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Leica ASP200 S - Documents: Leica Biosystems

1. Program duration cannot be specified It is determined by the total duration of all program steps plus the estimated fill and drain times To alter the duration of a program the duration of one or more individual program steps has to be modified e Retort or paraffin cleaning programs are preset They cannot he re i named added or deleted 48 Instructions for Use V 1 4 RevE 03 2013 Operation 5 1 6 Adding and or modifying programs Creating a new program 0 10 0000 10 0 0 0 G e OOD Doo 010 boo mragicimonidoea 2002010 0 0 8 8 Go Make sure you are logged on at supervisor level In the VIEW EDIT PROGRAMS screen Fig 45 highlight a program as similar as possible to the program you wish to create This minimizes the number of operating steps Press COPY to copy the selected program The new program will have the same name as the program copied however the figure 2 will be added to indicate the change Highlight the line containing the new program Press PROGRAM NAME at the top of the table to display the keyboard Enter the new program name Editing program steps Pressing EDIT in Fig 45 calls up the PROGRAM STEPS screen In the headline you will find the PROGRAM NAME The colors on the left border of the table indicate the reagent groups to which the reagents belong The program steps are displayed in the order in which they are carried out For each program up to 13 steps
2. Notes on Specimen Preparation e Cut the tissue samples that are to be embedded to a size that fits the type of tissue and embedding cassette being used Use a sharp and clean knife in order to prevent the transmission of contaminants and to avoid damaging the tissue samples e Leica recommends g e Using sponges to affix small tissue samples for processing or packing them in filter paper e Packing small biopsies into Leica CellSafe biopsy capsules biopsy sponges or biopsy bags Insufficiently prepared specimens can lead to the intrusion of artifacts into important instrument components and thus cause damage 86 Instructions for Use V 1 4 RevE 03 2013 Leica BIOSYSTEMS www LeicaBiosystems com Leica Biosystems Nussloch GmbH Heidelberger Stra se 17 19 D 69226 Nussloch Phone 49 6224 143 0 Fax 49 6224 143 268 Web www LeicaBlosystems com
3. 7 1 2 Paraffin cleaning It is possible to clean used paraffin of solvent residues xylene in the Leica ASP200 S Meru To do so select the paraffin bath for which the NEE paraffin should be cleaned in the CLEANING ina PROGRAMS menu If the last reagent in the retort is not compatible with paraffin carry out a retort cleaning first The following steps are taken during the paraffin Woe Clean im Cleaning amt ieme URL program e The paraffin is pumped into the retort Wax Clown dil Ladd ifad A pt alls e There itis heated to the highest possible tem Wax Clean h Extended Cleaning perature Coti cit mb STRUTT e The retort is put under vacuum causing the solvent vapors to be drawn out of the paraffin Fig 82 The duration of the paraffin cleaning process Is programmable To do so follow these steps e Inthe PROGRAMS menu select the PARAFFIN CLEANING line and press the EDIT button e nthe entry window specify the duration for the cleaning program The recommended time frame is one hour e Confirm the time specification with OK Fig 83 Leica ASP200S 715 7 Cleaning and maintenance 7 1 3 Smart clean 76 DA The smart cleaning prepares the ASP200 S for transport During a smart clean a series of air cleaning steps will be applied which will remove any excess liquid condensate from all internal tubing Before starting a smart cleaning a complete retort cleaning prog
4. 03 2013 7 Cleaning and Maintenance 7 1 Clean programs El e Three retort cleaning programs and a paraffin cleaning program are defined in the ASP200 S i Clean programs cannot be copied or deleted The cleaning programs are at the end of the list of all pro grams Fig 45 To display a clean program highlight the respective line and press EDIT Replacement schedule for cleaning reagents The cleaning reagents cleaning xylene and cleaning alcohol must be replaced weekly refer to Chapter 3 6 1 If fatty tissue bloody tissue biopsy sponges or the like are processed both the reagents and the cleaning reagents must be replaced more frequently 7 1 1 Retort cleaning programs A cleaning program comprises a minimum of three and a maximum of four steps 1 Solvent 1 step from station 11 2 Cleaning alcohol 1 step from station 12 3 Cleaning water 1 step from station 13 Optional between steps 2 and 3 Cleaning water detergent 1 step from station 13 ext Fig 81 Leica ASP200 S 73 7 Cleaning and Maintenance 7 1 1 Retort cleaning programs continued The steps of retort cleaning programs are listed in the order in which they are carried out Fig 81 The cleaning program skips any steps not required to complete the cleaning If e g an infiltra tion program has been aborted during the alcohol step the subsequent clean program will skip the cleaning solvent step and will star
5. 03 2013 7 Cleaning and Maintenance 13 Checklist for preventive maintenance Step Daily Weekly Monthly every 3 months Lubricate the O rings of the reagent con v ii tainer and check them for damage During re mote filling and draining After exiting the retort cleaning program 4 wipe the retort and cover dry Clean the outer surfaces of the instrument v with a soft cloth and a very small amount of xylene Check the retort filter screen for tissue or v paraffin residue Remove paraffin residue from the interior v surface of the paraffin reservoir cover Check the retort lid seal and clean it v if necessary Check the paraffin reservoir lid seal and v clean it if necessary Check the paraffin level and refill if neces v sary Check the fill levels of the reagent contain v ers Leica ASP200S 83 7 Cleaning and Maintenance Step Daily Weekly Monthly All 3 months Check the filter screens of the paraffin res ervoirs and clean if necessary Check the air circulation opening of the par affin reservoirs and clean if necessary Check and empty the condensate container Clean the inlet openings Check the status of the active carbon filter Replace the active carbon filter Check the level sensors and clean if necessary Check the electrical ports on the rear side of the instrument Clean the reagen
6. Entering modifying reagent thresholds If warning thresholds are required for a certain reagent enter them as fol lows 1 The respective threshold value applies for all reagent stations con Highlight the reagent to be modified either by pressing the reagent name or using the UP DOWN buttons Press the header of the parameter to be changed the corresponding entry screen appears Enter a new threshold value or if no warning is desired press CLEAR to remove the threshold altogether Press OK to confirm taining the same reagent Changing reagent names or reagent groups 5 If a reagent is already used in a program it can neither be renamed g nor can it be allocated to another reagent group The corresponding symbols will be disabled i e they will not be surrounded by a blue border If a reagent is renamed all stations and programs linked to that re agent need to be reedited as well Highlight the reagent the name or group of which you wish to change Press the corresponding button symbol in the headline In the entry window or via the keyboard enter the new reagent group allocation the new reagent name Press OK to save the new reagent group reagent name Instructions for Use V 1 4 RevE 03 2013 5 Operation Deleting reagents e Highlight the reagent to be deleted in the SET UP REAGENTS AND WARNING THRESHOLDS screen e Press CLEAR e Press YES in the scree
7. Fig 7 Fig 8 28 Magnetic stirrer Unpack the magnetic stirrer Fig 7 30 and insert It into the retort Important The magnetic stirrer must be inserted such that the outer curvature 32 of the two stir rer blades 31 faces downwards Fig 7 Do not insert them the other way around as then there will be no effective stirring Inserting the volume replacement body Important The instrument must be operated only when the volume replacement body is in the retort even during cleaning pro grams Otherwise malfunctions may cause damage to the instrument Take the volume replacement body Fig 8 25 atthe metal clip 26 and insert it into the retort 19 such that the bore 27 is above the posi tion of the magnetic stirrer Instructions for Use V 1 4 RevE 03 2013 4 instrument Setup 4 4 Making the data connections Printer optional e Swing the door of the instrument console 6 upwards e Connect the printer to the printer port 8 using a Centronics standard cable Fig 9 e Your Leica dealer can recommend a suitable printer e If compliance with the electromagnetic inter ference standards is of fundamental impor tance a specially shielded printer cable must be used Other terminals e For data transfer and storage the instrument console has a regular 1 44 MB floppy drive 11 for 3 5 diskettes and a serial RS 232 interface 12 Le
8. prompts that must both be answered with YES OK Afterwards follow the instructions on the screen When prompted insert the disk labeled Disk 2 into the disk drive Follow the same procedure for the other disks if present After the update process is complete the instrument software carries out a restart the screen shuts off and then restarts as if the instrument had been switched off and switched on again 43 5 Operation Configuring a printer gt m On the INSTALLATION screen press PRINTER TYPE to ial display the list of the printers that can be connected The Leica ASP200 S works with any printers that are compat ible with commercial PCs J e Connect the printer provided to the printer port using a Centronics standard cable For additional information refer to Chap 4 4 Fig 9 e In the SELECT THE PRINTER TYPE window highlight the printer that is connected to the instrument and press OK e If the printer driver you connected is not listed try a i similar printer of the same manufacturer If this approach does not work call Leica Technical Service to have the required printer driver installed Fig 39 Printing run logs Printing is possible when the PRINT symbol is displayed e The printer icon is displayed only after a printer has been config a ured for the instrument The following lists and protocols can be printed e Reagent list e Stat
9. Filling with paraffin pellets de ee E F E EE i E rja 1 rima aed raon tas i il I a i a b EJ egi Fig 59 Fig 60 Leica ASP200 S Important The level in a wax bath must NEVER Fill the paraffin reservoir to the brim Fig 60 1 with paraffin pellets This corresponds to ap prox 3 5 kg bath Leica Histowax pellets Press BACK and REAGENT STATUS to switch to the status table Fig 59 Select the filled wax bath and press the SET AS FULL button After approx 90 min add another 0 5 kg of paraffin pellets Do notinsertthe baffle plate during the heating phase The pellets need a total melting time of approx 10 hours fall below the mark for minimum level Fig 60 2 Replace the baffle plate when the paraffin is melted Software control After refilling with paraffin pellets the ASP200S does not allow you to run any pro grams until the paraffin is completely melted The software calculates the amount of time required for melting the paraffin and does not start a program until itis sure that the paraffin will have melted at the time of the first paraffin Cut 59 5 Operation Filling with liquid paraffin The temperature of filled liquid paraffin must not be greater than 70 C to prevent damage to the thermal fuse T 3 gt gt Senice e If filling with already melted paraffin the liquid metio level must not ex
10. 1 Connecting the power supply in the ON position 1 Once the instrument has been switched on the main switch ON OFF 5 should always remain e Connect the power cable 37 i i sar to the input socket 41 of the Fir main power supply I e The jumper cable provided a 38 connects the output of the e Ennn main power supply 43 to the i L input of the electronics module 40 i tert amp amp MM III Left Fig Right Fig Electrical ports on the rear Correct connection of the cables panel of the instrument important i The specification for the connection 40 is speci fied as follows LERI 100 120 V or Fig 4 230 240 V maximum 200 VA Leica ASP200 S 25 4 Initial Operation 4 2 2 Connecting an uninterruptible power supply UPS e An uninterruptible power supply UPS i protects machines and instruments against malfunctions in the power supply Leica recommends using an active tracking UPS with an output power of 1000 1500 VA to protect the instrument and the specimens from tem porary power failure voltage spikes undervoltages and excess voltages e Connect the ASP to a grounded socket using the power cable 37 e Using the jumper cable 38 connect the output of the main voltage supply to the UPS input e Using the jumper cable 38 connect the input of the electronics section 40 to one of the UPS outputs e Fig 4a
11. 4 RevE 03 2013 5 Operation Display Buzzer DISPLAY BUZZER 45 e The number next to DISPLAY OFF indicates the remaining time in min until the screen saver after the last user action is activated T e The BUZZER VOLUME can be set between 1 and 10 1 Fig 28 Instrument INSTRUMENT Press PARAFFIN BATH SET TEMP to open the input screen Fig 30 for the male wax bath temperature Set the temperature according to the value required by the paraffin used Run Options Select the highest permissible temperature for the paraffin to ensure that a minimum loss of temperature occurs when filling the retort Fig 29 The RUN OPTIONS displays the options with which a program starts The options set apply for ALL programs A printer option will be dis played only if a printer has been configured for the instrument The individual options are described in Chap 5 3 1 Paraffin temperature and run options screen Leica ASP200 S 39 5 Operation Security _ SECURITY z Access rights to the instrument are managed here as Ea m user profiles Enabled 1 Supervisor mode is disabled in factory condition Fig 31 SUPERVISOR MODE Enabled or Disabled Enabled There are two different user profiles A password is required for supervisor level access to the in strument Enabling SUPERVISOR MODE already requires entering the password 5 1 2 Access levels The Leica ASP
12. ABP ROOS i use the M0VE UP M0VE What ia doca masta DOWN buttons ee T1 The PREVIOUS TOPIC 1 but lt ton takes you from a detail RIA back to the index Tig Furi die Fraic dhe beget Chenin he AS IIDE EE FE EE dii BACK 2 displays the most recently active working window The CUSTOM HELP button 3 is displayed only if a custom laboratory help has been installed Fig 80 For detailed information on how to create and install a custom help file refer to the help index under the What is Custom Help header e In addition to the help index there are other help options which li are always provided in context These are displayed only when help is accessed within the window in which the problem occurs Help in the case of an error message To call up help in the case of an error message e Press the button symbol DETAILS or e Press the HELP button integrated in the message to receive information about the source of error Leica ASP200 S 69 6 Troubleshootin 6 1 General 6 2 Power failure 70 The Leica ASP200S is equipped with a cutting edge fault detection and troubleshooting system When detecting a malfunction the instrument provides the operator with detailed error messages and corresponding steps to take via the screen B For all error states the instrument takes corrective measures to a protect the specimens except in such cases where continued functioning of the i
13. Favorite To begin working with a Favorite press the corresponding symbol on the start screen The program Is started immediately After starting the end time or other program op tlons can be changed in exactly the same way as for any other running program Leica ASP200 S ALL PROGRAMS Fig 64 In the Start screen press the ALL PROGRAMS button This window displays all of the infiltration programs defined in the instrument To call up a program touch the button that is labeled with the program name A screen with the graphic representation of the program appears in it all of the stations necessary for this program are color coded according to reagent group Fig 65 Unlike a Favorite here you have the ability to modify a program before it is started However all modified processing steps apply only for the program that is currently called up 61 5 Operation 5 3 1 Editing a program that has been called up Resetting the end time e Touch the FINISH TIME button and reset the end time in the input window Fig 65 To modify a program before the start press the EDIT button A message appears that the changes will affect running programs only After confirming with YES the program edit window appears Fig 66 Fig 67 e Enter the day on which you want the program to end e Enter the time in 24 hour format at which you want the program to end e Press OK to confirm e Pr
14. fore cleaning in order to prevent unnecessary waiting times e Tounlock the retort turn the lever for locking unlocking Fig 71 approximately 45 clockwise Fig 72 and release the lever 10 mm during this time 1 A signal tone sounds for about 10 seconds The reagent level in the retort drops by about This prevents the reagents from spilling out of the retort when it is opened e After the signal tone stops turn the lever all the way to the right Fig 73 and open the retort lid Approx 45 Fig 71 Fig 72 5 3 4 Retort emergency release The retort lock is equipped with a safety system for unlocking the retort Electronic emergency unlock e f the retort cannot be opened after 10 seconds press the EXIT APPLICATION button and follow the instructions in Chap 4 10 e After shutting down see Chap 4 10 Fig 20 and 21 switch off the instrument s power switch Fig 4 42 The retort can then be opened and the samples can be removed Leica ASP200 S 65 5 Operation 5 3 4 Retort emergency release continued Aside from this the system is also equipped with a mechanical emergency unlock a predeter mined breaking point in the retort lock Mechanical emergency unlock e If the retort cannot be opened while in a powered down state g the stop can be overcome and the retort can be unlocked using the single head wrench 14 0330 50891 included in the delive
15. is provided as an example only e Switch the instrument on at the main switch i and shows the correct connection e Start the UPS of the ASP200S to an uninterruptible power supply UPS Fig 4a 26 Instructions for Use V 1 4 RevE 03 2013 4 instrument Setup 48 Installing accessories e Move the instrumentto its final setup location 13 18 Active carbon filter e Unpack the active carbon filter 13 and insert it see Fig 5 When doing so make sure that the filter is inserted with the correct side up Note the 1 U Pouance THIS FILTER ON i direction of the label 29 on the front of the filter the arrow mustbe LEICA PART NO 0476 34150 pointing upwards Fig 5 Remote fill drain hose e Connectthe supplied remote fill drain hose to the remote drain connection on the front of the instrument refer Fig 6 e Important When inserting the hose into the drain opening Fig 5 6 18 the connecting device 28 of the hose must engage with a clearly audible click e If it is possible to set up the bulk con i tainer for filling and draining in the immediate vicinity of the instrument the hose can be shortened so that it is easier to handle When shortening the hose you can cut a V shaped notch into the hose end to attain better flow Fig 6 Leica ASP200S 21 4 Initial Operation 4 3 Installing accessories continued
16. order to ensure that the seals always seal properly e Remove both covers for cleaning e First clean the stainless steel surface using the plastic spatulas then wipe to remove all dirt particles around the retort and the paraffin res ervoirs Reagent and condensate bottle seal lubrication e To ensure easy removal of the reagent and condensate bottles lubricate the O ring seals on the plug in nozzles with the O ring lubricant supplied chloroform O rings that have not been lubricated swell when ex posed to chloroform The reagent containers can then become very difficult to remove 1 This procedure is particularly important with bottles containing Checking the retort lid seal e Regularly check the retort lid seal for damage If the seal is damaged it must replaced without delay 80 Instructions for Use V 1 4 RevE 03 2013 7 Cleaning and Maintenance 7 2 2 Periodic cleaning and maintenance Cleaning the reagent containers e Empty and clean the reagent containers Using a bottle brush and a laboratory detergent in warm water Never clean reagent containers in an automatic dishwasher The reagent containers are NOT dishwasher proof e Refill and reconnect the bottles once cleaned Make sure the bottle lids are tight and the bottles are properly seated in their home position at the rear of the reagent module The reagent containers must be properly engaged in the home po sition in th
17. protection Overheating protection When power is off the air pump and air valves default to a safe condition retort vented no pressure generation lf the pump Is not stopped at the correct moment during the pressuriza tion the power supply Is interrupted by a separate electronic circuit In addition there is a safety relief valve that vents all excess air pump output to atmosphere Overcurrent conditions are protected against by both the main fuse and the separate heating power fuses An error Is indicated and all heating is stopped by the microprocessor control if the instrument detects any of the following conditions Over vacuum protection Overcurrent protection Leica ASP200 S Abnormally high temperature gt 75 C Contradictory results of the temperature sensors Failure of one or more heating power control components If the microprocessor fails to interrupt heating power independent tem perature limiting hardware circuits limit the temperature rise to a safe level If the temperature limiting circuits malfunction an independent hard ware thermal fuse circuit cuts power to the heating elements The vacuum system is not capable of generating a dangerous vacuum condition Overcurrent conditions are protected against by both the main fuse and the separate heating power fuses 13 3 Instrument Components and Specifications 3 1 Overview instrument components 16 Fig 2 14 Instructions
18. rated at less than 2 amp A maximum voltage of 30 V DC may be present Each alarm is connected to the plug 34 as follows see Fig 13 Shared terminal Tip 36 connection inside Normally open connection First neck 35 connection outside Normally Closed Contact Connection Second neck 33 Threaded connection 31 4 Initial Operation 47 Switching the instrument on 32 The instrument MUST be connected to a grounded power socket For additional electrical fuse protection we recommend connecting the Leica ASP200S to a socket with a residual current circuit breaker e Connect the power cable to the power socket If applicable switch on the switch for the power socket e To switch on the instrument press in the ON OFF switch on the rear panel of the instrument Fig 4 42 ON e Switch on the ON STOP switch on the right of the instrument ON The ON OFF switch and the side ON STOP switch should remain switched on at all times to keep the heater running for the wax baths The ON STOP switch can be used in emergencies to stop the instrument during while a proce dure is in progress e After being switched on the instrument will take a few minutes to initialize See opposite for cor vee Please Walt responding touchscreen display Fig 14 e f the retort is not locked a signal tone sounds for approx 10 sec during initialization of the instrument It is not p
19. usage fre quency of the individual reagents and enables automatic definition of the reagent sequence there is no more need to rearrange reagent containers If one or more reagents within a sequence are replaced the RMS automatically uses the reagents in the correct sequence organized in ascending order of cleanliness Liquid movement wave motion during the process for better and continuous mixture of the reagents System for non contact filling draining of reagents drains and fills the reagent container using a hose connected to the infiltration module without the operator being exposed to reagents in the process Non contact wax bath drainage Optical level meter Active paraffin cleaning program removes solvent residue from the paraffin lengthening its service life Magnetic stirrer for gentle circulation of the reagents thus ensuring a uniform reagent temperature Programmable end time for infiltration programs 3 step drainage of the retort adjustable for reducing reagent displacement Infiltration process at ambient pressure or with pressure vacuum or a combination of both Four programmable cleaning programs The cleaning programs automatically omit all steps that are not necessary to complete the cleaning procedure Instructions for Use V 1 4 RevE 03 2013 3 Instrument Components and Specifications 33 Standard delivery packing list i The standard equipment of the Leica ASP200S i
20. 0 to 1200 specimens have been processed or after 6 cycles of 100 to 200 specimens each e For formalin process alcohol and process xylene reagents ambient temperature Is recom mended e The recommended temperature for cleaning reagents in the cleaning cycle is 65 C e Only zinc formalin based on zinc sulfates may be used in the ASP200 S ASP300S If zinc for malin is used the cleaning program must include an additional cleaning water step e The use of formalin reagents containing zinc chloride can cause corrosion in and on the instrument 22 Instructions for Use V 1 4 RevE 03 2013 3 Instrument Components and Specifications 3 6 1 Cycle for changing reagents Reagent Week1 Week2 Week3 Week4 Formalin At least 3 times a week At least 3 times a week At least 3 times a week At least 3 times a week Formalin At least 3 times a week At least 3 times a week At least 3 times a week At least 3 times a week 710 Daily Daily Daily Daily 80 Once a week Once a week Once a week Once a week 95 Once a week Once a week 95 Once a week Once a week 100 Once a week Once a week 100 Once a week Once a week Xylene Once a week Once a week Xylene Once a week Once a week Paraffin 1 Run paraffin clean ing program daily Replace the paraf fin after 6 cleaning cycles Run the para
21. 200S may be configured to allow two levels of user access Operator symbol Operator access level e Operators may run programs and view results On this level the OPERA 1 TOR symbol is displayed in the upper right corner of the touchscreen all enabled buttons are surrounded by a black border Supervisor symbol Supervisor access level e Supervisors may perform all Operator functions and additionally create programs and perform the instrument setup functions In supervisor mode the SMART SCREEN menu displays a status bar with information about the retort and the wax baths see Fig 55 e To access Supervisor level press SUPERVISOR enter the required password and confirm After you enter the password the SUPERVISOR symbol appears in place of OPERATOR the outlining of all active buttons changes from black to blue the SUPERVISOR button is replaced by the OPERATOR button Disabled Default state of the instrument All instrument and software functions of the ASP200S are fully accessible to all staff 40 Instructions for Use V 1 4 RevE 03 2013 Operation LOCK MODE Enabled or Disabled In the Leica ASP200 S there is a lock mode to protect against operation by unauthorized per sons Enabled The LOCK key is active in the menu functions A password is required for activation If LOCK is pressed no keys can be enabled until the agreed password is entered Disabled All functions are acce
22. 76 34770 14 0330 50891 14 0222 04138 17 3 Instrument Components and Specifications 3 3 Standard delivery packing list continued Part No 1 Remote alarm connection 6 3 mm 14 6844 01005 1 Cleaning tools for prism 14 0495 47955 1 Microfiber cloth for prism 14 0495 47736 1 Power cable for Germany 14 0411 13558 1 Power cable for UK ST BU F 5A 14 0411 27822 1 Power cable for Brazil 10 A straight 14 0411 47869 1 Power cable for the USA Canada Japan for voltage variant 100 120 V 14 0411 13559 1 ASP200 S German English Instructions for Use language CD 14 0480 80001 1 Language CD with ASP200 S demo program 14 0480 80200 Please check all delivered parts against the packing list and against your order to verify whether the delivery is complete Should you find any discrepancies please contact your Lei ca sales office without delay mie 18 Instructions for Use V 1 4 RevE 03 2013 3 Instrument Components and Specifications 3 4 Technical Data Nominal supply voltages Nominal frequency Main fuses Nominal power Dimensions Lx W x H in mm Empty weight unpacked Weight packed Operating temperature range Relative humidity IEC 1010 classification Altitude Local remote alarm relay Paraffin reservoirs Number of containers Capacity Melting time Temperature Temperature accuracy Leica ASP200 S Two factory preset voltages not user adjustable 100 to 120 V
23. Buzzer e Date time e Security e Instrument Fig 24 Leica ASP200 S 37 5 Operation Frogram Options Station Allocation Wax Bath Order Sequential 1 Waxil 2 Waxill 3 Wax llll Prompt for Hum Blocks Disabled Fig 25 Date Time 2010712 10 07 18 Fig 26 38 PROGRAM OPTIONS Select the options with which programs are executed here Press a button to change the associated value e STATION SEQUENCE By Age or RMS is activated reagents will automatically be used in order of increasing cleanliness Sequential By Age Sequential reagents will be used in sequential order of stations e WAX BATH ORDER Auto or 1 2 3 Can only be activated if STATION SEQUENCE is set to Sequential otherwise the order of baths will be managed by the RMS e PROMPT FOR NUM BLOCKS Enabled or Disabled Enabled When starting a program the actual number of blocks must be entered This is recommended with the RMS being en abled Disabled Number can be entered but does not have to be DATE TIME Be sure to verify that the date and time entered do actually correspond to the local time date as this will ensure that all programs are carried out correctly Press the buttons to access the entry windows where settings or correc tions can be made If necessary Date and time setup screen Thu 20 Jul 2006 j Fig 27 Instructions for Use V 1
24. Seica BIOSYSTEMS Instructions for Use Leica AS P200 5 Advanced Smart Processor Vacuum Tissue Processor CE Leica ASP200 S V 1 4 RevE English 03 2013 Order No 14 0480 80101 RevE Always keep this manual with the instrument Read carefully before working with the instrument WARNING The information numerical data notes and value judgments contained in this manual represent the current state of scientific knowledge and state of the art technology as we understand it following thorough investigation in this field We are under no obligation to update the present manual periodically and on an ongoing basis ac cording to the latest technical developments nor to provide our customers with additional copies updates etc of this manual For erroneous statements drawings technical illustrations etc contained in this manual we exclude liability as far as permissible accord ing to the national legal system applicable in each individual case In particular no liability whatsoever Is accepted for any financial loss or consequential damage caused by or related to compliance with statements or other information in this manual Statements drawings illustrations and other information as regards contents or technical details of the present Instructions for Use are not to be considered as warranted characteristics of our products uil Leica Biosystems Nussloch GmbH Heidelberger Str 17 19 D 69226 Nu
25. can be defined The following characteristics of each program step can be edited Leica ASP200 S Reagent name Duration of step with the exception of fill and drain steps Retort temperature if Ambient is selected the display for the retort temperature remains empty Type of pressure and or vacuum cycle Retort drain time Delay step 49 5 Operation Editing program steps To edit a step highlight the corresponding line and press the respective headline In the entry windows that pop up enter select the program step settings Eaa Si Etuna Ahachna Ethianal Siaga 50 Fig 47 Instructions for Use V 1 4 RevE 03 2013 5 Operation Editing program steps continued Setting a delay step A delay step is a step that is extended to ensure that a program will finish at a specified time e Highlight the program step you wish to define as delay step e Touch the DELAY button The delay symbol is moved to the selected step thus defining the step as delay step Copying program steps e Highlight the step you wish to copy e Touch the COPY button e lf required modify properties of the step e Remember that a program step cannot be copied if the program al i ready contains the maximum numher of 13 steps e Use the MOVE UP MOVE DOWN buttons to move program steps up or down within an existing program without having to recreate those steps Deleti
26. ccess to basic instru ment settings Notice Only experienced operators may adjust the settings since incorrect use of the functions can result in serious malfunctions Fig 16 To exit this menu the device must be restarted press RESTART APPLICATION To reinitialize the instrument press YES to con firm the query ARE YOU SURE YOU WANT TO Fig 17 i Queries such as this are always made before important steps that are irre versible This allows the operator to undo changes caused by accidental key strokes e The initialization process starts again with the screen shown in Fig 14 33 4 Initial Operation 48 Touchscreen functions The Leica ASP200S is programmed and operated via a color LCD touchscreen The instrument s control software contains an online help feature including detailed information about all screen func tions and error messages The software functions are also explained here in detail Help can be accessed from any screen by pressing the HELP button Fig 18 Button symbols Press the button to activate the corresponding function on the Leica ASP200S touchscreen All buttons have a uniform design for easy identi fication The buttons may contain text labels or graphical icons Smart Clean Supervisor Enabled The buttons change their appearance depending on whether they are enabled or disabled A button is disabled if the function that it p
27. ceed the MAX level mark see Fig 60 1 in the paraffin reservoir e After a paraffin reservoir is filled with paraf Tha functions below shokl only be used by certiied Service Sant incorrect usa of fin it must be marked as full in the REAGENT STATUS table Software control If the instrument has been filled with liquid paraffin the instrument s internal calculation of the melting time can be disabled To do so in supervisor mode open the SERVICE FUNCTIONS Fig 61 window Press PARAFFIN MELTING Fig 61 A safety prompt ap pears that you have to confirm with YES In the time window enter the desired de lay time and confirm with OK Fig 62 Change the delay time only if you are absolutely sure that the entered time is correct If the instrument attempts to run a paraffin step with paraffin that is not completely melted substantial faults and malfunctions may result 60 Instructions for Use V 1 4 RevE 03 2013 5 Operation 5 3 Running programs There are two different windows from which a program can be started FAVORITES Fig 63 Up to five favorites can be configured in the ASP200S A FAVORITE is an infiltration program that is used frequently and thus has been assigned to the FAVORITES list All settings have already been programmed and only the number of blocks needs to be entered if this function has been activated Starting a
28. d power socket Do not interfere with the grounding function by using an extension cord without a ground wire Make sure to observe the voltage settings The set voltage CANNOT be changed by the user Severe damage may occur if the instrument is connected to a power supply voltage other than that to which it was originally set The installation location must be well ventilated there should be no ignition sources there of any kind The chemicals to be used in the Leica ASP200 S are both flammable and noxious Do not operate the instrument in rooms with explosion hazard Extreme temperature fluctuations between storage facility and setup site as well as high humidity may cause condensation to form If this is the case wait at least two hours before switching on the instrument Failure to comply with this may cause damage to the instrument 10 Instructions for Use V 1 4 RevE 03 2013 2 Safet 2 2 Warnings continued Warnings Operating the instrument The instrument may only be operated by trained laboratory personnel It must only be operat ed for the purpose of its designated use and according to the instructions contained in these Instructions for Use In an emergency the instrument can be switched off while working with specimens via the ON STOP switch located on the side of the instrument Before opening the retort when an infiltration process is in progress always press the PAUSE button so that the re
29. e connection manifolds at the rear inner wall of the re agent module Failure to correctly plug reagent containers into the manifold will cause an interruption to the processing run and may result in spilling of reagents While the reagent containers are outside of the reagent module wipe the stainless steel inner walls of the reagent module with a damp cloth moistened with a mild detergent Additional cleaning and maintenance tasks to be carried out periodically are listed in the table on the following pages Leica ASP200S 81 7 Cleaning and Maintenance 7 2 2 Periodic cleaning and maintenance continued Cleaning the level sensors e The level sensors must be cleaned of all residues reagents and paraffin after every i cleaning program You will be prompted to clean the sensors by the instrument software at the end of each cleaning program Fig 88 44 Fig 87 Fig 88 Fig 89 Use the cleaning tool together with the microfiber cloth Fig 87 as shown in Fig 89 NEVER use the cleaning tool WITHOUT the accompanying microfiber cloth as other wise the sensors will be scratched The cleaning tool has two different spoons The larger spoon Fig 87 46 is for use with the ASP6025 the smaller Fig 87 47 is for use with the ASP200S ASP300S To prevent damage to the sensors NEVER use the larger spoon for cleaning the sen sors in the ASP200S ASP300S 82 Instructions for Use V 1 4 RevE
30. eeseseesatsess 65 b4 Reagent status cc eceeessessssessesesecsecseseesecseseesusauseesesecseseeseuseseesaesessesauseseesausessusessesaeseesesensatenss 67 SEC UL I os am m mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm mi rr 68 20 TE ONNE NE i mmmmm mm m mrmrmrmrmrmrmrmmmmrmr rr rr rr mr mmvwavrmmamaiirrr rr 69 Troubleshooting mmmmuwwmwmwuewwuwwuvwvwwwvwwwwwvvvvv 10 IE CL 15 0c mmmmmmrmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmicH rmimrmrir eh 70 OL FOWO IUE er N ere en EEE ne eee 70 oS MN T s Ic 9 0 nee ee ee ee eee eee ee eee ee eee 71 6 4 Typical fill or drain problems uu cece cssecsesssssesesscssesessessesessesecsesaeseeseseesessessuseesesaesassesaneeses 72 Cleaning and Maintenmance scssccsssssessessssseeseesssseseseesesaeseeseesesaesssessessnsnsaesnssnsaess 73 Ll GVO GIT WTO OAS mmwwwwewvvewvwwwwwvwvvwuwwewwvwewuvwvvvvv 73 TAA Retortcieaning programs mm 73 Flat WGA IRN CMC iii mmm mmmmmmmmmmmmmmmmmm mmmmmmmmmm mmmmrmmrmmrmmmmmrk 75 FIR SME AN m m mmmmmmwwwwwwwwwwwwwewwwwwvwwwvvw wwwwvvwvvwvvevvvvwvwvwvvvvvmwwvvwwvwvwvwevwvvvwvvvvv 76 12 General cleaning St O10 aristecateen esate ciesaueacerataeiorecesuanecteseidensiatarenterezicnsverecantanmntonnseaetaretaeraewes 11 1 2 1 Daily cleaning and MaINteNaNCe ccccecseesesssssssessssessesecsesecsesaeseeseseeseesesauseesesaesessesaeeesees 19 1 2 2 Periodic cleaning and maintenanCe e enenenenenennrerinnnrirnnnrinnnnrurinn
31. er has been configured for the instrument Leica ASP200 S 63 5 Operation 5 3 2 Starting a program Raat ha EC Fa WFE Le anma Hab Ld Chee Fig 70 Fig 69 e Pressing START starts the program Confirm the prompt that follows with OK The number of blocks to be edited NUMBER OF BLOCKS must be entered if the RMS has been enabled e The FINISH TIME button displays the time when the currently running program will end If events occur that cause the end time to be delayed the end time display here will be updated accordingly e To modify a running program or open the retort to reload specimens see Chap 5 3 3 Opening the retort the program has to be stopped press the PAUSE button All buttons that have changeable functions are acti vated and can be edited To change or delete program steps press EDIT and make the changes in the input window CONTINUE restarts the program e The end time of a running program can be changed only if the li delay step has not yet been completed e You can switch from the graphical to the table display by touching the TABLE and back again with GRAPHICAL 64 Instructions for Use V 1 4 RevE 03 2013 5 Operation 5 3 3 Opening the retort during a program interruption e The signal tone and the 10 second waiting time occur each time the retort is unlocked i For this reason we recommend only locking the retort before starting a program or be
32. erforms Is not applicable at the moment Disabled icons have a thinner border than active ones as shown here If a disabled button is pressed a help text will be displayed explaining why this particular button is disabled 34 Instructions for Use V 1 4 RevE 03 2013 4 Instrument Setu 4 9 Checklist for initial operation e When the instrument is prepared to the point where it can be switched on the menus listed g below have to be opened and the corresponding parameters configured For detailed instructions about the individual parameters refer to the online help Screen display gt Press button s Fig 19 Leica ASP200 S Parameter selection Set warning values for the age of the carbon filter and the operating hours of the pressure air pump Enter the instrument name and select the lan guage Optionally set up the printer Here configure all the parameters as required particularly the wax bath temperature Check that the date and time are correct Enter the desired reagents and the threshold values for the CHANGE REAGENT warning Assign a reagent to each station bottle Fill the reagent containers Remote filling SMART SCREENS Manual filling REAGENT STATUS Create the required programs Both infiltration and cleaning programs can be copied and modified Assign your favorite programs to the Favorites menu and if desired assign the end time and a symbol f
33. ffin cleaning program once a week Run the paraffin cleaning program twice a week Run paraffin clean ing program daily Replace the paraf fin after 6 cleaning cycles Paraffin 2 Run the paraffin cleaning program twice a week Run paraffin clean ing program daily Replace the paraf fin after 6 cleaning cycles Run the paraffin cleaning program once a week Run the paraffin cleaning program twice a week Paraffin 3 Run the paraffin cleaning program once a week Run the paraffin cleaning program twice a week Run paraffin clean ing program daily Replace the paraf fin after 6 cleaning cycles Run the paraffin cleaning program once a week Cleaning xylene Once a week Once a week Once a week Once a week Cleaning alcohol Once a week Once a week Once a week Once a week Cleaning Water Once a week Once a week Paraffin cleaning program see Chap 7 1 2 Leica ASP200 S Once a week Once a week 23 4 Initial Operation 4 1 Installation site requirements e The instrument requires an installation area of approx 650 x 700 mm with vibration free floor e Room temperature consistently between 15 C and 35 C e Relative air humidity maximum 80 non condensing e Avoid vibrations direct sunlight and heavy variations in temperature 4 1 1 Moving the instrument After unpacking the instru
34. for Use V 1 4 RevE 03 2013 3 Instrument Components and Specifications Overview instrument components 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Basic instrument processor module Basic instrument reagent module Wax bath lids Retort lid Monitor Cover flap of the instrument console Instrument console with Printer port Local alarm connection Remote alarm connection Disk drive Serial port Active carbon filter Condensate container Reagent containers 13 units Drip tray Paraffin drain spout Remote drain connection Retort Wax baths Cassette basket Lid for cassette basket Basket carrier Baffle plate Volume replacement body Leica ASP200 S Instrument Components and Accessories Three wax baths and the retort comprise the infiltration module The touchscreen and the electronic components are there The cassettes are stored in two baskets Fig 2 21 each of which holds up to 84 cassettes with dividing spiral or up to 100 cassettes without dividing spiral The specimens are processed in the stainless steel retort at the preselected pressure vacuum and temperature conditions The reagent containers are located in the reagent cabinet 15 3 Instrument Components and Specifications 3 2 16 Specific instrument options Optionally usable Reagent Management System RMS displays service life and
35. g 35 kPa g 70 kPa g 35 kPa g 10 3 4 0 Optional Accessories ON OFF ON OFF ON OFF 16 min 20 min Supervisor Operator alphanumeric freely selectable ON OFF ON OFF Instructions for Use V 1 4 RevE 03 2013 3 Instrument Components and Specifications 3 4 Technical data continued Hardware and Software e Large color LCD touchscreen e User friendly intelligent software e 3 5 disk drive and printer port e Alarm system with two remote alarm sockets e Password protected instrument supervisor mode e Built in multiple specimen protection system Capacities e 15 programs that consist of up to 10 reagent and 3 paraffin processing steps each e Time per program step 0 to 99 h 59 min e Delay time max 7 days e Up to 200 cassettes can be processed simultaneously e 4programmable cleaning programs for the retort e 1 paraffin cleaning program e 10 reagent containers e 3 paraffin reservoirs e 3 containers for cleaning solutions e 1 condensate container e Reagent temperature selectable from 35 C to 55 C or room temperature e Paraffin temperature selectable from 40 C to 65 C e Choice of three retort drain rates of 80 120 or 140 seconds e Upto 100 reagent names in memory 3 5 Compatible reagents Use of the ASP200S is permitted with the reagents specified in Chap 3 5 only These reagents must be validated before use i e tissue processing with patient tissue for diagnost
36. g to recognized standards and regulations with regard to safety technology Operating or handling the instrument incorrectly can place the user or other personnel at risk of injury or can cause damage to the instrument or other property The instrument may be used only as intended and only if all of its safety features are in proper working condition Malfunctions which could impede safety must be remedied immediately e Only original spare parts and permitted original accessories may be used These Instructions for Use includes important information related to the operating safety and maintenance of the instrument The Instructions for Use are an important part of the product and must be read carefully prior to startup and use and must always be kept near the instrument i 2 2 Warnings These Instructions for Use must be ap propriately supplemented as required by the existing regulations on accident prevention and environmental safety in the operator s country This instrument has been built and tested in accordance with the safety requirements for electrical equipment for measurement control and laboratory use To maintain this condition and ensure safe operation the user must observe all notes and warnings contained in these Instructions for Use i For current information about appli cable standards please refer to the CE declaration for the instrument and to our Internet site http www LeicaBios
37. he instrument and display the user interface in the newly selected language Instructions for Use V 1 4 RevE 03 2013 5 Operation Setting the altitude of the installation location in meters above sea level Site Elevation metres Upgrading software Leica ASP200 S A Do not attempt a software upgrade if you do not have all diskettes This is important as it affects the actual pressure in the retort Press SITE ELEVATION meters enter the value in the number field and press OK This parameter in meters must be entered to ensure thatthe ASP200 S makes the appropriate corrections when calculating the proper pressure or vacuum Fig 37 New versions of the ASP200 S operating software are distributed on dis kettes These upgrade packages normally include 2 to 3 diskettes of a package available Read the documentation in the upgrade package to find out how to carry out the upgrade as the included documentation may still contain version specific additional information and to find out if new modified procedures parameters or data are present that have to be loaded or modified for the new software version to run First make a backup copy of the instrument s current data To do so you need an empty formatted diskette Insert the disk marked Disk 1 or similar of the software upgrade into the disk drive Press the UPGRADE SOFTWARE button This is followed by two security
38. ibly DB debarked Tip n Tell indicator to moni tor whether the shipment has been transported and stored in upright position according to your require ments With a pitch of 60 or more the blue quartz sand flows into the arrow shaped indicator window and sticks there permanently Improp er handling of the shipment is immediately detectable and can be proven defini tively 1 Important Information 1 2 Qualification of personnel e The Leica ASP200S may be operated by trained laboratory personnel only e All laboratory personnel designated to oper ate this instrument must read these Instruc tions for Use carefully and must be familiar with all technical features of the instrument before attempting to operate it 1 3 Intended use of instrument The instrument has been designed so that it Is safe to use by the operator as well as for pro cessing specimens provided that it is operated according to the present Operating Manual The Leica ASP200S is a modular automated tissue processor designed for the following laboratory applications e Fixation e Dehydration e Paraffin infiltration of histological tissue specimens The Leica ASP200 S must be operated exclusively with the reagents listed in Chap 3 5 Compatible reagents Any other use of the instrument is con sidered improper Failure to adhere to these instructions may result in an accident personal injury damage to the instrument or acce
39. ica ASP200 S T Fig 9 29 4 Initial Operation 4 5 Anti reflection clip Function The anti reflection clip Order no 140476 44135 prevents any reflections that might otherwise be emitted from the specimen basket 3 order no 14047634193 and that could affect the level sensor in the retort thus causing malfunctions Installing the clip e The anti reflection clips are intended for a installation on the specimen basket to prevent reflections of the level sensor e Insert the left lug 2a of the anti reflection clip 1 into the seventh hole from the left of the lower oval openings Fig 10 e Snap the right lug Fig 11 2b into the seventh hole from the right with gentle pressure e When inserting or removing the metal baskets a into from the retort always do so carefully so that they do not touch or become caught on the retort wall Changing the clip e Once the clip is installed the handle 4 of the speci men basket cannot be removed as otherwise the clip will be bent e o remove or replace a clip all parts that are inside the basket e g spiral insert and separating walls must be removed from the basket e Suitable tool screwdriver 5 Fig 12 Once bent clips may no longer be used and must be disposed of In this case install a new clip from the standard scope of delivery 30 Ins
40. ics by the laboratory itself according to the local or regional accreditation requirements Reagents other than those listed here may cause severe damage to the components of the instrument Acetone benzene chloroform and trichlorethane must NOT be used Leica ASP200S 21 3 Instrument Components and Specifications 3 5 Compatible reagents continued The following reagents may be used in the Leica ASP200S Fixatives Dehydration Clearing Paraffinizing 1st Formalin 1st Ethanol Ist Xylene Ist Wax buffered or 2nd Isopropanol 2nd Toluene unbuffered Methanol 3 Chloroform 2nd Formalin re 4 Butyl alcohol placement 5 Industrial methyl ated spirits Before using these reagents please obtain information from Leica or the supplier about required preventive measures the instrument and shorten instrument life If you choose to work with such fixatives it is essential to perform a clean cycle which con tains multiple water rinses each time after use to minimize damage In addition we recommend frequent and regular preventive maintenance by the Leica Techni cal Service 1 Fixatives containing mercuric salts acetic or picric acid will corrode metallic components in Reagents other than those listed here may damage some components of the instrument Do not use acetone benzene or trichlorethane in the instrument 3 6 Recommended reagent handling e The reagents used should be replaced after 60
41. ilter The arrow must point upwards LEICA PART NO 0476 34150 78 Instructions for Use V 1 4 RevE 03 2013 7 Cleaning and Maintenance 7 2 1 Daily cleaning and maintenance Cleaning the retort lid e Remove wax from the inside of the retort lid with the plastic scraper provided Thoroughly remove all wax deposits from around the lid seal e For convenience the lid may be removed during cleaning Lift the lid to a vertical position release the hinge lock and pull the lid toward you A Only use the plastic scraper provided when cleaning the retort lid and seal to avoid damage to the retort lid seal and to the PTFE coating on the retort lid Do not damage the edges of the seal with the scraper Cleaning the retort e The retort may be wiped clean using a cloth moistened with solvent xylene or alcohol or mild detergent In particular make sure that the air vent holes at the top front of the retort are not dirty Cleaning the retort sieve e Use alcohol or xylene to clean the strainer located at the bottom of the retort For convenience the sieve may be taken out to remove all solid dirt Cleaning the touchscreen e Onthe MENU FUNCTIONS screen press CLEAN TOUCHSCREEN e Clean the touchscreen e Press ENABLE EXIT to enable the BACK button Press BACK to return to MENU FUNCTIONS Leica ASP200S 19 7 Cleaning and Maintenance Cleaning the surface of the infiltration module Important in
42. ions list e Reagent status list e All programs e Run log e Error log Installing the laboratory help For additional information refer to Chap 5 6 The online help 44 Instructions for Use V 1 4 RevE 03 2013 5 Operation 5 1 4 Editing the reagent list Adding new reagents 1 Enter the reagent name and allocate the new reagent to the reagent group It belongs to 2 Determine how many stations bottles work with the new reagent 3 Fill the stations bottles according to the reagent list Entering reagent names Takes place via the REAGENTS menu option You must be logged on at supervisor access level to proceed e From the start screen press MENU in the MENU FUNCTIONS window there press the MORE button e The MORE MENU FUNCTIONS window appears There press the REAGENTS button e The SET UP REAGENTS AND WARNING THRESHOLDS window opens e To add a reagent e Press INSERT to display the keyboard e Enter the new reagent name e Press OK to confirm e You will then automatically be prompted to select the reagent group Fig 41 Allocate the new reagent to the desired group and press OK to confirm Fig 40 Leica ASP200 S 45 5 Operation Allocation of reagents to the correct reagent group is the basis for compatibility monitoring Allocation to the wrong reagent group can lead to reagent cross contamination Changeable parameters Fig 43 46
43. learly hear it click e Hook the other end of the hose into the bulk container that you are emptying or filling Fig 54 While performing a reagent fill drain ensure that the remote fill drain hose ts securely placed in the remote container and is not re moved from the container until the operation is fully completed Finally pressurized air is used to clear the hose after each fill drain so that no dirt remains The hose should therefore not be removed from the bulk container until this cleaning step is complete 56 Instructions for Use V 1 4 RevE 03 2013 5 Operation Status bar displayed in supervisor mode Fig 55 Select station Press button Remite station Drain Station Fetill i Fig 56 Leica ASP200 S Filling draining reagents From the FAVORITES screen press MENU In the MENU FUNCTIONS window tap the SMART SCREEN button The SMART SCREEN Fig 55 pops up The smart screen Is the initial screen for manual operation of the instrument A Status bar The following values are displayed e Pressure and temperature of the retort e Wax bath temperature e Value of the level sensor of the retort e Retort lid closed or open The following steps should only be carried out by trained laboratory personnel experienced in handling reagents Remote draining e Qn the screen select the reagent container No 3 and
44. ment see Unpack ing Instructions on the outside of the transport crate handle it only by the handles marked with to move it to its final location When operating the instrument the brakes on the instrument casters 24 must be engaged The instrument must be set up so that the power switch on the rear side of the instrument Fig 4 42 is easily accessible at any time 24 The chemicals to be used in the Leica ASP200S are both flammable and nox ious The installation site for the Leica ASP200S must be well ventilated and there must be no ignition sources of any kind in the area Never operate the instrument in rooms with an explosion hazard Instructions for Use V 1 4 RevE 03 2013 4 Instrument Setu 4 2 Electrical connection i Severe damage may occur if the in strument is connected to a power sup Notice ply voltage other than that to which it Observe the following instructions was originally set carefully to prevent damage to the The power supply voltage for the instrument refer also to Chap 2 2 instrument is factory preset and Warnings Transport and installa CANNOT be altered by the user tion e Check the voltage label Fig 3 on the rear of the instrument to ensure that the instrument CAUTION Unit wired for 230 240 Vac delivered is set to the correct voltage range Refer changing to qualified service personne Fig 3 4 2
45. mm mmmmmmmmmmmmmmmmmrmrmmmaH 40 51o INSTALLA TON i mmmwwvwwwwvwwewwvwvwvwvwuwvvwvewwwwvvwmwwwwwwvwwvvwwvwewvvwvwvvvv 42 4 Instructions for Use V 1 4 RevE 03 2013 Contents 8 Appe Ae Editing tne reagent i suiii inaa iadair 45 5 1 5 Viewing the program liSt e onenenenennnnnnnsnsnnnsrsnnnsrsrnnsnsrsrnnsrsrnnnnnrnnsnsrnrnrnrsrnrrsrnnnrsrnnnrsrsrnnnnnne 48 5 1 6 Adding and or modifying Programs ccccssssesssscsscsscsssecsessssesseseesessesaesesseseesesaeseseseesaseess 49 aE TVONICS o E EE 52 DLO CME GUI Me sStatlON ommmmmmmwwuwwuwvwwwwwwwwvwuwwwvwwvwwuwvv 54 Sma c 0 810 G01 Co ee ee ee ee ee 55 b2 Reagent Nandling cccssescssescsscssssesecsecseseesesseseesesecsecsessesesseseesessesaesessesausessuseesesaesessesensatenss 56 5 2 1 Draining filling reagents other than paraffin cesccscsssssscscsesssssscscssscsesecscssscseseseseteceesees 56 922 LG I Neparaii m mm weewwwwvevwwwwvwvwvwvvvvwvevvwevwwvwvevvvvvv 58 po RunNNA 91 0 ioc iiimmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmma 61 5 3 1 Editing a program that has been Called Up c ce cceeesssessseesssseesesessesessesesessesesseseesaseees 62 ooa SNT Ni kc eee ee ee en eee ee E 64 5 3 3 Opening the retort during a program interruption ceesesceeesesessssescsecseseseeeseseseeeteneeeans 65 5 3 4 Retort emergency rel aSe cccccccscsscsscsesscssssesecsssscseesessesessessesessusaesessesauseesesessesaes
46. n 12 can only be assigned a cleaning alcohol e Stations 13 and 13 ext can only be assigned cleaning water detergents e Wax baths may only be used for paraffin Instructions for Use V 1 4 RevE 03 2013 5 Operation 5 1 9 Reagent groups In this window Fig 53 the colors used in the graphical program display for each reagent group are displayed Changing the color of a reagent group Leica ASP200 S Highlight the line containing the reagent to be modified Press the COLOR button in the table header the SELECT COLOR window appears Select the color you want and confirm with OK To exit the display without changing any colors select CANCEL The newly configured color will now be used on all stations to represent the reagent 55 5 Operation 5 2 Reagent handling 5 2 1 Draining filling reagents other than paraffin 1 Manually changing the reagents e Remove the appropriate reagent container from the reagent cabinet remove the bottle screw cap e Drain refill the reagent by pouring to from a bulk container Use the included funnel for clean filling e On the REAGENT STATUS screen verify correct allocation and set the reagent container as full 2 Use the Remote Fill Drain features e Connect the hose for remote filling draining as shown in Fig 6 to the connection 7 Important Press the connection of the hose firmly into the holder until you can c
47. n to confirm the reagent is deleted a Please remember that a reagent which is already used in a pro a gram cannot be deleted Fig 44 Adding new reagents to stations Go to SMART SCREEN to remote fill the reagent container from an external bulk container or fill the reagent container manually After filling a bottle manually the bottle must be defined as full To do so follow these steps e Press the MENU icon to call up the MENU FUNCTIONS window e Press the REAGENT STATUS button e Inthe table highlight the reagent that has been manually filled e Press the SET AS FULL button symbol to set the status of the station to ur e Upon activation of the RMS all warning thresholds for the select a ed reagent are automatically reset to 0 Leica ASP200S 47 5 Operation 5 1 5 Viewing the program list ENI This list Fig 45 shows all programs defined in the ASP200S oe roqrams You can create e Up to 15 infiltration programs e 3retort cleaning programs e 1 paraffin cleaning program At supervisor access level Easain Cleaning program T e The program names for the infil pit Glee Pee me tration programs can be edited e New infiltration programs can be added and existing ones can be deleted Fig 45 e Important a New infiltration programs are created by copying an existing pro gram Therefore the list must contain at least one program at all times
48. n wax or removing baskets molten paraffin is hot and may cause burns Also avoid personal contact with paraffin reservoirs and retort walls they can be very hot as well When disposing of spent reagents observe the applicable local regulations and the waste disposal regulations of the company institution in which the instrument is being operated Do not clean reagent containers bottles in a dishwasher the containers are NOT dishwasher proof Warnings Cleaning and maintenance A Switch off the instrument each time before servicing and pull out the power plug Do not clean the instrument with solvents containing acetone or xylene No liquid may be spilled into the internal components of the instrument neither during operation nor during cleaning When using cleaners please comply with the safety instructions of the manufacturer and the laboratory safety regulations Check the condensate container at least once a week and if necessary drain it 12 Instructions for Use V 1 4 RevE 03 2013 2 Safety 23 Safety features on the instrument The Leica ASP200tissue processor is equipped with numerous safety func tions and with sophisticated software control mechanisms These ensure that the specimens remain undamaged in the event of a power failure or other malfunction during the infiltration process and that the infiltration is completed successfully Overpressure protection Overcurrent
49. ncludes the following parts To prevent damage to the instrument or specimens only accessories and spare parts autho rized by Leica may be used 1 Leica ASP200S basic instrument 13 Reagent bottles plastic in the instrument Condensate container plastic in the instrument Collecting vessel in the instrument 3 5 diskette empty affixed to the rear side of the console cover Accessory kit consisting of 1 1 1 1 1 AQ RO a s 3 Basket set ASP200S consisting of 1 Basket handle ASP200 S 1 Basket carrier ASP200 S 2 Plastic baskets with integrated spacers 1 Stainless steel basket cover for the top basket Stirrer Volume replacement body Reagent bottle plastic Set of adhesive bottle labels 24pcs each Funnel Active carbon filter assembly Filling draining hose assembly Paraffin drain hose Paraffin scraper plastic Lubricant for valves and O rings Molykote 111 100 gr Connecting cable power supply Maintenance kit 2 spare covers 9 O rings Baffle plate Single head wrench size 27 Allen key size 3 0 Leica ASP200 S Part No 14 0480 37121 14 0480 37122 14 0476 37350 14 0476 35915 14 0480 43728 14 0480 43577 14 0476 34713 14 0480 43578 14 0476 43569 14 0476 43362 14 0476 43630 14 0480 37127 14 0480 37121 14 0200 43464 14 0476 43631 14 0476 34150 14 0476 34716 14 0476 34721 14 0476 35923 14 0336 35460 14 0411 34604 14 0476 35921 14 04
50. ng program steps To delete a step from a program e Highlight the step you wish to delete e Press CLEAR e Remember that it is not possible to delete a step from a program a containing only one single step Programs must consist of at least one step Leica ASP200S 51 5 Operation 5 1 7 Favorites Up to five favorites can be configured in the ASP200 S Favorites can be programmed so that they e end as soon as possible ASAP or e end ata predefined time 4 Adding modifying a Favorite e Select the program line to be modified e Touch the PROGRAMS button e Select the program you want and press OK to confirm Setting the end time e Press the END TIME button e Inthe input window specify the end time using 24 hour notation Select ASAP if the program is to be terminated without a waiting time e Confirm the end time with OK If an end time is assigned to a Favorite the delay step is prolonged by the program so that the program is terminated at exactly the preselected time 52 Instructions for Use V 1 4 RevE 03 2013 5 Operation Assigning a day for the end time Day If an end time has been assigned to a Favorite program a specific weekday can also be set on which the program is to end e Press the DAY button e Select the desired day from the list and confirm with OK Assigning a symbol to a Favorite A corresponding s
51. nstrument would be possible only under hazard ous operating conditions All processes are recorded in detail in the Run Log To inspect the processes the Run Log file can be opened by pressing the MENU and RUN LOG symbols Power failure during an infiltration program If a power failure occurs during an ongoing infiltration program the Leica ASP200 S calculates the power failure duration into the total dura tion of the step taking place in other words the respective step is not lengthened due to the power failure lf the power failure continues for longer than the remaining duration of the step during which it occurred the Leica ASP200 S does not shorten the following steps If on account of a power failure the paraffin temperature is reduced to the point that the paraffin is no longer suitable for continuing the ongo ing program the Leica ASP200 S builds in a delay time sufficient to bring the paraffin back to a suitable operating temperature before the paraffin step Power failure during a retort or paraffin cleaning program If a retort or paraffin cleaning program is running during a power failure the total program duration Is lengthened by the duration of the power failure This is to make sure that the cleaning results are not impaired Instructions for Use V 1 4 RevE 03 2013 6 Troubleshootin 63 Troubleshooting Leica ASP200 S If a problem occurs in the Leica ASP200 S take the follo
52. ograms can he started up to 6 days in a advance So that the program is ended at the defined date time the delay step is lengthened accordingly Edit Ageptiros Crearaigh T du Sd 27 EE Ce oe T Fig 66 62 Instructions for Use V 1 4 RevE 03 2013 5 Operation Run Options The RUN OPTIONS function displays the options with which the current program Is started LEVEL TEST enabled The lower level sensor in the retort is acti vated The program is stopped with an error message If the level is not reached WAVE MOTION activated During each infiltration step the reagent is periodically pumped from the bottle to the re tort and back to achieve a more evenly mixed blend The first pump step begins after 16 min afterwards regularly after 12 min PRE TEST activated After the program is started the retort is filled and drained with the first reagent in the infil tration program to test whether all lines and valves are unobstructed STIRRER activated The magnetic stirrer is on PRINTER if activated At the end of the program a complete run log covering the entire program execution Is output at the printer a Important g The options set apply for ALL programs running All run options can be deactivated or activated according to requirements while the program is The printer option will be displayed only if a print
53. ol indicates the Environment friendly Use Period of the product The symbol is used if a substance restricted in China is used in excess of the maxi mum permitted limit y Symbol for labeling electrical and elec tronic equipment in accordance with N Section 7 of the German Electrical and Electronic Equipment Act ElektroG Ele ktroG is the law regarding the sale re turn and environmentally sound disposal of electrical and electronic equipment Instructions for Use V 1 4 RevE 03 2013 1 Important Information 1 1 Symbols in the text and their meanings continued SN Serial number REF Order No BH Observe the Instructions for Use E The package contents are fragile and must be handled with care t t Indicates the correct upright position of q the package The package must be kept in a dry en vironment Indicates the temperature range to which the medi cal device can be safely 29 C exposed Minimum 29 C Maximum 50 C 50 C Indicates the air humidity range to which the medical can be safely exposed Minimum 10 Maximum 85 Leica ASP200 S Example of labeling in accordance with IPPC IPPC symbol Country code in accordance with ISO 3166 e g DE for Germany Regional identifier e g HE for Hessen Producer treatment provider code unique assigned number starting with 49 Treatment code e g HT heat treatment MB methyl bromide and poss
54. or 230 to 240 V 50 to 60 Hz 2 melting fuses 20 x 5 mm UL approved e for 100 to 120 V F 10 A 250 VAC e for 230 to 240 VF 5 A 250 VAC 1000 VA 595 x 680 x 1325 approx 160 kg 220 kg 15 C to 35 C 10 to 80 non condensing Protection class 1 Pollution degree 2 Overvoltage installation category II e 800 V impulse 120 V systems e 1500 V impulse 240 V systems 2500 m maximum 30 VDC maximum 2 A 2 terminals Each with isolated switching contact operable both as normally open and normally closed circuit 3 4 3 per container approx 10h 40 to 65 C 1K 19 3 Instrument Components and Specifications 3 4 Technical data continued Retort Capacity Reagent volume Temperature paraffin Temperature processing reagents Temperature cleaning reagents Temperature accuracy Filling time Drain time Impregnation vacuum Infiltration pressure Filling vacuum Draining pressure General Reagent container Cleaning solution bottles Maximum bottle volume Printer Pretest check Fluid level sensor Recirculation pump in out a Time before 1st cycle b Time between cycles System setup Password status Type of password Reagent management system RMS Software interlock 20 max 200 cassettes 3 5 with volume replacement body 40 to 65 C Ambient temperature or 35 to 55 C 50 to 65 C 1K approx 90 sec approx 80 120 140 sec selectable 70 kPa
55. or these programs 35 4 Initial Operation 4 10 Switching off the instrument 36 lf the instrument must be completely switched off or disconnected from the power supply please proceed as follows e Press MENU to switch to the MENU FUNCTIONS window e Press the EXIT APPLICATION button there A message appears stating that all data has been stored and the system Is being shut down Shutdown in Progress Please wait while the system writes unsaved data to the disk Fig 20 Once all data has been stored the following message appears Shutdown Computer Fig 21 You can now switch off the instrument with the ON STOP switch on the right of the instrument and with the ON OFF switch on the rear panel of the instrument Fig 4 42 Pressing the RESTART key restarts the instrument Notice The instrument is allowed to be switched off completely in this way only Otherwise severe damage to the instrument s hardware and loss of data can occur Instructions for Use V 1 4 RevE 03 2013 5 Operation 5 1 Setting up the instrument parameters al gt gt From the start screen press MENU to switch to the MENU FUNCTIONS aes window and press the MORE button there Magra Fii ropiairrg Fig 22 Fig 23 Inthe MORE MENU FUNCTIONS press SYSTEM SETUP The SYSTEM SETUP screen is divided up into five selection fields e Program options e Display
56. ossible to lock the retort during this time eaten e f the retort is locked no signal tone sounds A signal tone sounds for approx 10 seconds wait Fig 14 ing time when attempting to open the retort The retort cannot be opened during this time e After that the FAVORITES screen will be displayed Fig 15 Screen saver e Ascreen saver will turn off the screen display if no key has been pressed for a user programmable time Press any part of the touchscreen to restore the screen After having been restored the on screen func tions will be nonoperational for a few seconds to avoid accidental activation of any keys Fig 15 Instructions for Use V 1 4 RevE 03 2013 4 Instrument Setu Sytem Dingnosics The following functions can be selected 1 Access for service technicians only 2 Displays the INSTALLATION menu 3 Aborts the current program 4 Aborts the current program and deletes the current allocation of reagents to bottles and retort 5 Deletes all reagents and resets programs and instrument status all lists will be empty 6 Saves the current instrument status 7 Displays the results log 8 Restarts the instrument Fig 17 Leica ASP200S SYSTEM DIAGNOSTICS menu lf TOUCH HERE is touched during initialization Fig 14 and the pass word for supervisor mode is en tered the SYSTEM DIAGNOSTICS menu Fig 16 opens This menu provides a
57. ram must be carried out in the ASP200 S To start a smart clean press the SMART CLEAN button on the MORE MENU FUNCTIONS screen and press OK to confirm The smart clean itself takes approx 15 minutes and consists of 3 phases Phase 1 Prior to starting the smart clean make sure all reagent containers are cor rectly inserted and connected All internal tubing is cleaned with compressed air to force any remaining reagents back into the reagent containers Phase 2 Before phase 2 starts the operator is prompted to remove all reagent con tainers from the instrument All internal tubing is again cleaned with compressed air Phase 3 When phase 3 starts the operator is prompted to place an empty container in station 11 The tubing is once again cleaned with pressurized air any remaining re agent residues are forced back into station 11 Empty and clean all reagent containers thoroughly before reinsert ing them into the instrument to make sure there will be no reagent spills from the bottles that could cause damage during transport Instructions for Use V 1 4 RevE 03 2013 7 Cleaning and Maintenance 7 2 General cleaning steps Paraffin reservoirs Work carefully Be careful as the walls of the paraffin reservoirs are very hot and may cause burns e Wipe the paraffin reservoirs and lids clean The lid can be removed for cleaning purposes e f they are dirty remove the wax straine
58. rarirnrnrarnnnrurnrnrnreennrenne 81 7 3 Checklist for preventive maintenance cccesccssesessssssescsesssscscseceesesesssscsecesacsnesarsncesaneners 83 Warranty and SEWN G Grea icagese sess creo saehacude ia si il enbia a eba aia 85 1 4 AE EAE E A AA E EA A A A A E T 86 Notes on Specimen Preparation sacicccasesttecacsscorce staat eueistccnsvetes sedges senitia gatas iaseeecsaceimenteemiaeneSanieente 86 Leica ASP200S 5 1 Important Information 1 1 Symbols in the text and their meanings A i Inflammable solvents and reagents are marked with this symbol A 5 ENTER Warnings appear in a gray box and are marked by a warning triangle Notes i e important user information appear in a gray box and are marked by an information symbol i Instrument surfaces which become hot during operation are marked with this symbol Avoid direct contact with these sur faces they may cause burns Numhers in parentheses refer to item numbers in illustrations Function keys to be pressed on the instrument touchscreen are written in bold print capital letters i Manufacturer In vitro diagnostics IVD medical device C amp This product fulfills the requirements of the Council s Directive 98 79 EC con cerning in vitro diagnostics IVD medi cal devices Environmental protection symbol of the China RoHS directive The number in the symb
59. rs from the paraffin reservoirs Clean dry and reinsert them e Ensure that the air vent hole at the top rear right hand corner is unob structed Instrument exterior Clean the instrument exterior as necessary Wipe with a damp cloth moist ened with mild detergent and dry A Do not use solvents on painted surfaces and or the touchscreen Checking the drip tray Regularly inspect the collecting tray 16 for signs of leaking chemicals Fig 84 Fig 84 Leica ASP200 S 71 7 Cleaning and Maintenance Draining the condensate container e Remove empty and reinsert the blue conden sate container Fig 85 Dispose of waste solvents with care according to local regulations and the waste management policy of the com pany or institution Replacing the active carbon filter e The life of the active carbon filter will depend on the reagent types used and the frequency 13 of vacuum cycles e The filter 13 should be replaced at least every 3 months Fig 86 After replacing the filter open the SMART MONITOR menu to reset the filter age to 0 For additional information refer to Chap 5 5 e Werecommend a smart clean prior to chang ing the filter 3 Filter label e When inserting the new filter make T UIP crance THIS FILTER ON i sure that it is inserted with the cor rect side up as specified on the label on the front side of the f
60. rsecesepcusecessnapeucueiaacseussinaeariineraevotseadesnraaeentiuard aecincaesniiceveancnts 8 IE Aoi YD oeiras aaa E a EA anaes 8 e Sa y o A 9 2i APOC QU e E E T EE 9 P ANN ea T A atapueneiaieaaniens 9 23 Safety features on the INStrUMENL cc ccseesescsessssescsecscsesesscscsesecassesecessesesatsuseseseeseeesanseseten 13 3 Instrument Components and Specifications ccssssseesseseceesesseeeseeeeeeseseeenanseees 14 31 Overview instrument components c ccscssescsessssescsseecsesesececseseeatsusesatseseeassusesarsuseatansnses 14 3 2 Specific instrument options ccccssssescsesecsesessercsesesecscsssecassesesacsnsesacsusesassusecassusesasensesasenseses 16 39 Standard delivery Pel CIN iiimwwwwwvvwwwwvewwvwwwvvvvvvvvvv 17 6 EC Lg r BE ener nr ene RE O Ene OTe Rio eno 19 Se WOM APOE Ie AOU S m m wwwwwwwwvwwwvwwuwwewvvvv 21 3 6 Recommended reagent handling ccccscscscsessssssscsssscsecsecsssessessesessessesecsesseseseesaesessesasses 22 3 0 1 Cyele for changing Fe a CNC sisssiisasesiirensa sisien ene aaaea eerie coon 23 4 Initial Operati0n iieeeceerererr EE THERE HE EH see can ice cdroniatevenec ect rea reietearneman dene 24 41 Installation site reQuir Ment ccccsccesessessssssssssssesscsessesecsessssessesaesesseseusesseseeseseesasseseesatees 24 AT Moving tme IAS Ur mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmr 24 A2 NEC BRE OEIC i jimmmmwwewwwwwwwwmvvmvvvvw
61. ry package Keep the single head wrench near the instrument Approx 45 e urn the retort lock clockwise to the stop at approximately 45 Fig 74 1 and release e Putthe single head wrench in place below the retort lock Fig 75 2 Ensure that the single head wrench is seated securely on the retort lock e Turn the retort lock further clockwise using the sin gle head wrench Fig 75 3 and overcome the stop breaking the retaining pin at the predetermined breaking point Notice A large amount of force is needed to do this Caution Risk of injury Fig 75 Once the stop has been overcome the retort can be opened Fig 76 4 and the samples can be removed and secured The instrument can no longer be operated after the retort has been unlocked using the mechanical emergency unlock Notify a responsible Leica service technician Fig 76 66 Instructions for Use V 1 4 RevE 03 2013 5 Operation b4 Reagent status ES full or empty here Reagent warning messages Ifthe RMS is active warning messages are out put if reagents are used for too long The output of the warning messages can take place after up to 3 criteria for normal reagents and after up to 6 criteria for paraffins Warning messages are displayed at the end of a cleaning program Then you can s
62. ses 1 There is insufficient reagent e Verify that the fill level of the reagent containers and the paraffin reservoirs is sufficient 2 Insufficient pressure or vacuum The instrument is unable to create sufficient vacuum for a fill or pres sure for a drain in the retort e Verify that the reagent container in question Is correctly inserted in the reagent cabinet e Verify that all reagent containers are fully pushed home into their sockets e Check whether there is some debris under the retort lid seal caus ing a leak 3 There is a blockage in the air or reagent lines Blockages in the reagent lines are typically caused by paraffin or tis sue debris If there is reagent in the retort that cannot be drained try to remove the blockage as follows e Heat the retort to the maximum possible temperature consistent with the reagent currently in the retort if any Leave the retort at this temperature for at least 15 minutes e While the retort is at maximum temperature attempt to fill or drain e f there is no reagent in the retort Run the extended retort cleaning program Use the maximum set tings for number of clean cycles and temperature consistent with the type of reagents solvents used in the clean program e lf you cannot eliminate the problem by carrying out the above list a ed steps call Leica Technical Service before attempting to run any further programs Instructions for Use V 1 4 RevE
63. ssible as long as the screen saver Is active Fig 32 Entry keyboard The keyboard is displayed any time text needs to be entered e The keyboard headline 1 tells you what kind of text to enter e 30 characters can be entered into each entry field though sometimes not all characters entered can be displayed Important keys Shift To shift to upper case symbols AltGr Permits the entry of special char acters lt Deletes the previous character Delete Deletes the entire line Leica ASP200 S 41 5 Operation 5 1 3 INSTALLATION menu T E BH 1 Fig 34 BBD Bobo NE m Pe Se 810 0 0 0 5 0010 oOo oon oa Dn a SUL tLe le IL ILL a es Fig 35 Press INSTRUMENT NAME to display the key board Enter a name 20 characters maximum for the instrument The instrument name is also displayed on the FAVORITES screen 42 Use this menu to set the name of the instrument the language of the user interface and configure a connected printer The serial number of the instrument and the cur rent software version are entered at the factory and cannot be edited Select a language Press the LANGUAGE key the SELECT THE LANGUAGE selection menu appears Select the desired language there and press OK 4 Fig 36 A message box will prompt you to restart the instrument in order to display the user interface in the selected language Press YES to restart t
64. ssloch Germany Phone 49 6224 143 0 Fax 49 6224 143 268 Internet http www LeicaBlosystems com Leica ASP200 S These are determined only by the contract provisions agreed between ourselves and our customers Leica reserves the right to change technical specifications as well as manufacturing process es without prior notice Only in this way is it pos sible to continuously improve the technology and manufacturing techniques used in our products This documentation is protected under copyright laws All copyrights to this documentation are held by Leica Biosystems Nussloch GmbH Any reproduction of text and illustrations or of any parts thereof by means of print photocopy microfiche web cam or other methods including any electronic systems and media re quires express prior permission in writing by Leica Biosystems Nussloch GmbH For the instrument serial number and year of manufacture please refer to the name plate at the back of the instrument Leica Biosystems Nussloch GmbH Contents 1 important Information a ecsseseeseeseseeeeseeeseeseeeeeeaeseneeaeeseneeaenenesaeaeseneeaesesenenaeeeness 6 1 1 Symbols in the text and their ME ANINGS cscscescescssssssssecsescssercseseceeseseersassesecatsesesarsuseeateees 6 1 2 Qualification Of personnel ccccccssesesessssesesssssscsesececsesesecseseseescsesesassesesacsesesarsesesatsusesassusesasones 8 183 Intended use of ISU UNMET cieccctncss
65. ssory equipment Proper and intended use includes compliance with all inspection and maintenance instructions along with the observance of all instructions in the Instructions for Use A 1 4 Instrument type All information provided in these Instructions for Use applies only to the instrument type indicated on the cover page A nameplate indicating the instrument serial number is attached to the rear side of the in strument The serial number is also displayed above the loading door on the front side of the instrument Fig 1 Fig 1 is provided as an example only and shows a valid nameplate for this instrument with the necessary in formation about instrument type and power requirement The precise data for the various versions is specified in Chap 3 2 Technical data Instructions for Use V 1 4 RevE 03 2013 2 Safety 2 1 Safety notes A other Leica products and access its internal components Residual risks e The safety and caution notes in this chapter must be observed at all times e Be sure to read these notes even if you are already familiar with the operation and use of e The protective devices located on the instrument and the accessories must not be removed or modified Only qualified service personnel authorized by Leica may repair the instrument e The instrument has been designed and constructed with the latest state of the art technol ogy and accordin
66. t containers from the inside if necessary Make sure that the shutter caps of the reagent containers and the O rings fit cor rectly and are tight Check that the reagent containers are fitted securely in the ports 84 Instructions for Use V 1 4 RevE 03 2013 8 Warranty and Service Warranty Service information Leica Biosystems Nussloch GmbH guarantees that the contractual product delivered has been subjected to a comprehensive quality control proce dure based on the Leica in house testing standards and that the product is faultless and complies with all technical specifications and or agreed characteristics warranted The scope of the warranty is based on the content of the concluded agree ment The warranty terms of your Leica sales organization or the organiza tion from which you have purchased the contractual product shall apply exclusively If you are in need of technical customer support or spare parts please contact your Leica representative or the Leica dealer where you purchased the instrument Please provide the following information e Model name and serial number of the instrument e Location of the instrument and name of a contact person e Reason for the service call e The date of delivery Decommissioning and disposal Leica ASP200 S The instrument or parts of the instrument must be disposed of according to existing applicable local regulations 85 Appendix 1
67. t with the cleaning alcohol step Editing steps 74 To edit a program step highlight the corresponding line and press the respective table header To disable a step set the number of cycles to 0 Only cleaning water steps can be disabled The following characteristics of each step can be edited 1 The finish times of clean programs cannot be edited Program duration is calculated auto Reagent name only those reagents that are compatible with the reagent station being edited will be displayed Number of cycles the duration displayed is calculated based on the number of cycles Retort temperature temperatures from 50 to 65 C can be set matically based on the number of cycles set Station 13 ext The designation 13 ext is used for an additional station that can be used in place of the standard station 13 Station no 13 always contains cleaning water For some applications it is desirable to use a cleaning water agent mixture between the cleaning alcohol and the cleaning water If a program contains the step Station 13 ext the operator is prompted to insert the reagent container 13 ext at the required point in time during the cleaning program then to remove it once It is no longer used e The station 13 ext can be assigned exclusively to reagents from the cleaning water a group It may only be used for cleaning programs Instructions for Use V 1 4 RevE 03 2013 7 Cleaning and Maintenance
68. the receptacle External Then press STATION DRAIN e Check that no reagent has leaked Remote filling e Qn the screen select an empty reagent container No 3 and the external receptacle External Then press the STATION REFILL button e The remote filling should be completed in less than 170 seconds Check that no reagent has leaked 57 5 Operation 5 2 2 Replacing the paraffin Draining the paraffin e Connect the paraffin drain hose 36 to the spout 17 of the paraffin drain at the front of 17 the instrument Fig 57 and into a catch tank When connecting the hose be sure to press it onto the O rings of the drain opening as far as it will go The paraffin drain hose must be securely hooked into the external re ceptacle and remain there through the entire drainage process When drainage is finished the hose is cleaned automatically using air Do not remove the hose from the exter nal receptacle until this cleaning step 36 is complete Fig 57 From FAVORITES call up the SMART SCREEN screen see previous chapter e Select the paraffin reservoir to be emptied and the receptacle External Fig 58 Then press STATION DRAIN e This ts followed by multiple security prompts that you have to confirm individually in order to continue Waxih f Fees Staton Brain Fig 58 58 Instructions for Use V 1 4 RevE 03 2013 5 Operation
69. tort is ventilated or vented The paraffin drain hose and the hose for remote filling draining are cleaned with compressed air after the filling or draining process Therefore never remove the hoses before a filling or draining process has been completed After refilling replacing reagent containers close the container covers again tightly The reagent containers must be properly pushed home into the connection manifolds at the rear inner wall of the reagent module Failure to plug the reagent containers into the manifold correctly will interrupt the infiltration process and may also result in spilling of reagents Fixing solutions that contain mercury salts acetic acid or picric acid can Cause corrosion on metal components After each paraffin step a retort clean cycle must be run Alternatively they can be downloaded from the following website 3 Material safety data sheets can be obtained from the supplier of the chemicals http www msdsonline com Leica ASP200S 11 2 Safet 2 2 Warnings continued Warnings Handling reagents Take care when handling solvents Always wear rubber gloves and safety goggles when handling the chemicals used in this instrument Reagents used for tissue infiltration can be both toxic and or flammable To prevent damage to the instrument use only the reagents listed in Chap 3 5 Do not use acetone benzene or trichlorethane Use caution when handling paraffi
70. tructions for Use V 1 4 RevE 03 2013 4 Instrument Setu 4 6 Alarm functions The Leica ASP200S is equipped with 3 different alarm functions Instrument alarm This instrument alarm is generated from within the instrument itself for all alarm messages Local alarm This alarm is external to the Leica ASP200S e g in the office of the instrument operator The local alarm is used when the instrument cannot continue with the current program or operation because of a problem Connect the alarm system optional If required connect the local or remote alarm system to the appropriate sockets 34 6 3 mm to the jacks provided for this purpose Fig 9 9 10 socket 9 Remote alarm socket 10 Local alarm Fig 13 Leica ASP200 S Remote alarm This alarm is also external to the Leica ASP200S If installed tt might typically be connected to a remote dialer that sends an automated phone message to the person responsible for after hours problems The remote alarm is only generated when the instrument cannot continue with an infiltration program Note that if installed the remote alarm will still operate even if the local alarm is not installed Both local and remote alarm options are relays that are voltage isolated from the rest of the instrument When an error condition occurs the relevant alarm circuit closes The remote alarm device connected to the instrument must be
71. urs AGE OF THE CARBON FILTER Displays the operating hours of the active carbon filter The configured warning value determines the triggering of a warning message The carbon filter must be replaced after approx 3 months Fig 78 After replacing the filter press the CLEAR button to set the age to 0 ROTARY VALVE RETRIES Provides information about the status of the rotary valve If the number specified there exceeds 50 maintenance is recommended FILL DRAIN The table shows the measured fill ing and drain times of all stations in seconds as average values Short term the last 5 operations Long term the last 20 operations The values are usually different but should not have any extremes If one of the values is signifi cantly above 250 contact Leica Service There could be a blockage which in a worst case scenario could cause the instrument to malfunction Fig 79 68 Instructions for Use V 1 4 RevE 03 2013 5 Operation 5 6 The online help The Leica ASP200S has an extensive help system that can be started from every main window To obtain information about basic problems you can use the Help index which ts called up in the Help window using the INDEX key The help topics are called up in the index according to the hyperlink principle ASP3003 help index semag LD Ure Mauren ARPS irp iapa Access contro To scroll in the help window Aeria usar profiles in che
72. vvvvvvv 25 4 2 1 Connecting the power SuUpplY se ssssrsrsesensresrersrrerurennnrursnnnnunsnrarnrnnnnnsnnnrunnnnnnnnunnnnnnrennnnsnnnnnno 25 4 2 2 Connecting an uninterruptible power supply UPS cee seesessessesssseesseestessetesneetetseen 26 4S WS CANNING IRHc m m mmm m m m m wwwwvwewvwvwwmwwvwwvwvvvwv 27 44 Making the data COMMS EONS ss scsscigascectussantetieecinicerintetsnasatindetsnecstaisadeneiiaseciganeudsininerertanaiaeinds 29 45 Anti reflection clip Function c cc cecseseesesseessessesesecssesesecsecaesessesaesesseseesesseseesesoesatsesensatees 30 46 Alarm FUNCTIONS cceeessesescesecesecseesesecsesaeseeseseeseeseseesesessaasesoesaesessusaesessusausesaesauseseesatseeaesanaes 31 41 SCI SW Ser TIE ON a is easa sad naan 32 AS OUCNSCTEEN MUNOUONS mmwwwwwwwwvwwawwwwvwwwewwewwwwvwvwvv 34 49 Checklistfor initial operatio racasnesestaciesgcsesarcnsevessrscstzeneaeeiterdvenieaianstateatenunigeanenreasaeaenaes 35 4 10 Switching off the instrUMent ccesscsessssessssescseseseescsseecsesesecacsesecassesecacsesecassusesarsnseeatenseses 36 5 Operation sssessssssessssssssesennnnennsunnnnnnnnnnnnnnnnnnnnnnnunnnnnnnnnnnnnnnnnnnnnannnnnnnnnnnunnnnnnnennn anann annnn ennenen nna 37 5 1 Setting up the instrument parameters cecescesescsessssesesscecsesesecseeeessesesessesesesseeeesanseseeens 37 Sl System seip mmwwvwvwwevvvwvwwvwevvvvwawwvvvv 37 SZ ACCESS OV CNS mmmmmmmmmmmmmmmmmmmmmmmm
73. wing steps to diag nose the problem 1 Use the SMART SCREEN functions to individually test operations Check for error messages indicating the nature of the problem If an error message Is displayed press the Help button on the message for any information relating to the cause Check the Run Log for any messages that indicate the nature of the fail ure If the failure occurred during a program run check the Run Log for an indication of whether the failure occurred during the fill processing or drain cycles and the reagent container in use at the time such as fill drain pressurizing and evacuation operations Power failures lf there is evidence of power to the instrument Verify that the power plug Is plugged into the socket and that the socket is switched ON Check whether the bridge cable is plugged in properly Verify that the power switches on the rear of the instrument adjacent to the power lead and on the side of the instrument are both switched ON Messages Indicating that there has been a partial power failure indicate that power has been lost to the heaters but not to the main control elec tronics Carry out the above steps to identify the nature of the problem 1 If you cannot identify the problem by carrying out the above listed steps call Leica Technical Service 71 6 Troubleshooting 64 Typical fill or drain problems 72 Fill and drain problems may be due to several cau
74. witch directly to the REAGENT STATUS display Warning messages also appear with a yellow background in the windows in which programs are started Leica ASP200 S This window Fig 77 is used to display and update the current reagent status of the stations In addition reagent stations can be marked as The following is displayed e The current age of each reagent e The current status of each station e Criteria that trigger warning mes sages fields highlighted in red To change the status of a reagent highlight the corresponding row and press the button symbol for the re spective action In addition you can switch directly to the REAGENTS and STATIONS windows to make current changes Fig 77 The criteria for warning messages For normal reagents it is the number of the fol lowing since the last reagent change e Edited blocks e Run programs e Days passed For paraffins warning messages can also be output according to the number of the following since the last paraffin cleaning e Edited blocks e Run programs e Days passed 67 5 Operation 5 5 System monitor The SYSTEM MONITOR function provides important infor mation about the status of the Leica ASP200S PUMP AGE Indication of the operating hours of the pressure vacuum pump The configured warning value determines the triggering of a warning message The pump must be maintained by Leica Service after approx 1000 operating ho
75. ymbol is displayed which helps the operator recognize a certain program e Press the ICON key in the table header e Select the symbol you want and press OK to confirm e The first symbol in the list is empty you can select this option if a you do not want any symbol Deleting a Favorite e Highlight a program to be deleted e Touch the CLEAR button symbol The highlighted program will be deleted without a security prompt The Favorite will only be removed from the FAVORITES list the program itself will not be deleted Leica ASP200S 53 5 Operation 5 1 8 Configuring the stations This window Fig 52 shows a list of all stations with the allocated reagents defined in the instrument a i bhanna Hyianah aera whet beamng Etharcl Beattie I Eer Waa Death iT Was Bah ig Adding changing a reagent Select the desired station Either by pressing the reagent name or using the UP DOWN buttons e Touch the REAGENT NAME button e The SELECT REAGENT field appears Only those reagents that are compat ible with the selected station will be offered for selection i e Highlight the reagent you want and confirm your selection with OK 54 Fig 52 Allocation of the reagents e Stations 1 10 can only be assigned specimen processing reagents other than paraffin e Station 11 can only be assigned a cleaning solvent e Statio
76. ystems com The safety devices installed in this instrument by the manufacturer only constitute the basis for accident prevention Operating the instrument safely is above all the responsibility of the owner as well as the designated personnel who operate service or repair the instrument To ensure trouble free operation of the instrument be sure to comply with the following instruc tions and warnings Leica ASP200 S 2 Safet 2 2 Warnings continued Warnings Markings on the instrument itself instructions as defined in these Instructions for Use must be followed when operating or re placing the item marked Failure to adhere to these instructions may result in an accident per sonal injury damage to the instrument or accessory equipment i Some instrument surfaces become hot during operation They are marked with this A Markings on the instrument showing the warning triangle indicate that the correct operating warning label Touching these surfaces may cause burns Transport and Installation Once unpacked the instrument may be transported only in an upright position Follow the unpacking instructions carefully to avoid damage to the instrument Prior to every transport in which it is possible for the instrument to be shaken tilted or lifted it must be cleaned for transport otherwise the interior of the instrument can be severely damaged Plug the instrument only into a grounde

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