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DonatelloTM

Tissue Processor User Manual

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Manufacturer:

Diapath S.p.A. Via Savoldini,71

24057 Martinengo (BG) Italy Tel. (+39)0363.986.411 Fax (+39)0363.948.000

www.diapath.com [email protected]

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Manual information This document is protected by copyright laws; copyrights of this document belong to Diapath S.p.A. It is strictly forbidden, full or in part, to modify this manual in absence of an explicit authorization. Diapath S.p.A. is not obliged to regulate updates of this manual, or to send regularly reviewed or updated versions of this manual to its customers. Information contained in this manual is subject to change without prior notice. Diapath S.p.A. guarantees the accuracy of the information present in this manual as a result of thorough research; if information is incorrect or unclear, please contact Diapath S.p.A. or the distributor. Diapath S.p.A. is not responsible for any kind of material damages or other damages related to non-compliance with indications or specific information present in this manual. Diapath S.p.A. continuously adopts a development policy and reserves the right to make changes and improvements to any product described in this manual without prior notice. The serial number and date of manufacture are reported on the registration plate attached on the rear part of the instrument. Inspired to: Donatello, Donato di Niccolò di Betto Bardi

Donatello (Florence, 1386 – Florence, 13 Dec. 1466), was an Italian sculptor, goldsmith and designer. With his long career was one of the three fathers of the Florentine Renaissance, along with Filippo Brunelleschi and Masaccio, and one of the most celebrated sculptors of all time. Gave a fundamental contribution to the renewal of the ways of the sculpture, setting aside the experiences of the late Gothic and overcoming the classic models of Roman art, the sign of a new and restless expressionism that pervades his best works.

David, 1440 – Most famous Donatello sculpture Bargello Museum - Florence

Manual revision: 5 Edition date: July 30th 2018

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Contents Manual information.......................................................................................................................................................................... 3 Contents ......................................................................................................................................................................................... 4 Preface ........................................................................................................................................................................................... 6 Destination of use ........................................................................................................................................................................... 6 Quality control................................................................................................................................................................................. 7 Unpacking and operation ............................................................................................................................................................... 12 Instrument placement and installation ............................................................................................................................................ 12 1 DonatelloTM Tissue Processor components ..................................................................................................................... 19 1.1 Instrument overview ............................................................................................................................................................ 19 1.2 Instrument rear part ............................................................................................................................................................... 20 1.3 Instrument features ................................................................................................................................................................. 20 1.4 Parts supplied – Packing list ..................................................................................................................................................... 22 1.5 Technical data ....................................................................................................................................................................... 23 1.6 Processing chamber (SPC) .................................................................................................................................................... 24 1.6.1 Processing capacity ..................................................................................................................................................... 24 1.6.2 Level sensors .............................................................................................................................................................. 24 1.6.3 Half load mode ............................................................................................................................................................ 25 1.7 Wax reservoir ........................................................................................................................................................................ 25

1.7.1 Cleaning wax system ................................................................................................................................................... 25 1.7.2 Exhausting wax dumping system (EWD/PWD) ............................................................................................................... 26

1.8 Reagent stations................................................................................................................................................................... 26 1.8.1 Compatible reagents ................................................................................................................................................... 27 1.8.2 Reagent management module ................................................................................................................................... 27 1.8.3 DAF (Decreasing Aging Factor) .................................................................................................................................... 28 1.8.4 Remote reagent fill and drain (RFill/RDrain) ............................................................................................................... 29 1.9 Fast Processing system (FPS) ................................................................................................................................................... 29 2 DonatelloTM tissue processor software operation ............................................................................................................. 30 2.1 Main screen.......................................................................................................................................................................... 30 2.1.1 Main screen upper area ............................................................................................................................................... 30 2.1.2 Main screen central area ............................................................................................................................................ 31 2.1.3 Main screen lower area .............................................................................................................................................. 35 2.2 Instrument status .................................................................................................................................................................. 36 2.3 Warnings and alarms ............................................................................................................................................................. 36 2.4 Tank position status.............................................................................................................................................................. 37 2.5 Starting processing ................................................................................................................................................................ 38

2.5.1 Normal processing ...................................................................................................................................................... 38 2.5.2 Safety procedures warning messages............................................................................................................................. 39 2.5.3 Inverted processing ...................................................................................................................................................... 39 2.5.4 Cassette tracking .......................................................................................................................................................... 39 2.5.5 Choice of processing end time ....................................................................................................................................... 40 2.5.6 Starting processing ....................................................................................................................................................... 41 2.5.7 Bubbling ...................................................................................................................................................................... 42

2.6 Washing ................................................................................................................................................................................ 43 2.6.1 Starting washing ........................................................................................................................................................... 43

2.7 Reagent replacement ............................................................................................................................................................. 44 2.7.1 Tank replacement ......................................................................................................................................................... 45 2.7.2 New tank ..................................................................................................................................................................... 49 2.7.3 Filter support system .................................................................................................................................................... 51

2.8 Main menu ............................................................................................................................................................................ 52 2.8.1 Instrument information ................................................................................................................................................. 53 2.8.2 General information ...................................................................................................................................................... 53 2.8.3 Diapath Setting ............................................................................................................................................................ 54 2.8.4 Modification of processing and washing procedures ........................................................................................................ 56 2.8.5 Manual operation .......................................................................................................................................................... 58 2.8.6 Reagent management ................................................................................................................................................... 61 2.8.7 MultiSense ................................................................................................................................................................. 64 2.8.8 Statistics menu ............................................................................................................................................................. 65 2.8.9 User management ........................................................................................................................................................ 70 3 Specimens Traceability .................................................................................................................................................... 74 3.1 Overview ................................................................................................................................................................................. 74 3.2 Specimen insertion ................................................................................................................................................................ 74 3.3 Statistics ................................................................................................................................................................................. 76

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4 Safety procedures.................................................................................................................................................................. 77 4.1 Safe procedure – Safe reagent ................................................................................................................................................. 77 4.2 Restart .................................................................................................................................................................................. 81 5 Alarms and warnings.............................................................................................................................................................. 84

5.1 Not blocking alarms .............................................................................................................................................................. 84 5.2 Blocking alarms .................................................................................................................................................................... 87

6 Cleaning and maintenance ................................................................................................................................................... 90 6.1 Maintenance Schedule ............................................................................................................................................................. 90 6.2 Instrument decontamination procedure ..................................................................................................................................... 91 6.2.1 Preventative measures and IPD to use ............................................................................................................................. 91 6.2.2 General information on sanitizing solution ........................................................................................................................ 91 6.2.3 Decontamination procedure............................................................................................................................................. 91 6.3 LCD display cleaning ................................................................................................................................................................ 92 6.4 External surfaces and process chamber cleaning........................................................................................................................ 92 6.5 Charcoal filter replacement ....................................................................................................................................................... 92 6.6 Lid gasket maintenance............................................................................................................................................................ 94 6.7 Fuses replacement ................................................................................................................................................................... 94 6.8 Preventive maintenance ........................................................................................................................................................... 95 7 Accessories ............................................................................................................................................................................ 96 8 Troubleshooting..................................................................................................................................................................... 97 9 WEEE Directive ...................................................................................................................................................................... 98 9.1 Uninstallation and disposal ....................................................................................................................................................... 98 10 Diapath instrument warranty ............................................................................................................................................. 98

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Preface Destination of use DonatelloTM is an automatic smart tissue processor for lab use. Its use is intended for fixation, dehydration and wax infiltration of histological specimen tissues. The instrument can be used, accordingly to all instruction on this manual, only by well-trained and authorized staff.

Any improper use of the instrument must be considered as an operation that is not allowed. Maintaining and reading of this manual is necessary for the use of the instrument in order to avoid dangerous situations. The operators shall be adequately trained in its use and must respect all safety rules and its use limits. Trained and authorized Diapath S.p.A. staff shall perform instrument maintenance, due to trouble or malfunction. The instrument complies with CISPR 11 Class A rules: in case of domestic use, it may cause radio interferences. In this case, a measurement and mitigation of such interference is necessary. Before installing the instrument, an analysis of electromagnetic interferences is performed. Do not use the device near sources of strong electromagnetic radiations, such as radiofrequency waves generators. In this case the radiations may interfere with normal functioning of the instrument. Here below all regulations followed for the development and manufacturing of DonatelloTM Tissue Processor: • Directives 98/79/CE of European Parliament on medical devices and medical devices in use • Directive 2014/53/EU of the European Parliament and of the council of 16 April 2014 on radio equipment • Legislative Decree 27th January 2010, n. 17 implementing Directive 2006/42/EC on machinery and amending Directive • 95/16/EC relating to lifts. ISO9001(*) Quality management system requirements • ISO 13485(*): Quality management system requirements for medical devices. Requirements for regulatory purposes and

specific requirements of the application of ISO 9001(*) • UNI CEI EN ISO 14971(*): application of risks management to medical devices • EN ISO 18113-3(*): In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3: In vitro

diagnostic instruments for professional use. • EN ISO 15223-1(*): Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General

requirements. • EN 61326-1(*): Electrical equipment for measurement, control and laboratory use - EMC requirements

Part 1: General requirements. • EN 61326-2-6(*): Electrical equipment for measurement, control and laboratory use - EMC requirements. Part 2-6: Particular

Requirements - In vitro diagnostic medical devices (IVD). • EN 61000-3-2(*): Electromagnetic compatibility (EMC) Part 3-2: Limits - Limits for harmonic current emissions. (Equipment

with input current <= 16A per phase). • EN 61000-3-3(*)+ A1(*)+ A2(*): Electromagnetic compatibility (EMC) Part 3-3: Limits - Limitation of voltage fluctuations and

of flicker in low voltage supply systems for equipment with rated current <= 16A and not subject to conditional connection. • EN 61010-1(*): Safety requirements for electrical equipment for measurement, control and laboratory use. Part 1: General

requirements. • EN 61010-2-101(*): Safety requirements for electrical equipment for measurements, control and laboratory use. Part 2-101:

Particular requirements for medical equipment for in-vitro diagnostics. • EN 62471(*) LED light – Category risk group 1. • ETSI EN 301 489-1(*) Part 1: General requirements; Harmonized standard covering the essential requirements of article 3.1 (b)

of Directive 2014/53/EU and essential requirements covering the essential requirements of article 6 of directive 2014/30/EU • ETSI EN 301 489-3(*) Part 3: Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 3: Specific

conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz and 246 GHz; Harmonized standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU

• ETSI EN 300 330-1(*): Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz; Part 1: Technical characteristics and test methods

• ETSI EN 300 330-2(*): Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive.

• EN 50364(*)Limitation of human exposure to electromagnetic fields from devices operating in the frequency range 0 Hz to 300 GHz, used in Electronic Article Surveillance (EAS), Radio Frequency Identification (RFID) and similar applications

(*) In the applicable edition

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Quality control

Diapath S.p.A. adopts quality management system ISO 9001(*) and ISO 13485(*) to design, make and improve the technical-scientific solution for the customer in medical and diagnostic in vitro systems, assuring high quality services with the help of an highly qualified and motivated staff to contribute to the improvement of Diapath S.p.A. products.

Diapath S.p.A. constantly looks for customer’s satisfaction, tries to perceive their expectations and to treat the customer without any discrimination. Diapath S.p.A. assures the application of normative requirements.

Quality assurance of data furnished by Diapath S.p.A. is obtained through these activities:

• Use only reference material • Execution of proofs of the whole production • Correlation of different results

The internal quality control foresees to monitor the most difficult passages of an analytic process so as to verify their stability, assuring that quality parameters estimated during the validation or check of the method are valid also for real instruments and that they will not worsen during the course of the time.

Diapath S.p.A. tests its own products according to some internal procedures, to reduce possibility of anomalies during the operation.

To identify and to find out its own instruments, Diapath S.p.A. uses some internal procedures to find production recording, assembling recording, tests recording, serial numbers or batch codes and configuration recording.

Instrument information All information present in this manual is only regarding the device shown on the cover. On instrument, there is the registration plate with the serial number (Picture 1).

Storage and handling For a correct storage and function of the instrument, all instructions provided in this manual concerning maintenance and installation should be respected. Also the showed below environmental requirements should be respected:

The instrument can work with 80% relative humidity conditions for temperatures up to 31 °C with a linear decrease up to 50% at the temperature of 40° C. Voltage variation can’t exceed +/-10% the nominal value. The instrument is planned only for internal use and up to 2000m o.s. altitude. Before instrument starting up (after taking it from storage), it is suggested that the instrument reaches environmental conditions (about 30 min).

Storage and transport temperature range: Da +10°C a +40°C Storage humidity: 80% Working temperature range: Da +10°C a +40°C

Picture 1 – Registration plate

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Safety information This manual contains many information for user safety. This chapter has been designed and tested in conformity with safety rules.

This manual, if necessary, must be integrated with the provisions on prevention and environmental protection in force in the country of the operator

Adopted symbols and their meaning

Danger – The danger instructions signal situations that might cause death or serious lesions

Caution - The caution instructions signal situations that might cause physical lesions to people or things

Biohazard – The biohazard instructions signal situations that might cause the contamination of people or parts involved in the process

Heated surface hazard – heated surface instructions signal surfaces that get hot during use. Risk of burn, avoid direct

contact.

Instructions of danger

Never disassemble, modify or repair the instrument or one of its part without written authorization by Diapath S.p.A.

Do not use any kind of different power supply from the mentioned ones.

Attention to the use of solvents and reagents. To avoid instrument damages or risks for the user, use reagents indicated in the chart 1.8.1. Reagents used for tissue infiltration are toxic, flammable and also harmful. Use gloves and protective glasses always. Gloves must be resistant to all reagents indicated in chart list 1.8.1. For a correct use of reagents, please refer to their technical data sheets During processing, do not replace reagents; it may cause damages to the instrument, processing specimens and operator health too.

All chemical products used in combination with the instrument are highly flammable and may have harmful effects on health. Install the instrument in a well-ventilated place and open flame free. People can not stay in the area for many time; otherwise, a ventilation system is necessary. Do not use in explosion-hazardous areas.

Instructions of caution

Do not place objects that are not involved in the use of the instrument

The use of specific individual protection device is recommended (for instance: gloves)

Replace reagents once exhausted or contaminated

For the disposal of exhausted reagents, please comply with current rules of the company/State where the instrument is used

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Instructions of Biohazard

Keep attention to the possible bio-contamination of the parts involved in the process. Follow all decontamination instructions present in the instrument before any maintenance activity or place the instrument into its case.

Special individual safety measures shall be used by operators, in accordance with the standards for safety in the laboratories and product safety data sheets in relation to current rules.

Instructions of Heated Surface hazard

Keep attention to liquid paraffin or during racks picking. Liquid paraffin is hot and can cause severe burns. Do not touch paraffin containers or wax chamber sides because may be hot. Follow all alerts present next to heated surfaces

Safety training

All the operators must be trained to use the tissue processor safely. After such training the operators must have understood that:

• The instrument must be connected to a voltage source in accordance with electrical data label • The use of the instrument differently from Diapath S.p.A. instructions might compromise the supplied protections

Users group DonatelloTM tissue processor must be used only by qualified and well-trained operators. All users can proceed with the use of the device only after reading this user manual and when all technical details are familiar to them.

Compliance with safety rules All safety related regulations, local codes and instructions that appear in the manual or on equipment must be observed to ensure personal safety and to prevent damage to either the instrument or equipment connected to it. If equipment is used incorrectly, the protection provided might be compromised.

Definition of further adopted symbols

In vitro diagnostic medical device

Built in

Important information for the user

Diapath innovation

European Community approval mark

Manufacturer

Read carefully the manual before instrument starting

Danger

Electrical shocks risk

See the user manual

Disposal

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Definitions

DAF: Decreasing aging factor is a reagent management system according to the number of cassettes processed. Its aim is to ensure the best use of reagents with an optimal processing.

According to RMS, a limit of usage for each reagent is established which corresponds to the maximum number of cassettes processed. This limit set by the manufacturer. The system automatically assigns the number of cassettes processed for each reagent and updates the datum at each processing. This datum resets at reagent replacement only. The real counter is the DAF (it allows reagent replacement request). DAF factor is not evaluated according to the number of cassettes processed but in relation to the sequence of reagent used among a group. Example:

3 tanks of alcohols and 100 cassettes processed during each processing, DAF regression percentage will be equal to 1 – 0.6 – 0.4 (other values 0.3 – 0.2 – 0.15 – 0.1 – 0.1 – 0.05).

After the first processing, the number of cassettes processed set by DAF will be equal to: 100 for the first used tank, 60 for the second and 40 for the third. The system uses the older tank for the first step,

the intermediate for the second and the other for the last step. Tank order use is not fixed and definitive, but changes when reagent replacement requests occur. Assign the most recent tank to the last step; it is possible to replace the reagent at any time without waiting for any DAF indications or in case of unexpected events, for i.e. loss of liquid from a tank. Manual reset, from RMS menu.

EWD: External wax dumping, external wax drain into any container. Exhausted or to replace wax is conducted (using the specific button) into the processing chamber, and from this last to EWD green connector, placed on instrument frontal part.

FPS: Fast Processing System: a device that heats the reagents Multisense: Technology that allows the instrument parameters is to be set automatically according to routing lab needs. There

are 5 preset adjustable profiles set by Diapath Service staff only during installation with the possibility to modify them in case of routine increase/decrease. Processing operation and the number of available racks inside the chamber differ from the set mode and the volume of reagent in the tanks. 1. HIGH procedure: a) Specific for high routine labs b) MAX 405 specimen c) RFID active d) Up to 3 racks with 135 specimens each used at the same time e) Tanks: 5 L f) FPS option active g) Use of standard reagent as xylene and alcohol

2. LOW procedure: a) Specific for low/medium routine lab b) MAX 270 specimens c) RFID active d) Up to 2 racks with 135 specimens each used at the same time e) Tanks: 4.1 L

f) FPS option active g) Use of standard reagent as xylene and alcohol

3. GREEN HIGH procedure: a) Specific for high routine labs b) MAX 450 specimens c) RFID active d) Up to 3 racks with 135 specimens each used at the same time e) Tanks: 5 L f) FPS option disable g) Use of reagent as Ottix Plus and Ottix Shaper

4. GREEN LOW procedure: a) Specific for low/medium routine lab b) MAX 270 specimens c) RFID active d) Up to 2 racks with 135 specimens each at the same time e) Tanks: 4.1 L f) FSP disable g) Use of reagent as Ottix Plus and Ottix Shaper

5. OPEN procedure: a) OPEN profile of the instrument depending on customer needs b) Possibility of use your own reagents c) MAX 405 specimens d) RFID disabled e) Up to 3 racks with 135 specimens each at the same time f) Remote Fill and Drain active

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g) Tanks: 5 L h) FPS active Possibility to use any kind of reagent at User’s discretion

PWD: Protected Wax Dumping. Use EWD or PWD mode to drain wax present inside melting cylinders. Liquid wax goes to

processing chamber and then out through EWD connector (green); use protecting mode avoiding leakages of possible volatile substances present in exhausted wax. This protect procedure conducts the flow to PWD tank (top right), always empty and specific for exhausted wax drain

RDRAIN: Reagent drain using RFILL connector (red) to an external container using a specific pipe (Available only with OPEN multi-sense profile)

RFILL: Reagent loading using RDRAIN connector (white) to an external container with its specific pipe (Available only with OPEN multi-sense profile)

RMS: Reagent management system, is a software page for setting aging limit of single reagent throughout DAF or process number

SPC: Specimens Processing Chamber (resistances and optical level sensors) WCS: Wax-cleaning system is a system for wax cleaning from solvent or contamination of alcohols. An airflow allows their

removal. WWC: Wax Warm Chamber SelfCheck: SelfCheck is a self-diagnostic system of instrument sensible parts; it prevents unexpected blocks during overnight

processing. The user can activate the procedure before processing: - Check on the operation of sensible mechanical parts - Patency test on all reagent position - Alert in case of malfunction that allows to check the instrument before start processing for a complete safety

of specimens

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Unpacking and operation Instrument placement and installation

Requirements for instrument placement

Before proceeding with instrument installation, check if: • Power sources complies with data supplied by the manufacturer (see Technical Data) • Place the instrument in a flat, stable and vibration free surface that can carry twice of instrument weight (see Technical Data) • Make sure that the instrument is level in length and width • The distance from possible walls shall be at least 20 cm

Delivery

Unpack all instrument parts taking care to not damage them

The instrument is tested before shipment Check the presence of possible damages due to transport on packaging or instrument. In case of damages, contact Diapath S.p.A. or local distributor

Unpacking

BOX OPENING

• To remove the instrument from its packaging box, open the frontal panel always maintaining it in vertical position

• Use a screw gun and remove all fixing screws from frontal panel (Picture 2)

• Pay attention to central screw present on the bottom

Picture 2 – Box opening

ATTENTION Check that the instrument case is always in a vertical position (including delivery and unpacking step). NEVER place the instrument in horizontal position, in order to avoid damaging it and/or its accessories.

ATTENTION • Due to its dimension and weight (at least 336 Kg), instrument moving shall be performed by several persons

using suitable lifting devices • Make sure that the instrument is placed and unpacked in a surface not less than 350 cm x 90 cm

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INTERNAL FIXING PARTS AND ACCESSORIES REMOVAL Once the frontal cover of the box has been removed, inside the instrument is as shown in Picture 8: To remove the instrument correctly, proceed as follow (see Picture 3): • Remove frontal protection black foam rubber (point 1) • Remove corner protection present on sides, frontal and back of the instrument (point 2) • Remove polystyrene box containing instrument racks (point 3) • Remove the box containing fill/drain pipes and paraffin external drain (point 4) • Remove the box containing 15” PC/monitor and cables (point 5)

Picture 3 – Inside the box

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ATTENTION • If the instrument is not used immediately, please leave it inside its original packaging.

Remove it only before instrument installation • Unless different orders, store the box and all inner packaging during instrument warranty

ATTENTION • DonatelloTM tissue processor functioning is not allowed in hazardous areas • Keep the instrument away from heat source as radiators, stoves and direct sunlight; and humidity sources as

basins, drains, etc.

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After removing corner and frontal protections and all boxes containing accessories, the instrument is as in Picture 4. Remove foam rubber protections and the plastic packaging that cover the instrument. Unlock the instrument (see detail Picture 4) and use panel frontal box as ramp. Picture 4 - Detail Apply a light pressure in the area and in the direction showed by the arrow, in order to unlock the wheel brake (Picture 4A and Picture 4B)

RAMP SETTING UP AND INSTRUMENT REMOVAL Use box frontal panel as ramp to move the instrument outside. Place the ramp as shown in Picture 5, ensuring that the two parts (ramp and box lower part) completely fit. Now it is possible to move the instrument outside (Picture 6).

Lock again the instrument by wheel brakes once located in its final position (see Picture 4A/4B).

Picture 4 – Inside DonatelloTM Box

Picture 6 –Move the instrument outside Picture 5 – Ramp and box lower part setting up

Picture 4B - Wheel brake off Picture 4A – Wheel brake on

ATTENTION Once unpacked, check both the external conditions of the instrument and the PC. In case of damage DO NOT plug the instrument to the mains, please contact the manufacturer.

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PC/MONITOR UNPACKING AND INSTALLATION Instrument PC/Monitor is inside instrument box (Picture 3, point 5). Its packaging is shown in Picture 7:

Remove fixing elements and PC plastic packaging taking care not to cause damage to it. Mount the PC on instrument supporting bracket as follow: 1. Open support safety lever of the instrument bracket (Picture 8) 2. Place the PC, ensuring its junction with instrument support safety lever is locked correctly (Picture 9) 3. Close safety lever and ensure that the Pc is locked in a correct position (Picture 10)

Picture 7 – Packaging

Picture 8 – Support safety lever Picture 9 – Pc support unlocked Picture 10 – Pc support locked

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Pc installation and instrument starting up

After fixing the PC to support bracket connect it to the instrument. All cables are installed (it is not necessary to connect them physically to the instrument because they are already connected internally). Here below (Picture 11) PC lower part with the list of all connections for instrument functioning: 1 – PC power cable 2 – USB ports for frontal USB port and RFID antenna connection 3 – RJ45 port for communication Ethernet cable and the instrument connection 4 – RJ45 port for instrument connection to local network INSTRUMENT POWER CONNECTION AND STARTING Once all cables have been correctly inserted on PC lower part, connect 16A power cable for instrument starting up (Picture 12):

• Ensure that 16A power cable is correctly inserted into instrument socket • Ensure that the red Voltage Selector, located just above the instrument electrical socket, is set to the correct

position (115V or 220V) in agreement with the local supplied electric voltage (Picture 12) • Insert cable extremity to an outlet • To start up the instrument, switch from 0 to 1 (Picture 12)

ATTENTION • Make sure that the red Voltage selector, located just above the instrument electrical socket, is set to the correct position

(115V or 220V) in agreement with the local supplied electric voltage. Using a higher voltage than the one set on the selector may cause instrument damage

• Connect the instrument to grounded socket. DO NOT use extension cable • Use power cable to disconnect the instrument from mains. Check if power cable is easy to access

Picture 11 – Instrument rear part

Picture 12 – Power cable

1

3

Picture 11 - PC rear part

4

2

IMPORTANT The only cable to plug in is the 16A instrument power supply. All cables are internally connected, the user only have to connect them to the PC.

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Re-packing When repacking due to instrument moving or uninstallation, proceed as follow: • Remove, if present, the clean basket of processing chamber • Remove the paraffin from storage reservoir following drain wizard (inner and external) doing a standard cleaning procedure

(see chapter 2) • Empty all reagent reservoirs (processing, cleaning and paraffin drain) • Empty the condensation trap (see chapter 2) • Unplug all cables connected to PC and secure them to the bracket as shown in Picture 13: • Insert all accessories and other parts as PC, fill/drain pipes and basket into their original packing and seal them carefully • Place the instrument inside the box: use box frontal wall to create a ramp and allow instrument movement inside the box (see

the procedure RAMP SETTING UP AND INSTRUMENT REMOVAL described before) • Block instrument wheels • Place frontal and corner protections inside the box taking care to rear corner ones (see Picture 14) • Place PC and accessories boxes on the processor, place original packing between instrument and PC’s box • Close box frontal panel by fixing it with screws

Pay attention to the possible bio-contamination of the parts involved in the process. Before maintenance activity or place instrument into its case, follow all decontamination instructions present in this manual.

Special individual safety measures should be used by operators, in accordance with the standards for safety in the laboratories and product safety data sheets in relation to current rules.

Transport Useful tips for transport:

• It is scientific instrumentation, it is fragile

• The instrument has electronic parts

• Avoid any contact with water and/or other liquids

• Transport and storage temperature MUST not exceed the following limits: from 5°C to 40°C.

• Move the instrument only using original packing and keep it always in vertical position. During the transport, special precaution must be taken in order to avoid instrument overturning.

Picture 13 –Side foam rubber Picture 14 – Instrument bracket

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Starting-up procedures Follow these procedures at processor first start-up:

• Check if power cable is in good condition and connect to both extremities correctly

• If UPS equipped: check its right functioning (see UPS user manual)

Perform these procedures as soon as instrument switching on: • Check system time and date

• Plan and/or check configuration parameters

• Plan and/or check all parameters of reagent management

• Plan and/or check tanks contents

• Refill wax containers

• Install reagent tanks

• Plan and/or check processing protocols

• Plan and/or check cleaning protocols

Procedure to follow before starting processing

Before starting a protocol, the user must follow the following steps:

• Check the level of paraffin and reagent containers

• Check the correct paraffin liquefaction

• Check and clean processing chamber

• Select processing program

• Set all cassettes and racks to process

• Open processing chamber and insert the rack with the specimens

• Close processing chamber cap, make sure that is tightly closed

• Set time and date of ending process

• Start the processing

Procedure to follow at the end of processing At the end of protocol, the operator must:

• Follow the instruction to drain the last reagent

• Wait for complete drain before opening processing chamber

• Remove all specimens from processing chamber

• Clean the processing chamber and its cap from possible residuals of paraffin

• Perform washing

• Once washing complete, check if processing chamber and its cap are well-cleaned, if necessary complete the cleaning by removing any presence of paraffin

• Check if optical sensors are well-cleaned, if not, clean them using a soft cloth

• Consult the graph and all statistics of the last processing in order to check if the processing has been accomplished correctly

Procedure to follow in case of instrument switch off • If the user has to switch the instrument off, please folllow the instruction below:

• Access instrument Main menu

• Access “Diapath settings” menu

• Select “Exit program” tab

• Select Exit

DonatelloTM Series 2 must be switch off ONLY following the procedure described above. In other case, many damages can involve the instrument and/or data losing

If DonatelloTM Series 2 is switched off for a long period or must be moved, it is important to accomplish chamber cleaning and instrument decontamination procedure before its switching off

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1 DonatelloTM Tissue Processor components 1.1 Instrument overview

1. 15” Color PC panel touch screen 2. Wax chamber WWC

3. Lever SPC door 4. Processing chamber (SPC)

5. RFID reader (for tanks code) 6. RFILL-RDRAIN connectors

7. USB port 8. Tanks compartment

9. Lock – Unlock Lever SPC door 10. EWD

11. PWD 12. P1 – P2 Washing tanks

Picture 15 – Instrument’s frontal view

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5

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1.2 Instrument rear part

Picture 16 shows instrument rear part:

13. Instrument power supply 14. Fuses connectors

15. LAN Ethernet port for PC panel connection 16. RJ12 connector for dialer remote alarm

1.3 Instrument features

• DonatelloTM tissue processor is an automatic smart tissue processor with vacuum/pressure functions and controlled heating of

reagents and paraffin. It optimizes the use of reagents in order to obtain and maintain an excellent quality of processing • Maximum loading of 405 cassettes for each run and possibility to set different loading: 270 standard cassettes (2 stainless

steel racks with 135 cassettes each, one above the other) or 405 standard cassettes (3 stainless steel racks with 135 cassettes each, one above the other), reagent quantity control according set loading

• PWD function (Protected Wax Dumping) for manual or automatic drain of exhaust wax in a specific tank • EWD function (External Wax Dumping) for manual or automatic drain of exhaust wax through insulated pipe • 9 stations for tanks with processing reagents • 2 stations for tanks with cleaning reagents • 3 basins for wax melting • 1 station for internal drain into wax tank • Detection of reagent tanks through RFID technology, control on reagent type, batch, expiry date, use and tracking • SelfCheck: SelfCheck system for the first instrument check components to avoid possible stops during overnight protocols • Tracking of processed specimens: By an external barcode reader, it is possible to integrate all information of processed

blocks (equipped with a 2D barcode), in order to have a complete tracking of fill/drain phases • Adjustable temperature range for wax basins; to use wax with melting point between 52-54°C up to 56-58°C • Visual processing graph with temperature and vacuum/pressure for each processing step • Possibility to data downloading by USB key • Processing with non-toxic reagents (Ottix Plus e Ottix Shaper) or with standard protocols (alcohol and xylene or substitutes) • High-performance charcoal filter to remove harmful vapors with expiry date control • Filter with suction fan to remove harmful vapors of processing chamber (starting up by the user) • Automatic system for purification and cleaning of wax (CWS - Cleaning Wax System) • Reagent pre-heating function, FPS (Fast Processing System) for fast processing of small biopsies • MultiSense Technology: Automatic setting of instrument parameters based on lab routine needs, 5 default profiles set

during installation and programmable according to routine increasing/decreasing • Possibility to set a default or customizable end of process by maintaining all specimens inside the first reagent for all delay

length • Reagent replacement guided by the software, it assists the user in all steps • Automatic management of reagent exhaustion level with visual alert in case of replacement

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Picture 16 – Instrument rear part

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• 4 sensor level inside the chamber, they allow distinguished loads of reagent according to lab necessity • Emergency sensor level, it avoids an excessive filling of chamber during full load processes • Color touch screen 15”, solvent resistant • Intuitive multi-user software with icon-based interface, for a quick, immediate and complete management of instrument

functions • Unlimited number of processing and cleaning procedures customizable by user • Possibility to create reverse cycle procedure for the recovery or not well processed specimens • Recording of all information about processing (alarms, step accomplished, temperature and pressure graphs, users), and

possibility to set filters or exporting data • Recording of all information about tanks (alarms, steps accomplished, batch, expiry date, users), possibility to set filter or

exporting data • Data export by USB key • Possibility to install remote alarm through software (optional)

IMPORTANT In order to avoid damages to the instrument or to specimens, we suggest using only spare parts or accessories Diapath S.p.A. trademark

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1.4 Parts supplied – Packing list

DonatelloTM automatic tissue processor consists of: 1. Processor:

Code Description Quantity SDSDN9000 DonatelloTM Automatic Tissue Processor 01 pc SDXCE0118 Panel PC 15” 01 pc

2. Power cable kit:

Code Description Quantity SDXCE0129 Power cable with Schuko plug C19 16A 01 pc SDXCE0095 Power cable with CN-plug C19 16A 01 pc

3. Accessories kit:

Code Description Quantity SDSPA0065 Tank stand 03 pcs SDSPA9012 Tank cap 11 pcs SDSPA9013 PWD Tank cap 01 pc SDSPA9050 Filter kit 01 pc SDSPA9035 RFILL/RDRAIN pipe 02 pcs SDSPA9032 External wax dumping pipe 01 pc 13.TAN5LT Empty tank (5L) 12 pcs SDSPA9036 Spacer 02 pcs SDSPA9031 SDSPA0129

Complete basket (405 cassettes, 3 layers with handle) Wax measurement level dipstick

01 pc 01 pc

4. Informative documentation:

Code Description Quantity 4MKT1250 DonatelloTM User Manual, hardcopy EN 01 pc N/A CE declaration 01 pc N/A Electrical test 01 pc

5. Optional accessories

Code Description Quantity SDSPA0131 Rack for Super-Mega-cassettes 01 pc

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1.5 Technical data

Electrical features

Tension 115/230 V~ ±10% Frequency 50-60Hz Power 2500VA Power supply F (Schuko) Altitude Up to 2000 m Fuses 2 x T16A 250V Breaking capacity 500A@250Vac

Environmental features Operative temperature range From 5°C to 40°C Humidity 80% Pollution degree 2 General features Certifications CE – IVD Noise level Max 50 dBA Weight and dimensions Instrument dimension (WxDxH) 700x750x1550 mm Weight without packaging 240 Kg Weight with reagents 305 Kg Functional features Capacity volume Up to 405 cassettes for process Up to 56 Super-Mega-Cassettes for process Up to 112 Slim Super-Mega-Cassette for process Load capacity Up to 3 racks with 135 cassettes each Standard rack capacity 135 cassettes Reagent stations 11 Reagent tank volume 4.1 or 5 liters Suction system Activates charcoal filter Storage Unlimited number of procedures saved

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1.6 Processing chamber (SPC)

DonatelloTM processing chamber (SPC) is totally made of high-quality stainless steel and it is corrosion-resistant (Picture 17). It is equipped with a locking system that guarantees the safety of the user, by preventing its opening during the processing. When possible, open the chamber through an unlocking lever placed on its left (Picture 15, point 3) after clicking on the icon:

1.6.1 Processing capacity DonatelloTM tissue processor can process a maximum of 405 cassettes. DonatelloTM tissue processor has several loadings (MultiSense setting, see chapter 4): 270 standard cassettes (2 stainless steel racks that contain 135 cassettes each, one above the other) or 405 standard cassettes (3 stainless steel racks that contain 135 cassettes each, one above the other). It also checks the quantity of reagent used according to the load. For good quality processing, it is important to follow these basic rules:

• On a daily basis, for high quantity of specimens processed it must correspond to a frequent replacement of reagents

• The procedure described before must be considered for big specimens too (ex. supermegacassettes)

• According to specimen kind or dimensions, it is necessary to set incubation time of the suited reagents, by diluting or reducing them

• The use of vacuum (vacuum/pressure cycle) and reagent heating in all processing steps, may increase the infiltration degree of reagents

1.6.2 Level sensors DonatelloTM tissue processor SPC chamber is equipped with 4 optical level sensors (see Picture 17), that allow to control the level of the reagent during the process and accomplish its partial load. For the excellent management of level sensors, at protocol starting up set track number present inside the SPC. Three sensors in the chamber (from the bottom) are used to control reagent quantity inside the chamber while the upper sensor avoids an excessive filling of the chamber in case of malfunction; working as a safety sensor.

Picture 17 – Optical level sensors

Optical level sensors

Open SPC

ATTENTION: If in the SPC the rack number is different than the one set, malfunction problems could appear

ATTENTION: After several processing, sensors could be dirty: after each cleaning into SPC, we suggest to cleaning them using a dry cloth or soft paper.

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1.6.3 Half load mode Half load function allows loading into the SPC only the reagent necessary to cover the racks inside. For example, when inserting only one rack, it is necessary to load almost 2 liters of reagent to cover it completely. Optical level sensors present inside the SPC detect partial levels. Half load function reduces both fill/drain and protocol timing. It allows to increase duration of accessories subject to usage (for example, air pump). Half load function is set by default.

1.7 Wax reservoir Paraffin is contained into 3 cylinders that are placed in the heated area of instrument rear part. The correct level of cylinder is 4 liters. Two engravings present inside the cylinders (see Picture 5) show min and max levels filling. Cylinders are in the specific heated chamber (WWC), to keep wax at the correct temperature (during the protocol, wax should remain melted for their picking). Load solid or granulated wax up to 10 mm to cylinder’s upper edge, taking care not to obstruct air circuit hole (Picture 18). Once melted, the wax reaches the correct height level between min and max level. Numerous tests, have been performed using different kinds of solid wax available on the market: we cannot guarantee that the reagent level is the same for all wax kind. It is therefore recommended conducting a test with your wax in order to verify the correct quantities. Once the wax has been loaded into the three cylinders, close them using their caps which are equipped with bayonet clasps. Place them over the cylinder (the cap must be level) and rotate 15° clockwise using the handle present on it. Finally, the cylinders containing wax are totally closed avoiding reagent or vapors leakages.

1.7.1 Cleaning wax system

Cleaning wax system (CWS), allows to increase wax because using it removes the previous reagent from all cylinders that causes the normal effect of specimen “dragging”. The removal allows hot air to flow into wax reservoir. See chapter 4 to set and manage cleaning wax system.

Picture 18 – Paraffin Cylinder

MAX level

MIN level

Air circuit hole

ATTENTION: Unless the normal temperature of wax is not dangerous for the user, a contact with it may provoke burns. It is suggested to:

- Handle with care liquid wax - Always use gloves and protective glasses - Cylinder caps should only be opened for filling

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1.7.2 Exhausting wax dumping system (EWD/PWD) To empty cylinders from wax they are first poured to processing chamber and then to EWD (External Wax Dumping) connector or to tank number 10 through PWD (Protected Wax Dumping). The emptying can be accomplished during reagent replacement or automatically during the process. If half load procedure is on, it is not possible to perform the automatic dumping of exhausted wax during processing, because the wax present in a specific cylinder cannot be unloaded directly out of the instrument. EWD system allows wax dumping, using the dedicate pipe, into instrument external container. Wax vapours (contaminated by Xylene or substitutes) are not suctioned and remain in the environment. PWD system allows wax dumping into tank number 10 in a protected way (no reagent should be present inside the tank). A recirculation circuit present inside the instrument, which ensures user safety, recovers wax fumes.

1.8 Reagent stations See chapter 4 for the placement and setting of reagent tanks, wax cylinders, washing reagents and charcoal filter. Here below their numeration:

1,2,3,4,5,6,7,8,9 Reagents for the processing 10 P1 P2 11,12,13

Wax dumping PWD Washing system 1 Washing system 2 Wax

For more information about the reagent tanks replacement (RFID or manual FILL/DRAIN), see chapter 4.

Picture 19 – Connectors

RDRAIN connector

EWD connector

RFILL connector

ATTENTION: All reagents used are toxic by inhalation and when in contact with the skin. It is recommended to ventilate the area during wax draining and use specific IDP (gloves, mask and protective glasses)

ATTENTION: To replace PWD tank it is necessary RFID reading. This procedure protects the user from possible errors that may block the instrument or the routine. See chapter 4 for the complete description of EWD and PWD procedure

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1.8.1 Compatible reagents The material used for the instrument’s manufacture allows the following reagents to be used without any damage: Reagent Auto ignition point [°C] Water NA Formalin NA Ottix Shaper >363°C Ottix Plus >200°C Ethyl alcohol (pure or denatured) and methyl Pure alcohol >363°C Xylene or substitutes (limonene based or other natural extracts)

>432°C

Wax >245°C

It is possible to use other reagents unless they not cause any damage to the following materials (used for instrument manufacturing): STAINLESS STEEL Processing chamber, different connections TEFLON Compressor KYNARFLEX Reagent pipes VITON Gaskets GLASS Anti-condensation traps HDPE Reagent tanks DELRIN (acetal resin) Various accessories NICKEL ANTICORODAL

Air pipes, electrovalves Various accessories

1.8.2 Reagent management module Reagent management module is necessary to:

• Optimize the use and consumption of reagents • Manage and standardize processing quality • Avoid paper notes • Avoid to move manually the tank at the end of each process. In this way the last used tank (considering the same reagent

kind) is the one with cleaner and fresher reagent • Have useful information to detect future problems

Reagent management module is very important for DonatelloTM tissue processor; since it could perform both fast protocols (using only some reagents) and standard protocols (using all reagents). This instrument feature provokes reagent consumption not regular as other tissue processor because some of them are used more frequently than others. It is important to use the best reagent possible that is available without considering its position inside instrument. The concept of “homogenous reagent type” is based on the kind of work accomplished by a reagent. 4 kinds of homogenous groups can be detected in histological processes:

• FIXATIVES • DEHYDRATES • CLARIFYING • PARAFFINS

DonatelloTM Tissue Processor can manage 7 kinds of reagents related, at least, to one of 4 homogenous reagent type present in histology:

• FIXATIVE • WATER • DEHYDRATES • CLARYFING • WAX • WASHING CLARIFYING • WASHING DEHYDRATES

ATTENTION: Do not use acetone, benzene and trichloroethane. It is forbidden to use fixatives with mercury salts, picric or acetic acid because may corrode instrument’s components.

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Reagent management module allows up to 9 tanks to be used containing a reagent that belongs to processing reagent, 1 tank containing a reagent that belongs to washing clarifying, 1 tank containing a reagent that belongs to washing dehydrates and up to 3 wax that belong to wax kind. During processing, the user could set organization tank use which changes the associated reagent features (Eg. Name) always considering the same reagent kind without setting it to a specific group. 1.8.3 DAF (Decreasing Aging Factor) It is possible to use two kinds of reagents with DonatelloTM Tissue Processor:

• Limit set on number of processes accomplished • Limit set on number of cassettes processed

To set the kind of limit go to reagent management main screen (see chapter 4). To optimize reagent management module it is necessary to set the correct limit for each reagent both for number of processes accomplished or cassettes processed. Both limits are set according to reagent typology as fixatives, water, dehydrates, clarifying, paraffin independently to their belonging to a homogeneous group. For specific washing reagents belonging to reagent typologies as washing clarifying and washing dehydrate, it is possible to set a limit based on the number of accomplished procedures. The limits are set during installation according to the lab routine

1. Aging through processes: this procedure allows setting a maximum number of use accomplished by each reagent present into the processor. This management is not accurate as DAF because it does not take into consideration how many specimens present inside chamber are in contact with the reagent

2. Aging through DAF (Decreasing Aging Factor): this procedure can establish the correct usage of a specific tank by considering its use and the processed cassette number. The first reagent is subject to a greater aging, whereas the last will age less.

Number of processes, number of cassettes and DAF are always saved by reagent management system and can be viewed by the user. For each tank replacement, this data is saved and can be used as storage or file archive.

1.8.3.1 Example of DAF functioning Example group: Clarifying agents Cassettes processed per process: 100 Regressive percentage of DAF into homogeneous group: 100, 60, 40, 30, 20, 15, 10, 10, 5 (minimum allowable) Pre-defined limit for 3 reagent: 300 cassettes

Process 1 Number of reagent Cassettes processed DAF (progressive counter) 7 100 100 8 100 60 9 100 40



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At this point the reagent management system requires the replacement of reagent 8 because its DAF has reached the pre-defined limit of processed cassettes. After the replacement its counters will be reset. In the next process the reagent will be the last in the group and, at the end of the processing, the counters will be as follow:


After process 4 the RMS will not require any replacement because none of the counter reached or exceeded the limit.


After process 5 the RMS will require the replacement of the reagent 9 because its DAF has exceeded the limit of processed cassettes. The next step will be the last for the group, at the end counters will have the following content:


And so on. The sequence here shown (usual for a long overnight process) would be surely influenced by changes in the quantity of processed cassettes and by the use of only one reagent for each group for a fast-short daytime process Using RMS procedure allows reagent tracking and more exact and automatic. Without it, it is not possible to count the right number. The RMS is not as rigid as it appears. If, for any reason (component malfunction, accidental leakage from a tank, etc.) it is necessary to replace a reagent independently from the RMS requests, that can be done without any risk to the sequence and quality of following process. If it is necessary to replace the tank manually, it will be necessary to reset the counters of the reagent from reagent setup menu. In the following process, the reagent will be used as last of its group. NOTE: If the limits of each reagent is correctly programmed it may never require the replacement of one of the same reagents belonging to the same typology. Although it is not required, the user can replace the reagent manually. 1.8.4 Remote reagent fill and drain (RFill/RDrain) The reagent can be replaced in two different ways: • Replacement of the tank containing an expired reagent or to replace with a new tank containing the same reagent • For the drain of expired reagent or their replacement through RDrain (Remote Drain) use the RED connector (without

removing the tank). Fill new reagent trough RFill (Remote Fill) using the WHITE connector (see Picture 6).

NOTE: Both procedures suppose that the reagent before its filling or its draining must pass through the processing chamber. This procedure shall be performed using RFILL and RDRAIN procedure.

1.9 Fast Processing system (FPS) FPS (Fast Processing System) is a device that heats the reagents (tanks from 1 to 9, P1 and P2) during their filling into the processing chamber that allows fast protocols. This device can increase reagent temperature of 30-35°C without any delays. The fill (transfer of the reagent from its tank to the processing chamber) lasts at least 1 minute more as compared to the same load accomplished without FPS. Reagent heating up to 50-60°C reduces processing timing and remove downtimes. The heating through FPS is fast and safe: the reagent never directly touches heating elements. FPS is place in the instrument inner part and it is not visible outside.

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2 DonatelloTM tissue processor software operation 2.1 Main screen It is possible to manage instrument configuration, processing and washing protocols starting, reagents replacement, instrument operation and protocols history by monitor.

The screen is divided into three main areas:

• Upper Area: DonatelloTM tissue processor status, current user, current time and date and login button

• Central Area: Instrument rendering, SPC processing chamber, SelfCheck button and 16 tank position icons. According to their status, the icons have different colors

• Lower Area: 6 buttons for the activation of main instrument features 2.1.1 Main screen upper area Main screen upper part:

Login: User general authentication as GUEST. Press it to Login. Disconnect user: Key for user Logout. It indicates current user active status.

User authentication is for tracking and safety, by this way each user can accomplish only authorized procedures. At instrument starting the user has to insert username and password (Picture 21) or tag datamatrix 2D reader (if it is present a compatible barcode reader). Now the user is logged. Login button from inactive to active status.

Picture 20 – Main screen

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Pressing disconnect user or after a default inactive period (customizable using instrument setting) the user is logged automatically out. User ID to avoid actions accomplished by non-authorized GUEST user.

2.1.2 Main screen central area In this area are: • Processing chamber (SPC) and level detection sensors: Current status of processing chamber filling. Chamber status is divided into 5 different levels, each level is related to the current active level sensor. The chamber is empty (no active level sensor).

Processing chamber filled up to the first level sensor (using reagent).

Processing chamber filled up to the second level sensor (using reagent).

Processing chamber filled up to the third level sensor (using reagent).

Processing chamber filled up to the fourth level sensor (emergency sensor, the chamber is too full).

Picture 21 – Login

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Arrows indicating sensor status (next to processing chamber):

Level sensor. They are 4 (Level 1, Level 2, Level 3, Level 4). Level sensor 4 is safety sensor, it avoids the overfilling of processing chamber overfilling through a safety operation. For each level are present 3 status: Inactive status due to remote board disconnection Level sensor active due to the reagent in the chamber, it reaches or exceeds the level shown by the sensor Level sensor inactive because the chamber is empty or the reagent does not reach the sensor

• SelfCheck: SelfCheck is a self-diagnostic system of instrument sensible parts; it prevents unexpected blocks during overnight processing. The user can activate the procedure before processing:

− Check on the operation of sensible mechanical parts − Patency test on all reagent position − Alert in case of malfunction that allows to check the instrument before start processing for a complete safety of

specimens

SelfCheck button. SelfCheck allows to accomplish a preliminary diagnosis at each processing, in order to foresee possible errors. Automatic SelfCheck (before processing starting) can be activated or deactivated by the user through the button on configuration menu. Using SelfCheck button on main screen is possible to accomplish a manual SelfCheck.

SelfCheck consists of:

Chamber control 1 Chamber control 2 Tank control 1 Tank control 2 Tank control 3 Tank control 4 Tank control 5 Tank control 6 Tank control 7 Tank control 8 Tank control 9 Tank control 11 Tank control 12 Tank control 13

SelfCheck is useful to detect the following malfunctions:

o Not functioning pump o Problems related to valve functioning (not detectable, firmware side, i.e.: the valve does not close) o Vacuum valve problems (not detectable, firmware side, i.e.: the valve does not close) o Pressure valve problems (not detectable, firmware side, i.e.: the valve does not close) o Air circuit leakage o Air circuit obstruction o Chamber not properly closed o Processing chamber gasket worn o Reagent line 1 blocked o Reagent line 2 blocked o Reagent line 3 blocked o Reagent line 4 blocked o Reagent line 5 blocked o Reagent line 6 blocked o Reagent line 7 blocked o Reagent line 8 blocked o Reagent line 9 blocked o Reagent line 11 blocked o Reagent line 12 blocked o Reagent line 13 blocked

NOTE: The possible obstruction of a line during the processing could block the protocol without ensuring that all specimens are in a safe position. It is well recommended that the user is always the same at starting and finishing SelfCheck in order to detect possible anomalies.

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SelfCheck finish time is variable due to: o Duration of vacuum test into the chamber o Reachable pressure limit during vacuum test o Duration of pressure test into the chamber o Reachable pressure limit during pressure test o Maximum pressure o Reachable limit after slot valve opening (minimum pressure) o Test duration

SelfCheck interface shows a LED for each check (Picture 22). All LEDs are grey and change their color at the end of processing: green when a test is completed successfully, red if not. Each graphic LED shows test outcomes. LEDs are placed on the instrument and are only for reagents from 1 to 9, they are activated at test starting. These LEDs show the test in progress. If SelfCheck has a positive result, all LEDs will turn off and a countdown will start; in case of negative result all LEDs will flash and will be followed by an acoustic alarm.

• SelfCheck interface:

Check not accomplished or in progress

Check accomplished and positive outcome

Check accomplished and negative outcome

Check accomplished due to current status of wax melting, it could provokes false positives

A LED will turn on during each test and, in case of negative SelfCheck no processing will start.

Picture 22 – Selfcheck

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• Reagent tanks position: In main screen central area are shown all tanks for processing, washing and wax drain. It is possible to connect a tank to a color that indicates its current status:

Empty tank (No reagent connected to the position) Reagent connected to the position but not installed Installed and available tank Installed and available tank; reagent status at 75% according to its expiry date or exhausting

Expired or not suitable tank

Moving or in use tank, visible only in execution processing screen

Wax Cylinders:

Empty wax (No reagent connected) Wax linked but not installed yet

Installed and available wax for the use

Installed and available wax; wax status at 75% according to its expiry date or exhausting Expired, not present or not suitable wax with current reagent configuration Moving or in use wax, visible only in the screen

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Wax melting status for each cylinder. If present, it means that the wax inside the cylinder has changed within 12 hours or the cylinder has not reached the temperature previously set. This icon is present under wax cylinder in main screen.

Charcoal filter:

Installed and available charcoal filter Installed and available charcoal filter, 75% according to limit set Not installed or expired charcoal filter

2.1.3 Main screen lower area In this area it is possible to open the processing chamber or starting processing and washing protocols:

Instrument status

Processing chamber (SPC) opening. The color shows the current status of lock system (opening/closing).

Start processing Start a washing

Management and replacement of tanks Main menu

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2.2 Instrument status In the following picture are shown all real-time information about instrument temperature and pressure (Picture 23). Temperature concerns the chamber and wax tanks, pressure indicates processing chamber only. It is possible to check external UPS status (if connected and compatible with the device). No parameters available in case of lack of connection with remote board.

“Instrument status” buttons:

Closing of instrument status screen Alarms screen

LED indicating alarms status:

No warning or alarms

Presence of at least one warning

Presence of one alarm possibly followed by warnings

2.3 Warnings and alarms All warnings and alarms are shown in this screen. They are divided into WARNINGS, ALARMS and SAFETY REAGENT (Picture 24); a LED light show their status. Press statistics from main menu to see this screen. WARNINGS: It shows the list of all instrument warnings followed by a code and a description. It is not a blocking warning and consists of two status:

No warning Warning

ALARMS: It shows the list of all instrument blocking alarms followed by a code and a description. No alarm Alarm

SAFETY REAGENT: Safety reagent status

If START_REAG_SEC alarm is and END_REAG_SEC alarm is the protocol has not started or finished

If START_REAG_SEC alarm is and END_REAG_SEC alarm is the protocol has started

If START_REAG_SEC alarm is and END_REAG_SEC is the protocol has finished

Picture 23 – Instrument status

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2.4 Tank position status From this screen it is possible to control all 16 DonatelloTM tissue processor stations. Select a tank position to see all information regarding the reagent inside the tank (Picture 25).

Tank position status

The screen is divided into 4 main areas: • General: DonatelloTM tissue processor main setting • Reagent: Information about the reagent connected to the chosen position and its limits • Counters: Information about aging counters of the installed tank. No information available if the tank is not installed • Tank: Information about the tank installed in the selected position. No information available if the tank is not installed

Picture 25 – Tank position status

Picture 24 – Alarms

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2.5 Starting processing Start a processing protocol from this screen. For a correct processing protocol do not accomplish any washing before. If the user presses “Starting processing” and the instrument requires a washing, a warning message will appear to starting washing or return to main menu.

2.5.1 Normal processing The screen shows all DonatelloTM tissue processor processing protocols by time and date (Picture 26). Not accomplished process if RED (not all necessary reagents present), if GREY the process will be accomplished. For a normal processing all tanks shall not be expired or not installed (exception for filter kit). If the instrument detects not installed charcoal filters, an informative message will appear. The user can start a process. NOTE: To accomplish a processing that foresees 2 steps using a specific reagent, the installation of 2 different tanks with the same reagent is necessary. DonatelloTM tissue processor picks twice from the same tank only in case of errors or malfunction. After selecting desired processing protocol, the step from where it will start can be chosen (select the line on right chart). If no step is selected, the processing will start from the first step indicated in the protocol (tank with cleaner reagent – first reagent group installed). Processing duration changes in accordance with starting point and MultiSense configuration (see MultiSense section). The duration changes for: • Kind of tanks (5 liters 4.1 liters) • Use of Half load (1 rack, 2 racks, 3 racks) • Use of Full Load • Use of FPS pre-heating

Picture 26 – Normal processing

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2.5.2 Safety procedures warning messages In order to guarantee more safety for the specimens, it is necessary inserting Safe Reagent in each step. On the contrary, an alert message will appear, it alerts the impossibility to start the selected procedure. See chapter 4 for more information regarding Safe reagent. 2.5.3 Inverted processing Inverted processing is calculated by removing wax steps from processing protocol and then inverting step running order. This mode is activated by simply clicking on the dedicated button (Picture 27, red circle).

2.5.4 Cassette tracking This screen will only be displayed if processed cassette tracking has been enabled. In this screen each cassette to be processed is allocated to its rack. DonatelloTM tissue processor will associate the process for all steps to be performed. This information will be available in the screen concerning processed cassettes (under main menu, statistics).

Picture 27 – Inverted processing

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2.5.5 Choice of processing end time In the next screen it is possible to set the number of cassettes and racks (if traceability mode is off) and the kind protocol arrival (Picture 28). There are 4 different types of protocol arrival: • IMMEDIATE: The process will start immediately and the duration depends on the total duration of the process. • OVERNIGHT: The process will start to end before the following lab working day start according to time set in user configuration parameters. • WEEKEND: The process will start to end before the following Monday working day according to time set in user configuration parameters. • CUSTOM: The process will start to finish exactly on the day and time set by the user. During the creation of each processing protocol, an arrival set by the user in its editing screen, which will be automatically selected as soon as this screen is displayed. If arrival time can’t be respected due to protocol duration, the user will be informed with a message. NOTE: For processing with OVERNIGHT arrival, end process time can be set by the user in the main menu, in the general settings.

After pressing START button, the user can decide whether to cancel the protocol start during a 10-second countdown, otherwise processing will start. If Automatic SelfCheck is active, the control procedure will start immediately after pressing the START button.

Picture 28 – Processing end time

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2.5.6 Starting processing

During processing, a screen similar to the one shown in Picture 29 will appear. On the left side there are some information labels concerning the process:

• Start time: it indicates the actual time at which the processing was started by the user. • End time: it indicates the processing time end. • Delay end time: it indicates when processing will begin without considering delay time applied to the first step. • Step end time: during processing step (excluding delay), it displays the time at the end of the current step. This time does not include the loading and unloading steps and the delay applied to the first step. During processing, it is also possible to perform the following operations:

Button to temporally suspend processing. This button is available only during reagent processing. A qualified user authentication is required. Button to continue processing, only if previously suspended. A qualified user authentication is required. Button to change cassette and racks associated to processing, increasing number if some specimens are added. This button is available only if processing has been suspended. A qualified user authentication is required. Button to skip first processing step delay and to start immediately processing protocol. A qualified user authentication is required.

NOTE: delay step is automatically calculated according to processing arrival time.

Button to stop processing. A qualified user authentication and a double confirmation is required.

When processing ends, a message will inform the user. By confirming, the reagent unloading from the chamber begins.

Picture 29 – Starting processing

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NOTE: if some errors occur during processing, automatic unloading will not start. It will be possible to perform it after checking the error and by the procedure During final unloading, a dedicated screen will allow interaction with unloading step of the last protocol reagent (Picture 30).

On screen in Picture 30 these different function buttons are displayed:

Button to monitor instrument status

Button to stop unloading or loading step

NOTE: if unloading step is stopped, it will be necessary to unload reagent by manual procedure, enabled from main menu under manual procedures by a qualified user.

Button to open SPC, displayed only when final unloading ends

Button to go back to main screen, displayed only when final unloading ends

2.5.7 Bubbling Mix procedure used during reagent standstill step into SPC . From protocol-creation screen it is possible to choose, for each processing step, how many minutes does mix procedure have to be accomplished during reagent standstill into SPC. Possible pauses:

• Disabled • 5 minutes • 10 minutes • 15 minutes • 20 minutes • 30 minutes

Bubbling occurs when the Tissue Processor fills the SPC with all the reagent from source tank (or till warning activation [505] FULL_FILLP): the instrument starts creating vacuum into the chamber till it reaches a specific pressure value (see Mix aspiration vacuum 3 basket, Chapter 4.1, Diapath setting, Service manual) and draws air or reagent (if present) from the tank for a specific period of time (see Mix duration 3 basket, Chapter 4.1, Diapath setting, Service manual). Air suction procedure, from the tank, will create a hydro-massage effect to tissues simplifying the absorption of the reagent into the SPC.

Picture 30 – SPC chamber drain

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2.6 Washing The washing procedure is required whenever wax moves to or from the processing chamber. Performing a washing procedure is important to remove any wax residues left both in the reagent circuit and into the chamber: it is useful to prevent them from solidifying and/or contaminating all other reagents in the instrument (causing possible mechanical blocks). The washing request is made automatically by the instrument after the wax unloading step at the end of processing. It is good practice, before starting the washing, to remove the rack from the chamber, retrieve cassettes for the embedding step, and position the rack in the chamber and then start washing; in this way also the rack will also be cleaned from wax residues.

NOTE: It is highly recommended not to use the washing protocol to clean the metallic molds used during embedding to mould wax blocks. However, on the contrary, it is considerably reduced the processing limit necessary to change washing reagents.

To start a washing protocol it is mandatory that P1 and P2 tanks are installed and have not expired. Anyway, if any other tanks are expired or not properly installed, the washing protocol will start. If DonatelloTM tissue processor detects that filter kit is not installed, a message will be displayed but anyway a washing could still be started.

Washing protocol is always made up of four steps:

1. Wax drain 2. Reagent P1 (solvent) 3. Reagent P2 (absolute alcohol or alcoholic mixture) 4. Chamber drying (optional)

When the protocol reaches drying step, the washing is considered complete even if the user stops it.

If washing step is automatically suggested at the end of the process is skipped, the instrument will indicate the need to run a washing by displaying a red frame around its icon in the main menu, while a message at the top of the screen will remind the user that it is necessary to run a washing.

To manually start a washing, please press icon “Start washing” present on Main Screen of Automatic Tissue Processor Donatello Series 2. The screen that appears after pressing the start button will display DonatelloTM tissue processor washing protocols, sorted by date and time according to the most recently used. If the protocol is red, it will not be performable, and if it is gray it will be.

The washing startup screen is similar to the processing one, with the difference that the inverted processing button is unavailable. Unlike processing protocols, when a washing protocol is started, there is no intermediate screen for selecting arrival time, number of cassettes, number of racks or a countdown to start the procedure. When the protocol is set, the washing will immediately start (Picture 31). 2.6.1 Starting washing

At the end of the washing protocol, no final reagent unloading in the chamber will be required. If the protocol is stopped in a step including a washing reagent, the final unloading of the reagent in the processing chamber will be performed. During washing, it is possible to stop and resume from where the protocol was stopped.

NOTE: Washing steps (reagents, time, temperature) shown on Picture 31 are suggested by Diapath S.p.A. They are related to standard washing (WASH DEF), set as default in Donatello Series 2 Tissue Processor.

Picture 31 – Starting washing

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2.7 Reagent replacement

In this screen tank, wax, charcoal filters replacement and condensation tank unloading can be managed.

In this screen tank, wax cylinder and charcoal filter status is the same as in DonatelloTM tissue processor main screen in the previous chapter.

Button to close reagent management screen.

Reagent replacement is a procedure for removing a reagent that has reached cassette or processing limit and is therefore exhausted or to install a new selected reagent.

Button to display reagent replacement screen at the bottom of main screen

Set but uninstalled reagent

The same is also applicable for reagent tanks, wax stations and filter kits, identified by their icons.

Reagent replacement is mandatory when in the selected position the installed tank has expired or has a reagent different from the set one (red tank) or no tank is installed (grey tanks). However, it is still possible to replace the tank manually even if these conditions do not exist. If DonatelloTM tissue processor MultiSense is not set in OPEN mode, it is necessary to use the RFID antenna (Picture 33) to detect both the tank to be removed and the new tank to be installed (double check minimizes the possibility of reagent position error inside the device). PWD tank and charcoal filters also require OPEN mode of RFID antenna to be detected during installation and replacement. NOTE: DonatelloTM tissue processor offers an ergonomic system for tank positioning during label reading to minimize errors resulting from the interaction between the antenna and the label and to weigh less on the musculoskeletal and physiological health of the operator. The first action to perform during reagent replacement is to prepare the new reagent to be installed. By clicking the button to enter the reagent replacement screen, if necessary, the list of reagents to be installed or replaced appears.

Picture 32 – Reagent replacement

Expired reagent

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2.7.1 Tank replacement Remove the current tank. This procedure is necessary even for first placement (in order not to OPEN device, remove all tanks without using RFID reader). For manual replacement, press over the desired tank (including wax position of filter kit) and follow the instructions.

Undo button. It allows to cancel the procedure and display reagent replacement screen. All modifications accomplished before pressing this button are valid (i.e.: if a tank is read yet, it is no necessary a re-reading)

This button allows to be replaced and confirms the replacement of the old tank

Wax removal through PWD/EWD system Manual wax replacement can be accomplished in two ways: PWD (drain into empty inner tank in PWD position) or EWD (external drain using an insulated pipe). NOTE: Do not use RFID reader for wax replacement. Press the following button to choose wax drain (Picture 34).

Wax drain through EWD/PWD. Cylinders emptying is given by wax loading into processing chamber. From here, the wax is sent to EWD (External Wax Dumping) frontal drain connector or to PWD (Protected Wax Dumping).

Picture 34 – Reagent management

Picture 33 – RFID antenna

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EWD and PWD systems have the same purpose but operate in a different way: • EWD: wax drain using an external pipe. Fumes/vapors (presence of Xylene or its substitutes) are recovered and end in the

environment. • PWD: drain into n.10 tank (any reagent can be contained in the tank) during protect mode. Wax fumes are recovered by

recirculation circuit inside the instrument.

Use RFID label for PWD tank replacement. In this way, the user will always follow the right procedure. During the following wax drain, the line must be obstructed due to the removal of a full PWD tank during tank replacement. From the screen below (Picture 35) it is possible to choose EWD or PWD. If PWD tank is installed in a wrong way or exhausted, PWD drain is not possible. Using this procedure it is only possible to drain wax.

The chart on the left shows where it is necessary to replace the tank.

Close reagent management screen DonatelloTM tissue processor status Stop the procedure, visible only if procedure is active

EWD active (or inactive)

PWD mode active (or inactive)

Start EWD/PWD procedure

Picture 35 – EWD procedure

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Removal using RFID system For this procedure use the label over the tank or charcoal filter to remove as shown on the following screen (Picture 36): For a correct removal, place the tank as shown in Picture 37. If the tank is different from the one inserted before, too many tanks are detected next to RFID antenna or the reagent is different, an error message will be shown. Repeat the procedure. NOTE: For DonatelloTM tissue processor MultiSense HIGH, LOW, GREEN HIGH, GREEN LOW use RFID reader for the label present over the tank to replace. If reagent label is unreadable (malfunctioning or tag damage), remove the tank manually using “REMOVE SINGLE TANK” button present on main menu, inside submenu TANKS. Reagent manual replacement using FILL and DRAIN system: Using DonatelloTM tissue processor MultiSense OPEN replace the reagent by selecting its replacement or removing it from the selected position using the external drain RDRAIN. For the external drain, connect one pipe supplied with DonatelloTM tissue processor to the RED connector. Tank emptying is accomplished by loading the reagent into processing chamber and from here to frontal drain red connector RDRAIN. For this procedure processing chamber must be empty and closed. Do not drain wax with this procedure.

Picture 36 – Tank to replace

Picture 37 – Tank replacement

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Press the button below to start RDRAIN procedure (Picture 37):

NOTE: Before starting a procedure, place a container under drain pipe (the container must be suitable for exhausted reagents).

Picture 39 shows tank position where accomplish reagent RDRAIN.

Picture 38 – Reagent replacement

Picture 39 – RFILL/DRAIN

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The chart on the right (Picture 38), select automatically the slot of tank replacement. Close reagent replacement screen DonatelloTM tissue processor status

Stop procedure, visible when the procedure is active RDRAIN procedure starting

2.7.2 New tank Insertion of a tank with cleaned reagent into the selected position.

Cancel procedure and return to reagent replacement screen. All modifications accomplished before are valid. Proceed with tank replacement and confirm the new one.

If reagent replacement is for wax position, using both RFID and manual RDRAIN system, there will be an equivalent procedure for tank placement. Here below all procedures: Wax placement Once wax reservoir is empty from reagent, fill it again with new wax. Use liquid or solid wax (granulate or drops). Using liquid wax, reach the level between MIN and MAX mark inside the container (Picture 40). In case of granulated or drops wax, fill the reservoir up to “air circuit slot” level (Picture 40). Picture 40 – Cylinder

MAX level

MIN level

Air circuit hole

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NOTE: Check if liquid reagent is between MIN and MAX level. If not, add new liquid or solid wax up to correct level. If wax packaging is not equipped with RFID tag, click over the specific button on reagent replacement screen. In this way, a message informs the user to the complete filling and the reagent is ready for the use. Placement using RFID system Tank placement using RFID system: the system reads the label over the tank, wax packaging or charcoal filter to remove. In case of exhausted or used tank, too many tanks detected next RFID antenna or non-corresponding reagent, an error message will be shown. Repeat the procedure. In case of right procedure, insert the tank, the reagent or the filter in the right position and a message like in Picture 41 will be shown. NOTE: For DonatelloTM tissue processor MultiSense HIGH, LOW, GREEN HIGH, GREEN LOW use RFID reader always Reagent manual placement using Fill and Drain system: DonatelloTM tissue processor MultiSense OPEN allows a reagent to be inserted by clicking over a specific position (in this case, insert the reagent manually inside the tank after removing the exhausted one). In this way, the device informs the user about the presence of the reagent to use for processing. A safer replacement procedure is RFILL (it corresponds to RDRAIN for reagent replacement). For external load, connect one of the pipes equipped with DonatelloTM tissue processor to the green connector. For tank filling, load corresponding reagent through RFILL green connector to the processing chamber and from here to desired tank. For this operation the chamber must be closed and empty. Do not load a reagent (wax kind) with this procedure. RFILL procedure is similar to RDRAIN, click over the button below (for the screen, see reagent replacement through RDRAIN section):

NOTE: Before starting the procedure, place a container under new reagent loading pipe. MultiSense OPEN configuration is set for 5 liters of reagent.

Picture 41 – Tank reading

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2.7.3 Filter support system DonatelloTM tissue processor is equipped with a water trap system placed just before the filter. In this way, the filter is cleaner because all condensate produced during washing and processing procedure goes into a specific container. The specific button allows the draining of collected condensation (Picture 42). It is possible to drain condensation whenever you want, connect external pipe to RDRAIN red pipe. Remove the liquid to avoid water trap overfilling (it includes a sensor level).

Condensation trap status:

If the button is green the water trap is not full. If the button becomes red, water trap is full of condensation and the user must empty it. An alarm will appear on warning and alarm screen. According to reagent used, empty water trap 2/4 times a year.

NOTE: Water trap can contain up to 2 liters MAX; use a suitable container for draining.

Close condensation drain screen

Start condensation drain

Stop condensation drain, visible only after instrument starts


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2.8 Main menu Access to all DonatelloTM tissue processor functions from main menu. Click the button below to access main menu: Below is shown main menu Here below a short description regarding all procedures present on main menu:

General Setting, procedures adjustable by the User

Diapath setting, procedures adjustable by Service user only Modification of processing protocols. Create, copy, delete or modify a processing protocol

Modification of washing protocols. Create, copy, delete or modify washing protocols Manual setting for SPC loading and unloading, patency test, vacuum test, pressure test, temperature test and Clarifying wax system (CWS)

Reagent management. To manage DonatelloTM tissue processor reagent configuration MultiSense screen. Modify DonatelloTM tissue processor configuration

Picture 43 – Main menu

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User and procedures management

Statistics screen. It is possible to view the history of processing, graphs, used tanks and processing cassettes

Main menu

Instrument information

2.8.1 Instrument information All information regarding: software version, main board and remote board firmware version (without Ethernet connection information will be incomplete) and other general information about DonatelloTM tissue processor (Picture 44).

2.8.2 General information

Click over the specific tab on left column on Picture 44 to modify DonatelloTM tissue processor general setting:

1. Device: Active or inactive automatic SelfCheck before processing, set duration (in minutes) of automatic user logout and starting working time (used as end processing time for procedures set as Overnight)

2. Language: Set language system

3. Audio: Set volume sound effects and, if necessary, enable them

4. Time and date: Change time and date present on DonatelloTM tissue processor screen (top-right of each screen)

5. Load/ Download: Download of database with DonatelloTM tissue processor current status on external device (USB key)

6. System restore: Reset instrument parameters up to last automatic saved restore

7. Restart: Restart DonatelloTM tissue processor software

Save modification permanently

Exit from the screen

Picture 44 – DonatelloTM general information

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2.8.3 Diapath Setting

Diapath setting screen is for SERVICE user only. This area has instrument functioning parameters (Picture 45).

ATTENTION: Diapath S.p.A. has no responsibilities for malfunctioning due to the modification of Diapath Setting accomplished by not authorized or well trained staff. Select the following setting from tab list 1. Fill/Drain: allows user to modify setting values that regulate loading and unloading run into the processing chamber

2. Temperatures: allows user to modify MAX values of temperature related to processor components

3. Inf/Mix: allows user to modify the values related to parameters regarding infiltration runs and processing chamber mixing runs

4. Washing: modify the parameters related to drying, wax drain and clarifying

5. Test: modify functioning parameters regarding tests on functioning test screen

6. Others: modify FPS setting, half load, level sensor, barcode reader door, RFID antenna door and altitude

7. Save/load: allows current configuration into a binary file to be saved, sent to DonatelloTM tissue processor a configuration file saved before and send to DonatelloTM tissue processor functioning parameters file

8. Advanced: allows resistances parameters to be modified and to accomplish advanced tests.

ATTENTION: As described before, only Diapath S.p.A. staff can manage these settings

o Output Test: allows single and selective modification of DonatelloTM S.p.A. outputs status and it is possible to activate manually some functions not generally available

o Pid: allows to modify pid adjusting values

9. Exit program: exit from DonatelloTM tissue processor software For a more detailed description see DonatelloTM tissue processor Service Manual

Save modifications Exit from the screen

Picture 45 – Configuration

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Picture 46 – Service (Fill/Drain)

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2.8.4 Modification of processing and washing procedures

From these two icons it is possible to create, copy, modify and delete processing and washing procedures. They are shown together because their procedure on protocol is the same

NOTE: Protocols in red shown in the screen below cannot be executable because internal instrument reagent layout is not present for all the tanks shown in each step (Picture 47).

Procedures of the two icons for protocol modification:

Exit from the screen Modify a processing protocol or an existing washing Create processing or washing protocol

Copy processing protocol or an existing washing Delete processing protocol or existing washing

Icons for browse processes, reagents and steps charts

Picture 47 – Processing procedure management

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Press modification icon on right chart (are present all steps for current processing protocol or washing). Below, all available icons:

Cancel modifications and exit from modification mode Save modifications and exit from modify mode Add a new processing or washing step (if available) Remove existing step from current protocol Default washing configuration

On reagent chart are displayed only the reagents (use Reagent management function) that have still not been added into current processing or washing are displayed. Available reagents are set in order that avoid the creation of two consecutive steps of incompatible reagents (i.e. it is impossible to create a step where wax follows a formalin step, because the two reagents belong to incompatible families (Picture 48). Reagent families are set by default. DonatelloTM tissue processor MultiSense OPEN version allows manual set of reagent families.

Customizable protocol properties: • Name of protocol: Name of processing or washing protocol • Kind of starting: Starting of processing or washing protocol

Kind of processing protocol starting:

o Immediate: The protocol starts immediately all processing steps

o Overnight: The protocol accomplishes immediately the loading of the first reagent set, but stays in a waiting status until the starting of a new lab working day. Modify start working from Main Menu, General Setting and Instrument. If the processing lasts more than the start working set, a warning message informs the user

o Weekend: The protocol starts immediately the loading of the first reagent set, it stays in a waiting status until the next Monday to time set as lab start working time

Picture 48 – Processing protocol management

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o Custom: The protocol starts immediately the loading of the first reagent set, but stays in a waiting status in order to finish at the time set by the user

Washing protocols have an Immediate mode. Customizable starting is available at real starting of the protocol. Pressing columns “Time”, “°F/°C”, “Inf”, ”Mix”, “FPS”, “Safety reagent” it is possible to modify the features of each step:

• Time: Real time of reagent stationing into processing chamber, excluding loading and unloading times

• °F/°C: Processing chamber temperature to reach and maintain for reagent stationing time into processing chamber

• Inf: Kind of infiltration used (Off, Room temperature, Pressure, Vacuum, Pressure/Vacuum step), not available with wax drain or drying

• Mix: Frequency of reagent mix (Off, 5 min, 10 min, 15 min, 20 min), not available with wax drain or drying. Two ways of mixing: if inside the tank some reagent is present, it is picked inside the chamber and mixed with the other present, then it is drained into the tank (It does not leave the specimens uncovered). If inside the tank there is no reagent because it has been used by the processor (three racks full load), the instrument mixes the reagent into the chamber it adds air.

• FPS (Fast Processing System): Use the heater to accelerate reagent heating into SPC; it can’t be used with reagents as paraffin, wax drain and drying NOTE: FPS function not available if DonatelloTM tissue processor MultiSense set on GREEN HIGH or GREEN LOW.

• Safety reagent: Safe reagent to use in case of power failure, not available for washing protocols (Picture 49) For further information of Safe reagent procedure, see Chapter 4

2.8.5 Manual operation From the screens below are available different manual operations or tests for the user. Check if the user has all available documents for their execution. NOTE: Pay attention using these procedures because manual procedures are not usually required for instrument operation. Contact Diapath S.p.A. for any question. Here below a list of available functions present on Manual Operation menu: • Vacuum test: Check for possible leakages on vacuum circuit or its components as processing chamber (pump, valve for

reagent inlet). The test is complete only if vacuum stays between MIN and MAX vacuum value during the whole test (Picture 50)

• Pressure test: Check possible leakages on pressure circuit or its components as processing chamber (pump, valve for reagent inlet). The test is complete only if pressure stays between MIN and MAX pressure value during the whole test (Picture 51)

• Permeability test: Check if the set position is free or obstructed with some residues. The test is complete only if pressure decreases up to a permeability limit within fixed time (Picture 52)

• SPC load: Load SPC using a reagent from the list (Picture 53). If the chamber is full or open do not load a reagent.

ATTENTION: If during manual loads the instrument needs a washing, some wax residues could finish towards DonatelloTM tissue processor cold areas and they could obstruct the normal use of the instrument. Be sure if the instrument does not need a washing before starting procedure.

• SPC unload: Unload the SPC using a reagent from the list. If the chamber is full, the selected position shall be used as unloading destination. Ignoring this message, every time the user select a new position a notification message will advise the user. In case of washing, a message will inform the user. ATTENTION: If during manual unloads the instrument needs a washing, some wax residues could finish towards DonatelloTM tissue processor cold areas and they could obstruct the normal use of the instrument. Be sure if the instrument does not need a washing before starting procedure.

Picture 49 – Safe reagent

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• SPC heating: Check the correct heating inside SPC chamber and its cap. The test is complete only if the processing chamber

and the cap reach the set temperature within fixed limit (Picture 54) All tests and protocols can be start and stop using the icons below:

Start procedure Stop procedure

Picture 50 – Vacuum test

Picture 51 – Pressure test

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Picture 52 – Permeability test

Picture 53 – SPC load

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2.8.6 Reagent management Set reagent’s properties. Available only with specific authorization. Available procedures: • Reagent definition: Assign a reagent for each position. If a reagent is insert yet, it is possible to change it (reset position and

insert the new reagent through Reagent Management screen). Modify set reagent for each position. The available list of reagents depends on MultiSense configuration set.

• Reagents: Modify the properties of each reagent (Picture 55 and Picture 56). Customizable setting only for authorized users:

o Limit for reagents, cassettes numbers (Max Daf) and processing (Max Proc)

o Insert new reagent (only for MultiSense OPEN configuration)

o Elimination of reagent created before (only for MultiSense OPEN). Do not eliminate reagents set by default

Picture 54 – SPC heating


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• Tanks: Remove functions (single or total) or reset counter (single or total) for each installed tank and present within the chart

(Picture 57). If the user removes a tank, it will not be displayed in the main menu; install it from Reagent replacement screen. The removed tank will not be displayed within the chart. Counter reset allows to reset cassettes counters and processes for each selected tank (single) or for the whole tanks within the chart (total). These operations are available only if the user is authorized.

Picture 57 – Tanks


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• RMS: Active or deactivate reagent management system. The user can modify this procedure only if authorized (Picture 58).

If RMS is active, use DAF for tanks aging; if the RMS is deactivated only processing counter will be used.

• Automatic drain: Automatic drain is used to automatically drain exhausted wax during processing (Picture 59). In this case, if

aging wax counter used for a protocol exceeds the set limit, the wax will be drained into the PWD (inner empty tank) or into an external tank (EWD).

Picture 58 – RMS

Picture 59 – Automatic drain

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2.8.7 MultiSense DonatelloTM tissue processor is equipped with a new MultiSense technology that allows the instrument parameters to be set automatically according to routing lab needs. 5 preset adjustable profiles during installation with the possibility to modify them in case of routine increase/decrease. Processing operation and the number of available racks inside the chamber differ from the set mode and tanks’ volume of reagent (Picture 60).

Select one of the following MultiSense icons (HIGH, LOW, GREEN HIGH, GREEN LOW, OPEN) to activate one processing procedure:

1. HIGH profile: h) Specific for high routine labs i) MAX 405 specimen j) RFID active k) Up to 3 racks with 135 specimens each used at the same time l) Tanks: 5 L m) FPS option active n) Use of standard reagent as xylene and alcohol

2. LOW profile: h) Specific for low/medium routine lab i) MAX 270 specimens j) RFID active k) Up to 2 racks with 135 specimens each used at the same time l) Tanks: 4.1 L m) FPS option active n) Use of standard reagent as xylene and alcohol

3. GREEN HIGH profile: h) Specific for high routine labs i) MAX 450 specimens j) RFID active k) Up to 3 racks with 135 specimens each used at the same time l) Tanks: 5 L m) FPS option disable n) Use of reagent as Ottix Plus and Ottix Shaper

4. GREEN LOW profile: h) Specific for low/medium routine lab i) MAX 270 specimens j) RFID active k) Up to 2 racks with 135 specimens each at the same time l) Tanks: 4.1 L m) FSP disable n) Use of reagent as Ottix Plus and Ottix Shaper

Picture 60 – MultiSense

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5. OPEN profile: i) OPEN profile of the instrument depending on customer needs j) Possibility of use your own reagents k) MAX 405 specimens l) RFID disable m) Up to 3 racks with 135 specimens each at the same time n) Remote Fill and Drain active o) Tanks: 5 L p) FPS active q) Possibility to use any kind of reagent at User’s discretion

2.8.8 Statistics menu Menu to manage all procedures linked to DonatelloTM tissue processor statistics (Picture 60). Here below all statistics menu functions:

Exit from the screen View the list of accomplished protocols, pressure and temperature graphs linked to each protocol and all information about tanks. It is also possible to filter protocol list within a date range

View the list of accomplished processes on a specific specimen identified by a Datamatrix code

Print processing and washing protocols saved as PDF

Visualize warnings and alarms shown during DonatelloTM tissue processor use

View tanks’ list and their use during the whole instrument operation

Picture 61 – Statistics menu

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2.8.8.1 Protocol register

View the history of accomplished protocols and details are shows for one of them about set values and tanks used (Picture 62).


Browse alarm history chart

Visualize the graph linked to current protocol

Visualize all details about used tank during current protocol Print current protocol Filter protocol history chart for a period within two dates Remove filters set before

Picture 62 – Protocol register

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2.8.8.2 Cassettes tracking Visualize the history of accomplished processing on a specific specimen identified by Datamatrix code (Picture 62). To accomplish this procedure, scan cassettes at instrument starting as described in Chapter 3.

Exit from screen

Browse alarms history chart

Visualize the graph linked to current protocol Visualize all details about used tank during current protocol Print current protocol

2.8.8.3 Print protocols Click over the icon to print washing and processing protocols save into DonatelloTM tissue processor in PDF, save them on hard disk or use a USB key.

Picture 63 – Cassettes tracking

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2.8.8.4 Warnings register Visualize alarms and warnings shown during DonatelloTM tissue processor use. Alarms are shown in a chart and reordered for time and date, other important information are shown for their identification (Picture 64).


Browse alarms history chart

Filter alarm history chart in a specific period between two dates Remove filters set before Print current alarm list

Picture 64 – Alarm history

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2.8.8.5 Tanks tracking List of tanks used with DonatelloTM tissue processor. For each tank, in the chart, are shown all details about its use (Picture 65).


Browse tanks history chart and their use with linked processes

Filter tanks chart in a period between two dates Remove filters set before Print the list of current tank

Picture 65 – Statistics

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2.8.9 User management List of users for role, it is possible to modify, add or remove them (Picture 66).

Exit from the screen Modify current user (Picture 66) Add new user Remove existing user

Browse user chart

Delete possible modifications, shown only after pressing modify user icon

Link a Datamatrix code to the user, shown only after pressing modify user icon

Visualize all password linked to current user, shown only after pressing modify user icon Confirm all modification, shown only after pressing modify user

Picture 66 – Users

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2.8.9.1 Roles management Modify procedures for each role

Confirm modification Exit from the screen

Each logged user has a specific role. The role fixes all authorized activities for the user (Picture 68). Each user has to login. For each role (Choose from Role menu) active/inactive the access to instrument procedures. The roles are:

• Diapath • Service • Advanced User • User • Guest

Below are shown all permissions related to pre-installed roles: Guest:

Picture 67 – Users

Picture 68 – Guest Role

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User:

AdvUser:

Picture 69 – User Role

Picture 70 – AdvUser

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Service:

Diapath: Der Diapath-Benutzer hat alle Berechtigungen

Picture 71 – Service Role

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3 Specimens Traceability

3.1 Overview

DonatelloTM Series 2 allows specimen traceability and to identify where they have been processed, including the basket, because of cassettes equipped with barcode and barcode reader. This feature allows, in case of irregular or improper processing, to identify possible critical actions linked to the specimen during “process history”.

3.2 Specimen insertion From this screen it is possible to link a cassette to the basket in which it is inserted in order to create a connection between the process and all following steps.

Picture 72 – Specimen Traceability

Picture 73 – Cassette insertion

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Picture 74 – Operation confirmation

Picture 75 – Cassettes inserted

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3.3 Statistics From statistics menu visualize the barcode and all following information:

- Specimen identity - Starting process - Ending process - Basket position in which the cassette has been processed - Number of baskets processed - Number of cassettes processed - MultiSense configuration installed

Picture 76 – Statistics

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4 Safety procedures 4.1 Safe procedure – Safe reagent

Safe reagent procedure is active in case of power failure. It consists of filling a present reagent by the user in the chamber as safe reagent in case of power failure or miscommunication between mainboard and PC. Once ended filling procedure, the specimen will stay into safe reagent till subsequent action by the user.

Reagent procedure guarantees specimen preservation and its antigenicity without compromising the diagnosis in case of power failure. Reagent procedure active only if the processor is connected to UPS. This procedure allows reagent draining into processing chamber and the loading of associated safety reagent.

If reagent and safety reagent are the same then the procedure will be completed without unloading the reagent and loading the associated safety reagent.

4.1.1 Safe procedure activation

Activation of safety procedure: 1. Control board: If during processing there is a lack of Ethernet connection between control board and the computer for

almost 10 minutes (set during installation procedure). Pay attention: if no safe reagent is linked to current protocol step the procedure cannot start.

2. Software: If the instrument is linked to an UPS and there is a lack of power for almost 10 minutes (set during installation procedure). Pay attention: if no safe reagent is linked to current protocol step the procedure can’t start.

In status screen is possible to see when an UPS is connected or not. NOTE: Activation of safety procedure from software is available only if the instrument is linked to an external UPS suitable with the software.

Picture 77 –UPS battery ON Picture 79 – Connected UPS Picture 78 – UPS disconnected

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Whether power failure occurs it is possible to see time remaining from where the procedure will start.

When safe reagent starts procedure it will not be possible to stop the procedure. The processing will be finished and the safe reagent will start.

Picture 80 – Main screen

Picture 81 – Safe reagent procedure

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NOTE: • Activation of safety procedure from software is available only if the instrument is linked to an external UPS suitable with

the software. • In case of lacking of Ethernet connection between Control board and PC, the software will automatically refresh on the screen • Only a well-trained technician can modify a safe reagent linked to a specific processing step

4.1.2 Safe procedure restore If safe procedure starts, the user must restart the protocol from the safe reagent step. All operations to be performed after safe reagent are under user’s responsibility.

At the end of the processing run, the screen below will be displayed. Before starting to unload the SPC while taking care of samples currently safe reagent, the user can see some detailed information about the safe reagent and the last step performed in the process.

After Safe Reagent procedure, the used reagent will expire automatically. Replace it.

Picture 82 – Safe reagent procedure complete

Picture 83 – Final screen

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4.1.3 Tracing Safe Procedure It is possible to see details regarding safe reagent in history alarms screen or in history protocols screen.

Picture 84 – Final screen

Picture 85 – Alarm history

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4.1.4 Compatible UPS

Software integration allows the instrument communicating through rs232 communication with the UPS controlling the basic parameters. Communication protocol is “MegaTec Communication Protocol Version 2.7”. Available list with UPS using this protocol on http://www.megatec.com.tw/Compatible.htm; only the PS with the tick () on the column UPSilon 2000 use the MegaTec Communication Protocol Version 2.7 protocol through rs232. Compatible UPS must have these 3 basic requirements:

• 3 KVA • 2400 W • On line Sinusoidal double conversion

4.2 Restart

Restart allows the instrument proceeding with the processing restart or interrupted washing suddenly due to electrical shutdown (or from an unpredictable event that shutdown the PC and the instrument), if the UPS is disconnected. In this case, the instrument and the specimens are in uncontrolled status for an unpredictable time (duration of lack of power) until the recover procedure restart.

4.2.1 Unpredictable events

Possible events that may cause instrument switching off:

• Power supply fails and there is no safe line under the UPS • Power supply fails and there is no connection UPS • Power supply fails and the UPS is not connected correctly • Power supply fails and the UPS does not work properly • An operating system error causes a sudden restart of the instrument

The restart does not work in the following cases:

• The process was terminated due to user intention • The process was terminated due to an error • The process was terminated by itself • The process was terminated due to safety reagent procedure

4.2.2 Uses cases During a process or a wash is possible that the following events occur:

• A process or a wash is interrupted during fill procedure. The instrument first drains the SPC and after restarting the process or the wash from the last step executed

• A process or a wash is interrupted during SPC stationing procedure. First, the instrument drains the SPC and after restarting the process or the wash from the last step executed. The instrument decreases the time in which the reagent must remain into SPC respect elapsed time, either with the machine switched on or off

• A process or a wash is interrupted during drain procedure. The instrument first drains the SPC and afterwards can restart again the process or the wash from the step immediately following the last one executed.

• A wash is interrupted during the wax cleaning. The instrument restarts the procedure of wax cleaning. • A wash is interrupted during the drying. The instrument considers the wash completed.

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4.2.3 Heating phases

If the instrument is switched-off for a long period of time, temperatures go down and restart procedure must wait till heated components reach the set temperature only if a wax movement has taken place or must occur.

A wax movement includes the following procedures:

• Wax filling during a process • SPC stationing during a process • Wax draining during a process • Wax cleaning during a wash • Filling from P1 tank during a wash • SPC stationing from P1 during a wash • Draining from P1 during a wash

The heating phase is composed of two different subphases:

• First is when the temperatures of the heated components must reach the set temperature. It is not possible to skip this phase during a restart to force the start of the process

• The second is a period of additional time to guarantee that the wax in the cylinders is completely melted. This phase is active only after more than three hours from the instrument switching off. There is the possibility to skip this phase and force the restarting of the process only after being sure that the wax are completely melted.

Picture 86 – Restart procedure

Picture 87 – Restart procedure: SPC drain

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If a wax step must occur before the current step the time to reach the wax step from the current step will be subtracted from the second heating subphase, if present.

Note: the user can abort restart procedure always Note: If SPC is empty wait till temperature are reached again, then restart process At the end of procedure, all processing or washing in progress at power failure will restart from the point at which they were stopped.

Picture 88 – Restart procedure: pre-heating

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5 Alarms and warnings Here following all alarms related to DonatelloTM tissue processor. Legend:

• [Code] Name o Description o Possible causes o Result

5.1 Warnings • [201] POWER_FAILURE:

o Operating UPS (if present) o Power failure o UPS avoids power failure

• [502] DIFFICULT_DRAIN:

o Difficult reagent drain. The reagent lasts more time than MAX time set o Possible obstruction of reagent line in use or problems related to water system o Second attempt on drain. [507] LONG_DRAIN alarm appears in case of good execution; if problem persists, [564]

DRAIN_TIME_OUT_B alarm will be shown

• [503] SHORT_DRAIN: o Reagent drain too short respect set time o No consequence o Not enough reagent quantity into the tank. Reagent loading time lasts less than set time (see [514] SHORT_FILL) or

water system problems (i.e.: processing chamber gasket is damaged or dirty)

• [404] PV_TIMEOUT o The instrument takes too much time to reach a specific pressure or vacuum value during loading/drain/infiltration/mix

or any special procedure as processing chamber drying or wax drain. o Possible water system problems (i.e.: processing chamber gasket is damaged or dirty), possible high temperatures

into the processing chamber that avoid an easier reach of vacuum or pressure values o No operation problem. Delay on reaching a specific vacuum or pressure limit only

• [505] FULL_FILLP

o Too much reagent into the processing chamber and reaches safety level sensor o Reagent fulfill into the current tank or possible instrument anomalies that may cause a lack of draining (previous

reagent) or a double load at the same time o During reagent filling, the procedure is blocked and the instrument continues to processing procedure. Whereas,

during mix procedure, current mixing is blocked without stopping processing

• [506] ABORTED_STEP o Aborted step during reagent loading o Reagent way to fill is blocked o Try filling a similar reagent from another tank (if present), otherwise, error [553] LINE_CLOGGED_B is active

• [507] LONG_DRAIN

o If present [502] DIFFICULT_DRAIN error, but at second attempt the User can drain the reagent from processing chamber to selected tank

o Obstruction problems within current reagent line or lack of pressure, due to: wasteful air pump, air leakage from processing chamber door gasket

o Possible future problems on instrument operation and its ability to correctly end a processing

• [208] WWC_TEMPLOW o The temperature inside hot chamber, which contains cylinders with wax, is lower in respect to set value o The instrument has been switched on after a period of inactivity or problem related to a specific instrument part o During processing, before using wax, WWC temperature is lower than the value set. The process continues regularly

up the last reagent. Before filling wax, WWC temperature could reach the right level; on the contrary, the process is blocked and will appear [259] WWC_TEMPLOW_B error

• [409] PNV_TIMEOUT o Normal pressure within processing chamber takes too much time before ends correctly o Any operation problems o Instrument part malfunctioning, specific for this procedure that does not allow the correct normalization within

maximum desired time. Check if the little hole located on SPC’s upper-right is free, otherwise clean it • [210] WAX1_TEMPLOW

o Cylinder 11 (wax) lower temperature than set value o The instrument has been switched on after a period of inactivity or problems related to a specific part of it o Possible problems related to reagent moving within cylinder 11

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• [211] WAX2_TEMPLOW o Cylinder 12 (wax) lower temperature than set value o The instrument has been switched on after a period of inactivity or problems related to a specific part of it o Possible problems related to reagent moving within cylinder 12

• [212] WAX3_TEMPLOW o Cylinder 13 (wax) lower temperature than set value o The instrument has been switched on after a period of inactivity or problems related to a specific part of it o Possible problems related to reagent moving within cylinder 13

• [213] SPC_TEMP_LOW o Chamber temperature not achieved before drain (current step) o Possible problems on temperature set during processing protocol or current washing o The reagent has not reached desired temperature and processing or washing result could be different than expected

• [514] SHORT_FILL o Too short filling time respect MIN set time o Reagent level, into the tank, is lower than suggested or problems on water system that has early detected the ending

of reagent filling o The reagent could not entirely cover all racks into the processing chamber. The instrument will try to fill an alternative

reagent with the same name and kind from another tank (if present). Otherwise, [556] SHORT_FILL_B alarm will appear

• [215] TS_WAX1_OUT

o Temperature probe of cylinder 11 detects a wrong value o Temperature probe could be damaged or does not work o Possible problems related to reagent shaking into the cylinder 11

• [216] TS_WAX2_OUT

o Temperature probe of cylinder 12detects a wrong value o Temperature probe could be damaged or does not work o Possible problems related to reagent shaking into the cylinder 12

• [217] TS_WAX3_OUT o Temperature probe of cylinder 13 detects a wrong value o Temperature probe could be damaged or does not work o Possible problems related to reagent shaking into the cylinder 13

• [518] TRAP_FILLED o Rear floating is active for chamber filling, but it has not been detected by safety level sensor o Safety level sensor is damaged, malfunctioning or inactive o Do a manual drain before proceeding with other procedure. If the trap has been filled with paraffin reagent, contact

Technical Assistance

• [119] PROC_SUSP_USER o Processing stopped by the User o Processing stopped by the User o Processing could delay its ending time

• [120] PROC_SUSP_LID o Processing chamber cap open during processing o If [119] PROC_SUSP_USER warning is active, the User has manually suspended the process. If inactive or absent, the

cap has been manually opened or problems related on opening sensor cap o The processing will start when cap will be closed again

• [121] PROC_SUSP_INDEF o Processing stopped for more than 3 minutes o Processing stopped by the User for more than 3 minutes o Processing stopped up to restart (User)

• [522] OVER_FILL_P o Unused o Unused o Unused

• [223] SPC5_TEMP_LOW o During temperature test, processing chamber’s cap has not reached the temperature set within set time o Heating problems on processing chamber’s cap o Negative temperature test

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• [524] SHORT_FILL_L1 o If short fill option active. Tank fill accomplished within MIN set time but first level sensor not activated in time o Reagent level too low and does not reach level 1 o Some specimens could not be covered correctly

• [525] SHORT_FILL_L2

o If short fill option active. Tank fill accomplished within MIN set time but second level sensor not activated in time o Reagent level too low to correctly cover 2 racks or wrong number of cassettes into the first rack o Some specimens could not be covered correctly

• [526] SHORT_FILL_L3

o If short fill option active. Tank fill accomplished within MIN set time but third level sensor not activated in time o Reagent level too low to correctly cover 3 racks or wrong number of cassettes into first and second rack o Some specimens could not be covered correctly

• [227] WAX1_OVERTEMP

o Cylinder 11 (wax) over-temperature o Possible electrical problem or corresponding temperature probe damaged o An automatic system will bring temperature back to the one set before

• [228] WAX2_OVERTEMP o Cylinder 12 (wax) over-temperature o Possible electrical problem or corresponding temperature probe damaged o An automatic system will bring temperature back to the one set before

• [229] WAX3_OVERTEMP o Cylinder 13 (wax) over-temperature o Possible electrical problem or corresponding temperature probe damaged o An automatic system will bring temperature back to the one set before

• [131] VT2_ACTIVATED o Description: the condensation trap has reach the max level. o Probable causes: the condensation that create when a drain procedure take place fill the condensation trap. o Consequences: is necessary to start the procedure to empty the condensation trap.

• [530] VT2_ACTIVATED o Condensation trap has reached MAX level filling o Activate condensation trap unloading procedure o Condensation trap is full due to atmospheric temperature range. It happens when a reagent that is too hot is poured

into a room temperature tank

• [132] RESET_COUNTERS o Reset counters of all tanks installed o The User reset tanks’ counters o Tanks can be used for future processing

• [234] START_REAG_SEC o Safety reagent procedure active o UPS active o Safety reagent procedure active

• [235] END_REAG_SEC o Safety reagent procedure complete o UPS active o Safety reagent procedure complete

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5.2 Blocking alarms

• [450] PT_FAILURE_B o Pressure sensor failure o Pressure sensor does not work correctly o Current process is ended

• [451] FILL_NO_VACUUM_B o During reagent filling step, no vacuum in processing chamber accomplished o Pump failure or problem related to air system o No reagent fill, current process is ended

• [552] FILL_TIME_OUT_B o Reagent filling lasts more than expected o Fill the chamber with a reagent from an empty position o Current process is ended

• [553] LINE_CLOGGED_B

o No suitable reagent to fill which line is not clogged o All line are clogged o Current process is ended

• [254] SPC_OVERTEMP_B

o Processing chamber temperature is higher than MAX tolerated temperature o Heating problems o Current process is ended during loading, processing or unloading phase

• [255] TS_SPC_OUT_B

o Processing chamber’s temperature probe failure o Temperature probe damaged and must be replaced o Current process is ended during loading, processing or unloading phase

• [556] SHORT_FILL_B o No suitable reagent to fill. Their level is not enough to cover all racks insert by the User o All levels of suitable reagent are not enough to cover all racks insert by the User o The process is ended and the chamber is filled with available reagent. Not enough level

• [557] EV_FAILURE_B o Valve, connected to current reagent, failure o Valve failure or disconnected o The process is ended only if the error is detected on current valve

• [258] SPC_TEMP_LOW_B o Chamber temperature low during paraffin filling, temperature test, paraffin drain or processing chamber drying. o Not suitable temperature into the processing chamber just before drain phase o Problems related to chamber heating

• [259] WWC_TEMP_LOW_B

o Processing chamber temperature lower respect temperature set during wax filling or drain starting phase o Processing chamber heating problems o Processing interrupted before wax loading or drain

• [260] WWC_OVERTEMP_B

o Processing chamber temperature higher respect temperature set o Heating problems o Current process ends on filling, processing or drain procedures only during wax moving

• [261] TS_WWC_OUT_B

o Processing chamber’s temperature probe failure o Processing chamber’s temperature probe damaged and must be replaced o Current process is ended during filling, processing or drain procedures

• [462] PRESSURE_NR_B

o During starting drain procedure it is impossible to continue due to lack of pressure into the chamber. During line cleaning, after drain, it is impossible to accomplish the procedure because of pressure leakage or not reaching the expected value

o Check possible water system or pump failure o It is impossible to drain the reagent into the chamber, lack of cleaning or not complete cleaning of water system

• [463] DRAIN_NO_PRESS_B

o During filling it is impossible to follow the procedure due to lack of pressure into the processing chamber o It is impossible to fill the reagent into the chamber o Check malfunctioning on water system or pump

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• [564] DRAIN_TIME_OUT_B o IN case of [502] DIFFICULT_DRAIN error and at second attempt it is impossible to drain the reagent from

processing chamber to destination tank o It is impossible to drain the reagent present into the chamber o Check possible obstructions that avoid reagent drain

• [565] SPC_NOT_EMPTY_B o During reagent filling the chamber is fully or partially occupied o Current process is ended o Check current content into the processing chamber and check why it is not completely empty

• [566] OVER_FILLP_B o Unused o Unused o Unused

• [267] FPS_OVERTEMP_B o Current FPS temperature higher than the set one before o Heating problems o Current process is ended during filling phase and only if a heater is used

• [268] FPS_TS_OUT_B o FPS’ temperature probe failure o FPS’ temperature probe damaged and must be replaced o Current process is ended during filling, processing or drain phase

• [269] FPS_TEMPLOW_B o FPS temperature has not reached desired value during starting filling (component with pre-heating active) o Heating problems o Process is ended during filling phase

• [470] ERR_PEMEABILITY_TEST o Permeability test failure o Test failure o Check reagent status

• [471] ERR_PRESSURE_TEST o Pressure test failure o Check air system components status up to processing chamber o Test failure

• [472] ERR_VACUUM_TEST o Vacuum test failure o Check air system components status up to processing chamber o Test failure

• [273] ERR_HEATING_TEST o Chamber heating test failure o Check chamber’s resistances status o Test failure

• [274] WAX_OVERTEMP_B o Temperature of all three cylinders higher than temperature set o Heating problems o No measure

• [275] TS_LID_OUT_B o Processing chamber’s lid temperature probe failure o Processing chamber’s lid temperature probe damaged, must be replaced o Current process ends during filling, processing or drain phase

• [276] LID_OVERTEMP_B o Processing chamber lid temperature, during processing, is higher than temperature set. Or, out of processing is

higher than MAX tolerated temperature o Heating problems o Current process ends during filling, processing or drain phase

• [177] COM_ERR_REM_B o Faulty connection between the two instrument boards o Processing chamber’s lid temperature probe damage and must be replaced o Current process ends during filling, processing or drain phase

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• [178] ERR_ETH_LINK_B

o Faulty connection between PC and instrument board o Check LAN cables o Safety procedure active only if a valid safety reagent has been set before and if maximum time set is ended

before cable connection

• [279] WAX_TEMPLOW_B o The temperature of cylinders 11, 12 and 13 are lower than set values o The instrument has been switched on after a long time of inactivity or a part of it is damaged o Possible problems for reagent movement (wax-kind)

• [280] WAX1_OVERTEMP_B o Cylinder 11 (wax) over-temperature o Possible electrical damage or temperature probe damaged o An automatic system will bring temperature back to the one set before



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6 Cleaning and maintenance 6.1 Maintenance Schedule This paragraph describes controls and cleaning procedures to be done. All system maintenance schedules need daily, monthly and yearly check. For a correct and long-lasting use, clean all instrument parts at least once a week.

Maintenance activity Daily Monthly Annual

Clean the PC screen with a lint-free cloth Follow the manufacturer instructions when using screen cleaner (4.3)

Ѵ

Clean processing chamber taking care to sensors and to processing chamber gasket (4.4)

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Check the correct reagent tanks placement Check for possible replacement of reagent and wax

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Check the absence of residuals on the bottom of tanks or wax containers, in case remove them

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Replace activated charcoal filters (4.5)

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Lid’s gasket maintenance (4.6)

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Diapath Preventive Maintenance (4.8)

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6.1.1 PC screen cleaning

Use a cloth damped with water, alcohol 70 or screen cleanser in order to remove possible residuals from PC screen

ATTENTION • If necessary, switch instrument off and unplug power cable before cleaning procedures • For cleaning products please follow the safety information and prescriptions on the basis of the local country lab • Remove all reagents residuals from the instrument • Do not use abrasive substances or cleansers containing acetone or xylene, for external surfaces cleaning; • It is strictly forbidden the presence of liquids into electrical plugs, inside the instrument.

ATTENZIONE Use I.P.D. (gloves, masks, etc. according to the cases) to perform maintenance operations safely.

ATTENTION

Use a lint-free cloth

ATTENTION Pay attention to the possible bio-contamination of the parts involved in the process. Follow decontamination instructions present in this manual before any maintenance activity or before place the instrument into its case.

ATTENTION

Dispose of all contaminated material according to the current lab regulation, by treating specimens’ residuals as special potentially infected waste.

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6.1.2 Cleaning of chamber and level sensors

Use a cloth damped with alcohol 70 for cleaning processing chamber inner area and level sensors at the end of each washing

6.1.3 Cleaning of SPC LID gasket

Use a cloth damped with solvent for removing wax residuals around SPC’s lid gasket.

6.2 Instrument decontamination procedure

We inform that specialist and technical staff is well-informed and trained about possible risks due to exposure and contamination during their working activities in labs. Anatomic pathology labs are classified as slow biological risk and medium chemical risk. However, the staff is well-trained for these risks. Technical and specialist staff shall demand information about possible higher risks. 6.2.1 Preventative measures and IPD to use Follow these safety rules for user’s health:

• Use disposable protective gloves • Wear protective glasses or eyeshades • Wear lab overalls • Wear a mask

ATTENTION: Avoid any contact with skin or mucosa. In case of eye-contact wash with tap running water. Users with skin injuries or skin infection shall not follow the procedure, otherwise they shall cover the affected part.

6.2.2 General information on sanitizing solution Cleansers, disinfectants and medical surgical devices as:

• Ammoniac solutions • Alcoholic solutions

Suitable solutions for instrument and accessories cleaning 6.2.3 Decontamination procedure

1. Turn instrument off and disconnect from mains 2. Use IPD 3. Place blotting paper over working plan next to the instrument 4. Remove, if present, all instrument mobile parts and place them over blotting papers 5. Sanitize instrument removed parts using blotting paper soaked with sanitizing solution 6. Sanitize the instrument (inner and external parts) using disposable blotting paper soaked with sanitizing solution 7. Dispose of blotting paper into special waste

ATTENTION Do not use chlorinated solutions or bleach for instrument decontamination, because they can damage instrument surface. For any doubts regarding the solution to use, please contact Diapath staff.

ATTENTION

Use a lint-free cloth

ATTENTION

Do NOT scratch the gasket using sharp object in order to avoid damages. If the gasket is damaged, contact Technical Assistance

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6.3 LCD display cleaning To clean the display, use a common screen detergent (according with instructions given by the detergent manufacturer).

6.4 External surfaces and process chamber cleaning If necessary, clean instrument external surfaces with a cloth dampened with water or water and soap, then wipe with a dry cloth. For the cleaning of processing chamber (SPC) and its inner cap use Ottix Plus, Microclearing or xylene. We recommend you to perform the complete cleaning of the instrument at the end of each working day.

6.5 Charcoal filter replacement Charcoal filter replacement is required by DonatelloTM tissue processor once exceeded set limit on RMS Setup. Automatic management of charcoal filter limits can be accomplished even when RMS is inactive, from Main Menu it is possible to view their consumption by percentage only. In this case, to replace charcoal filter and reset the percentage it is necessary to enter RMS Setup from Main Menu and reset their counters. Follow current State rules, for charcoal filter displacement. For the replacement of main filter proceed as following:

Remove ventilation grid unscrewing fixed screws marked with n.1 (attention, picture 68 shows screws placement; these screws, once unscrewed, remain fixed to ventilation grid). Proceed with main filter removal; remove fixing support using knurled knobs marked with n. 2.

ATTENTION Do NOT use any solvents to clean external painted surfaces

Picture 89 – Main filter box

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Remove exhausted filter using the specific handle Place a new filter. Handle is not in central position, pay attention to the direction of insertion. Keep handle upwards avoiding any contact with fixing support. See next picture, filter on its position and fixed to support (ref. handles identified with n.2)

Picture 90 – Filter removal

Picture 91 – Main Filter in its seat

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To replace secondary filter, open processing chamber and locate corresponding slot:

To open it, move it at the bottom of the instrument and pull it out

Filter is now visible. Pull it out (no block present). Place the small door again and close the chamber. Filter replacement complete. 6.6 Lid gasket maintenance Lid gasket of processing chamber is a fluorinated rubber. Use TEFLON grease monthly to maintain its duration. To replace it, remove it using a not-metallic sharp. Before inserting it, clean the area.

6.7 Fuses replacement For fuses replacement, proceed as following:

• Make sure that electrical power supply is disconnected and the switch is turned on OFF position

(Picture 94)

• Open fuse unscrew black cap as shown in Picture 95

ATTENTION Activated charcoal filter is a preventive measure used for reducing the presence of harmful vapours in the area around the instrument. It is necessary to ventilate working area

Picture 92 – Secondary filter slot

Picture 93 – Secondary filter extraction

Picture 94

Picture 95

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• Extract the fuses from their housing and check that the filament is not interrupted; in case, replace the fuse with a new one with same features (see Technical Data for fuses features)

• Connect power supply and switch ON the instrument

In case of failure restore, see Troubleshooting If problem persists, please contact Diapath S.p.A. or local distributor. 6.8 Preventive maintenance Diapath technical service supply one intervention per year for preventive maintenance, as in the agreement. Any other intervention is considered as additional.

ATTENTION We strongly suggest annual preventive maintenance

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7 Troubleshooting

The instrument does not turn on

Possible cause Corrective action

Power key has not been pressed Press the key on ON

Power cable is disconnected Check if power cable is connected to instrument an to electrical outlet

Electrical system protections are intervened Set again the protection

Fuses are burnt Insert new fuses inside the fuse holder

No voltage Contact engineering service or qualified staff for the verification of electric system

Paraffin does not melt in one of the three cylinders

Possible cause Corrective action Cylinder temperature set (too low value) Check parameters on instrument Setup Menu

If problems persist or are not described in the chart, please contact Diapath S.p.A. or your local distributor

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8 Accessories Here below the accessory list with their related code: Optionals: Basket, single layer (135 cassettes) SDSPA9031 Handle for basket SDSPA0102 Key for ONU tanks 5/10/20 L R5000 Auto dialer 539018 UPS CRDEA903-IIIPRO

Consumables:

Filter kit SDSPA9034 Available accessories:

Tank cap SDSPA9012 PWD Tank cap SDSPA9013 RFILL/RDRAIN pipe SDSPA9035 External wax dumping pipe SDSPA9032 Empty tank (5L) H0005 Rack holder SDSPA0130

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9 WEEE Directive 9.1 Uninstallation and disposal Before uninstalling the instrument, perform its decontamination, according to current laboratory standards. Before transporting the instrument, insert it into a suitable packaging to minimize the risk of contact with the parts of the instrument. The instrument or parts of the instrument must be disposed of in compliance with the local laws.

10 Diapath instrument warranty Art. 1 Instrument warranty is 12 months from delivery. Art. 2 Warranty expires in case of improper use, negligence, fraud and interference by not allowed third party. Defects of all parts subject to wear and tear and consumables are not covered by warranty. The present warranty cancels and replaces all warranties used or approved before.

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Diapath S.p.A. Via Savoldini,71 24057 Martinengo (BG) Italy Tel. (+39)0363.986.411 Fax (+39)0363.948.000 www.diapath.com [email protected]

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