiological saline solution, check with care the quantity of with physiological saline solution, check with care the quantity of physiological saline solution iphysiological saline solution iphysiological saline solution iphysiological saline solution infused to the patient to prevent weight loss nfused to the patient to prevent weight loss nfused to the patient to prevent weight loss nfused to the patient to prevent weight loss errors.errors.errors.errors.






• The venous and arterial pressure alarms absolute thresholds are set automatically (if the double clamp is present).

• Upon transition to the Rinseback II phase (see the general chapter on patient rinseback), the equipment stops the blood pump (PUMP STOP message) and closes the electric safety clamp.

• Press to infuse any blood-saline solution in the venous line • The arterial pump performs continuous rotation with a reduced flow. If necessary,

adjust the blood flow using the flow regulator.

• Set the arterial flow regulator to zero or press . • Disconnect the venous line from the patient. • Disconnect the blue dialyser connector and insert it in its housing on the machine. The Filter Emptying procedure will be performed automatically.

• Turn the dialyser and wait until it empties out completely. • Disconnect the red dialyser connector and insert it in its housing on the machine. • If the sodium bicarbonate powder cartridge is present, perform the emptying procedure (see the Chapter “PATIENT RINSEBACK”).

• Remove disposable accessories. • Position the concentrate connectors in their housings on the machine.

ENG – Ed. 11/09 chap. 4.3 – SNdp Haemodialysis 1 of 10

4.3 SINGLE NEEDLE DOUBLE PUMP HAEMODIALYSIS4.3 SINGLE NEEDLE DOUBLE PUMP HAEMODIALYSIS4.3 SINGLE NEEDLE DOUBLE PUMP HAEMODIALYSIS4.3 SINGLE NEEDLE DOUBLE PUMP HAEMODIALYSIS ---- SNdp SNdp SNdp SNdp









• Fix the arterial pump segment inlet in the lower set guide . (For semi-automatic loading of the pump segment, refer to the relevant paragraph in the chapter PREPARATION OF TREATMENT).




• Accurately insert the arterial line in the blood detector (2) and in the fixing clip (3) next to the electric safety clamp. If the arterial electric safety clamp (double clamp) (3b) is present, insert the arterial line following the instructions described in the paragraph “Automatic opening of the clamp” in the chapter PREPARATION OF TREATMENT.

• Connect the Luer-lock connector of the blood catcher (at pump inlet) to the pressure gauge (4) (red). (Do not perform this operation in Single Needle with (Do not perform this operation in Single Needle with (Do not perform this operation in Single Needle with (Do not perform this operation in Single Needle with Single Pump)Single Pump)Single Pump)Single Pump)

• Connect the red line connector to the blood inflow connector of the dialyser.




2 of 10 - chap. 4.3 – SNdp Haemodialysis ENG - Ed. 11/09

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• Insert the switching chamber into the clip (1). • Open the cover of the venous pump. • Lift the folding drive handle of the pump. • Insert the switching chamber outlet line in the infusion end detector (2). • Fasten the inlet of the venous pump segment in the left set guide (follow the

direction of the blue arrow). (For semi-automatic loading of the pump segment, refer to the relevant paragraph in the chapter PREPARATION OF THE TREATMENT).

• Turn the pump anti-clockwise and fit the segment. • Fasten the other end of the pump segment in the right guide set. • Fold the drive handle back into the pump block and close the cover. • Insert the venous drip chamber into its support (3), positioning it approximately

halfway. The internal filter must remain below the support. • Insert the venous line into the air detector (4). • Insert the line into the electric safety clamp pressing the lever downward and

accurately position the tube in the fastening clip. (For automatic opening of the clamp, refer to the corresponding paragraph in the chapter PREPARATION OF TREATMENT).

• Attach the blue connector leading to the switching chamber to the blue blood outlet connector of the dialyser.

• Connect the Luer-lock connector of the blood catcher for measuring the venous pressure (in the drip chamber) to the venous pressure gauge (blue) (5).

• Fasten the line in the relevant clip on the dialyser holder. • Connect the Luer-lock connector of the blood catcher for measuring the switching

pressure (on the switching chamber) to the switching pressure/infusion gauge (6).

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PRIMING THE BLOOD LINES IN SINGLE NEEDLE WITH DOUBLE PRIMING THE BLOOD LINES IN SINGLE NEEDLE WITH DOUBLE PRIMING THE BLOOD LINES IN SINGLE NEEDLE WITH DOUBLE PRIMING THE BLOOD LINES IN SINGLE NEEDLE WITH DOUBLE PUMP (SNdp)PUMP (SNdp)PUMP (SNdp)PUMP (SNdp)

• Start the blood pump ( ). • Vent the venous drip chamber and the switching chamber.... • Set the blood pump flow with the red flow regulator. • Fill the arterial expansion chamber up to 1/3. • Fill the switching chamber up to its level (1/3) and close it.

• In case of alarms, press and . • After reaching the switching pressure of 50 mmHg, the venous pump begins to

operate together with the arterial pump. The venous pump speed is regulated automatically by the equipment on the basis of the set value (with red flow regulator) and the measured switching pressure.

• Fill the venous drip chamber up to its level (2/3) and close it. • As soon as the level has been reached in the venous drip chamber, the electric

safety clamp opens and line priming ends. • To change the bag or bottle of physiological solution, stop the blood pump by

pressing . Once replaced, reactivate the pump. • The machine stops 0.2 l before the Stop Priming value is reached. (If the stop

priming is = 0= 0= 0= 0, the equipment continues to operate). • If recirculation is desired, inter-connect the venous line and the arterial line.

to continue.

• The machine stops again 0.4 l before the End primingEnd primingEnd primingEnd priming value is reached and after every 0.2 litres circulated until blood is detected in the arterial line.

• Start dialysis fluid preparation.



Single Needle Double Pump operation involves alternation of two phases: Arterial phaseArterial phaseArterial phaseArterial phase Blood is drawn from the patient with the arterial pump operating, the venous pump off and the clamp closed. The phase ends when a certain value above the switching pressure is reached.

Venous phaseVenous phaseVenous phaseVenous phase The blood is returned to the patient with the arterial pump off, the venous pump operating and the clamp open. The phase ends when a certain value of venous pump revolutions is reached which corresponds to the set stroke volume. These two phases are referred to as CYCLECYCLECYCLECYCLE. Single Needle Double Pump operation can only be performed on formula 2000 or formula Therapy machines, that is machines equipped with two blood pumps. Single Needle Double Pump run by formula 2000 is a “PRESSURE-STROKE” single needle. “Pressure” refers to the switching pressure measured downstream from the dialyser, “stroke” refers to the volume of blood pumped in a cycle. The Single Needle Double Pump dialysis run by formula 2000 is a highly automatic treatment aimed at optimising parameters. The user only needs to move only the arterial pump flow regulator since the venous return speed is managed by the equipment. The system has two adapting algorithms which automate, respectively.

a) Maximum switching pressure

b) Venous blood pump speed If the blood pump stops due to an alarm or stop arterial pump condition, the treatment continues in the arterial phase. Single Needle Double Pump operation is active when SNdpSNdpSNdpSNdp appear in the machine configuration at «treatment type». Some of the parameters require particular values to allow correct operation of the dialysis machine. Refer to the “Configuration” chapter to set these parameters.










• As soon as blood in the arterial line is detected, the message CONNECT appears on the top right bar (blood section). Blood circulates to prime the venous blood line and the dialyser. As soon as blood is detected in the venous drip chamber, if the relevant parameter was set in configuration, an additional pump stop is performed; if not wait until the message DIALYSIS appears. The left status bar will read BIC. (ACETATE/BIDRY) + STD A. CONC. (LYMPHA) - PROG.





- - the UF setting corresponds to the extreme pre-set values - - the UF value does not correspond to the ratio between weight loss and treatment time settings.

• The preset parameters (temperature, conductivity, dialysate flow, treatment time, UF/h, weight loss) can be set at any time during the dialysis treatment session.

see/mod. parameters

and follow the indications shown in chap. Operator Interface.


see/mod. parameters

and

dialysate



see/mod. parameters




• Set the min switch. p. value (Pc) which is the lower switching pressure threshold. It is advisable to set a value between 10 and 50 mmHg to prevent draining the drip chambers.

• Set the max ven. p. value which is the maximum venous pressure threshold. Pay careful attention when setting the value because it is an operating pressure and not an alarm threshold.

• Set the stroke volume which is the amount of blood pumped during each cycle. • To optimise the treatment performance, it is advisable to keep the drip chamber

level (located before and after the dialyser) between 1/3 and 2/3 during each cycle. In particular, avoid letting the drip chambers become too full when the blood flow is high, to prevent sudden changes in pressure.

• The transmembrane pressure is calculated as follows:

TMP = P. switch. Average – P.UF average –30 mmHg

where:


P.switch. average is the average value of switching pressure during a cycle P.UF average is the average value of ultrafiltration pressure during a

cycle. 30 mmHg pressure loss in dialysate compartment

NOTENOTENOTENOTE

If you need to change to SNsp or DN, remove the venous segment and:If you need to change to SNsp or DN, remove the venous segment and:If you need to change to SNsp or DN, remove the venous segment and:If you need to change to SNsp or DN, remove the venous segment and:

modify treatment

s. needle (s. pump)

or or or or

double needle




If formula was configured for rinseback in Double NeedleDouble NeedleDouble NeedleDouble Needle (the Service configuration setting is Rins. in SNdp = OFF): • The message “DISCONNECT THE VENOUS PUMP SEGMENT, WHEN THE PUMPS STOP”

is displayed. • Remove the venous pump segment while both pumps are stopped and the clamp is

closed. • Patient rinseback continues as in Double Needle operation. The venous pump

remains stopped, only the arterial pump operates. If formula® is configured for rinseback in Single Needle Single Needle Single Needle Single Needle (the Service configuration setting is SNdp Rinseback = ON), rinseback is performed with the two pumps working at the same time. In this case, extraction of the venous segment is not necessary and the venous pump speed is automatically regulated by the equipment based on the arterial flow and the measured switching pressure.

RINSEBACK WITH AIRRINSEBACK WITH AIRRINSEBACK WITH AIRRINSEBACK WITH AIR

• After confirming the Rinseback command, the equipment activates the transition to the Rinseback I phase (see the general chapter on patient rinseback): the blood pump stops (the pumps stop) (PUMP STOP message), the dialyser is isolated, ultrafiltration is interrupted.


• Reactivate the pump (pumps) ( ) to begin the rinseback phase.



• Upon transition to the Rinseback II phase (see the general chapter on patient rinseback), the blood pump stops (the blood pumps stop) (PUMP STOP message) and the electric safety clamp is closed.

• to infuse any blood present in the venous line. The arterial pump rotates only one time before coming to a stop.


If rinseback If rinseback If rinseback If rinseback with air with air with air with air is performed, the AIR DETECTED alarm is not active during is performed, the AIR DETECTED alarm is not active during is performed, the AIR DETECTED alarm is not active during is performed, the AIR DETECTED alarm is not active during emptying (emptying (emptying (emptying (Rinseback IIRinseback IIRinseback IIRinseback II). ). ). ). ThThThTherefore carry out patient erefore carry out patient erefore carry out patient erefore carry out patient rinsebackrinsebackrinsebackrinseback with extreme with extreme with extreme with extreme care to prevent passage of air bubbles into the vein.care to prevent passage of air bubbles into the vein.care to prevent passage of air bubbles into the vein.care to prevent passage of air bubbles into the vein.

• Set the arterial flow regulator to zero or . • Disconnect the venous line from the patient. • Disconnect the blue dialyser connector and insert it in its housing on the machine.

The Filter Emptying procedure will be performed automatically. • Turn the dialyser and wait until it empties out completely. • Disconnect the red dialyser connector and insert it in its housing on the machine. • If the piercing cartridge is present, perform the emptying procedure (see the

Chapter “PATIENT RINSEBACK”).




RINSEBACK WITH PHYSIOLOGICAL SALINE SOLUTIONRINSEBACK WITH PHYSIOLOGICAL SALINE SOLUTIONRINSEBACK WITH PHYSIOLOGICAL SALINE SOLUTIONRINSEBACK WITH PHYSIOLOGICAL SALINE SOLUTION


In In In In RinsebackRinsebackRinsebackRinseback with with with with physiological saline solution, check with care the quantity of physiological saline solution, check with care the quantity of physiological saline solution, check with care the quantity of physiological saline solution, check with care the quantity of physiological saline solution infused to the patient to prevent weight loss physiological saline solution infused to the patient to prevent weight loss physiological saline solution infused to the patient to prevent weight loss physiological saline solution infused to the patient to prevent weight loss errors.errors.errors.errors.


• After confirming the Rinseback command, the equipment activates the transition to the Rinseback I phase (see the general chapter on patient rinseback): the pump stops (the pumps stop) (PUMP STOP message), the dialyser is isolated, ultrafiltration is interrupted.


• Reactivate the pump (pumps) ( ) to begin the rinseback phase.



• Upon transition to the Rinseback II phase (see the general chapter on patient rinseback), the equipment stops the pump (pumps) (PUMP STOP message) and closes the electric safety clamp.

• to infuse any blood-saline solution eventually present in the venous line.

• The arterial pump performs (The pumps perform) continuous rotation with a reduced flow. If necessary, adjust the blood flow using the flow regulator.






• If the sodium bicarbonate powder cartridge is present, perform the emptying procedure (see the Chapter “PATIENT RINSEBACK”).



ENG – Ed. 11/09 chap. 5.1 – Haemodiafiltration with bags - HDF - 1 of 10

5.1 HAEMODIAFILTRATION 5.1 HAEMODIAFILTRATION 5.1 HAEMODIAFILTRATION 5.1 HAEMODIAFILTRATION WITH BAGS WITH BAGS WITH BAGS WITH BAGS ---- HDF HDF HDF HDF



• Connect the Luer connector of the blood catcher to the prefilter arterial pressure gauge (1b) (red).



• Fix the arterial pump segment inlet in the lower set guide . (For semi-automatic loading of the pump segment, refer to the relevant paragraph in the PREPARATION OF TREATMENT chapter).




• Accurately insert the arterial line in the blood detector (2) and in the fixing clip (3) next to the electric safety clamp. If the arterial electric safety clamp (double clamp) (3b) is present, insert the arterial line following the instructions described in the paragraph “Automatic opening of the clamp” in the PREPARATION OF TREATMENT chapter.

• Connect the Luer-lock connector of the blood catcher (at pump inlet) to the pressure gauge (4) (red).

• Connect the red connector of the line to the blood inlet connector of the dialyser.




2 of 10 - chap. 5.1 – Haemodiafiltration with bags – HDF ENG – Ed. 11/09

VENOUS/INFUSION LINE ASSEMBLY VENOUS/INFUSION LINE ASSEMBLY VENOUS/INFUSION LINE ASSEMBLY VENOUS/INFUSION LINE ASSEMBLY

• Insert the infusion drip chamber into the relevant clip (1).

• Insert the outlet line from the infusion drip chamber in the end infusion detector (2).

• Open the infusion pump cover.

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1 b



• Fasten the inlet of the infusion pump segment in the left guide set (follow the direction of the blue arrow). (For semi-automatic loading of the pump segment, refer to the relevant paragraph in the PREPARATION OF TREATMENT chapter ).

• Fit the pump segment, rotating the pump anticlockwise.

• Fasten the other end of the pump segment in the right guide set.

• Fold the drive handle back into the pump and close the cover.



• Insert the line into the electroclamp (5), pressing the lever downwards and accurately position the tube into the fastening chip (For automatic opening of the clamp, refer to the relevant paragraph in the Preparation of treatment chapter).


• Connect the luer-lock connector of the blood catcher to the venous pressure detector (blue) (6).


• Fasten the line from the dialyser into the relevant clip (blue) (7).

• Hang the priming liquid collection bag on its support on the stand (8).

• Hang the infusion bags on the scale hooks (9).

• Connect the bags to the infusion line and open the clamps positioned on the line.


PATIENT CONNECTION APATIENT CONNECTION APATIENT CONNECTION APATIENT CONNECTION AND START OF TREATMENTND START OF TREATMENTND START OF TREATMENTND START OF TREATMENT

Haemodiafiltration treatment (HDF) is a haemodialysis technique that removes high quantities of plasmatic water by means of high permeability membranes and partially reintegrates the ultrafiltrate infusing replacement solutions taken from sterile bags.

Haemodiafiltration treatment (HDF) is possible only on formula® 2000 equipment, i.e. equipment furnished with the scale Formula 2000.





• As soon as blood in the arterial line is detected, the message CONNECT appears on the top right bar (blood section).

• Blood circulates to prime the venous blood line and the dialyser. As soon as blood is detected in the venous drip chamber, if the relevant parameter was set in configuration, an additional pump stop is performed; if not, wait until the

5 1

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2 1

3 1

4 1

6 1

7 1

8 1


message DIALYSIS appears. In the left status bar the message BIC. (ACETATE/BIDRY) + STD A. CONC. (LYMPHA) - PROG. appears.

• to stop the blood pump again and connect the venous line to the patient.







• During dialysis the instrument indicating the UF setting becomes orange if: - the UF setting corresponds to the extreme pre-set values; - the UF value does not correspond to the ratio between weight loss and treatment time settings.

• The preset parameters (temperature, conductivity, dialysis fluid flow, treatment time, UF/h, weight loss) can be set at any time during the dialysis treatment

session.

see/mod. parameters

and follow the indications shown in chap. “Operator Interface”.


see/mod. parameters

and

dialysate

are selected, the total running treatment time is shown beneath the treatment time tool.


see/mod. parameters




• Ultrafiltration must be set without taking account of the infusion, since formula

automatically adjusts hourly ultrafiltration.

• The treatment is indicated with the letters HDF in the status bar on the upper right of the display.

• If the infusion flow has not been set, a warning appears.

• At any moment during the dialysis session it is possible to display and change the infusion flow. The total amount infused is displayed on the second page of

the screen.

see/mod. parameters


.


• During treatment the ultrafiltration program is active only if the infusion pump is in operation and vice versa, with the exception of isolated UF dialysis during which the infusion pump is off.

The following functions keys are available during dialysis:

modifytreatment

Changes the selected treatment or the concentrate type.

see/mod.parameters

Displays and modifies the treatment parameters.

heparinon

Enables the heparin program (see Chapter « Heparin »).

The function is available only if the heparin infusion value has been set.

ufoff

Interrupts the UF program in progress, activating a minimum UF of 0.1 kg/h. The treatment time continues to advance.

To restart the UF program, press

ufon

. When the UF program is reactivated, a window warns the user to check in the

see/mod.parameters

and

dialysate

menu that the ultrafiltration parameters are as desired.

isolated ufon

Activates isolated UF.

sensors

To access the sensor menu and the Kt/V application

rinseback

Enables the restitution of blood to the patient.

sphygmo measure

Enables sphygmomanometer measurement.


PATIENT RINSEBACK PATIENT RINSEBACK PATIENT RINSEBACK PATIENT RINSEBACK

WARNINGWARNINGWARNINGWARNING During the patient During the patient During the patient During the patient rinsebackrinsebackrinsebackrinseback phase some machine protections are not active. phase some machine protections are not active. phase some machine protections are not active. phase some machine protections are not active. Check the rinseback procedure with extreme care to prevent passage of air Check the rinseback procedure with extreme care to prevent passage of air Check the rinseback procedure with extreme care to prevent passage of air Check the rinseback procedure with extreme care to prevent passage of air bububububbles into the vein.bbles into the vein.bbles into the vein.bbles into the vein. In HDF during blood rinseback, the UF/infusion pump remains still. In HDF during blood rinseback, the UF/infusion pump remains still. In HDF during blood rinseback, the UF/infusion pump remains still. In HDF during blood rinseback, the UF/infusion pump remains still. To interrupt the treatment or when the treatment time has ended (the END UF

warning message appears),

rinseback

.

A message appears requesting to confirm rinseback.

no

to cancel the operation, or

yes

to confirm.

NOTENOTENOTENOTE When rinseback has started, you may not return to dialysis.When rinseback has started, you may not return to dialysis.When rinseback has started, you may not return to dialysis.When rinseback has started, you may not return to dialysis.

• The blood pump stops (PUMP OFF warning), the dialyser is bypassed, ultrafiltration is interrupted and the blood flow is automatically reduced.

• If necessary, regulate the blood flow with the flow regulator (it can be set between 20 and 250 ml/min).

• If Rinseback with air is accomplished (the Service configuration setting is Rinseback with physiological saline solution = OFF), disconnect the arterial line from the patient and leave the connector in free air.

• If Rinseback with physiological saline solution is accomplished (the Service configuration setting is Rinseback with physiological saline solution = ON), disconnect the arterial line from the patient and connect it to a bag of physiological saline solution

• Reactivate the pump to start blood rinseback.

• The absolute alarm thresholds of the venous and arterial pressure automatically set to the following values:

-150 +450 mmHg venous pressure


-300 +200 mmHg arterial pressure

• When all the following conditions are fulfilled, that is:

Rinseback with air Rinseback with air Rinseback with air Rinseback with air

- the arterial line does not contain any more blood, - air is detected in the venous line for at least 2 sec, - the emptying of the venous drip chamber, or blood is mixed with the physiological solution

Rinseback with physiological saline solution Rinseback with physiological saline solution Rinseback with physiological saline solution Rinseback with physiological saline solution

- the arterial line does not contain any more blood, - the emptying of the venous drip chamber, or blood is mixed with the physiological solution

the blood pump stops, the electroclamp closes and the blood flow value automatically decreases.

• If necessary, regulate the blood flow with the arterial flow regulator to between 20 and 180 ml/min.

• Complete rinseback but note that:

- rinseback with airrinseback with airrinseback with airrinseback with air: the arterial pump makes a complete turn and then stops;

to restart the pump every time it stops, that is to say after each turn, and complete rinseback.

- rinseback with physiological rinseback with physiological rinseback with physiological rinseback with physiological saline solution:saline solution:saline solution:saline solution: the arterial pump goes on running without interruption after each turn.


If you have set rinseback with air, the AIR DETECTED alarm is not active If you have set rinseback with air, the AIR DETECTED alarm is not active If you have set rinseback with air, the AIR DETECTED alarm is not active If you have set rinseback with air, the AIR DETECTED alarm is not active during emptying. during emptying. during emptying. during emptying. Therefore carry out patient Therefore carry out patient Therefore carry out patient Therefore carry out patient rinsebackrinsebackrinsebackrinseback with extreme care to with extreme care to with extreme care to with extreme care to prevent pprevent pprevent pprevent passage of air bubbles into the vein.assage of air bubbles into the vein.assage of air bubbles into the vein.assage of air bubbles into the vein.

If you have set rinseback with physiological solution, check with care the If you have set rinseback with physiological solution, check with care the If you have set rinseback with physiological solution, check with care the If you have set rinseback with physiological solution, check with care the quantity of physiological saline solution infused to the patient to prevent quantity of physiological saline solution infused to the patient to prevent quantity of physiological saline solution infused to the patient to prevent quantity of physiological saline solution infused to the patient to prevent weight loss errors.weight loss errors.weight loss errors.weight loss errors.

• Set to zero the arterial flow regulator or .


• Disconnect the blue dialyser connector and insert it in its housing on the machine.





rinsing

rinsing

and confirm (

yes

) to start a few minute rinsing cycle during which the self-diagnostics tests are performed.

Then formula reverts to a low-consumption rinsing condition and waits for operator’s intervention.



and confirm (

yes

) to start a short, high flux rinsing phase (800 ml/min) at the end of which only the disinfection/cleaning program is allowed.

Dialysis will be enabled only after the self-test phase, at the end of the disinfection/cleaning program.

dialyser drain on

The function is available when the message EMPTYING appears on

the top right bar. Press

dialyser drain on

to empty the dialyser again.

bidry drain on

The function is available only in case of bicarbonate cartridge dialysis (also see the Chapter “PATIENT RINSEBACK”).

Press the key to empty the cartridge. Disconnect the blue cartridge connector and check that the clamps are open.

When using a pierceable bicarbonate cartridge, remove the upper piercing connector from the upper clip support and disconnect it from the cartridge. Keep the cartridge in the lower piercing

connector.

bidry drain on

. Wait for the cartridge to empty and then remove it.

Re-close the mobile bypass over the lower piercing connector. Re-close the upper piercing connector over the mobile bypass and lock it with the locking bracket.

• Remove the disposable accessories and discard them.


ENG – Ed. 06/09 ch. 8.1 - Operation during PHF - 1 of 20

6666.1 OPERATION DURING H.1 OPERATION DURING H.1 OPERATION DURING H.1 OPERATION DURING HAAAAEMODIAFILTRATION WITH EMODIAFILTRATION WITH EMODIAFILTRATION WITH EMODIAFILTRATION WITH

INFUSION OF DIALYSIS FLUID (PHFINFUSION OF DIALYSIS FLUID (PHFINFUSION OF DIALYSIS FLUID (PHFINFUSION OF DIALYSIS FLUID (PHF PRE, PHF POST PRE, PHF POST PRE, PHF POST PRE, PHF POST))))

INDICATIONSINDICATIONSINDICATIONSINDICATIONS

Haemodiafiltration with infusion of dialysis fluid (PHF – Paired Haemodiafiltration) is indicated for patients who have hemodynamic stability problems and when molecules of medium- to high molecular weight have to be removed.


Haemodiafiltration with infusion of dialysis fluid (PHF) is not indicated where the quality of the haemodialysis supply water is not strictly controlled and does not comply with the relevant standards.

DESCRIPTIONDESCRIPTIONDESCRIPTIONDESCRIPTION

Haemodiafiltration with infusion of dialysis fluid (PHF) is a technique that involves the infusion of liquid prepared directly by the equipment and derived from the dialysis fluid. It is an on-line technique that enables optimisation of high flow rate treatments since it allows the use of high exchange volumes, without the need to manage a large number of bags. The treatment utilises a double chamber dialyser which enables the separation of the dialysis process from the infusate filtration process. The disposable polyethersulfone dialyser is 100% tested during the production process. Before dialysis the dialyser is also subject to an automatic, patented on-line fibre integrity test, with inversion of the infusion pump for a period of time sufficient for the blood detector (BLD), located on the line, to detect a possible leakage of blood from the fibres. PHF treatment may be executed only on formula 2000 machines, i.e. machines equipped with infusion pump.

WARNINGWARNINGWARNINGWARNING • Chemical substances potentially toxic for infusion, present in the Chemical substances potentially toxic for infusion, present in the Chemical substances potentially toxic for infusion, present in the Chemical substances potentially toxic for infusion, present in the

deionised water distribution network or in concentrate solutions are not deionised water distribution network or in concentrate solutions are not deionised water distribution network or in concentrate solutions are not deionised water distribution network or in concentrate solutions are not detectable by detectable by detectable by detectable by formula®.

• It is the responsibility of the dialysis centre to use water suitable for It is the responsibility of the dialysis centre to use water suitable for It is the responsibility of the dialysis centre to use water suitable for It is the responsibility of the dialysis centre to use water suitable for infusinfusinfusinfusion.ion.ion.ion.

• To avoid potentially dangerous situations, carefully read the directions on To avoid potentially dangerous situations, carefully read the directions on To avoid potentially dangerous situations, carefully read the directions on To avoid potentially dangerous situations, carefully read the directions on the device packaging. the device packaging. the device packaging. the device packaging.

• Check that the packaging of the disposable material, which ensures their Check that the packaging of the disposable material, which ensures their Check that the packaging of the disposable material, which ensures their Check that the packaging of the disposable material, which ensures their sterility, is not damaged and that the sterilisation validity date has not sterility, is not damaged and that the sterilisation validity date has not sterility, is not damaged and that the sterilisation validity date has not sterility, is not damaged and that the sterilisation validity date has not expiexpiexpiexpired.red.red.red.

• Ensure that the installation is carried out properly using aseptic Ensure that the installation is carried out properly using aseptic Ensure that the installation is carried out properly using aseptic Ensure that the installation is carried out properly using aseptic techniques.techniques.techniques.techniques.

• Only use not pyrogenic concentrate solutions, qualitatively in compliance Only use not pyrogenic concentrate solutions, qualitatively in compliance Only use not pyrogenic concentrate solutions, qualitatively in compliance Only use not pyrogenic concentrate solutions, qualitatively in compliance with the monographs of the European Pharmacopoeia.with the monographs of the European Pharmacopoeia.with the monographs of the European Pharmacopoeia.with the monographs of the European Pharmacopoeia.

• The concentrate solutions to be used for prepaThe concentrate solutions to be used for prepaThe concentrate solutions to be used for prepaThe concentrate solutions to be used for preparation of dialysis fluid ration of dialysis fluid ration of dialysis fluid ration of dialysis fluid

2 of 20 - ch. 6.1 - Operation during PHF ENG – Ed. 06/09

must be intact, opened only at the moment of use. Once opened, they must be intact, opened only at the moment of use. Once opened, they must be intact, opened only at the moment of use. Once opened, they must be intact, opened only at the moment of use. Once opened, they must be used for one treatment only within 24 hours.must be used for one treatment only within 24 hours.must be used for one treatment only within 24 hours.must be used for one treatment only within 24 hours.

• Before carrying out a PHF dialysis, take a sample of Before carrying out a PHF dialysis, take a sample of Before carrying out a PHF dialysis, take a sample of Before carrying out a PHF dialysis, take a sample of dialysis fluiddialysis fluiddialysis fluiddialysis fluid and and and and check for the absence of disinfectant check for the absence of disinfectant check for the absence of disinfectant check for the absence of disinfectant agents.agents.agents.agents.

• Before and during PHF treatment, check the exact mixture of the Before and during PHF treatment, check the exact mixture of the Before and during PHF treatment, check the exact mixture of the Before and during PHF treatment, check the exact mixture of the concentrates with water.concentrates with water.concentrates with water.concentrates with water.

• Before and at the end of each PHF treatment always run a disinfection Before and at the end of each PHF treatment always run a disinfection Before and at the end of each PHF treatment always run a disinfection Before and at the end of each PHF treatment always run a disinfection program. program. program. program. The manufacturerThe manufacturerThe manufacturerThe manufacturer declines any declines any declines any declines any responsibilityresponsibilityresponsibilityresponsibility for patient safety for patient safety for patient safety for patient safety in the event of in the event of in the event of in the event of failure to carry out proper disinfection.failure to carry out proper disinfection.failure to carry out proper disinfection.failure to carry out proper disinfection.

• Regularly change the Multipure and Forclean filters to ensure the Regularly change the Multipure and Forclean filters to ensure the Regularly change the Multipure and Forclean filters to ensure the Regularly change the Multipure and Forclean filters to ensure the maximum apyrogenicity of the liquid used.maximum apyrogenicity of the liquid used.maximum apyrogenicity of the liquid used.maximum apyrogenicity of the liquid used.

• The Qinf value must be chosen taking into consideration the dilution The Qinf value must be chosen taking into consideration the dilution The Qinf value must be chosen taking into consideration the dilution The Qinf value must be chosen taking into consideration the dilution mode, in particular in POST dilution mode, in particular in POST dilution mode, in particular in POST dilution mode, in particular in POST dilution (PHF POST) a careful evaluation of the (PHF POST) a careful evaluation of the (PHF POST) a careful evaluation of the (PHF POST) a careful evaluation of the set value is necessary. Refer to the literature and the clinical scene of the set value is necessary. Refer to the literature and the clinical scene of the set value is necessary. Refer to the literature and the clinical scene of the set value is necessary. Refer to the literature and the clinical scene of the patient to avoid potentially dangerous conditions.patient to avoid potentially dangerous conditions.patient to avoid potentially dangerous conditions.patient to avoid potentially dangerous conditions.

During PHF treatment, in addition to the parameters displayed in Double Needle, the following tools are present:

INFUSION FLOWINFUSION FLOWINFUSION FLOWINFUSION FLOW

The tool displays the infusion flow set (settable between

0 and 21 kg/h).

To modify this value, turn the infusion pump blue flow regulator

- clockwise to increase,

- anti-clockwise to decrease.

NOTENOTENOTENOTE If a dialysIf a dialysIf a dialysIf a dialysis fluid flow of 800 ml/min is set, the flow that is actually sent to is fluid flow of 800 ml/min is set, the flow that is actually sent to is fluid flow of 800 ml/min is set, the flow that is actually sent to is fluid flow of 800 ml/min is set, the flow that is actually sent to the dialyser will not correspond to the set value, but will be equal to the set the dialyser will not correspond to the set value, but will be equal to the set the dialyser will not correspond to the set value, but will be equal to the set the dialyser will not correspond to the set value, but will be equal to the set value less the infusion flow. value less the infusion flow. value less the infusion flow. value less the infusion flow. If the dialysis fluid flow of 500 ml/min. and an infusion flow less than 18If the dialysis fluid flow of 500 ml/min. and an infusion flow less than 18If the dialysis fluid flow of 500 ml/min. and an infusion flow less than 18If the dialysis fluid flow of 500 ml/min. and an infusion flow less than 18 kg/h are set, the flow entering the dialyser will coincide with the set flow. If kg/h are set, the flow entering the dialyser will coincide with the set flow. If kg/h are set, the flow entering the dialyser will coincide with the set flow. If kg/h are set, the flow entering the dialyser will coincide with the set flow. If the infusion flow is greater than 18 kg/h, then the flow entering the dialyser the infusion flow is greater than 18 kg/h, then the flow entering the dialyser the infusion flow is greater than 18 kg/h, then the flow entering the dialyser the infusion flow is greater than 18 kg/h, then the flow entering the dialyser will be equal to the maximum flow (800 ml/min) less the infusion flow. will be equal to the maximum flow (800 ml/min) less the infusion flow. will be equal to the maximum flow (800 ml/min) less the infusion flow. will be equal to the maximum flow (800 ml/min) less the infusion flow. If a dialysis fluid floIf a dialysis fluid floIf a dialysis fluid floIf a dialysis fluid flow of 300 ml/min is set, the flow entering the dialyser will w of 300 ml/min is set, the flow entering the dialyser will w of 300 ml/min is set, the flow entering the dialyser will w of 300 ml/min is set, the flow entering the dialyser will coincide with the set flow.coincide with the set flow.coincide with the set flow.coincide with the set flow.

OTHER PARAMETERSOTHER PARAMETERSOTHER PARAMETERSOTHER PARAMETERS

In the second page of the display the following parameters are displayed :

- infused fluid volume (in kg); the tool starts calculating only when blood is detected (thus not during priming)

- infusion fluid pressure.

To display these parameters,

see/mod. parameters


.


INSTALLATION OF DISPINSTALLATION OF DISPINSTALLATION OF DISPINSTALLATION OF DISPOSABLE MATERIALSOSABLE MATERIALSOSABLE MATERIALSOSABLE MATERIALS

Refer to chapter ”Disposable Materials and accessories” for the disposables to use in PHF treatment.

DIALYSERDIALYSERDIALYSERDIALYSER

WARNINGWARNINGWARNINGWARNING PHF treatment may only be carried out with PHF dialysersPHF treatment may only be carried out with PHF dialysersPHF treatment may only be carried out with PHF dialysersPHF treatment may only be carried out with PHF dialysers (see chapter (see chapter (see chapter (see chapter Disposable Materials and accessoriesDisposable Materials and accessoriesDisposable Materials and accessoriesDisposable Materials and accessories)))).... The dialyser inlet/outlet connectors conform to ISO 8637 and EN 1283 The dialyser inlet/outlet connectors conform to ISO 8637 and EN 1283 The dialyser inlet/outlet connectors conform to ISO 8637 and EN 1283 The dialyser inlet/outlet connectors conform to ISO 8637 and EN 1283 standards.standards.standards.standards. Install the double chamber PHF dialyser in its support and carefully read the instructions on the packaging related to the direction of the blood flow, depending on the dilution mode chosen.

To perform PHF treatment in PRE-DILUTION mode (PHF PRE), install the dialyser with the filtration chamber upwards.

To perform PHF in POST-DILUTION mode (PHF POST), install the dialyser with the filtration chamber downwards.


LINES LINES LINES LINES


• UsUsUsUse of specific lines is recommended e of specific lines is recommended e of specific lines is recommended e of specific lines is recommended (see chapter (see chapter (see chapter (see chapter Disposable Materials Disposable Materials Disposable Materials Disposable Materials and accessoriesand accessoriesand accessoriesand accessories)))). . . . Alarms and performance may be affected if Alarms and performance may be affected if Alarms and performance may be affected if Alarms and performance may be affected if inappropriate lines are used, i.e. air detector alarm or ultrafiltration inappropriate lines are used, i.e. air detector alarm or ultrafiltration inappropriate lines are used, i.e. air detector alarm or ultrafiltration inappropriate lines are used, i.e. air detector alarm or ultrafiltration accuracy.accuracy.accuracy.accuracy.

• Use only lines with blood catcher for the coUse only lines with blood catcher for the coUse only lines with blood catcher for the coUse only lines with blood catcher for the connection to the pressure nnection to the pressure nnection to the pressure nnection to the pressure transducers.transducers.transducers.transducers.

• During dialysis, if blood or any other fluid comes into contact with the During dialysis, if blood or any other fluid comes into contact with the During dialysis, if blood or any other fluid comes into contact with the During dialysis, if blood or any other fluid comes into contact with the blood catcher, and fluid passage through the membrane is detected or blood catcher, and fluid passage through the membrane is detected or blood catcher, and fluid passage through the membrane is detected or blood catcher, and fluid passage through the membrane is detected or suspected, proceed as follows:suspected, proceed as follows:suspected, proceed as follows:suspected, proceed as follows:

---- replace the line as indicated in the instru replace the line as indicated in the instru replace the line as indicated in the instru replace the line as indicated in the instructions given by the manufacturer;ctions given by the manufacturer;ctions given by the manufacturer;ctions given by the manufacturer; ---- contact authorized technicians to verify and disinfect the internal contact authorized technicians to verify and disinfect the internal contact authorized technicians to verify and disinfect the internal contact authorized technicians to verify and disinfect the internal measurement set;measurement set;measurement set;measurement set; ---- DO NOT USE the machine for further treatments before it has been DO NOT USE the machine for further treatments before it has been DO NOT USE the machine for further treatments before it has been DO NOT USE the machine for further treatments before it has been checked and disinfected.checked and disinfected.checked and disinfected.checked and disinfected.


INFUSION LINEINFUSION LINEINFUSION LINEINFUSION LINE

The procedure described belThe procedure described belThe procedure described belThe procedure described below is for both preow is for both preow is for both preow is for both pre----dilution (PHF PRE) and post dilution (PHF PRE) and post dilution (PHF PRE) and post dilution (PHF PRE) and post dilution (PHF POST) modes. dilution (PHF POST) modes. dilution (PHF POST) modes. dilution (PHF POST) modes. Pictures are provided relative Pictures are provided relative Pictures are provided relative Pictures are provided relative onlyonlyonlyonly to to to to predilution predilution predilution predilution mode (PHFmode (PHFmode (PHFmode (PHF----PRE).PRE).PRE).PRE).

- Connect the yellow end (1) of the infusion line to the inlet of the filtration section of the double chamber dialyser.

- Position the drip chamber in the appropriate right side clip (2).

- Open the infusion pump cover and fasten the initial blue connector of the infusion pump segment in the left guide set of the infusion pump head (follow the direction of the blue arrow). (For the semi-automatic loading of the pump segment, refer to the relevant paragraph in the PREPARATION OF TREATMENT chapter).

- Load the pump segment, rotating the pump anticlockwise.

- Fasten the other end of the pump segment in the right guide set.

- Fold the drive handle back into the pump and close the cover of the infusion pump.

- Insert a segment of the pre-pump line into the infusion end detector (3).

- Connect the luer connector of the blood catcher to the infusion pressure transducer (4).

- Insert the segment of the line in proximity of the yellow end into the blood leak detector block (BLD) (green) (5).

- Insert the PHF sampling connector (7) into the dialysate inlet port (blue) of the dialyser.

WARNINGWARNINGWARNINGWARNING Do not clamDo not clamDo not clamDo not clamp the pressure measurement linep the pressure measurement linep the pressure measurement linep the pressure measurement line....

5

7

1

2

3

4

6


ARTERARTERARTERARTERIIIIAL LINEAL LINEAL LINEAL LINE

The procedure described below is for both preThe procedure described below is for both preThe procedure described below is for both preThe procedure described below is for both pre----dilution (PHF PRE) and post dilution (PHF PRE) and post dilution (PHF PRE) and post dilution (PHF PRE) and post dilution (PHF POST) modes. dilution (PHF POST) modes. dilution (PHF POST) modes. dilution (PHF POST) modes. Pictures are provided relative Pictures are provided relative Pictures are provided relative Pictures are provided relative onlyonlyonlyonly to to to to predilution mode (PHFpredilution mode (PHFpredilution mode (PHFpredilution mode (PHF----PRE).PRE).PRE).PRE).

- Fix the expansion chamber into the relevant support (1).

- Connect the Luer connector of the blood catcher to the prefilter arterial pressure gauge (1b, red).

- Open the cover of the arterial pump.

- Lift the folding drive handle of the pump.

- Fasten the inlet of the arterial segment in the lower guide set (follow the direction of the red arrow). (For semi-automatic loading of the pump segment, refer to the relevant paragraph in the Preparation of Treatment chapter).

- Load the pump segment, rotating the pump anticlockwise.

- Fasten the other end of the pump segment in the right guide set.

- Fold the drive handle back into the pump and close the cover.

- Accurately insert the arterial line in the blood detector (2) and in the fixing clip (3) next to the electroclamp. If the arterial electric safety clamp (double clamp) (3b) is present, insert the arterial line following the instructions described in the paragraph “Automatic opening of the clamp” in the Preparation of Treatment chapter.

- Connect the Luer-lock connector of the blood catcher (at pump inlet) to the pressure meter(red) (4).

- Connect the red connector of the line to the blood inlet connector of the dual chamber dialyser according to the dilution mode chosen (pre- or post-dilution).

- Fasten the line in the relevant clip on the dialyser holder.

- Fasten the line into the relevant clip (red) (5).

- Connect the heparin syringe (see chapter on Heparin).


When priming is executed with BAGS OF PHYSIOLOGICAL SOLUTION (PHF Self Priming = OFF was set during service configuration),

- Hang the bag of physiological solution on the support on the I.V. pole.

Connect the arterial line to the bag of physiological solution.

When priming is executed with ultrapure DIALYSIS FLUID (PHF Self Priming = ON was set during service configuration), Connect the arterial line to sampling point on the venous line.

1b

4

5

1

2

3


VENOUS LINEVENOUS LINEVENOUS LINEVENOUS LINE

The procedure described below is for both preThe procedure described below is for both preThe procedure described below is for both preThe procedure described below is for both pre----dilution (PHF PRE) and post dilution (PHF PRE) and post dilution (PHF PRE) and post dilution (PHF PRE) and post dilution (PHF POST) modes. dilution (PHF POST) modes. dilution (PHF POST) modes. dilution (PHF POST) modes. Pictures are provided relative Pictures are provided relative Pictures are provided relative Pictures are provided relative onlyonlyonlyonly to to to to predilution mode (PHFpredilution mode (PHFpredilution mode (PHFpredilution mode (PHF----PRE).PRE).PRE).PRE).

- Insert the venous drip chamber into its support (1), positioning it approximately halfway. The internal filter must remain below the support.

- Insert the venous line into the air detector (2).

- Insert the line into the electroclamp and carefully position the tube in the fastening clip. (For semi-automatic opening of the clamp, refer to the corresponding paragraph in the chapter Preparation of Treatment).

- Connect the blue connector to the dialyser blood outlet connector (blue), according to the dilution mode chosen (pre- or post-dilution).

- Connect the Luer connector of the blood catcher to the venous pressure meter(3) (blue).


- Fasten the line into the relevant clip (blue) (4).

- Hang the priming liquid collection bag on its support on the I.V. pole.

3

1

2

4


PRIMINGPRIMINGPRIMINGPRIMING BLOOD LINES BLOOD LINES BLOOD LINES BLOOD LINES

To activate blood line priming

select priming

.

return

to cancel and return to the previous menu, or

phf pre

or

phf post

to select the PHF treatment with the desired dilution mode and

ok

to confirm.

NOTENOTENOTENOTE

The LED next to keys The LED next to keys The LED next to keys The LED next to keys andandandand indicates:indicates:indicates:indicates: LED off = function inactive,LED off = function inactive,LED off = function inactive,LED off = function inactive, LED on = function active.LED on = function active.LED on = function active.LED on = function active.

The LED next to keys The LED next to keys The LED next to keys The LED next to keys andandandand indicatesindicatesindicatesindicates: LED off = function inactive,LED off = function inactive,LED off = function inactive,LED off = function inactive, LED on permanently = function active,LED on permanently = function active,LED on permanently = function active,LED on permanently = function active, LED flashing = function activaLED flashing = function activaLED flashing = function activaLED flashing = function activatatatatable.ble.ble.ble.

NOTENOTENOTENOTE

cancel priming


WARNINGWARNINGWARNINGWARNING Do not set a priming volume greater than or equal to 20 litres asDo not set a priming volume greater than or equal to 20 litres asDo not set a priming volume greater than or equal to 20 litres asDo not set a priming volume greater than or equal to 20 litres as,,,, in this in this in this in this casecasecasecase,,,, the machine will not take into account the pr the machine will not take into account the pr the machine will not take into account the pr the machine will not take into account the priming mode set in the iming mode set in the iming mode set in the iming mode set in the configuration and will configuration and will configuration and will configuration and will onlyonlyonlyonly allow the lines to be primed with bags of allow the lines to be primed with bags of allow the lines to be primed with bags of allow the lines to be primed with bags of physiological solutionphysiological solutionphysiological solutionphysiological solution.... It is advisable to place the dialyser in dialysis mode, that is to say with the arterial line upwards. In particular, if carrying out a PHF PRE, it may be helpful to turn the dialyser after adjusting the level in the venous expansion chamber; the dialyser must then be re-set to dialysis mode to complete the priming.

There are different modes for line priming if using BAGS OF PHYSIOLOGICAL SALINE SOLUTION (PHF Self Priming = OFF set during Technical configuration) or with ultrapure DIALYSATE FLUID (PHF Self Priming = ON). The two different methods are described below.


PRIMING WITH BAGS OFPRIMING WITH BAGS OFPRIMING WITH BAGS OFPRIMING WITH BAGS OF PHYSIOLOGICAL SOLUT PHYSIOLOGICAL SOLUT PHYSIOLOGICAL SOLUT PHYSIOLOGICAL SOLUTION ION ION ION

• Set the equipment to conductivity (refer to the chapter “Dialysis fluid preparation”) and connect the dialysis fluid connectors to the dialyser via the PHF sampling connector (7). The BLUE Hansen connector must be connected to the PHF sampling connector and not directly to the dialyser.

• Set infusion pump flow to 0 using the blue flow regulator.Set infusion pump flow to 0 using the blue flow regulator.Set infusion pump flow to 0 using the blue flow regulator.Set infusion pump flow to 0 using the blue flow regulator.

• Start the blood pump (press ).


• Set the blood pump flow with the red flow regulator.

• Fill the arterial expansion chamber up to 1/3 and adjust the level.

• Adjust the level (up to 2/3) in the venous drip chamber .

• If there are alarms, refer to the ALARMS chapter for the use of the and

keys.

• As soon as the venous drip chamber level had been reached, the electric safety clamp opens.

•

dialyser rinse on

to carry out an ultrafiltration and remove any substances, e.g. glycerine, from the dialyser.

• After the passage of approximately 1 litre of physiological saline solution, check that no air flows from the venous outlet. If the priming of the blood lines is carried out in post-dilution mode, rotate the double chamber filter so as the arterial line is facing upwards.

• Adjust blood flow to 200 ml/min.

• Start the infusion pump by adjusting the blue flow regulator and set a flow different from 0 (e.g. the infusion value of the treatment): initially the pump will turn clockwise at a speed of 60 cc/min for 1 to 3 minutes, subsequently it will stop for the entire duration of priming.

• To change the bag or bottle of physiological solution, stop the blood pump by

pressing . Once replaced, reactivate the pump.

• The machine stops 0.2 l before the Stop Priming value is reached. (If the stop priming is = 0= 0= 0= 0, the equipment continues to operate).

• If recirculation is desired, inter-connect the venous line and the arterial line.

Press to continue.

• formula® stops again 0.4 l before the End priming value is reached.

NOTENOTENOTENOTE


see/mod. parameters

and and and and

blood

and respectively select and respectively select and respectively select and respectively select

stop priming

or or or or

priming volume

....


• .

• The blood pump stops after every 0.2 litres circulated, until blood is detected in the arterial line.

• Priming terminates when the sensor on the arterial line detects blood.

• Disconnect the venous line from the collection bag and connect it to the patient.

WARNINGWARNINGWARNINGWARNING This operation must absolutely be done in order to avoid uncontrolled This operation must absolutely be done in order to avoid uncontrolled This operation must absolutely be done in order to avoid uncontrolled This operation must absolutely be done in order to avoid uncontrolled weight loss in the patient.weight loss in the patient.weight loss in the patient.weight loss in the patient.


PRIMING WITH ULTRAPUPRIMING WITH ULTRAPUPRIMING WITH ULTRAPUPRIMING WITH ULTRAPURE DIALYSATE FLUID RE DIALYSATE FLUID RE DIALYSATE FLUID RE DIALYSATE FLUID

• Set the equipment to conductivity (refer to the chapter “Dialysis fluid preparation”)

• Connect the dialysis fluid connectors to the dialyser via the PHF sampling connector (7). The BLUE Hansen connector must be connected to the PHF sampling connector and not directly to the dialyser.

• Set priming without heparin to 2 litres or priming with heparin to 3.6 litres with first stop to 1,6 litres.

• Set blood and infusion flows. As flows in the first priming phase are automatic, blood (Qb) and infusion flows (Qinf) are to be set to any flow other than zero (i.e. in accordance to dialysis prescription).

• ; initially only the infusion pump will turn.

• Maintain the dialyser with the arterial line facing upwards (filtration chamber upwards in PHF-PRE and downwards in PHF-POST) and wait until the dialysate compartment is filled up.

• Adjust the level in the drip chamber of the infusion line.

• Open the drip chamber of the arterial line and fill it up.

• Turn the dialyser with the venous line upwards (filtration chamber downwards in PHF-PRE and upwards in PHF-POST).

• Adjust the level in the venous drip chamber up to 2/3. If this operation is delayed, an arterial or venous pressure alarm could intervene. After venting air from the drip chambers the alarms can be overridden.

• As soon as the level has been reached in the venous drip chamber, the electroclamp opens and the arterial pump also starts. The blood flow is set with the arterial pump flow regulator; the infusion flow (Qinf) is automatically set by the machine. Check and adjust, if necessary, the levels in the drip chambers.

• Automatic recalculation of the arterial and venous pressures is carried out throughout priming.

• If priming is executed with heparin, perform a heparin bolus at the first stop and then continue priming upon conclusion.

• On completion of line rinsing, set the dialyser with the arterial line upwards again (filtration chamber upwards in PHF-PRE and downwards in PHF-POST).

• formula® stops 0.2 litres before the Stop Priming value is reached. (If the stop priming is = 0, the equipment continues to operate).

• formula® stops again 0.4 l before the End primingEnd primingEnd primingEnd priming value is reached and after every 0.2 litres circulated, until blood is detected in the arterial line.

NOTENOTENOTENOTE


see/mod. parameters

and and and and

blood


stop priming

or or or or

priming volume

....


• Before connecting the patient and starting the treatment, disconnect the arterial line from the sampling point of the venous line (after closing it with a clamp) and connect it to the patient.

WARNINGWARNINGWARNINGWARNING Close the sampling point on the venous line Close the sampling point on the venous line Close the sampling point on the venous line Close the sampling point on the venous line by by by by clampclampclampclampinginginging the tube and the tube and the tube and the tube and fitting fitting fitting fitting the safety cap.the safety cap.the safety cap.the safety cap.

• Priming ends when the sensor on the arterial line detects blood.

WARNINGWARNINGWARNINGWARNING When connecting the patient, it When connecting the patient, it When connecting the patient, it When connecting the patient, it is necessary to check that is necessary to check that is necessary to check that is necessary to check that formula® switches switches switches switches to CONNECT or DIALYSIS (blood section status bar message). Lack of to CONNECT or DIALYSIS (blood section status bar message). Lack of to CONNECT or DIALYSIS (blood section status bar message). Lack of to CONNECT or DIALYSIS (blood section status bar message). Lack of detection of blood by the blood detector (with resulting stay in priming) can detection of blood by the blood detector (with resulting stay in priming) can detection of blood by the blood detector (with resulting stay in priming) can detection of blood by the blood detector (with resulting stay in priming) can determine the infusion of ultrapure dialysis fluid to the patient.determine the infusion of ultrapure dialysis fluid to the patient.determine the infusion of ultrapure dialysis fluid to the patient.determine the infusion of ultrapure dialysis fluid to the patient. (also see the (also see the (also see the (also see the Alarms chapterAlarms chapterAlarms chapterAlarms chapter 10.3 10.3 10.3 10.3: BLOOD LEVEL ALARM). : BLOOD LEVEL ALARM). : BLOOD LEVEL ALARM). : BLOOD LEVEL ALARM).

DIALYSIS FLUID PREPADIALYSIS FLUID PREPADIALYSIS FLUID PREPADIALYSIS FLUID PREPARATION, SETTING OF URATION, SETTING OF URATION, SETTING OF URATION, SETTING OF UF PROGRAM AND F PROGRAM AND F PROGRAM AND F PROGRAM AND OPERATION DURING PHFOPERATION DURING PHFOPERATION DURING PHFOPERATION DURING PHF

For the dialysis fluid preparation, the setting of the ultrafiltration program, the execution and change of the treatment, refers to the descriptions in the corresponding chapters of the user manual. The only differences are as follows:The only differences are as follows:The only differences are as follows:The only differences are as follows:

• Ultrafiltration must be set without taking account of the infusion, since formula automatically adapts hourly ultrafiltration.

• The treatment is indicated with the letters PHF-PRE or PHF-POST in the status bar at the top right side of the display.

• If the infusion flow has not been set, the relevant warning appears.

• At any moment during the dialysis session it is possible to display and modify the infusion flow. The total amount infused is shown on the second page of the

display.

see/mod. parameters


.

• The infusion pump operates only if the blood pump is active and no alarms of the dialysate compartment are active.

• During treatment the ultrafiltration programme is active only if the infusion pump is in operation and vice versa, with the exception of isolated UF dialysis during which the infusion pump is off.

WARNINGWARNINGWARNINGWARNING In case of leaks of infusion liIn case of leaks of infusion liIn case of leaks of infusion liIn case of leaks of infusion liquid into the environment, check the patient quid into the environment, check the patient quid into the environment, check the patient quid into the environment, check the patient weight, immediately interrupt the PHF treatment and continue in Double weight, immediately interrupt the PHF treatment and continue in Double weight, immediately interrupt the PHF treatment and continue in Double weight, immediately interrupt the PHF treatment and continue in Double Needle.Needle.Needle.Needle.


INFUSION FLOW ADJUSTINFUSION FLOW ADJUSTINFUSION FLOW ADJUSTINFUSION FLOW ADJUSTMENTMENTMENTMENT

If the Press. Transd. KitPress. Transd. KitPress. Transd. KitPress. Transd. Kit parameter is set to a value below 2 in Technical configuration, the infusion flow is set by means of the infusion flow regulator. Otherwise, when entering dialysis, automatic adjustment of the infusion flow is enabled. This mechanism automatically adjusts the infusion flow value based on the average TMP measured by the machine and the working TMP set by the user. In particular, the infusion flow is automatically adjusted by the machine so that the average TMP is maintained within a range of ± 10 mmHg around the working TMP set. The average TMP is obtained from the following relations:

TreatmentTreatmentTreatmentTreatment Formula for TMP calculationFormula for TMP calculationFormula for TMP calculationFormula for TMP calculation

PHF PRE ( ) ( )30

2+−

+∆−= dout

vefilt PPPP

TMP

PHF POST ( ) ( )302

+−∆++

= doutevfilt P

PPPTMP

where Pfilt is the prefilter arterial pressure, Pv the venous pressure, Pdout the dialysate pressure measured at the dialyser outlet, and ∆Pe the pressure drop on the blood filter of the dual chamber filter (20 mmHg). To modify the working TMP:

see/mod. parameters

blood

set TMP

.

Press the or keys to set the new value and then confirm with . If the working TMP is not set, the application uses a default value of 250 mmHg in PHF PRE and 200 mmHg in PHF POST. The moment the control is activated, Qinf goes to a prefixed value which depends on the treatment selected (see table below) . Subsequently, Qinf is automatically changed to within minimum and maximum thresholds which again depend on the treatment (see table).

TreatmentTreatmentTreatmentTreatment Minimum Qinf Minimum Qinf Minimum Qinf Minimum Qinf (kg/h)(kg/h)(kg/h)(kg/h)

Maximum Qinf Maximum Qinf Maximum Qinf Maximum Qinf (kg/h)(kg/h)(kg/h)(kg/h)

PHF PRE 2 21

PHF POST 1 10

It is therefore possible that during a treatment, although not being around the set working TMP, Qinf is not changed since it coincides with one of the maximum and minimum limits. To view the Qinf tool with these limits:

see/mod. parameters

blood


Automatic infusion flow adjustment can be disabled at any time during dialysis:

see/mod. parameters

blood

disable auto Qinf

or re-enabled:

see/mod. parameters

blood

enable auto Qinf

If automatic adjustment is disabled, the infusion flow is set by means of the infusion flow regulator.

PPPPHF DIALYSER INTEGRITHF DIALYSER INTEGRITHF DIALYSER INTEGRITHF DIALYSER INTEGRITY TEST Y TEST Y TEST Y TEST

At the beginning of each PHF treatment, a test to check the integrity of the membrane of the convective section of the PHF dialyser is automatically carried out.

During this test, which lasts max. 3 minutes, the infusion pump turns clockwise, thus permitting removal of ultrafiltrate from the PHF dialyser. The blood leak sensor checks the extracted ultrafiltrate for any potential presence of blood. In the case of a negative result, the infusion pump re-starts turning anticlockwise to start the infusion.

If, however, the presence of blood is detected, the “Haemofilter Test failed” (yellow window) alarm is displayed which indicates a rupture of the membrane in the convective section of the PHF dialyser.

Check the dialyser and the line and proceed in one of the following ways:

repeat filter test

To repeat the PHF dialyser test.

NOTENOTENOTENOTE TheTheTheThe PHF dialyser test may be performed at any point PHF dialyser test may be performed at any point PHF dialyser test may be performed at any point PHF dialyser test may be performed at any point during treatment even if no alarm situation exists. during treatment even if no alarm situation exists. during treatment even if no alarm situation exists. during treatment even if no alarm situation exists.

see/mod. parameters

test

filter management

test

repeat filter test

....

change filter test

To allow substitution of PHF dialyser and infusion line. Activating this function enables the following conditions:

- stop of the infusion pump

- dialysis time interrupted

- dialyser bypass

Once replaced, the PHF dialyser test is automatically re-run.

NOTENOTENOTENOTE In case of rupture of the PHF dialyseIn case of rupture of the PHF dialyseIn case of rupture of the PHF dialyseIn case of rupture of the PHF dialyser, it is always r, it is always r, it is always r, it is always necessary to substitute both the dialyser and infusion necessary to substitute both the dialyser and infusion necessary to substitute both the dialyser and infusion necessary to substitute both the dialyser and infusion line.line.line.line.


If, in addition to the PHF dialyser, the blood lines need If, in addition to the PHF dialyser, the blood lines need If, in addition to the PHF dialyser, the blood lines need If, in addition to the PHF dialyser, the blood lines need also to be replaced, it is advisable to disconnect the also to be replaced, it is advisable to disconnect the also to be replaced, it is advisable to disconnect the also to be replaced, it is advisable to disconnect the patient and prime again the whole blood circuit.patient and prime again the whole blood circuit.patient and prime again the whole blood circuit.patient and prime again the whole blood circuit.

continue

To continue the treatment regardless of a negative result of the PHF dialyser test.

WARNINGWARNINGWARNINGWARNING It is sole and full responsibility of the operator It is sole and full responsibility of the operator It is sole and full responsibility of the operator It is sole and full responsibility of the operator ccccontinuing the treatment despite ontinuing the treatment despite ontinuing the treatment despite ontinuing the treatment despite the the the the failed test .failed test .failed test .failed test .

rinseback

To begin the rinseback procedure.

INFUSION BOLUSESINFUSION BOLUSESINFUSION BOLUSESINFUSION BOLUSES

Boluses of dialysis fluid can be infused at any time during dialysis. To infuse a bolus,

see/mod. parameters

dialysate


infusion bolus

and set the amount to be infused (between 0 and 500 ml).

The bolus will not be subtracted by the ultrafiltration program, so the actual The bolus will not be subtracted by the ultrafiltration program, so the actual The bolus will not be subtracted by the ultrafiltration program, so the actual The bolus will not be subtracted by the ultrafiltration program, so the actual weight loss at the end of dialysis is given by the total weight loss set less the weight loss at the end of dialysis is given by the total weight loss set less the weight loss at the end of dialysis is given by the total weight loss set less the weight loss at the end of dialysis is given by the total weight loss set less the sum of the boluses infused during sum of the boluses infused during sum of the boluses infused during sum of the boluses infused during treatment.treatment.treatment.treatment. During infusion of the bolus, the dialysis fluid is infused at a flow rate that may vary between 3 and 12 kg/h in relation to the blood flow. Infusion of the bolus can be stopped by resetting the value to the volume infused up to that moment. The total amount of boluses infused during treatment is also displayed.


PATIENT PATIENT PATIENT PATIENT RINSEBACKRINSEBACKRINSEBACKRINSEBACK (WITH PHYSIOLOGICAL (WITH PHYSIOLOGICAL (WITH PHYSIOLOGICAL (WITH PHYSIOLOGICAL SOLUTION OR SOLUTION OR SOLUTION OR SOLUTION OR AIR)AIR)AIR)AIR)

This rinseback mode is available in PHF treatment both in POST-DILUTION (PHF-POST) and PRE-DILUTION (PHF PRE), provided that in Service configuration the parameter Rinseback Online was set to OFF (Rins. Online PHFpre = OFF). (check the Technical configuration parameters in the help on line). During patient rinseback the infusion pump is off. Please refer to the relevant chapter in the user manual.

PATIENT PATIENT PATIENT PATIENT RINSEBACKRINSEBACKRINSEBACKRINSEBACK WITH ULTRAPURE WITH ULTRAPURE WITH ULTRAPURE WITH ULTRAPURE DIALYSIS FLUIDDIALYSIS FLUIDDIALYSIS FLUIDDIALYSIS FLUID

This rinseback mode is available only in PRE-DILUTION (PHF PRE) PHF treatment provided that in Service configuration the parameter Rinseback Online was set to ON (Rins. Online PHFpre = ON). (Check the Technical configuration parameters in the help on line).


During patient During patient During patient During patient rinsebackrinsebackrinsebackrinseback some machine protections are not active. some machine protections are not active. some machine protections are not active. some machine protections are not active.

Check the rinseback procedure with extreme care to prevent passage of air Check the rinseback procedure with extreme care to prevent passage of air Check the rinseback procedure with extreme care to prevent passage of air Check the rinseback procedure with extreme care to prevent passage of air bubbles into the vein.bubbles into the vein.bubbles into the vein.bubbles into the vein. To interrupt the treatment or when the dialysis time has ended (the END UF warning

appears),

rinseback

. A message appears requesting to confirm rinseback.

no

to cancel the operation, or

yes

to confirm.

NOTENOTENOTENOTE When rinseback has started, you When rinseback has started, you When rinseback has started, you When rinseback has started, you are are are are not not not not allowed to allowed to allowed to allowed to return to dialysis.return to dialysis.return to dialysis.return to dialysis.

• The blood pump stops (PUMP OFF warning), the dialyser is bypassed, ultrafiltration is interrupted and the blood flow is automatically reduced.


• Reactivate the pump to start blood rinseback.

• The absolute alarm thresholds of the venous and arterial pressure automatically set to the following values:

-150 +300 mmHg venous pressure

-300 +200 mmHg arterial pressure

• About 25 sec. later the blood pump stops and dialysis fluid is infused by the infusion pump. The infusion flow rate, automatically set at 10 kg/h, is displayed with a negative value in the hourly UF tool on the monitor.


• The arterial pressure alarm is disabled and the alarm thresholds of the infusion pressure alarm are automatically set to -200 ÷ +770 mmHg .

• The total dialysis fluid infused during the rinseback procedure (VTot. Inf.) together with the infusion pressure (Pinf) are displayed by the dedicated tool on

the monitor.


PPPPay careful attention to the amount of dialysis fluid infused to the patient to ay careful attention to the amount of dialysis fluid infused to the patient to ay careful attention to the amount of dialysis fluid infused to the patient to ay careful attention to the amount of dialysis fluid infused to the patient to prevent weight loss errors.prevent weight loss errors.prevent weight loss errors.prevent weight loss errors.

At any moment reinfusion of dialysis fluid to the patient can be interrupted At any moment reinfusion of dialysis fluid to the patient can be interrupted At any moment reinfusion of dialysis fluid to the patient can be interrupted At any moment reinfusion of dialysis fluid to the patient can be interrupted

by setting the infusionby setting the infusionby setting the infusionby setting the infusion flow regulator to zero or pressing flow regulator to zero or pressing flow regulator to zero or pressing flow regulator to zero or pressing ....

• When allallallall the following conditions are fulfilled, that is: - the arterial line does not contain any more blood, - the emptying of the venous drip chamber, or blood is mixed with ultrapure dialysis fluid the blood pump stops (PUMP OFF warning), the electroclamp closes and the infusion flow value is automatically reduced.

• Restart the pump to complete rinseback but pay attention because the infusion pump goes on running without interruption.

• Set the infusion flow regulator to zero or .


• .

• Disconnect the blue dialyser connector and insert it in its housing on the machine.




rinsing

rinsing

and confirm (

yes

) to start a few minute rinsing cycle during which the self-diagnostic tests are performed.

Then the machine reverts to a low-consumption rinsing condition and waits for operator’s intervention.




and confirm (

yes

) to start a short high flux rinsing phase (90 sec. at 800 ml/min) at the end of which only the disinfection/cleaning program is allowed.

Dialysis will be enabled only after the self-test phase, at the end of disinfection/cleaning.

dialyser drain on

The function is available when the message EMPTYING appears on the top right bar. Press the key to empty the dialyser again.


dialyser drain on

(or (or (or (or ) before removing the BLUE Hansen ) before removing the BLUE Hansen ) before removing the BLUE Hansen ) before removing the BLUE Hansen connector from the dialyser.connector from the dialyser.connector from the dialyser.connector from the dialyser.

bidry drain on

The function is available only in case of bicarbonate cartridge dialysis (also see the Chapter “PATIENT RINSEBACK”). Press the key to empty the cartridge. Disconnect the blue cartridge connector and check that the clamps are open. When using a pierceable bicarbonate cartridge, remove the upper piercing connector from the upper clip support and disconnect it from the cartridge. Keep the cartridge in the lower piercing

connector.

bidry drain on

. Wait for the cartridge to empty and then remove it. Re-close the mobile bypass over the lower piercing connector. Re-close the upper piercing connector over the mobile bypass and lock it with the locking bracket.


Once Once Once Once the the the the

dialyser drain on

or or or or

bidry drain on

key functions have been pressed, the key functions have been pressed, the key functions have been pressed, the key functions have been pressed, the dialyser is bypassed and it is impossible to continue rinseback infusing dialyser is bypassed and it is impossible to continue rinseback infusing dialyser is bypassed and it is impossible to continue rinseback infusing dialyser is bypassed and it is impossible to continue rinseback infusing ultrapure dialysultrapure dialysultrapure dialysultrapure dialysis fluid.is fluid.is fluid.is fluid.

• Remove the disposable accessories and discard them.


ENG – Ed. 06/09 chap. 7.1 - Haemodiafiltration HFR - 1 of 18

7.1 HAEMODIAFILTRATION WITH ENDOGENOUS 7.1 HAEMODIAFILTRATION WITH ENDOGENOUS 7.1 HAEMODIAFILTRATION WITH ENDOGENOUS 7.1 HAEMODIAFILTRATION WITH ENDOGENOUS

REINFUSION OF ULTRAFILTRATE (HFR)REINFUSION OF ULTRAFILTRATE (HFR)REINFUSION OF ULTRAFILTRATE (HFR)REINFUSION OF ULTRAFILTRATE (HFR)

DESCRIPTIONDESCRIPTIONDESCRIPTIONDESCRIPTION

Haemodiafiltration with on-line reinfusion to the patient of his/her own ultrafiltrate (HFR) utilises a double chamber dialyser that enables separation of the diffusive and convective processes. The ultrafiltrate obtained from the convective section of the dialyser crosses an adsorbent cartridge containing both insoluble synthetic styrene resin and uncovered active carbon (SELECTA PLUS) or only resin (SELECTA). These materials are immobilised inside the cartridge by means of disc filters. This treatment may be carried out only on formula 2000 machines, i.e. machines equipped with UF/infusion pump.

INSTALLATION OF DISPINSTALLATION OF DISPINSTALLATION OF DISPINSTALLATION OF DISPOSABLE MATERIALSOSABLE MATERIALSOSABLE MATERIALSOSABLE MATERIALS

Refer to chapter on Disposable materials for use in HFR treatment.

DIALYSERDIALYSERDIALYSERDIALYSER Install the dialyser in its support and carefully read the instructions on the packaging related to use of the filter.

WARNINGWARNINGWARNINGWARNING HFR treatment may be carried out only HFR treatment may be carried out only HFR treatment may be carried out only HFR treatment may be carried out only with with with with HFRHFRHFRHFR dialysers and SELECTA or dialysers and SELECTA or dialysers and SELECTA or dialysers and SELECTA or SELECTA PLUS adsorbent cartridges.SELECTA PLUS adsorbent cartridges.SELECTA PLUS adsorbent cartridges.SELECTA PLUS adsorbent cartridges.

ADSORBENT CARTRIDGEADSORBENT CARTRIDGEADSORBENT CARTRIDGEADSORBENT CARTRIDGE The adsorbent cartridge is to be mounted on the relevant support hooked onto the stand.

BLOOD AND INFUSION LINES BLOOD AND INFUSION LINES BLOOD AND INFUSION LINES BLOOD AND INFUSION LINES

WARNINGWARNINGWARNINGWARNING • To avoid potentially dangerous situations, carefully read the directions on To avoid potentially dangerous situations, carefully read the directions on To avoid potentially dangerous situations, carefully read the directions on To avoid potentially dangerous situations, carefully read the directions on

the device packaging. the device packaging. the device packaging. the device packaging. • Check that the device packaging, which ensures their sterility, is not Check that the device packaging, which ensures their sterility, is not Check that the device packaging, which ensures their sterility, is not Check that the device packaging, which ensures their sterility, is not

damaged and that the sterilization validity date has not expired.damaged and that the sterilization validity date has not expired.damaged and that the sterilization validity date has not expired.damaged and that the sterilization validity date has not expired. • Ensure that installation is carried out properly using aseptic techniques. Ensure that installation is carried out properly using aseptic techniques. Ensure that installation is carried out properly using aseptic techniques. Ensure that installation is carried out properly using aseptic techniques. • It is recommended to use the specificIt is recommended to use the specificIt is recommended to use the specificIt is recommended to use the specific lines (see Disposable materials lines (see Disposable materials lines (see Disposable materials lines (see Disposable materials

chapter). Alarms and performance may be affected if inappropriate lines chapter). Alarms and performance may be affected if inappropriate lines chapter). Alarms and performance may be affected if inappropriate lines chapter). Alarms and performance may be affected if inappropriate lines are used. are used. are used. are used.

• Use only lines with blood catcher for the connection to the pressure Use only lines with blood catcher for the connection to the pressure Use only lines with blood catcher for the connection to the pressure Use only lines with blood catcher for the connection to the pressure transducers.transducers.transducers.transducers.

• During dialysis, if blood or any other fluid comes into contact with the During dialysis, if blood or any other fluid comes into contact with the During dialysis, if blood or any other fluid comes into contact with the During dialysis, if blood or any other fluid comes into contact with the blood catcher, and fluid passage through the membrane is detected or blood catcher, and fluid passage through the membrane is detected or blood catcher, and fluid passage through the membrane is detected or blood catcher, and fluid passage through the membrane is detected or suspected, proceed as follows:suspected, proceed as follows:suspected, proceed as follows:suspected, proceed as follows:

---- replace the line as indicated in the instructions given by the manufacturer; replace the line as indicated in the instructions given by the manufacturer; replace the line as indicated in the instructions given by the manufacturer; replace the line as indicated in the instructions given by the manufacturer;

2 of 18 - chap. 7.1 – Haemodiafiltration HFR ENG – Ed. 06/09

---- c c c contact the authorised Technical Services to check and disinfect the ontact the authorised Technical Services to check and disinfect the ontact the authorised Technical Services to check and disinfect the ontact the authorised Technical Services to check and disinfect the internal measuring set;internal measuring set;internal measuring set;internal measuring set; ---- DO NOT USE the machine for further treatments before it has been DO NOT USE the machine for further treatments before it has been DO NOT USE the machine for further treatments before it has been DO NOT USE the machine for further treatments before it has been checked and disinfected.checked and disinfected.checked and disinfected.checked and disinfected.


ARTERIAL LINEARTERIAL LINEARTERIAL LINEARTERIAL LINE

- Fix the expansion chamber in the relevant support (1).

- Connect the Luer connector of the blood catcher (if present on the arterial expansion chamber) to the prefilter arterial pressure gauge (1b) (red).

- Open the cover of the arterial pump.


- Fasten the inlet of the arterial segment in the lower guide set (follow the direction of the screen-printed red arrow). (For semi-automatic loading of the pump segment, refer to the relevant paragraph in the chapter PREPARATION OF TREATMENT).

- Turn the pump anti-clockwise and fit the segment.

- Fasten the other end of the segment in the upper guide set.

- Fold the drive handle back into the pump block and close the cover.

- Accurately insert the arterial line into the blood detector (2) and the fixing clip (3) next to the electric safety clamp. If the arterial electric clamp (double clamp) is fitted, insert the arterial line following the instructions in the paragraph “Automatic opening of the clamp” in the chapter PREPARATION OF TREATMENT.

- Connect the Luer-lock connector of the blood catcher (at pump inlet) to the pressure gauge (4) (red).

- Connect the red line connector to the blood inflow connector of the HFR dialyser.

- Fasten the line in the clip on the dialyser holder.

- Fasten the line in the clip (red) (5).

- Connect the heparin syringe (see chapter “Heparin”).


4

5

1

2

3

1b


VENOUS LINE VENOUS LINE VENOUS LINE VENOUS LINE

- Insert the venous drip chamber into its support (1), positioning it approximately halfway. The internal filter must remain below the support.

- Insert the venous line into the air detector (2).

- Insert the line into the electroclamp pressing the lever downward and accurately position the tube in the fastening clip. (For automatic opening of the electroclamp, refer to the relevant paragraph in the chapter “PREPARATION OF TREATMENT”).

- Attach the connector (blue) to the blood outlet connector (blue) of the HFR dialyser.

- Connect the Luer-lock connector of the blood catcher to the venous pressure gauge (blue) (3).


- Fasten the line in the relevant clip (blue) (4).

- Hang the priming liquid collection bag on its support on the stand.

3

1

2

4


ULTRAFILTRATION/INFUULTRAFILTRATION/INFUULTRAFILTRATION/INFUULTRAFILTRATION/INFUSION LINE SION LINE SION LINE SION LINE

- Position the adsorbent cartridge (1) in its support on the stand below the HFR dialyser and the infusion line drip chamber.

WARNINGWARNINGWARNINGWARNING � The cartridge has to be positioned with the inlet facing upwards (refer to The cartridge has to be positioned with the inlet facing upwards (refer to The cartridge has to be positioned with the inlet facing upwards (refer to The cartridge has to be positioned with the inlet facing upwards (refer to

the instructions on the label).the instructions on the label).the instructions on the label).the instructions on the label). � Should air bubbles form inside the cartridge, they must be removed Should air bubbles form inside the cartridge, they must be removed Should air bubbles form inside the cartridge, they must be removed Should air bubbles form inside the cartridge, they must be removed

during rinsing. Air may cause excessive pressure loss. during rinsing. Air may cause excessive pressure loss. during rinsing. Air may cause excessive pressure loss. during rinsing. Air may cause excessive pressure loss.

- Connect the yellow terminal of the ultrafiltrate circulation line (2) to the outlet of the convective section of the HFR dialyser and the other terminal (3) to the inlet of the adsorbent cartridge.

- Clamp the section of line between the first deaeration filter and the cartridge.

- Connect the section of line connected to the priming liquid collection bag to the outlet of the adsorbent cartridge (4) .

- Hang the priming liquid collection bag on its support on the stand (5).

WARNINGWARNINGWARNINGWARNING • If using a If using a If using a If using a SelectaSelectaSelectaSelecta cartridge, disconnect the end section of the line leading cartridge, disconnect the end section of the line leading cartridge, disconnect the end section of the line leading cartridge, disconnect the end section of the line leading

from the adsorbent cartridge from the collection bag and connect it to from the adsorbent cartridge from the collection bag and connect it to from the adsorbent cartridge from the collection bag and connect it to from the adsorbent cartridge from the collection bag and connect it to the infusion point of the dialyser (10), then proceed with the next steps.the infusion point of the dialyser (10), then proceed with the next steps.the infusion point of the dialyser (10), then proceed with the next steps.the infusion point of the dialyser (10), then proceed with the next steps.

• If using a If using a If using a If using a Selecta PlusSelecta PlusSelecta PlusSelecta Plus cartridge, proceed with the next steps. cartridge, proceed with the next steps. cartridge, proceed with the next steps. cartridge, proceed with the next steps.

- Position the drip chamber in the right-hand side clip (6).

- Open the UF/infusion pump cover.

- Lift the folding drive handle of the infusion head.

- Fasten the initial connection of the infusion pump segment (tube leading from the dialyser) in the left guide set of the infusion pump head (follow the direction of the screen-printed blue arrow). (For semi-automatic loading of the pump segment, see chapter Preparation of Treatment).

- Make the segment stick to the inner wall of the head by simultaneously turning the rotor (anticlockwise).

- Insert a segment of the pre-pump line into the end-of-infusion detector (7).

- Connect the transparent Luer connector of the blood catcher (tube on the drip chamber) to the infusion pressure transducer (8).

- Only after selecting priming, connect the Luer connector of the blood catcher (if present on the UF/infusion line) to the UF/infusion pressure transducer (8b) (yellow).

- Insert the segment of line between the drip chamber and the deaeration filter into the blood leak detector (BLD) block (green) (9).

- Prepare the physiological solution for priming. It is suggested to use a heparin solution of 5000 IU/l (if necessary, use the Y-connector to join two bags).


NOTENOTENOTENOTE

To modify the stop priming or end priming volumes, pressTo modify the stop priming or end priming volumes, pressTo modify the stop priming or end priming volumes, pressTo modify the stop priming or end priming volumes, press

see/mod. parameters

andandandand

blood

and respectively selectand respectively selectand respectively selectand respectively select

stop priming

or or or or

priming volume

.

WARNINGWARNINGWARNINGWARNING • Be extremely caBe extremely caBe extremely caBe extremely careful when connecting the cartridge, in particular when reful when connecting the cartridge, in particular when reful when connecting the cartridge, in particular when reful when connecting the cartridge, in particular when

removing the protective caps, to prevent spilling filling liquid. Follow the removing the protective caps, to prevent spilling filling liquid. Follow the removing the protective caps, to prevent spilling filling liquid. Follow the removing the protective caps, to prevent spilling filling liquid. Follow the instructions for direction of flow shown on the label.instructions for direction of flow shown on the label.instructions for direction of flow shown on the label.instructions for direction of flow shown on the label.

• Replace the cartridge if the internal liquid runs out or in the event of Replace the cartridge if the internal liquid runs out or in the event of Replace the cartridge if the internal liquid runs out or in the event of Replace the cartridge if the internal liquid runs out or in the event of excessive air.excessive air.excessive air.excessive air.

• Do not clamp the pressure measurement line.Do not clamp the pressure measurement line.Do not clamp the pressure measurement line.Do not clamp the pressure measurement line.

Infusion line assembly with SELECTA SELECTA SELECTA SELECTA cartridge

Infusion line assembly with SESESESELECTA PLUSLECTA PLUSLECTA PLUSLECTA PLUS cartridge


SELECTING LINE PRIMISELECTING LINE PRIMISELECTING LINE PRIMISELECTING LINE PRIMINGNGNGNG

To activate blood line priming

select priming

.

return

to cancel and return to the previous menu. There are various options to select the treatment depending on the cartridge to be used:

hfr Selecta

to select HFR treatment with use of the SELECTA cartridge. This function is the only one available if the following is set during service configuration:

HFR cartridge = SELECTAHFR cartridge = SELECTAHFR cartridge = SELECTAHFR cartridge = SELECTA

hfr Selecta Plus

to select HFR treatment with use of the SELECTA PLUS cartridge. This function is the only one available if the following is set during service configuration:

HFR cartridge =HFR cartridge =HFR cartridge =HFR cartridge = SELECTA PLUS SELECTA PLUS SELECTA PLUS SELECTA PLUS If, however, configuring:

HFR cartridge = BOTHHFR cartridge = BOTHHFR cartridge = BOTHHFR cartridge = BOTH the two functions are both available, and are associated with the same button.

Only in this case, when pressing

ok

to confirm, the following dialogue window appears: or:

return

to cancel and return to the previous menu

ok

to confirm.

HFRHFRHFRHFR cartridge: cartridge: cartridge: cartridge: SELECTASELECTASELECTASELECTA Do you confirm?Do you confirm?Do you confirm?Do you confirm?

HFRHFRHFRHFR cartridge cartridge cartridge cartridge:::: SELECTA PLUSSELECTA PLUSSELECTA PLUSSELECTA PLUS Do you confirm?Do you confirm?Do you confirm?Do you confirm?


NOTENOTENOTENOTE

cancel priming


NOTENOTENOTENOTE If configuring:If configuring:If configuring:If configuring:

HFR cartridge = BOTHHFR cartridge = BOTHHFR cartridge = BOTHHFR cartridge = BOTH the configured values for HFR Priming QB, HFR Priming Vol. and HFR Stop the configured values for HFR Priming QB, HFR Priming Vol. and HFR Stop the configured values for HFR Priming QB, HFR Priming Vol. and HFR Stop the configured values for HFR Priming QB, HFR Priming Vol. and HFR Stop Priming Vol. refer to line priming with Selecta cartridge.Priming Vol. refer to line priming with Selecta cartridge.Priming Vol. refer to line priming with Selecta cartridge.Priming Vol. refer to line priming with Selecta cartridge. In the case of line In the case of line In the case of line In the case of line primingprimingprimingpriming with Selecta Plus cartridge, these respectively assume the following with Selecta Plus cartridge, these respectively assume the following with Selecta Plus cartridge, these respectively assume the following with Selecta Plus cartridge, these respectively assume the following default values: 200 ml/min, default values: 200 ml/min, default values: 200 ml/min, default values: 200 ml/min, 4 l and 4 l and 4 l and 4 l and 1 l. 1 l. 1 l. 1 l. It is however possible to modify the stop priming and end priming volumes It is however possible to modify the stop priming and end priming volumes It is however possible to modify the stop priming and end priming volumes It is however possible to modify the stop priming and end priming volumes

see/mod. parameters

and and and and

blood


stop priming

or or or or

priming volume

LINE PRIMING WITH SELINE PRIMING WITH SELINE PRIMING WITH SELINE PRIMING WITH SELECTA PLUS CARTRIDGELECTA PLUS CARTRIDGELECTA PLUS CARTRIDGELECTA PLUS CARTRIDGE

• Position the HFR dialyser with the arterial inlet facing down.

• Start the blood pump ( ). The infusion pump stays off.


• Set the blood pump flow with the red flow regulator.

• It is suggested to prime the dialyser with flows not exceeding 100 ml/min.

• Fill the arterial expansion chamber up to 1/3 and connect the Luer connector of the blood catcher (if present on the arterial expansion chamber) to the prefilter arterial pressure gauge (red).

• Fill the venous drip chamber up to 2/3.

• As soon as the level has been reached in the venous drip chamber, the electroclamp opens and line priming ends.

• After the first stop (i.e. 0.2 litres before the HFR STOP PRIMING VOL. has been reached), check that no air flows from the venous outlet and turn the HFR dialyser so that the arterial inlet faces upwards.

• Check that the UF/infusion pump is not set to 0. . The blood pump will automatically operate at a rate of 90 ml/min and the UF/infusion pump at a rate of 60 ml/min for 1 to 3 minutes. Unclamp as soon as the priming fluid reaches the first deaeration filter and the level in the infusion drip chamber is about 1/3.

• After the initial 1-3 min and for the entire duration of the remaining priming volume, the blood flow is automatically set to the HFR PRIMING Qb value (displayed via the Eff. Qb tool) and the UF/infusion flow is automatically set to 2/3 of the blood flow.


• In this phase the infusion pump stops whenever the blood pump stops.

WARNINGWARNINGWARNINGWARNING Priming of the infusion line should be caPriming of the infusion line should be caPriming of the infusion line should be caPriming of the infusion line should be carried out correctly in order to rried out correctly in order to rried out correctly in order to rried out correctly in order to replace all the fluid contained in the adsorbent cartridge.replace all the fluid contained in the adsorbent cartridge.replace all the fluid contained in the adsorbent cartridge.replace all the fluid contained in the adsorbent cartridge.

The cartridge must be rinsed with at least two litres of saline solution.The cartridge must be rinsed with at least two litres of saline solution.The cartridge must be rinsed with at least two litres of saline solution.The cartridge must be rinsed with at least two litres of saline solution.

IIIIf changingf changingf changingf changing the treatment mode during HFR the treatment mode during HFR the treatment mode during HFR the treatment mode during HFR priming priming priming priming (e.g. switching from (e.g. switching from (e.g. switching from (e.g. switching from HFR to DN and then HFR to DN and then HFR to DN and then HFR to DN and then back to HFR), back to HFR), back to HFR), back to HFR), the totalized priming volume will be resetthe totalized priming volume will be resetthe totalized priming volume will be resetthe totalized priming volume will be reset....



• The machine stops 0.2 l before the Stop Priming value is reached.

• formula stops again 0.4 l before the End primingEnd primingEnd primingEnd priming value is reached and after every 0.2 litres circulated until blood is detected in the arterial line.

• Priming in any case ends when the sensor on the arterial line detects blood.

• On completion of rinsing, set the UF/infusion flow regulator to zero and connect the terminal section of the line leading from the adsorbent cartridge to the dialyser infusion point (10).

It is absolutely essential that the latter operation be carried outIt is absolutely essential that the latter operation be carried outIt is absolutely essential that the latter operation be carried outIt is absolutely essential that the latter operation be carried out in order to in order to in order to in order to avoid uncontrolled patient weight loss.avoid uncontrolled patient weight loss.avoid uncontrolled patient weight loss.avoid uncontrolled patient weight loss.

LINE PRIMING WITH SELINE PRIMING WITH SELINE PRIMING WITH SELINE PRIMING WITH SELECTA CARTRIDGELECTA CARTRIDGELECTA CARTRIDGELECTA CARTRIDGE

• Position the dialyser with the arterial inlet facing down.

• Start the blood pump ( ). In this phase the blood flow is automatically set to the configured HFR Priming Qb value. The infusion pump stays off.


• Fill the arterial expansion chamber up to 1/3 and connect the Luer connector of the blood catcher (if present on the arterial expansion chamber) to the prefilter arterial pressure gauge (red).

• Fill the venous drip chamber up to 2/3.

• As soon as the level has been reached in the venous drip chamber, the electroclamp opens and line priming ends.

• After the first stop (i.e. 0.2 litres before the HFR STOP PRIMING VOL. set during configuration has been reached), check that no air flows from the venous outlet and turn the HFR dialyser so that the arterial inlet faces upwards.

• Check that the UF/infusion pump is not set to 0. . The blood pump will automatically operate at a rate of 90 ml/min and the UF/infusion pump at a rate of 60 ml/min for 1 to 3 minutes. Unclamp as soon as the priming fluid reaches the first deaeration filter and the level in the infusion drip chamber is about 1/3.


• After the initial 1-3 min and for the entire duration of the remaining priming volume, the blood flow is automatically set to 150 ml/min (displayed via the Eff. Qb tool) and the UF/infusion flow is automatically set to 133 ml/min.

• In this phase the infusion pump stops whenever the blood pump stops.

WARNINGWARNINGWARNINGWARNING Priming of the infusion line should be carried out correctly in order to Priming of the infusion line should be carried out correctly in order to Priming of the infusion line should be carried out correctly in order to Priming of the infusion line should be carried out correctly in order to replace all the fluid contained in the adsorbent cartridge.replace all the fluid contained in the adsorbent cartridge.replace all the fluid contained in the adsorbent cartridge.replace all the fluid contained in the adsorbent cartridge.

The cartridge must be rinsed with at least two litres of saline solution.The cartridge must be rinsed with at least two litres of saline solution.The cartridge must be rinsed with at least two litres of saline solution.The cartridge must be rinsed with at least two litres of saline solution.

If changing the treatment mode during HFR priming (e.g. switching from If changing the treatment mode during HFR priming (e.g. switching from If changing the treatment mode during HFR priming (e.g. switching from If changing the treatment mode during HFR priming (e.g. switching from HFR to DN and then back to HFR), the totalized priming volume will be reset.HFR to DN and then back to HFR), the totalized priming volume will be reset.HFR to DN and then back to HFR), the totalized priming volume will be reset.HFR to DN and then back to HFR), the totalized priming volume will be reset.



• The machine stops again 0.4 l before the End primingEnd primingEnd primingEnd priming value is reached and after every 0.2 litres circulated until blood is detected in the arterial line.

• Priming in any case ends when the sensor on the arterial line detects blood.



For preparation of the dialysis fluid, setting the ultrafiltration program and changing treatment mode, refer to the descriptions in the corresponding chapters of the user manual.


• to bypass the HFR dialyser.






• to connect the HFR dialyser to the dialysis fluid.

• As soon as blood in the arterial line is detected, the message CONNECT appears on the top right bar (blood section). Blood circulates to prime the venous blood line and the HFR dialyser. As soon as blood is detected in the venous drip chamber, if the relevant parameter was set in configuration, an additional pump stop is performed; if not, wait until the message DIALYSIS appears. In the left status bar appears the message BIC. (/BIDRY/ACETATE) + STD A. CONC. (LYMPHA) - PROG.






• The preset parameters (temperature, conductivity, dialysate flow, treatment time, UF/h, weight loss) can be set at any time during the dialysis treatment session.

see/mod. parameters

and follow the indications shown in chap. Operator Interface.


see/mod. parameters

and

dialysate




see/mod. parameters

and


and refer to the “blood volume” instrument in chap. Operator Interface.


OPERATING IN HFROPERATING IN HFROPERATING IN HFROPERATING IN HFR

• Ultrafiltration must be set without taking account of infusion.

• The treatment is indicated with the letters HFR shown in the top status bar on the display.

• If the UF/infusion flow has not been set (= 0), the NO INFUSION FLOW warning appears. NULLO.

• At any moment during the dialysis session the UF/infusion flow can be displayed. The total UF/infused amount is shown on the second page of the display.

see/mod. parameters


.

• The UF/infusion pump operates only if the blood pump is active.

• The dialyser bypass and UF/infusion pump are independent of each other, i.e.

1. the UF/infusion pump operates even when the weight loss program is inactive.

2. the weight loss program continues even if the UF/infusion pump has stopped due to an alarm in the UF/infusion section.

WARNINGWARNINGWARNINGWARNING In case of leaks of UF/infusion liquid into the environment, check the patient In case of leaks of UF/infusion liquid into the environment, check the patient In case of leaks of UF/infusion liquid into the environment, check the patient In case of leaks of UF/infusion liquid into the environment, check the patient weight, immediately interrupt the HFR treatment and continue in Double weight, immediately interrupt the HFR treatment and continue in Double weight, immediately interrupt the HFR treatment and continue in Double weight, immediately interrupt the HFR treatment and continue in Double Needle.Needle.Needle.Needle. To enable the Aequilibrium application (also in Isonatric mode) in HFR, see the Chapter “PROFILER”.

ADJUSTING THE UF/INFADJUSTING THE UF/INFADJUSTING THE UF/INFADJUSTING THE UF/INFUSION FLOWUSION FLOWUSION FLOWUSION FLOW

If the parameter Kit Press.Kit Press.Kit Press.Kit Press. Transd. Transd. Transd. Transd. is set to zero during service configuration, the UF/infusion flow is set by means of the UF/infusion flow regulator. Otherwise, the automatic UF/infusion flow adjustment is enabled when entering HFR dialysis. This mechanism determines the optimal value of the UF/infusion flow on the basis of the hematocrit of the patient (if the Hemox sensor is present), the transmembrane pressure measured on the hemofilter and the control parameters (Qinf Qinf Qinf Qinf LV, FF max, TMPH maxLV, FF max, TMPH maxLV, FF max, TMPH maxLV, FF max, TMPH max) set during configuration (refer to the chapter “Configuration” ). The UF/infusion flow rate is initially set to the configured value so as to guarantee optimal linear velocity (Qinf (Qinf (Qinf (Qinf LVLVLVLV). This flow rate decreases if the transmembrane pressure measured on the hemofilter exceeds the threshold set in configuration (TMPH maxTMPH maxTMPH maxTMPH max) and/or if the fraction of filtration exceeds the maximum configured threshold (FF maxFF maxFF maxFF max). In any case, the


automatic adjustment mechanism does not reduce the UF/infusion flow to below 1 l/h. When automatic UF/infusion flow adjustment is enabled, the Qinf tool has a green background. Automatic flow adjustment can be disabled during dialysis:

see/mod. parameters

blood

Auto Qinf on

or re-enabled:

see/mod. parameters

blood

Auto Qinf on

Should automatic flow adjustment be disabled, the UF/infusion flow is set by means of the UF/infusion flow regulator.


Refer to the Patient Rinseback chapter for general information.

NOTE NOTE NOTE NOTE

During During During During rinsebackrinsebackrinsebackrinseback with air, the infusion pump remains still. with air, the infusion pump remains still. with air, the infusion pump remains still. with air, the infusion pump remains still.

PATIENT PATIENT PATIENT PATIENT RINSEBACKRINSEBACKRINSEBACKRINSEBACK WITH AIRWITH AIRWITH AIRWITH AIR






• Upon transition to the Rinseback II phase (see the general chapter on patient rinseback), the blood pump stops (PUMP STOP message) and the electroclamp is closed.

• Press to infuse any blood present in the venous line. The arterial pump rotates only one time before coming to a stop.



If rinseback is performed with air, the AIR DETECTED alarm is not active If rinseback is performed with air, the AIR DETECTED alarm is not active If rinseback is performed with air, the AIR DETECTED alarm is not active If rinseback is performed with air, the AIR DETECTED alarm is not active during emptying (during emptying (during emptying (during emptying (Rinseback IIRinseback IIRinseback IIRinseback II). ). ). ). Therefore carry out Therefore carry out Therefore carry out Therefore carry out patient rinsebackpatient rinsebackpatient rinsebackpatient rinseback with with with with extreme care to prevent passage of air bubbles into the vein.extreme care to prevent passage of air bubbles into the vein.extreme care to prevent passage of air bubbles into the vein.extreme care to prevent passage of air bubbles into the vein.

• Set the arterial flow regulator to zero or . • Disconnect the venous line from the patient. • Disconnect the blue dialyser connector and insert it in its housing on the

machine. The Filter Emptying procedure will be performed automatically. • Turn the dialyser and wait until it empties out completely. • Disconnect the red dialyser connector and insert it in its housing on the machine. • If the bicarbonate powder cartridge is present, perform the emptying procedure

(see the Chapter “PATIENT RINSEBACK”).




RINSEBACK WITH PHYSIRINSEBACK WITH PHYSIRINSEBACK WITH PHYSIRINSEBACK WITH PHYSIOLOGICAL SALINE SOLUOLOGICAL SALINE SOLUOLOGICAL SALINE SOLUOLOGICAL SALINE SOLUTION TION TION TION


In RinsebackIn RinsebackIn RinsebackIn Rinseback with physiological saline solution, check with care the quantity with physiological saline solution, check with care the quantity with physiological saline solution, check with care the quantity with physiological saline solution, check with care the quantity of physiological saline solution infused to the patient to prevent weight loss of physiological saline solution infused to the patient to prevent weight loss of physiological saline solution infused to the patient to prevent weight loss of physiological saline solution infused to the patient to prevent weight loss errors.errors.errors.errors.







• Upon transition to the Rinseback II phase (see the general chapter on patient rinseback), the equipment stops the blood pump (PUMP STOP message) and closes the electroclamp.

• to infuse any blood-saline solution in the venous line • The arterial pump performs continuous rotation with a reduced flow. If

necessary, adjust the blood flow using the flow regulator.

• Set the arterial flow regulator to zero or . • Disconnect the venous line from the patient. • Disconnect the blue dialyser connector and insert it in its housing on the machine. The Filter Emptying procedure will be performed automatically.

• Turn the dialyser and wait until it empties out completely. • Disconnect the red dialyser connector and insert it in its housing on the machine. • If the sodium bicarbonate powder cartridge is present, perform the emptying procedure (see the Chapter “PATIENT RINSEBACK”)



ENG – Ed. 12/07 chap. 8.1 - Profiles - 1 of 26

8.1 PROFILES

INDICATIONS Dialysis is generally performed using constant values for dialysis parameters, which are set at the beginning of the treatment and are changed throughout the session only further to eventual problems.

The profiling feature represents a different approach to the dialysis treatment: it enables the physician to appropriately change some parameters during the dialysis session and therefore to execute patient tailored treatments.

THE PROFILES The profiles are curves defining the variations to which certain parameters are subjected during dialysis in order to make treatment more tolerable. The profiles can be divided into: STANDARD PROFILES : profiles with qualitative predefined characteristics, which are easy for the operator to use and require , when used, the input of very few parameters. To use these profiles, the following parameters are to be set during service configuration (by technical or authorized personnel)

PROFILES = STD

Profiled parameters: 1. Hourly weight loss rate 2. Total conductivity USER PROFILES: profiles that are entirely defined by the user in configuration mode. To use both standard and user profiles, the following parameters are to be set in configuration:

PROFILES = SPE

Profiled parameters: 1. Hourly weight loss rate 2. Sequential dialysis (hourly weight loss + isolated dialysis) 3. Total conductivity 4. Partial conductivity 5. Heparin (continuous infusion + Boluses) NOTE The user profiles are extremely versatile, as they allow the user to create a profile with no limitations and to associate weight loss rate profiles with both total and partial conductivity profiles, as well as with heparin (both by continuous infusion and by bolus) and isolated dialysis. However, due to this versatility, their definition in configuration mode and their subsequent use in dialysis is not such a simple process, and if incorrectly used, they may cause serious harm to the patient.

2 of 26 – chap. 8.1 - Profiles ENG – Ed. 12/07

The USER PROFILES are therefore for “skilled” users only, and those interested in their use should contact the Marketing Department and/or Post Sales Department to obtain further information and, if necessary, suitable training.

WARNINGS These profiles are only to be used by adequately trained medical staff. Before using the profiles, check that the profiling parameters have been correctly configured during installation of formula ®. The setting of the profile parameters in configuration can only be done by Technicians authorized by the manufacturer or by medical staff. Adequacy of these parameters for dialysis is the sole responsibility of the medical staff. The setting of the profiling parameters is not subject to any special controls by formula® (which merely guarantees that the profiles will be carried out as they have been configured and set by the operator), to allow the greatest possible level of versatility. However, it is consequently recommended that the medical staff of the dialysis unit manage these parameters with extreme care, to avoid dialysis that is inadequate or even harmful for the patient. The use of profiles, the association of a weight loss rate profile to a specific total conductivity profile rather than to constant total conductivity of the dialysing fluid, substitution or cancellation of a profile during treatment, may all, if incorrectly used, cause serious injury to the patient; the machine is obviously unable to evaluate whether or not the above options are suitable (as they depend on the patient and his/her specific clinical characteristics), and the medical staff of the dialysis unit is therefore solely responsible for case-by-case evaluation of how and when to use the profiles. It is recommended that great attention is paid to the warning message VERIFY PROFILE, as it indicates that the machine is not able to follow the selected profiles completely; if you do not adjust the set parameters so as to make the warning

message disappear, but merely press to override it, this means that the expected total weight loss and/or amount of electrolytes to be exchanged will not be obtained. Whenever you set or modify the dialysis parameters, you are recommended to use the on-line HELP function to consult the profile tables, and check that the values displayed are the ones you require.


STANDARD PROFILES formula® allows seven types of standard profiles, each of which can be independently applied to weight loss rate (kg/h) and total conductivity (mS/cm), so as to combine different types of profiles for the two parameters. The standard profiles available on formula®are the following: LINEAR PROFILE The profiled parameter varies according to a LINEAR rule over the time. The user has to set the desired starting value.

WARNING The total treatment time is divided into 15 min intervals in which the parameter value is constant. PARABOLIC PROFILE The profiled parameter varies according to a PARABOLIC rule over the time. The user has to set the desired max. value and the instant in which the max. value is to be reached.

WARNING The total treatment time is divided into 15 min intervals in which the parameter value is constant.

T

Start value

T

Max value

TMAX


CUBIC PROFILE The profiled parameter varies according to a CUBIC rule over the time. The user has to set the starting value, the maximum value and the instant in which the max. value is to be reached.

WARNING The total treatment time is divided into 15 min intervals in which the parameter value is constant. EXPONENTIAL PROFILE The profiled parameter varies according to an EXPONENTIAL rule over the time. The user has to set the desired starting value.

WARNING The total treatment time is divided into 15 min intervals in which the parameter value is constant.

T

Start value

T

Max value

TMAX

Start value


STEPPED PROFILE The treatment time is divided into 4 phases of equal duration: during each phase the profiled parameter corresponds to the percentage set for that phase.

WARNING The total treatment time is split into 4 phases each lasting 15 min. (the fourth phase may have a different duration than the other three). SQUARE WAVE PROFILE Dialysis is carried out in a succession of cycles. Each cycle is made up of 2 phases: in the first phase the profiled value depends on the dialysis parameters; in the second phase it takes on the constant value set by the user. Phase time can be set by the user.

WARNING The total treatment time is divided into 15 min intervals in which the parameter value is constant. Depending on the configured and set times, the phases of the last cycle may be different from the set values.

T

T

T1 T2

Set value


REVERSE SQUARE WAVE PROFILE Dialysis is carried out in a succession of cycles. Each cycle is made up of 2 phases: in the first phase the parameter corresponds to the value set by the user; in the second phase it depends on the dialysis parameters. Phase time can be set by the user.

WARNING The total treatment time is divided into 15 min intervals in which the parameter value is constant. Depending on the configured and set times, the phases of the last cycle may be different from the set values.

T

T1 T2

Set value


SETTING THE STANDARD PROFILE To set the standard profile to be used for dialysis, proceed as follows:

see/mod. parameters

profiles

Standard profiles

The following windows will appear:

As it can be noticed, it is possible to separately select the UF and TC profiles to combine and

activate. To do this, press UF profile type and TC profile type and then use the keys or

to select the desired profile. It is also possible to activate only one of the two profiles by selecting no profile for the other one.

ok

to confirm and to access the pages for parameter settings. If a UF profile has been activated, the first window to be displayed is that pertaining to the weight loss rate. Here below the window of the UF cubic profile is given as an example:


return

To return to the main page.

treatment time

To set the duration of the treatment (hh:mm).

weight loss

To set the total weight loss (Kg).

starting UF

To set the UF value (Kg/h) in the first quarter of an hour.

UF Max

To set the max. UF value (Kg/h) of the profile.

Tmax

To set the instant in which the UF has to reach the max. set value (UF Max). Tmax changes every quarter of an hour and the maximum UF value is kept unchanged for the whole following quarter.

The table displayed below the graphic tools shows the calculated and discrete profile in numerical pattern, with the values to use during dialysis. The menus of the other profiles are similar to that shown; here below only the parameters, which differ from those already explained, are indicated. STEPPED PROFILE

1st step

To set the weight loss percentage in the first quarter of the dialysis session.

2nd step

To set the weight loss percentage in the second quarter of the dialysis session.

3rd step

To set the weight loss percentage in the third quarter of the dialysis session.

4th step

To set the weight loss percentage in the last quarter of the dialysis session.


SQUARE WAVE PROFILE

UF 2nd sector

To set the UF value in the second phase of the wave.

1st phase

To set the duration of the first phase of the wave.

2nd phase

To set the duration of the second phase of the wave.

REVERSE SQUARE WAVE PROFILE

UF 1st sector

To set the UF value in the first phase of the wave.

1st phase

To set the duration of the first phase of the wave.

2nd phase

To set the duration of the second phase of the wave.

Press OK to confirm and to display the profile graph; should it not meet the user requirements, return to the setting parameter page by pressing return:

The next window pertains to total conductivity profile settings (if this has been selected ); the menus are analogous to those described for ultrafiltration, simply refer to total conductivity rather than to weight loss rate.


WARNING If an UF profile has already been set, the treatment duration cannot be modified in the window of the TC profile parameters. Once confirmed also the total conductivity profile, the window of the treatment parameters is shown, in which the parameters not previously set can now be selected (i.e. partial conductivity).

At this point it is recommended to press and display the on-line HELP for the selected

profile, and then press or to check that the values indicated in the displayed tables are the ones required. NOTE The tables show the weight loss rate in kg/h and the total conductivity in mS/cm every 15-minute intervals. During dialysis with profiles, according to the type of treatment, one of the following messages will be displayed in the top left bar of the screen:

BIC+STD. A. CONC. - PROF. instead of BIC+STD. A. CONC. - PROG. BIC + LYMPHA – PROF. instead of BIC + LYMPHA – PROG. ACETATE - PROF. instead of ACETATE - PROG. BIDRY+STD. A. CONC. - PROF. instead of BIDRY+STD. A. CONC. - PROG. BIDRY + LYMPHA – PROF. instead of BIDRY+ LYMPHA – PROG. During dialysis the tools for weight loss rate and total conductivity may be displayed with a background of one of the following colours: text field (left hand side of the tool): - GREY not profiled variable

- GREEN profiled variable

- ORANGE profiled variable, but with value limited to max. or min. allowed number field (right hand side of the tool): - WHITE active, not profiled variable

- RED light

- GREEN active, profiled variable

- ORANGE variable with value limited to max. or min. allowed, but not in alarm mode


CHANGING THE STANDARD PROFILE Once the profile is active, it can be changed at any moment during the treatment by pressing

see/mod. parameters

profiles

standard profiles

modify profile

Thus doing it is possible to recall all the windows for profile setting (see par. SETTING THE STANDARD PROFILE) and modify the type and/or the parameters. WARNING Carry out this procedure also when the treatment time, the total weight loss and the total conductivity are to be modified, as changing these parameters requires that the profile is recalculated and then reconfirmed by the user. Therefore, if the profile is active, modification of the a.m. parameters cannot be carried out by pressing

see/mod. parameters

dialysate

SAVING A STANDARD PROFILE AS A USER PROFILE If during Service configuration the following parameter has been set:

Profiles = SPE

the standard profile in progress can be saved as a user profile, thus allowing the user to recall it in the next dialysis sessions without having to reset it up. By pressing:

see/mod. parameters

profiles

Save Profile

the following screen will open:


Identifier

To select, using the keys or , the position in which to save the current profile inside the profile file. If the position is already occupied, the fields show the name of the profile stored in that position, which can anyway be overwritten.

Profile name

To set the name of the profile to save. Use the keys or to move

on the character to be modified, use the keys or to change the selected character .

WARNING The first three characters identified as "{s}" are fixed and allow to distinguish the user profiles, created by saving some standard profiles, from the others. Such distinction is required as such profiles, which can be recalled as the other user profiles, do not allow to modify the treatment duration (such limitation allows to keep the curve of the profile unchanged). Therefore the treatment duration will correspond to the value set in the standard profile.

CANCELLING THE STANDARD PROFILE It is possible, even during dialysis, to cancel an active standard profile and to continue treatment without using profiles.

To cancel the profile, proceed as follows:

see/mod. parameters

profiles

The following menu will appear:

Cancel UF profile

To cancel only the weight loss profile and to continue dialysis with a constant weight loss rate.

Cancel TC profile

To cancel only the total conductivity profile and to continue dialysis with a constant total conductivity.

Cancel profile

To cancell all the active profiles and to continue dialysis with constant weight loss rate and conductivity.

Once cancelling the profile is confirmed, the modification page of the dialysis parameters is automatically displayed. This page allows to set the constant values of the parameters no longer profiled.


IMPORTANT Carefully check that:

1. The constant weight loss rate and total conductivity used after cancelling the profile are the ones desired.

2. Interruption of the profile in progress - with consequent use of those constant hourly weight loss and total conductivity values until the end of dialysis - is compatible with the adequacy of the dialysis in progress and the specific clinical needs of the patient treated.


USER PROFILES User profiles can be divided into: NORMAL It allows free profiling of weight loss rate, sequential dialysis (weight loss rate + isolated dialysis), total and partial conductivity, heparin (continuous flow + boluses). LINEAR It allows profiling of weight loss rate and total conductivity in linear mode, while heparin (continuous flow + boluses) is profiled freely, as in the NORMAL profile. STEPPED It allows profiling of weight loss rate and total conductivity in stepped mode, while heparin (continuous flow + boluses) is profiled freely, as in the NORMAL profile. SQUARE WAVE It allows profiling of weight loss rate and total conductivity in square wave mode, while heparin (continuous flow + boluses) is profiled freely, as in the NORMAL profile. For every user profile there are parameters set in configuration (accessible to the nurse), which define the qualitative feature, as well as parameters set during dialysis, which determine the quantitative feature. According to the values given to these parameters, the system calculates the correct setting for the profiled parameter. The vectors which define the user profiles are stored in files; this allows the storage of up to 100 different profiles, each with an identifying name and number, which can be freely associated with a patient name or a particular curve shape. The setting of the data in configuration refers to a 4-hour standard dialysis with weight loss of 4 kg and total conductivity of 14.0 mS/cm; the treatment time is the leading profiling parameter which is the temporal variable for the calculation of the parameter trends. The values set in dialysis are correlated to those set in configuration; it is obvious that not all the set values are compatible with the chosen profile, but this is also true, for example, for the simple setting of the weight loss rate program. The considerations above apply to each of the profiled parameters: the machine guarantees that the set value does not exceed the range but it cannot assure that the result is always the one wished by the operator; therefore the profiled value undergoes a limitation before the profiling function takes place.


CONFIGURATION OF USER PROFILES The user profiles are set in configuration, starting from the page shown on the following screen (see chapter Configuration to set configuration parameters):

In this page first of all it is possible to select the profile identification number; if this number corresponds to an existing profile, the name and type are shown. The profile type and name can now be changed. Once confirmed, the pages of the profiling parameters, which depend on the selected profile, will be accessed. NORMAL PROFILE – hourly weight loss rate

In this page you can set the desired weight loss rate (in kg/h), for every 15-minute interval, in a theoretical standard 4-hour dialysis; it therefore sets the qualitative trend of the weight loss


rate curve. Furthermore you can set the Treat. time and total weight loss rate (also called “simulation variables”) to display – in the BLUE table – the profile that would be effectively carried out if just those values of treatment duration and total weight loss had been input (refer to the par. RESULTING CURVE AND SIMULATION VARIABLES). This rule applies to all of the remaining pages. NORMAL PROFILE – sequential dialysis (1) This page is analogous to the weight loss rate page, but the resulting table is used for the sequential dialysis profile, in which dialysis and isolated dialysis alternate following the outline set in the successive page. NORMAL PROFILE – sequential dialysis (2) In this page you can select, for each 15-minute interval, if the UF value, already set in the previous page, is to be carried out in standard dialysis mode (DIA) or isolated dialysis mode (ISO).

NORMAL PROFILE – total conductivity In this page, analogous to the weight loss rate page, you can set the desired total conductivity (mS/cm), for every 15-minute interval, in a theoretical 4-hour standard dialysis. NORMAL PROFILE – partial conductivity In this page, analogous to the weight loss rate page, you can set the desired partial conductivity (mS/cm), for every 15-minute interval, in a theoretical 4-hour standard dialysis. NORMAL PROFILE – heparin infusion In this page, analogous to the weight loss rate page, you can set the heparin infusion rate (in cc/h), for a theoretical 4-hour standard dialysis.


NORMAL PROFILE – heparin boluses In this page, for every 15-minute interval of a 4-hour standard dialysis, you can set the amount of heparin to administer at the beginning of each quarter of an hour. WARNING The NORMAL user profile, whose name starts with “{s}”, results from a standard profile saved during dialysis. The configuration of these profiles is quite similar to the configuration of a NORMAL user profile, except for the following: 1. the pages of sequential dialysis are not present; 2. the pages of weight loss rate and total conductivity simply display the stored data

(eventually simulating variation of weight loss rate or total conductivity): it is not allowed to modify these tables as for any NORMAL profile.

Let’ s now go through the settings of linear, stepped and square wave profiles. For all these profiles the pages pertaining to sequential dialysis and partial conductivity are not present, while those pertaining to infusion and heparin boluses are quite similar to a NORMAL profile page. Therefore the only pages not yet described are those of weight loss rate and total conductivity. LINEAR PROFILE – hourly weight loss rate

SETTING 'LINEAR' PROFILE

RANGE

Starting weight loss rate (Kg/hr)

0.1 ÷ 2.5 The weight loss rate at the beginning of dialysis depends on the set total weight loss and treatment time; then, every 15 min the weight loss will vary by: (Starting weight loss rateconfigured - Final weight loss rateconfigured) / 16 CAUTION: The starting and final values of weight loss rate DO NOT correspond to the values of beginning and end dialysis; these values are only used for the qualitative definition of the profile.

Final weight loss rate (kg/hr)

0.1 ÷ 2.5


LINEAR PROFILE – total conductivity

SETTING 'LINEAR' PROFILE

RANGE

Starting total conductivity (mS/cm)

12.1 ÷ 15.7

Final total conductivity (mS/cm)

12.1 ÷ 15.7

The total conductivity at the beginning of dialysis depends on the set total conductivity and treatment time; then, every 15 min the total conductivity will vary by: (Starting total conductivityconfigured – Final total conductivityconfigured) / 16. CAUTION: The starting and final values of total conductivity DO NOT correspond to the values of beginning and end dialysis; these values are only used for the qualitative definition of the profile.

STEPPED PROFILE – hourly weight loss rate

SETTING 'STEPPED' PROFILE

RANGE

Weight Loss: first phase (%) 0 ÷ 100 Weight Loss: Second phase (%)

0 ÷ 100

Weight Loss: Third phase (%)

0 ÷ 100

Weight Loss: Fourth phase (%)

0 ÷ 100

The treatment time is divided into 4 phases of equal duration: during each phase there is a weight loss rate corresponding to the percentage configured for that phase. In practice, the total weight loss set for dialysis is achieved in four phases, during each of which a percentage of the total weight loss is extracted equivalent to the one set for that phase . CAUTION: The total treatment time is split into 4 phases each lasting 15 min. (the fourth phase may have a different duration than the other three).


STEPPED PROFILE – total conductivity

SETTING 'STEPPED' PROFILE

RANGE

Total conductivity: first phase (%)

0 ÷ 100

Total conductivity: Second phase (%)

0 ÷ 100

Total conductivity: Third phase (%)

0 ÷ 100

Total conductivity: Fourth phase (%)

0 ÷ 100

The treatment time is divided into 4 phases of equal duration: during each phase a total conductivity corresponding to the percentage configured for that phase is set. CAUTION: The total treatment time is split into 4 phases each lasting 15 min. (the fourth phase may have a different duration than the other three).

SQUARE WAVE PROFILE – hourly weight loss rate

SETTING 'SQUARE WAVE' PROFILE

RANGE

Weight loss rate: second phase (kg/hr)

0.1 ÷ 2.5

Cycle duration : first phase (min)

0 ÷ 600

Cycle duration : second phase (min)

0 ÷ 600

Dialysis is carried out in a succession of cycles. Each cycle is made up of 2 phases: • the first phase is carried out with a weight loss

rate which depends on the set total weight loss and treatment time.

• the second phase is carried out with a weight loss rate equal to the value specified in configuration.

CAUTION: Depending on the configured and set times, the phases of the last cycle may be different from the configured values.

SQUARE WAVE PROFILE – total conductivity

SETTING 'SQUARE WAVE' PROFILE

RANGE

Total conductivity: second phase (mS/cm)

0.1 ÷ 2.5

Cycle duration : first phase (min)

0 ÷ 600

Cycle duration : second phase (min)

0 ÷ 600

Dialysis is carried out in a succession of cycles. Each cycle is made up of 2 phases: • the first phase is carried out with a total

conductivity which depends on the set total mean conductivity and treatment time.

• the second phase is carried out with a total conductivity value equal to the value specified in configuration.

CAUTION: Depending on the configured and set times, the phases of the last cycle may be different from the configured values.


RESULTING PROFILE AND SIMULATION VARIABLES In the user profile configuration pages, the RESULTING PROFILE of the profiled parameters is displayed by way of example. The resulting profile is a table displaying the values which the profiled parameters would assume during the treatment, provided dialysis is carried out with parameter values equal to that of simulation variables. In other words, if after configuring the linear profile parameters:

Starting weight loss rate (kg/h) Final weight loss rate (kg/hr)

the following values are set: Treatment time (min) = 180 Total weight loss (kg) = 3.0

read at intervals of 15 min, the table will show the weight loss rate values during a hypothetical dialysis of 3 kg in 3 hours, carried out with a linear profile. The residual and total values are displayed along with the resulting profile. The duration of dialysis may not be an entire multiple of 15 min; the residual is the remainder (expressed in minutes) after dividing the treatment time by 15. The totals constitute the weight loss rate, the mean conductivity (total or partial) and the administered heparin achieved by the profile. WARNING The values indicated in the table, as well as those for the residual and totals are merely an example; when the profile is used for dialysis, it is suitably and automatically adapted to the parameters specified for that particular dialysis, and will therefore have different values from those shown as an example in the table that is displayed during configuration. THE "RED" FIELDS The resulting profile has an important function in checking and controlling the profiling parameters while they are being configured. The choice of profiling parameters may NOT match the parameter setting, in which case, the corresponding fields in the tables displayed using HELP are coloured RED. The RED fields thus indicate those values that, according to the profile configured and the simulation variables, would be outside the limits set by formula®; these values are not acceptable, and are therefore automatically reset to the minimum value (or to the maximum value, accordingly) that will be accepted by formula®. Example: If, on the basis of the weight loss rate profile and simulation variables, the first 15 min would give a weight loss rate of 3.0 kg/h, this value would be displayed as 2.5 kg/h (the maximum value allowed) on a RED ground. Even during dialysis with parameters that are the same as the simulation parameters, the weight loss rate would be limited automatically to 2.5 kg/h, and in this way the total weight loss set would not be obtained.


NOTE Whether or not the fields turn RED will obviously depend on the values selected for the simulation variables. It is therefore recommended, during configuration, to set the simulation variables to typical dialysis values, or in any case to values as close as possible to those to be used during dialysis. In this way it is eventually possible to modify the profiling parameters, so as to avoid the presence of RED fields; this will enable the profiles to be performed in the way in which they are configured.


RECALLING THE USER PROFILE To recall a configured user profile, proceed as follows:

see/mod. parameters

profiles

user profiles

Thus a menu is accessed which allows the operator to choose the desired user profile. After confirming the profile type, the following window will appear:

return


Ufr profile

To enable UF profiling. This function is available as alternative to

seq. Ufr profile

seq. Ufr profile

To enable the sequential UF program.

This function is available as alternative to

Ufr profile

.

tot. cond. profile

To enable total conductivity profiling.

par. cond. profile

To enable partial conductivity profiling.

Profile name

To select the desired profile among the ones stored of the same type.

cancel profile

To cancel the profile, when it is active.


After confirming the profile, the dialysis parameter modification page is automatically displayed. The highlighted BLUE keys correspond to the parameters involved in the selected profile. Now proceed by setting time, weight and conductivity parameters adequate to the patient and to the selected profile, then confirm. A page is accessed which allows the operator to set heparin profiling according to the profile selected with the function key. NOTE At any moment during the treatment it is possible to enable or disable heparin profiling by pressing either:

see/mod. parameters

heparin

use profile

or:

see/mod. parameters

heparin

profile off

After confirming also the heparin page, press to display the on-line HELP for the selected

profile, and or to check that the values indicated in the tables are the ones you require. NOTE The tables show the weight loss rate in kg/h and the total conductivity in mS/cm every 15-minute intervals. During dialysis with profiles, according to the type of treatment, one of the following messages will be displayed in the top left bar of the screen:

BIC+STD. A. CONC. - PROF. instead of BIC+STD. A. CONC. - PROG. BIC + LYMPHA – PROF. instead of BIC + LYMPHA – PROG. ACETATE - PROF. instead of ACETATE - PROG. BIDRY+STD. A. CONC. - PROF. instead of BIDRY+STD. A. CONC. - PROG. BIDRY + LYMPHA – PROF. instead of BIDRY+ LYMPHA – PROG. During dialysis the tools for weight loss rate, partial and total conductivity may be displayed with a background of one of the following colours: text field (left hand side of the tool): - GREY not profiled variable

- GREEN profiled variable

- ORANGE profiled variable, but with value limited to max. or min. allowed number field (right hand side of the tool): - WHITE active, not profiled variable


- RED light

- GREEN active, profiled variable

- ORANGE variable with value limited to max. or min. allowed, but not in alarm mode

The heparin program status is indicated by a syringe icon at the top right of the monitor, as described in chap. Heparin. USER PROFILES: CHANGE DIALYSIS PARAMETERS It is always possible, even during dialysis with user profiles, to modify any of the dialysis

parameters. To do this,

see/mod. parameters

.

After the modification has been made, press to display the on-line HELP for the selected

profile, and or to check that the values indicated in the tables displayed are the ones you require.

CANCELLING THE USER PROFILE It is possible, even during dialysis, to cancel a user profile and to continue treatment without using profiles.

To cancel the profile, proceed as follows:

•

see/mod. parameters

profiles

cancel profile

.

• when cancelling profile is confirmed, the dialysis parameters modification page is automatically displayed

• dialysis continues with constant parameters equal to the values set.

IMPORTANT Carefully check that:

1. the constant values used after cancelling the profile are the ones desired.

2. interruption of the current profile with the consequent use of constant values up to the treatment end is compatible with the dialysis adequacy and the specific clinical demands of the patient.


CHANGING THE USER PROFILE It is possible, even during dialysis, to change the type of user profile (i.e. to change from a linear to a stepped profile). To change the profile, first cancel the current profile and then select the new one (refer to previous paragraphs).

WARNING It is recommended NOT to change the profile during treatment, even if allowed, as the trend of the profiled parameters might not be sufficiently clear to the operator.

Carefully check the on-line help table to ensure that the profiled parameters take on the desired values.

'VERIFY PROFILE' WARNING MESSAGE The settings for dialysis time, weight and total conductivity parameters may NOT be entirely congruent with the type of profile selected (standard or user); if this is the case, the corresponding fields in the tables displayed using HELP are coloured RED. The RED fields thus indicate those values that, according to the selected profile and the set parameters, would be outside the limits allowed by formula®; these values are not acceptable, and are therefore reset automatically to the minimum value (or to the maximum value, accordingly) that will be accepted by formula®. IMPORTANT If, while setting and/or modifying the dialysis parameters, the warning message VERIFY

PROFILE is displayed, terminate the modification and press or to check

which of the fields in the table are RED. Then press

see/mod. parameters

again and adjust the settings until the warning message VERIFY PROFILE disappears. If, after checking which fields have turned red, you want to maintain the set values anyway,

press to override the VERIFY PROFILE warning ( this message will reappear every time

you modify a parameter and can be overridden each time by pressing ). IMPORTANT The presence of RED fields in the tables displayed using HELP means that during treatment the profile will not always follow the curve foreseen, but that there will be intervals of 15 min during which the profiled parameters will be restricted, according to the situation, either to the minimum value allowed or to the maximum value allowed.

In the above conditions the operator must bear in mind that the expected total values will not be achieved (weight loss and/or conductivity and/or heparin).


DISPLAYING THE PROFILE After confirming the profile (standard or user), the parameters may be graphically displayed:

see/mod. parameters

profiles

profile graphs

.

This sequence allows the operator to enter the relevant menu and select the profiled parameter to be displayed in graphic form. Or, to display the information in numeric form:

see/mod. parameters

profiles

profile tables

.

This sequence allows the operator to enter the relevant menu and select the profiled parameter to be displayed in numeric form.

END UF If a dialysis with profiles is performed, the profile is NOT cancelled when the END UF is signalled. WARNING To continue dialysis after the END UF message has appeared, it is recommended to cancel the profile and go on with constant weight loss rate and total conductivity, otherwise the trend of the profiled parameters might not be sufficiently clear to the operator.

To continue with the profile active, carefully check the on-line help table to ensure that the profiled parameters take on the desired values.

ENG – Ed. 06/09 chap. - Profiler - 1 of 10

8.2 PROFILER8.2 PROFILER8.2 PROFILER8.2 PROFILER


Thanks to Profiler, formula allows the operator to exploit a new profiling method based on the use of a mathematical model of the kinetics of the body fluids and the main solutes, such as sodium and urea. It is possible to generate profiles of sodium concentrate in the dialysis fluid and ultrafiltration profiles, which reduce the incidence of low blood pressure and disequilibrium syndrome based on certain input parameters. The application strategy is based on a priori processing of patient tailored profiles which can be displayed in both numerical and graphic time form. The aim is to compensate the high loss in plasmatic osmolarity during the first two hours of dialysis (at maximum diffusion) by increasing the sodium concentration of the dialysis liquid (reduced sodium removal) and subsequently completing the necessary removal of sodium during the second half of the session (at minimum diffusion) by reducing the sodium concentration of the dialysis fluid (increased sodium removal). In the modelling application panorama Profiler stands out for its capability of reconciling the descriptive complexity of a mathematical model with the ease of use required in clinical practice.

SETTING THE PROFILESSETTING THE PROFILESSETTING THE PROFILESSETTING THE PROFILES

Profiler setting is accessed via the function keys of the operator interface.

see/mod. parameters

profiles

Profiler/ Aequilibrium .

2 of 10 – chap. 8.2 - Profiler ENG – Ed. 06/09

Thus a menu is accessed which allows the operator to set various parameters:

Profile name

To select the patient name, i.e. the data already stored for that profile. This data serves as initial values for the current profiling.

modify name

This allows the operator to enter a screen from which to change the saved profile name.

enable Aequilibrium

In HFR only, this allows enabling automatic recalculation of the total conductivity profile based on the ultrafiltrate conductivity reading taken from the Natrium sensor.

enable Isonatric

In HFR only, this allows enabling the Aequilibrium application in Isonatric mode, consisting of automatic recalculation of the total conductivity profile in order to reach a final patient sodium concentration equal to the initial sodium concentration obtained from the Natrium sensor.

When the settings have been made,

ok

to confirm the data set and enter the Profiler parameter edit menu. This type of menu is displayed in a sequence and allows to modify the preset values for the selected patient.

Dialysis parameter menu 1 Dialysis parameter menu 1 Dialysis parameter menu 1 Dialysis parameter menu 1

return


treatment duration

To set the duration (min) of the dialysis treatment.

flow

To set the dialysis fluid flow (ml/min).

temperature

To set the dialysis fluid temperature (°C).

Qb

To set the patient blood flow (ml/min) to be maintained during dialysis.

weight end

To set the patient weight (kg) at the end of dialysis.

weight loss

To set the patient weight loss (kg).


Dialysis parameter menu 2 Dialysis parameter menu 2 Dialysis parameter menu 2 Dialysis parameter menu 2

return

To return to dialysis parameter 1dialysis parameter 1dialysis parameter 1dialysis parameter 1 menu.

filter

To select the type of dialyser used.

acid concentrate

To select the type of acid concentrate used.

tot cond max

To set the maximum total conductivity level attainable by that profile.

tot cond min

To set the minimum total conductivity level attainable by that profile.

bicarbonate cond.

To set the 1st step conductivity level (bicarbonate conductivity)

Patient parameter menuPatient parameter menuPatient parameter menuPatient parameter menu

return

To return to dialysis parameter 2dialysis parameter 2dialysis parameter 2dialysis parameter 2 menu.

[Urea]pl start

To set the concentration of plasmatic urea (g/l) at the beginning of dialysis.

[Na]pl start

To set the concentration of plasmatic sodium (mEq/l) at the beginning of dialysis. The presence of this button and the corresponding instrument depends on the Configuration Service setting (Profiler parameter).

removal Na

[Na]pl end/ character.

To set the sodium removal (mEq) or the concentration of plasmatic sodium (mEq/l) to be achieved at the end of treatment. The possibility of setting one or the other parameter depends on the Service Configuration settings (Profiler parameter). Characteristic [Na]pl means the value to be set if isonatric dialysis is enabled (characteristic patient sodium concentration level).

max uf

To set the maximum ultrafiltration value (kg/h).

save profile data

profilo

To overwrite the data previously stored with the new data set for the selected profile. Overwriting requires an additional confirmation by the operator through a dialogue window.


Once the required settings have been made,

ok

to calculate and display the total conductivity and UF profiles.

Confirm both profiles to activate profiling.

WARNINGWARNINGWARNINGWARNING formula is unable to evaluate the adequacy of the profile set (which is unable to evaluate the adequacy of the profile set (which is unable to evaluate the adequacy of the profile set (which is unable to evaluate the adequacy of the profile set (which depends on the patient and his/her specific clinical characteristics).depends on the patient and his/her specific clinical characteristics).depends on the patient and his/her specific clinical characteristics).depends on the patient and his/her specific clinical characteristics). The The The The operator is hence solely responsible for setting and confirming the profiles.operator is hence solely responsible for setting and confirming the profiles.operator is hence solely responsible for setting and confirming the profiles.operator is hence solely responsible for setting and confirming the profiles.

WARNINGWARNINGWARNINGWARNING The Profiler is not available in PHF PRE, PHF POST, HDF and HDF OnLine The Profiler is not available in PHF PRE, PHF POST, HDF and HDF OnLine The Profiler is not available in PHF PRE, PHF POST, HDF and HDF OnLine The Profiler is not available in PHF PRE, PHF POST, HDF and HDF OnLine treatments.treatments.treatments.treatments.

If the profiles are not confirmed, the profile display menu is exited to return to the parameter edit menu to allow the operator to modify the parameters and relaunch the profile calculation or to quit the edit menu.

If the profile calculation fails due to failed compliance with some mathematical constraints, the operator will be instructed which parameters to modify for proper execution of the calculation to then continue with the display/confirmation of the profiles.


AEQUILIBRIUM AEQUILIBRIUM AEQUILIBRIUM AEQUILIBRIUM

During HFR dialysis and when using a Natrium sensor, the Aequilibrium application can be enabled within the first five minutes of treatment:

see/mod. parameters

profiles

Profiler/ Aequilibrium

enable Aequilibrium

This application consists of automatic recalculation of the total conductivity profile, carried out after the first fifteen minutes of dialysis. The recalculation is generated if the patient’s plasma sodium concentration (taken from the Natrium reading) should differ from the level set by the model based on the initial sodium concentration setting. If the Natrium sensor does not read any sodium concentration measurement within the first five minutes of treatment, the warning “SODIUM CONCENTRATION NOT DETECTED” is generated (see the chapter on alarms). In this case, check that the probe is properly inserted in the sensor. If the profile recalculation should fail due to any mathematical errors, the display will read "AEQUIL./ISONA. NOT AVAIL.” and the system will continue to run in the original profile set (see the chapter on alarms). However, the operator may interrupt profiling at any moment using the "Profiler Off” function described in the next chapter. As the recalculation is performed after the first fifteen minutes of dialysis, the Aequilibrium application can be disabled in this period:

see/mod. parameters

profiles


disable Aequilibrium

WARNINGWARNINGWARNINGWARNING Using the following key sequence:Using the following key sequence:Using the following key sequence:Using the following key sequence:

see/mod. parameters

profiles

Profile graphs

or:or:or:or:

see/mod. parameters

profiles

Profile tables

the active profile can be displayed in graphic or numeric form at any time.the active profile can be displayed in graphic or numeric form at any time.the active profile can be displayed in graphic or numeric form at any time.the active profile can be displayed in graphic or numeric form at any time. If If If If this is not requested by the user, it can be cancelled.this is not requested by the user, it can be cancelled.this is not requested by the user, it can be cancelled.this is not requested by the user, it can be cancelled.

see/mod. parameters

profiles


cancel profile


ISONATRIC DIALYSISISONATRIC DIALYSISISONATRIC DIALYSISISONATRIC DIALYSIS The isonatric dialysis application is a particular operating mode of the Aequilibrium application, available if the Profiler parameter has been set to 4 or 6 during Service Configuration. In this mode, the patient’s initial concentration of plasmatic sodium obtained from the Natrium sensor during the first fifteen minutes of dialysis is also used as the final sodium concentration setting at the time of recalculation. That way, a total conductivity profile is achieved, which, in line with the aims of the Aequilibrium strategy, allows at the end of dialysis obtaining a concentration of plasmatic sodium equal to the initial concentration. If the Natrium sensor does not read any sodium concentration measurement within the first five minutes of treatment, the warning “SODIUM CONCENTRATION NOT DETECTED” is generated (see the chapter on alarms). In this case, check that the probe is properly inserted in the sensor. If the profile recalculation should fail due to any mathematical errors, the display will read "AEQUIL/ISONA NOT AVAIL.” and the system will continue to run in the original profile set (see the chapter on alarms). However, the operator may interrupt profiling at any moment using the "Profiler Off” function described in the next chapter. During HFR dialysis and when using a Natrium sensor, the Isonatric application can be enabled within the first five minutes of treatment:

see/mod. parameters

profiles


enable isonatric

The setting parameters have the same meaning as for Aequilibrium, the only difference is the “[Na]pl end/character.” key which in the case of isonatric dialysis is for the characteristic sodium of the patient and is used to identify the level of sodium concentration in the patient. Like for Aequilibrium, given that the recalculation is performed after the first fifteen minutes of dialysis, the isonatric application can be disabled in this period:

see/mod. parameters

profiles


disable Isonatric

WARNINGWARNINGWARNINGWARNING Using the following key sequence:Using the following key sequence:Using the following key sequence:Using the following key sequence:

see/mod. parameters

profiles

Profile graphs

or:or:or:or:

see/mod. parameters

profiles

Profile tables

the active profile can be displayed in graphic or numeric form at any time.the active profile can be displayed in graphic or numeric form at any time.the active profile can be displayed in graphic or numeric form at any time.the active profile can be displayed in graphic or numeric form at any time. If If If If this is not requested by the user, it can be cancelled.this is not requested by the user, it can be cancelled.this is not requested by the user, it can be cancelled.this is not requested by the user, it can be cancelled.

see/mod. parameters

profiles


cancel profile


DEACTIVATING PROFILEDEACTIVATING PROFILEDEACTIVATING PROFILEDEACTIVATING PROFILERRRR

During treatment, the total conductivity and hourly ultrafiltration profiles set with Profiler can be cancelled to continue normally without profiles.

To deactivate Profiler, proceed as follows:

see/mod. parameters

profiles


cancel profile

When deactivation of the profile is confirmed, the dialysis parameter edit page is automatically displayed, where the constant values of the no longer profiled magnitudes can be set.

WARNINGWARNINGWARNINGWARNING Carefully check that:Carefully check that:Carefully check that:Carefully check that: 1111.... The constant hourly weight loss and toThe constant hourly weight loss and toThe constant hourly weight loss and toThe constant hourly weight loss and total conductivity values applied after tal conductivity values applied after tal conductivity values applied after tal conductivity values applied after deactivating the profile are those desired.deactivating the profile are those desired.deactivating the profile are those desired.deactivating the profile are those desired. 2222.... InterruptiInterruptiInterruptiInterruption of the profile in progress on of the profile in progress on of the profile in progress on of the profile in progress ---- with consequent use of those with consequent use of those with consequent use of those with consequent use of those constant hourly weight loss and total conductivity values until the end of constant hourly weight loss and total conductivity values until the end of constant hourly weight loss and total conductivity values until the end of constant hourly weight loss and total conductivity values until the end of dialysis dialysis dialysis dialysis ---- is compatibl is compatibl is compatibl is compatible with the adequacy of the dialysis in progress and the e with the adequacy of the dialysis in progress and the e with the adequacy of the dialysis in progress and the e with the adequacy of the dialysis in progress and the specific clinical needs of the patient treated.specific clinical needs of the patient treated.specific clinical needs of the patient treated.specific clinical needs of the patient treated.

NOTENOTENOTENOTE If the Profiler parameter was set to 3 or 4 during Service Configuration, If the Profiler parameter was set to 3 or 4 during Service Configuration, If the Profiler parameter was set to 3 or 4 during Service Configuration, If the Profiler parameter was set to 3 or 4 during Service Configuration, changing the treatment from HFR to DNchanging the treatment from HFR to DNchanging the treatment from HFR to DNchanging the treatment from HFR to DN when dialysis is i when dialysis is i when dialysis is i when dialysis is innnn progress will progress will progress will progress will result in cancellation of any running profile.result in cancellation of any running profile.result in cancellation of any running profile.result in cancellation of any running profile.


PARAMETER DISPLAY PARAMETER DISPLAY PARAMETER DISPLAY PARAMETER DISPLAY

The total conductivity and ultrafiltration profiles for the dialysis in process can be displayed in graphic form at any time.

see/mod. parameters

profiles

Profile graphs

The profiles are displayed as follows:

To view the values set for the profiled dialysis in progress an additional menu is available, accessed by selecting the functions below:

see/mod. parameters

profiles



return

To exit the display menu and return to the main menu.

save profile data

profilo

To overwrite the data previously stored with the new data set for the selected profile. Overwriting requires an additional confirmation by the operator through a dialogue window.

modify name

This allows the operator to enter a screen from which to change the saved profile name.

enable Aequilibrium

In HFR only, this will launch an application to automatically recalculate the total conductivity profile based on the ultrafiltrate conductivity reading taken from the Natrium sensor.

enable Isonatric

In HFR only, this allows enabling the Aequilibrium application in Isonatric mode, consisting of automatic recalculation of the total conductivity profile in order to reach a final patient sodium concentration equal to the initial sodium concentration obtained from the Natrium sensor.

display output

Function not active.

cancel profile

To cancel the profiling in progress. A dialogue window will ask the operator to reconfirm the cancellation.

The “Remov. [Na] calc” tool allows displaying the sodium removal achieved by means of the calculated profile and corresponding to the final sodium set. If Aequilibrium (also in Isonatric mode) is active, this value is displayed only after the recalculation performed after the first fifteen minutes of dialysis (otherwise it is zero). If setting sodium removal, the tool displayed instead of “Remov. [Na] calc” is “[Na] end calc” which performs the same functions relating to the final sodium. The “[Na] start calc” tool allows displaying the patient’s initial plasmatic concentration recalculated by the Aequilibrium application (also in Isonatric mode) after the first fifteen minutes of dialysis. In all other cases it is zero.

ENG – Ed. 11/09 chap. 8.3 - Formula plus sensors- 1 of 24

8.3 FORMULA PLUS8.3 FORMULA PLUS8.3 FORMULA PLUS8.3 FORMULA PLUS SENSORS SENSORS SENSORS SENSORS

GENERAL AND WARNINGSGENERAL AND WARNINGSGENERAL AND WARNINGSGENERAL AND WARNINGS

The formula dialysis machine is equipped with some sensors able to control the progress of dialysis and its dose, monitor the patient and prevent any complications from arising. The sensors that may be implemented on models formula plus/ formula 2000 plus (referred to as formula plus in the next chapter) are the following:

SENSORSENSORSENSORSENSOR NAMENAMENAMENAME

Sphygmomanometer SphygmoSphygmoSphygmoSphygmo

Blood temperature and conductivity sensor

Ultrafiltrate conductivity and temperature sensor

NatriumNatriumNatriumNatrium

Hematocrit and oxygen saturation measuring system

HemoxHemoxHemoxHemox

Heart rate meter (only for 220-240 Vac power supply machines)

PulsarPulsarPulsarPulsar

WARNINGWARNINGWARNINGWARNING Carefully read the instructions contained in this chapter before using the Carefully read the instructions contained in this chapter before using the Carefully read the instructions contained in this chapter before using the Carefully read the instructions contained in this chapter before using the sensors. Nonsensors. Nonsensors. Nonsensors. Non----conform use, applicaconform use, applicaconform use, applicaconform use, application of procedures different from those tion of procedures different from those tion of procedures different from those tion of procedures different from those indicated or use of accessory devices not provided for may determine indicated or use of accessory devices not provided for may determine indicated or use of accessory devices not provided for may determine indicated or use of accessory devices not provided for may determine improper functioning and give rise to incorrect and/or unreliable improper functioning and give rise to incorrect and/or unreliable improper functioning and give rise to incorrect and/or unreliable improper functioning and give rise to incorrect and/or unreliable measurements.measurements.measurements.measurements.


The sensors usable on formula plus are not designed, marketed or intended for use different from that specified. Moreover, they must not be used outside the specifications and the operating values indicated by the manufacturer.

SENSOR TESTSENSOR TESTSENSOR TESTSENSOR TEST

The formula plus sensor test refers to the conductivity sensor (Natrium) and the hematocrit measuring system (Hemox). The test starts automatically as soon as the tests on the blood side have been completed and the system enters into the STANDBY state. In the event that the test result is negative, the following warning appears: FORMULA+ SENSORS TEST.

2 of 24 – chap. 8.3 - Formula plus sensors ENG – Ed. 11/09

BLOOD LINE INSTALLATBLOOD LINE INSTALLATBLOOD LINE INSTALLATBLOOD LINE INSTALLATIONIONIONION

ARTERIAL LINE (FOR HARTERIAL LINE (FOR HARTERIAL LINE (FOR HARTERIAL LINE (FOR HEMOX AND NATRIUM)EMOX AND NATRIUM)EMOX AND NATRIUM)EMOX AND NATRIUM)

- Fix the expansion chamber (1) in the relevant support.

- Open the cover of the arterial pump (2).


- Fasten the inlet of the arterial segment (3) in the lower guide set (follow the direction of the screen-printed red arrow). (For semi-automatic pump loading of the pump segment, see chap. Preparation of Treatment).

- Turn the pump anti-clockwise and fit the segment.

- Fasten the other end of the segment in the upper guide set.

- Fold the drive handle back into the pump block and close the cover.

- Accurately insert the arterial line into the blood detector (4) and the fixing clip (5) next to the electric safety clamp. If using the arterial electric safety clamp (double clamp), insert the arterial line.

- Connect the Luer-lock connector (at pump inlet) to the pressure gauge (6) (red).

- Connect the red line connector to the blood inflow connector of the dialyser.

- Open the cover of the Natrium sensor (7) turning the unlocking lever to the right.

4

5

6 2

3

1


- If present, insert the arterial probe (8), positioned on the outlet tube from the expansion chamber, into the Natrium sensor on the left-hand side (red arrow). The blood flow must run upward.

- Close the cover of the Natrium sensor.

- If present, insert the cuvette (9) on the inlet tube to the expansion chamber into the Hemox sensor. Exert a light pressure on the ends of the cuvette and check correct positioning in its seat.

- Fasten the line in the clip (red) (10).

- Connect the heparin syringe (see chapter on Heparin).

7

8

10

9


ULTRAFILTRATION/INFUULTRAFILTRATION/INFUULTRAFILTRATION/INFUULTRAFILTRATION/INFUSION LISION LISION LISION LINE (FOR NATRIUM IN HNE (FOR NATRIUM IN HNE (FOR NATRIUM IN HNE (FOR NATRIUM IN HFR)FR)FR)FR)

- Position the adsorbent cartridge in its support on the IV pole below the dual-chamber dialyser and the infusion line drip chamber.

WARNINGWARNINGWARNINGWARNING � The cartridge has to be positioned with the inlet facing upwards (refer to The cartridge has to be positioned with the inlet facing upwards (refer to The cartridge has to be positioned with the inlet facing upwards (refer to The cartridge has to be positioned with the inlet facing upwards (refer to

the instructionsthe instructionsthe instructionsthe instructions on the label). on the label). on the label). on the label). � Should air bubbles form inside the cartridge, they must be removed Should air bubbles form inside the cartridge, they must be removed Should air bubbles form inside the cartridge, they must be removed Should air bubbles form inside the cartridge, they must be removed

during rinsing. during rinsing. during rinsing. during rinsing. Air may cause excessive pressure loss. Air may cause excessive pressure loss. Air may cause excessive pressure loss. Air may cause excessive pressure loss.

- Connect the yellow terminal of the ultrafiltration line (1) to the outlet of the convective section of the dialyser, and the other terminal to the inlet of the adsorbent cartridge.

- Clamp the section of line between the first deaeration filter and the cartridge.

- Connect the section of the line connected to the priming liquid collection bag to the outlet of the adsorbent cartridge.

- Hang the priming liquid collection bag on its support on the stand.

WARNINGWARNINGWARNINGWARNING • If using a If using a If using a If using a SelectaSelectaSelectaSelecta cartridge, disconnect the end section of the line leading cartridge, disconnect the end section of the line leading cartridge, disconnect the end section of the line leading cartridge, disconnect the end section of the line leading

from the adsorbent cartridge from the collection bag and connecfrom the adsorbent cartridge from the collection bag and connecfrom the adsorbent cartridge from the collection bag and connecfrom the adsorbent cartridge from the collection bag and connect it to t it to t it to t it to the infusion point of the dialyser (1), then proceed with the next steps.the infusion point of the dialyser (1), then proceed with the next steps.the infusion point of the dialyser (1), then proceed with the next steps.the infusion point of the dialyser (1), then proceed with the next steps.

• If using a If using a If using a If using a Selecta PlusSelecta PlusSelecta PlusSelecta Plus cartridge, proceed with the next steps. cartridge, proceed with the next steps. cartridge, proceed with the next steps. cartridge, proceed with the next steps.

- Position the drip chamber in the right-hand side clip (2).

1


- Open the UF/infusion pump cover.

- Lift the folding drive handle of the infusion head.

- Fasten the initial connection of the infusion pump segment (tube leading from the dialyser) in the left guide set of the infusion pump head (follow the direction of the screen-printed blue arrow). (For semi-automatic pump loading of the pump segment, see the chapter "Preparation of Treatment ").

- Make the segment stick to the inner wall of the head by simultaneously turning the rotor (anticlockwise).

- Insert a segment of the pre-pump line into the end-of-infusion detector (3).

- Connect the tube on the drip chamber to the infusion pressure transducer (4).

- Insert the segment of line between the drip chamber and the deaeration filter (5) into the blood leak detector (BLD) block (6).

- Open the cover of the Natrium sensor turning the unlocking lever to the right.

- If present, insert the ultrafiltrate probe (7) into the Natrium sensor on the right (the ultrafiltrate flow must follow the direction of the green arrow).

- Close the cover of the Natrium sensor.

- Prepare the physiological solution for priming. It is suggested to use a heparinoid solution of 5000 IU/l (if necessary, use the Y-connector to join two bags).

- To prime the blood lines, refer to the dedicated chapter in the user manual.

WARNINGWARNINGWARNINGWARNING • Be extremely cBe extremely cBe extremely cBe extremely careful when connecting the cartridge, in particular when areful when connecting the cartridge, in particular when areful when connecting the cartridge, in particular when areful when connecting the cartridge, in particular when

removing the protective caps, to prevent spilling filling liquid. Follow the removing the protective caps, to prevent spilling filling liquid. Follow the removing the protective caps, to prevent spilling filling liquid. Follow the removing the protective caps, to prevent spilling filling liquid. Follow the instructions for direction of flow shown on the label.instructions for direction of flow shown on the label.instructions for direction of flow shown on the label.instructions for direction of flow shown on the label.

• Replace the cartridge if the internal liquid runs out or in the eveReplace the cartridge if the internal liquid runs out or in the eveReplace the cartridge if the internal liquid runs out or in the eveReplace the cartridge if the internal liquid runs out or in the event of nt of nt of nt of excessive air.excessive air.excessive air.excessive air.

• Do not clamp the pressure measurement line.Do not clamp the pressure measurement line.Do not clamp the pressure measurement line.Do not clamp the pressure measurement line.

2

4

3

6


5

7


FEATURESFEATURESFEATURESFEATURES

Sphygmo is an automatic non-invasive arterial pressure measuring system with the possibility to display the mean arterial pressure, the systolic pressure, the diastolic pressure and the heart rate. Sphygmo, which uses the principle of oscillometric measurement, is composed of a special card installed and connected behind the display, inside the case. The card is connected to a rubber tube at the end of which a cuff is attached. The system allows making measurements on demand of the operator as well as automatically at programmable time intervals. It also allows storing the readings so that they are available whenever the operator requires. All the measurements made are displayed in both numerical and graphic form with the additional possibility of crossing the values measured by Sphygmo with the values read by the other sensors of the machine. On the basis of clinical needs, thresholds can be set on the arterial pressure values which, if exceeded, generate a warning for the operator. The system can be used on adult patients of different build but not on infants.

PRECAUTIONS FOR USEPRECAUTIONS FOR USEPRECAUTIONS FOR USEPRECAUTIONS FOR USE

To obtain an accurate arterial pressure measurement, it is necessary that:

• the size of the cuff is suited to the diameter of the patient’s arm,

• the cuff is accurately positioned.

An inadequate size or an incorrect attachment of the cuff may result in incorrect measurements. The pressure measurement can be affected by the patient’s position and his physiological conditions. The patient must therefore be relaxed and in a comfortable position.

WARNING Sphygmo can be used on adult patients only.Sphygmo can be used on adult patients only.Sphygmo can be used on adult patients only.Sphygmo can be used on adult patients only. Avoid compressure or restriction of pressure tubes.Avoid compressure or restriction of pressure tubes.Avoid compressure or restriction of pressure tubes.Avoid compressure or restriction of pressure tubes. Check (for example examinCheck (for example examinCheck (for example examinCheck (for example examining the involved arm) for possible prolonged ing the involved arm) for possible prolonged ing the involved arm) for possible prolonged ing the involved arm) for possible prolonged impairment of the circulation of the patient.impairment of the circulation of the patient.impairment of the circulation of the patient.impairment of the circulation of the patient. Thanks to its insulating material, Thanks to its insulating material, Thanks to its insulating material, Thanks to its insulating material, Sphygmo Sphygmo Sphygmo Sphygmo ““““applied partapplied partapplied partapplied part”””” (type BF) (type BF) (type BF) (type BF) is is is is protected against effects of defibrillator dischargeprotected against effects of defibrillator dischargeprotected against effects of defibrillator dischargeprotected against effects of defibrillator discharge.... In case of accidental wetting of the cufIn case of accidental wetting of the cufIn case of accidental wetting of the cufIn case of accidental wetting of the cuff or the connections, dry them f or the connections, dry them f or the connections, dry them f or the connections, dry them immediately in order to prevent dampness from entering the measuring immediately in order to prevent dampness from entering the measuring immediately in order to prevent dampness from entering the measuring immediately in order to prevent dampness from entering the measuring systemsystemsystemsystem....

OPERATIONOPERATIONOPERATIONOPERATION

Wrap the cuff around the upper arm of the patient (at the same level as the heart) in such a way that the arrow pointing to the artery is aligned with the brachial artery as shown in the figure. Ensure that the tube connected to the cuff is not compressed, squashed or damaged.


To enter the main Sphygmo page:

sensors

Sphygmo

At the bottom right of the display a box appears with the data of the last three measurements made. A menu is also accessed activating the following functions:

return

To return to the main menu.

measure

To activate the arterial pressure measurement. The cuff automatically starts inflating to a pressure higher than the arterial pressure. (If the key is pressed while measuring is in progress, the process is interrupted immediately). On the right of the display a box appears indicating “MEASURE IN PROG.”

At the end of the measurement the following values are displayed in the box: • Systolic pressure (maximum), Sys. • Diastolic pressure (minimum), Dia. • Mean arterial pressure (MAP) • Heart rate (number of beats a minute) Should the pressure measurement result negative, an error code or a message appears in the box. The main causes for an error may be: • Cuff positioned incorrectly • Air tube disconnected from cuff • Patient movement during measurement Check which of the above has caused the error and then


measure

to repeat the measurement.

auto BP on

To automatically activate pressure measurement at variable time intervals. To set the time interval between one automatic pressure measurement and the next,

see/mod. parameters

measure interval

. The minimum interval settable is 5 minutes. Automatic measurements are disabled when rinseback starts.

see/mod. parameters

MAX SYS threshold

or

MIN SYS threshold

to set, respectively, the maximum or minimum systolic pressure thresholds for setting off the alarm signal.

MAX DIA threshold

or

MIN DIA threshold

to set, respectively, the maximum or minimum diastolic pressure thresholds for setting off the alarm signal.

Use the and keys to set and press

ok

to confirm. These thresholds can be preset during configuration (see the Chapter “CONFIGURATION”).

warning on

to activate the warning

warning off

to deactivate the warning

ok

to confirm.

display

To enable a submenu where the functions related to the variables measured appear. Pressing any one of these functions activates the graph associated with it. For the graphs, refer to the related description.

open table

To view a table containing the data of the last measurements made for a maximum of 16 measurements. The data displayed for each measurement are: time and duration of the treatment in which the measurement was carried out, systolic and diastolic pressure, MAP, heart rate.

ok

To confirm the parameters set.

When the measurement has been completed, do not immediately remove the cuff, but leave it on the arm for a few seconds to allow complete deflation. After removing the cuff, fold it, wind the tube and place it on the holder provided on the rear of the dialysis machine.


In the priming, dialysis and rinseback states, pressure measurement can be

activated by means of the

sphygmo measure

function on the main page near the key.

When measurement is active, the

interrupt measure

key is present in the same position, which allows interrupting the measurement. If an automatic sphygmomanometer

measuring program is enabled, the

sphygmo measure

key turns green; also in this case,

when measurement is active,

interrupt measure

to interrupt the measurement.



Thanks to Pulsar, formula plus can continuously measure the heartbeat during all the dialytic treatment phases. The technology used exploits radio waves in such a way as not to tie the patient to the equipment and leave him free in his/her movements. Pulsar is composed of a low-frequency transmitter inserted in a band fitted around the chest of the patient. The chest band is personal, easy to use and can be worn at any time as it is activated automatically. Before use moisten the electrode areas on the back with gel for electrocardiographs. Fit the band around the check, check that the Polar logo is in a central, upright position and the wet electrode areas are firmly against the skin. In addition to the transmitter there is also a receiver connected to the dialysis machine, which must be positioned on the patient’s bed. The system reads the depolarisation signal of the cardiac muscle in such a way as not to be affected by the variation in peripheral vascularization and the position of the vascular access. The Pulsar outputs, similar to the other sensors of formula plus, are displayed in numerical form as far as the instantaneous value is concerned and in graphic form for the time trend. Depending on the clinical requirements and the patient, the minimum and maximum heart rate values can be set, on the basis of which the operator is alerted.


Measuring the heart rate is important as it supplies fundamental information to understand the patient’s compensation capacity under haemodynamic stress due to ultrafiltration induced by the machine control of the patient weight loss. The information relating to the heart rate together with the hematocrit measurement provide an indication of the refilling capacity (transfer of water from the intracellular to the extracellular compartment).

WARNINGWARNINGWARNINGWARNING Pulsar is a system composed of a receiver specially designed and connected Pulsar is a system composed of a receiver specially designed and connected Pulsar is a system composed of a receiver specially designed and connected Pulsar is a system composed of a receiver specially designed and connected to a thoracic transmitter (chest band) of the heart rate meter manufactured to a thoracic transmitter (chest band) of the heart rate meter manufactured to a thoracic transmitter (chest band) of the heart rate meter manufactured to a thoracic transmitter (chest band) of the heart rate meter manufactured by Polarby Polarby Polarby Polar. Carefully read the user manual of the . Carefully read the user manual of the . Carefully read the user manual of the . Carefully read the user manual of the Polar heart rate meter Polar heart rate meter Polar heart rate meter Polar heart rate meter before using the Pulsar system.before using the Pulsar system.before using the Pulsar system.before using the Pulsar system. The system has been designed to function with the PolarThe system has been designed to function with the PolarThe system has been designed to function with the PolarThe system has been designed to function with the Polar transmitter. Use transmitter. Use transmitter. Use transmitter. Use


of transmitters different from the one specified is not allowed. of transmitters different from the one specified is not allowed. of transmitters different from the one specified is not allowed. of transmitters different from the one specified is not allowed. The receiver must be positioned on the patient’s bed within aThe receiver must be positioned on the patient’s bed within aThe receiver must be positioned on the patient’s bed within aThe receiver must be positioned on the patient’s bed within a range of 50 range of 50 range of 50 range of 50 cm from the chest band and oriented in such a way that the longest side is cm from the chest band and oriented in such a way that the longest side is cm from the chest band and oriented in such a way that the longest side is cm from the chest band and oriented in such a way that the longest side is parallel to the chest band.parallel to the chest band.parallel to the chest band.parallel to the chest band. The Polar heart rate meter is equipped with a receiver (wrist clock) which The Polar heart rate meter is equipped with a receiver (wrist clock) which The Polar heart rate meter is equipped with a receiver (wrist clock) which The Polar heart rate meter is equipped with a receiver (wrist clock) which may only be used as additional receiver to check, before the diamay only be used as additional receiver to check, before the diamay only be used as additional receiver to check, before the diamay only be used as additional receiver to check, before the dialysis lysis lysis lysis treatment, correspondence of the measurements with the data displayed by treatment, correspondence of the measurements with the data displayed by treatment, correspondence of the measurements with the data displayed by treatment, correspondence of the measurements with the data displayed by formula plus.


To display the heart rate measurement,

sensors

Pulsar

. At the bottom of the monitor a window opens displaying the heart rate value in real-time. A menu is also accessed activating the following functions:

return


see/mod. parameters

MAX. HR threshold

or

MIN. HR threshold

to set the maximum or minimum

heart rate thresholds generating alarm signalling. Use the and

keys to set parameters.

warning on

to activate or deactivate alarm signalling.

ok

to confirm the parameters set.

display HR

To view the heart rate time trend.



Thanks to Hemox, formula plus can continuously supply the absolute measurement of hematocrit and oxygen saturation. This is made possible by a disposable probe integrated in the arterial bloodline and a reader (fixed on the stand) which makes optical absorbance measurements at three different wavelengths and does not require initial calibration. The qualities of the system are the non-invasive measurement, the absolute sterility and the ease of use for the operator. In fact, the personnel do not have to perform any extra operations to install the dedicated line. Knowing the hematocrit value moreover allows supplying the percentage volume loss during dialysis.

The operator interface allows, as for the other formula plus sensors, displaying the data in both numerical and graphic form. It is also possible to set customised thresholds on the hematocrit, saturation and percentage volume loss values, which generate a warning for the operator if they are exceeded.


The hematocrit measurement is of fundamental importance to understand the state of water accumulation in the patient (in the intradialytic interval) and to monitor its variation during treatment. This variation is closely tied to the quantity of water extracted from the extracellular compartment as well as the rate of water transfer from the intracellular to the extracellular compartment. Of course, the process is governed not only by movements of volumes of water but also by the concentrations of sodium in the dialysing fluid and in the extracellular and intracellular compartments. Moreover, as already mentioned for Pulsar, the hematocrit and heart rate data provides a valid support to the clinic to understand the haemodynamic state of the patient, the refilling capacity and the need to modify the dialysis fluid parameters which, together with ultrafiltration modulation, can improve the haemodynamic state of the patient preventing possible hypotensive states.


The information relating to oxygen saturation is important as the contact of the patient’s tissues (blood) with foreign bodies (blood lines and dialyser) may induce hypoxaemia. This parameter is related to the biocompatibility of the disposable materials and the dialysing fluid.


To view the hematocrit and oxygen saturation measurement, proceed as follows:

sensors

Hemox

At the bottom of the monitor a window opens displaying in real-time the hematocrit, oxygen saturation and percentage volume loss data. A menu is also accessed activating the following functions:

return


see/mod. parameters

MAX. HCT threshold

/

MIN. HCT threshold

or

MAX. SO2 threshold

/

MIN. SO2 threshold

or

VL% threshold

to set the threshold to generate alarm signalling. Use the

and keys to set parameters.

warning on

to activate or deactivate alarm signalling.

ok

to confirm the parameters set.

display HCT

To view the hematocrit time trend.

display SO2

To view the oxygen saturation time trend.

display VL%

To view the percentage volume loss time trend.



Direct and continuous measurement of blood and ultrafiltrate conductivity is made possible on formula plus thanks to the use of two disposable probes and a reading system able to measure not only the conductivity but also the temperature of the fluids flowing across the probes. To measure the fluid resistivity, this system, defined as Natrium, makes use of electromagnetic coupling, galvanically isolating the probe from the rest of the circuit. The temperature measurement occurs via the probe by thermal contact with the fluid. The probe on the arterial line measures conductivity in all haemodialysis treatments, while the probe on the ultrafiltrate line is present only in HFR, where ultrafiltrate is available. In this case, the patient’s plasma sodium concentration level is also given, which may be increased by the ultrafiltrate conductivity. The non-invasive measurement, ease of use and complete safety for the patient (no direct electrical contact) constitute the strengths of this sensor. The operator interface allows, as for the other formula plus sensors, displaying the data in both numerical and graphic form.



To view the plasma sodium concentration:

sensors

Natrium

At the bottom of the monitor, a window opens displaying real-time data for plasma sodium concentration:

display [Na]

for graphic display

To view other readings, proceed as follows:

sensors

applications

cond/temp blood/uf

At the bottom of the monitor a window opens displaying the data in real-time of:

- Blood conductivity

display BC

for graphic display

- Ultrafiltrate conductivity

display CUF

for graphic display

- Blood temperature

display BT

for graphic display

- Ultrafiltrate temperature

display UFT

for graphic display

return

to return to the main menu.


THERMAL BALANCETHERMAL BALANCETHERMAL BALANCETHERMAL BALANCE

sensors

applications

thermal balance

Via the Natrium sensor formula plus is able to continuously, directly and non-invasively monitor the blood temperature at the dialyser inlet during all treatments and the ultrafiltrate temperature during HFR. Through the “Thermal balance” application, this data can be compared with the dialysis fluid temperature (in real-time and graphic form) thus allowing evaluation of the correct thermal balance in the course of treatment. A menu is accessed activating the following functions:

return


display BT

To view the blood temperature in graphic form.

display DT

To view the dialysis fluid temperature in graphic form.

display UFT

To view the ultrafiltrate temperature in graphic form.

NOTENOTENOTENOTE The Thermal Balance application is disabled if the Natrium sensor is not The Thermal Balance application is disabled if the Natrium sensor is not The Thermal Balance application is disabled if the Natrium sensor is not The Thermal Balance application is disabled if the Natrium sensor is not installed.installed.installed.installed.


CARDIUM CARDIUM CARDIUM CARDIUM

sensors

applications

cardium

Cardium is the formula plus application which, integrating the Sphygmo and Pulsar measurements, allows interactive control of the heart rate and arterial pressure. The advantages of this integration are:

• The possibility of automatic activation of the sphygmomanometer in the event that the values measured by Pulsar exceed given thresholds.

• Display, on the same graph, of the heart rate measured by Pulsar and the pressure measurements obtained with Sphygmo in order to immediately understand the state the patient is in.

A menu is accessed activating the following functions:

return


see/mod. parameters

MAX HR threshold

/

MIN HR threshold

to set the thresholds on the absolute value of the heart rate.

% threshold

to set the thresholds on the percentage value with respect to the basal value of the heart rate .

derivative threshold

to set the thresholds on the heart rate variation. The derivative thresholds are calculated as the difference between the mean values/minute measured in two consecutive minutes.

Use the and keys to set parameters.

ok

to confirm.

Cardium on

To enable the Cardium application after the setting of the thresholds.

display



Automatic disabling of the set arterial pressure measurements is allowed at any

time.

Cardium off

. Only manual arterial pressure measurements can be made in the 5 minutes following each activation of Cardium. In this way, the patient is not excessively exposed to stress.

NOTENOTENOTENOTE The Cardium application is disabled if the Pulsar or Sphygmo sensor is not The Cardium application is disabled if the Pulsar or Sphygmo sensor is not The Cardium application is disabled if the Pulsar or Sphygmo sensor is not The Cardium application is disabled if the Pulsar or Sphygmo sensor is not installed.installed.installed.installed.


KT/VKT/VKT/VKT/V

The Kt/V application has the function of measuring certain dialysis efficiency parameters (Clearance, Kt, Kt/V) during dialysis. The measurement method involves generating conductivity steps in the dialysate solution entering the filter; the method uses a 1mS/cm step to alternate upward and downward steps, in successive measurements, in order to balance the flow of sodium from and to the patient. This alternation is absent if the set total conductivity is greater than 14.7mS/cm (downward steps only) or less than 13.5mS/cm (upward steps only). In regard to timing, the measurement process may be performed automatically, during dialysis, every 15 or 30 minutes (depending on the "Kt/V Level" parameter set in Service Configuration); in any case (i.e. without automatic measurement), measurements may be taken manually at any time during the dialysis. The total measurement time varies according to flow, i.e. the lower the dialysis flow, the longer it takes for the modified conductivity liquid used to reach the dialyser; throughout the measurement process, the message "Kt/V" will appear on the status bar, advising the operator that the measurement is in process. Both automatic and manual measurements may only be taken in conditions in which they can be activated. More specifically, for automatic measurements, each one can only be taken provided the following conditions are met:

• The system is not in alarm or isolated UF • The measurement will not overlap the T0 test of the UF system • The measurement will not overlap a total conductivity variation (for example,

due to execution of a profile). • The system is not in a “change filter” state • An infusion bolus is not in progress.

If any of these conditions are not met, the measurement is automatically postponed until it can be taken correctly. The same conditions apply for manual measurements; in this case, however, failure to satisfy the conditions would not postpone the measurement, but would disable the button to activate it (“measurement”). During measurement, the following checks are carried out:

• If an alarm sounds for the closure of the bypass or if the machine switches to isolated UF, the measurement is interrupted and cancelled.

• The total conductivity cannot be changed. • The dialysis flow cannot be changed. • If performing an infusion bolus the measurement is interrupted and

cancelled. • The measurement can always be interrupted and cancelled by pressing

interrupt measure

The key sequence


sensors

applications

Kt/V

brings up the application menu and a window showing a breakdown of the measurement data:

return


measure

Allows manual measurement to be started.

When measurement is active, the

interrupt measure

key is set to the same position, which allows the measurement to be interrupted.

see/mod. parameters

To access the application parameter setting menu.

display


In regard to the window, given below are the meanings for the sizes shown.

KKKK

The instant clearance shown with the last measurement

KtKtKtKt The instant Kt taken with the last measurement, where K is the clearance and t is the treatment time elapsed

Kt prevKt prevKt prevKt prev

Predicted Kt at end of treatment

Kt/VKt/VKt/VKt/V The instant Kt/V taken with the last measurement, where V is the patient distribution volume, to be entered by the operator

Kt/V prevKt/V prevKt/V prevKt/V prev

Predicted Kt/V at end of treatment.


T to gT to gT to gT to goal oal oal oal Kt/VKt/VKt/VKt/V

Remaining minutes of dialysis required to reach the desired Kt/V set by the user via the “view/edit parameters” page

see/mod. parameters

to enter the following menu:

return


distribution volume

To enter the menu for setting the distribution volume, which can also be selected from a list of stored data.

goal Kt/V

To set the desired Kt/V at end of treatment.


min Kt/V

To set the minimum acceptable Kt/V at end of treatment.


min Clearance

To set the minimum acceptable clearance for each measurement (expressed in % blood flow).


meas. int. (min)

To set the system to carry out automatic Kt/V measurements, setting the delay between one automatic measurement and the next (0 = only manual measurements).


warning on

To enable alerts associated with set parameters (see chapter on alarms and indicators)


ok

To confirm changes, saving the new settings to file

distribution volume

to enter the distribution volume setting menu, also using a database of saved settings.

return


distribution volume

To set the distribution volume setting.


name

To open a previously saved setting.

Select the desired data using either button or .

modify name

To rename saved setting.

Use keys and to select the box to be changed, and keys

or to select the new alphanumeric code to be attributed to the box.

ok

To confirm changes, saving the new settings to file

To set a distribution volume without associating it to a name, simply select the two horizontal bars (“- -“) in the name box.

display

to view graphs for the measurements taken, graphs “Kt” and “Kt/V” show the values taken with a continuous line and those set with a discontinuous line. However, the “Clearance” graph shows only the measured values.

ENG – Ed. 12/07 cap. 8.4 – Other functions - 1 of 4

8.4 OTHER FUNCTIONS8.4 OTHER FUNCTIONS8.4 OTHER FUNCTIONS8.4 OTHER FUNCTIONS

SERIAL CONNECTION SERIAL CONNECTION SERIAL CONNECTION SERIAL CONNECTION

Thanks to a dedicated interface it is possible to connect with formula by means of a RS 232C serial connection for the acquisition of the system data. Connection is performed thanks to a Formula protocol. The serial connection kit (if not fitted) can be installed upon request, but only by technicians authorised by the manufacturer. The serial connection does not alter the functioning of formula. No specific indication of its presence is given to the user, even during data transmission.

CAUTIONCAUTIONCAUTIONCAUTION

formula may only be connected to equipment which comply with CEI EN may only be connected to equipment which comply with CEI EN may only be connected to equipment which comply with CEI EN may only be connected to equipment which comply with CEI EN 60950 or EN 6060160950 or EN 6060160950 or EN 6060160950 or EN 60601----1 standards, provided that they are properly grounded.1 standards, provided that they are properly grounded.1 standards, provided that they are properly grounded.1 standards, provided that they are properly grounded. The connection must be in conformity with the requirements included in EN The connection must be in conformity with the requirements included in EN The connection must be in conformity with the requirements included in EN The connection must be in conformity with the requirements included in EN 60601606016060160601----1111----1 1 1 1 standard.standard.standard.standard.

It must be connected using cables that comply with the RS 232C serial It must be connected using cables that comply with the RS 232C serial It must be connected using cables that comply with the RS 232C serial It must be connected using cables that comply with the RS 232C serial connection ( connection ( connection ( connection ( ±±±± 12V, 1W). 12V, 1W). 12V, 1W). 12V, 1W).

The use of nonThe use of nonThe use of nonThe use of non----conform cables and equipment which do not comply with the conform cables and equipment which do not comply with the conform cables and equipment which do not comply with the conform cables and equipment which do not comply with the specifications may damage the interface.specifications may damage the interface.specifications may damage the interface.specifications may damage the interface.

If the connector is not used (refer tIf the connector is not used (refer tIf the connector is not used (refer tIf the connector is not used (refer to chapter 2.1, back panel), do not remove o chapter 2.1, back panel), do not remove o chapter 2.1, back panel), do not remove o chapter 2.1, back panel), do not remove the cover.the cover.the cover.the cover.

BACKBACKBACKBACK----UP BATTERY UP BATTERY UP BATTERY UP BATTERY

The back-up battery makes it possible to continue extra-corporeal circulation of the blood if the power fails while waiting for it to be restored, or to return the blood to the patient without having to manually rotate the pump. The installation of the back-up battery is performed only on request. The battery must be activated during configuration of the machine by authorised personnel. Once activated, the battery is tested every time the machine is switched on.

If a red icon appears on the display during the rinsing phase, it indicates that the battery test did not have a positive outcome and therefore the machine will not be able to operate if there is a power fail.

If a green icon appears, it indicates that the battery is operating and the machine will be able to withstand a power fail for approximately 5 minutes.

The overall duration of the battery depends on its preservation, on the operating conditions of formula and on the charge condition of the battery.

2 of 4 - chap. 8.4 – Other functions ENG – Ed. 12/07

The battery activates in PATIENT CONNECTION, DIALYSIS and RINSEBACK phases allowing only the extracorporeal circuit to operate. In the other operating conditions, that is RINSING, DISINFECTION and DESCALING, if there is a power fail, the machine switches off. Only 5 sec. after the power is restored it switches back on and starts from where it was interrupted. Battery operation is indicated by a flashing orange LED next to the ON key. An alarm signal also goes on (BATTERY) with a visual and acoustic signal warning the operator that the battery is activated. If there is a power fail during dialysis or in any other machine condition where blood is present in the blood lines, a circular instrument is displayed on the left side of the display which indicates the charge of the battery.

The arc of the instrument is divided into two sectors: - the green sector indicates the battery

is charged. - the red sector indicates a low battery

charge. When the circular crown is only coloured in the red part, the machine can operate autonomously for approximately 2 min. before switching off.

When the battery is empty, formula® enters offline mode, yet it is still able to save operating data for at least 2 mins. Once the mains power is restored, the machine restarts but, if it should go offline again within a short period of time, the battery backup power will not be guaranteed.

CAUTIONCAUTIONCAUTIONCAUTION

The battery employed is a leadThe battery employed is a leadThe battery employed is a leadThe battery employed is a lead----type battery and recharges during type battery and recharges during type battery and recharges during type battery and recharges during formula operation; any maintenancoperation; any maintenancoperation; any maintenancoperation; any maintenance/interventions on the battery should be e/interventions on the battery should be e/interventions on the battery should be e/interventions on the battery should be performed exclusively by technicians authorised by the manufacturer.performed exclusively by technicians authorised by the manufacturer.performed exclusively by technicians authorised by the manufacturer.performed exclusively by technicians authorised by the manufacturer. Do not use the battery in room temperatures over 40 °C.Do not use the battery in room temperatures over 40 °C.Do not use the battery in room temperatures over 40 °C.Do not use the battery in room temperatures over 40 °C. Never remove the plug from the socket if the main rear switch is on.Never remove the plug from the socket if the main rear switch is on.Never remove the plug from the socket if the main rear switch is on.Never remove the plug from the socket if the main rear switch is on. If the battery leaIf the battery leaIf the battery leaIf the battery leaks, turn off the machine and immediately contact the ks, turn off the machine and immediately contact the ks, turn off the machine and immediately contact the ks, turn off the machine and immediately contact the authorised technicians.authorised technicians.authorised technicians.authorised technicians. In case the equipment is not used for long periods (longer than one month) it In case the equipment is not used for long periods (longer than one month) it In case the equipment is not used for long periods (longer than one month) it In case the equipment is not used for long periods (longer than one month) it is recommended to contact the authorised technicians to remove the battery.is recommended to contact the authorised technicians to remove the battery.is recommended to contact the authorised technicians to remove the battery.is recommended to contact the authorised technicians to remove the battery. At the end of its lifeAt the end of its lifeAt the end of its lifeAt the end of its life----ccccycle the battery should not be disposed of with regular ycle the battery should not be disposed of with regular ycle the battery should not be disposed of with regular ycle the battery should not be disposed of with regular waste but given to authorised disposal services (contact the manufacturer or waste but given to authorised disposal services (contact the manufacturer or waste but given to authorised disposal services (contact the manufacturer or waste but given to authorised disposal services (contact the manufacturer or the authorised technicians).the authorised technicians).the authorised technicians).the authorised technicians).

ENG – Ed. 12/07 cap. 8.4 – Other functions - 3 of 4

PERFORATED POWDER BICARBONATE CARTRIDGE: FILLING PERFORATED POWDER BICARBONATE CARTRIDGE: FILLING PERFORATED POWDER BICARBONATE CARTRIDGE: FILLING PERFORATED POWDER BICARBONATE CARTRIDGE: FILLING UNDER PRESSUREUNDER PRESSUREUNDER PRESSUREUNDER PRESSURE

The perforated sodium bicarbonate cartridge allows the preparation of dialysis fluid for dialysis treatment. This cartridge can only be used on machines equipped with a support which permits perforation of the cartridge. The equipment can be modified by expert and qualified technical personnel to keep the cartridges in pressure during the use. The procedure of use of the cartridge described in the user’s manual does not change, but it is recommended to follow the warnings given below.

WARNINGWARNINGWARNINGWARNING Do not disconnect the upper perforation cDo not disconnect the upper perforation cDo not disconnect the upper perforation cDo not disconnect the upper perforation connector in any machine onnector in any machine onnector in any machine onnector in any machine conditions (particularly during disinfection/cleaning), except for conditions (particularly during disinfection/cleaning), except for conditions (particularly during disinfection/cleaning), except for conditions (particularly during disinfection/cleaning), except for connecting the concentrate containers after selecting dialysis mode.connecting the concentrate containers after selecting dialysis mode.connecting the concentrate containers after selecting dialysis mode.connecting the concentrate containers after selecting dialysis mode. To replace the cartridge during treatment, see chapter Problem solving.To replace the cartridge during treatment, see chapter Problem solving.To replace the cartridge during treatment, see chapter Problem solving.To replace the cartridge during treatment, see chapter Problem solving.

4 of 4 - chap. 8.4 – Other functions ENG – Ed. 12/07

ENG – Ed. 11/09 ch. 9.1 – Disinfection/cleaning - 1 of 16

9999. 1 DISINFECTION/CLEANING. 1 DISINFECTION/CLEANING. 1 DISINFECTION/CLEANING. 1 DISINFECTION/CLEANING


The actions necessary to “clean" the haemodialysis equipment must take in account some characteristics, among which the fact that they manage, during every session, more than 100 litres of dialysis fluid composed of saline solutions, bicarbonates and organic substances that may contain bacterial colonies and endotoxins. In such sense, a total action on the machines consists in using chemical or physical agents which are able to remove scaling and saline accumulation, to prevent and/or to remove organic substances and biofilms and to be effective against bacteria, virus and endotoxins. To this aim, formula is provided with automatic rinsing and disinfection/cleaning cycles where chemical solutions, according to prefixed dilution ratios, or high temperature water come into contact with the hydraulic circuit for periods of time, such as to guarantee removal of substances and bacterial formations (biofilms). These terms are defined as they apply to formula: RINSING:RINSING:RINSING:RINSING: physical process that uses water to remove eventual deposits from the fluid pathway. DESCALINGDESCALINGDESCALINGDESCALING: process to remove eventual inorganic deposits normally left by the solutions used in the fluid pathway of haemodialysis monitors. DISINFECTIONDISINFECTIONDISINFECTIONDISINFECTION: chemical or physical process which has effect on living microorganisms, however with possibility of survival of some vegetative forms (spore). DISINFECTION/CLEANINGDISINFECTION/CLEANINGDISINFECTION/CLEANINGDISINFECTION/CLEANING: in the user manual as well as in user interface this procedure generally indicates the process of "cleaning" the machine, that may consists in a disinfection, descaling or rinsing cycle. All disinfecting/cleaning cycles occur rigorously in single-pass and are followed by high-flow rinsing which guarantees removal of any traces of chemical agents and deposits. The chemical agents may be harmful to the materials used for the fluid pathway and may also contain additives which generate foam or which are difficult to remove. To this aim, the chemical agents listed in this manual have been tested on formula and are compatible with the materials of the machine, provided that they are used in accordance with the specifications indicated.


As the As the As the As the haemodialysishaemodialysishaemodialysishaemodialysis delivery system is a medical device, the accessories delivery system is a medical device, the accessories delivery system is a medical device, the accessories delivery system is a medical device, the accessories used with it must comply with the MDD Europeanused with it must comply with the MDD Europeanused with it must comply with the MDD Europeanused with it must comply with the MDD European Directive and therefore, if Directive and therefore, if Directive and therefore, if Directive and therefore, if it is the case, be in their turn CE marked Medical Devices. In the specific case it is the case, be in their turn CE marked Medical Devices. In the specific case it is the case, be in their turn CE marked Medical Devices. In the specific case it is the case, be in their turn CE marked Medical Devices. In the specific case of the products used for disinfection, the Medical Devices used must belong of the products used for disinfection, the Medical Devices used must belong of the products used for disinfection, the Medical Devices used must belong of the products used for disinfection, the Medical Devices used must belong to Class IIa. to Class IIa. to Class IIa. to Class IIa.

2 of 16 - ch. 9.1 – Disinfection/cleaning ENG – Ed. 11/09

The maximum dwell times of the disinfectants have been defined and tested in such a way as not to damage the internal parts of the fluid pathway and cause malfunctioning of the machine. A disinfection protocol is available on request from Marketing Department.

NOTENOTENOTENOTE The test procedure used to verify the disiThe test procedure used to verify the disiThe test procedure used to verify the disiThe test procedure used to verify the disinfection efficacy nfection efficacy nfection efficacy nfection efficacy is available on is available on is available on is available on demanddemanddemanddemand....

WARNING AND CAUTIONSWARNING AND CAUTIONSWARNING AND CAUTIONSWARNING AND CAUTIONS

The chemical agents may be toxic. Take the necessary precautions before The chemical agents may be toxic. Take the necessary precautions before The chemical agents may be toxic. Take the necessary precautions before The chemical agents may be toxic. Take the necessary precautions before use. Follow the instructions and warnings printed on the package labels and use. Follow the instructions and warnings printed on the package labels and use. Follow the instructions and warnings printed on the package labels and use. Follow the instructions and warnings printed on the package labels and safety sheets.safety sheets.safety sheets.safety sheets.

It is recommended to disinIt is recommended to disinIt is recommended to disinIt is recommended to disinfect the machine after each dialysis session. The fect the machine after each dialysis session. The fect the machine after each dialysis session. The fect the machine after each dialysis session. The disinfectant action must be combined with the use of a descaling agent on disinfectant action must be combined with the use of a descaling agent on disinfectant action must be combined with the use of a descaling agent on disinfectant action must be combined with the use of a descaling agent on alternate days. Descaling must be performed before disinfection, not after.alternate days. Descaling must be performed before disinfection, not after.alternate days. Descaling must be performed before disinfection, not after.alternate days. Descaling must be performed before disinfection, not after.

The manufacturer will not guarantee the machine disinfecThe manufacturer will not guarantee the machine disinfecThe manufacturer will not guarantee the machine disinfecThe manufacturer will not guarantee the machine disinfection or descaling, tion or descaling, tion or descaling, tion or descaling, nor the rinse efficacy, when using nor the rinse efficacy, when using nor the rinse efficacy, when using nor the rinse efficacy, when using the the the the USER disinfection/cleaningUSER disinfection/cleaningUSER disinfection/cleaningUSER disinfection/cleaning programprogramprogramprogram....

If the machine is not used for a certain period of time, even short (24h), run If the machine is not used for a certain period of time, even short (24h), run If the machine is not used for a certain period of time, even short (24h), run If the machine is not used for a certain period of time, even short (24h), run a disinfection cycle before carrying out a dialysis treatment.a disinfection cycle before carrying out a dialysis treatment.a disinfection cycle before carrying out a dialysis treatment.a disinfection cycle before carrying out a dialysis treatment.

The temperature of tThe temperature of tThe temperature of tThe temperature of the liquid circulating in the tubes during heat he liquid circulating in the tubes during heat he liquid circulating in the tubes during heat he liquid circulating in the tubes during heat disinfection/cleaning is extremely high. disinfection/cleaning is extremely high. disinfection/cleaning is extremely high. disinfection/cleaning is extremely high. Do not disconnect the connectors, Do not disconnect the connectors, Do not disconnect the connectors, Do not disconnect the connectors, and do not touch the tubes and the Forclean ultrafilter until the and do not touch the tubes and the Forclean ultrafilter until the and do not touch the tubes and the Forclean ultrafilter until the and do not touch the tubes and the Forclean ultrafilter until the disinfection/cleaning cycle has been completed.disinfection/cleaning cycle has been completed.disinfection/cleaning cycle has been completed.disinfection/cleaning cycle has been completed.

After each disinfecAfter each disinfecAfter each disinfecAfter each disinfection/cleaning cycle and in any case before dialysing the tion/cleaning cycle and in any case before dialysing the tion/cleaning cycle and in any case before dialysing the tion/cleaning cycle and in any case before dialysing the patient, the operator must ensure that there are no residues of chemical patient, the operator must ensure that there are no residues of chemical patient, the operator must ensure that there are no residues of chemical patient, the operator must ensure that there are no residues of chemical agent in the machine or in the dialysis fluid. Draw a agent in the machine or in the dialysis fluid. Draw a agent in the machine or in the dialysis fluid. Draw a agent in the machine or in the dialysis fluid. Draw a dialysis fluiddialysis fluiddialysis fluiddialysis fluid sample sample sample sample (through the special connector on the dialyser lin(through the special connector on the dialyser lin(through the special connector on the dialyser lin(through the special connector on the dialyser line) and run specific control e) and run specific control e) and run specific control e) and run specific control tests for the chemical agent used. Follow the indications recommended by tests for the chemical agent used. Follow the indications recommended by tests for the chemical agent used. Follow the indications recommended by tests for the chemical agent used. Follow the indications recommended by the manufacturer of the chemical agent.the manufacturer of the chemical agent.the manufacturer of the chemical agent.the manufacturer of the chemical agent.

Do not mix different disinfecting /descaling solutions.Do not mix different disinfecting /descaling solutions.Do not mix different disinfecting /descaling solutions.Do not mix different disinfecting /descaling solutions.

Do not turn off the machine leaving the disinfecting or theDo not turn off the machine leaving the disinfecting or theDo not turn off the machine leaving the disinfecting or theDo not turn off the machine leaving the disinfecting or the descaling agent descaling agent descaling agent descaling agent inside the circuit, except in the case where dwell time has been inside the circuit, except in the case where dwell time has been inside the circuit, except in the case where dwell time has been inside the circuit, except in the case where dwell time has been programmed.programmed.programmed.programmed.

The tube marked yellow (provided with the machine) must be used only for The tube marked yellow (provided with the machine) must be used only for The tube marked yellow (provided with the machine) must be used only for The tube marked yellow (provided with the machine) must be used only for the container of the disinfecting/descaling agent. the container of the disinfecting/descaling agent. the container of the disinfecting/descaling agent. the container of the disinfecting/descaling agent.

Always disinfect the concentrate aspiAlways disinfect the concentrate aspiAlways disinfect the concentrate aspiAlways disinfect the concentrate aspiration tubes.ration tubes.ration tubes.ration tubes.

Do not use the chemical agent AMUSAFE any longer.Do not use the chemical agent AMUSAFE any longer.Do not use the chemical agent AMUSAFE any longer.Do not use the chemical agent AMUSAFE any longer.

CAUTIONCAUTIONCAUTIONCAUTION A disinfection/descaling in progress can never be cancelled nor can the A disinfection/descaling in progress can never be cancelled nor can the A disinfection/descaling in progress can never be cancelled nor can the A disinfection/descaling in progress can never be cancelled nor can the chemical agent or the selected type be modified.chemical agent or the selected type be modified.chemical agent or the selected type be modified.chemical agent or the selected type be modified.


formula provides for the following disinfection/cleaning programs: • Chemical standard

• Chemical-full (this cycle involves the whole fluid pathway, including the heating tank)

• Chemical-heat

• Heat (inlet water is heated to 98°C in the heating container, guaranteeing an average temperature of 85°C in the fluid pathway, without recirculation, for 15-20 minutes).

• Centralized disinfection/cleaning with the possibility to intake the chemical agent or hot water directly from the dialysis centre water distribution system.

REMEMBER:REMEMBER:REMEMBER:REMEMBER:

• Each time a disinfection/cleaning program is entered, the parameters set during configuration are displayed.

• If disinfection/cleaning is interrupted by turning off the machine with the main rear switch, when it is turned on again, the program runs the tests and then restarts from the point of interruption.

formula carries out a triple control: conductimetric, volumetric and thermal, in order to guarantee proper conduction of the disinfection/cleaning method selected. In case of faults, the equipment warns the user.

ICON OF DISINFECTED/CLEANEICON OF DISINFECTED/CLEANEICON OF DISINFECTED/CLEANEICON OF DISINFECTED/CLEANED MACHINED MACHINED MACHINED MACHINE

If the parameter “Disinfection/cleaning icon available in rinsing” has been set to ON during configuration, the icon changes according to the following criteria: Once the program STD. DISINFECTION/CLEANING, or COMPLETE FULL DISINFECTION/CLEANING, or CHEMICAL HEAT DISINFECTION/CLEANING, or CHEMICAL HEAT DESCALING, or HEAT DISINFECTION or CENTRALIZED HEAT

DISINFECTION/ HEAT SPECIAL has been run, the icon indicates that the

program has been successfully completed. On the contrary, if the icon appears, it means that the program has not been performed correctly.


It is responsibility of the user to run a new dialysis treatment only when the It is responsibility of the user to run a new dialysis treatment only when the It is responsibility of the user to run a new dialysis treatment only when the It is responsibility of the user to run a new dialysis treatment only when the

icon icon icon icon is present and the program run was not a simple descaling but a is present and the program run was not a simple descaling but a is present and the program run was not a simple descaling but a is present and the program run was not a simple descaling but a disinfection performed widisinfection performed widisinfection performed widisinfection performed with a suitable agent. th a suitable agent. th a suitable agent. th a suitable agent.

In case of centralized programs (CHEMICAL/CHEMICAL SPECIAL and HEAT

WASHING/HEAT WASHING SPECIAL), the icons and do not refer to the


program just completed. This means that the displayed icon will remain as it was before the program. To know the date and type of the last performed disinfection/cleaning, enter the

help on line and press the key

parameters disinf./clean.

.


STANDARD CHEMICAL DISTANDARD CHEMICAL DISTANDARD CHEMICAL DISTANDARD CHEMICAL DISINFECTION/CLEANINGSINFECTION/CLEANINGSINFECTION/CLEANINGSINFECTION/CLEANING

In standard chemical disinfection/cleaning a specific chemical solution is aspirated and circulated through the fluid pathway, between the concentrate aspiration point and the drain with the exception of the heating tank. the heating tank. the heating tank. the heating tank.

PARAMETERS OF STD. CPARAMETERS OF STD. CPARAMETERS OF STD. CPARAMETERS OF STD. CHEMICAL DISINFECTIONHEMICAL DISINFECTIONHEMICAL DISINFECTIONHEMICAL DISINFECTION/CLEANING /CLEANING /CLEANING /CLEANING

DISINFECTIONDISINFECTIONDISINFECTIONDISINFECTION

Chemical Chemical Chemical Chemical

agentsagentsagentsagents

DilutionDilutionDilutionDilution CoCoCoConsumptionsumptionsumptionsumption (cc)n (cc)n (cc)n (cc)

Contact time Contact time Contact time Contact time (min)(min)(min)(min)

(configurable)(configurable)(configurable)(configurable)

Rinsing time Rinsing time Rinsing time Rinsing time (min)(min)(min)(min)

(configurable)(configurable)(configurable)(configurable)

Total durationTotal durationTotal durationTotal duration

(min)(min)(min)(min)

Sodium

hypochlorite

>7%

1:30 ∼ 90 ∼ 120

7

11

25 or 30

30

32 or 37

41

Peresal 1:30 ∼ 90 ∼ 120

7

11

25 or 30

30

32 or 37

41

Amuchina 1:6 ∼ 250 ∼ 400

6

10

25 or 30

30

31 or 36

41

Tiutol 1:30 ∼ 90 ∼ 120

7

11

25 or 30

30

32 or 37

41

Instrunet 1:6 ∼ 250 ∼ 400

6

10

25 or 30

30

31 or 36

40

Puristeril 1:30 ∼ 90 ∼ 120

7

11

25 or 30

30

32 or 37

41

Oxagal 1:6 ∼ 250 ∼ 400

6

10

25 or 30

30

31 or 36

40

Renaxid 1:30 ∼ 90 ∼ 120

7

11

25 or 30

30

32 or 37

41

WARNINGWARNINGWARNINGWARNING ““““>>>>7%7%7%7% Sodium hyp Sodium hyp Sodium hyp Sodium hypochlorite” is any Medical Device whose composition is ochlorite” is any Medical Device whose composition is ochlorite” is any Medical Device whose composition is ochlorite” is any Medical Device whose composition is based on sodium hypochlorite with based on sodium hypochlorite with based on sodium hypochlorite with based on sodium hypochlorite with >>>>7%7%7%7% concentrati concentrati concentrati concentration.on.on.on.

DESCALINGDESCALINGDESCALINGDESCALING

Acetic acid

10%

1:6 ∼ 250 ∼ 400

6

10

25 or 30

30

31 or 36

40

WARNINGWARNINGWARNINGWARNING “10%Acetic acid” is any suitable solution made of acetic acid with 10% “10%Acetic acid” is any suitable solution made of acetic acid with 10% “10%Acetic acid” is any suitable solution made of acetic acid with 10% “10%Acetic acid” is any suitable solution made of acetic acid with 10% concentration.concentration.concentration.concentration.


USER PROGRAMUSER PROGRAMUSER PROGRAMUSER PROGRAM

User According to the preset values

WARNINGWARNINGWARNINGWARNING If the USER program has been selected, the user must check that a Medical If the USER program has been selected, the user must check that a Medical If the USER program has been selected, the user must check that a Medical If the USER program has been selected, the user must check that a Medical DevicDevicDevicDevice is being used. The manufacturer will not guarantee machine e is being used. The manufacturer will not guarantee machine e is being used. The manufacturer will not guarantee machine e is being used. The manufacturer will not guarantee machine disinfection or descaling, nor rinse efficacy.disinfection or descaling, nor rinse efficacy.disinfection or descaling, nor rinse efficacy.disinfection or descaling, nor rinse efficacy.

CHEMICAL FULL DISINFECTION/CLEANINGCHEMICAL FULL DISINFECTION/CLEANINGCHEMICAL FULL DISINFECTION/CLEANINGCHEMICAL FULL DISINFECTION/CLEANING

In chemical full disinfection/cleaning a specific chemical solution is aspirated, circulated and eventually dwelt inside the entire fluid pathway, including the heating tank, but with the exception of the water inlet section. Dwell of the chemical agent is allowed only if DIALOX or OXAGAL are used.

PARAMETERS OF CHEMICPARAMETERS OF CHEMICPARAMETERS OF CHEMICPARAMETERS OF CHEMICALALALAL----FULL DISINFECTION/CLFULL DISINFECTION/CLFULL DISINFECTION/CLFULL DISINFECTION/CLEANINGEANINGEANINGEANING

Chemical Chemical Chemical Chemical agenagenagenagentstststs

DilutionDilutionDilutionDilution ConsumptioConsumptioConsumptioConsumption (cc)n (cc)n (cc)n (cc)

Intake + Intake + Intake + Intake + Contact time Contact time Contact time Contact time


Dwell time Dwell time Dwell time Dwell time configurableconfigurableconfigurableconfigurable

(h)(h)(h)(h)

Rinsing timeRinsing timeRinsing timeRinsing time

configurableconfigurableconfigurableconfigurable


Total Total Total Total timetimetimetime


Sodium

hypochlorite

>7%

1:30 ∼ 45 8 - 23 or 33 31 or 41

Peresal 1:30 ∼ 45 8

- 23 or 33 31 or 41

Amuchina 1:6 ∼ 180 8

- 23 or 33 31 or 41

Dialox

+ dwell

time

1:6 ∼ 180 ∼ 250

8

12

80 max.

23 or 33

23 or 33

31 or 41

35 or 45

+ dwell

time

Oxagal

+ dwell

time

1:6 ∼ 180

8

80 max.

23 or 33

31 or 41

Instrunet 1:6 ∼ 180 8

- 23 or 33 31 or 41

Renaxid 1:30 ∼ 45 8 - 23 or 33 31 or 41

WARNINGWARNINGWARNINGWARNING ““““>>>>7%7%7%7% Sodium hypochlorite” is any Medical Device whose comp Sodium hypochlorite” is any Medical Device whose comp Sodium hypochlorite” is any Medical Device whose comp Sodium hypochlorite” is any Medical Device whose composition is osition is osition is osition is based on sodium hypochlorite with based on sodium hypochlorite with based on sodium hypochlorite with based on sodium hypochlorite with >>>>7%7%7%7% conc conc conc concentration.entration.entration.entration.


USER PROGRAMUSER PROGRAMUSER PROGRAMUSER PROGRAM


WARNINGWARNINGWARNINGWARNING If the USER program has been selected, tIf the USER program has been selected, tIf the USER program has been selected, tIf the USER program has been selected, the user must check that a Medical he user must check that a Medical he user must check that a Medical he user must check that a Medical Device is being used. The manufacturer will not guarantee machine Device is being used. The manufacturer will not guarantee machine Device is being used. The manufacturer will not guarantee machine Device is being used. The manufacturer will not guarantee machine disinfection or descaling, nor rinse efficacy.disinfection or descaling, nor rinse efficacy.disinfection or descaling, nor rinse efficacy.disinfection or descaling, nor rinse efficacy.

CHEMICAL HEAT DISINFECTION/CLEANING CHEMICAL HEAT DISINFECTION/CLEANING CHEMICAL HEAT DISINFECTION/CLEANING CHEMICAL HEAT DISINFECTION/CLEANING

Chemical heat disinfection/cleaning combines the properties of heat with the characteristics of a specific chemical agent delivered through the entire fluid pathway but with the exception of the water inlet section.

PARAMETERS OF CHEMICPARAMETERS OF CHEMICPARAMETERS OF CHEMICPARAMETERS OF CHEMICALALALAL----HEAT DISINFECTION/CLHEAT DISINFECTION/CLHEAT DISINFECTION/CLHEAT DISINFECTION/CLEANINGEANINGEANINGEANING

Chemical Chemical Chemical Chemical agentsagentsagentsagents

DilutionDilutionDilutionDilution Consumption Consumption Consumption Consumption (cc)(cc)(cc)(cc)

Heating./Heating./Heating./Heating./

aspiraspiraspiraspir. time. time. time. time


configurableconfigurableconfigurableconfigurable

Contact Contact Contact Contact timetimetimetime


Rinsing Rinsing Rinsing Rinsing timetimetimetime


Total Total Total Total duration duration duration duration (min)(min)(min)(min)

Citric

acid 12%

1:6 ∼ 180

15 or 20 3 23 51 or 56


WARNINGWARNINGWARNINGWARNING “Citric acid 12%” is any suitable solution made of critic acid with “Citric acid 12%” is any suitable solution made of critic acid with “Citric acid 12%” is any suitable solution made of critic acid with “Citric acid 12%” is any suitable solution made of critic acid with 12%12%12%12%.concentration. .concentration. .concentration. .concentration. If the USER program has been selected, the user must check that a Medical If the USER program has been selected, the user must check that a Medical If the USER program has been selected, the user must check that a Medical If the USER program has been selected, the user must check that a Medical Device is being used. The manufacturer will not Device is being used. The manufacturer will not Device is being used. The manufacturer will not Device is being used. The manufacturer will not however however however however guarantee the guarantee the guarantee the guarantee the machine disinfection or descaling, nor the rinse efficacy.machine disinfection or descaling, nor the rinse efficacy.machine disinfection or descaling, nor the rinse efficacy.machine disinfection or descaling, nor the rinse efficacy. Pay attention in selecting the chePay attention in selecting the chePay attention in selecting the chePay attention in selecting the chemical agent: it must be compatible with mical agent: it must be compatible with mical agent: it must be compatible with mical agent: it must be compatible with high temperatures.high temperatures.high temperatures.high temperatures. If chemical heat descaling is programmed in error and citric acid or user If chemical heat descaling is programmed in error and citric acid or user If chemical heat descaling is programmed in error and citric acid or user If chemical heat descaling is programmed in error and citric acid or user chemical agent are unavailable, use water only. Wait for the program to end chemical agent are unavailable, use water only. Wait for the program to end chemical agent are unavailable, use water only. Wait for the program to end chemical agent are unavailable, use water only. Wait for the program to end and then select a new descaling cycle.and then select a new descaling cycle.and then select a new descaling cycle.and then select a new descaling cycle.


HEAT HEAT HEAT HEAT DISINFECTIONDISINFECTIONDISINFECTIONDISINFECTION

In heat disinfection hot water (temperature greater than 85°C) is circulated through the fluid pathway, with the exception of the water inlet section. The advantage of this program is to combine the gaseous activity due to steam with the efficiency of heat.

KIT FOR INCOMING HOTKIT FOR INCOMING HOTKIT FOR INCOMING HOTKIT FOR INCOMING HOT WATER WATER WATER WATER

The kit for incoming hot water allows formula to draw in hot water for heat disinfection up to 94 °C max. If necessary, contact the authorized technical staff to check if the kit is installed on the dialysis machine. Hot water is allowed to be drawn in only when the machine is not in dialysis mode.

WARNINGWARNINGWARNINGWARNING formula builds in all the necessary alarm systems to prevent the dialysis builds in all the necessary alarm systems to prevent the dialysis builds in all the necessary alarm systems to prevent the dialysis builds in all the necessary alarm systems to prevent the dialysis treatment be executed if the temperature of the incoming water is superior treatment be executed if the temperature of the incoming water is superior treatment be executed if the temperature of the incoming water is superior treatment be executed if the temperature of the incoming water is superior than than than than 40°C.40°C.40°C.40°C. The manufacturer does not undertake any responsibility for possible The manufacturer does not undertake any responsibility for possible The manufacturer does not undertake any responsibility for possible The manufacturer does not undertake any responsibility for possible damages caused by use of waterdamages caused by use of waterdamages caused by use of waterdamages caused by use of water to temperatures higher than 94 to temperatures higher than 94 to temperatures higher than 94 to temperatures higher than 94°°°°CCCC and/or and/or and/or and/or pressure superior than 7.5 bars.pressure superior than 7.5 bars.pressure superior than 7.5 bars.pressure superior than 7.5 bars. The manufacturer does not undertake any responsibility for possible The manufacturer does not undertake any responsibility for possible The manufacturer does not undertake any responsibility for possible The manufacturer does not undertake any responsibility for possible damages damages damages damages caused by incorrect connection of caused by incorrect connection of caused by incorrect connection of caused by incorrect connection of formula to the water to the water to the water to the water distribution plant, whether for the materials used, or for the lengths of the distribution plant, whether for the materials used, or for the lengths of the distribution plant, whether for the materials used, or for the lengths of the distribution plant, whether for the materials used, or for the lengths of the pipes, or for height of the drain from ground.pipes, or for height of the drain from ground.pipes, or for height of the drain from ground.pipes, or for height of the drain from ground.

CENTRALISED DISINFECCENTRALISED DISINFECCENTRALISED DISINFECCENTRALISED DISINFECTION/CLEANINGTION/CLEANINGTION/CLEANINGTION/CLEANING

Centralised disinfection/cleaning entails circulating a chemical agent or water in the fluid pathway of the machine at the same time as the dialysis centre water distribution system is being disinfected. formula provides for the following centralized disinfection/cleaning programs:

• chemical

• heat washing

• heat disinfection

• chemical special

• heat washing special

• heat disinfection special

The “special” programs were suitably designed for those dialysis centres in which the machine receives water to a temperature superior than 50°C at start-up.


Dwell of the chemical agent may be set for every program of centralized disinfection/cleaning. Before carrying out centralised disinfection/cleaning, remove the MULTIPURE filter to avoid damaging it (for further information, please contact Post Sales Department). To remove the Multipure filter, follow the directions described in the chapter “Management of ultrafilters and Multipure filter” of this user manual. When the program is over, reposition the MULTIPURE filter.

CENTRALIZED CHEMICALCENTRALIZED CHEMICALCENTRALIZED CHEMICALCENTRALIZED CHEMICAL/CHEMICAL SP/CHEMICAL SP/CHEMICAL SP/CHEMICAL SPECIALECIALECIALECIAL

The machine receives a solution of water and chemical agent from the dialysis centre water distribution system. The water inlet tubes are flushed with flows at 300 ml/min. The chemical agents used in the centralised chemical programs and their concentrations are not controlled by the machine; the operator must ensure that the chemical agents used and their concentrations correspond to those indicated for the chemical full disinfection/cleaning. The effectiveness of the following rinsing cycle is only guaranteed if the rinse times established for each type of chemical agent are observed and if the water used contains no chemical agents. However, it is operator’s responsibility to verify conformity of the water used for rinsing.

CENTRALIZED HEAT WASCENTRALIZED HEAT WASCENTRALIZED HEAT WASCENTRALIZED HEAT WASHING/HEAT WASHING SPHING/HEAT WASHING SPHING/HEAT WASHING SPHING/HEAT WASHING SPECIALECIALECIALECIAL

The machine receives hot water from the dialysis centre water distribution system. The water inlet tubes are flushed with flows at 300 ml/min.


The programs CENTRALIZED CHEMICAL/CHEMICAL SPECIALS and HEAT The programs CENTRALIZED CHEMICAL/CHEMICAL SPECIALS and HEAT The programs CENTRALIZED CHEMICAL/CHEMICAL SPECIALS and HEAT The programs CENTRALIZED CHEMICAL/CHEMICAL SPECIALS and HEAT WASHING/HEAT WASWASHING/HEAT WASWASHING/HEAT WASWASHING/HEAT WASHING SPECIAL are HING SPECIAL are HING SPECIAL are HING SPECIAL are ADDITIONAL proceduresADDITIONAL proceduresADDITIONAL proceduresADDITIONAL procedures and DO NOT and DO NOT and DO NOT and DO NOT substitute machine disinfection.substitute machine disinfection.substitute machine disinfection.substitute machine disinfection.

Therefore, it is recommended to execute another disinfecting cycle by Therefore, it is recommended to execute another disinfecting cycle by Therefore, it is recommended to execute another disinfecting cycle by Therefore, it is recommended to execute another disinfecting cycle by selecting one of those available on selecting one of those available on selecting one of those available on selecting one of those available on formula ....

CENTRALIZED HEAT DISCENTRALIZED HEAT DISCENTRALIZED HEAT DISCENTRALIZED HEAT DISINFECTION/HEAT DISININFECTION/HEAT DISININFECTION/HEAT DISININFECTION/HEAT DISINFECTION FECTION FECTION FECTION SPECIASPECIASPECIASPECIALLLL

The machine receives hot water from the dialysis centre water distribution system. Water is later warmed to 90-95°C inside the machine.


MANUAL SETTINGMANUAL SETTINGMANUAL SETTINGMANUAL SETTING


manual disinf./clean.

from the main menu. The following window appears:

Select the type of disinfection/cleaning desired with the relevant function key.


DISINFECTING/CLEANINDISINFECTING/CLEANINDISINFECTING/CLEANINDISINFECTING/CLEANING PROCEDUREG PROCEDUREG PROCEDUREG PROCEDURE

Each time a disinfection/cleaning program is entered (Chemical standard, Chemical Full, Chemical Heat, Heat, Centralized), the selection is automatically set on the parameters fixed during configuration. If the parameters are not the ones desired, modify them by selecting them one at a time. The function and the field of the parameter selected turn light blue. Grey fields indicate parameters which may not be set.

Use the and keys to make the changes.

For instance, after pressing

water inlet tube

, the following window will appear:

disinf./clean. type

Indicates the type of disinfection/cleaning selected.

agent

To select the chemical agent or the type of centralized disinfection/cleaning.

start time

To display the starting time of the program.

disinf./clean. time

In centralized disinfection/cleaning – chemical and heat washing: sets the duration of the aspiration of the chemical agent or hot water from the plant. If NO WATER is selected, the aspiration phase ends when the NO WATER alarm message appears and remains at least 1 minute on the display.

In all other programs: displays the total duration of the program.


rinsing time

Not available in the disinfection/cleaning program which does not allow dwell of chemical agent. In full-chemical and centralized disinfection/cleaning: sets automatic machine switching on after dwell of the chemical agent. Should the machine be switched on before the set time, then the following window is displayed:

In chemical full disinfection with DIALOX or OXAGAL, this field may be left void (digit - -). Rinsing will start immediately after aspiration of the chemical agent, without dwell. This field may be left void also in centralized disinfection/cleaning (digit - -). In such condition, the machine will remain on after aspiration of the chemical agent and will wait for a confirmation from the operator. When the aspiration phase is completed, a window displays the message:

automatic off

To set automatic machine turning off at the end of disinfection/cleaning (enabled/disabled). The time for machine turn off can be set only in centralized disinfection/cleaning. This setting allows the operator to extend the minimum rinsing time.

Once the desired parameters have been set, ok

to start disinfection/cleaning. Check if the container of the chemical agent has already been connected, provided it is required for the selected program.

return to cancel the operations executed and return to the main menu.

Ensure there are no chemical agents Ensure there are no chemical agents Ensure there are no chemical agents Ensure there are no chemical agents

and control temperature in the water supply and control temperature in the water supply and control temperature in the water supply and control temperature in the water supply systemsystemsystemsystem

and then and then and then and then

press 'continue' to start rinsingpress 'continue' to start rinsingpress 'continue' to start rinsingpress 'continue' to start rinsing

DwelDwelDwelDwelling phase. ling phase. ling phase. ling phase. Ensure there are no chemical agents and Ensure there are no chemical agents and Ensure there are no chemical agents and Ensure there are no chemical agents and control temperature in the water supply control temperature in the water supply control temperature in the water supply control temperature in the water supply

system"system"system"system" Press Press Press Press 'OK''OK''OK''OK' to anticipate to anticipate to anticipate to anticipate rinsing. rinsing. rinsing. rinsing.


The following data will appear on the display:

type of disinfection/cleaning

chemical agent selected

water temperature reached in the container

duration of the disinfection/cleaning: yellow sector =aspiration /heating time blue sector = rinsing/cooling time

In this phase the following functions are active:

second disinf./clean.

To set a second disinfection/cleaning which will start when the one in progress has ended. The procedure is identical to that previously described:

• Select the type of disinfection/cleaning.

• Set the parameters if different from the default values.

• Connect the container of the chemical agent (perform this operation only after the agent used for the first disinfection/cleaning has completely been aspirated – the second sector of the circle is blue) .

• ok

.

• The second disinfection/cleaning will start as soon as the one in progress has ended; it may be cancelled on the condition that intake of the chemical agent has not started. To cancel,

cancel 2nd disinf./clean.

.

NOTENOTENOTENOTE Dwell time of the chemical agent cannot be set for the second Dwell time of the chemical agent cannot be set for the second Dwell time of the chemical agent cannot be set for the second Dwell time of the chemical agent cannot be set for the second disidisidisidisinfection/cleaning if priming of the blood lines has started.nfection/cleaning if priming of the blood lines has started.nfection/cleaning if priming of the blood lines has started.nfection/cleaning if priming of the blood lines has started.

selectpriming

To prime the blood lines.

enableswitch off

To enable the automatic off function if not previously done. The message « Automatic OFF » warns the operator that the function has been activated. Switching off is ignored in the following cases:

• when a second disinfection/cleaning has been programmed. If


the machine is to be switched off after the second disinfection/cleaning, the machine switches off as a consequence of the second setting.

• when priming of the blood lines has been set.

When the second disinfection/cleaning or priming is cancelled, automatic off is reset. If the disinfection/cleaning program is not completed successfully, the programmed “automatic off” remains active: the machine switches off, but when it is switched on again, the operator is warned that disinfection/cleaning has not been carried out (the icon

appears).

sensors

To enable the sensor menu.

USER CUSER CUSER CUSER CHEMICAL AGENTHEMICAL AGENTHEMICAL AGENTHEMICAL AGENT

As “USER chemical agent” it is meant the use of a different agent from those listed for any type of disinfection/cleaning. For a correct use of the USER chemical agent: - during configuration set appropriate operation parameters (dilution ratio, rinse

time, minimum and maximum conductivity) - check that no residues of chemical agent are present in the machine or in the

dialysis fluid before dialysing the patient. The use of the USER chemical agent can be activated/deactivated during the machine configuration carried out by technicians authorized by the manufacturer.


USING THE ULTRAFILTEUSING THE ULTRAFILTEUSING THE ULTRAFILTEUSING THE ULTRAFILTERS FORCLEAN RS FORCLEAN RS FORCLEAN RS FORCLEAN

Guidelines for the disinfection/cleaning cycles and the chemical agents tested to be used with the new ultrafilters FORCLEAN:

PROGRAMPROGRAMPROGRAMPROGRAM

CHEMCHEMCHEMCHEMICALICALICALICAL

AGENT AGENT AGENT AGENT

DILUTIONDILUTIONDILUTIONDILUTION

TEMP.TEMP.TEMP.TEMP.

(°C)(°C)(°C)(°C)

(in the (in the (in the (in the container)container)container)container)

QUANTITY QUANTITY QUANTITY QUANTITY ASPIRATEDASPIRATEDASPIRATEDASPIRATED

(ml)(ml)(ml)(ml)

MINIMUMMINIMUMMINIMUMMINIMUM DURATION DURATION DURATION DURATION (min)(min)(min)(min)

CHEMICALCHEMICALCHEMICALCHEMICAL

HYPOCHLOR.

>7%

AMUCHINA

PERESAL

OXAGAL

TIUTOL

HD INSTRUNET

RENAXID

PURISTERIL

Acetic Acid 10%

(descaling)

1 : 30

1 : 6

1 : 30

1 : 6

1: 30

1 : 6

1: 30

1: 30

1 : 6

38

90

250

90

250

90

250

90

90

250

31

CHEMICAL FULLCHEMICAL FULLCHEMICAL FULLCHEMICAL FULL HYPOCHLOR.

>7%

AMUCHINA

PERESAL

OXAGAL

TIUTOL

HD INSTRUNET

RENAXID

DIALOX

1 : 30

1 : 6

1 : 30

1 : 6

1 : 30

1 : 6

1 : 30

1 : 6

38

45

166

45

180

45

166

45

166

31

DWELL TIMEDWELL TIMEDWELL TIMEDWELL TIME DIALOX

OXAGAL

1 : 6

1 : 6

38

38

250

250

35 + 80 h

35 + 80 h

HEATHEATHEATHEAT NONE

- 98 - 30

CHEMICAL HEATCHEMICAL HEATCHEMICAL HEATCHEMICAL HEAT CITRIC ACID

12%

descaling

1 : 6 98 166 51

ENG – Ed. 05/08 ch. 9.2 - Weekly disinfection/cleaning - 1 of 4

9.9.9.9. 2 WEEKLY DISINFECTION/CLEANING 2 WEEKLY DISINFECTION/CLEANING 2 WEEKLY DISINFECTION/CLEANING 2 WEEKLY DISINFECTION/CLEANING


Weekly disinfection/cleaning allows programming a disinfection/cleaning for each day of the week. The parameters are set in the configuration menu and are repeated week after week, unless modified by the operator. The weekly disinfection/cleaning cycles are identical to those of manual disinfection/cleaning (Chemical std., Chemical-full, Chemical-Heat, Heat, Centralized), use the same chemical agents, aspiration times, etc. Refer to the instructions included in chapter 9.1 for further details.

This icon reminds the operator that at least one disinfection/cleaning has been programmed for the week.

This icon indicates that no disinfection/cleaning has been programmed.

It is recommended to set the daily disinfection/cleaning far from the normal dialysis session. Once the weekly program has been set, every day the machine automatically switches on 10 minutes before the time fixed for the disinfection/cleaning program and runs the initial tests. The operator is prompted whether he/she intends to cancel the disinfection/cleaning procedure.

yes

to cancel the procedure or wait for the tests to be completed and the start of disinfection/cleaning. Only in the special programs of centralized disinfection/cleaning (chemical special, heat washing special, heat disinfection special) the machine switches on at the fixed time and does not run any tests. The essential conditions for automatic switching ON of the machine are the following:

- the power cable must be connected to the power outlet.

- the main switch must be in the on position “I”.

- the machine is connected to a haemodialysis water source, the distribution plant is working and the tap is open.

- the yellow connector is connected to the disinfectant intake tube placed in the tank of the disinfecting agent.

No modification can be made in the 10 minutes prior the start of the programmed disinfection/cleaning. Any modification becomes definitive, if the parameters are changed in the configuration of the machine. On the contrary, the modification will be valid only that day.

2 of 4 – ch. 9.2 - Weekly disinfection/cleaning ENG – Ed. 05/08

DISINFECTING/CLEANINDISINFECTING/CLEANINDISINFECTING/CLEANINDISINFECTING/CLEANING PROCEDUREG PROCEDUREG PROCEDUREG PROCEDURE

To enter the weekly disinfection/cleaning program,

disinfection/ cleaning

and


in the main menu.

Select the desired day with the or key and ok

to confirm.

Each time the daily disinfection/cleaning program is entered, the selection is automatically set on the parameters fixed during configuration. If the parameters are not the desired ones, modify them by selecting them one at a time. The function and the field of the parameter selected turn light blue.

Use the and keys to make the changes.

disinf./clean. type

Indicates the type of disinfection/cleaning selected.

agent

Selects the chemical agent or the type of centralized disinfection/cleaning.

start time

Sets the starting time of disinfection/cleaning.

disinf./clean. time

In centralized disinfection/cleaning – chemical and heat washing: sets the duration of the aspiration of the chemical agent or hot water from the distribution plant. If NO WATER is selected, the aspiration phase ends when the NO WATER alarm message appears and remains at least 1 minute on the display.

ENG – Ed. 05/08 ch. 9.2 - Weekly disinfection/cleaning - 3 of 4

In all other programs different from centralized disinfection/cleaning: displays the total duration of the program.

rinsing time

Not available in the disinfection/cleaning cycles in which dwell of the chemical agent is not allowed. In full-chemical and centralized disinfection/cleaning: sets the automatic machine switching on after dwell of chemical agent. Should the machine be switched on before the set time, then the following message is displayed:

In chemical full disinfection/cleaning with DIALOX or OXAGAL, this field may be left void (digit - -). Rinsing will start immediately after aspiration of the chemical agent, without dwell. This field may be left void also in centralized disinfection/cleaning (digit - -). In such condition, the machine will remain on after aspiration of the chemical agent and will wait for a confirmation from the operator. When the aspiration phase is completed, a window displays the message:

automatic off

Sets automatic switching off at the end of disinfection/cleaning (enabled/disabled). Switching off time can be set only in centralized disinfection/cleaning. This setting allows the operator to extend the minimum rinsing time.

Ensure there are no chemical agents Ensure there are no chemical agents Ensure there are no chemical agents Ensure there are no chemical agents

and coand coand coand control temperature in the water supply ntrol temperature in the water supply ntrol temperature in the water supply ntrol temperature in the water supply systemsystemsystemsystem

and then and then and then and then

press 'continue' to start rinsingpress 'continue' to start rinsingpress 'continue' to start rinsingpress 'continue' to start rinsing

Dwelling phase. Dwelling phase. Dwelling phase. Dwelling phase. Ensure there are no chemical agents and Ensure there are no chemical agents and Ensure there are no chemical agents and Ensure there are no chemical agents and control temperature in the water supply control temperature in the water supply control temperature in the water supply control temperature in the water supply

system"system"system"system" Press 'OK' to anticipate rinsing.Press 'OK' to anticipate rinsing.Press 'OK' to anticipate rinsing.Press 'OK' to anticipate rinsing.

4 of 4 – ch. 9.2 - Weekly disinfection/cleaning ENG – Ed. 05/08

CANCELLING THE PROGRCANCELLING THE PROGRCANCELLING THE PROGRCANCELLING THE PROGRAMMED DISINFECTION/CAMMED DISINFECTION/CAMMED DISINFECTION/CAMMED DISINFECTION/CLEANING LEANING LEANING LEANING

To permanently cancel the disinfection/cleaning programmed for a certain To permanently cancel the disinfection/cleaning programmed for a certain To permanently cancel the disinfection/cleaning programmed for a certain To permanently cancel the disinfection/cleaning programmed for a certain day (e.g. Mondays) the machine configuration must be modified (see chapter day (e.g. Mondays) the machine configuration must be modified (see chapter day (e.g. Mondays) the machine configuration must be modified (see chapter day (e.g. Mondays) the machine configuration must be modified (see chapter “Configuration”). “Configuration”). “Configuration”). “Configuration”). There are conditions where the disinfection/cleaning programmed for a certain day is automatically cancelled, and others where the operator can intervene to cancel it. Disinfection/cleaning is automatically cancelled:Disinfection/cleaning is automatically cancelled:Disinfection/cleaning is automatically cancelled:Disinfection/cleaning is automatically cancelled:

• if the tests fail after automatic switching on;

• if the machine is in dialysis or disinfection/cleaning 10 minutes before the set time.

To cancel disinfection/cleaning:To cancel disinfection/cleaning:To cancel disinfection/cleaning:To cancel disinfection/cleaning:

-

yes

when the window with the specific prompt appears (i.e. 10 minutes before the start of the program);

- by setting the starting time to “--:--”. To do this,


.

The disinfection/cleaning will be cancelled for that day (e.g. Monday), but the following Monday will be repeated with the configuration values.

ENG – Ed. 06/09 chap. 9.3 - Routine Cleaning and Maintenance - 1 of 4

9.3 9.3 9.3 9.3 ROUTINE CROUTINE CROUTINE CROUTINE CLEANING AND MAINTENANCELEANING AND MAINTENANCELEANING AND MAINTENANCELEANING AND MAINTENANCE

CLEANINGCLEANINGCLEANINGCLEANING

NOTENOTENOTENOTE The operator may not carry out any cleaning or maintenance operation The operator may not carry out any cleaning or maintenance operation The operator may not carry out any cleaning or maintenance operation The operator may not carry out any cleaning or maintenance operation different from those listed. different from those listed. different from those listed. different from those listed. The side panels which allow access to the The side panels which allow access to the The side panels which allow access to the The side panels which allow access to the electronic components may only be opened by technicians authorizelectronic components may only be opened by technicians authorizelectronic components may only be opened by technicians authorizelectronic components may only be opened by technicians authorized by the ed by the ed by the ed by the manufacturer.manufacturer.manufacturer.manufacturer. Refer to the technical manual.Refer to the technical manual.Refer to the technical manual.Refer to the technical manual. Before any maintenance operation, disconnect the power supply by pulling out Before any maintenance operation, disconnect the power supply by pulling out Before any maintenance operation, disconnect the power supply by pulling out Before any maintenance operation, disconnect the power supply by pulling out the plug or turning off the main switch. The hands must be dry when touching the plug or turning off the main switch. The hands must be dry when touching the plug or turning off the main switch. The hands must be dry when touching the plug or turning off the main switch. The hands must be dry when touching the switch or live parts.the switch or live parts.the switch or live parts.the switch or live parts. UNITIZED BODY UNITIZED BODY UNITIZED BODY UNITIZED BODY

The dust which deposits on the external panels and on the screen can be removed with a cloth or soft brush. Any deposits of salt, blood, etc. can be removed with a cloth moistened in a neutral detergent. Never spray detergents directly onto the machine surface or onto components to be cleaned. A certain number of detergents/disinfectants commonly used in dialysis centres have been tested and did not cause any alteration or damage to the keyboards and panels of the machine. These products are therefore recommended.

• ANTISAPRIL Amuchina

• CITROSIL Manetti - Roberts

• Ethyl ALCOHOL

• QUATHOEX B. Braun

• MELSEPT SPRAY B. Braun

• HYGIEN SPRAY B. Braun

In case of using different products, contact the manufacturer to check compatibility.

CAUTIONCAUTIONCAUTIONCAUTION Any liquid spillAny liquid spillAny liquid spillAny liquid spilled on the machine must be removed immediately to prevent ed on the machine must be removed immediately to prevent ed on the machine must be removed immediately to prevent ed on the machine must be removed immediately to prevent penetration into the machine damaging the components.penetration into the machine damaging the components.penetration into the machine damaging the components.penetration into the machine damaging the components. Do not use chemical products containing benzene, acetone, toluene, xylene, Do not use chemical products containing benzene, acetone, toluene, xylene, Do not use chemical products containing benzene, acetone, toluene, xylene, Do not use chemical products containing benzene, acetone, toluene, xylene, iodine or similar solvents. These solutions damage the polyurethane aiodine or similar solvents. These solutions damage the polyurethane aiodine or similar solvents. These solutions damage the polyurethane aiodine or similar solvents. These solutions damage the polyurethane and nd nd nd polystyrene panels.polystyrene panels.polystyrene panels.polystyrene panels.

2 of 4 – chap. 9.3 – Routine Cleaning and Maintenance ENG – Ed. 06/09

BLOOD PUMPSBLOOD PUMPSBLOOD PUMPSBLOOD PUMPS

• Open the pump cover.

• Pull the drive handle outwards.

• Turn the rotor until finding the unhooking point.

• Remove the rotor from the shaft.

• Clean the cover, the pump cup and the rotor rollers with a cloth moistened in disinfectant (see above).

ROUTINE MAINTROUTINE MAINTROUTINE MAINTROUTINE MAINTENANCE (by the authorized technician)ENANCE (by the authorized technician)ENANCE (by the authorized technician)ENANCE (by the authorized technician)

Routine maintenance must be carried out every 3000 hours of operation or every 12 months by personnel or technicians authorized by the manufacturer. Refer to the technical manual for more tips.

REPLACING THE ISOPRENE PLUG IN THE REPLACING THE ISOPRENE PLUG IN THE REPLACING THE ISOPRENE PLUG IN THE REPLACING THE ISOPRENE PLUG IN THE FORMULA FORMULA FORMULA FORMULA PIERCEABLE PIERCEABLE PIERCEABLE PIERCEABLE SAMPLING VALVE SAMPLING VALVE SAMPLING VALVE SAMPLING VALVE

Use the isoprene plug only in the formula pierceable sampling valve. The isoprene plug must periodically be replaced since the successive perforations with the needle damage it and compromise its integrity over time. The plug must be replaced every 6 perforations by paramedical or technical staff. For replacement follow the procedure below:

1. Turn off formula

2. Unscrew the valve cap. 3. Remove the worn isoprene plug and discard it in a container for hospital waste. 4. Insert a new isoprene plug in the valve cap taking care to insert it properly (the plug is a small cylinder which is pressure-fitted into the cylindrical housing of the cap).

5. Screw on the valve cap until it fits against the valve body. 6. Turn on formula and run a disinfection program. WARNINGSWARNINGSWARNINGSWARNINGS The following human errorsThe following human errorsThe following human errorsThe following human errors:::: ---- iiiimpropermpropermpropermproper insertion of the plug in the valve c insertion of the plug in the valve c insertion of the plug in the valve c insertion of the plug in the valve capapapap ---- cap not or not fully screwed down onto the valve bodycap not or not fully screwed down onto the valve bodycap not or not fully screwed down onto the valve bodycap not or not fully screwed down onto the valve body ---- number of perforations excenumber of perforations excenumber of perforations excenumber of perforations exceedingedingedingeding that that that that permittedpermittedpermittedpermitted (max. 6) (max. 6) (max. 6) (max. 6) ---- failfailfailfailure toure toure toure to execut execut execut executeeee disinfection after replac disinfection after replac disinfection after replac disinfection after replacing the pluging the pluging the pluging the plug may causemay causemay causemay cause:::: ---- the dialysis fluid to leak out with a consequent error in patient weight lossthe dialysis fluid to leak out with a consequent error in patient weight lossthe dialysis fluid to leak out with a consequent error in patient weight lossthe dialysis fluid to leak out with a consequent error in patient weight loss ---- the chemical agent or hot water to leak out during the disinfection/cleaning the chemical agent or hot water to leak out during the disinfection/cleaning the chemical agent or hot water to leak out during the disinfection/cleaning the chemical agent or hot water to leak out during the disinfection/cleaning cyclecyclecyclecycle ---- bacterial contamination of the hydraulic circuit.bacterial contamination of the hydraulic circuit.bacterial contamination of the hydraulic circuit.bacterial contamination of the hydraulic circuit.

Before starting a treatment or a disinfection/Before starting a treatment or a disinfection/Before starting a treatment or a disinfection/Before starting a treatment or a disinfection/cleaningcleaningcleaningcleaning cycle cycle cycle cycle, , , , always check that always check that always check that always check that no no no no fluid fluid fluid fluid leakleakleakleakssss from the sampling valve from the sampling valve from the sampling valve from the sampling valve....

ENG – Ed. 06/09 chap. 9.3 - Routine Cleaning and Maintenance - 3 of 4

DDDDestroy the used plugs estroy the used plugs estroy the used plugs estroy the used plugs taking the appropriate measures for potentially taking the appropriate measures for potentially taking the appropriate measures for potentially taking the appropriate measures for potentially contaminated contaminated contaminated contaminated materialmaterialmaterialmaterial.... When handling the sampling valve and plugs, take the necessary and When handling the sampling valve and plugs, take the necessary and When handling the sampling valve and plugs, take the necessary and When handling the sampling valve and plugs, take the necessary and appropriate precautions to prevent any exposure to or transmission of appropriate precautions to prevent any exposure to or transmission of appropriate precautions to prevent any exposure to or transmission of appropriate precautions to prevent any exposure to or transmission of infectious agents, HIV virus and hepatitisinfectious agents, HIV virus and hepatitisinfectious agents, HIV virus and hepatitisinfectious agents, HIV virus and hepatitis....

ORDINARY MAINTENANCE (ORDINARY MAINTENANCE (ORDINARY MAINTENANCE (ORDINARY MAINTENANCE (by the operatorby the operatorby the operatorby the operator))))

DESCALINGDESCALINGDESCALINGDESCALING

To prevent scaling resulting from the delayed precipitation of calcium carbonates, it is

advisable to clean the hydraulic circuit with acetic acid at least twice a week. Descaling

with acetic and citric acid is included in the heat and cold descaling program,

respectively.

MACHINE DISCONNECTIONMACHINE DISCONNECTIONMACHINE DISCONNECTIONMACHINE DISCONNECTION

Before removing the machine from the dialysis room to transfer it to another place or to store it, perform a rinsing cycle and then carry out the following operations:

switch off

.

CAUTIONCAUTIONCAUTIONCAUTION Before turning off the Before turning off the Before turning off the Before turning off the machine using the main switch on the back, wait for the machine using the main switch on the back, wait for the machine using the main switch on the back, wait for the machine using the main switch on the back, wait for the automatic power off controlled from the operator interface.automatic power off controlled from the operator interface.automatic power off controlled from the operator interface.automatic power off controlled from the operator interface. The machine must never be turned off directly at the main rear switch.The machine must never be turned off directly at the main rear switch.The machine must never be turned off directly at the main rear switch.The machine must never be turned off directly at the main rear switch. A message appears asking for confirmation that you want to turn off.

yes to confirm.

To drain the water from the hydraulic circuit

drain on

• Wait for the machine to turn off automatically and set the main rear switch to the “O” (OFF) position.

• Disconnect the mains cable and the equipotential cable (if present) from the power outlet.

• Close the water delivery tube and disconnect the water inlet tube.

• Disconnect the drain tube.

4 of 4 – chap. 9.3 – Routine Cleaning and Maintenance ENG – Ed. 06/09

• Remove the wheel block.

• Move the machine by pushing it from behind.

ENG – Ed. 05/08 chap. 9.4 – Management of ultrafilters and Multipure - 1 of 4

9.4 MANAGEMENT9.4 MANAGEMENT9.4 MANAGEMENT9.4 MANAGEMENT OF ULTRAFILTERS AND MULTIPURE OF ULTRAFILTERS AND MULTIPURE OF ULTRAFILTERS AND MULTIPURE OF ULTRAFILTERS AND MULTIPURE

FILTER FILTER FILTER FILTER

formula® is equipped with filters which operate simultaneously to prevent bacterial contamination and to prevent pyrogenic substances from entering the dialysate. The FORCLEAN ultrafilter is an apyrogenic ultrafilter in Medisulfone placed after the dialysis fluid preparation point and before the dialyser. By filtering the dialysis fluid, the filters retain bacteria and adsorb endotoxins emerging from concentrated solutions and/or from inside the machine. This ultrafilter is disinfected with the machine. The ultrafilter is manufactured in two models Forclean Plus and Forclean I. The FORCLEAN I ultrafilter is equipped with a transponder which, by means of the Lector system, allows the machine to identify the ultrafilter (code) and the actual run time.

NOTENOTENOTENOTE The Therapy model is equipped with two Forclean ultrafilters in sequence, The Therapy model is equipped with two Forclean ultrafilters in sequence, The Therapy model is equipped with two Forclean ultrafilters in sequence, The Therapy model is equipped with two Forclean ultrafilters in sequence, which must be checked for integrity before each treatment.which must be checked for integrity before each treatment.which must be checked for integrity before each treatment.which must be checked for integrity before each treatment.

WARNINGWARNINGWARNINGWARNING The FORCLEAN ultrafilter must be replaced after a maximum number of The FORCLEAN ultrafilter must be replaced after a maximum number of The FORCLEAN ultrafilter must be replaced after a maximum number of The FORCLEAN ultrafilter must be replaced after a maximum number of dialysis dialysis dialysis dialysis hours as indicated in the instructions for use of the ultrafilterhours as indicated in the instructions for use of the ultrafilterhours as indicated in the instructions for use of the ultrafilterhours as indicated in the instructions for use of the ultrafilter.... On the On the On the On the formula® therapy model, both FORCLEAN filters must be changed at the model, both FORCLEAN filters must be changed at the model, both FORCLEAN filters must be changed at the model, both FORCLEAN filters must be changed at the same time.same time.same time.same time. When the ultrafilter is installed on a machine for the first time, installation When the ultrafilter is installed on a machine for the first time, installation When the ultrafilter is installed on a machine for the first time, installation When the ultrafilter is installed on a machine for the first time, installation must be done by technicians authorized by the manufacturer, since the must be done by technicians authorized by the manufacturer, since the must be done by technicians authorized by the manufacturer, since the must be done by technicians authorized by the manufacturer, since the machine has to be reconfigured.machine has to be reconfigured.machine has to be reconfigured.machine has to be reconfigured.

2 of 4 – chap. 9.4 - Management of ultrafilters and Multipure ENG – Ed. 05/08

LECTOR: FORCLEAN I RECOGNITION DEVICELECTOR: FORCLEAN I RECOGNITION DEVICELECTOR: FORCLEAN I RECOGNITION DEVICELECTOR: FORCLEAN I RECOGNITION DEVICE

Lector consists of a reader system built into the filter support which recognises the FORCLEAN I ultrafilter fitted into the formula® plus and formula® therapy machines. formula, taking account of the hours of treatment, advises the operator that it needs to be replaced 20 hours before it expires. Lector has different levels of safety on the basis of which the operator is informed – by means of warnings and/or alarms and/or dialogue windows - on the state of use of the ultrafilter and on any restrictions in the selection of dialysis treatments in the presence of unsuitable ultrafiltrate. These levels may only be set by techincians authorized by the manufacturer on the basis of the requirements of the dialysis centre. If activated, Lector runs a recognition test of the installed Forclean I ultrafilter during the machine tests. This recognition test is automatically repeated each time the

replace FORCLEAN

function has been activated or, after an alarm, when the

FORCLEAN check

function key has been pressed. Lector recognises each time the ultrafilter is replaced, stores the new code recognised and, through the dialogue window, prompts the operator to start the automatic

priming/spilling sequence of the ultrafilter.

filter management

and

replace FORCLEAN

. Counting of the hours elapsed since the last ultrafilter replacement is reset only if this procedure is performed. In the dialogue window two additional parameters are displayed: - time of use of the recognized code (i.e. of the ultrafilter installed)

- time elapsed since the

replace FORCLEAN

key was last pressed.

ENG – Ed. 05/08 chap. 9.4 – Management of ultrafilters and Multipure - 3 of 4

REPLACING ULTRAFILTERS (by the operator)REPLACING ULTRAFILTERS (by the operator)REPLACING ULTRAFILTERS (by the operator)REPLACING ULTRAFILTERS (by the operator)

For Therapy models:For Therapy models:For Therapy models:For Therapy models:

1. Switch off the machine with the main switch on the rear panel.

2. Open the protective cover.

3. Remove the six Hansen connectors.

4. Unfasten the elastic band around the FORCLEAN I ultrafilter and remove the ultrafilters.

5. Place the new Forclean ultrafilter into the fixing clips.

6. Tie the elastic clip again.

7. Reattach the filter connectors, checking the colour code and the assembly tag on the back of the machine, and ensure none of the tubes are bended or squashed.

8. Using the clip provided, attach the second ultrafilter to the first.

9. Attach the filter connectors, checking the colour code and the assembly tag on the back of the machine, and ensure none of the tubes are bent or squashed.

10. Replace the protective cover, making sure none of the tubes are bent or

squashed.

11. Switch on the machine.

12.

maintenance

filter management

replace FORCLEAN

. The automatic filter priming/spilling sequence will be started and the dialysis hour counter reset.

13. Always perform a disinfection before using the formula machine for a dialysis treatment.

For the other models:For the other models:For the other models:For the other models:


2. Remove the protective cover.

3. Detach the elastic clip holding the ultrafilter.

4. Disconnect the three connectors from the ultrafilter and remove it.

5. Mount the new ultrafilter in the fixing clips.

6. Tie the elastic clip again.

7. Reconnect the connectors to the filter, taking care not to bend or squash the tubes.

8. Replace the protective cover.


10.

filter management

replace FORCLEAN

. The automatic filter priming/spilling sequence will be started and the dialysis hour counter reset.

4 of 4 – chap. 9.4 - Management of ultrafilters and Multipure ENG – Ed. 05/08


MULTIPURE FILTERMULTIPURE FILTERMULTIPURE FILTERMULTIPURE FILTER

The MULTIPURE filter, positioned after the water supply inlet and accessible from the back of the machine, is a bacterial microfilter designed to remove endotoxins. It thus prevents the microbiological contamination of the machine.

WARNINGWARNINGWARNINGWARNING The MultipureThe MultipureThe MultipureThe Multipure filter must be replaced after 600 hours of operation. filter must be replaced after 600 hours of operation. filter must be replaced after 600 hours of operation. filter must be replaced after 600 hours of operation.

NOTENOTENOTENOTE The operator is warned when the filter needs to be replaced by the message The operator is warned when the filter needs to be replaced by the message The operator is warned when the filter needs to be replaced by the message The operator is warned when the filter needs to be replaced by the message “REPLACE MULTIPURE” .“REPLACE MULTIPURE” .“REPLACE MULTIPURE” .“REPLACE MULTIPURE” .

REPLACING MULTIPURE FILTER (by the operator)REPLACING MULTIPURE FILTER (by the operator)REPLACING MULTIPURE FILTER (by the operator)REPLACING MULTIPURE FILTER (by the operator)


2. Close the haemodialysis water delivery tap.

3. Unscrew the wing screw to remove the filter retaining band.

4. Disconnect the two quick couplings and remove the filter from its housing.

5. Mount the new filter.

6. Reconnect the two quick couplings.

7. Refit the filter retaining bar.

8. Open the water delivery tap.

9. Open the upper valve of the filter to bleed the air.


11. For Therapy modelsFor Therapy modelsFor Therapy modelsFor Therapy models:

maintenance

filter management

replace MULTIPURE

to reset the dialysis hour counter.

For the other models:For the other models:For the other models:For the other models:

filter management

replace MULTIPURE

to reset the dialysis hour counter.


ENG – Ed. 12/07 chap. 9.5 – Sanitation for online HDF - 1 of 2

9.5 DISINFECTION/CLEANING PROCEDURE FOR FORMULA 9.5 DISINFECTION/CLEANING PROCEDURE FOR FORMULA 9.5 DISINFECTION/CLEANING PROCEDURE FOR FORMULA 9.5 DISINFECTION/CLEANING PROCEDURE FOR FORMULA

MACHINES MACHINES MACHINES MACHINES PERFORMINGPERFORMINGPERFORMINGPERFORMING ONLINE HAEMODIAFILTRATION ONLINE HAEMODIAFILTRATION ONLINE HAEMODIAFILTRATION ONLINE HAEMODIAFILTRATION

TREATMENT TREATMENT TREATMENT TREATMENT

All dialysis treatments, and particularly on-line techniques with dialysis fluid infusion, may only be performed using a properly sanitised machine. Dialysis fluid is filtered through three levels of cold filtering positioned in sequence, characterised by adsorbent, microfilter surfaces with different properties: a Multipure microfilter at the water inlet, a Forclean double (formula Therapy model only) or single (all other models) ultrafilter for dialysate and, for PHF only, a PHF filter chamber for dialysis fluid infused through backfiltration. Below follows a description of the disinfection procedures for formula 2000. These procedures have to be carried out by the nursing and/or technical staff of the dialysis centre in order to prepare the equipment to perform PHF treatment. WARNINGWARNINGWARNINGWARNING The manufacturer declines all responsibility for any harm to the patient The manufacturer declines all responsibility for any harm to the patient The manufacturer declines all responsibility for any harm to the patient The manufacturer declines all responsibility for any harm to the patient caused by failed or improper use of these dicaused by failed or improper use of these dicaused by failed or improper use of these dicaused by failed or improper use of these disinfection/cleaning procedures.sinfection/cleaning procedures.sinfection/cleaning procedures.sinfection/cleaning procedures. Furthermore, the manufacturer does not guarantee proper disinfection of Furthermore, the manufacturer does not guarantee proper disinfection of Furthermore, the manufacturer does not guarantee proper disinfection of Furthermore, the manufacturer does not guarantee proper disinfection of formula for for for for On Line HaemodifiltrationOn Line HaemodifiltrationOn Line HaemodifiltrationOn Line Haemodifiltration treatments if chemical agents and/or treatments if chemical agents and/or treatments if chemical agents and/or treatments if chemical agents and/or disinfection/cleaning procedures different from those described are used.disinfection/cleaning procedures different from those described are used.disinfection/cleaning procedures different from those described are used.disinfection/cleaning procedures different from those described are used.

SSSSTARTTARTTARTTART----UP DISINFECTION PROCUP DISINFECTION PROCUP DISINFECTION PROCUP DISINFECTION PROCEDURE FOR FORMULA EDURE FOR FORMULA EDURE FOR FORMULA EDURE FOR FORMULA MACHINES USED FOR ONMACHINES USED FOR ONMACHINES USED FOR ONMACHINES USED FOR ONLINE HAEMODIAFILTRATLINE HAEMODIAFILTRATLINE HAEMODIAFILTRATLINE HAEMODIAFILTRATION ION ION ION TREATMENT TREATMENT TREATMENT TREATMENT

WARNINGWARNINGWARNINGWARNING This procedure must be used in the following cases:This procedure must be used in the following cases:This procedure must be used in the following cases:This procedure must be used in the following cases: • ffffirst installation of the machine.irst installation of the machine.irst installation of the machine.irst installation of the machine. • each time each time each time each time online online online online HDF treatment is performed on machines that hHDF treatment is performed on machines that hHDF treatment is performed on machines that hHDF treatment is performed on machines that have been ave been ave been ave been

used for other treatments.used for other treatments.used for other treatments.used for other treatments. • performing performing performing performing online online online online HDF treatment using machines not disinfected HDF treatment using machines not disinfected HDF treatment using machines not disinfected HDF treatment using machines not disinfected

following the recommended “maintenance“ disinfection procedure. following the recommended “maintenance“ disinfection procedure. following the recommended “maintenance“ disinfection procedure. following the recommended “maintenance“ disinfection procedure. • performing performing performing performing online online online online HDF treatment using machines that have remained HDF treatment using machines that have remained HDF treatment using machines that have remained HDF treatment using machines that have remained

inactive or off for a longinactive or off for a longinactive or off for a longinactive or off for a long time. time. time. time. Proceed as follows:

1. perform a DISINFECTION from the machine water intake using a suitable device (to be used only by personnel authorised by the manufacturer).

2. perform a descaling procedure by selecting HEAT DESCALING with citric acid.

3. perform a disinfection by selecting FULL CHEMICAL DISINFECTION with Oxagal with DWELL TIME, until used for PHF (pre/post) or HDF (pre/post/mid) dialysis treatment.

2 of 2 – chap. 9.5 - Sanitation for online HDFOnLine ENG – Ed. 12/07

“MAINTENANCE” SANITA“MAINTENANCE” SANITA“MAINTENANCE” SANITA“MAINTENANCE” SANITATION FOR FORMULA MACTION FOR FORMULA MACTION FOR FORMULA MACTION FOR FORMULA MACHINES USED HINES USED HINES USED HINES USED FORFORFORFOR ONLINE HAEMODIAFILT ONLINE HAEMODIAFILT ONLINE HAEMODIAFILT ONLINE HAEMODIAFILTRATION TREATMENT RATION TREATMENT RATION TREATMENT RATION TREATMENT

WARNINGWARNINGWARNINGWARNING TTTThis procedure must be performed on all his procedure must be performed on all his procedure must be performed on all his procedure must be performed on all formula® machines used regularly machines used regularly machines used regularly machines used regularly for online haemodiafiltration.for online haemodiafiltration.for online haemodiafiltration.for online haemodiafiltration. If use is:If use is:If use is:If use is: • not continuous (periods of inactivity), not continuous (periods of inactivity), not continuous (periods of inactivity), not continuous (periods of inactivity), • not governed by the not governed by the not governed by the not governed by the ““““maintenancemaintenancemaintenancemaintenance”””” disinfection procedure described disinfection procedure described disinfection procedure described disinfection procedure described

below,below,below,below, the “startthe “startthe “startthe “start----up” disinfectionup” disinfectionup” disinfectionup” disinfection procedure above described must be carried out procedure above described must be carried out procedure above described must be carried out procedure above described must be carried out preliminarily.preliminarily.preliminarily.preliminarily. The machine must be sanitized regularly following a specific protocol. This protocol must be chosen and supervised by the physician. Responsibility lies This protocol must be chosen and supervised by the physician. Responsibility lies This protocol must be chosen and supervised by the physician. Responsibility lies This protocol must be chosen and supervised by the physician. Responsibility lies exclusively with the physician in chargexclusively with the physician in chargexclusively with the physician in chargexclusively with the physician in charge. e. e. e. The manufacturer recommends performing dwell time during nightThe manufacturer recommends performing dwell time during nightThe manufacturer recommends performing dwell time during nightThe manufacturer recommends performing dwell time during night----time hours and time hours and time hours and time hours and two citric acid descaling cycles per week (activated by selecting heat descaling with two citric acid descaling cycles per week (activated by selecting heat descaling with two citric acid descaling cycles per week (activated by selecting heat descaling with two citric acid descaling cycles per week (activated by selecting heat descaling with citric acid).citric acid).citric acid).citric acid). Here below a protocol example is given.

SANITIZATION PROTOCOL EXAMPLE FOSANITIZATION PROTOCOL EXAMPLE FOSANITIZATION PROTOCOL EXAMPLE FOSANITIZATION PROTOCOL EXAMPLE FOR PHF OR HDF ONR PHF OR HDF ONR PHF OR HDF ONR PHF OR HDF ON----LINELINELINELINE

After 1After 1After 1After 1stststst dialysis dialysis dialysis dialysis After 2After 2After 2After 2ndndndnd dialysis dialysis dialysis dialysis After 3After 3After 3After 3rdrdrdrd dialysis and dialysis and dialysis and dialysis and nightnightnightnight

Monday

free free Descal. (citric a.)

+

Dwell with Oxagal

Tuesday

free free Dwell with Oxagal

Wednesday


Thursday


Friday


Saturday

free free Descal. (citric a.)

+

Dwell with Oxagal

Sunday

Dwell with Oxagal

Descaling with citric acid can be performed on Mondays and Saturdays, it can be done in the evening, before using OXAGAL. In case of only two dialysis sessions per day, do not take into consideration the first column.

ENG – Ed. 06/09 chap. 10.1 – Alarms and warnings - General - 1 of 8

10.1 ALARMS AND WARNINGS10.1 ALARMS AND WARNINGS10.1 ALARMS AND WARNINGS10.1 ALARMS AND WARNINGS ---- GENERAL GENERAL GENERAL GENERAL

The alarms and warnings for the operator are indicated by messages displayed on

the bar at the bottom of the screen, on the right those relative to the blood section,

on the left those relative to the dialysate section.

This bar, which normally is grey, turns

---- red red red red when an alarmalarmalarmalarm occurs,

---- orange orange orange orange when a warning warning warning warning is signalled,

---- yellow yellow yellow yellow if the alarm has been disableddisableddisableddisabled temporarily.

Each alarm/warning is characterised by visual and acoustic signalling.

The visual signalling (red indicator on I.V. pole) continues flashing for the entire duration of the alarm.

Acoustic warning signals have different intensity and time intervals according to a

scale of priorities.

An active alarm covers any warning present relative to the same section (the orange

bar turns red).

A warning in one of the two sections (blood or dialysate) is highlighted in red if an

alarm occurs on the other section.

In the event of an alarm/warning indicator, the following buttons can be used:

To silence the alarm sound for 5 minutes in priming and 2 minutes in dialysis.

Where allowed, this key permits to temporarily override the alarm (5 min. during priming and 2 min. during dialysis), thus allowing to restart the machine and remove the cause of the alarm. The machine permanently monitors the parameters connected with the alarm condition.

In some conditions the key is used to cancel a warning or an alarm.

If the parameter in alarm condition is displayed on the screen, the relevant graphic tool turns red.

2 of 8 – chap. 10.1 – Alarms and warnings – General ENG – Ed. 06/09

NOTENOTENOTENOTE

The LED next to the keys The LED next to the keys The LED next to the keys The LED next to the keys and and and and indicates: indicates: indicates: indicates: • LED off = the function is inactive.LED off = the function is inactive.LED off = the function is inactive.LED off = the function is inactive.

• LED on LED on LED on LED on permanently = the function is activepermanently = the function is activepermanently = the function is activepermanently = the function is active

• LED flashing = the function is activatLED flashing = the function is activatLED flashing = the function is activatLED flashing = the function is activataaaable.ble.ble.ble. Alarms/indicators are described in the following chapters, subdivided into a dialysate section and a blood section.

For each alarm and warning the following are indicated:

- Machine operating status

- Alarm message

- Effects produced (pump stop, electroclamp closure,...).

- Cause of the alarm

- Action to take

In the alarm description if the symbol appears, it means that the acoustic alarm can be silenced with the relevant key.

Likewise, if the symbol appears, it means that the alarm can be temporarily overridden.

ALARMS SILENCED DURIALARMS SILENCED DURIALARMS SILENCED DURIALARMS SILENCED DURING PRIMING AND RINSENG PRIMING AND RINSENG PRIMING AND RINSENG PRIMING AND RINSEBACKBACKBACKBACK

In configuration mode it is possible to set formula (ACOUSTIC ALARMS IN RINSEBACK: OFF, ACOUSTIC ALARMS IN PRIMING: OFF) in order to automatically silence some alarms during priming and/or disconnection:

PRIMINGPRIMINGPRIMINGPRIMING

PUMP OFF

BICARB. CONDUCTIVITY

TOTAL CONDUCTIVITY


END UF

EMPTYINGEMPTYINGEMPTYINGEMPTYING

All alarms (except the AIR DETECTED alarm if rinseback with physiological solution was configured )


LIST OF ALARMS LIST OF ALARMS LIST OF ALARMS LIST OF ALARMS ---- WARNINGS WARNINGS WARNINGS WARNINGS

The table below allows you to have quick consultation of the alarms/warnings displayed by the formula. The table indicates the alarm/warning message, the denomination and the chapter of the user manual in which the operator can read the relevant information.

WARNING MESSAGEWARNING MESSAGEWARNING MESSAGEWARNING MESSAGE ALARMALARMALARMALARM CHAPTER CHAPTER CHAPTER CHAPTER

Error 0 alarm chap. 10.1

DIALYSATE SIDEDIALYSATE SIDEDIALYSATE SIDEDIALYSATE SIDE

BICARB. CONDUCTIVITY Partial conductivity alarm chap. 10.2

TOTAL CONDUCTIVITY Total conductivity alarm chap. 10.2

CONCENTRATE CONNECTORS Concentrate connector alarm chap. 10.2

DIALYSER CONNECTORS Dialyser connector alarm chap. 10.2

DISINFECTANT CONNECTOR Disinfectant connector alarm chap. 10.2

INFUSION CONNECTOR Infusion connector alarm chap. 10.2

CONCENTRATE ERROR Concentrate error alarm chap. 10.2

HYDRAULIC Hydraulic alarm chap. 10.2

NO WATER No water alarm chap. 10.2

TMP OUT OF RANGE Transmembrane pressure alarm (absolute limit)

chap. 10.2

P_UF OUT OF RANGE Ultrafiltration pressure alarm (absolute limit)

chap. 10.2

TMP MINMAX Transmembrane pressure alarm (relative limit)

chap. 10.2

P_UF MINMAX Ultrafiltration pressure alarm (relative limit)

chap. 10.2

BIDRY NOT FILLED Bidry not filled alarm chap. 10.2

TEMPERATURE Temperature alarm chap. 10.2

REVERSE UF Reverse ultrafiltration alarm chap. 10.2

BLUE CON. Blue connector alarm chap. 10.2

BATTERY Battery alarm chap. 10.2

UF TEST FAILED Ultrafiltration system test alarm chap.10.2

REPLACE FORCLEAN Replace Forclean alarm chap. 10.2

FORCLEAN ABSENT Missing Forclean alarm chap. 10.2

DIALYSATE INFUSION Incorrect dialysate infusion alarm chap. 10.2

START [Na] Initial [Na] with Aequilibrium alarm chap. 10.2

TECHNICAL ALARM XXX:XXX Dialysate technical alarm code xxx:xxx Chap. 10.2

HYDRAULIC XXX Hydraulic alarm code xxx Chap. 10.2


BLOOD SIDEBLOOD SIDEBLOOD SIDEBLOOD SIDE

CLAMP OPEN Open clamp alarm chap. 10.3

BLD BLD alarm chap. 10.3

ART. PUMP COVER Arterial pump cover alarm chap. 10.3

HEPARIN RUN OUT End heparin alarm chap. 10.3

ARTERIAL PUMP REVOL. Arterial pump revolution alarm chap. 10.3

WRONG ART. LINE Arterial line set up alarm chap. 10.3

BLOOD LEVEL Blood level alarm chap. 10.3

PA MINMAX Min/max arterial pressure alarm chap. 10.3

PA OUT OF RANGE Arterial pressure out of range alarm chap. 10.3

FILTER INLET PRESSURE Dialyser inlet arterial pressure out of range alarm

chap. 10.3

PUMP OFF Pump off alarm chap. 10.3

ABNORMAL COMM. PRESSURE Abnormal switching pressure alarm chap. 10.3

HEPARIN INFUSION Incorrect heparin infusion alarm chap. 10.3

AIR DETECTED Air detection alarm chap. 10.3

PV MINMAX Min/max venous pressure alarm chap. 10.3

PV OUT OF RANGE Venous pressure out of range alarm chap. 10.3

ARTERIAL PHASE TIMEOUT Arterial phase timeout alarm chap. 10.3

VENOUS PHASE TIMEOUT Arterial phase time alarm chap. 10.3

BLOOD VOLUME Venous phase time alarm chap. 10.3

END INFUSION End infusion alarm chap. 10.3

EXCESSIVE LOAD Excessive load alarm chap. 10.3

LOAD INSUFFICIENT Insufficient load alarm chap. 10.3

LOAD MODIFIED Modified load alarm chap. 10.3

LOAD UNSTABLE Unstable load alarm chap. 10.3

LOAD ABNORMAL Abnormal load alarm chap. 10.3

INFUSION ERROR Infusion error alarm chap. 10.3

EXCESSIVE INFUSION Excessive infusion alarm chap. 10.3

INSUFFICIENT INFUSION Insufficient infusion alarm chap. 10.3

INVERSE INFUSION Inverse infusion alarm chap. 10.3

INFUSION PUMP COVER Infusion pump cover alarm chap. 10.3

INF. PUMP ROTATION No. Infusion pump revolution alarm chap. 10.3

MAX. VEN. P. Maximum venous pressure alarm chap. 10.3

VEN. PUMP COVER Venous pump cover alarm chap. 10.3

V. PUMP ROTATION No. Venous pump revolution alarm chap. 10.3

EXTRACT V. PUMP SEGMENT Venous segment alarm chap. 10.3

INF. PRESS. OUT OF RANGE Infusion pressure out of range alarm chap. 10.3

HFR LINE PRIME TIMEOUT HFR line prime timeout alarm chap. 10.3

WRONG HFR LINE INSERTION Incorrect infusion line insertion alarm chap. 10.3

BLOOD DET. IN INF. LINE Blood detected in infusion line alarm chap. 10.3

INADEQUATE FLOWS UF/infusion flow too high alarm chap. 10.3


TMPH OUT OF RANGE Transmembrane pressure HFR out of range alarm

chap. 10.3

WRONG INF. LINE INSERTION Incorrect infusion line insertion alarm chap. 10.3

INF. LINE TEST TIMEOUT Infusion line priming timeout/PHF filter test alarm

chap. 10.3

TECHNICAL ALARM XXX:XXX Blood side technical alarm Chap 10.3

WARNING MESSAGEWARNING MESSAGEWARNING MESSAGEWARNING MESSAGE WARNINGWARNINGWARNINGWARNING CHAPTERCHAPTERCHAPTERCHAPTER

DIALYSATE SIDEDIALYSATE SIDEDIALYSATE SIDEDIALYSATE SIDE

WATER UNSUITABLE Unsuitable water warning chap. 10.2

BACKFILTRATION Backfiltration warning chap. 10.2

BYPASS Dialyser bypass warning chap. 10.2

DISINFECTION (not Therapy

model) or

MAINTENANCE (Therapy

model)

Disinfection (not Therapy model) or maintenance (Therapy model) procedure not completed warning

chap. 10.2

END UF End UF warning chap. 10.2

PUMP REVOLUTIONS Concentrate pump revolution warning chap. 10.2

DISINFECTANT NOT INTAKEN No disinfectant/descaling agent intake alert

chap. 10.2

INFUSION CONNECTOR Infusion connector warning chap. 10.2

TESTING TEMP. INSUF. Testing temperature insufficient warning

chap. 10.2

SYSTEM READY System ready warning chap. 10.2

MINIMAL UF Minimum UF warning chap. 10.2

UF NOT ACTIVATED UF not activated warning chap. 10.2

UF NOT PROGRAMMED UF not programmed warning chap. 10.2

WAITING FOR RINSING Waiting for rinsing warning chap. 10.2

TMP MAX. Maximum TMP out of range warning chap. 10.2

VERIFY PROFILE Incorrect profile warning chap. 10.2

AEQUIL/ISONA NOT AVAIL. Aequilibrium or Isonatric indicator unavailable warning

chap. 10.2

REPLACE MULTIPURE Warning: replace Multipure warning chap. 10.2

REPLACE FORCLEAN Replace Forclean warning chap. 10.2

FORCLEAN ABSENT Missing Forclean warning chap. 10.2

BLOOD SIDEBLOOD SIDEBLOOD SIDEBLOOD SIDE

HEPARIN OFF Heparin not active warning chap. 10.3

NO HEPARIN SETTING Heparin not set warning chap. 10.3

FLOW SET TO ZERO Zero blood flow warning chap. 10.3

INADEQUATE BLOOD FLOW Blood flow inadequate warning chap. 10.3

MODIFY ARTERIAL FLOW Arterial flow modification warning chap. 10.3

BLOOD DETECTED Blood detection warning chap. 10.3

ART./ FILTER INLET PRESS. Arterial pressure/prefilter warning chap. 10.3


BLOOD LINE EMPTYING Line emptying warning chap. 10.3

ERROR: LINE PRESSURE Infusion line pressure warning chap. 10.3

Kt/V MIN OUT OF RANGE Kt/V min out of range warning chap. 10.3

Kt/V GOAL OUT OF RANGE Kt/V goal out of range warning chap. 10.3

K MIN OUT OF RANGE Clearance out of range warning chap. 10.3

ERROR: BLD BLD detector line error warning chap. 10.3

NO INFUSION FLOW No infusion flow warning chap. 10.3

INCOMPL. INF. LINE PRIMING Uncompleted HFR line priming warning chap. 10.3

EFFICIENCY Efficiency warning chap. 10.3

COMM. PRESSURE Switching pressure warning chap. 10.3

ERROR: WEIGHT ON SCALE Weight on scale warning chap. 10.3

INCOMPL. HFR LINE PRIMING Uncompleted HFR line priming warning chap. 10.3

SPHYGMO ERROR Sphygmo measurement error warning chap. 10.3

SYSTOLIC OUT OF RANGE Warning: systolic pressure out of range chap. 10.3

DIASTOLIC OUT OF RANGE Warning: diastolic pressure out of range

chap. 10.3

HR OUT OF RANGE Warning: heart rate out of range chap. 10.3

HCT OUT OF RANGE Warning: hematocrit out of range

chap. 10.3

SO2 OUT OF RANGE Warning: oxygen saturation out of range

chap. 10.3

VL% OUT OF RANGE Warning: percent volume loss out of range

chap. 10.3

CARDIUM HR OUT OF RANGE Cardium warning: heart rate out of the absolute range

chap. 10.3

CARDIUM HR % OUT OF

RANGE

Cardium warning: heart rate out of the percent range

chap. 10.3

CARDIUM HR DER. OUT OF

RANGE

Cardium warning: heart rate out of the derivative range

chap. 10.3

TEST SENSORS FORMULA + Warning: Formula Plus test sensor failed

chap. 10.3

SODIUM CONCENTRATION

NOT DETECTED

Sodium concentration not detected warning

Chap. 10.3


MACHINE ERRORMACHINE ERRORMACHINE ERRORMACHINE ERROR

ERROR 0 ALARM ERROR 0 ALARM ERROR 0 ALARM ERROR 0 ALARM duringduringduringduring all operational phases all operational phases all operational phases all operational phases

REDREDREDRED////BLUE ALARM WINDOWBLUE ALARM WINDOWBLUE ALARM WINDOWBLUE ALARM WINDOW

EffectsEffectsEffectsEffects

Visual warning Acoustic warning Blood pump stop Clamp closure Dialyser bypass Dialysis/ rinsing/ disinfection time interrupted

CausesCausesCausesCauses - Clamp closure after an alarm was not detected

by the machine, as the clamp was been opened manually.

- The blood pump has been forced while off.

- Internal machine problem.

- A condition dangerous to the patient has been detected.

- At turning on, the water tap has remained closed.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Note down the error code.

- Press the power key (green LED) for at least 5 seconds. If ERROR 0 does not disappear, switch off the machine using the main switch in the rear panel and contact After-Sales Service.

- Open the water tap.

ENG – Ed. 06/09 chap. 10. 2 – Alarms and warnings – Dialysate section - 1 of 18

10.2 ALARMS AND WARNINGS 10.2 ALARMS AND WARNINGS 10.2 ALARMS AND WARNINGS 10.2 ALARMS AND WARNINGS –––– DIALYSATE SECTION DIALYSATE SECTION DIALYSATE SECTION DIALYSATE SECTION

ALARMSALARMSALARMSALARMS

PARTIAL CONDUCTIVITY ALARM during dialysisPARTIAL CONDUCTIVITY ALARM during dialysisPARTIAL CONDUCTIVITY ALARM during dialysisPARTIAL CONDUCTIVITY ALARM during dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: BICARB.BICARB.BICARB.BICARB. CONDUCTIVITYCONDUCTIVITYCONDUCTIVITYCONDUCTIVITY


Visual warning Acoustic warning dialyser bypass dialysis time interrupted

CausesCausesCausesCauses - The bicarbonate concentrate conductivity is

outside the set values (+/-5%) or is outside the permitted limits.

- The bicarbonate concentrate is not aspirated properly.

- The bicarbonate concentrate container is empty.

- Unsuitable concentrate solutions have been used.

- Air in the circuit. - The machine has just entered the preparation

phase. - Air from the bicarbonate powder cartridge. - Variation of the dialysate flow rate.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check suitability of the bicarbonate

concentrate and its proper aspiration. - Remove the air from the concentrate suction

tubes. - Seal the concentrate connectors on the

cannulas of the containers.

2 of 18 - Chap. 10. 2 – Alarms and warnings – Dialysate section ENG – Ed. 06/09

TOTAL CONDUCTIVITY ALARMTOTAL CONDUCTIVITY ALARMTOTAL CONDUCTIVITY ALARMTOTAL CONDUCTIVITY ALARM during dialysis during dialysis during dialysis during dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: TOTALTOTALTOTALTOTAL CONDUCTIVITYCONDUCTIVITYCONDUCTIVITYCONDUCTIVITY



CausesCausesCausesCauses - The dialysis fluid conductivity is outside the set

values (+/- 5%) or is outside the permitted limits. - The concentrate containers are empty or the

concentrate is not aspirated properly. - Unsuitable concentrate solutions have been used. - Air in the circuit. - The machine has just entered the preparation

phase.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check suitability of the concentrates and their

intake. - Remove the air from the concentrate suction tubes.

CONCENTRATE CONNECTOR ALARMCONCENTRATE CONNECTOR ALARMCONCENTRATE CONNECTOR ALARMCONCENTRATE CONNECTOR ALARM during dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaning

MMMMESSAGEESSAGEESSAGEESSAGE:::: CONCENTRATECONCENTRATECONCENTRATECONCENTRATE CONNECTORSCONNECTORSCONNECTORSCONNECTORS

EffectsEffectsEffectsEffects Visual warning Acoustic warning dialyser bypass Dialysis/rinsing/disinfection time interrupted

CausesCausesCausesCauses - The concentrate connectors are not properly

inserted in the block or their position is not in conformance with the operating phase the machine is in.

- The bracket has not been closed correctly. - The upper piercing connector has not been properly

closed.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the position of the concentrate connectors

and change it if necessary. - Make sure the upper piercing connector and the

locking bracket are in the correct position.


DIALYSER CONNECTORS ALARM DIALYSER CONNECTORS ALARM DIALYSER CONNECTORS ALARM DIALYSER CONNECTORS ALARM during dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaning

Message: DIALYSER CONNECTORSMessage: DIALYSER CONNECTORSMessage: DIALYSER CONNECTORSMessage: DIALYSER CONNECTORS


CausesCausesCausesCauses - The dialyser connectors are not properly

inserted in the block or their position is not in conformity with the machine operating phase.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check and, if necessary, correct the position of

the dialyser connectors.

DISINFECTANT CONNECTOR ALARMDISINFECTANT CONNECTOR ALARMDISINFECTANT CONNECTOR ALARMDISINFECTANT CONNECTOR ALARM during dialysis and during dialysis and during dialysis and during dialysis and disinfection/cleaningdisinfection/cleaningdisinfection/cleaningdisinfection/cleaning

Message: DISINFECTANT CONNECTORMessage: DISINFECTANT CONNECTORMessage: DISINFECTANT CONNECTORMessage: DISINFECTANT CONNECTOR

Effects Effects Effects Effects

Visual warning Acoustic warning dialyser bypass Dialysis/disinfection time interrupted

CausesCausesCausesCauses - The disinfectant connector is not properly

inserted in the block or its position is not in conformity with the machine operating phase.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check and, if necessary, correct the position of

the disinfectant connector.

INFUSION CONNECTOR ALARMINFUSION CONNECTOR ALARMINFUSION CONNECTOR ALARMINFUSION CONNECTOR ALARM during cleaning, dialysis and during cleaning, dialysis and during cleaning, dialysis and during cleaning, dialysis and disinfection/cleaningdisinfection/cleaningdisinfection/cleaningdisinfection/cleaning

Message: INFUSION CONNECTORMessage: INFUSION CONNECTORMessage: INFUSION CONNECTORMessage: INFUSION CONNECTOR


Visual warning Acoustic warning dialyser bypass Dialysis/disinfection time interrupted

CausesCausesCausesCauses - The infusion connector cover is not closed

properly or its position is not in conformity with the machine operating phase.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the position of the infusion connector

cover.


CONCENTRATE ERROR ALARMCONCENTRATE ERROR ALARMCONCENTRATE ERROR ALARMCONCENTRATE ERROR ALARM during dialysis during dialysis during dialysis during dialysis

Message: CONCENTRATE ERRORMessage: CONCENTRATE ERRORMessage: CONCENTRATE ERRORMessage: CONCENTRATE ERROR



CausesCausesCausesCauses - Unsuitable concentrate solutions have been

used. - The cannulas of the containers have been

inverted. - The concentrate pumps turn outside the preset

speed. - The water inlet flow is incorrect.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the connection and the type of

concentrates used.

HYDRAULIC ALARMHYDRAULIC ALARMHYDRAULIC ALARMHYDRAULIC ALARM during dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaning

Message: HYDRAULICMessage: HYDRAULICMessage: HYDRAULICMessage: HYDRAULIC


Visual warning Acoustic warning dialyser bypass Dialysis/ rinsing/ disinfection time interrupted

CausesCausesCausesCauses - Excessive pressure measured in the hydraulic

circuit.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check possible occlusions of the drain tube. - Check possible occlusions of the dialyser

connection tubes. - Check if the Forclean ultrafilter is installed

correctly. - Check the proper connection of the powder

bicarbonate cartridge or the position of the Bidry connector.

If the HYDRAULIC alarm is followed by a number, refer to the HYDRAULIC ALARM: XXX hereinafter.

NO WATERNO WATERNO WATERNO WATER ALARM ALARM ALARM ALARM during dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaningduring dialysis, rinsing and disinfection/cleaning

Message: NO WATERMessage: NO WATERMessage: NO WATERMessage: NO WATER


CausesCausesCausesCauses - The water supply pressure is too low. - No water supply to machine inlet.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the water tap is open. - Check that the machine water supply pressure

is correct and that the inlet tube is not squashed or clogged.


TRANSMEMBRANE PRESSURE OUT OF ABSOLUTE RANGE ALARMTRANSMEMBRANE PRESSURE OUT OF ABSOLUTE RANGE ALARMTRANSMEMBRANE PRESSURE OUT OF ABSOLUTE RANGE ALARMTRANSMEMBRANE PRESSURE OUT OF ABSOLUTE RANGE ALARM during during during during dialysisdialysisdialysisdialysis

Message: TMP OUT OF RANGEMessage: TMP OUT OF RANGEMessage: TMP OUT OF RANGEMessage: TMP OUT OF RANGE



CausesCausesCausesCauses - The transmembrane pressure has exceeded the

absolute maximum or minimum value set during configuration.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the ultrafiltration set is in

accordance with the type of filter being used.

ULTRAFILTRATION PRESSULTRAFILTRATION PRESSULTRAFILTRATION PRESSULTRAFILTRATION PRESSURE OUT OF ABSOLUTE RANGE ALARM URE OUT OF ABSOLUTE RANGE ALARM URE OUT OF ABSOLUTE RANGE ALARM URE OUT OF ABSOLUTE RANGE ALARM during during during during dialysisdialysisdialysisdialysis

Message: P_UF OUT OF RANGEMessage: P_UF OUT OF RANGEMessage: P_UF OUT OF RANGEMessage: P_UF OUT OF RANGE



CausesCausesCausesCauses - The dialyser outlet pressure has exceeded the

absolute minimum or maximum value set during configuration.


accordance with the type of filter being used. - Check that the dialyser connection tubes are

not occluded.

TRANSMEMBRANE PRESSURE MIN / MAX ALARMTRANSMEMBRANE PRESSURE MIN / MAX ALARMTRANSMEMBRANE PRESSURE MIN / MAX ALARMTRANSMEMBRANE PRESSURE MIN / MAX ALARM during dialysisduring dialysisduring dialysisduring dialysis

Message: TMP Message: TMP Message: TMP Message: TMP MINMAXMINMAXMINMAXMINMAX



CausesCausesCausesCauses - The transmembrane pressure exceeds the

operating thresholds.


accordance with the type of filter being used. - Check for leakage and obstructions. - Check the alarm range set.


MIN./MAX. ULTRAFILTRATION PRESSURE ALARMMIN./MAX. ULTRAFILTRATION PRESSURE ALARMMIN./MAX. ULTRAFILTRATION PRESSURE ALARMMIN./MAX. ULTRAFILTRATION PRESSURE ALARM during dialysisduring dialysisduring dialysisduring dialysis

Message: P_UF Message: P_UF Message: P_UF Message: P_UF MINMAXMINMAXMINMAXMINMAX



CausesCausesCausesCauses - The dialyser outlet pressure exceeds the

operating thresholds.


accordance with the type of filter being used. - Check that the dialyser connection tubes are

not occluded. - Check for leakage and obstructions. - Check the alarm range set.

BIDRY NOT FILLED ALARM BIDRY NOT FILLED ALARM BIDRY NOT FILLED ALARM BIDRY NOT FILLED ALARM during dialysisduring dialysisduring dialysisduring dialysis

Message: BIDRY NOT FILLEDMessage: BIDRY NOT FILLEDMessage: BIDRY NOT FILLEDMessage: BIDRY NOT FILLED



CausesCausesCausesCauses - The Bidry cartridge has not been filled correctly.

The most common causes are: 1. the clamps on the cartridge lines are closed, 2. the cartridge is not connected properly, 3. the cartridge is broken.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the cartridge connections and possible

obstructions in the lines. Repeat filling. - Check that the cartridge is undamaged and

replace it if necessary.

TEMPERATURE ALARMTEMPERATURE ALARMTEMPERATURE ALARMTEMPERATURE ALARM during dialysis during dialysis during dialysis during dialysis

Message: TEMPERATUREMessage: TEMPERATUREMessage: TEMPERATUREMessage: TEMPERATURE

EffectsEffectsEffectsEffects Visual warning Acoustic warning dialyser bypass dialysis time interrupted

CausesCausesCausesCauses - The dialysis fluid temperature is outside the

34 - 40 °C range.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Wait for the temperature to spontaneously

return within the permitted range.


REVERSE ULTRAFILTRATION ALARMREVERSE ULTRAFILTRATION ALARMREVERSE ULTRAFILTRATION ALARMREVERSE ULTRAFILTRATION ALARM during dialysis during dialysis during dialysis during dialysis

Message: REVERSE UFMessage: REVERSE UFMessage: REVERSE UFMessage: REVERSE UF

EffectsEffectsEffectsEffects Visual warning Acoustic warning dialyser bypass dialysis time interrupted

CausesCausesCausesCauses - Reverse filtration detected by reading of the

differential flowmeter.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the drain tube or the dialyser tubes

are not occluded. - Check that air is not present in the circuit. - Check the patient's precise weight since reverse

ultrafiltration may be dangerous.

BLUE CONNECTOR ALARMBLUE CONNECTOR ALARMBLUE CONNECTOR ALARMBLUE CONNECTOR ALARM during dialysis during dialysis during dialysis during dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: BLUEBLUEBLUEBLUE CON.CON.CON.CON.

EffectsEffectsEffectsEffects Visual warning Acoustic warning dialyser bypass

CausesCausesCausesCauses - The blue dialyser connector is not connected to

the machine while the filter is being drained.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Connect the blue dialyser connector to the

machine.

BATTERY ALARMBATTERY ALARMBATTERY ALARMBATTERY ALARM during priming and dialysisduring priming and dialysisduring priming and dialysisduring priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: BATTERYBATTERYBATTERYBATTERY

EffectsEffectsEffectsEffects Visual warning Acoustic warning Flashing orange led close to the

key

CausesCausesCausesCauses - During the connection phase in priming or

during dialysis treatment, there is a mains power shortage and the machine has switched to the auxiliary battery power.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - The machine will run for the entire life cycle of

the battery during dialysis (refer to the corresponding paragraph in chapter 8.4 ("Other functions")).

- Wait for the mains power supply to reconnect. - Disconnect the patient if the mains power is

not restored.


ULTRAFILTRATION SYSTEM TEST FAILURE ALARM ULTRAFILTRATION SYSTEM TEST FAILURE ALARM ULTRAFILTRATION SYSTEM TEST FAILURE ALARM ULTRAFILTRATION SYSTEM TEST FAILURE ALARM during dialysis during dialysis during dialysis during dialysis

Message: UF TEST FAILEDMessage: UF TEST FAILEDMessage: UF TEST FAILEDMessage: UF TEST FAILED



CausesCausesCausesCauses - The ultrafiltration system may have a failure. - Possible damage to Forclean(s). - Possible presence of air in the hydraulic circuit. - Possible leak in the hydraulic circuit.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the integrity of the Forclean(s).

- Press

repeat test

and eventually perform a filling of the cartridge.

REPLACE REPLACE REPLACE REPLACE ULTRAFILTER ULTRAFILTER ULTRAFILTER ULTRAFILTER FORCLEAN ALARM FORCLEAN ALARM FORCLEAN ALARM FORCLEAN ALARM during during during during rins rins rins rinsinginginging

MMMMESSAGEESSAGEESSAGEESSAGE:::: REPLACEREPLACEREPLACEREPLACE FORCLEANFORCLEANFORCLEANFORCLEAN


Visual warning Acoustic warning Rinse time interrupted Unable to select treatments. dialyser bypass

CausesCausesCausesCauses - A number of hours equal to the maximum

configured has passed since the ultrafilter(s) was(were) last replaced.

- The Forclean ultrafilter(s) has(have) totalled a number of hours of dialysis exceeding the maximum configured.

Suggested actionsSuggested actionsSuggested actionsSuggested actions

- Press to cancel the alert and replace the ultrafilter(s).

MISSING MISSING MISSING MISSING FORCLEAN ALARM FORCLEAN ALARM FORCLEAN ALARM FORCLEAN ALARM during rinsing during rinsing during rinsing during rinsing

MMMMESSAGEESSAGEESSAGEESSAGE:::: FORCLEANFORCLEANFORCLEANFORCLEAN ABSENTABSENTABSENTABSENT


Visual warning Acoustic warning Rinse time interrupted Unable to select treatments. dialyser bypass

CausesCausesCausesCauses - "Forclean I” ultrafilter not detected. - Incorrect installation of “Forclean i” ultrafilter.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Insert the ultrafilter in its holder. - Check positioning of the ultrafilter.

- Press to cancel the warning.


INCORRECT DIALYSATE INFUSION ALARMINCORRECT DIALYSATE INFUSION ALARMINCORRECT DIALYSATE INFUSION ALARMINCORRECT DIALYSATE INFUSION ALARM in priming, dialysis and rinseback of onin priming, dialysis and rinseback of onin priming, dialysis and rinseback of onin priming, dialysis and rinseback of on----line haemodiafiltration treatmentsline haemodiafiltration treatmentsline haemodiafiltration treatmentsline haemodiafiltration treatments

MMMMESSAGEESSAGEESSAGEESSAGE:::: DIALYSATEDIALYSATEDIALYSATEDIALYSATE INFUSIONINFUSIONINFUSIONINFUSION

EffectsEffectsEffectsEffects Visual warning Acoustic warning infusion pump stop dialyser bypass dialysis time interrupted

CausesCausesCausesCauses

- During priming:

Priming is not carried out at the established infusion flow rate.

- During dialysis: The bolus is not infused at a flow rate consistent with the set Qb value.

- In Rinseback with ultrapure dialysis fluid: Reinfusion is not carried out at the established infusion flow rate.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - During priming: Increase the value set for Qinf. During dialysis:

- Check the value set for Qb. - Check the value set for Qinf.

START [Na] WITH AEQUILIBRIUM ALARMSTART [Na] WITH AEQUILIBRIUM ALARMSTART [Na] WITH AEQUILIBRIUM ALARMSTART [Na] WITH AEQUILIBRIUM ALARM in in in in HFR dialysis with Profiler and Aequilibrium enabledHFR dialysis with Profiler and Aequilibrium enabledHFR dialysis with Profiler and Aequilibrium enabledHFR dialysis with Profiler and Aequilibrium enabled

MMMMESSAGEESSAGEESSAGEESSAGE:::: STARTSTARTSTARTSTART [N[N[N[NAAAA]]]]

EffectsEffectsEffectsEffects Visual warning Acoustic warning

CausesCausesCausesCauses - The sodium concentration measured by Natrium

shows a difference of at least 3mEq/L against the initial concentration set.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Press “yes” to enable the profile recount, or "no"

to continue with the profiling in progress.


DIALYSATE TECHNICAL ALARM CODE XXX:XXXDIALYSATE TECHNICAL ALARM CODE XXX:XXXDIALYSATE TECHNICAL ALARM CODE XXX:XXXDIALYSATE TECHNICAL ALARM CODE XXX:XXX in all machine in all machine in all machine in all machine statesstatesstatesstates

MMMMESSAGEESSAGEESSAGEESSAGE:::: TECHNICALTECHNICALTECHNICALTECHNICAL ALARMALARMALARMALARM XXX:XXXXXX:XXXXXX:XXXXXX:XXX

EffectsEffectsEffectsEffects Visual warning Acoustic warning Dialyser bypass Rinsing/dialysis time interrupted

CausesCausesCausesCauses - Signal conformity tests on the dialysate side failed .


- If possible, press to clear the alarm. - If the alarm persists, note down the alarm code

XXX:XXX and contact After-sales Service.

HYDRAULIC ALARM XXXHYDRAULIC ALARM XXXHYDRAULIC ALARM XXXHYDRAULIC ALARM XXX in dialysis, rinsing and in dialysis, rinsing and in dialysis, rinsing and in dialysis, rinsing and disinfectiondisinfectiondisinfectiondisinfection/cleaning/cleaning/cleaning/cleaning

MMMMESSAGEESSAGEESSAGEESSAGE:::: HYDRAULICHYDRAULICHYDRAULICHYDRAULIC XXXXXXXXXXXX

EffectsEffectsEffectsEffects Visual warning Acoustic warning Dialyser bypass Rinsing/dialysis time interrupted

CausesCausesCausesCauses - Bypass state not conform with machine state .



XXX and contact After-sales Service.


WARNINGSWARNINGSWARNINGSWARNINGS

UNSUITABLE WATER WARNINGUNSUITABLE WATER WARNINGUNSUITABLE WATER WARNINGUNSUITABLE WATER WARNING during rinsing during rinsing during rinsing during rinsing

Message: WATER UNSUITABLEMessage: WATER UNSUITABLEMessage: WATER UNSUITABLEMessage: WATER UNSUITABLE


Visual warning Acoustic warning

CausesCausesCausesCauses - The inlet water conductivity is higher than the

permitted limit. - Dialysis liquid is left inside the machine during

post-dialysis rinsing.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the water distribution system. - Wait for rinsing end. The warning disappears

automatically.

BACKFILTRATION WARNINGBACKFILTRATION WARNINGBACKFILTRATION WARNINGBACKFILTRATION WARNING during dialysisduring dialysisduring dialysisduring dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: BACKFILTRATIONBACKFILTRATIONBACKFILTRATIONBACKFILTRATION



CausesCausesCausesCauses - The TMP value has exceeded the threshold set

in configuration.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Change the blood flow and/or dialysis fluid flow

and, if necessary, reset the ultrafiltration program.

- Check that the UF program is in accordance with the dialyser being used.

DIALYSER BYPASS WARNINGDIALYSER BYPASS WARNINGDIALYSER BYPASS WARNINGDIALYSER BYPASS WARNING during priming and dialysisduring priming and dialysisduring priming and dialysisduring priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: BYPASSBYPASSBYPASSBYPASS


Acoustic warning Visual warning dialyser bypass dialysis time interrupted

WARNINGWARNINGWARNINGWARNING The acoustic warning is The acoustic warning is The acoustic warning is The acoustic warning is disabled during filter change.disabled during filter change.disabled during filter change.disabled during filter change.


- The key has been pressed.


- Press again to disable the function.


DISINFECTION DISINFECTION DISINFECTION DISINFECTION WARNING WARNING WARNING WARNING (not Therapy model) or (not Therapy model) or (not Therapy model) or (not Therapy model) or MAINTENANCE MAINTENANCE MAINTENANCE MAINTENANCE WARNING WARNING WARNING WARNING (Therapy model)(Therapy model)(Therapy model)(Therapy model) during during during during disinfection/cleaning disinfection/cleaning disinfection/cleaning disinfection/cleaning

Message: Message: Message: Message: DISINFECTION (not Therapy model) or DISINFECTION (not Therapy model) or DISINFECTION (not Therapy model) or DISINFECTION (not Therapy model) or Message: Message: Message: Message: MAINTENANCE (Therapy model)MAINTENANCE (Therapy model)MAINTENANCE (Therapy model)MAINTENANCE (Therapy model)



CausesCausesCausesCauses - Disinfection/cleaning not completed correctly

since the machine could not detect the disinfectant or descaler within a set time period.

- The disinfectant or descaler uptaken does not match that selected.

- The suitable temperature for heat disinfection has not been reached.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the disinfectant or descaler used

matches that selected. - Check that the concentration of the disinfectant

or descaler is correct.

- Press to cancel the warning. - Restart the disinfection or descaling process.

END UF WARNINGEND UF WARNINGEND UF WARNINGEND UF WARNING during dialysisduring dialysisduring dialysisduring dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: ENDENDENDEND UFUFUFUF



CausesCausesCausesCauses - The UF program time has run out.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Re-set a new ultrafiltration program or

disconnect the patient.

CONCENCONCENCONCENCONCENTRATE PUMP REVOLUTIONS TRATE PUMP REVOLUTIONS TRATE PUMP REVOLUTIONS TRATE PUMP REVOLUTIONS during rinse and disinfection/cleaningduring rinse and disinfection/cleaningduring rinse and disinfection/cleaningduring rinse and disinfection/cleaning

MMMMESSAGEESSAGEESSAGEESSAGE:::: PUMPPUMPPUMPPUMP REVOLUTIONSREVOLUTIONSREVOLUTIONSREVOLUTIONS

EffectsEffectsEffectsEffects Visual warning Acoustic warning Rinsing/ disinfection time interrupted

CausesCausesCausesCauses - The concentrate pumps are locked.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Wait and eventually contact After-Sales Service.


DISINFECTANT/DESCALER NOT UPTAKEN DISINFECTANT/DESCALER NOT UPTAKEN DISINFECTANT/DESCALER NOT UPTAKEN DISINFECTANT/DESCALER NOT UPTAKEN WARNINGWARNINGWARNINGWARNING in disinfection/cleaningin disinfection/cleaningin disinfection/cleaningin disinfection/cleaning

MMMMESSAGEESSAGEESSAGEESSAGE:::: DISINFECTANTDISINFECTANTDISINFECTANTDISINFECTANT NOTNOTNOTNOT INTAKENINTAKENINTAKENINTAKEN


CausesCausesCausesCauses - The disinfectant or descaler has not been drawn

correctly.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that there is disinfectant or descaler in

the container. - Check that there is no air in the

disinfectant/descaler suction tube. - Check that the disinfectant/descaler suction

tube is not clogged or squashed. - Contact After-Sales Service .

INFUSION CONNECTOR INFUSION CONNECTOR INFUSION CONNECTOR INFUSION CONNECTOR WARNING WARNING WARNING WARNING (Therapy model only)(Therapy model only)(Therapy model only)(Therapy model only) during rinsingduring rinsingduring rinsingduring rinsing

Message: INFUSION CONNECTORMessage: INFUSION CONNECTORMessage: INFUSION CONNECTORMessage: INFUSION CONNECTOR

Effects

Visual warning Acoustic warning dialyser bypass Rinsing time interrupted

CausesCausesCausesCauses - Infusion connector window not closed correctly

or not in correct position for the operational phase of the machine.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the position of the infusion connector

window.

TESTING TEMPERATURE INSUFFICIENT WARNINGTESTING TEMPERATURE INSUFFICIENT WARNINGTESTING TEMPERATURE INSUFFICIENT WARNINGTESTING TEMPERATURE INSUFFICIENT WARNING during rinsing during rinsing during rinsing during rinsing

MMMMESSAGEESSAGEESSAGEESSAGE:::: TESTINGTESTINGTESTINGTESTING TEMP.TEMP.TEMP.TEMP. INSUF.INSUF.INSUF.INSUF.


CausesCausesCausesCauses - The perfect temperature for execution of the

autodiagnostic tests has not been reached.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Contact After-Sales Service .


SYSTEM READY WARNING SYSTEM READY WARNING SYSTEM READY WARNING SYSTEM READY WARNING during rinsing during rinsing during rinsing during rinsing

Message: SYSTEM READYMessage: SYSTEM READYMessage: SYSTEM READYMessage: SYSTEM READY

EffectsEffectsEffectsEffects Acoustic warning Visual warning

CausesCausesCausesCauses - The tests have been completed successfully.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - The system is ready to be programmed.

MINIMUM UF WARNINGMINIMUM UF WARNINGMINIMUM UF WARNINGMINIMUM UF WARNING during dialysis during dialysis during dialysis during dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: MINIMALMINIMALMINIMALMINIMAL UFUFUFUF


Acoustic warning (the time delay between one alert and the next can be either 20 seconds or 2 minutes depending on the parameter set during configuration for acoustic minimum UF alert) Minimum UF

CausesCausesCausesCauses - The ultrafiltration program has been

deactivated

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Activate or re-activate the ultrafiltration

program with the function key

uf on

.

UF NOT ACTIVATED WARNINGUF NOT ACTIVATED WARNINGUF NOT ACTIVATED WARNINGUF NOT ACTIVATED WARNING dudududuring dialysisring dialysisring dialysisring dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: UFUFUFUF NOTNOTNOTNOT ACTIVATEDACTIVATEDACTIVATEDACTIVATED


Acoustic warning Minimum UF

CausesCausesCausesCauses - The ultrafiltration program has been set but not

enabled.


- Press

uf on

.


UF NOT PROGRAMMED WARNINGUF NOT PROGRAMMED WARNINGUF NOT PROGRAMMED WARNINGUF NOT PROGRAMMED WARNING during dialysis during dialysis during dialysis during dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: UFUFUFUF NOTNOTNOTNOT PROGRAMMEDPROGRAMMEDPROGRAMMEDPROGRAMMED


Acoustic warning Minimum UF

CausesCausesCausesCauses - The ultrafiltration program has not been set.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Set and activate the ultrafiltration program.

WAITING FOR RINSING WAITING FOR RINSING WAITING FOR RINSING WAITING FOR RINSING WARNINGWARNINGWARNINGWARNING duringduringduringduring centralised disinfection centralised disinfection centralised disinfection centralised disinfection

MMMMESSAGEESSAGEESSAGEESSAGE:::: WAITINGWAITINGWAITINGWAITING FORFORFORFOR RINSINGRINSINGRINSINGRINSING



CausesCausesCausesCauses - The machine is waiting for the start of the

rinsing phase during centralised disinfection.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - The machine automatically restarts as soon as

the waiting for rinsing time set in configuration has elapsed.

- If the time set is = 0, manually activate rinsing:

press

continue

.

MAXIMUM TRANSMEMBRANE PRESSURE MAXIMUM TRANSMEMBRANE PRESSURE MAXIMUM TRANSMEMBRANE PRESSURE MAXIMUM TRANSMEMBRANE PRESSURE OUT OF RANGEOUT OF RANGEOUT OF RANGEOUT OF RANGE WARNING WARNING WARNING WARNING during dialysis DN, HFR, HDFduring dialysis DN, HFR, HDFduring dialysis DN, HFR, HDFduring dialysis DN, HFR, HDF and online haemodiafiltration and online haemodiafiltration and online haemodiafiltration and online haemodiafiltration

Message: TMP Message: TMP Message: TMP Message: TMP MAX.MAX.MAX.MAX.



CausesCausesCausesCauses - The maximum TMP measured on the dialyser

has exceeded the permitted limit. - Possible dialyser clogging. - Blood flow and/or hourly UF and/or infusion

flow too high.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the condition of the dialyser. - Reduce the blood flow. - Reduce the hourly UF. - Reduce the infusion flow


INCORRECINCORRECINCORRECINCORRECT PROFILE WARNINGT PROFILE WARNINGT PROFILE WARNINGT PROFILE WARNING during dialysis with profiles during dialysis with profiles during dialysis with profiles during dialysis with profiles

MMMMESSAGEESSAGEESSAGEESSAGE:::: VERIFYVERIFYVERIFYVERIFY PROFILEPROFILEPROFILEPROFILE



CausesCausesCausesCauses - The resulting profile differs from the

programmed one because some parameters are out of the settable range.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the set values and the rusulting profile. - Refer to the par. “Verify profile warning

message” in the chap. “Profiles”.

AEQUILIBRIUMAEQUILIBRIUMAEQUILIBRIUMAEQUILIBRIUM/ISONATRIC/ISONATRIC/ISONATRIC/ISONATRIC NOT AVAILABLE NOT AVAILABLE NOT AVAILABLE NOT AVAILABLE WARNINGWARNINGWARNINGWARNING in HFR dialysis with Profiler and Aequilibrium in HFR dialysis with Profiler and Aequilibrium in HFR dialysis with Profiler and Aequilibrium in HFR dialysis with Profiler and Aequilibrium or Isonatric or Isonatric or Isonatric or Isonatric enabledenabledenabledenabled

MMMMESSAGEESSAGEESSAGEESSAGE:::: AEQUAEQUAEQUAEQUILILILIL/ISONA/ISONA/ISONA/ISONA NNNNOTOTOTOT AVAIL.AVAIL.AVAIL.AVAIL.



- The ultrafilter temperature and/or conductivity levels measured by Natrium prevent the automatic total conductivity profile recount.



REPLACE MULTIPURE REPLACE MULTIPURE REPLACE MULTIPURE REPLACE MULTIPURE WARNINGWARNINGWARNINGWARNING during rinsing during rinsing during rinsing during rinsing

MMMMESSAGEESSAGEESSAGEESSAGE:::: REPLACEREPLACEREPLACEREPLACE MULTIPUREMULTIPUREMULTIPUREMULTIPURE


Acoustic warning Window appears showing information on the filter status.

CausesCausesCausesCauses - At least 580 hours have passed since the last

replacement of the filter.


- Press to cancel the alert and replace the filter at the end of the following dialysis or within the deadline of 600 hours.


REPLACE FORCLEAN REPLACE FORCLEAN REPLACE FORCLEAN REPLACE FORCLEAN WARNINGWARNINGWARNINGWARNING during rinsduring rinsduring rinsduring rinsinginginging

MMMMESSAGEESSAGEESSAGEESSAGE:::: REPLACEREPLACEREPLACEREPLACE FORCLEANFORCLEANFORCLEANFORCLEAN


Acoustic warning Window appears showing information on the filter status.

CausesCausesCausesCauses - Less than 20 hours remaining until reaching the

maximum number of hours configured since the last replacement of the ultrafilter(s).

- The ultrafilter(s) has(have) totalled at least a number of hours of dialysis equal to 20 hours less than the maximum number of hours configured.


- Press to cancel the alert and replace the ultrafilter(s) at the end of the following dialysis or within the deadline of the maximum number of hours configured.

MISSING FORCLEAN ALERT MISSING FORCLEAN ALERT MISSING FORCLEAN ALERT MISSING FORCLEAN ALERT WARNING WARNING WARNING WARNING during rinsing during rinsing during rinsing during rinsing

MMMMESSAGEESSAGEESSAGEESSAGE:::: FORCLEANFORCLEANFORCLEANFORCLEAN ABSENTABSENTABSENTABSENT


Acoustic warning

CausesCausesCausesCauses - "Forclean i” ultrafilter not detected. - Incorrect installation of “Forclean i” ultrafilter.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Insert the ultrafilter into its holder. - Check positioning of ultrafilter.


ENG – Ed. 06/09 chap. 10.3 – Alarms and warnings – Blood Section - 1 of 30

10.3 ALARMS AND WARNINGS 10.3 ALARMS AND WARNINGS 10.3 ALARMS AND WARNINGS 10.3 ALARMS AND WARNINGS –––– BLOOD SECTION BLOOD SECTION BLOOD SECTION BLOOD SECTION

ALARMSALARMSALARMSALARMS

CLAMP OPEN ALARMCLAMP OPEN ALARMCLAMP OPEN ALARMCLAMP OPEN ALARM during dialysis during dialysis during dialysis during dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: CLAMPCLAMPCLAMPCLAMP OPENOPENOPENOPEN


Visual warning Continuous acoustic warning Blood pump stop

CausCausCausCauseseseses - The clamp was open during an alarm.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Release the clamp. - Check for mechanical obstructions

BLD ALARMBLD ALARMBLD ALARMBLD ALARM during dialysis during dialysis during dialysis during dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: BLDBLDBLDBLD


Visual warning Acoustic warning Blood pump stop dialyser bypass Clamp closure dialysis time interrupted

CausesCausesCausesCauses - Dialyser membrane broken. - Air in the detecting device.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check for blood leaks at the dialyser outlet, or

air intake by the dialyser connectors. - If necessary, replace the dialyser.

ARTERIAL ARTERIAL ARTERIAL ARTERIAL PUMP COVER ALARMPUMP COVER ALARMPUMP COVER ALARMPUMP COVER ALARM during priming and dialysisduring priming and dialysisduring priming and dialysisduring priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: ART.ART.ART.ART. PUMPPUMPPUMPPUMP COVERCOVERCOVERCOVER

EffectsEffectsEffectsEffects Visual warning Acoustic warning Blood pump stop Dialyser bypass Clamp closure Dialysis time interrupted

CausesCausesCausesCauses - The arterial pump cover is open or not properly

closed.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Close the cover.

2 of 30 – chap. 10.3 – Alarms and warnings – Blood Section ENG – Ed. 06/09

END HEPARIN ALARMEND HEPARIN ALARMEND HEPARIN ALARMEND HEPARIN ALARM during dialysis during dialysis during dialysis during dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: HEPARINHEPARINHEPARINHEPARIN RUNRUNRUNRUN OUTOUTOUTOUT



CausesCausesCausesCauses - The syringe plunger has reached the end of

travel.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that there is heparin in the syringe and if

not, refill it.

ARTERIAL PUMP ROTATION ALARMARTERIAL PUMP ROTATION ALARMARTERIAL PUMP ROTATION ALARMARTERIAL PUMP ROTATION ALARM during priming and dialysis during priming and dialysis during priming and dialysis during priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: ARTERIALARTERIALARTERIALARTERIAL PUMPPUMPPUMPPUMP REVOL.REVOL.REVOL.REVOL.


CausesCausesCausesCauses - The arterial pump rotation speed is not

coherent with the blood flow set (the blood flow is too low or flow changes have been done abruptly.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Set a flow greater than 30 ml/min. - Make sure the line and pump segment are

installed correctly. - Contact After-Sales Service.

ARTERIAL LINE SETARTERIAL LINE SETARTERIAL LINE SETARTERIAL LINE SET----UP ALARMUP ALARMUP ALARMUP ALARM during priming and dialysisduring priming and dialysisduring priming and dialysisduring priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: WRONGWRONGWRONGWRONG ART.ART.ART.ART. LINELINELINELINE

EffectsEffectsEffectsEffects Visual warning Acoustic warning Blood pump stop Clamp closure Dialyser bypass Dialysis time interrupted

CausesCausesCausesCauses - The arterial line has not been installed properly.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Position arterial line in blood line detector.


BLOOD LEVEL ALARMBLOOD LEVEL ALARMBLOOD LEVEL ALARMBLOOD LEVEL ALARM during priming and dialysis during priming and dialysis during priming and dialysis during priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: BLOODBLOODBLOODBLOOD LEVELLEVELLEVELLEVEL


CausesCausesCausesCauses - Possible presence of foam in the venous drip

chamber. - The level in the venous drip chamber has

lowered. - No blood has been detected.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Restore the level using the relevant regulator. - Complete priming of the line. During priming, once at least one litre of priming volume has been circulated, an alarm intervenes together with the following warning notice:

This notice is to remind the user that the level alarm can be triggered by the presence of blood in the venous expansion chamber due to a lack of blood detected by the sensor installed. In this situation, before continuing, the user must check that the arterial line is correctly inserted and that the machine status has changed to CONNECT or DIALYSIS (shown on the blood section status bar).

ARTERIAL PRESSURE OUT OF RANGE ALARMARTERIAL PRESSURE OUT OF RANGE ALARMARTERIAL PRESSURE OUT OF RANGE ALARMARTERIAL PRESSURE OUT OF RANGE ALARM during dialysis during dialysis during dialysis during dialysis

Message: PA MINMAXMessage: PA MINMAXMessage: PA MINMAXMessage: PA MINMAX


CausesCausesCausesCauses - The arterial pressure is outside the maximum

and minimum operating thresholds.


- Press to restart the pump and recalculate the average venous pressure.

- Check that there are no obstructions along the arterial line and the needle is not disconnected.

After the patient has been connected, check that the machine is in CONNECT or DIALYSIS

mode. Check that the arterial line is\n correctly positioned in the blood detector


ARTERIAL PRESSURE OUT OF ARTERIAL PRESSURE OUT OF ARTERIAL PRESSURE OUT OF ARTERIAL PRESSURE OUT OF ABSOLUTE ABSOLUTE ABSOLUTE ABSOLUTE RANGE ALARM during priming and RANGE ALARM during priming and RANGE ALARM during priming and RANGE ALARM during priming and dialysis dialysis dialysis dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: PAPAPAPA OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE

EffectsEffectsEffectsEffects Visual warning Acoustic warning Blood pump stop dialyser bypass Clamp closure dialysis time interrupted

CausesCausesCausesCauses - The arterial pressure is outside the absolute

operating values. - When using machines with a double clamp, for non

single needle treatments, the arterial line must be inserted into the arterial clamp.

- Presence of closed clamps along the line.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the blood flow is not too high with

respect to the fistula capacity. - Remove the line from the arterial clamp or any

klemmers present.

DIALYSER INLET ARTERIAL PRESSURE OUT OF RANGE ALARM DIALYSER INLET ARTERIAL PRESSURE OUT OF RANGE ALARM DIALYSER INLET ARTERIAL PRESSURE OUT OF RANGE ALARM DIALYSER INLET ARTERIAL PRESSURE OUT OF RANGE ALARM during dialysisduring dialysisduring dialysisduring dialysis

Message: FIMessage: FIMessage: FIMessage: FILTER INLET PRESSURELTER INLET PRESSURELTER INLET PRESSURELTER INLET PRESSURE


CausesCausesCausesCauses - The dialyser inlet pressure is outside the operating

thresholds: if p<+20 mmHg, or if p>+770 mmHg

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check for dialyser obstruction.

- Press to restart the pump.

PUMP OFF ALARMPUMP OFF ALARMPUMP OFF ALARMPUMP OFF ALARM during priming and dialysis during priming and dialysis during priming and dialysis during priming and dialysis

Message: PUMP OFFMessage: PUMP OFFMessage: PUMP OFFMessage: PUMP OFF


Visual warning Acoustic warning Blood pump stop Dialyser bypass Clamp closure Dialysis time interrupted


- The key has been pressed. - The stop/end priming volume set has been

reached. - The patient is being disconnected.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check which of the above conditions has caused the

pump to lock.

- Press again to restart.


ABNORMAL SWITCHING PRESSURE ALARM ABNORMAL SWITCHING PRESSURE ALARM ABNORMAL SWITCHING PRESSURE ALARM ABNORMAL SWITCHING PRESSURE ALARM during priming and dialysis SNsp and SNdp during priming and dialysis SNsp and SNdp during priming and dialysis SNsp and SNdp during priming and dialysis SNsp and SNdp

Message: ABNORMAL COMM. PRESSUREMessage: ABNORMAL COMM. PRESSUREMessage: ABNORMAL COMM. PRESSUREMessage: ABNORMAL COMM. PRESSURE


CausesCausesCausesCauses - In SNsp, air is in the blood circuit. - In SNdp, the switching pressure has an irregular

trend (it increases during the arterial phase and decreases during the venous phase).

Suggested actionsSuggested actionsSuggested actionsSuggested actions - In SNsp, vent air out of the circuit. - In SNdp, make sure that line for measuring the

switching pressure is not obstructed. - In SNdp, make sure the blood catcher is not

wet. - In SNdp, make sure that the blood line is not

obstructed and that the dialyser is not clotted. - In SNdp, make sure air is not being sucked in

and no blood is leaking. - In SNdp, make sure the level in the drip

chambers is not too low.

HEPARIN INFUSION ALARMHEPARIN INFUSION ALARMHEPARIN INFUSION ALARMHEPARIN INFUSION ALARM during dialysisduring dialysisduring dialysisduring dialysis

MMMMESSAGE ESSAGE ESSAGE ESSAGE :::: HEPARINHEPARINHEPARINHEPARIN INFUSIONINFUSIONINFUSIONINFUSION


Visual warning Acoustic warning Stop heparin infusion

CausesCausesCausesCauses - The heparin pump drive does not correspond to

the set programmed.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check for any mechanical obstructions which

prevent heparin pump functioning. - Check functioning of the heparin pump using

the manual drive buttons.

- Press and re-enable the heparin if wishing to reactivate its infusion.


AIR DETECTION ALARMAIR DETECTION ALARMAIR DETECTION ALARMAIR DETECTION ALARM during dialysis during dialysis during dialysis during dialysis

Message: AIR DETECTEDMessage: AIR DETECTEDMessage: AIR DETECTEDMessage: AIR DETECTED


CausesCausesCausesCauses - The venous line is not properly positioned in

the air detector. - The detector situated on the venous line has

detected an air bubble greater than 100 µl. Suggested actionsSuggested actionsSuggested actionsSuggested actions DO NOT REMOVE THE LINE FROM THE DO NOT REMOVE THE LINE FROM THE DO NOT REMOVE THE LINE FROM THE DO NOT REMOVE THE LINE FROM THE ELECTROCLAMP.ELECTROCLAMP.ELECTROCLAMP.ELECTROCLAMP.

- Accurately position the venous line. - Identify the source of the air bubble. If air

bubbles are detected in the venous line, remove them in the following way:

a) Clamp the dialyser outlet tube. b) Clamp also the electroclamp outlet tube. c) Insert a syringe at the access point of the

venous drip chamber, open the clamp on the tube and release the pressure in the drip chamber.

d) Remove the clamp previously placed from the electroclamp outlet tube.

e) Manually open the electroclamp and simultaneously aspirate with the syringe. The negative pressure in the drip chamber will aspirate the air until it is completely removed.

f) If the key If the key If the key If the key has been pressed as a has been pressed as a has been pressed as a has been pressed as a consequence of an alarm, do not force the consequence of an alarm, do not force the consequence of an alarm, do not force the consequence of an alarm, do not force the clamp to pclamp to pclamp to pclamp to prevent the machine from blocking.revent the machine from blocking.revent the machine from blocking.revent the machine from blocking.

g) Remove the clamp previously placed on the dialyser outlet tube.

h) Close the clamp on the venous drip chamber and remove the syringe.

i) Press to restart.


VVVVENOUS PRESSURE OUT OF RANGE ALARMENOUS PRESSURE OUT OF RANGE ALARMENOUS PRESSURE OUT OF RANGE ALARMENOUS PRESSURE OUT OF RANGE ALARM during dialysis during dialysis during dialysis during dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: PVPVPVPV MINMAXMINMAXMINMAXMINMAX


CausesCausesCausesCauses - The venous pressure is outside the maximum

and minimum operating threshold.


- Press to restart the pump and recalculate the average venous pressure.

- Check if there are any obstructions along the venous line and, if necessary, remove them.

VENOUS PRESSURE OUT OF ABS. RANGE ALARMVENOUS PRESSURE OUT OF ABS. RANGE ALARMVENOUS PRESSURE OUT OF ABS. RANGE ALARMVENOUS PRESSURE OUT OF ABS. RANGE ALARM during priming and dialysis during priming and dialysis during priming and dialysis during priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: PVPVPVPV OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The venous pressure is outside the absolute

operating values. - During dialysis, the venous pressure is below a

set limit ( + 10 mmHg).

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check if there are any obstructions along the

venous line. - Check that the needle of the venous line has not

detached from the fistula. - Return the pressure within the permitted range

by adjusting the level in the venous drip chamber.

- Return the venous pressure above the +10

mmHg limit and press .


ARTERIAL PHASE TIMEOUT ALARM ARTERIAL PHASE TIMEOUT ALARM ARTERIAL PHASE TIMEOUT ALARM ARTERIAL PHASE TIMEOUT ALARM during priming and dialysis SNsp during priming and dialysis SNsp during priming and dialysis SNsp during priming and dialysis SNsp and SNdpand SNdpand SNdpand SNdp

Message: ARTERIAL PHASE TIMEOUTMessage: ARTERIAL PHASE TIMEOUTMessage: ARTERIAL PHASE TIMEOUTMessage: ARTERIAL PHASE TIMEOUT

EffectsEffectsEffectsEffects Visual warning Acoustic warning Blood pump stop dialyser bypass Clamp closure dialysis time interrupted

CausesCausesCausesCauses - In priming, the blood pump cycling has not been

carried out within the max. allowed time. - In dialysis, the blood pump has performed a

number of revolutions greater than the set limit before switching.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Make sure the line for measuring the switching

pressure is not obstructed - Make sure the blood catcher is not wet. - Make sure no air is being sucked into the blood

circuit or that blood is leaking. - In SNdp, make sure that the blood line is not

obstructed and that the dialyser is not clotted. - In SNdp, make sure the level in the drip chambers

is not too low. - In SNdp, make sure the needle is inserted correctly

into the vein and that there are no suction problems.

- In SNdp, make sure that the Time Out alarm value set in configuration is compatible with the set stroke (e.g. with a stroke equal to 40 ml, the time out alarm needs to be configured at least 40/10 +2 =6, where 10 is the delivery per revolution (in ml.) of the arterial pump.


INFUSION TIMEOUT ALARM during priming and SNsp and SNdp dialysisINFUSION TIMEOUT ALARM during priming and SNsp and SNdp dialysisINFUSION TIMEOUT ALARM during priming and SNsp and SNdp dialysisINFUSION TIMEOUT ALARM during priming and SNsp and SNdp dialysis

Message: VENOUS PHASE TIMEOUTMessage: VENOUS PHASE TIMEOUTMessage: VENOUS PHASE TIMEOUTMessage: VENOUS PHASE TIMEOUT


Visual warning Acoustic warning Blood pump stop Dialyser bypass Clamp closure Dialysis time interrupted

CausesCausesCausesCauses - The venous phase has exceeded the max. allowed

time. - In SNdp, the venous pump revolutions have

exceeded the maximum value set in configuration.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - In SNsp, check if there are any obstructions along

the switching pressure measurement line, or there is no air in the blood circuit, or the blood catcher is not wet.

- In SNsp, check if there are any obstructions along the venous line.

- In SNdp, make sure that the Out of Range alarm value set in configuration is compatible with the set stroke (e.g. with a stroke equal to 40 ml, the time out alarm needs to be configured at least 40/10 +2 = 6, where 10 is the delivery per revolution (in ml.) of the venous pump.

- Contact After-Sales Service .

BLOOD VOLUME ALARMBLOOD VOLUME ALARMBLOOD VOLUME ALARMBLOOD VOLUME ALARM during dialysis in SNsp during dialysis in SNsp during dialysis in SNsp during dialysis in SNsp and SNdpand SNdpand SNdpand SNdp

Message: BLOOD VOLUMEMessage: BLOOD VOLUMEMessage: BLOOD VOLUMEMessage: BLOOD VOLUME


Visual warning Acoustic warning Blood pump stop dialyser bypass Clamp closure dialysis time interrupted

CausesCausesCausesCauses - In SNsp, during the arterial phase (the pump is

running) the switching pressure has exceeded the max. threshold before the stroke.

- During the venous phase the switching pressure fell below the set minimum threshold.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - In SNsp, decrease the level in the expansion

chamber and the venous drip chamber. - In SNsp, increase the max. switching pressure

value. - In SNdp, make sure that the stroke set is suitable

for the line being used and if necessary decrease it. - In SNdp, reduce the levels in the drip chambers. - In SNdp, make sure that the blood line is not

obstructed and that the dialyser is not clotted.


END INFUSION ALARMEND INFUSION ALARMEND INFUSION ALARMEND INFUSION ALARM durdurdurdurinininingggg priming, dialysis and rinseback in priming, dialysis and rinseback in priming, dialysis and rinseback in priming, dialysis and rinseback in online PHF online PHF online PHF online PHF and online HDF and online HDF and online HDF and online HDF (Therapy(Therapy(Therapy(Therapy model model model model) ) ) ) –––– in in in in HHHHFR FR FR FR priming priming priming priming andandandand dial dial dial dialysisysisysisysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: ENDENDENDEND INFUSIONINFUSIONINFUSIONINFUSION

EffectsEffectsEffectsEffects Visual warning Acoustic warning infusion pump stop during on-line haemodiafiltration: dialyser bypass and dialysis time interrupted

CausesCausesCausesCauses - Air has been detected by the infusion end detector

along the line.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - During HFR and ON-LINE HDF, check that the line

used is the correct one for the selected treatment.

- During HFR and ON-LINE HDF, check the integrity of the infusion line and that it is correctly fitted.

- During HFR and ON-LINE HDF, check that the dialyser is not packed, in which case reduce the

infusion flow or replace the dialyser.

- Press to restart. EXCESSIVE LOAD ALARM EXCESSIVE LOAD ALARM EXCESSIVE LOAD ALARM EXCESSIVE LOAD ALARM during HDF dialysis during HDF dialysis during HDF dialysis during HDF dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: LOADLOADLOADLOAD EXCESSIVEEXCESSIVEEXCESSIVEEXCESSIVE


CausesCausesCausesCauses - A load heavier than 16 kg has been hung from the

scale.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Remove a bag of infusion liquid so that the load is

lighter than 16 kg.

- Press to restart.

INSUFFICIENT LOAD ALARMINSUFFICIENT LOAD ALARMINSUFFICIENT LOAD ALARMINSUFFICIENT LOAD ALARM during HDF priming and dialysisduring HDF priming and dialysisduring HDF priming and dialysisduring HDF priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: LOADLOADLOADLOAD INSUFFICIENTINSUFFICIENTINSUFFICIENTINSUFFICIENT


CausesCausesCausesCauses - The load suspended from the scale is less than 0.3

kg (bags are nearly empty).


- Add a new bag and press to restart. DO NOT REMOVE THE EMPTY BAGS.


MODIFIED LOAD ALARM MODIFIED LOAD ALARM MODIFIED LOAD ALARM MODIFIED LOAD ALARM during HDF dialysisduring HDF dialysisduring HDF dialysisduring HDF dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: LOADLOADLOADLOAD MODIFIEDMODIFIEDMODIFIEDMODIFIED


CauseCauseCauseCause - An increase or reduction in the load on the balance

greater than 1 kg has been detected.

Azioni suggeriteAzioni suggeriteAzioni suggeriteAzioni suggerite - Check that all bags have been properly connected.

- Press to restart.

UNSTABLE LOAD ALARMUNSTABLE LOAD ALARMUNSTABLE LOAD ALARMUNSTABLE LOAD ALARM during HDF during HDF during HDF during HDF dialysisdialysisdialysisdialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: LOADLOADLOADLOAD UNSTABLEUNSTABLEUNSTABLEUNSTABLE


CausesCausesCausesCauses - Unstable scale reading has been detected.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the bags hanging from the scale are not

swinging or being knocked continuously.

- Press to restart.

ABNORMAL LOAD ALARM ABNORMAL LOAD ALARM ABNORMAL LOAD ALARM ABNORMAL LOAD ALARM during HDF dialysisduring HDF dialysisduring HDF dialysisduring HDF dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: LOADLOADLOADLOAD ABNORMALABNORMALABNORMALABNORMAL


CausesCausesCausesCauses - An increase or reduction of the load on the scale of

between 0.2 and 1 kg has been detected.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Do not add or remove loads lighter than 1 kg. - Leave empty bags hanging on the scale.

- Press to restart.


INFUSION ERROR ALARMINFUSION ERROR ALARMINFUSION ERROR ALARMINFUSION ERROR ALARM during HDF dialysisduring HDF dialysisduring HDF dialysisduring HDF dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: INFUSIONINFUSIONINFUSIONINFUSION ERRORERRORERRORERROR


CausesCausesCausesCauses - An infusion error greater than 0.3 kg has been

detected.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check for possible leaks or obstructions along the

infusion line and verify effective patient weight loss using bed scale.

- Press to restart. If after a few minutes the alarm does not clear, complete the treatment in Double Needle.

EXCESSIVE INFUSION ALARMEXCESSIVE INFUSION ALARMEXCESSIVE INFUSION ALARMEXCESSIVE INFUSION ALARM during HDF dialysisduring HDF dialysisduring HDF dialysisduring HDF dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: EXCESSIVEEXCESSIVEEXCESSIVEEXCESSIVE INFUSIONINFUSIONINFUSIONINFUSION


CausesCausesCausesCauses - The infusion effected is greater than the value

foreseen for the set interval of time.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that there are no leaks from the bags. If leaks

are found, complete the treatment in Double Needle. - Check that the klemmers on the infusion line are not

closed.

- Press to restart.

INSUFFICIENT INFUSION ALARMINSUFFICIENT INFUSION ALARMINSUFFICIENT INFUSION ALARMINSUFFICIENT INFUSION ALARM during HDF dialysisduring HDF dialysisduring HDF dialysisduring HDF dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: INSUFFICIENTINSUFFICIENTINSUFFICIENTINSUFFICIENT INFUSIONINFUSIONINFUSIONINFUSION

EffectsEffectsEffectsEffects Visual warning Acoustic warning Infusion pump stop Dialyser bypass Dialysis time interrupted

CausesCausesCausesCauses - The infusion effected is less than the value foreseen

for the set interval of time.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that there are no obstructions on the infusion

line and that the pump segment is not crushed. - Check that the klemmers on the infusion line are not

closed.

- Press to restart.


INVERSE INFUSION ALARM INVERSE INFUSION ALARM INVERSE INFUSION ALARM INVERSE INFUSION ALARM during HDF dialysisduring HDF dialysisduring HDF dialysisduring HDF dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: INVERSEINVERSEINVERSEINVERSE INFUSIONINFUSIONINFUSIONINFUSION


CauseCauseCauseCausessss - The scale has detected an increase in weight of the

bags due to probable reverse infusion.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the infusion pump segment is not

blocked or installed in the wrong way.

- Press to restart.

INFUSION PUMP COVER ALARMINFUSION PUMP COVER ALARMINFUSION PUMP COVER ALARMINFUSION PUMP COVER ALARM during priming, dialysis and rinseback of haemodiafiltration during priming, dialysis and rinseback of haemodiafiltration during priming, dialysis and rinseback of haemodiafiltration during priming, dialysis and rinseback of haemodiafiltration

treatmentstreatmentstreatmentstreatments

MMMMESSAGEESSAGEESSAGEESSAGE:::: INFUSIONINFUSIONINFUSIONINFUSION PUMPPUMPPUMPPUMP COVERCOVERCOVERCOVER

Effects Visual warning Acoustic warning infusion pump stop dialyser bypass dialysis time interrupted

CausesCausesCausesCauses - The infusion pump cover is open or not properly

closed. Suggested actionsSuggested actionsSuggested actionsSuggested actions - Close the cover.

INFUSION PUMP ROTATION ALARMINFUSION PUMP ROTATION ALARMINFUSION PUMP ROTATION ALARMINFUSION PUMP ROTATION ALARM during priming and dialysisduring priming and dialysisduring priming and dialysisduring priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: INF.INF.INF.INF. PUMPPUMPPUMPPUMP ROTATIONROTATIONROTATIONROTATION NNNNOOOO....


CausesCausesCausesCauses - The speed of rotation of the infusion pump does

not match the set infusion flow. Suggested actionsSuggested actionsSuggested actionsSuggested actions - Make sure the line and pump segment are installed

correctly. - Contact After-Sales Service.


MAXIMUM VENOUS PRESSURE ALARM MAXIMUM VENOUS PRESSURE ALARM MAXIMUM VENOUS PRESSURE ALARM MAXIMUM VENOUS PRESSURE ALARM during SNdp dialysisduring SNdp dialysisduring SNdp dialysisduring SNdp dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: MAX.MAX.MAX.MAX. VEN.VEN.VEN.VEN. P.P.P.P.

EffectsEffectsEffectsEffects Visual warning Acoustic warning pumps stopped dialyser bypass Clamp closure dialysis time interrupted

CausesCausesCausesCauses - During the venous phase the venous pressure has

exceeded the set maximum threshold. Suggested actionsSuggested actionsSuggested actionsSuggested actions - Reduce the pump speed using the red flow

regulator.

VENOUS PUMP COVER ALARM VENOUS PUMP COVER ALARM VENOUS PUMP COVER ALARM VENOUS PUMP COVER ALARM during SNdp priming and dialysisduring SNdp priming and dialysisduring SNdp priming and dialysisduring SNdp priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: VEN.VEN.VEN.VEN. PUMPPUMPPUMPPUMP COVERCOVERCOVERCOVER


CausesCausesCausesCauses - The venous pump cover is open or incorrectly

closed. Suggested actionsSuggested actionsSuggested actionsSuggested actions - Close the cover.

VENOUS PUMP ROTATION ALARMVENOUS PUMP ROTATION ALARMVENOUS PUMP ROTATION ALARMVENOUS PUMP ROTATION ALARM during SNdp priming and dialysisduring SNdp priming and dialysisduring SNdp priming and dialysisduring SNdp priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: V.V.V.V. PUMPPUMPPUMPPUMP ROTATIONROTATIONROTATIONROTATION NNNNOOOO....


CausesCausesCausesCauses - The rotation speed of the venous pump does not

match the set blood flow. Suggested actionsSuggested actionsSuggested actionsSuggested actions - Make sure the line and pump segment are installed

correctly. - Contact After-Sales Service.


VENOUS SEGMENT ALARM VENOUS SEGMENT ALARM VENOUS SEGMENT ALARM VENOUS SEGMENT ALARM during SNdp rinsebackduring SNdp rinsebackduring SNdp rinsebackduring SNdp rinseback

MMMMESSAGEESSAGEESSAGEESSAGE:::: EXTRACTEXTRACTEXTRACTEXTRACT V.V.V.V. PUMPPUMPPUMPPUMP SEGMENTSEGMENTSEGMENTSEGMENT


CausesCausesCausesCauses - The switching pressure has exceeded the max. or

min. operating limits (-200, +300 mmHg). Suggested actionsSuggested actionsSuggested actionsSuggested actions - Remove the venous pump segment from its seat to

correctly carry out the rinseback procedure.

INFUSION PRESSURE OUT OF RANGEINFUSION PRESSURE OUT OF RANGEINFUSION PRESSURE OUT OF RANGEINFUSION PRESSURE OUT OF RANGE

during during during during priming, dialysis and rinseback in priming, dialysis and rinseback in priming, dialysis and rinseback in priming, dialysis and rinseback in online PHF and online online PHF and online online PHF and online online PHF and online HDF HDF HDF HDF (Therapy) (Therapy) (Therapy) (Therapy) –––– during HFR during HFR during HFR during HFR priming priming priming priming andandandand dial dial dial dialyyyysisisisissss

MMMMESSAGEESSAGEESSAGEESSAGE:::: INF.INF.INF.INF. PRESS.PRESS.PRESS.PRESS. OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE

EffectsEffectsEffectsEffects Visual warning Acoustic warning infusion pump stop during on-line haemodiafiltration: dialyser bypass and dialysis time interrupted

CausesCausesCausesCauses - Pressure out of range detected by the infusion

pressure transducer.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the line is the correct type for the

treatment carried out. - Check that the line has been correctly installed, in

particular that it is not clamped and the infusion pump segment has not been installed the wrong way round.

- Check that the blood catcher on the line is not clogged.

- Check that the infusion line is intact. If not, check the patient weight and suspend the treatment.

- During HFR, check for any adsorbent cartridge damage and then continue with Double Needle.

- If none of the above conditions are present, reduce the infusion flow.


ALARM: HFR LINE PRIME TIMEOUTALARM: HFR LINE PRIME TIMEOUTALARM: HFR LINE PRIME TIMEOUTALARM: HFR LINE PRIME TIMEOUT during during during during HFR priming HFR priming HFR priming HFR priming

MMMMESSAGEESSAGEESSAGEESSAGE:::: HFRHFRHFRHFR LINELINELINELINE PRIMEPRIMEPRIMEPRIME TIMEOUTTIMEOUTTIMEOUTTIMEOUT


Visual warning Acoustic warning stop UF/infusion pump

CausesCausesCausesCauses - The UF/infusion line has not been properly

primed.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the line is correctly installed, in

particular that it is correctly inserted in the end

infusion detector. Subsequently press .

ALARM: HFR LINE INCORRECTLY INSERTEDALARM: HFR LINE INCORRECTLY INSERTEDALARM: HFR LINE INCORRECTLY INSERTEDALARM: HFR LINE INCORRECTLY INSERTED during during during during HFR priming HFR priming HFR priming HFR priming

MMMMESSAGEESSAGEESSAGEESSAGE:::: WRONGWRONGWRONGWRONG HFRHFRHFRHFR LINELINELINELINE INSERTIONINSERTIONINSERTIONINSERTION

EffectsEffectsEffectsEffects Visual warning Acoustic warning stop UF/infusion pump

CausesCausesCausesCauses - The UF/infusion line is incorrectly inserted.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the line inserted in the blood leak

detector is the UF/infusion line required for HFR treatment.

- Check that the line is correctly installed, in particular check that it is correctly inserted in the blood leak detector. Subsequently press

.


ALARM: BLOOD DETECTED IN INFUSION LINEALARM: BLOOD DETECTED IN INFUSION LINEALARM: BLOOD DETECTED IN INFUSION LINEALARM: BLOOD DETECTED IN INFUSION LINE during during during during HFR dialysis HFR dialysis HFR dialysis HFR dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: BLOODBLOODBLOODBLOOD DET.DET.DET.DET. ININININ INF.INF.INF.INF. LINELINELINELINE

EffectsEffectsEffectsEffects Visual warning Acoustic warning Stop UF/infusion pump Blood pump stop Dialysis time interrupted Dialyser bypass

CausesCausesCausesCauses - A rupture of the haemofilter has probably

occurred.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Remove any residual air bubbles from the blood

leak detector. - Check that the line inserted in the blood leak

detector is the UF/infusion line required for HFR treatment.

- Check that the line has been correctly installed, in particular check that the UF/infusion pump segment has not been installed the wrong way round.

- Check for possible rupture of the haemofilter (convective section). In case of rupture, continue the treatment in Double Needle.

ALARM: UF/INFUSION FLOW TOO HIGH ALARM: UF/INFUSION FLOW TOO HIGH ALARM: UF/INFUSION FLOW TOO HIGH ALARM: UF/INFUSION FLOW TOO HIGH in HFR dialysisin HFR dialysisin HFR dialysisin HFR dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: INADEQUATEINADEQUATEINADEQUATEINADEQUATE FLOWSFLOWSFLOWSFLOWS

EffectsEffectsEffectsEffects Visual warning Acoustic warning UF/infusion pump stop

CausesCausesCausesCauses - Air in the UF/infusion line.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Reduce the infusion flow. - If the problem persists, further reduce the

infusion flow and possibly stop the UF/infusion pump for a few minutes.

- Remove any residual microbubbles from the end infusion sensor.

ALARM: TRANSMEMBRANE PRESSURE HFR OUT OF RANGE ALARM: TRANSMEMBRANE PRESSURE HFR OUT OF RANGE ALARM: TRANSMEMBRANE PRESSURE HFR OUT OF RANGE ALARM: TRANSMEMBRANE PRESSURE HFR OUT OF RANGE in HFR dialysisin HFR dialysisin HFR dialysisin HFR dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: TMPHTMPHTMPHTMPH OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE

EffectsEffectsEffectsEffects Visual warning Acoustic warning UF/infusion pump stop

CausesCausesCausesCauses - The transmembrane pressure measured on the

hemofilter is outside the operating thresholds.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check if the hemofilter has clogged.

- Press to restart the pump.


ALARM: HFR LINE INCORRECTLY INSERTEDALARM: HFR LINE INCORRECTLY INSERTEDALARM: HFR LINE INCORRECTLY INSERTEDALARM: HFR LINE INCORRECTLY INSERTED (not Therapy model) (not Therapy model) (not Therapy model) (not Therapy model) in PHF primingin PHF primingin PHF primingin PHF priming

MMMMESSAGEESSAGEESSAGEESSAGE:::: WRONGWRONGWRONGWRONG INF.INF.INF.INF. LINELINELINELINE INSERTIONINSERTIONINSERTIONINSERTION

EffectsEffectsEffectsEffects Visual warning Acoustic warning Infusion pump stop

CausesCausesCausesCauses - The infusion line is incorrectly inserted.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the line inserted into the blood leak

detector is the infusion line required by PHF treatment.

- Check that the line is correctly installed, in particular check that it is correctly inserted in the blood leak detector. Subsequently

. INCORRECT DIALYSATE INFUSION ALARMINCORRECT DIALYSATE INFUSION ALARMINCORRECT DIALYSATE INFUSION ALARMINCORRECT DIALYSATE INFUSION ALARM

in PHF priming in PHF priming in PHF priming in PHF priming and dialysis and in rinseback with ultrapure dialysis fluidand dialysis and in rinseback with ultrapure dialysis fluidand dialysis and in rinseback with ultrapure dialysis fluidand dialysis and in rinseback with ultrapure dialysis fluid

MMMMESSAGEESSAGEESSAGEESSAGE:::: DIALYSATEDIALYSATEDIALYSATEDIALYSATE INFUSIONINFUSIONINFUSIONINFUSION


CausesCausesCausesCauses - During priming:

Priming is not carried out at the established infusion flow rate.

- During dialysis: The infusion bolus is not produced at a flow level that matches the set Qb.

- In Rinseback with ultrapure dialysis fluid: Reinfusion is not carried out at the established infusion flow rate.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - During priming: Increase the value set for Qinf. - During dialysis: Check the value set for Qb. Check the value set for Qinf.


TIMEOUT FOR INFUSION LINE PRITIMEOUT FOR INFUSION LINE PRITIMEOUT FOR INFUSION LINE PRITIMEOUT FOR INFUSION LINE PRIMING/PHF FILTER TEST ALARM (non MING/PHF FILTER TEST ALARM (non MING/PHF FILTER TEST ALARM (non MING/PHF FILTER TEST ALARM (non Therapy Therapy Therapy Therapy models only) during PHF priming and dialysismodels only) during PHF priming and dialysismodels only) during PHF priming and dialysismodels only) during PHF priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: INF.INF.INF.INF. LINELINELINELINE TESTTESTTESTTEST TIMETIMETIMETIMEOUTOUTOUTOUT


CausesCausesCausesCauses - The infusion line has not been properly primed.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the line is correctly installed, in particular

that it is correctly inserted in the end infusion

detector. Subsequently press .

BLOOD SIDE TECHNICAL ALARM CODE XXX:XXXBLOOD SIDE TECHNICAL ALARM CODE XXX:XXXBLOOD SIDE TECHNICAL ALARM CODE XXX:XXXBLOOD SIDE TECHNICAL ALARM CODE XXX:XXX in all machine in all machine in all machine in all machine statesstatesstatesstates

MMMMESSAGEESSAGEESSAGEESSAGE:::: TECHNICALTECHNICALTECHNICALTECHNICAL ALARMALARMALARMALARM XXX:XXXXXX:XXXXXX:XXXXXX:XXX

EffectsEffectsEffectsEffects Visual warning Acoustic warning Blood pump stop Rinsing/dialysis time interrupted Dialyser bypass

CausesCausesCausesCauses - Signal conformity tests on the blood side failed .



XXX:XXX and contact After-sales Service.


WARNINGS WARNINGS WARNINGS WARNINGS

HEPARIN NOT ACTIVE WARNINGHEPARIN NOT ACTIVE WARNINGHEPARIN NOT ACTIVE WARNINGHEPARIN NOT ACTIVE WARNING during dialysisduring dialysisduring dialysisduring dialysis

Message: HEPARIN OFFMessage: HEPARIN OFFMessage: HEPARIN OFFMessage: HEPARIN OFF



CausesCausesCausesCauses - The heparin program has not been activated. - The pre-stop heparin value has been reached.


- Press

heparin on

. - Reduce the pre-stop time or increase the

duration of the treatment.

HEPARIN NOT SET WARNINGHEPARIN NOT SET WARNINGHEPARIN NOT SET WARNINGHEPARIN NOT SET WARNING during dialysisduring dialysisduring dialysisduring dialysis

Message: NO HEPARIN SETTINGMessage: NO HEPARIN SETTINGMessage: NO HEPARIN SETTINGMessage: NO HEPARIN SETTING



CausesCausesCausesCauses - The heparin program has not been set.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Set the heparin infusion flow rate.

BLOOD FLOW SET TO ZERO ALERTBLOOD FLOW SET TO ZERO ALERTBLOOD FLOW SET TO ZERO ALERTBLOOD FLOW SET TO ZERO ALERT during priming and dialysisduring priming and dialysisduring priming and dialysisduring priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: FLOWFLOWFLOWFLOW SETSETSETSET TOTOTOTO ZEROZEROZEROZERO

EffectsEffectsEffectsEffects Visual warning Acoustic warning Blood pump stop Dialyser bypass Dialysis time interrupted Clamp closure

CausesCausesCausesCauses - Blood flow is set to zero.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Set the flow rate to a value different from 0 by

using the arterial pump flow regulator.


BLOOD FLOW INADEQUATE WARNING BLOOD FLOW INADEQUATE WARNING BLOOD FLOW INADEQUATE WARNING BLOOD FLOW INADEQUATE WARNING during priming and dialysis during priming and dialysis during priming and dialysis during priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: INADEQUATEINADEQUATEINADEQUATEINADEQUATE BLOODBLOODBLOODBLOOD FLOWFLOWFLOWFLOW

EffectsEffectsEffectsEffects Visual warning Acoustic warning Intermittent blood pump stop

CausesCausesCausesCauses - The arterial pressure is less than – 250 mmHg

and the blood pump flow rate might not be congruent with the set value.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Decrease the blood flow using the flow

regulator.

MODIFY ARTERIAL FLOW ALERTMODIFY ARTERIAL FLOW ALERTMODIFY ARTERIAL FLOW ALERTMODIFY ARTERIAL FLOW ALERT during priming and during priming and during priming and during priming and dialysis dialysis dialysis dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: MODIFYMODIFYMODIFYMODIFY ARTERIALARTERIALARTERIALARTERIAL FLOWFLOWFLOWFLOW


CausesCausesCausesCauses - The blood flow has been changed during

alarm overriding with the key .

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Reset the blood flow to the original value or

modify it slightly.

BLOOD DETECTION WARNINGBLOOD DETECTION WARNINGBLOOD DETECTION WARNINGBLOOD DETECTION WARNING during dialysisduring dialysisduring dialysisduring dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: BLOODBLOODBLOODBLOOD DETECTEDDETECTEDDETECTEDDETECTED



CausesCausesCausesCauses - Blood has been detected along the arterial

line, but the dialysate section has not entered dialysis mode yet.

- The dialyser is not connected.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Activate preparation of the dialysis fluid. - Connect the dialyser.


ARTERIAL PRESSUREARTERIAL PRESSUREARTERIAL PRESSUREARTERIAL PRESSURE/PREFILTER/PREFILTER/PREFILTER/PREFILTER WARNING WARNING WARNING WARNING during dialysisduring dialysisduring dialysisduring dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: ART.ART.ART.ART. /FILTER/FILTER/FILTER/FILTER INLETINLETINLETINLET PRESSPRESSPRESSPRESS....


CausesCausesCausesCauses - In Single Needle with single clamp, a pressure has

been detected in the arterial pressure transducer. - In other treatments, there are no variations detected

in the arterial pressure measurement and/or the prefilter arterial pressure measurement (except SN for the latter).

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Disconnect the arterial pressure measurement line

(Single Needle with Single Clamp). - Properly insert the blood catcher in the arterial

pressure measurement connector and/or the prefilter arterial pressure connector and check that the blood catcher is not clogged (other treatments).

The control of the arterial pressure variation is not The control of the arterial pressure variation is not The control of the arterial pressure variation is not The control of the arterial pressure variation is not perperperperformed if the formed if the formed if the formed if the blood flow rate is < 10blood flow rate is < 10blood flow rate is < 10blood flow rate is < 100 ml/min.0 ml/min.0 ml/min.0 ml/min.

During treatments other than the single needle During treatments other than the single needle During treatments other than the single needle During treatments other than the single needle type (single clamp), alerts may be disabled by type (single clamp), alerts may be disabled by type (single clamp), alerts may be disabled by type (single clamp), alerts may be disabled by

pressing pressing pressing pressing

see/mod. parameters

blood

disable PA warning

. To . To . To . To

enable it, from the same menu, press enable it, from the same menu, press enable it, from the same menu, press enable it, from the same menu, press

enable PA warning

....

WARNINGWARNINGWARNINGWARNING DisablinDisablinDisablinDisabling the warning may result in failed g the warning may result in failed g the warning may result in failed g the warning may result in failed detection of arterial and/or prefilter pressure detection of arterial and/or prefilter pressure detection of arterial and/or prefilter pressure detection of arterial and/or prefilter pressure measurement problems.measurement problems.measurement problems.measurement problems.

LINE EMPTYING WARNING LINE EMPTYING WARNING LINE EMPTYING WARNING LINE EMPTYING WARNING during rinsebackduring rinsebackduring rinsebackduring rinseback

Message: BLOOD LINE EMPTYINGMessage: BLOOD LINE EMPTYINGMessage: BLOOD LINE EMPTYINGMessage: BLOOD LINE EMPTYING



CausesCausesCausesCauses - Emptying of the blood lines.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Proceed with patient rinseback, carefully paying

attention not to infuse air in blood.


INFUSION LINE PRESSURE WARNINGINFUSION LINE PRESSURE WARNINGINFUSION LINE PRESSURE WARNINGINFUSION LINE PRESSURE WARNING during HDF priming and dialysisduring HDF priming and dialysisduring HDF priming and dialysisduring HDF priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: ERRORERRORERRORERROR :::: INF.INF.INF.INF. LINELINELINELINE PRESSUREPRESSUREPRESSUREPRESSURE


CausesCausesCausesCauses - Abnormal pressure detected on the infusion

pressure transducer (not used in HDF).

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Disconnect the line if connected by mistake to the

transducer.

Kt/V MIN OUT OF RANGE Kt/V MIN OUT OF RANGE Kt/V MIN OUT OF RANGE Kt/V MIN OUT OF RANGE WARNINGWARNINGWARNINGWARNING during dialysisduring dialysisduring dialysisduring dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: KKKKTTTT/V/V/V/V MINMINMINMIN OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The Kt/V measured is less than the minimum set

Kt/V.


- Press to cancel the warning. - Check the set threshold.

Kt/V GOAL OUT OF RANGE Kt/V GOAL OUT OF RANGE Kt/V GOAL OUT OF RANGE Kt/V GOAL OUT OF RANGE WARNINGWARNINGWARNINGWARNING during dialysisduring dialysisduring dialysisduring dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: KKKKTTTT/V/V/V/V GOALGOALGOALGOAL OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The time required to reach the desired Kt/V

exceeds the set treatment time by more than 15 min.



CLEARANCECLEARANCECLEARANCECLEARANCE OUT OF RANGE OUT OF RANGE OUT OF RANGE OUT OF RANGE WARNINGWARNINGWARNINGWARNING during dialysisduring dialysisduring dialysisduring dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: KKKK MINMINMINMIN OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The clearance measured is less than the minimum

set




BLD DETECTOR LINE ERROR WARNINGBLD DETECTOR LINE ERROR WARNINGBLD DETECTOR LINE ERROR WARNINGBLD DETECTOR LINE ERROR WARNING in PHF priming and dialysis (not Therapy model) and in HFR priming and in PHF priming and dialysis (not Therapy model) and in HFR priming and in PHF priming and dialysis (not Therapy model) and in HFR priming and in PHF priming and dialysis (not Therapy model) and in HFR priming and dialysisdialysisdialysisdialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: ERRORERRORERRORERROR :::: INF.INF.INF.INF. BLDBLDBLDBLD


CausesCausesCausesCauses - The BLD has detected the absence of the infusion

line.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the line used is the infusion line

required for PHF treatment. - Check that the line is correctly installed, in

particular check that it is correctly inserted in the blood leak detector.

NO INFUSION FLOW WARNINGNO INFUSION FLOW WARNINGNO INFUSION FLOW WARNINGNO INFUSION FLOW WARNING dudududuring priming, dialysis and rinseback of haemodiafiltration ring priming, dialysis and rinseback of haemodiafiltration ring priming, dialysis and rinseback of haemodiafiltration ring priming, dialysis and rinseback of haemodiafiltration treatmentstreatmentstreatmentstreatments

MMMMESSAGEESSAGEESSAGEESSAGE:::: NONONONO INFUSIONINFUSIONINFUSIONINFUSION FLOWFLOWFLOWFLOW

EffectsEffectsEffectsEffects Visual warning Acoustic warning in priming Infusion pump stop Dialyser bypass Dialysis time interrupted

CausesCausesCausesCauses - The infusion flow regulator is at 0.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Set a flow other than 0.

INCOMPLETE INFUSION LINE PRIMING ALERT (not Therapy model)INCOMPLETE INFUSION LINE PRIMING ALERT (not Therapy model)INCOMPLETE INFUSION LINE PRIMING ALERT (not Therapy model)INCOMPLETE INFUSION LINE PRIMING ALERT (not Therapy model) in PHF dialysisin PHF dialysisin PHF dialysisin PHF dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: INCOMPL.INCOMPL.INCOMPL.INCOMPL. INF.INF.INF.INF. LINELINELINELINE PRIMINGPRIMINGPRIMINGPRIMING


CausesCausesCausesCauses - Priming of the infusion line has not been

completed.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the line has been correctly installed, in

particular check that it is correctly inserted in the end infusion detector and the blood leak detector.


EFFICIENCY WARNING EFFICIENCY WARNING EFFICIENCY WARNING EFFICIENCY WARNING during SNdp dialysis during SNdp dialysis during SNdp dialysis during SNdp dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: EFFICIENCYEFFICIENCYEFFICIENCYEFFICIENCY


CausesCausesCausesCauses - Cycle efficiency is out of range. Practically, due to

an excessive negative suction pressure, the arterial pump executes a much greater number of revolutions than the venous pump.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Make sure there are no suction problems on the

arterial line and if necessary reduce the pump speed using the red flow regulator.

- Check and, if necessary, adjust the set threshold.

SWITCHING PRESSURE WARNING SWITCHING PRESSURE WARNING SWITCHING PRESSURE WARNING SWITCHING PRESSURE WARNING during SNdp dialysis during SNdp dialysis during SNdp dialysis during SNdp dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: COMM.COMM.COMM.COMM. PRESSUREPRESSUREPRESSUREPRESSURE



CausesCausesCausesCauses - No variations have been detected in the

measurement of the switching pressure. Suggested actionsSuggested actionsSuggested actionsSuggested actions - Connect the line for measuring switching pressure. - Make sure the blood catcher is not wet. The control of the pressure variation is not The control of the pressure variation is not The control of the pressure variation is not The control of the pressure variation is not performed if the flow rate is < 150 ml/min.performed if the flow rate is < 150 ml/min.performed if the flow rate is < 150 ml/min.performed if the flow rate is < 150 ml/min.

WARNING: WEIGHT ON SCALEWARNING: WEIGHT ON SCALEWARNING: WEIGHT ON SCALEWARNING: WEIGHT ON SCALE in PHF priming and dialysis (not Therapy model) and in HFR priming and in PHF priming and dialysis (not Therapy model) and in HFR priming and in PHF priming and dialysis (not Therapy model) and in HFR priming and in PHF priming and dialysis (not Therapy model) and in HFR priming and dialysisdialysisdialysisdialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: ERRORERRORERRORERROR :::: WEIGHTWEIGHTWEIGHTWEIGHT ONONONON SCALESCALESCALESCALE


CausesCausesCausesCauses - The load hanging on the scale hooks is in excess of

6.0 kg.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the line used is the infusion line required

for the treatment in progress. - Check that the line is correctly installed, in particular

check that there are no bags hanging on the scale.


INCOMPLETE HFR LINE PRIMING ALERTINCOMPLETE HFR LINE PRIMING ALERTINCOMPLETE HFR LINE PRIMING ALERTINCOMPLETE HFR LINE PRIMING ALERT in HFR dialysis in HFR dialysis in HFR dialysis in HFR dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: INCOMPL.INCOMPL.INCOMPL.INCOMPL. HFRHFRHFRHFR LINELINELINELINE PRIMINGPRIMINGPRIMINGPRIMING


CausesCausesCausesCauses - Priming of the UF/infusion line has not been

completed. The external BLD has not detected the passage of saline solution.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the line has been correctly installed, in

particular check that it is correctly inserted in the end infusion detector and the blood leak detector.

WARNING: SPHYGMO MEASUREMENT ERRORWARNING: SPHYGMO MEASUREMENT ERRORWARNING: SPHYGMO MEASUREMENT ERRORWARNING: SPHYGMO MEASUREMENT ERROR

during rinsing, priming, dialysis, rinseback and during rinsing, priming, dialysis, rinseback and during rinsing, priming, dialysis, rinseback and during rinsing, priming, dialysis, rinseback and disinfection/cleaningdisinfection/cleaningdisinfection/cleaningdisinfection/cleaning

MMMMESSAGEESSAGEESSAGEESSAGE:::: SPHYGMOSPHYGMOSPHYGMOSPHYGMO ERRORERRORERRORERROR


CausesCausesCausesCauses - The sphygmomanometer is not connected to the

machine. - The sphygmomanometer has not been properly put

on the arm. - The sphygmomanometer has not been properly

deflated between one measurement and the next.


- Press and repeat the measurement after eliminating the causes.

WARNING: SYSTOLIC PRESSURE OUT OF RANGEWARNING: SYSTOLIC PRESSURE OUT OF RANGEWARNING: SYSTOLIC PRESSURE OUT OF RANGEWARNING: SYSTOLIC PRESSURE OUT OF RANGE

during rinsing, priming and dialysisduring rinsing, priming and dialysisduring rinsing, priming and dialysisduring rinsing, priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: SYSTOLICSYSTOLICSYSTOLICSYSTOLIC OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The systolic pressure is outside the thresholds set.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the thresholds set.



WARNING: DIASTOLIC PRESSURE OUT OF RANGEWARNING: DIASTOLIC PRESSURE OUT OF RANGEWARNING: DIASTOLIC PRESSURE OUT OF RANGEWARNING: DIASTOLIC PRESSURE OUT OF RANGE during rinsing, priming and dialysisduring rinsing, priming and dialysisduring rinsing, priming and dialysisduring rinsing, priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: DIASTOLICDIASTOLICDIASTOLICDIASTOLIC OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The diastolic pressure is outside the thresholds

set.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the thresholds set.


WARNING: HEART RATE OUT OF RANGE WARNING: HEART RATE OUT OF RANGE WARNING: HEART RATE OUT OF RANGE WARNING: HEART RATE OUT OF RANGE during rinsing, priming and dialysisduring rinsing, priming and dialysisduring rinsing, priming and dialysisduring rinsing, priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: HRHRHRHR OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The heart rate is outside the thresholds set.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the thresholds set. - The warning is automatically deactivated as soon

as the heart rate returns to within the thresholds set.

HEMATOCRIT OUT OF RANGE ALHEMATOCRIT OUT OF RANGE ALHEMATOCRIT OUT OF RANGE ALHEMATOCRIT OUT OF RANGE ALERTERTERTERT during dialysisduring dialysisduring dialysisduring dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: HCTHCTHCTHCT OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The hematocrit is outside the thresholds set.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the thresholds set. - The warning is automatically deactivated as soon

as the value measured returns to within the thresholds set.

WARNING: OXYGEN SATURATION OUT OF RANGE WARNING: OXYGEN SATURATION OUT OF RANGE WARNING: OXYGEN SATURATION OUT OF RANGE WARNING: OXYGEN SATURATION OUT OF RANGE during dialysis during dialysis during dialysis during dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: SO2SO2SO2SO2 OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The oxygen saturation is outside the

thresholds set.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the thresholds set. - The warning is automatically deactivated as

soon as the value measured returns to within the thresholds set.


WARNING: PERCENT VOLUME LOSS OUT OF RANGE WARNING: PERCENT VOLUME LOSS OUT OF RANGE WARNING: PERCENT VOLUME LOSS OUT OF RANGE WARNING: PERCENT VOLUME LOSS OUT OF RANGE during dialysisduring dialysisduring dialysisduring dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: VL%VL%VL%VL% OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The percent volume loss is outside the

thresholds set.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check the thresholds set. - The warning is automatically deactivated as

soon as the value measured returns to within the thresholds set.

CARDIUM WARNING: HEART RATE OUT OF THE CARDIUM WARNING: HEART RATE OUT OF THE CARDIUM WARNING: HEART RATE OUT OF THE CARDIUM WARNING: HEART RATE OUT OF THE ABSOLUTE ABSOLUTE ABSOLUTE ABSOLUTE RANGERANGERANGERANGE during rinsing, priming and dialysisduring rinsing, priming and dialysisduring rinsing, priming and dialysisduring rinsing, priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: CARDIUMCARDIUMCARDIUMCARDIUM HRHRHRHR OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE

EffectsEffectsEffectsEffects Acoustic warning Visual warning Automatic pressure measurement

CauseCauseCauseCause - The heart rate is outside the absolute

thresholds set for the Cardium application.


- Press to cancel the warning until the next pressure measurement, during which the warning is reactivated only if the heart rate has returned to within the set range.

CARDIUM WARNING: HEART RATE OUT OF THE CARDIUM WARNING: HEART RATE OUT OF THE CARDIUM WARNING: HEART RATE OUT OF THE CARDIUM WARNING: HEART RATE OUT OF THE PERCENT PERCENT PERCENT PERCENT RANGERANGERANGERANGE during rinsing, priming and dialysis during rinsing, priming and dialysis during rinsing, priming and dialysis during rinsing, priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: CARDIUMCARDIUMCARDIUMCARDIUM HRHRHRHR %%%% OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The heart rate is outside the percent thresholds

set for the Cardium application.




CARDIUM WARNING: HEART RATE OUT OF THE CARDIUM WARNING: HEART RATE OUT OF THE CARDIUM WARNING: HEART RATE OUT OF THE CARDIUM WARNING: HEART RATE OUT OF THE DERIVATIVE DERIVATIVE DERIVATIVE DERIVATIVE RANGERANGERANGERANGE during rinsing, priming and dialysisduring rinsing, priming and dialysisduring rinsing, priming and dialysisduring rinsing, priming and dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: CARDIUMCARDIUMCARDIUMCARDIUM HRHRHRHR DER.DER.DER.DER. OUTOUTOUTOUT OFOFOFOF RANGERANGERANGERANGE


CausesCausesCausesCauses - The difference between the mean values/minute of

the heart rate is outside the thresholds set.


- Press to cancel the warning until the next minute.


WARNING: FORMULA PLUS TEST SENSOR FAILED during rinsingWARNING: FORMULA PLUS TEST SENSOR FAILED during rinsingWARNING: FORMULA PLUS TEST SENSOR FAILED during rinsingWARNING: FORMULA PLUS TEST SENSOR FAILED during rinsing

MMMMESSAGEESSAGEESSAGEESSAGE:::: TESTTESTTESTTEST SENSORSSENSORSSENSORSSENSORS FORMULAFORMULAFORMULAFORMULA ++++


CausesCausesCausesCauses - The Formula Plus sensor test has failed.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check which sensor has failed the test. Press

sensors

then

Natrium

and

Hemox

. A message will be displayed (e.g.: NATRIUM(TEST N.P.)

- Remove the lines from the sensors and repeat the

tests. Press

sensors

and

repeat test

.

- Press to cancel the warning and enter into dialysis. The sensor that has failed the test remains operational but shows the test failed message. The operator is warned that the measurement of the sensor may not be correct.

WARNING: SODIUM CONCENTRATION NOT DETECTEDWARNING: SODIUM CONCENTRATION NOT DETECTEDWARNING: SODIUM CONCENTRATION NOT DETECTEDWARNING: SODIUM CONCENTRATION NOT DETECTED in HFR dialysisin HFR dialysisin HFR dialysisin HFR dialysis

MMMMESSAGEESSAGEESSAGEESSAGE:::: SODIUMSODIUMSODIUMSODIUM CONCENTRATIONCONCENTRATIONCONCENTRATIONCONCENTRATION NOTNOTNOTNOT DETECTEDDETECTEDDETECTEDDETECTED

EffectsEffectsEffectsEffects Acoustic warning Visual warning If the warning persists, Aequilibrium activation has failed

CausesCausesCausesCauses - Ultrafiltrate conductivity probe possibly incorrectly

positioned in the seat of the Natrium sensor. - Ultrafiltrate conductivity probe possibly incorrectly

positioned in the blood seat of the Natrium sensor (left-hand side) rather than in the dedicated seat (right-hand side).

- Natrium sensor reading error.

Suggested actionsSuggested actionsSuggested actionsSuggested actions - Check that the ultrafiltrate probe is correctly

positioned in the dedicated seat (right-hand side) of the Natrium sensor.

- If the warning persists, disable the Aequilibrium application.

ENG – Ed. 06/09 chap. 11.1 – Problem solving - 1 of 8

11.11.11.11.1 PROBLEM SOLVING1 PROBLEM SOLVING1 PROBLEM SOLVING1 PROBLEM SOLVING This chapter describes some “special” operating procedures and some problems which can be solved by the operator. It is recommended to consult this list in the event that the conditions stated below occur. If in spite of following the instructions, the problem cannot be solved, contact After-Sales Service.

THE MONITOR REMAINS OFF WHEN TURNING THE MACHINE ONTHE MONITOR REMAINS OFF WHEN TURNING THE MACHINE ONTHE MONITOR REMAINS OFF WHEN TURNING THE MACHINE ONTHE MONITOR REMAINS OFF WHEN TURNING THE MACHINE ON Likely internal fault. Force a power failure to reset the system. If the problem is not solved, contact After-Sales Service.

THE MONITOR TURNS OFF DURING TREATMENT THE MONITOR TURNS OFF DURING TREATMENT THE MONITOR TURNS OFF DURING TREATMENT THE MONITOR TURNS OFF DURING TREATMENT Firstly check that the screensaver has been activated (see chap. Operator Interface). If this does not solve the issue, there is probably an internal fault. The machine remains in a safe state for the patient since all the functions remain active. Force a power failure to reset the system. If the monitor does not come back on within 2 minutes, carry out manual rinseback of blood to the patient. Subsequently, contact After-Sales Service.

RESTARTING PROCEDURERESTARTING PROCEDURERESTARTING PROCEDURERESTARTING PROCEDURE In case of ERROR 0 ALARM (red/blue alarm window) it is possible to restart formula pushing the power key (green LED) for at least 5 seconds. This must be considered an emergency procedure to continue the dialysis.

WARNINGWARNINGWARNINGWARNING If ERROR 0 ALARM does not disappear,If ERROR 0 ALARM does not disappear,If ERROR 0 ALARM does not disappear,If ERROR 0 ALARM does not disappear, switch off switch off switch off switch off formula using the main using the main using the main using the main switch in the rear panel and contact Afterswitch in the rear panel and contact Afterswitch in the rear panel and contact Afterswitch in the rear panel and contact After----Sales Service.Sales Service.Sales Service.Sales Service.

TESTSTESTSTESTSTESTS

INITIAL TESTS FAILED If the haemodialysis water tap is closed, or the first sequence of the tests was not completed successfully, a full-screen 0 ERROR message will appear. Turn off the machine with the main switch located at the rear and open the water tap. Then turn on the machine and repeat the operations already described. If the machine does not restart, contact Post-Sales Dept.

FAILED TESTS - BLOOD SIDE

A window appears on the right side of the display with the indication of the failed test and the error code to communicate, if necessary, to the After-Sales Dept.

2 of 8 - chap. 11.1 – Problem solving ENG – Ed. 06/09

retryblood tests

to repeat the tests of the blood section.

FAILED TESTS - DIALYSATE SIDE

A window appears on the left side of the display with the indication of the error codes to communicate, if necessary, to the After-Sales Dept.

retryhydraulic test

to repeat the tests of the dialysate section. In this case the following message appears:

yes

to confirm. Before repeating the hydraulic tests, the machine carries out a spilling of a few minutes in order to remove any residual air in the circuit. This phase is indicated by AUTOMATIC SPILLING displayed on the top left status bar of the screen. Upon conclusion of the first test sequence, a rinsing phase which lasts a few minutes (not modifiable by the operator) starts. Simultaneously the self-diagnostics tests are performed both on the dialysate and the blood compartment. When the blood tests are successfully completed, WAIT appears on the top right status

bar of the screen. The function key

select priming

appears. At this point it is possible to At this point it is possible to At this point it is possible to At this point it is possible to start installing the blood linestart installing the blood linestart installing the blood linestart installing the blood lines.s.s.s.

THE BLOOD PUMP STOPSTHE BLOOD PUMP STOPSTHE BLOOD PUMP STOPSTHE BLOOD PUMP STOPS

1.1.1.1. An alarm in the blood section has occurred.An alarm in the blood section has occurred.An alarm in the blood section has occurred.An alarm in the blood section has occurred.

Correct the alarm condition. to restart.

2.2.2.2. Blood leaks in the dialysate compartment (BLD alarm)Blood leaks in the dialysate compartment (BLD alarm)Blood leaks in the dialysate compartment (BLD alarm)Blood leaks in the dialysate compartment (BLD alarm)

Wait a few seconds and then .

3.3.3.3. Blood flow is set to zero.Blood flow is set to zero.Blood flow is set to zero.Blood flow is set to zero.

Set the blood flow using the arterial flow regulator.

4.4.4.4. key is pressedkey is pressedkey is pressedkey is pressed....

Disable the key.

Do you want to RETRY Do you want to RETRY Do you want to RETRY Do you want to RETRY

hydraulic testshydraulic testshydraulic testshydraulic tests????


MANUAL RINSEBACK OF THE PATIENTMANUAL RINSEBACK OF THE PATIENTMANUAL RINSEBACK OF THE PATIENTMANUAL RINSEBACK OF THE PATIENT WARNINGWARNINGWARNINGWARNING Be extremely careful to prevent dangerous conditions to the patient. When the Be extremely careful to prevent dangerous conditions to the patient. When the Be extremely careful to prevent dangerous conditions to the patient. When the Be extremely careful to prevent dangerous conditions to the patient. When the machine is turned off, all the protections are deactivated.machine is turned off, all the protections are deactivated.machine is turned off, all the protections are deactivated.machine is turned off, all the protections are deactivated.

1. Turn off the machine with the main switch on the rear panel.

2. Open the blood pump cover.

3. Vent air out of the venous drip chamber with the aid of a syringe.

4. Carefully extract the venous blood line from the clamp.

5. If performing a Double Pump/Single Needle treatment, remove the venous pump line.

6. Fold the arterial pump handle outwards.

7. Disconnect the arterial line from the patient.

8. Revolve the blood pump anticlockwise until the blood lines are empty and patient’s rinseback is completed. Be careful not to let air into the patient’s infusion line.

9. Disconnect the venous line from the patient.

DIALYSER REPLACEMENT DURING DIALYSIS DIALYSER REPLACEMENT DURING DIALYSIS DIALYSER REPLACEMENT DURING DIALYSIS DIALYSER REPLACEMENT DURING DIALYSIS

•

see/mod. parameters

and

hemofilter management

•

change filter

.

• The following dialog window appears:

•

yes

to continue. In the upper right bar (blood section) FILTER CHANGE appears and the blood pumps stop.

• The BYPASS message appears. In DN, SNsp, SNdp, HDF and HFR treatments,

pressing automatically activates a minimum ultrafiltration of 0.1kg/h.

• Connect the arterial line to the container of physiological solution.

• .

• Adjust the blood flow to the speed used in the dialysis centre.

• The level alarm is automatically disabled and the absolute alarm thresholds for the venous and arterial pressures set to priming values.

• The air detector is always enabled.

• Return the blood to the patient. Should the AIR DETECTED alarm intervene, press

and be extremely careful not to infuse air.

DDDDO YOU WANT TO O YOU WANT TO O YOU WANT TO O YOU WANT TO CHANGECHANGECHANGECHANGE THE THE THE THE DIALYSER?DIALYSER?DIALYSER?DIALYSER?


• Wait until the dialyser empties (only normal saline should be left), remove and replace it with a new one.

• Prime the new dialyser, circulating as much normal saline as necessary.

• Connect the arterial line and wait until blood is detected: from this point 90 sec. will pass before the machine starts dialysis.

• The BYPASS message appears.

• .

• If a BLD alarm intervenes (caused by detection of air), press .


The AIR DETECTOR alarm can not be overriddenThe AIR DETECTOR alarm can not be overriddenThe AIR DETECTOR alarm can not be overriddenThe AIR DETECTOR alarm can not be overridden with the key with the key with the key with the key . This may . This may . This may . This may happen only during the dialyser replacement procedure.happen only during the dialyser replacement procedure.happen only during the dialyser replacement procedure.happen only during the dialyser replacement procedure. In the event of an alarm or warning during the filter change procedure, press In the event of an alarm or warning during the filter change procedure, press In the event of an alarm or warning during the filter change procedure, press In the event of an alarm or warning during the filter change procedure, press

the keythe keythe keythe key to silence ALL the alarms and warnings for five minutes. In to silence ALL the alarms and warnings for five minutes. In to silence ALL the alarms and warnings for five minutes. In to silence ALL the alarms and warnings for five minutes. In addition, the BYPASS FILTEaddition, the BYPASS FILTEaddition, the BYPASS FILTEaddition, the BYPASS FILTER warning is automatically silenced for the entire R warning is automatically silenced for the entire R warning is automatically silenced for the entire R warning is automatically silenced for the entire duration of the procedure.duration of the procedure.duration of the procedure.duration of the procedure.

ARTERIAL LINE REPLACEMENT DURING DIALYSISARTERIAL LINE REPLACEMENT DURING DIALYSISARTERIAL LINE REPLACEMENT DURING DIALYSISARTERIAL LINE REPLACEMENT DURING DIALYSIS (as a result of breakage of the pressure transducer or bending of the tube)

•

see/mod. parameters

hemofilter management

change filter

.

• A dialog window with confirmation request appears:

•

yes

to continue. In the upper right bar (blood section) FILTER CHANGE appears and the blood pumps stop.

• Connect the arterial line to the container of physiological solution.

• .

• Set the blood flow to 100 -150 ml/min.

• The level alarm is automatically disabled and the absolute alarm thresholds for the venous and arterial pressures set to priming values.

• The air detector is always enabled.

• Return blood without completely emptying the venous return line.

• Remove the old blood line and mount the new one.

• Prime the line with physiological solution.

• When priming has been completed, connect the arterial line to the patient and wait until blood is detected: from this point 90 sec. will pass before the machine starts dialysis.

DDDDO YOU WANT TO O YOU WANT TO O YOU WANT TO O YOU WANT TO CHANGECHANGECHANGECHANGE THE THE THE THE DIALYSER?DIALYSER?DIALYSER?DIALYSER?


• The BYPASS message appears. .

• If a BLD alarm intervenes (caused by detection of air), .

• During the operations mentioned above, in DN, SNsp, SNdp, HDF and HFR treatments, a minimum ultrafiltration of 0.1kg/h is set automatically.

WARNINGWARNINGWARNINGWARNING In the event of an alarm or warning during tIn the event of an alarm or warning during tIn the event of an alarm or warning during tIn the event of an alarm or warning during the filter change procedure, press he filter change procedure, press he filter change procedure, press he filter change procedure, press

the keythe keythe keythe key to silence ALL the alarms and warnings for five minutes. In to silence ALL the alarms and warnings for five minutes. In to silence ALL the alarms and warnings for five minutes. In to silence ALL the alarms and warnings for five minutes. In addition, the BYPASS FILTER warning is automatically silenced for the entire addition, the BYPASS FILTER warning is automatically silenced for the entire addition, the BYPASS FILTER warning is automatically silenced for the entire addition, the BYPASS FILTER warning is automatically silenced for the entire duration of the procedure.duration of the procedure.duration of the procedure.duration of the procedure.

IMPOSSIBLE TO PASS FROM THE REINFUSION PHASE IMPOSSIBLE TO PASS FROM THE REINFUSION PHASE IMPOSSIBLE TO PASS FROM THE REINFUSION PHASE IMPOSSIBLE TO PASS FROM THE REINFUSION PHASE TO THE RINSING PHASETO THE RINSING PHASETO THE RINSING PHASETO THE RINSING PHASE This condition may happen as follows:

1.1.1.1. Blood in the venous drip chamber or on the end priming detectorBlood in the venous drip chamber or on the end priming detectorBlood in the venous drip chamber or on the end priming detectorBlood in the venous drip chamber or on the end priming detector Remove the drip chamber from the block and/or any traces of blood from the end priming cycle sensor.

2.2.2.2. Air Alarm not detectedAir Alarm not detectedAir Alarm not detectedAir Alarm not detected (the line is full of physiological solution or blood) (the line is full of physiological solution or blood) (the line is full of physiological solution or blood) (the line is full of physiological solution or blood) Remove the line from the air detector. A few seconds later the blood pump will stop.

3.3.3.3. “HYDRAULIC” alarm“HYDRAULIC” alarm“HYDRAULIC” alarm“HYDRAULIC” alarm

4.4.4.4. “NO WATER” alarm“NO WATER” alarm“NO WATER” alarm“NO WATER” alarm Wait for the condition to return to normal.

THTHTHTHE VENOUS DRIP CHAMBER IS TOO FULL OR DOES NOT REACH THE LEVELE VENOUS DRIP CHAMBER IS TOO FULL OR DOES NOT REACH THE LEVELE VENOUS DRIP CHAMBER IS TOO FULL OR DOES NOT REACH THE LEVELE VENOUS DRIP CHAMBER IS TOO FULL OR DOES NOT REACH THE LEVEL To prevent a pressure alarm,

1.

see/mod. parameters

blood

recalcul. on

.

1.

ok

to confirm.

2. Act on the regulator until reaching the desired level.


NO POWERNO POWERNO POWERNO POWER The machine signals this condition with an intermittent acoustic alarm which cannot be silenced. The LED next to the power key turns red.

1.1.1.1. The power cable is not inserted in the mains socket.The power cable is not inserted in the mains socket.The power cable is not inserted in the mains socket.The power cable is not inserted in the mains socket. Connect the power cable.

2.2.2.2. The wall socket does not deliver power.The wall socket does not deliver power.The wall socket does not deliver power.The wall socket does not deliver power. Connect the machine to another socket or interrupt dialysis returning blood to the patient by hand.

3.3.3.3. No power in the whole dialysis centre.No power in the whole dialysis centre.No power in the whole dialysis centre.No power in the whole dialysis centre. Wait for power to be restored. If necessary, interrupt dialysis returning blood to the patient by hand.

The machine will turn on automatically when the power is restored; the machine status remains in memory for a guaranteed time of at least 2 minutes. If a power failure occurs:

- during disinfection/cleaningduring disinfection/cleaningduring disinfection/cleaningduring disinfection/cleaning, the machine starts from the point at which it was interrupted;

- during dialysisduring dialysisduring dialysisduring dialysis, when power has been restored, the blood pump remains off with consequent closure of the bypass. Check that the data has not been altered.

to restart the pump and, if necessary, press ....

THE MACHINE IS SWITCHED OFF WITH THE MAIN SWITCH DURING THE MACHINE IS SWITCHED OFF WITH THE MAIN SWITCH DURING THE MACHINE IS SWITCHED OFF WITH THE MAIN SWITCH DURING THE MACHINE IS SWITCHED OFF WITH THE MAIN SWITCH DURING DISINFECTION/CLEANINGDISINFECTION/CLEANINGDISINFECTION/CLEANINGDISINFECTION/CLEANING When the machine is switched on again, the initial tests are re-run, then disinfection/cleaning continues from the point of interruption.

THE MACHINE IS SWITCHED ON MANUALTHE MACHINE IS SWITCHED ON MANUALTHE MACHINE IS SWITCHED ON MANUALTHE MACHINE IS SWITCHED ON MANUALLY WHILE THE CHEMICAL AGENT IS LY WHILE THE CHEMICAL AGENT IS LY WHILE THE CHEMICAL AGENT IS LY WHILE THE CHEMICAL AGENT IS STILL DWELLINGSTILL DWELLINGSTILL DWELLINGSTILL DWELLING The following message appears: “Press OK to anticipate rinsing”

1.

ok

to run the tests and start the rinsing cycle or

2. wait a few minutes until the machine switches off automatically.

PATIEPATIEPATIEPATIENT WEIGHT NOT IN CONFORMITY WITH THE SET PROGRAMNT WEIGHT NOT IN CONFORMITY WITH THE SET PROGRAMNT WEIGHT NOT IN CONFORMITY WITH THE SET PROGRAMNT WEIGHT NOT IN CONFORMITY WITH THE SET PROGRAM If the weight is not in conformity with that set:

1. Record the patient weight (with scale bed) and the time indicated by the treatment-time tool on the screen.


2. Carefully check the food and drink consumed by the patient and any objects on the scale bed.

3. After 30 min. (or an hour) again check the weight. Should the new weight differ from the theoretical weight by a value greater than +/- 80 g/h (+/- 160 g/h in HDF with bags), the error can be attributed to the machine.

4. Contact After-Sales Service.

FILLING AND REPLACEMENT OF THE POWDER BICARBONATE CARTRIDGEFILLING AND REPLACEMENT OF THE POWDER BICARBONATE CARTRIDGEFILLING AND REPLACEMENT OF THE POWDER BICARBONATE CARTRIDGEFILLING AND REPLACEMENT OF THE POWDER BICARBONATE CARTRIDGE

When using the powder bicarbonate cartridge,

see/mod. parameters

dialysate

other parameters

to have the following functions available:

•

bidry fill-up

to fill the cartridge.

•

change bidry

to replace the cartridge during the dialysis session.

To replace the powder bicarbonate (traditional or perforated) cartridge, To replace the powder bicarbonate (traditional or perforated) cartridge, To replace the powder bicarbonate (traditional or perforated) cartridge, To replace the powder bicarbonate (traditional or perforated) cartridge, proceed as follows:proceed as follows:proceed as follows:proceed as follows:

•

change bidry

.


•

yes

. The function key

bidry change on

appears.

• Proceed with the cartridge replacement.

•

bidry change on

.


•

yes

.

• At this point the automatic filling of the cartridge takes place. The function key

bidry fill-up on

appears.

• Wait until it is completely full and has returned to normal

To fill the powder bicarbonate (traditional or perforated) cartridge, To fill the powder bicarbonate (traditional or perforated) cartridge, To fill the powder bicarbonate (traditional or perforated) cartridge, To fill the powder bicarbonate (traditional or perforated) cartridge, proceed as proceed as proceed as proceed as follows:follows:follows:follows:

•

see/mod. parameters

dialysate

other parameters

bidry fill-up

to

Do you want to CHANGE the bidry cartridge?

Bidry change COMPLETED?


start cartridge fill-up.

• The function key

bidry fill-up on

appears.

• Wait until it is completely full and has returned to normal.

THE PATIENT HAS BEEN CONNECTED TO THE BLOOD LINES ALTHOUGH THE THE PATIENT HAS BEEN CONNECTED TO THE BLOOD LINES ALTHOUGH THE THE PATIENT HAS BEEN CONNECTED TO THE BLOOD LINES ALTHOUGH THE THE PATIENT HAS BEEN CONNECTED TO THE BLOOD LINES ALTHOUGH THE MACHINE IS STILL IN THE DISINFECTION/CLEANING PHASEMACHINE IS STILL IN THE DISINFECTION/CLEANING PHASEMACHINE IS STILL IN THE DISINFECTION/CLEANING PHASEMACHINE IS STILL IN THE DISINFECTION/CLEANING PHASE

The blood pump is off and does not start until disinfection/cleaning has been completed. Since more than 10 minutes elapse before starting the treatment (end of disinfection/cleaning, tests, dialysis fluid preparation), it is advisable to manually return the blood to the patient.

bellco formula 2000 user manual

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