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Fluido®AirGuard System

Blood and Fluid Warming SystemUser manual

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Table of Contents1 General information 6

1.1 About this manual 61.2 Intended use 61.3 Contact address 61.4 Warranty 61.5 Authorisation of personnel 71.6 Warning, caution and note 71.7 Disclaimer 7

2 Safety 82.1 Safety precautions 8

2.1.1 Fluido® Blood and Fluid Warmer 82.1.2 Fluido® Air Guard 102.1.3 Fluido® Pressure Chambers 112.1.4 Fluido® Compressor 122.1.5 Fluido® IV Pole 132.1.6 Disposable sets 142.1.7 Literature 14

2.2 Symbols 15

3 Description 213.1 Fluido® AirGuard System 213.2 Fluido® Blood and Fluid Warmer 22

3.2.1 Device 223.2.2 Control panel 233.2.3 Display 243.2.4 Control thermometer 26

3.3 Fluido® Air Guard 273.3.1 Device 273.3.2 Control panel 28

3.4 Fluido® Pressure Chambers 293.5 Fluido® Compressor 303.6 Fluido® IV Pole 313.7 Disposable sets 32

3.7.1 Fluido® Standard Set 323.7.2 Fluido® Trauma Set 333.7.3 Fluido® Trauma Plus Set 34

Table of Contents

3

4 Installation 354.1 Fluido® IV Pole 354.2 Fluido® Blood and Fluid Warmer 36

4.2.1 Mounting the device to the IV pole 364.2.2 Connecting the power supply cord 374.2.3 Mounting the Fluido® Air Deflector (option) 37

4.3 Fluido® Air Guard 384.3.1 Mounting the device to the IV pole 384.3.2 Connecting the power supply cord 38

4.4 Fluido® Pressure Chambers 394.4.1 Mounting the device to the IV pole 394.4.2 Connecting the air inlet tube 39

4.5 Fluido® Compressor 404.5.1 Mounting the device to the IV pole 404.5.2 Connecting the air outlet tube 404.5.3 Connecting the power supply cord 41

5 Operation 425.1 Fluido® Blood and Fluid Warmer 42

5.1.1 Setting the device to standby mode 425.1.2 Switching on the device 435.1.3 Inserting and removing a disposable set 435.1.4 Priming the Fluido® Standard Set 455.1.5 Priming the Fluido® Trauma Set / Trauma Plus Set 455.1.6 Start warming blood or IV fluids 465.1.7 Deaerating the deaeration chamber 465.1.8 Stop warming blood or IV fluids 475.1.9 Audible alarm suppression 485.1.10 Switching off the device 485.1.11 Extra options 49

5.2 Fluido® Air Guard 505.2.1 Priming the deaeration chamber 505.2.2 Setting the device to standby mode 515.2.3 Placing the deaeration chamber 515.2.4 Placing the tube into the shutoff valve 525.2.5 Switching on the device 525.2.6 Deaerating the deaeration chamber 525.2.7 Audible alarm suppression 535.2.8 Switching off the device 54

Table of Contents

4

5.3 Fluido® Pressure Chambers 545.3.1 Preparation 555.3.2 Attaching an IV bag 555.3.3 Inflating the bladder 56

5.4 Fluido® Compressor 57

6 Cleaning and maintenance 586.1 Cleaning 586.2 Maintenance 59

7 Troubleshooting 607.1 Fluido® Blood and Fluid Warmer 607.2 Fluido® Air Guard 657.3 Fluido® Pressure Chambers 717.4 Fluido® Compressor 72

8 Specifications 738.1 Fluido® Blood and Fluid Warmer 738.2 Fluido® Air Guard 758.3 Fluido® Pressure Chambers 768.4 Fluido® Compressor 778.5 Fluido® IV Pole 788.6 Disposable sets 78

8.6.1 Fluido® Standard Set 788.6.2 Fluido® Trauma Set 798.6.3 Fluido® Trauma Plus Set 808.6.4 End-of-line temperature / Flow 81

9 Electromagnetic compatibility 829.1 Electromagnetic immunity 829.2 Electromagnetic emissions 849.3 Recommended separation distances 85

Table of Contents

5

1 General information

1.1 About this manualIn this manual, you can find important information about how to operate theFluido® AirGuard System (hereafter referred to as ‘the system’).The Fluido® AirGuard System consists of these components (hereafter referredto as ‘the device’):

• Fluido® Blood and Fluid Warmer• Fluido® Air Guard• Fluido® Pressure Chambers• Fluido® Compressor• Fluido® IV Pole

The manual helps you with the operation and the maintenance of the system, ina safe and responsible manner.Read this manual carefully. Complete all the procedures. Do the procedures inthe given sequence. Always keep the manual near the system.

1.2 Intended useThe device is developed to supply warm fluids to a patient. The Fluido® AirGuardSystem is developed for adults. Use the device for warming:

• crystalloid• colloid IV-fluids• anti-coagulated blood• plasma

1.3 Contact addressThe 37CompanyBeeldschermweg 6FNL-3821 AH AmersfoortThe Netherlands

1.4 WarrantyFor the warranty provisions, refer to the website: www.the37company.com

General information

6 INT/R757-EN/0-09/15 Fluido®AirGuard System

1.5 Authorisation of personnelOnly authorized personnel - physicians, nurses and assistants in the medicalprofessional fields involved in controlling hypothermia and trained to use thesystem - are permitted to operate the system.

1.6 Warning, caution and noteThis manual gives more information about dangerous situations.

WARNING!"WARNING" tells you that there is a risk of personal injury ordeath.

CAUTION!"CAUTION" tells you that there is a risk of damage to the system,one of the devices or to other equipment.

NOTE!"Note" gives more information.

1.7 DisclaimerThe manufacturer reserves all rights. No part of this document may bereproduced or published, electronically, mechanically, in print, photographic print,on microfilm or by any other means whatsoever, without the explicit consent ofmanufacturer.The content of this document has been compiled with the greatest possible careand this information can be regarded as reliable. Nevertheless, the manufacturerreserves the right to make alterations and improvements to the device. Thesemay not yet have been described in the instructions. The manufacturer cannot beheld liable for the final outcome of the patients’ treatment.This document contains proprietary information that may not be disclosed to thirdparties. This document may not be used without the explicit written consent ofthe manufacturer.These instructions are intended for personnel authorised to work with and/orservice the medical device described in this manual.

General information

Fluido®AirGuard System INT/R757-EN/0-09/15 7

2 Safety

2.1 Safety precautions

2.1.1 Fluido® Blood and Fluid Warmer

• Only use the device in compliance with the safety precautions and theinstructions for use as described in the manual. The manufacturer cannotassume liability for injuries or damage caused by failure to obey the safetyprecautions and the instructions for use as described in the manual.

• Adequate grounding reliability can only be achieved when the equipment isconnected to an equivalent receptacle (for US: marked 'hospital grade').

• If national or local guidelines or protocols stipulate a stricter regimen forhandling, processing and administering blood and IV fluids, these guidelinesor protocols prevail over the safety precautions and the instructions for useas described in the manual.

• Do not use the device near devices that cause interference. The device iscertified according IEC 60601-1-2 for electromagnetic interference. Ifinterference effects with different devices occur, correct the interference.• Switch devices in the vicinity off and on to isolate the interfering devices.• Relocate the interfering devices.• Increase the distance between the device and the interfering devices.

Connect the interfering devices to a different wall socket.• Contact the service centre for support.

• Keep the device away from portable and mobile radio-frequencycommunication equipment and high-frequency surgical instruments orendocardial catheters. Portable and mobile radio-frequency communicationequipment and high-frequency surgical instruments or endocardial catheterscan cause the device to operate incorrectly.

• Do not use a damaged device. If the device is damaged, contact the servicecentre.

• Do not modify the device.• If you use power supply cords or spare parts for internal components other

than specified by the manufacturer, this can result in increased emission ordecreased immunity of the device.

• Connect the mains plug to an earthed wall socket only.• Install the device in such a way that you can easily disconnect the mains plug

from the wall socket if there is an emergency.• Disconnect the mains plug from the wall socket to remove all power from the

device. Do not disconnect the mains plug from the wall socket when you usethe device together with the Fluido® Air Guard.

• The device does not have an isolating switch. If the power supply istemporarily interrupted, the device will go to standby mode.

Safety


• Use the device for warming crystalloid IV fluids, colloid IV fluids, anti-coagulated blood and plasma. Do not use the device for warming platelets,cryoprecipitates or granulocyte suspense.

• Do not use blood with a temperature below 4 °C. The device has been testedwith blood with a temperature between 4-6 °C. The high viscosity of theblood can cause blood clots.

• Use saline (0.9% sodium chloride) to dilute erythrocytes to lower theviscosity.

• Use blood products that comply to EU and/or US standards.• Do not mix fresh-frozen plasma or erythrocytes with drugs.• Do not mix dextrose solution (5%) with blood components. Dextrose solution

(5%) can cause haemolysis.• If you use the device for warming blood, do not use calcium-rich supplements

(e.g. Hartmann's solution or Ringer's Lactate solution) as priming solution oras an addition to blood. Calcium-rich supplements will reverse the anti-coagulant effect of the citrate, which can cause blood clots.

• Use a new hospital administration set for every application.• Do not block the ventilation openings.• Constantly monitor the user interface of the device during a self-test and

during use.• Before you connect the IV line to a patient, obey the standard IV line

protocols for priming the complete infusion set. Make sure that there is no airin the IV line to prevent an air embolism. Regularly inspect the IV line foraccumulated air bubbles.

• If the IV line runs dry, disconnect the IV line from the patient, prime thesystem to remove all air and connect the IV line to the patient again.

• Check the condition and the temperature of the patient at least every 15minutes.

• Do not clean the device during use.• Only let qualified technicians do maintenance and repairs on the device.• A physician order is required for setting temperature and for continued use.• Do not do maintenance on the device during use with a patient.

Safety


2.1.2 Fluido® Air Guard










device.• The device does not have an isolating switch. If the power supply is

temporarily interrupted, the device will go to standby mode.• Use the device with Fluido® disposable sets only. Do not use the device with

other disposable sets.• Do not use the device together with Fluido® Irrigation Set.• Do not block the ventilation openings.• Constantly monitor the user interface of the device during a self-test and

during use.• Do not clean the device during use.• Only let qualified technicians do maintenance and repairs on the device.• Only use fuses from the spare parts list.• Remember that the tube downstream of the deaeration chamber goes

straight through the tube sensor and the shutoff valve. This makes sure that:• the device operates correctly.• unwanted alarms are decreased.

Safety


2.1.3 Fluido® Pressure Chambers



• Do not modify the device.• Close the closure lid before inflation.• Only let qualified technicians do maintenance and repairs on the device.• Do not put the device in fluid. Clean the device with a moist cloth or alcohol

tissues.• Do not do maintenance on the device during use with a patient.

Safety


2.1.4 Fluido® Compressor










device.• Do not put the device in fluid. Clean the device with a moist cloth or alcohol

tissues.• Do not do maintenance on the device during use with a patient.• Only use fuses from the spare parts list.

Safety


2.1.5 Fluido® IV Pole

• Only use the IV pole in compliance with the safety precautions and theinstructions for use as described in the manual. The manufacturer cannotassume liability for injuries or damage caused by failure to obey the safetyprecautions and the instructions for use as described in the manual.

• Do not exceed the maximum capacity. The maximum capacity for each hookof the suspension point is 2.0 kg. If you use the IV pole together with theFluido® AirGuard System, the maximum capacity for each hook of thesuspension point is 1.0 kg.

• The mass of the IV pole is 13 kg.• Do not hang heavy objects (e.g. lead aprons) on the IV pole.• Do not use or store the IV pole on an inclined surface. The maximum

inclination is 10% (5.7°) for a total load of 8 kg.• Before you use the IV pole, make sure that the brakes are locked. Before you

move the IV pole, make sure that the brakes are unlocked. Move the IV poleby hand only. Be very careful when you move the IV pole across obstacles,soft floors and slopes. If the slope is more than 10%, make sure that theinner tube is in its minimum position.

• Before you use or move the IV pole, make sure that the height adjustmentlever is locked. Do not unlock the height adjustment lever without holding theinner tube. Do not use force to lock the height adjustment lever.


• Do not modify the device.• The safe work load is 6 kg:

• 2x 1 liter fluid bags in the pressure chambers (1x 1 liter fluid bag perchamber).

• 4x 1 liter fluid bags on the fluid bag hooks (1x 1 liter fluid bag per hook).

Safety


2.1.6 Disposable sets

• Use Fluido® disposable sets only. Do not use other disposable sets. Useeach disposable set for only one patient. Do not use a disposable set if theexpiration date has passed.

• Use the disposable sets for warming crystalloid and colloid IV fluids, anti-coagulated blood, plasma or completely thawed fresh-frozen plasma. Do notuse the disposable sets for warming platelets, cryoprecipitates or granulocytesuspense.

• Do not use a damaged disposable set. If the disposable set is damaged, usea new disposable set.

• Do not modify the disposable set.• To administer one IV bag with blood, use a Fluido® Standard Set. To

administer more than one IV bag with blood, use a Fluido® Trauma Set or aFluido® Trauma Plus Set.

• Only use disposable sets for warming fresh-frozen plasma in theseconditions:• The fresh-frozen plasma is thawed completely at a temperature of 22 °C

(± 2 °C).• The cryoprecipitate caused by thawing the fresh-frozen plasma is

dissolved completely.• If you administer fresh-frozen plasma together with blood, the flow is

monitored constantly.• After you use the disposable set to administer blood products, prime the IV

line with one priming volume of saline: Fluido® Standard Set ~ 90 ml; Fluido®

Trauma Set ~ 145 ml; Fluido® Trauma Plus Set ~ 155 ml.• Use a new disposable set to administer a different fluid after adminstering

blood.• Do not use the disposable set longer than 24 hours.• Do not use a leukocyte reduction filter together with the disposable sets.

2.1.7 Literature

1. Reserved operations Blood transfusion, Jacques, M.B., DirectorateEducation & Training, 2008, Leids Universitair Medisch Centrum; Reader,2009-04-06.

2. Handbook of Transfusion Medicine, DBLL McClelland, UK blood service 4thEdition, ISBN 0-11-322677-2.

3. Blood and Transplant, NHS, December 2009 version 1.4. Guidelines for the use of blood warming devices, AABB, 2002.5. Fantl and Morris, Thorax (1965),20,372, Influence of dextrose on heparinized

blood. Guide to Preparation use and quality assurance of blood components,7th edition, Council of Europe Publishing, 2001.

Safety


2.2 Symbols

Read the user manual.

Read the instructions for use.

CAUTION

Catalogue number / Article number / Part number

Serial number

Manufacturer

Federal US law restricts this device to sale by or on orderof a physician.

Safety


IPX1The device is protected against falling water equivalent to3-5 mm rainfall per minute for a duration of 10 minutes.The device is placed in its normal operating position(according to IEC 60529).

Risk of electrical shock.

Connect the device to an earthed wall socket only.

AC voltage

151413121110987

MOD RECORD

654321

Modification update, example = MOD 6

Ambient temperature range (transport and storage)

Relative humidity range (transport and storage)

Safety


Atmospheric pressure limitation (transport and storage)

Type CF applied parts (according to IEC 60601-1)

Fuse

Equipotentiality

>300mmHg

Make sure that the pressure does not exceed 300 mmHg.Do not use a (manually) operated pressure device withouta pressure indicator.

CE marking of conformity (XXXX = identification numberof Notified Body).

Dispose of the device according to EC Directive2002/96/EC (WEEE).

Safety


Expiry date (year/month)

Single patient use only. Do not re-use disposable sets.

LATEX

The disposable sets do not contain natural latex compo-nents.

The disposable sets do not contain DEHP.

The disposable sets are sterile. Method of sterilisation:ethylene oxide.

Batch code / lot number

Class II equipment

Safety


Quantity

Do not use the device if the package is damaged.

Keep away from sunlight.

Keep away from rain.

Low-priority alarm

Medium-priority alarm

High-priority alarm

Safety


Audible alarm suppression

Non-pyrogenic

Standby

Safety


3 Description

3.1 Fluido® AirGuard System

D

E

B

A

C

A. Fluido® Blood and Fluid WarmerB. Fluido® Air GuardC. Fluido® Pressure Chambers

D. Fluido® CompressorE. Fluido® IV Pole

Description


3.2 Fluido® Blood and Fluid Warmer

3.2.1 Device

A

FG

C

B

D

H

E

H

A. Control panelB. Slot for disposable setC. Eject button for disposable setD. Deaeration chamber holder

E. Mounting clampF. Power supply cord connectionG. Cord anchorH. Ventilation openings

Description


3.2.2 Control panel

B

C

D

E

A

F

A. DisplayB. On/standby button / On/standby

indicatorC. Flow/volume button

D. Audible alarm suppression buttonE. Control thermometerF. Temperature setting buttons (+/-)

Description


3.2.3 Display

Flow indicator (ml/min), increments of 1 ml (0-20), 5 ml(20-150) and 10 ml (as of 150)

Volume indicator (l)

Number of operating hours

Insert the disposable set into the device.

Remove the disposable set from the device.

Between 1000 - 1500 operating hours: If you switch on thedevice, the display shows the symbol for 5 seconds. Youcan still operate the device, but maintenance must takeplace before 2001 operating hours.

Between 1500 - 2000 operating hours: If you switch on thedevice, the display shows the symbol continuously. Youcan still operate the device, but maintenance must takeplace before 2001 operating hours.

Description


After 2000 operating hours: If you switch on the device,the display shows the symbol continuously and a continu-ous audible beep will sound. You can still operate thedevice, but maintenance must take place within 48 operat-ing hours.

Lamp replacement indicators (five lamps): If a specific barflashes, replace the relevant lamp.

Malfunction. Reset the device or contact the service cen-tre.

Audible alarm suppression

Set temperature at the end of the line

Maximum temperature, monitored when the IV fluid leavesthe cassette

Tilt sensor error

Description


Error code

The internal temperature is too high to switch on thedevice (after safety temperature check).

3.2.4 Control thermometer

The device does not warm the blood or fluid in the cas-sette.

The end temperature is more than 1 °C lower than the settemperature.

The end temperature is equal to the set temperature.

The input temperature or the output temperature is higherthan the set temperature. An alarm sounds.

There is a defect. An alarm sounds. The display showsthe maintenance symbol to indicate that maitenance musttake place.

Description


3.3 Fluido® Air Guard

3.3.1 Device

LM

A

B

F/G

N

DE

H/IJ

CK

A. Control panelB. Deaeration chamber holderC. Lock knob (deaeration chamber holder)D. Ultrasonic sensorE. Upper limit strutF. Lower limit strutG. Tube sensor

H. Shutoff valveI. Lock knob (shutoff valve)J. Counteracting knobK. Mounting clampL. Power supply cord connectionM. Cord anchorN. Ventilation openings

Description


3.3.2 Control panel

B

C D E F G

A

A. On/standby button / On/standbyindicator

B. Audible alarm suppression button /Audible alarm suppression indicator

C. Tube detection indicator

D. Air detection indicatorE. Mains power failure indicatorF. Low-battery indicatorG. Repair indicator

Low-priority alarm Medium-priority alarm High-priority alarm

Description


3.4 Fluido® Pressure Chambers

CBG

J

A

FE

D

H

I

FE

D

G

C

A. Pressure selectorB. Pressure regulatorC. Pressure gaugeD. DoorE. Lid

F. Attachment point for IV bag (500 ml)G. Attachment point for IV bag (1000 ml)H. Air inlet tubeI. Mounting clamp

Description


3.5 Fluido® Compressor

D

E G

F A

C

B

A. On/off switchB. Air outlet tubeC. Mounting clampD. Power supply cord connection

E. Cord anchorF. Fuse holderG. Ventilation openings

Description


3.6 Fluido® IV Pole

A

D

C

E

B

A. Suspension point for IV bagB. Height adjustment leverC. Air outlet tube connection (Fluido®

Compressor)

D. Air inlet tube connection (Fluido®

Pressure Chambers)E. Wheel (incl. brake)

Description


3.7 Disposable sets

3.7.1 Fluido® Standard Set

E F

B

H

H

BG B

C

D

A

A. CassetteB. InsertC. IV administration line connectionD. Patient line

E. Deaeration chamberF. Air relief valveG. Non-return valveH. Clamp

Description


3.7.2 Fluido® Trauma Set

L C K

J

GFH I

K

D

A

K

E

B B

B

A. CassetteB. InsertC. IV administration lineD. Patient lineE. Drip chamberF. Deaeration chamber

G. Air relief valveH. FilterI. Non-return valveJ. Administration portK. ClampL. Roller clamp

Description


3.7.3 Fluido® Trauma Plus Set

L C K

J

G I B BFH

K

D

A

B

K

E

A. CassetteB. InsertC. IV administration lineD. Patient lineE. Drip chamberF. Deaeration chamber

G. Air relief valveH. FilterI. Non-return valveJ. Administration portK. ClampL. Roller clamp

Description


4 Installation

4.1 Fluido® IV Pole

WARNING!

• Before you use or move the IV pole, make sure that theheight adjustment lever is locked. Do not unlock the heightadjustment lever without holding the inner tube. Do not useforce to lock the height adjustment lever.

1 Install the mid-section (D) to the pole(C).

2 Install the pole (C) to the base (E).3 Install the screw (G) and the washer

(F).4 Install the height adjustment lever (B) to

the pole (C).5 Install the suspension point (A) to the

pole (C).

A

C

D

EFG

B

Installation


4.2 Fluido® Blood and Fluid Warmer

WARNING!

• Hang the device upright on the IV pole. Make sure that theangle variation does not exceed 2.5° forward or backward.

• Make sure that the wheelbase of the IV pole (x) is in aspecific ratio to the height of the mounting clamp of thedevice (y).

4.2.1 Mounting the device to the IV pole

1 Turn the lock knob (A)counterclockwise to open the mountingclamp (B).

2 Mount the device to the IV pole with themounting clamp (B).

3 Turn the lock knob (A) clockwise toclose the mounting clamp (B).

AB

Installation


4.2.2 Connecting the power supply cord

1 Loosen the screw (A).2 Move the cord anchor (B) away to

access the power supply cordconnection (D).

3 Connect the power supply cord (C) tothe power supply cord connection (D).

4 Move the cord anchor (B) back to itsoriginal position.

5 Tighten the screw (A).B A D

C

4.2.3 Mounting the Fluido® Air Deflector (option)

1 Click the Fluido® Air Deflector (A) ontothe fan outlet (B).

B

A

NOTE!

• If you use the device on a table, you must remove theFluido® Air Deflector from the device.

Installation


4.3 Fluido® Air Guard



2 Mount the device to the IV pole with themounting clamp (B).


AB


1 Remove the screws (A).2 Remove the cord anchor (B) to access

the power supply cord connection (D).3 Connect the power supply cord (C) to

the power supply cord connection (D).4 Install the cord anchor (B).5 Install the screws (A).

C

BDA

Installation


4.4 Fluido® Pressure Chambers


1 Turn the lock knobs (A)counterclockwise to open the mountingclamps (B).

2 Mount the device to the IV pole with themounting clamps (B). Make sure thatthe device is mounted at a height ofapproximately 175 cm.

3 Turn the lock knobs (A) clockwise toclose the mounting clamps (B).

A

A

B

B

4.4.2 Connecting the air inlet tube

1 Remove the protective cover from theair inlet tube connection (A).

2 Connect the air inlet tube (B) to the airinlet tube connection (A).

3 Slightly pull the air inlet tube (B) tocheck whether the tube is connectedcorrectly.

4 To disconnect the tube, press the outerring (C) of the coupling and pull the airinlet tube (B).

BA B

C

Installation


4.5 Fluido® Compressor



2 Mount the device to the IV pole with themounting clamp (B). Make sure that thedevice is mounted at a height ofapproximately 35 cm.


AB

4.5.2 Connecting the air outlet tube

1 Remove the protective cover from theair outlet tube connection (A).

2 Connect the air outlet tube (B) to the airoutlet tube connection (A).

3 Slightly pull the air outlet tube (B) tocheck whether the tube is connectedcorrectly.

4 To disconnect the tube, press the outerring (C) of the coupling and pull the airoutlet tube (B).

B

BA

C

Installation



1 Connect the power supply cord (A) tothe power supply cord connection (B).

2 Remove the screw (C).3 Secure the power supply cord (A) at the

cord anchor (D).4 Install the screw (C).

B A

DC

Installation


5 Operation

5.1 Fluido® Blood and Fluid WarmerThe device is used to warm blood and IV fluids using infrared technology. Thecontrol thermometer continuously shows whether the temperature at the end ofthe IV administration line is the same as the set temperature. The softwarecalculates the cooling in the tube and adjusts the warming level whenevernecessary.The Fluido® Blood and Fluid Warmer can be used as a stand-alone device ortogether with the Fluido® Air Guard, the Fluido® Pressure Chambers, the Fluido®

Compressor and the Fluido® IV Pole.

WARNING!

• Do not use a damaged device. If the device is damaged,contact the service centre.

• Do not block the ventilation openings.

5.1.1 Setting the device to standby mode

NOTE!

• If a disposable set is inserted in the device, remove it fromthe device.

1 Connect the mains plug of the single,dual or triple power supply cord adapterto an earthed wall socket. The devicedoes a four-second self-test. The'remove cassette' symbol flashesduring the self-test. The display (A)lights green. The on/standby indicator(B) lights orange. The device is instandby mode.

BCD

E

A

F

Operation


5.1.2 Switching on the device

1 Press the on/standby button (B). Theon/standby indicator (B) lights green.An acoustic signal sounds. The displaybriefly shows all the symbols. Thecontrol thermometer briefly lights greenand red. The display (A) shows thesymbol that tells you to insert thedisposable set. The device is switchedon.

BCD

E

A

F

NOTE!

• If you do not use the device for 15 minutes, it willautomatically switch to standby mode. The on/standbyindicator (B) goes off.

5.1.3 Inserting and removing a disposable set

Different disposable sets can be used with the device: Fluido® Standard Set,Fluido® Trauma Set and Fluido® Trauma Plus Set.The Fluido® Standard Set consists of a cassette and a patient line with adeaeration chamber. The Fluido® Trauma Set and Fluido® Trauma Plus Setconsist of a cassette, an IV administration line and a patient line with adeaeration chamber. The cassette can be used for low-flow and high-flowapplications.The cassette consists of ten channels through which the IV fluid flows and ismixed well. The flow and temperature are measured at four measuring points.The cassette is inserted into the device. The blood or IV fluid enters the cassetteat the bottom. The halogen lamps in the device supply infrared energy to warmthe blood or IV fluid in the cassette. The infrared energy is absorbed by the bloodor IV fluid that flows through the cassette. The inserts in the cassette are used tomeasure the temperature and calculate the flow rate. The device uses thecalculations to determine the required infrared energy that must be transferred tothe blood or IV fluid.

Operation


WARNING!

• Only use Fluido® disposable sets.• Do not use damaged disposable sets. Inspect the cassette

for cracks. Inspect the reflective layer for damage. Inspectthe IV administration line and patient line for punctures. If thedisposable set is damaged, use another disposable set.

• Only use clean disposable sets. If you remove thedisposable set from the packaging, use the disposasable setimmediately. The disposable set can be used for a maximumof 24 hours.

1 Inserting a disposable set: Hold thecassette (A) by the clamp (B) and insertthe cassette (A) into the slot (C) untilyou hear a click. The display shows thetemperature and the flow rate.

AB

C

2 Removing a disposable set: Press theeject button (D), hold the cassette (A)by the clamp (B) and remove thecassette (A) from the slot (C).

AB

C

D

Operation


5.1.4 Priming the Fluido® Standard Set

WARNING!

• Before you prime the disposable sets, prepare the hospital IVadministration line in accordance with the hospital guidelines.

• Prime the disposable sets with a crystalloid IV fluid.

1 Close the clamps (A) of the disposableset.

2 Remove the protective cap from the IVadministration line (B) of the disposableset. Connect the IV administration line(B) of the disposable set to the hospitalIV administration line.

3 Hold the deaeration chamber (C)upside down.

4 Open the clamps (A) of the disposableset.

5 Fill the deaeration chamber (C) with acrystalloid IV fluid completely. Hold thedeaeration chamber (C) upright again.

6 Deaerate the rest of the patient line (E).7 Close the clamps (A) of the disposable

set.

A

EC

A B

5.1.5 Priming the Fluido® Trauma Set / Trauma Plus Set

WARNING!

• Prime the disposable sets with a crystalloid IV fluid.

Operation


1 Close the clamps (A) of the disposableset.

2 Remove the protective cap from the IVadministration line (B) of the disposableset. Connect the IV administration line(B) of the disposable set to the hospitalIV bag. Hold the drip chamber (C)upside down.

3 Open the clamps (A) of the disposableset. Do not open the clamp of theunused spikes.

4 Fill the drip chamber (C) with acrystalloid IV fluid halfway. Hold thedrip chamber (C) upright again.

5 Close the roller clamp (D). Hold thedeaeration chamber (E) upside down.

6 Open the roller clamp (D).7 Fill the deaeration chamber (E) with a

crystalloid IV fluid completely. Hold thedeaeration chamber (E) upright again.

8 Deaerate the rest of the patient line (F).9 Close the roller clamp (D).

A

FE

A BCD

EC

5.1.6 Start warming blood or IV fluids

The display shows the initial temperature (37 °C).1 Remove the protective cap from the

patient line of the disposable set.Connect the patient line of thedisposable set to the patient or theoperating element.

2 Regulate the flow with the roller clamp.3 Set the temperature with the

temperature setting buttons (+/-). Thedevice warms the blood or the IV fluid.The display shows the flow rate. Thecontrol thermometer lights green.

5.1.7 Deaerating the deaeration chamber

If the deaeration chamber is three-quarters full of IV fluid, dearate the deaerationchamber.

Operation


1 Remove the vent cap (A) from thedeaeration chamber (B).

2 Put a syringe (C) into the vent valveand lightly press the syringe to openthe vent valve. It is recommended touse a Luer Lock syringe (20 ml orlarger).

3 Remove the air and/or the foam untilthe deaeration chamber is filled with IVfluid completely.

4 Put the vent cap (A) onto thedeaeration chamber (B).

A

C

B

5.1.8 Stop warming blood or IV fluids

1 Press the on/standby button. The fancontinues to operate for two minutes.

2 Press the eject button to remove thedisposable set from the device. The on/standby indicator lights orange. Thedevice is in standby mode.

3 To continue the IV administration:a. Place the disposable set near the patient.

4 To stop the IV administration:a. Close the clamps of the disposable set.b. Disconnect the patient line of the disposable set from the patient or the

operating element.

Operation


5.1.9 Audible alarm suppression

1 If an alarm sounds, press the audiblealarm suppression button (D) tosuppress the alarm for three minutes.The audible alarm suppressionindicator appears on the display (A).

2 If you press the audible alarmsuppression button (D) again, the alarmwill sound again. The audible alarmsuppression indicator disappears fromthe display (A).

BCD

E

A

F

5.1.10 Switching off the device

1 Press the on/standby button (B). Theon/standby indicator (B) lights orange.The device is switched off.

BCD

E

A

F

Operation


5.1.11 Extra options

1 In operation mode, repeatedly pressthe flow/volume button (C). The display(A) shows the flow only, the volumeonly or both the flow and the volume.

2 In standby mode, press and hold theflow/volume button (C). The display (A)shows the total volume of warmedblood or IV fluid (liters).

3 In operation mode, press and hold theflow/volume button (C) and thetemperature setting button (-) (F) toreset the volume indicator to 0. Thevolume indicator is automatically resetto 0 after 15 minutes of non-operation.

4 In standby mode, press and hold thetemperature setting buttons (+/-) (F).The display (A) shows the total numberof operating hours.

5 In operation mode, press and hold thetemperature setting buttons (+/-) (F).The display (A) shows the temperatureat the end of the line (Tout).

6 In standby mode, press and hold theaudible alarm suppression button (D)and the temperature setting button (+)(F) to do a safety test. The display (A)shows the temperature at the end ofthe line (Tout) during the safety test.

BCD

E

A

F

NOTE!

• Before you do a safety test, you must remove the disposableset from the device.

• The device automatically resets the volume indicator when:• you disconnect the mains plug of the single, dual or triple

power supply cord adapter from the earthed wall socketfor more than 40 seconds.

• you reset the device manually.

Operation


5.2 Fluido® Air GuardThe device is used to detect air in the deaeration chamber of the disposable setsand to clamp the patient line. The deaeration chamber is held against theultrasonic sensor in the deaeration chamber holder. The tube downstream of thedeaeration chamber is placed into the shutoff valve. If the ultrasonic sensordetects that the IV fluid level in the deaeration chamber becomes too low, theshutoff valve will close the supply tube to make sure that no air is supplied to thepatient.

WARNING!



5.2.1 Priming the deaeration chamber

1 Prime the disposable set to make surethat the deaeration chamber (A) is filledcompletely.

A

B

Operation


5.2.2 Setting the device to standby mode

1 Connect the mains plug of the single,dual or triple power supply cord adapterto an earthed wall socket. The on/standby indicator (A) lights orange. Thedevice is in standby mode. B

C D E FG

A

5.2.3 Placing the deaeration chamber

1 Turn the lock knob (A)counterclockwise and hold the lockknob (A) to open the deaerationchamber holder (B).

2 Place the deaeration chamber (C)between the upper limit strut (D) andlower limit strut (E).

3 Release the lock knob (A) to close thedeaeration chamber holder (B). A

E

BD

C

Operation


5.2.4 Placing the tube into the shutoff valve

1 Press the lock knob (A) and pull thecounteracting knob (B) at the sametime to open the shutoff valve (C).

2 Place the tube (D) into the centre of theshutoff valve (C).

3 Make sure that the tube (D)downstream of the deaeration chamber(E) goes straight through the tubesensor (F) and the shutoff valve (C).

4 Release the lock knob (A) to close theshutoff valve (C).

F

E

D

A/C

B

5.2.5 Switching on the device

1 Press the on/standby button (A). Theon/standby indicator (A) lights green.The tube detection indicator (C) lightsgreen. The device is switched on.

2 The device continuously scans for thepresence of air in the deaerationchamber. If the ultrasonic sensordetects that the IV fluid level in thedeaeration chamber becomes too low,the shutoff valve will close the supplytube. The air detection indicator (D)flashes yellow. The tube detectionindicator (C) goes off. An alarm sounds.

B

C D E FG

A

NOTE!

• If the tube is not placed in the shutoff valve correctly, thetube detection indicator (C) will flash yellow.

• The device treats the transition of IV fluid to foam the sameway as the transition of IV fluid to air.

5.2.6 Deaerating the deaeration chamber

If the device detects air or foam and the shutoff valve is closed, deaerate thedeaeration chamber.

Operation


1 Remove the vent cap from thedeaeration chamber (A).

2 Put a syringe (B) into the vent valveand lightly press the syringe to openthe vent valve. It is recommended touse a Luer Lock syringe (20 ml orlarger).

3 Remove the air and/or the foam untilthe deaeration chamber is filled with IVfluid completely.

4 Put the vent cap onto the deaerationchamber (A).

5 If the IV fluid level increases andpasses the ultrasonic sensor, thedevice will open the shutoff valve aftera few seconds.

B

A

5.2.7 Audible alarm suppression

1 If an alarm sounds, press the audiblealarm suppression button (B) tosuppress the alarm for three minutes.The audible alarm suppressionindicator (B) lights orange.

2 If the alarm is suppressed, the alarmwill be automatically reset after theultrasonic sensor detects IV fluid.

3 If you press the audible alarmsuppression button (B) again, the alarmwill sound again. The audible alarmsuppression indicator (B) goes off.

B

C D E FG

A

Operation


5.2.8 Switching off the device

1 Press the on/standby button (A). Theon/standby indicator (A) goes off. Thedevice is switched off.

B

C D E FG

A

5.3 Fluido® Pressure ChambersThe Fluido® Pressure Chambers are used to generate a pressurised blood or IVfluid flow to patients together with the Fluido® Blood and Fluid Warmer and theFluido® Air Guard. The pressure regulator controls the pressure of the pressurechambers. To avoid pressure drop of the bladder (reverse flow), each pressurechamber is equipped with a non-return valve. The pressure selector controls theinflation and deflation of the bladder. Both pressure chambers have a pressuregauge with units in mmHg. A pressure relief valve is included to preventoverpressure (maximum pressure = 300 mmHg).

WARNING!


• Do not inflate the bladders with unlocked or open doors.

NOTE!

• During a mains power failure, the bladder is not inflated bythe Fluido® Compressor, but the IV fluid flow will decreaseslowly until it reaches the maximum flow possible withgravity. If the maximum flow is too low, remove the IV bagand attach it to one of the suspension points for IV bags onthe Fluido® IV Pole.

Operation


5.3.1 Preparation

1 Set the pressure selector (A) to "-".2 Turn the pressure regulator (B) fully

counterclockwise ("-").3 Connect the Fluido® Pressure

Chambers to the Fluido® Compressor.4 Switch on the Fluido® Compressor.

B

A

5.3.2 Attaching an IV bag

WARNING!

• Do not use glass or plastic IV bottles. Only use 500 ml and1000 ml IV bags.

• When you lock the door, make sure that the connectors arenot caught.

• When the IV bag is inflated, do not close the door.• Open the door carefully. This will prevent damage to the

door.

Operation


1 Open the lid.2 Open the door.3 Manually press the bladder to fully

deflate the bladder.4 Attach an IV bag.

a. Attach a small IV bag (500 ml) (A)to the relevant attachment point(B).

b. Attach a large IV bag (1000 ml) (C)to the relevant attachment point(D).

5 Close the door.6 Close the lid.

A

B

D

C

5.3.3 Inflating the bladder

WARNING!

• Before you inflate blatter, make sure that the lid is closed.

1 Inflate the bladder.a. Set the pressure selector (A) to "+".b. Slowly turn the pressure regulator

(B) clockwise.2 Set the pressure regulator (B) to the

specified pressure (indicated on thepressure gauge).

3 If the set pressure is too high, set thepressure selector (A) to "-" to deflatethe bladder, set the pressure regulator(B) to "-" and set the pressure selector(A) to "+" to inflate the bladder again.

B

A

Operation


5.4 Fluido® CompressorThe Fluido® Compressor is a device to supply compressed air to the Fluido®

Pressure Chambers.

WARNING!



1 To switch on the device, set the on/offswitch (A) to the "I" position.

2 To switch off the device, set the on/offswitch (A) to the "O" position.

A

Operation


6 Cleaning and maintenanceThe Fluido® AirGuard System includes these components:

• Fluido® Blood and Fluid Warmer• Fluido® Air Guard• Fluido® Pressure Chambers• Fluido® Compressor• Fluido® IV Pole

The procedure is applicable to all components.

6.1 Cleaning

WARNING!

• Before you clean the device, disconnect the power supplycord from the mains.

• Make sure that water cannot come into the electrical areas ofthe device.

CAUTION!

• Do not use dripping wet cloths.• Do not use ketones (MEK, acetone, etc.) or abrasive

cleaners.• Do not use steam sterilisation (autoclave) or dry heat to

sterilise the device.

Clean the device after each use:

• Clean the device with a moist cloth or alcohol tissues.• Use one of these cleaning agents:

• 90% (or 70%) isopropyl alcohol• mild detergent solution• diluted chlorine bleach (30 ml/l water)• ammonia-based cleaners• glutaraldehyde-based cleaners 2.4%• hydrogen peroxide 3%

• Remove all remaining cleaning agent from the device with a soft, dry cloth.• Let the device dry naturally.• Keep the device in a cool, dry area when it is not in use.

Cleaning and maintenance


6.2 MaintenanceFluido® devices have no parts that can be maintained by the user.

WARNING!

• If the device has a malfunction, contact the service centre fortechnical support. Make sure that you have the serial numberof the device available.

• Do not try to open the device or correct the malfunctionyourself.

Cleaning and maintenance


7 Troubleshooting

7.1 Fluido® Blood and Fluid WarmerIf a problem occurs, an audible and visual alarm starts. Press the audible alarmsuppression button. Press the temperature setting buttons (+/-) together with theflow/volume button for 2 seconds to reset the device.If the problem still occurs, do not use the device. Use the tables to solve theproblem yourself. If you cannot solve the problem yourself, contact the servicecentre.

Problem Cause Solution

The on/standby indicatoris off.

No power. Make sure that thepower supply cord isconnected to the powersupply cord connection.Make sure that themains plug of the single,dual or triple power sup-ply cord adapter is con-nected to an earthedwall socket.

Malfunction. Contact the service cen-tre.


The on/standby indicatoris off.

An information signalsounds.

Malfunction. Contact the service cen-tre.

Troubleshooting



The device does notstart. The 'insert cas-sette' symbol flashes.

An incorrect cassette isinserted in the device.

Use a correct disposableset.


The on/standby indicatorgoes off during use.


Power failure. Restore the power. Ifyou restore the powerwithin 30 seconds, theprocess will restart auto-matically. If you do notrestore the power within30 seconds, remove thecassette and restart thedevice.

Problem Cause Cause

The display shows thatthere is no flow.

The clamps are closed. Open the clamps.

The flow is too low. Increase the flow.

Blockage in the drip sys-tem.

Replace the drip system.

The tube is bended. Unbend the tube.

No blood or IV fluid inthe IV bag.

Replace the IV bag.

Troubleshooting



The control thermometeris entirely red.

The display shows themaintenance symbol.


Malfunction.The temperature of theblood or the IV fluid isequal to or higher than45 °C.

Contact the service cen-tre.


The bottom section ofthe control thermometeris green.

The end temperature isstill not at the set tem-perature after using thedisposable set for a fewminutes.

The flow is too high. Decrease the flow.


The top section of thecontrol thermometer isred.

The display shows thatthere is no flow.

A pulsing signal sounds.

The temperature of theincoming or outgoingblood or IV fluid exceedsthe set temperature.

Stop the administrationof warmed blood or IVfluid. The device auto-matically stops warmingand restarts warmingwhen the temperature isdecreased.If the top section of thecontrol thermometerstays red, contact theservice centre.

Troubleshooting



The middle three bars ofthe lamp replacementindicator flash.


An information signalsounds. The devicekeeps operating.

One of the lamps isdefective.



The top or bottom bar ofthe lamp replacementindicator flashes.



An information signalsounds. The devicestops operating.

One of the lamps isdefective.


Troubleshooting




The display shows theletter 't'.

The device stops operat-ing.

The device does nothang upright on the IVpole. The angle variationexceeds 2.5° forward orbackward.

Hang the device uprighton the IV pole.


The cover of the slot forthe disposable set isblocked.

The cover is defective.The slot for the disposa-ble set is dirty.



Blood or IV fluid is leak-ing from the slot for thecassette.

Leakage. Stop the administrationof warmed blood or IVfluid. Remove andinspect the disposableset.Contact the service cen-tre.


If the eject button ispressed, the cassette isnot ejected from the slotfor the disposable set.

Malfunction. Leave the cassette inplace.Contact the service cen-tre.

Troubleshooting



The display shows anerror code.

Malfunction. Press the temperaturesetting buttons (+/-) toobtain the error codeduring an audible andvisible alarm.Reset the error code tocheck whether the cur-rent error code is theactual error code: Pressand hold the tempera-ture setting buttons (+/-)together with the flow/volume button for 2 sec-onds.If the information signalkeeps appearing, recordthe error code and con-tact the service centre.

7.2 Fluido® Air GuardIf a problem occurs, do not use the device. Use the tables to solve the problemyourself. If you cannot solve the problem yourself, contact the service centre.

Troubleshooting


Indicators /Alarms


The standby indi-cator lights green.

The tube detec-tion indicatorflashes yellow.

The air detectionindicator flashesyellow.

The repair indica-tor flashes red.

High-priorityalarm: 10 beepssound every 2.5seconds.

Air or foam isdetected by ultra-sonic sensor.Shutoff valve fail-ure.

Electrical prob-lem: The ultra-sonic sensoroperates correctlyand sends a clos-ing signal. How-ever, the closingsignal does notarrive at shutoffvalve connector(J2) at the powerboard.

Contact the serv-ice centre.

Troubleshooting


Indicators /Alarms




Medium-priorityalarm: 3 beepssound every 8seconds.

Air or foam isdetected by ultra-sonic sensor.

Leakage atupstream infusionline.

Check the cou-plings.Check the spikeat the fluid bag.Deaerate the dea-eration chamber.

Entrapped air viathe pressurechamber due toempty fluid bag.

Replace theempty fluid bag.Deaerate the dea-eration chamber.

Rigid object infront of ultrasonicsensor.

Filter in front ofultrasonic sensor.

Adjust the deaer-ation chamberuntil the indicatorsand alarms aredisabled.

No detection ispossible.

Bad contact ofdeaeration cham-ber against ultra-sonic sensor.

Check the deaer-ation chamberholder.Check the deaer-ation chamber.Clean the ultra-sonic sensor witha moist cloth oralcohol tissues.

Troubleshooting


Indicators /Alarms


The standby indi-cator is off.


The mains powerfailure indicatorflashes yellow.


No mains powerfor medium periodof time.The shutoff valveis closed.The device is notoperative. Onlyindicators andalarms are bat-tery-operated.

Mains power fail-ure.If the indicatorsand alarms areenabled for amedium period oftime, the batterywill become low(< 50%).

Make sure thatthe power supplycord is connectedto the power sup-ply cord connec-tion.Make sure thatthe mains plug ofthe single, dual ortriple power sup-ply cord adapteris connected to anearthed wallsocket.You can press thestandby button toexit the mode andswitch off thedevice com-pletely.

Troubleshooting


Indicators /Alarms


The standby indi-cator is off.


The mains powerfailure indicatorflashes yellow.

The low-batteryindicator flashesyellow.


No mains powerfor a long periodof time.The shutoff valveis closed.The device is notoperative. Onlyindicators andalarms are bat-tery-operated.

Mains power fail-ure.Low battery.If the indicatorsand alarms areenabled for a longperiod of time, thebattery willbecome low (<50%). The batterycondition canbecome insuffi-cient to enablethe indicators andalarms.

Make sure thatthe power supplycord is connectedto the power sup-ply cord connec-tion.Make sure thatthe mains plug ofthe single, dual ortriple power sup-ply cord adapteris connected to anearthed wallsocket.Leave the deviceconnected to themains power. Thebattery isrecharged after 6to 12 hours ofoperation.

Troubleshooting


Indicators /Alarms



The tube detec-tion indicatorflashes yellow.

Low-priorityalarm: 2 beepssound every 20seconds.

Fluid is detectedby the ultrasonicsensor, but thetube is not detec-ted by tube sen-sor.

The tube is out-side the tube sen-sor and the shut-off valve.

Place the tubeinside the tubesensor and theshutoff valve.

The tube sensoris dirty.

Clean the tubesensor with amoist cloth oralcohol tissues.

Troubleshooting


7.3 Fluido® Pressure ChambersIf a problem occurs, do not use the device. Use the tables to solve the problemyourself. If you cannot solve the problem yourself, contact the service centre.


The bladder does notinflate.

No air supply. Check the air supply.

Leakage at internal cou-plings.

Press the internal tubingtightly to the couplings.

The pressure selector isdefective.


The pressure regulator isdefective


The non-return valve isdefective.


Bladder leakage. Contact the service cen-tre.

The overpressure reliefvalve failed to open.



Long bladder inflationtime / Low air pressure.

Bad external pneumaticconnections betweenFluido® Compressor andFluido® Pressure Cham-bers.

Press the external tubingtightly to the couplings.

Leakage at internal cou-plings.

Press the internal tubingtightly to the couplings.

The pressure regulator isdefective


Leakage at connectionbetween elbow couplingand bladder tube.


Bladder leakage. Contact the service cen-tre.

Troubleshooting


7.4 Fluido® CompressorIf a problem occurs, do not use the device. Use the tables to solve the problemyourself. If you cannot solve the problem yourself, contact the service centre.


Low air pressure / Lowair flow.

Leakage. Check the pneumaticcouplings between theFluido® Compressor andthe Fluido® PressureChamber.

The external air tubesare kinked.

Check for kinked airtubes between the Flu-ido® Compressor andthe Fluido® PressureChamber.

The external air tubesare obstructed.

Clean the air tubes.

The air filter is dirty. Contact the service cen-tre.

The internal air supplycouplings are loose.


Pump leakage. Contact the service cen-tre.

Troubleshooting


8 Specifications

8.1 Fluido® Blood and Fluid WarmerGeneral specifications

Part number 651230

Voltage 220-240 V~

Frequency 50/60 Hz

Current 6 A

Maximum power 1400 VA

Fuses 8A Time-Lag, 250 V, 6.3x32 mm (2x)

Dimensions (H x W x D) 387 x 215 x 255 mm

Weight ± 9.5 kg

Setpoint temperature 30 °C ~ 39 °C., increments of 1 °C

Maximum temperature (Tout) 43 °C

Accuracy of temperature (Tout) ± 2.5 °C

Resolution of flow meter Flow in ml/min., increments of 1 ml(0-20), 5 ml (20-150) and 10 ml (>150)

Accuracy of flow meter ± 20%

Warming and measurement technol-ogy

Infrared

Warming lamps 300 W (4x)

Flow lamp 150 W (1x)

GMDN code 47623

Classification (IEC 60529) IPX1

Classification (IEC 60601-1) Class I, Cardiac Floating

Classification (MDD 93/42/EEC) Class IIb

Product life time 7 years

Specifications


Environmental specifications

Ambient temperature 15 °C ~ 30 °C

Relative humidity 30% ~ 75%

Atmospheric pressure 70-106 kPa

Transport and storage specifications

Ambient temperature -40 °C ~ 70 °C

Relative humidity 10% ~ 90% (non-condensing)


Specifications


8.2 Fluido® Air GuardGeneral specifications

Part number 660400

Voltage 220-240 V~

Frequency 50/60 Hz

Current 0.1 A

Maximum power 25 VA

Fuses - Primary circuit 200 mA Time-Lag High breakingcapacity, 125 V, 5x20 mm (2x)

Fuses - Secondary circuit 10 V: 1.6AT, type IEC127, 250 V,5x20 mm, self-resettable (1x)

12 V: 0.5AT, type IEC127, 250 V,5x20 mm, self-resettable (1x)

10 V: 0.25AT, type IEC127, 250 V,5x20 mm, self-resettable (1x)


Weight ± 4.5 kg

Sound pressure (alarm) Low priority: 52 dBA

Medium priority: 52 dBA

High priority: 54 dBA

GMDN code 47040


Classification (IEC 60601-1) Class I, Cardiac Floating

Classification (MDD 93/42/EEC) Class IIb






Specifications






8.3 Fluido® Pressure ChambersGeneral specifications

Part number 660300


Weight ± 4.2 kg

Maximum overpressure 300 mmHg ±10%

GMDN code 38468


Classification (MDD 93/42/EEC) Class IIa










Specifications


8.4 Fluido® CompressorGeneral specifications

Part number 660200A

Voltage 100-240 V~

Frequency 50/60 Hz

Current 0.08-0.03 A

Maximum power 6-16 VA

Fuses - Primary circuit 400 mA Time-Lag High breakingcapacity, 250 V, 5x20 mm (2x)


Weight ± 1.3 kg

Air flow 3 l/min. (unloaded)

Maximum pressure 1.0 bar / 750 mmHg

GMDN code 31253


Classification (IEC 60601-1) Class II, Cardiac Floating

Classification (MDD 93/42/EEC) Class I










Specifications


8.5 Fluido® IV PoleGeneral specifications

Part number 660500

Height 1914-2236 mm

IV pole diameter (Ø) 38 mm

Wheelbase diameter (Ø) 630 mm

Weight 13 kg

GMDN code 36069

8.6 Disposable setsIn the table below, you will find:

• the maximum normothermic flow rate with an incoming fluid temperature of20 °C of the Fluido® disposable sets.

• the maximum flow rate of the Fluido® disposable sets.

During warming, the output temperature can be lower than your set point at theflow rate.

8.6.1 Fluido® Standard Set

Part number 671200

Patient line 150 cm

Maximum pressure 300 mmHg

Maximum flow* 650 ml/min.

Normothermic flow** 20-400 ml/min.

Priming volume 90 ml

GMDN code 47622

Transport specifications




Specifications


Storage specifications



Atmospheric pressure 50-106 kPa* Free flow with 300 mmHg without catheter attached.** Incoming fluid temperature of 20 °C and normothermic flow between 36 °C and37.5 °C.

8.6.2 Fluido® Trauma Set

Part number 671500

Patient line 150 cm





Filter 200 μm

GMDN code 47622









Specifications


8.6.3 Fluido® Trauma Plus Set

Part number 671700

Patient line 200 cm





Filter 200 μm

GMDN code 47622









The incoming fluid temperature is 20 °C. Changes of the environmentaltemperature have an effect on the end of the lines.

Specifications


8.6.4 End-of-line temperature / Flow

X

Y

2034

35

36

37

38

39

40

41

30 50 100 200 500 750 10000

• X: Flow [ml/min]• Y: End-of-line temperature [°C]• Red: Fluido® Standard Set• Green: Fluido® Trauma Set• Purple: Fluido® Trauma Plus Set

The incoming fluid temperature is 20 °C. A change of the ambient temperaturehas an effect on the temperature at the end of the line.

Specifications


9 Electromagnetic compatibility

9.1 Electromagnetic immunityGuidance and manufacturer’s declarationThe device is intended for use in the electromagnetic environment specifiedbelow. The customer or the user of the device must assure that the device isused in such an environment.

Immunity test IEC60601 test level /Compliance level

Electromagnetic environ-ment

Electrostatic dis-charge (ESD)IEC 61000-4-2

±6 kV (contact)±8 kV (air)

Floors must be made ofwood, concrete or ceramictiles.If floors are covered withsynthetic material, the rela-tive humidity must be atleast 30%.

Electrical fast tran-sient/burst (EFT/B)IEC 61000-4-4

±2 kV (power supply lines)±1kV (input/output lines)

The mains power qualitymust be that of a typicalcommercial or hospital envi-ronment.

SurgeIEC 61000-4-5

±1 kV (differential mode)±2 kV (common mode)

The mains power qualitymust be that of a typicalcommercial or hospital envi-ronment.

Voltage dips, shortinterruptions andvoltage variationson power supplyinput linesIEC 61000-4-11

<5% UT (>95% dip in UT)for 0.5 cycle40% UT (60% dip in UT)for 5 cycles70% UT (30% dip in UT)for 25 cycles<5% UT (>95% dip in UT)for 5 seconds

The mains power qualitymust be that of a typicalcommercial or hospital envi-ronment.If the user requires contin-ued operations during mainspower interruptions, it is rec-ommended that the deviceis powered from an uninter-ruptible power supply or abackup battery system.

NOTE: UT is the AC voltage before application of the test level.

Electromagnetic compatibility




Power frequencymagnetic field(50/60 Hz)IEC 61000-4-8

3 A/m The power frequency mag-netic fields must be at levelscharacteristic of a typicallocation in a typical com-mercial or hospital environ-ment.

Conducted RFIEC 61000-4-6Radiated RFIEC 61000-4-3

3 Vrms(150 kHz - 80 MHz)3 V/m(80 MHz- 2.5 GHz)

The portable and mobile RFcommunications equipmentmust not be used closer toany part of the device(including cables) than therecommended separationdistance calculated from theequation applicable to thefrequency of the transmitter.

Recommended separation distance:d = 1.2 √ Pd = 1.2 √ P (80 MHz - 800 MHz)d = 2.3 √ P (800 MHz- 2.5 GHz)where P is the maximum output power rating of thetransmitter in watts (W) according to the transmitter man-ufacturer and d is the recommended separation distancein meters (m).

Field strengths from fixed RF transmitters, as determinedby an electromagnetic site survey a), must be less thanthe compliance level in each frequency range b).

Interference can occur in the vicinity of equipmentmarked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2: These guidelines may not apply to all situations. Electromagneticpropagation is affected by absorption and reflection from structures, objectsand people.





a) Field strengths from fixed RF transmitters - such as base stations for radio(cellular/cordless) telephones and land mobile radios, amateur radio, AM andFM radio broadcast and TV broadcast - cannot be predicted theoretically withaccuracy. To assess the electromagnetic environment due to fixed RF transmit-ters, an electromagnetic site survey must be considered. If the measured fieldstrength in the location in which the device is used exceeds the applicable RFcompliance level above, the device must be observed to verify normal opera-tions. If abnormal performance is observed, additional measures may be nec-essary, such as reorienting or relocating the device.b) Over the frequency range 150 kHz - 80 MHz, field strengths must be lessthan 3 V/m.

9.2 Electromagnetic emissionsGuidance and manufacturer’s declarationThe device is intended for use in the electromagnetic environment specifiedbelow. The customer or the user of the device must assure that the device isused in such an environment.

Emissions test Compliance Electromagnetic envi-ronment

RF emissionsCISPR 11

Group 1 The device uses RFenergy only for its inter-nal function. Therefore,its RF emissions arevery low and are notlikely to cause any inter-ference in nearby elec-tronic equipment.

RF emissionsCISPR 11

Class A The device is suitable foruse in all establishmentsother than domestic andthose directly connectedto the public low-voltagepower supply networkthat supplies buildingsused for domestic purpo-ses.

Harmonic emissionsIEC 61000-3-2

Not applicable

Voltage fluctuations/flicker emissionsIEC 61000-3-3

Not applicable



9.3 Recommended separation distancesRecommended separation distances between portable and mobile RFcommunications equipment and the deviceThe device is intended for use in an electromagnetic environment in whichradiated RF disturbances are controlled. The customer or the user of the devicecan help prevent electromagnetic interference by maintaining a minimumdistance between portable and mobile RF communications equipment(transmitters) and the device as recommended below, according to the maximumoutput power of the communications equipment.

Separation distance according to frequency of transmitter

Rated maximumoutput power oftransmitter

150 kHz -80 MHz

80 MHz -800 MHz

800 MHz -2.5 GHz

0.01 W 0.12 m 0.12 m 0.24 m

0.1 W 0.37 m 0.37 m 0.74 m

1 W 1.17 m 1.17 m 2.34 m

10 W 3.69 m 3.69 m 7.38 m

100 W 11.67 m 11.67 m 23.34 mFor transmitters rated at a maximum output power not listed above, therecommended separation distance d in metres (m) can be estimated using theequation applicable to the frequency of the transmitter, where P is the maximumoutput power rating of the transmitter in watts (W) according to the transmittermanufacturer.NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higherfrequency range applies.NOTE 2: These guidelines may not apply to all situations. Electromagneticpropagation is affected by absorption and reflection from structures, objects andpeople.



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