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.
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 .................................
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.
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.
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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.
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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 Donatello tissue processor must be used only by qualified and well-trained operators.
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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.
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Tanks: 5 L 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.
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 ATTENTION ·...
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Unless different orders, store the box and all inner packaging during instrument warranty ATTENTION · Donatello 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...
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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) Picture 4 – Inside Donatello Picture 4A – Wheel brake on Picture 4B - Wheel brake off RAMP SETTING UP AND INSTRUMENT REMOVAL Use box frontal panel as ramp to move the instrument outside.
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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: Picture 7 – Packaging Remove fixing elements and PC plastic packaging taking care not to cause damage to it. Mount the PC on instrument supporting bracket as follow: Open support safety lever of the instrument bracket (Picture 8) Place the PC, ensuring its junction with instrument support safety lever is locked correctly (Picture 9)
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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: Picture 11 - PC rear part Picture 11 –...
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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) ·...
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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 Donatello Series 2 must be switch off ONLY following the procedure described above.
1.3 Instrument features · Donatello 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 ·...
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· 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...
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 Pollution degree General features Certifications...
1.6.1 Processing capacity Donatello tissue processor can process a maximum of 405 cassettes. Donatello 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).
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.
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.
· Have useful information to detect future problems Reagent management module is very important for Donatello 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.
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 Donatello Tissue Processor: ·...
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: Process 4 Number of reagent...
The screen is divided into three main areas: · Upper Area: Donatello 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 ·...
Picture 21 – Login 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: ·...
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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...
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SelfCheck finish time is variable due to: Duration of vacuum test into the chamber Reachable pressure limit during vacuum test Duration of pressure test into the chamber Reachable pressure limit during pressure test Maximum pressure Reachable limit after slot valve opening (minimum pressure) Test duration SelfCheck interface shows a LED for each check (Picture 22).
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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;...
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...
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).
Picture 24 – Alarms Tank position status From this screen it is possible to control all 16 Donatello tissue processor stations. Select a tank position to see all information regarding the reagent inside the tank (Picture 25). Picture 25 – Tank position status...
2.5.1 Normal processing The screen shows all Donatello 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.
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. Donatello tissue processor will associate the process for all steps to be performed. This information will be...
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: •...
2.5.6 Starting processing Picture 29 – 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. •...
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 Mix duration 3 basket of time (see , Chapter 4.1, Diapath setting, Service manual).
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 Donatello tissue processor washing protocols, sorted by date and time according to the most recently used.
Picture 32 – 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 Donatello tissue processor main screen in the previous chapter.
Picture 33 – RFID antenna 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.
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Picture 35 – EWD procedure The chart on the left shows where it is necessary to replace the tank. Close reagent management screen Donatello tissue processor status Stop the procedure, visible only if procedure is active EWD active (or inactive)
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MultiSense OPEN replace the reagent by selecting its replacement or removing it from the Using Donatello selected position using the external drain RDRAIN. For the external drain, connect one pipe supplied with Donatello 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.
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Press the button below to start RDRAIN procedure (Picture 37): Picture 38 – Reagent replacement 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 39 –...
The chart on the right (Picture 38), select automatically the slot of tank replacement. Close reagent replacement screen Donatello 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.
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A safer replacement procedure is RFILL (it corresponds to RDRAIN for reagent replacement). For external load, connect one of the pipes equipped with Donatello 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.
2.7.3 Filter support system Donatello 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).
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...
Picture 44 – Donatello general information 2.8.2 General information Click over the specific tab on left column on Picture 44 to modify Donatello tissue processor general setting: Device : Active or inactive automatic SelfCheck before processing, set duration (in minutes) of automatic user logout and...
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.
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).
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(i.e. it is impossible to create a step where wax follows a formalin step, because the two reagents belong to tissue processor MultiSense OPEN version allows incompatible families (Picture 48). Reagent families are set by default. Donatello manual set of reagent families.
· ATTENTION: If during manual loads the instrument needs a washing, some wax residues could finish towards Donatello 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.
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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 –...
Picture 54 – SPC heating 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).
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Picture 56 – Reagent management 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.
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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. Picture 58 – RMS Automatic drain: Automatic drain is used to automatically drain exhausted wax during processing (Picture 59).
2.8.7 MultiSense Donatello 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’...
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 Donatello 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.
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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). Exit from the screen 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...
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Visualize all details about used tank during current protocol Print current protocol Picture 63 – Cassettes tracking 2.8.8.3 Print protocols Click over the icon to print washing and processing protocols save into Donatello tissue processor in PDF, save them on hard disk or use a USB key.
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2.8.8.4 Warnings register Visualize alarms and warnings shown during Donatello 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). Exit from the screen Browse alarms history chart...
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2.8.8.5 Tanks tracking List of tanks used with Donatello tissue processor. For each tank, in the chart, are shown all details about its use (Picture 65). Exit from the screen Browse tanks history chart and their use with linked processes...
2.8.9 User management List of users for role, it is possible to modify, add or remove them (Picture 66). Picture 66 – Users 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...
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Each logged user has a specific role. The role fixes all authorized activities for the user (Picture 68). Each user has to login. Role For each role (Choose from menu) active/inactive the access to instrument procedures. The roles are: Diapath · Service · Advanced User ·...
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User: Picture 69 – User Role AdvUser: Picture 70 – AdvUser...
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Service: Picture 71 – Service Role Diapath: Der Diapath-Benutzer hat alle Berechtigungen...
Specimens Traceability 3.1 Overview Donatello 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”.
3.3 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...
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.
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Whether power failure occurs it is possible to see time remaining from where the procedure will start. Picture 80 – Main screen 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.
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Picture 82 – Safe reagent procedure complete 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 ·...
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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...
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.
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Picture 86 – Restart procedure 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: ·...
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Picture 88 – Restart procedure: pre-heating 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.
5 Alarms and warnings Here following all alarms related to Donatello tissue processor. Legend: Code Name · Description Possible causes Result 5.1 Warnings · [201] POWER_FAILURE: Operating UPS (if present) Power failure UPS avoids power failure [502] DIFFICULT_DRAIN: · Difficult reagent drain. The reagent lasts more time than MAX time set Possible obstruction of reagent line in use or problems related to water system Second attempt on drain.
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[211] WAX2_TEMPLOW · Cylinder 12 (wax) lower temperature than set value The instrument has been switched on after a period of inactivity or problems related to a specific part of it Possible problems related to reagent moving within cylinder 12 [212] WAX3_TEMPLOW ·...
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[524] SHORT_FILL_L1 · If short fill option active. Tank fill accomplished within MIN set time but first level sensor not activated in time Reagent level too low and does not reach level 1 Some specimens could not be covered correctly [525] SHORT_FILL_L2 ·...
5.2 Blocking alarms · [450] PT_FAILURE_B Pressure sensor failure Pressure sensor does not work correctly Current process is ended · [451] FILL_NO_VACUUM_B During reagent filling step, no vacuum in processing chamber accomplished Pump failure or problem related to air system No reagent fill, current process is ended ·...
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[564] DRAIN_TIME_OUT_B · IN case of [502] DIFFICULT_DRAIN error and at second attempt it is impossible to drain the reagent from processing chamber to destination tank It is impossible to drain the reagent present into the chamber Check possible obstructions that avoid reagent drain ·...
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· [178] ERR_ETH_LINK_B Faulty connection between PC and instrument board Check LAN cables 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 The temperature of cylinders 11, 12 and 13 are lower than set values The instrument has been switched on after a long time of inactivity or a part of it is damaged Possible problems for reagent movement (wax-kind) [280] WAX1_OVERTEMP_B...
Replace activated charcoal filters (4.5) Ѵ Lid’s gasket maintenance (4.6) Ѵ Diapath Preventive Maintenance (4.8) Ѵ 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...
Suitable solutions for instrument and accessories cleaning 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. 6.2.3 Decontamination procedure Turn instrument off and disconnect from mains...
Do NOT use any solvents to clean external painted surfaces 6.5 Charcoal filter replacement Charcoal filter replacement is required by Donatello 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.
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Picture 90 – Filter removal 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 91 –...
To replace secondary filter, open processing chamber and locate corresponding slot: Picture 92 – Secondary filter slot To open it, move it at the bottom of the instrument and pull it out Picture 93 – Secondary filter extraction Filter is now visible. Pull it out (no block present). Place the small door again and close the chamber. Filter replacement complete. ATTENTION Activated charcoal filter is a preventive measure used for reducing the presence of harmful vapours in the area around 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...
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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...
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 CRDEA903-IIIPRO Consumables: Filter kit SDSPA9034 Available accessories: Tank cap SDSPA9012 PWD Tank cap SDSPA9013...
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.
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