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Leica PELORIS and Leica PELORIS II User Manual

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1. X EX uERUCROR ARX Tet o ERR UC RS ORAT UAR 148 9 3 Reprocessing Recommendations ns 149 10 Consumables and Accessories 153 L Specifications 5e eua con b 154 WING OK om R A A aka A a A bar s b 156 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 16 Introduction The Leica Peloris rapid tissue processor is a dual retort tissue processor that offers fast high quality tissue processing for histology laboratories With reagent capacity sufficient to run the two retorts independently it allows a high degree of scheduling flexibility Intelligent software lets you configure the instrument to suit your laboratory s workflows while providing checks and restrictions that help you avoid mistakes that could damage tissue The reagent management system closely tracks reagent condition Depending on your setup it uses this information to select the optimal reagent for each protocol step It alerts you when to replace reagent so that quality is never compromised at the same time ensuring you get full use of all reagents The clear intuitive touch screen interface makes loading and monitoring runs easy and protocol configuration reagent setup and other system settings are equally straightforward And behind all this you have the support of Leica Microsystems with years of experience developing top quality industry leading histolo
2. For instructions on returning to the internal carbon filter system see Returning to the Internal Filter System Some instruments do not have the vapor select valve fitted Hovvever your service representative can easily connect these instruments to an external vapor system Connecting to an External System VVARNI NG VVhen the vapor select valve is in the external position you must ensure an external vapor system is correctly installed or potentially dangerous fumes will be released into the laboratory environment Use the following procedure to connect the instrument to an external vapor system 1 Connect the instrument s vapor outlet into the external system see item 2 in Figure 18 2 Turn the vapor select valve a quarter turn anticlockwise to direct vapors to the vapor outlet see Figure 19 Note to access the valve you may need to remove a blanking plug e AVA Figure 19 Vapor select valve in the external system position 3 Set the carbon filter threshold to one of the follovving options i The inspection interval for the external system see 6 2 1 Instrument Settings ii The maximum value 1000 to limit the number of unwanted warnings see 6 2 1 Instrument Settings iii Overridden contact your service representative to arrange this setting Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 36 Hardware Returning to the I nternal Filter System WARNING LA When th
3. Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 118 Cleaning and Maintenance If the retort has a build up of salt precipitate from formalin or other fixatives that you cannot remove by wiping run a retort acid clean 7 5 Retort Acid Clean Check Reagent Levels Ensure that all reagent bottles and wax chambers are filled to the two or three basket level depending on the reagent fill level setting for your instrument on the Instrument settings screen Add more reagent or wax if required see 5 4 Replacing Reagents Clean Top Surface Use a lint free cloth with 70 alcohol and if necessary the plastic scraper to clean the lids and other surfaces on the top of the instrument Ensure all wax is removed Take special care that wax does not go down the wax bath vent see Figure 63 Clean Touch screen Wipe the touch screen or touch screen protector with a lint free cloth moistened with 70 alcohol Replace the touch screen protector if using if necessary Lock the touch screen before cleaning see 6 2 2 Device Settings Never use abrasive cleaners or strong solvents on the touch screen Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 119 7 3 Cleaning and Maintenance Weekly Tasks Empty Condensate Bottle Empty the condensate bottle weekly This is especially important if running xylene free protocols which have more condensate Check Reagent Bottles
4. Reagent Setup 12 The instrument will now fill the bottle s via the selected retort The fill volume is determined by the reagent fill level set in the Instrument settings screen see 6 2 1 Instrument Settings Monitor the fill progress in the status panel When finished the retort will have an Empty state and the bottle will have a Full state At any time during the drain or fill you can tap the Abandon button to terminate all current and pending fill drain operations If you abandon a drain such that both the retort and bottle are left partially full you must drain the retort back to the original bottle to continue To drain the retort deselect the Remote icon then tap the Drain retort button VVARNI NG A Do not open a retort while it is being used for a remote fill or drain operation as the retort could be pressurized and may contain hot reagent and fumes Allow the fill or drain to complete or abandon the process before opening the retort Remote Fill and Drain Sequences The following reagent sequences are recommended when filling and draining multiple bottles Order Drain sequence Fill sequence 1 Fixatives Cleaning solvents 2 Cleaning alcohols Clearers 3 Dehydrants Defatting solvents 4 Defatting alcohols Defatting alcohols 5 Defatting solvents Cleaning alcohols 6 Cleaning solvents Dehydrants 7 Clearers Fixatives Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty
5. e Pin 1 normally open is connected to Pin 3 common e Pin 2 normally closed is open Figure 24 Alarm pins in alarm state Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 39 Running Protocols This chapter describes how to run protocols on the Peloris system The first section gives all the steps to run a protocol once reagents and protocols have been configured The second describes cleaning protocols and the third describes the Status screen where you control and monitor processing The fourth and fifth sections give details about modifying or pausing protocol runs The sixth section discusses general issues about scheduling protocols e 3 1 Quick Start Running a Protocol e 3 2 Cleaning Protocols e 3 3 Status Screen 3 4 Protocol Run Options e 3 5 Pausing and Abandoning Protocols e 3 6 Retort Scheduling 3 1 Quick Start Running a Protocol Follow the instructions below to run a protocol Before you begin all the reagents you need must be configured and there must be a validated protocol ready to load See 5 3 Managing Reagent Stations and 4 2 Creating Editing and Viewing Protocols for direction on these topics Instrument Checks and Setup 1 Onthe screen tap the Status button to view the Status screen i Check that the retort icon shows the retort is clean or has residue of a reagent compatible with the first reagent of the protocol ii Check for hatched bottl
6. Leica PELORIS Leica PELORIS Il Rapid Tissue Processor User Manual Living up to Life deica MICROSYSTEMS Legal Notices Intended Use Statement The Peloris dual retort rapid tissue processor prepares tissue samples for sectioning by transforming fixed samples into wax embedded samples This is achieved by exposing the tissue samples to a sequence of reagents in the processing retorts Trademarks Leica and the Leica logo are registered trademarks of Leica Microsystems IR GmbH and used under license PELORIS PELORIS II Waxsol Parablocks ActivFlo and RemoteCare are trademarks of Leica Biosystems Melbourne Pty Ltd ACN 008 582 401 Other trademarks are the property of their owners Copyright Leica Biosystems Melbourne Pty Ltd owns the copyright on this document and any associated software Leica Biosystems Melbourne is part of the Leica Microsystems group of companies Under law our written permission is required before either the documentation or the software is copied reproduced translated or converted to electronic or other machine readable form in whole or in part Doc 26 7501 500 Rev K Leica Biosystems Melbourne Pty Ltd 2011 Manufacturer Leica Biosystems Melbourne Pty Ltd 495 Blackburn Rd Mt Waverley VIC 3149 Australia Important Information for All Users Persons operating the Peloris tissue processor MUST e Follow the instructions for use exactly as described in this user manual Any deviation fro
7. Reagent change Final reagent thresholds thresholds Max temperatures C Type Conc Cassettes Conc 90 Cassettes Ambient Vacuum Safe or cycles or cycles Formalin 1500 cass 60 45 85 ethanol 55 45 80 20 ethanol IPA 51 45 4500 cass 95 55 45 Wax 4500 cass 95 100 77 Cleaning Waxsol i 6 cycles 100 45 Cleaning ethanol 6 cycles 51 45 This differs from the recommendation for cleaning ethanol in xylene processing because the cleaning solvent in xylene free protocols is less efficient than the cleaning solvent in xylene protocols Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 125 Reference 8 2 Protocols The protocols in this section have been developed and extensively tested by Leica Microsystems for use on the Peloris tissue processor Some are included as pre defined protocols with all Peloris systems When used for the recommended tissue types the protocols all produce optimum processing quality with consistent high quality results Use these protocols and the suggested station configurations see 8 3 Station Configurations as a reference point when developing protocols that suit your specific requirements and practices This section has the following subsections e 8 2 1 Specimen Type and Protocol Duration 8 2 2 List of Pre defined Protocols e 8 2 3 Xylene Protocols e 8 2 4 Xylene free Protocols 8 2
8. Reagent type names do not affect reagent concentration For example when assigning a reagent O type called Ethanol 70 to a station the initial concentration value would be the type s default value probably 70 but you could set the initial concentration to anything between 0 and 100 Stations The Peloris tissue processor has 20 reagent stations the 16 reagent bottles and the 4 wax chambers Each station has the following properties e The reagent type that the station contains e The concentration of the reagent in the station as calculated by the Peloris system e The station s use history number of cassettes processed with the reagent in the station number of runs cycles processed with the reagent in the station number of days the reagent has been in the station e The station s state Diy the station has been completely drained leaving only a small amount of residue It can be filled with any reagent Empty reagent has been removed from the station to fill a retort Reagent in excess of the amount needed to fill the retort remains in the station In use a reagent transfer is in progress or has been abandoned Full the station holds enough reagent to fill a retort Not molten for wax chambers only the state to set when adding solid wax see 5 4 5 Replacing Wax For wax chambers only the chamber s current temperature Use the Reagent stations management screen
9. User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 105 6 2 3 6 2 4 Settings amp Ancillary Operations Color Schemes There are two software color schemes one lighter and one darker Select the better color scheme for the lighting conditions in your laboratory e To change the color scheme tap the cell beside Color scheme in the Color schemes table on the Device settings screen Select Original blue or Dark blue Screen Lock Use the screen lock function on the device settings screen to lock the touch screen for cleaning To lock the screen tap the Lock for cleaning button The Clean screen dialog box opens you can safely clean the screen without accidentally selecting any controls while this is open When finished cleaning tap the Clean screen buttons in the correct order to unlock the screen and return to normal operation Service Settings Use the Service settings screen Control menu Service settings to view instrument and software information The unit information area shows the instrument name location model and serial number Supervisors can change the instrument name other values are read only The software area displays the current software firmware and translation version numbers The software version may be needed when reporting a fault Event Log The event log Control menu Event log displays a history of system events You can sort the events by time or by frequency and you can a
10. contains hot reagent Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 100 Settings amp Ancillary Operations 6 1 2 Reagent Management Use the Reagent management screen Reagents menu Management to set the default number of cassettes per run and default carryover setting per run to turn wax cleaning on and off and to set wax standby and melting temperatures Supervisor access is required A range of other configuration settings can be viewed but not changed contact customer support to change any of these The screen also displays the state of each retort and the last reagent in each retort Controls on the Reagent management screen are described below grouped by section General e Conc Management view only the method the system uses to assign concentration values to reagent bottles see 5 1 2 Concentration Management e Prompt for number of cassettes view only under the default enabled setting Peloris prompts you to enter the number of cassettes before each run When the function is disabled the system assumes that each run processes the default number of cassettes see below e Default number of cassettes set the default number of cassettes for each processing run If Prompt for number of cassettes is enabled the prompt dialog box opens before each run showing this number of cassettes to accept or change If Prompt for number of cassettes is disabled then the system us
11. d D b 3 8L 1US gal min 5L 1 32US gal max Paraffin wax stations 4 each station is capable of filling one retort Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 154 Specifications Environmental Maximum ambient temperature eee nennen nennen nennen nnn nnne nnn nnn nnn 35 C Minimum ambient temperature nnn nnn nnn nnn nnn nnne nnn nnn 5 C Humidity noncondensing s s nennen nnnm nnne nnn nnn nnn nnns 10 to 8096 RH Altit de 2 5 Eee eet tene iia 0 to 2000 m above sea level Sound pressure level output at 1 m 65 dB Maximum heating energy output 1450 W 100 to 120 V 2150 W 220 to 240 V Electrical Operating Voltage piar ae pee etc p e P aaa 100 to 120V 220 to 240 Vw Operating current MAXIMUM 15 A 100 to 120V 10 A 220 to 240 V Mains frequency oi A 50 60 Hz 100 to 120 V 50 Hz 220 to 240 V Power consumption aran 1450 W 100 to 120V 2150 W 220 to 240 V Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 155 Index A abandoning protocols 54 access level 22 setting 108 accessories 153 acid clean for retort 123 active reagent types 80 alarms 107 connections 38 power off setting 105 arch
12. detail files Instrument condition files are automatically transferred with service logs and event details 1 Attach a USB device to the instrument see Attach or Remove a USB Key above 2 Configure the Transfer configuration files and event summaries section of the File transfer screen as described below depending on the types of files you want to transfer Event details select to transfer detailed event files Service logs A M select to transfer service log files Incident report Period up to incident date select to transfer files All files from this number of days before an incident 7 11 2009 Incident date enter the date of the incident for which the log and or details information is required Estimate size aay Transfer files transfer files when you have finished configuration Transfer files Figure 60 Transfer configuration files and event summaries section of Transfer files screen transfer instrument condition files do not tap any of the additional file type buttons Service logs Event details or I ncident report Go straight to the Transfer files button next step To transfer service logs tap Service logs and set an incident date Check the Event log screen to identify when the event you are interested in occurred Select whether to transfer all service logs up to that date or logs for three or one days preceding the date Leica PELORIS User Manual Rev
13. sound for these events For example a sound can be set for key touches on the touch screen or to accompany a prompt dialog box or warning There is also volume control for all instrument sounds e To change the sound associated with an event type tap the cell beside the event type in the Sound settings table Select a sound file in the Select sound file dialog box then tap OK Select no sound to have no sound for the event type To hear a sound in the Select sound file select it then tap Play To change sound volume tap the cell beside Master volume in the Sound settings table Set a value between 100 loudest and 0 silent Touch screen Settings All users can change the brightness of the touch screen on the Device settings screen Tap the the cell beside Brightness in the Touch screen settings table then enter the required value from 0 dimmest to 100 brightest The default value is 70 Alarm Power Off Settings Use the alarm power off settings on the Device settings screen to control the behavior of the external LOCAL ALARM and REMOTE ALARM see 2 7 Alarm Connections in the event of a power failure If the power off state is set to Enabled the alarm will activate sound if there is a power failure To change the setting tap the cell beside Local alarm or Remote alarm in the Alarm power off settings table then OK in the dialog box You require supervisor level access to alter these settings Leica PELORIS
14. 5 3 Managing Reagent Stations The Peloris processor has 20 stations 16 reagent bottles and four wax chambers You must set the stations in the software to the reagent types loaded on the instrument Once this is done the system tracks each station s use history the numbers of runs and cassettes processed and number of days loaded on the instrument current concentration and for wax chambers the current temperature See Stations in 5 1 1 Reagent Groups Types and Stations for further details Supervisors can set the reagent type for each station and change concentration values if they know that actual concentrations are different from those in the system Both supervisors and operators can change station states if required The use history details can only be viewed It is essential for safe operation of the Peloris that there are bottles loaded into all bays in the reagent cabinet If you do not wish to use a particular station set its state to Dry and for non wax stations insert an empty bottle into the station s reagent cabinet location The choice of which reagent types to load on the instrument and how many bottles of each is an important question that you must decide along with consideration of the protocols you run See 8 3 Station Configurations for configurations suitable for the default protocols 5 3 1 Reagent Stations Screen Use the Reagent stations screen Reagents menu Stations to set up and manage reagent sta
15. 5 Cleaning Protocol 8 2 1 Specimen Type and Protocol Duration The following table lists recommended protocol durations for different specimen types Duration Maximum tissue hours dimensions mm Specimen type 1 1 5 Endoscopies and needle biopsies 2 3 All biopsies up to 3 mm diameter gastrointestinal biopsies renal prostatic hepatic and breast cores punch biopsies of skin small colonic polyps 4 3 Small specimens of non dense tissues e g kidney liver bowel excisional and incisional skin biopsies skin ellipses 6 15x 10x3 All routine tissues up to maximum dimensions excluding fatty or brain specimens 8 15x10x4 All routine tissues up to maximum dimensions excluding fatty or brain specimens 12 20x10x5 All routine tissues up to maximum dimensions Very thick fatty specimens may require a longer protocol 8 2 2 List of Pre defined Protocols Leica Microsystems provides 11 pre defined protocols with each Peloris system You can use these as they are or base new protocols on them see Copying Protocols in 4 2 3 Creating New Protocols for instructions to copy pre defined protocols Descriptions of the pre defined protocols are included in the following sections Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 126 The pre defined protocols are Factory ihr Xylene Standard see Xylene 1 Hour Factory 2hr Xylene Standard see Xylene 2 Hour e Factory 4h
16. 8 2 1 Specimen Type and Protocol Duration Unfixed or poorly fixed tissue is damaged by processing the alcohol and high temperatures exert a fixative effect different to that of formaldehyde As a result blocks become more susceptible to hardening and shrinkage When combined with under processing blocks may be unusable Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 151 Rapid Reverse Cleaning Protocol Step Reagent type Temp C Troubleshooting Drip 1 Cleaning solvent 12 65 Ambient High 10 2 Cleaning ethanol 6 55 Ambient High 10 Processing time 18 Slow Reverse Cleaning Protocol Step Reagent type Time Temp C P V Stirrer Drip min time s 1 Cleaning solvent 60 65 Ambient High 10 2 Cleaning solvent 60 65 Ambient High 10 3 Cleaning ethanol 60 45 Ambient High 10 4 Cleaning ethanol 60 45 Ambient High 10 Processing time 240 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 152 10 Consumables and Accessories The following consumable items and accessories are available from Leica Microsystems Name Part No Waxsol Cleaning Solution 20 liters S26 0390 Reagent bottle labels S26 6001 Carbon filter S26 0434 Touch screen protectors 10 S26 0389 Reagent bottle S26 0802 Condensate bottle S26 0812 Bottle caps S26 0301 Bottle connector sealing ca
17. Check all bottles weekly Note bottles that are becoming dirty Clean the bottles when next replacing reagent While bottles are removed wipe the interior of the reagent cabinet with 70 alcohol To clean bottles pour in a small amount of fresh reagent i e the reagent the bottle is used for cap the openings and shake Use sealing caps from Leica Microsystems to seal the bottle Empty the bottle and check it is clean If so refill and replace in the instrument see 5 4 Replacing Reagents for instructions to reset the station properties If the bottle is still stained use a bottle brush and laboratory detergent to clean Rinse thoroughly with water Then prepare the bottle to refill with reagent e For formalin and alcohol bottles where the reagent is miscible with water rinse with a small amount of the bottle s reagent to clear the water then refill e For clearer and cleaning solvent bottles e g xylene where the reagent is not miscible with water dry thoroughly before adding fresh reagent or rinse with a small amount of alcohol then a small amount of the bottle s reagent before refilling WARNING Wear suitable protective clothing and eyewear to avoid splashes when cleaning bottles WARNING Ensure lids are tight and the bottles are correctly plugged into the manifold after replacing reagent to avoid reagent spills CAUTI ON Do not clean reagent bottles in an automatic dishwasher as they may be damaged gt bb Clean Wa
18. K Leica Biosystems Melbourne Pty Ltd 2011 112 Settings amp Ancillary Operations transfer event details tap Event details and set an incident date Check the Event log screen to identify when the event you are interested in occurred Select whether to transfer all event details up to that date or event details for three or one days preceding the date Tap Transfer files to begin the file transfer 4 Tap OK in the confirmation dialog box to continue with the transfer Tap Cancel to terminate the procedure if there is not room for the files on your USB key Remote Device File Structure The file structure on the remote device is as follows 1 All files for a particular instrument are stored in a folder with the instrument s name see item 1 in Figure 61 2 Each file transfer operation creates a sub directory with a name corresponding to the time and date the transfer commenced see item 2 in Figure 61 Incident report places a compressed file in this sub directory 3 Each file type except Incident report has a sub directory that contains the transferred files see item 3 in Figure 61 e Removable Disk E 1 gt 5 026nnnn 2 4 20040707 002327 C3 configfiles logs C3 protocols C3 statefiles Figure 61 Remote device folder structure The configuration files are placed in the configfiles folder the protocol files are placed in the protocols folder the state files are placed
19. Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 133 8 2 5 Cleaning Protocol Quick Clean e Pre defined protocol Quick Clean e Bottle configuration one bottle each of cleaning solvent and cleaning alcohol Reference e Never run a cleaning protocol while tissue is in the retort as the dry step will damage the tissue Step Reagent group Time min Temp C P V Stirrer a ame 1 Cleaning solvents 12 75 Ambient 1High 10 2 Cleaning alcohols 6 55 Ambient 1High 10 3 Dry step 12 80 N A Off N A Processing time 0 34 00 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 134 8 3 Reference Station Configurations Use the station configurations in this section for the protocols described in 8 2 Protocols If considering alternative station configurations remember to take into account how you will configure your protocols including the reagent selection method see 4 1 2 Reagent Selection Method For example some laboratories use explicitly graded alcohols with reagent types identified as Ethanol 70 Ethanol 90 etc This sort of station configuration requires that protocols use type or station selection and of course the protocols must be configured to use the alcohol grades in the correct order Xylene Configuration This is the suggested station configuration when running xylene protocols see 8 2 3 Xylene Protocols See note b
20. Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 156 Event log screen 106 event severity amp color codes 107 external vapor filter 35 F factory protocols list of 126 file structure on remote device 113 file transfer 109 fill and drain retorts 99 fill level bottles amp wax bath 26 set for retorts 104 filter carbon 34 change 122 external vapor 35 final reagent thresholds 77 flowcharts troubleshooting 140 function bar 20 G grossing 79 group definition 73 selection method 60 H heat wax lines 99 I incident report files 111 initial fill 56 instrument name model amp serial number 106 Instrument settings screen 103 K keypads in software 20 L language 105 lid cleaning 117 retort 25 lid seal change 123 liquid level sensors LLS 27 local alarm 38 lock touch screen 106 lockout 76 log files archiving 113 M magnetic stirrer 28 maintenance 60 90 days 122 daily 117 schedule 115 weekly 120 manual drain drip time 104 manual operations 99 drip time 104 wax preheat 100 marking tissue 79 melt temperature 102 N navigation software 20 o operator 22 over processed tissue instrument problems 142 reagent problems 143 P pausing protocols 54 preclean purge 44 pre defined protocols 61 protocols list 126 reagent types 80 predicted end time 50 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 157 protocol abandoning 54
21. Medium 10 13 Paraffin wax Wax 80 65 Vacuum Medium 10 Processing time 12 02 00 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 130 Reference 8 2 4 Xylene free Protocols All the xylene free protocols below are designed for use with the xylene free bottle configuration in 8 3 Station Configurations Xylene free 1 Hour e Pre defined protocol Factory 1 hr Xylene Free e Carryover setting in pre defined protocol 100 Step Reagent type Time min Temp C P V Stirrer r ume 1 Formalin 1 Ambient Ambient Medium 10 2 85 Ethanol 1 Ambient Ambient X Medium 10 3 85 Ethanol 6 55 Ambient Medium 10 4 80 20 Ethanol IPA 1 Ambient Ambient Medium 10 5 80 20 Ethanol IPA 6 55 Ambient Medium 10 6 IPA 1 Ambient Ambient Medium 10 7 IPA 1 Ambient Ambient Medium 10 8 IPA 12 55 Ambient X Medium 10 9 Wax 20 85 Vacuum Medium 10 10 Wax 5 85 Vacuum Medium 10 11 Wax 1 65 Vacuum Medium 10 Processing time 1 19 00 Xylene free 2 Hour Pre defined protocol Factory 2 hr Xylene Free e Carryover setting in pre defined protocol 75 Step Reagent type Time min Temp C P V Stirrer or aime 1 Formalin 1 Ambient Ambient Medium 10 2 85 Ethanol 1 Ambient Ambient Medium 10 3 85 Ethanol 12 55 Ambient Medium 10 4 80 20 Ethanol IPA 1 Ambient Ambient Medium 10 5 80 20 Ethanol IPA 25 55 Ambient Medium 10 6 IPA 1 Ambient Ambi
22. Opera operations ponents tions Management Set basic reagent management options 6 1 2 Reagent Manage ment man nun D settings EM P P g time Device Change sound touch screen and alarm set 16 2 2 Device Settings settings tings Service View the instrument serial number and soft 6 2 3 Service Settings settings ware versions Event log View all system events 6 2 4 Event Log Alarms Clear or silence active alarms 6 2 5 Alarms Access level Set the access level 6 2 6 Access Level File transfer Transfer files to and from the instrument Open an HTML version of the user manual in the Peloris software Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 6 2 7 File Transfer 1 3 Help 21 1 2 3 1 3 Introduction Access Levels Peloris has two user access levels available to laboratory staff operator and supervisor Operators can carry out all routine tasks such as running protocols and replacing reagents But operators cannot edit protocols or set bottle configurations you must have supervisor rights for these actions Supervisors also have greater rights to configure the system Some configuration settings displayed in the software require service level access to change These are provided so you can view the settings but you must contact your customer support representative if you want to change them You automatically begin at operator level when you start the sof
23. Reference descriptions of the pre defined protocols and recommended bottle configurations Recommended reagent thresholds and reagent compatibility tables e Chapter 10 Consumables and Accessories a list of Peloris consumables and accessories with part numbers for easy ordering e Chapter 11 Specifications system specifications 1 2 Using the Software Control all instrument functions from the touch screen This section describes basic touch screen operation and how to navigate the software with a summary of all the software screens It also describes user access levels See sections e 1 2 1 Basic Operation 1 2 2 Navigation e 1 2 3 Access Levels Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 18 1 2 1 Introduction Basic Operation Buttons Tap buttons to open menus screens and dialogs and to start and stop actions in the instrument Enabled buttons are blue and appear raised Selected buttons are orange and appear sunken Disabled buttons are dimmed Protocols Figure 1 Button states selected available and unavailable Icons Icons are used to represent various Peloris tissue processor elements including reagent stations and retorts Selectable icons appear raised A selected icon appears raised with a red outline Nonselectable elements appear flat and are used for indication only Select an icon by tapping it as you would a button Figure 2 Reagent station select
24. Touch screen e 2 6 External Vapor Removal Systems e 2 7 Alarm Connections 2 1 Switching On and Shutting Down Under normal conditions keep the Peloris on at all times even when idle for extended periods Shut down for servicing or if moving the instrument Start 1 Plug the power cable into the mains socket and switch on the power 2 Press the power button to start the instrument Normal Shutdown For a normal shutdown the instrument must be idle with no protocols or other operations in progress 1 Tap the shutdown button on the Function bar to shut down the software in an orderly manner 2 Wait for the touch screen to go blank then press the power button to remove all power from the instrument 3 Switch the power off at the mains socket and pull out the power cable Emergency Shutdown For emergency shutdown press the power button immediately If conditions permit switch the power off at the mains socket and pull out the power cable Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 24 Hardware 2 2 Retorts The Peloris tissue processor has tvvo independent processing retorts vvith each retort holding up to 300 tissue samples in three Peloris cassette baskets Each retort operates independently vvith separate temperature pressure vacuum and stirrer speed control The Peloris tissue processor schedules resources to ensure both retorts operate efficiently with one set of reagents
25. User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 80 5 2 2 Editing Active Reagent Types Reagent Setup Use the Reagent types screen Reagents menu Types to view and edit the active reagent types list You also access other reagent type management options from this screen When you open the screen you see the list of active reagent types These reagent types are available to set for reagent stations There are two views of the active list one each for purity and temperature thresholds both views show default concentrations Change views with the Purity thresholds and Temperature thresholds buttons Figure 44 and Figure 45 show the two views List of active reagent Reagent change Final reagent types thresholds thresholds tap cells tap cells to change to change Selected reagent type select by tapping in the name cell Defaults Concentration tap cells to change Purity thresholds and Temperature thresholds buttons to switch views Add reagent button bring dormant reagent onto the active list Remove reagent button remove selected reagent from the active to the dormant list Figure 44 Reagent types screen purity thresholds view using recommended reagent types for xylene free processing Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 81 Reagent Setup List of active reagent Max temperatures types tap cells to change Purity thresholds and Temperature th
26. ade saw days 02030ud eunsu3 s moq 1 ul suonnios e ejda 40 abueyo p ss oo d JaA9 Japun nep eynil 2424 51 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 Troubleshooting 9 2 8 Block Artifact aun 155 20 se uJ sdaqs Buissa301d uauw saul uoneipAyap aseaou 215 nssn sp q days 02010 0 1 sd s aseaou Buissa30 d 5 spjouseuu 3snfpy uonexiy buues 5 5 And Ayund palos 3e pue 1224105 je pue uea ueop ae sjuebeai eunsu3 ae s u fe eJnsu3 uoneJjgul Jo aun spjouse4yy pue uojeipAyap Burssad01d juabeas Buueap 5 Md JU NIYNSUI 102 02 1 14 5 el I Buissa30 1d buueep anssy qua yynsuy 14010 5 quamunsur queninsur yoolq enbedo nssn Buneams ebexuuus nss L nssn au JO 3ZIS y 104 3224400 SI 02010 0 zey 5 SA M V 148 Leica PELORIS User Manual Rev Leica Biosystems Melbourne Pty Ltd 2011 Troubleshooting 9 3 Reprocessing Recommendations Not all problem tissue requires reprocessing Some common problems and possible solutions are listed below 1 Tough Brittle Over Processed Tissue Gritty Tissue due to Calcium Deposits Hard Shriveled Tissue Dried Out Before Wax Infiltration Hard Shriveled Tissue Dri
27. and remote alarms have one of two on states Momentary triggers the alarm once only while Repetitive continues the alarm until it is cleared or for the internal alarm only silenced e To clear or silence an active alarm in the Alarms screen tap the Activated cell for the alarm event and tap Off or Silenced Off stops all alarm outputs and removes the event from the Alarms screen Silenced silences the internal alarm but the alarm is still active on the Alarms screen e To clear or silence an alarm in an alarm popup select the event in the table of alarm events there may be more than one alarm active at once and tap Clear or Silence Clear stops all alarm outputs and removes the event from the popup and Alarms screen The popup closes if there is only one alarm event Silence silences the internal alarm but the alarm is still active on the Alarms screen The popup closes if there is only one alarm event If there is more than one alarm event in a popup you can use Clear all or Silence all to clear or silence all the alarms at once 6 2 6 Access Level Use the Access level screen Control menu Access level to set the user access level in the Peloris system see 1 2 3 Access Levels e To change access level select the appropriate button Operator or Supervisor You have to provide a password if changing to supervisor level e To change the supervisor password tap the Change password button beside the Supervisor button
28. backup 111 cleaning 43 59 conventional 59 copying 71 delayed end time 56 delete 69 duration amp specimen type 126 edit 66 edit for single run 53 icon 66 initial fill 56 list of pre defined protocols 126 new 70 overview 58 panels 49 pausing 54 reagent clashes 56 reagent selection method 60 running 40 save files 65 scheduling 50 selection screen 65 set end time 52 standard 59 standard reprocessing 59 step temperatures 137 types 59 validation 62 viewing 71 xylene free 59 xylene free reprocessing 59 purity thresholds 76 guidelines 125 Q Quick Clean 43 134 R rapid reverse cleaning protocol 152 rapid reverse process 150 reagent cabinet 33 change thresholds 76 compatibility 80 compatibility tables 137 fill level 104 groups types and stations 73 list of recommended reagents 78 managing types 80 manual operations 99 overview 72 pre defined types 80 purity thresholds 76 Reagent types screen 81 recommended station configurations 135 select for protocol 68 selection method 60 temperature thresholds 77 threshold check 101 threshold guidelines 125 thresholds 76 unavailability 57 unavoidable clashes 56 reagent bottles 34 cleaning 120 status 46 reagent station assigning a reagent type 86 drain 91 fill and drain 88 managing 84 Reagent stations screen 84 setting concentration 87 state set 87 reagent type definition 73 edit 81 managing 80 recommended reagents 78 regulatory approvals 13 remote alarm 38 re
29. box opens the retort s default end time is shown the default end time is set to ASAP the protocol is scheduled to end at the earliest possible time Ifthe default setting is a specific time of day the dialog box defaults to that time on the following day You have four options 1 Accept the default values as they are Edit the protocol for the run if required see 3 4 2 Editing the Protocol for a Single Run then tap Start to begin the run 2 Keep the default time but change the day the protocol will run Tap the day or day button to keep the default end time but change the day If the default setting is a specific time of day the dialog box opens with the run set to the following day To run the protocol on the current day tap the day button once Depending on the time you do this the new end time may not be possible If so the Predicted end time is highlighted red 3 Start the run as soon as possible Tap the ASAP button The protocol will normally start immediately However if there is a reagent clash caused by a protocol running in the other retort the actual start of the protocol may be delayed see 3 6 1 Delayed End Times and Initial Fills 4 Set a new end time Tap the Edit end time button to open the Run protocol edit end time dialog box see the next section for instructions Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 51 Running Protocols Entering a New
30. e 2 2 1 Opening and Closing Retort Lids 2 2 2 Fill Levels 2 2 3 Magnetic Stirrer e 2 2 4 Cassette Baskets 2 2 1 Opening and Closing Retort Lids Use the handles on the front of the instrument to latch and unlatch the retort lids Figure 2 Opening a retort lid Always be aware of the contents temperature and pressure of a retort before opening it In some cases you may need to set the retort pressure and temperature manually before you can safely open it see Venting a Retort below You may see a warning if the retort temperature is greater than either the retort empty access temperature view on the Reagent management screen or the safe access temperature associated with the reagent in the retort set on the Reagent types screen The retort lids can be removed for cleaning see Clean Lids and Seals in 7 2 Daily Tasks Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 25 2 2 2 Hardware Some instruments have retort latch locks to disallow opening retorts when a protocol is running or the retort temperature is high See your service representative if you have latch locks on your instrument WARNING Retorts may contain very hot fluid that could cause severe burns Wear suitable protective clothing and eyewear when opening a retort WARNING Retorts may contain hazardous reagents and vapors Wear suitable protective clothing and eyewear and ensure adequate ventilation when opening a ret
31. enter the current password and then the new password Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 108 6 2 7 Settings amp Ancillary Operations File Transfer The file transfer functions Control menu File transfer allow you to copy protocol configuration current state log and event summary files to and from 3 5 floppy disks or USB memory devices You can then use these files as a backup especially useful for protocols or to send to Leica Microsystems or your service representative to aid system health diagnosis All user levels can transfer files Basic configuration for file transfer consists of three steps 1 Set Peloris to use a USB key or floppy disk and attach the device to the instrument 2 Configure which files to transfer 3 Tap Transfer files to copy the files onto the remote device The File transfer screen is shown in Figure 59 with the areas used for the three steps shown Run archive tasks now Incident report archive recent event and Select files related to a service log files and delete specific event to transfer very old ones see Transferring Incident Report Files Import Export protocols copy protocol files to or from the remote connection m select the device type to transfer files to Select event and status files to transfer Refresh update the remote connection information shovvn belovv button Estimate size Transfer files tap to s
32. fluid that could cause severe burns and hazardous reagents and vapors Read any warning messages e g if the retort is above safe access temperature and take appropriate precautions before continuing Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 54 Running Protocols Emergency Stop and Abandon After you have paused the instrument you can abandon all protocols with the Emergency stop button Note that this does not shut down or remove power from the instrument see 2 1 Switching On and Shutting Down Alternatively abandon the protocol run in one retort only with the appropriate Abandon button Any protocol running in the other retort will resume When processing stops the Peloris goes through the same routines carried out at the end of a normal protocol run It prompts you to drain the retort if full remove cassettes and run a cleaning protocol After abandoning a protocol you may vvish to run a reprocessing protocol to recover your cassettes In this case do not remove your cassettes or run a cleaning protocol when prompted to do so If the last reagent was a fixative you may skip the cleaning protocol as the residue will not prevent you running a typical processing protocol If you decide to run a cleaning protocol set the first step to a cleaning alcohol Cleaning solvents are incompatible with fixatives Access Retort You can access retorts in a paused instrument in order to add or ret
33. for initial bottle setup Station Reagent type Bottle 1 Formalin Bottle 2 Formalin Bottle 3 85 Ethanol Bottle 4 85 Ethanol Bottle 5 85 Ethanol Bottle 6 80 20 Ethanol IPA Bottle 7 80 20 Ethanol IPA Bottle 8 80 20 Ethanol IPA Bottle 9 IPA Bottle 10 IPA Bottle 11 IPA Bottle 12 IPA Bottle 13 Waxsol Bottle 14 Waxsol Bottle 15 Cleaning ethanol Bottle 16 Cleaning ethanol Wax 1 Wax Wax 2 Wax Wax 3 Wax Wax 4 Wax All alcohol dehydrants after fixative should be labeled and named in the software 85 Ethano However if setting up bottles on a new instrument or replacing all the ethanol bottles at once the first two bottles should be filled with 70 ethanol but still be named 85 Ethanol As operation continues and you are prompted to replace degraded bottles replace with 85 ethanol Other initially higher concentration bottles will have degraded so there will always be at least one bottle at a low concentration Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 136 Reference 8 4 Protocol Step Temperatures The Peloris tissue processor uses five protocol types to accommodate different processing functions Each protocol type has a set of reagent compatibility sequences that comply with the intended use see 8 5 Reagent Compatibility Tables for more information The allowable temperature range for each step i
34. in the statefiles folder The logs folder contains the additional log files if selected The compressed incident report file produces the same sub directory structure when uncompressed Archiving Log Files Archiving log files has two purposes It compacts the files so they take up less space on your instrument It discards any files older than three months Archiving normally happens automatically but you may be required to manually archive the log files if requested by your service representative Archived files can be copied to a remote device and sent to Leica Microsystems or your service representative Tap the Run archive tasks now button on the File transfer screen to archive files Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 113 Cleaning and Maintenance Follow the maintenance and cleaning instructions in this chapter to keep your Peloris processor in top condition This will help ensure quality processing at all times and avoid unnecessary service calls Besides the tasks listed below ensure that the Peloris is left on at all times even when idle This keeps wax molten and allows preventative maintenance routines controlled by the software to be carried out Ensure that the instrument has a preventative maintenance service call once a year contact your service representative to organize this WARNING Always wear gloves and other suitable protective clothing when cleaning the instr
35. on the instrument on the I nstrument settings screen Any user can configure the three date and time formats shortened normal and extended used in the system To change the system time tap the Set time button then use the Up and Down buttons as required to set the correct time To change time formats tap the Set date time format button and then the Modify button for the format you want to change Select the required format from the list in the Select time format or Select date format dialog box I nstrument Shutdown Tap the Shutdown instrument button on the I nstrument settings screen to turn off the instrument in an orderly manner This uses the same shutdown routine as the shutdown button on the Function bar When the touch screen goes blank turn off the red power button See 2 1 Switching On and Shutting Down Reagent Fill Levels The reagent fill levels determine the volume used to fill a retort and the reagent volume needed for a station to have a full state You configure the instrument to fill the retorts with sufficient reagent to process either two or three cassette baskets If the retorts are set for three baskets the bottle fill level must also be three baskets to ensure sufficient reagent to fill the retorts You must be a supervisor to change fill levels on the Instrument settings screen e Tosetthe retort fill level tap the Retort fill level button and select two or three baskets e To set the reagent statio
36. reagent for the specified basket level Icon Full The reagent or wax level is between full and empty this usually occurs during a fill or drain operation The retort is drained but contains residue d Empty 4 There is no residue in the retort This only occurs r after a cleaning protocol Clean Retort A A red cross over a retort indicates that a hardvvare failure has occurred and the retort is unavailable Retort Contact your service representative inoperative Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 48 Running Protocols 3 3 2 Protocol Panels Panels on each side of the Status screen show the steps of the protocols loaded for each retort Use the panels to load and unload protocols initiate processing runs and monitor protocol runs You can view the panels in two modes standard and expanded see images below Protocol name Show details Show details tap to expand protocol panel Reagent Completed steps are checked Protocol steps Progress through current step elelelolo Jololololalalo Protocol finish time The station scheduled for the ste a different station may be used Wed 11 Nov dn on start a loaded protocol or pause a Select Unload protocol 22 19 25 load and unload protocols disabled vvhile protocol is running Abandoning Protocols Figure 29 Protocol panel standard mode In expanded
37. runs lower the cycle purity thresholds for the cleaning reagents used Failure to do so can lead to overly contaminated cleaning reagents and lower quality cleaning Modifying Cleaning Protocols for Different Retort Residues Always run a complete cleaning protocol as soon as possible if wax or clearing reagent are left in the retorts For alcohol residue skip the first step of the protocol to start at the alcohol step see 3 4 2 Editing the Protocol for a Single Run A residue of clean formalin can be allowed to stay in a retort if the next processing protocol begins with a formalin step If you are left with formalin in a retort at the end of a protocol tap Clean later when prompted to continue without cleaning If you need to clean a retort with formalin residue in it start the cleaning protocol with the alcohol step as for alcohol residue Pre cleaning Purges Cleaning protocols are generally run to clean wax residue from the retorts as wax is the final step of processing protocols To help maximize the useful life of the cleaning solvent the instrument usually purges any wax residue from the retort to the wax chamber it came from before the cleaning protocol begins If you attempt to load a processing protocol to a retort with incompatible residue you are warned with event 10011 Incompatible reagent in retort Clean retort or edit protocol A cleaning protocol run after this warning will not have the normal purge to the wax ch
38. size 0 McCormick MC 605 Sample Calculation The average run of a protocol uses the following proportions of tissue carriers e Surgipath ActivFlo Routine I 40 Surgipath Biopsy Wraps in Surgipath ActivFlo Routine I 60 Multiply the proportion of each carrier with its value from the table above to calculate the additional carryover value for that carrier e Surgipath ActivFlo Routine I 40 x 0 e Surgipath Biopsy Wraps in Surgipath ActivFlo Routine I 60 x 20 12 Add the resulting values e 0 12 12 Enter a carryover value of 12 for the protocol Peloris softvvare versions before version 1 40 had a Biopsy pad setting for small tissue carrier carryover Users with satisfactory Biopsy pad settings in those versions should use the same numeric value for the Carryover setting Other Products For small tissue carriers other than those in the table above we recommend you start with a carryover setting of 50 Use your own observations of tissue and reagent quality to refine this value Tissue shrinkage in the block and excess solvent in the wax bath might both be indications that you have too low a carryover setting It is users responsibility to validate the carryover settings in their protocols Contact your technical support representative if you require assistance setting suitable carryover settings Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 64 Protoc
39. the services or the cost of having the services supplied again at Leica Microsystems option and b in the case of goods the lowest of the cost of replacing the goods acquiring equivalent goods or having the goods repaired Exclusion of liability To the extent permitted by law Leica Microsystems excludes all liability including liability for negligence for a any indirect or consequential expenses losses damages or costs including without limitation loss of profits loss of revenue loss of or damage to data failure to achieve anticipated savings or benefits and any third party claims incurred by or awarded against the Licensee under or in any way connected with this agreement or the use of the Software or Documentation b without limiting the foregoing any expenses losses damages or costs incurred by or awarded against the Licensee arising directly or indirectly in respect of clinical including without limitation diagnostic prescription and other treatment errors made while using or otherwise associated with the use of the Software or Documentation and c the operation or performance of and any expenses losses damages or costs suffered or incurred by the Licensee as a result of its use of any Third Party Material Limitation of liability To the extent permitted by law Leica Microsystems limits its total aggregate liability including liability for negligence for any damage arising under or in any way connect
40. the tissue which can then be processed normally Saline is a non toxic reagent that can be safely used in an open laboratory B Rapid Reverse Process Process using a fast modified cleaning protocol see Rapid Reverse Cleaning Protocol below Do not use the default Quick Clean protocol or protocols derived from this because they finish with a drying step that will damage the tissue After the cleaning protocol reprocess from formalin using a schedule suitable for the size and nature of the specimen see 8 2 1 Specimen Type and Protocol Duration Processor cleaning reagents provide a convenient automated method to remove wax and take the tissue back to alcohol It is however a potentially harsher method than methods A or C Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 150 Troubleshooting C Slow Reverse Process Process using a modified cleaning protocol for a period equal to the time required to forward process the tissue see Slow Reverse Cleaning Protocol below Then reprocess from formalin using a schedule suitable for the size and nature of the specimen see 8 2 1 Specimen Type and Protocol Duration A long reverse process is very gentle on the tissue If time permits this is the favored option D Direct Reprocessing In this method wax is not removed before reprocessing Place cassettes directly back into formalin and then with no other pretreatment reprocess using a schedule suitable for t
41. there is the possibility of damaging patient tissue samples Warnings in this manual use symbols with a red border as illustrated below TOXIC HAZARD There is danger of ingestion inhalation or skin contact with toxic material HEAT HAZARD There is danger of burns CHEMI CAL HAZARD There is a danger of exposure to corrosive chemicals ELECTRICAL HAZARD There is danger of electric shock GENERAL HAZARD There is danger of personal injury or damage to patient tissue samples gt bb Cautions Cautions are notifications of hazards that could lead to damage to the Peloris instrument or other equipment Cautions in this manual use symbols with a yellow border as illustrated below CAUTION There is danger of damage to the Peloris instrument or other equipment gt Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 9 Safety Notices General Warnings and Cautions Persons operating the Peloris must be fully aware of the following warnings in order to mitigate possible tissue damage or loss Reagent Configuration WARNING Always ensure that the reagents configured in the software are the actual reagents loaded on the instrument A station containing different reagent could damage tissue samples Replacing Reagents WARNING Always change reagents when prompted Always update station details correctly never update the details without replacing the reagent Failure to follow these dire
42. to define reagent stations and to monitor their use history and concentration see 5 3 Managing Reagent Stations 5 1 2 Concentration Management The high quality tissue processing delivered by the Peloris system is largely due to its accurate monitoring of the concentration of the reagents in each station This section describes the main features of concentration management in the system Concentration in the Peloris System Concentration is the proportion of a reagent that is of the group to which the reagent is assigned The following examples illustrate how the concentration is determined A dehydrant that is 80 ethanol a dehydrant and 20 water not a dehydrant has a concentration of 80 e A dehydrant that is 80 ethanol a dehydrant and 20 IPA also a dehydrant has a concentration of 100 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 74 Reagent Setup e Absolute ethanol 100 dehydrant contaminated by carryover from absolute IMS 100 dehydrant has a concentration of 100 as both the original reagent and the contaminant are dehydrants e Anew xylene 100 clearer contaminated by carryover from absolute ethanol 100 dehydrant has a reduced concentration typically around 94 after one cycle as it will consist of 94 xylene clearer and 6 ethanol not a clearer A reagent that is used early in a sequence of the same group will have a rapid concentration decline as most of
43. to the following values e Reagent 35 C minimum to 85 C maximum restricted to 65 C maximum when running tissue processing protocols Wax Wax melting point 2 C minimum to 85 C maximum restricted to 77 C when running standard protocols View the current wax melting point temperature on the Reagent management screen Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 99 Settings amp Ancillary Operations Additional limitations may apply depending on the retort state and the reagent in the retort You cannot raise the retort temperature above the safe temperature threshold of the reagent Wax Transfers The wax path comprising the wax valves and the transfer pipes and the retort must be at the wax standby temperature before you attempt to fill a retort with wax Use the Wax heater buttons for at least five minutes to enable wax path heating Use the Temp button to set the retort to the wax standby temperature and wait until the retort reaches the temperature before filling Filling and Draining Retorts Fill or drain the retorts from any reagent station using commands on the Manual operations screen The fill and drain functions operate with a series of rules designed to avoid reagent contamination reagent overflow spills and reagent overheating You can override some rules but this will often result in reduced reagent concentration The rules for manually filling and draining
44. uo NE e REGN REN e E 45 Status Areas went A d aps ciis e esr ey a er abr ocv eta Cue 46 Protocol Panels 25 2 RU yaa de Pas sr Feeds des m ee Lay US ES ds E 49 3 4 Protocol Run Options 0 hr hrs 50 Scheduling Protocols ici s ea b ee Aa Me ec Ph ae al 50 Editing the Protocol for a Single Run 53 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 14 3 5 Pausing and Abandoning Protocols illie 54 3 6 Retort Seheduling 4 s ns n ec aoe Bead ee IR Aa E ae ak A E 56 Delayed End Times and Initial Fills II 56 Unavoidable Reagent Clashes ee es 56 Unavailable Reagents lt i da ese a ak le Aaa kx sr aa a ee 57 q Protocol Sep iai ose is ed oe LA 89 HUE AD RAD R da s 58 4 1 Protocol Overview xa sex ada ete eis A Ras o yan Aaaa AAA a v EY ES 58 Protocol Types cde toes doe Was Band ae aaa RA Goh RA Hae Apes Asia 59 Reagent Selection Method 4 4 aee tye A hed aod ha ea 60 Pre defined Protocols he Da a ec Ra ee Re Re a RACK CR Re a 61 Protocol Validation cd iii ateedaseek de iad neues ead ee 62 Carryover Setting ai yale ee Date RR Rho ea bie ale eee 62 Saving Protocol FilGS Court Pure m ear eG a A a gates Badman a OS RA RR a aba 65 4 2 Creating Editing and Viewing Protocols 65 The Protoc
45. with the first scheduled reagent usually a fixative to protect the samples Unless the reagent is wax no heating or agitation occurs If the initial step is wax for reprocessing or wax only protocols the retort temperature will be set to wax standby and the stirrer will be set to the first step s speed Once the initial fill period is over the protocol will run normally and will finish at the predicted end time We recommend that all protocols start with a fixative step even if only very short so that a fixative is used for any initial fill If there is no fixative step an initial fill may leave your tissue covered with dehydrant for a long period and this can cause the tissue to become hard and brittle 3 6 2 Unavoidable Reagent Clashes Unavoidable clashes often occur when there are insufficient reagent stations available for both protocols to satisfy the reagent selection rules see 4 1 2 Reagent Selection Method This occurs more frequently when using by type and by station protocols as they have limited station assignment flexibility Always ensure sufficient stations of the first reagent group or type so a station is available for an initial fill Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 56 Running Protocols 3 6 3 Unavailable Reagents Once a protocol starts group and type select protocols may reassign stations to recover from errors caused by unavailable reagents for exampl
46. 0 bottles on the instrument and the first dehydrant step of the protocol is configured to the first of these bottles that bottle will be used regardless of the concentration of reagent in the other bottle Station Selection Rules The system uses the following rules to select stations for protocols with group and type reagent selection Sequence as used below means a series of protocol steps using the same reagent group or reagent type e The first step of a sequence uses the lowest concentration station available e The last step of a sequence uses the highest concentration station available e Intermediate steps in a sequence use the lowest concentration station that has not already been used e Where there is a single step for a particular reagent group or type the highest concentration station is used e Stations that have exceeded any of their use thresholds and are not locked out are not selected unless there is no other station available Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 60 4 1 3 Protocol Setup Reagent Selection Methods Compared When creating protocols decide which method best suits your processing needs and reagent management strategy Note however that xylene free protocols cannot use group selection Xylene free protocols use dehydrants for two different functions and group selection cannot differentiate these Group selection ensures optimal reagent selection w
47. 0 45 Ambient Medium 10 2 Ethanol Dehydrants 120 45 Ambient Medium 10 3 Ethanol Dehydrants 120 45 Ambient Medium 10 4 Ethanol Dehydrants 120 45 Ambient Medium 10 5 Ethanol Dehydrants 120 45 Ambient Medium 10 6 Ethanol Dehydrants 140 45 Ambient Medium 10 7 Ethanol Dehydrants 160 45 Ambient Medium 10 8 Xylene Clearers 30 45 Ambient X Medium 10 9 Xylene Clearers 30 45 Ambient X Medium 10 10 Xylene Clearers 60 45 Ambient Medium 10 11 Paraffin wax Wax 40 65 Vacuum Medium 10 12 jParaffin wax Wax 40 65 Vacuum Medium 10 13 Paraffin wax Wax 60 65 Vacuum Medium 10 Processing time 8 08 00 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 129 Xylene 12 Hour e Pre defined protocol Factory 12hr Xylene Standard e Carryover setting in pre defined protocol 25 Reference Step Reagent type 7 ls o p P V Stirrer i ume 1 Formalin Fixatives 44 45 Ambient Medium 10 2 Ethanol Dehydrants 130 45 Ambient Medium 10 3 Ethanol Dehydrants 130 45 Ambient Medium 10 4 Ethanol Dehydrants 130 45 Ambient Medium 10 5 Ethanol Dehydrants 130 45 Ambient Medium 10 6 Ethanol Dehydrants 160 45 Ambient Medium 10 7 Ethanol Dehydrants 190 45 Ambient Medium 10 8 Xylene Clearers 45 45 Ambient X Medium 10 9 Xylene Clearers 45 45 Ambient X Medium 10 10 Xylene Clearers 90 45 Ambient Medium 10 11 Paraffin wax Wax 60 65 Vacuum Medium 10 12 Paraffin wax Wax 60 65 Vacuum
48. 011 82 223 Reagent Setup Managing the Reagent Types Lists Apart from editing the properties of active reagents and moving them to the dormant list all management of the reagent types lists uses the Add reagents dialog box Figure 46 opened from the Reagent types screen The dialog box lists all reagent types ordered by reagent group on the left Filter the list by reagent group with buttons on the right Complete list of reagent types Create reagent create a filtered by reagent group new reagent to add to the with buttons at right dormant list Delete Delete the selected reagent type user defined protocols only Reagent group filters tap to show just the reagent ES in the left of the dialog box Selected reagent type in the selected groups tap button to select Add reagent transfer the selected reagent type from the dormant to the active list Figure 46 Add reagent dialog box To add reagent types to the active list select a reagent type from the list and tap the Add reagent button To add a new reagent type to the dormant list tap the Create reagent button Choose a reagent group for the new reagent type and then set a unique name for it Use the Delete button to remove user defined reagent types from the dormant list This deletes them from the software completely You cannot delete pre defined reagent types Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 83 Reagent Setup
49. 11 Wax 30 65 Vacuum Medium 10 Processing time 6 04 00 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 132 Xylene free 8 Hour Pre defined protocol Factory 8 hr Xylene Free e Carryover setting in pre defined protocol 26 Reference Step Reagent type Time min Temp C P V Stirrer 2 ame 1 Formalin 30 55 Ambient Medium 10 2 85 Ethanol 20 55 Ambient Medium 10 3 85 Ethanol 30 55 Ambient X Medium 10 4 80 20 Ethanol IPA 30 55 Ambient Medium 10 5 80 20 Ethanol IPA 60 55 Ambient Medium 10 6 IPA 20 55 Ambient Medium 10 7 IPA 40 55 Ambient Medium 10 8 IPA 80 55 Ambient Medium 10 9 Wax 60 85 Vacuum Medium 10 10 Wax 50 85 Vacuum Medium 10 11 Wax 40 65 Vacuum Medium 10 Processing time 8 04 00 Xylene free 12 Hour e Pre defined protocol Factory 12 hr Xylene Free e Carryover setting in pre defined protocol 26 Step Reagent type Time min Temp C P V Stirrer di Hu 1 Formalin 68 55 Ambient Medium 10 2 85 Ethanol 30 55 Ambient Medium 10 3 85 Ethanol 40 55 Ambient Medium 10 4 80 20 Ethanol IPA 50 55 Ambient Medium 10 5 80 20 Ethanol IPA 90 55 Ambient Medium 10 6 IPA 30 55 Ambient X Medium 10 7 IPA 60 55 Ambient X Medium 10 8 IPA 120 55 Ambient X Medium 10 9 Wax 80 85 Vacuum Medium 10 10 Wax 70 85 Vacuum Medium 10 11 Wax 60 65 Vacuum Medium 10 Processing time 12 02 00
50. Bottle 4 Bottle 5 Bottle 6 Bottle 7 Bottle 8 Bottle 9 Bottle 10 Bottle 11 Bottle 12 Bottle 13 Bottle 14 Bottle 15 Bottle 16 Wax 1 Wax 2 Wax 3 Wax 4 Clean top surface Clean touch screen Weekly Tasks Empty condensate bottle Check reagent bottles Clean wax bath Check bottle connectors Clean exterior surfaces Every 60 90 Days Change carbon filter Check lid seals Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 116 Cleaning and Maintenance 7 2 Daily Tasks Clean Lids and Seals Use the plastic scraper provided to scrape wax off the inside surfaces of the retort and wax bath lids Carefully remove wax from around the lid seals Replace any seals that are damaged see Check Lid Seals Remove the retort lids to clean To remove open the lids fully then slide to the left Figure 62 Removing a retort lid Scrape around the rims of the retorts and wax bath on the top of the instrument where the lids sit Ensure that the lids seal fully when closed In the wax bath make sure that the air vent on the back rim under the left lid is clear of wax Do not allow wax to fall into the vent Air vent Figure 63 Wax bath air vent CAUTION Only use the plastic scraper provided to clean the lids to avoid damage to th
51. End Time or Default Scheduling Setting Change the end time for a specific run in the Run protocol edit end time dialog box opened from the Scheduling dialog box with the Edit end time button Also set the default scheduling setting for the current retort in the Run protocol edit end time dialog box Scheduled time of day Scheduled day Keypad to enter time in top field above Use 24 hour clock Enter required end time 13 30 day 9 Nov Pal 6 Clear bs S p LU 5 Set as default ASAP Use if setting the as soon as possible option as the retort default 415 change the scheduled time of day in 15 minute increments Day change the scheduled day Set as default Set the time of day currently entered or as soon as possible setting as the retort default Figure 32 The Run protocol edit end time dialog box e TO set a new end time for a protocol run use the keypad to enter the required end time of day 24 hour format or use the 15 or 15 buttons to increment the time in 15 minute steps Use the Day and Day buttons to change the day Tap OK when finished e To set a new retort scheduling default enter a time of day as you would to change the end time for an individual run or tap ASAP The day is not relevant to the default setting Tap Set as default then OK Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pt
52. Ltd 2011 149 Troubleshooting 20 mL 5 sodium carbonate e Ethanol glycerol 90 mL 60 ethanol 10mL glycerol Then process tissue normally 4 Hard Shriveled Tissue Dried Out but Processed Through to Wax Remove wax and rehydrate as detailed in problem 6 below Apply a reconstitution solution as described in problem 3 5 Tissue I nsufficiently I nfiltrated with Wax Place the cassettes back into the wax bath with vacuum and stirrer on and temperature at 65 C This may be necessary when tissue has been prematurely removed from the wax 6 Adequately Fixed Under processed Tissue This problem can be due to too short a protocol too large a specimen or processor failure Four methods are recommended but first identify the problem and rectify it Test your fix by running control tissue through the processor before reprocessing the patient tissue or use another processor For all the follovving solutions first melt dovvn the blocks blot off excess vvax and then place the specimens in nevv cassettes This minimizes vvax contamination of the processing reagents A Taggart s Method Place the cassettes into a beaker of isotonic saline aqueous solution of 0 9 sodium chloride in an incubator at 65 C for 1 hr The wax rises to the surface Remove the tissue and reprocess from formalin using a protocol suitable for its size and nature see 8 2 1 Specimen Type and Protocol Duration The saline gently rehydrates
53. Ltd 2011 93 Reagent Setup 5 4 4 Replacing Reagent Manual To replace bottles manually remove the bottles and dispose of the old reagent following your laboratory s standard procedures Clean the bottle if necessary and then fill with fresh reagent Load back on to the instrument When the bottle is reinserted the Inserted bottle configuration dialog box opens showing the reagent type concentration and use history for either e the bottle when it was removed or e the bottle as configured in the Reagent stations screen if you assigned a new reagent type to the station after the bottle was removed see Assigning New Reagents to Stations Tap in the table row to select the bottle then select an option button below No change select if you did not do anything to the reagent in the bottle Topped off up Changed select if you added a select ONLY if you replaced small amount of reagent the bottle contents with to the bottle to ane up fresh reagent its leve Figure 56 Inserted bottle configuration dialog box The bottle state is set to Unknown in the dialog box Tap the table row and select one of the options at the bottom of the dialog box e Changed select if you replaced the old reagent with fresh reagent With this option the software prompts you to accept the default concentration for the reagent in the station If you know the concentration to be other than the default you can enter a different concentrat
54. Reagent boiling points are lower when in a retort operating with a vacuum or with pressure vacuum cycling WARNING Handle and dispose of reagents and condensate in accordance with all relevant procedures and government regulations that apply at the laboratory site WARNING Do not use fixatives containing picric acid as picric acid is explosive when dry WARNING Molten wax is hot and may cause burns Use caution when handling wax and removing baskets CAUTION Do not use acetone or other ketones These damage the instrument s valves CAUTION Do not use reagents containing corrosive chemicals such as mercuric salts picric acid nitric acid and hydrochloric acid gt Bb Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 12 Regulatory Approvals IEC 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 2nd Edition General requirements UL 61010A 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements CAN CSA C22 2 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 No 1010 1 General requirements IEC 61010 2 010 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 Particular requirements for the heating of materials IEC 61010 2 081 Safety requirements for electrical equipment for meas
55. Remote fill drain hose with locking ring 1 WARNING Always ensure that you fill from or drain to a large stable container The fill drain functions include a strong purge which may cause an unstable container to tip over and spill The container must also be of sufficient volume to easily accommodate all of the drained fluid If you need to use a small container you must support the container and hose during the fill or drain WARNING Always use the hose supplied with the Peloris system for reagent bottle operations WARNING Ensure you use the correct size wax drain hose to avoid wax leakage Old and new instruments have different sized wax waste line connectors WARNING Always wear suitable eye protection and other protective clothing when handling reagents to protect yourself from splashed reagent b b Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 90 Reagent Setup 5 4 3 Replacing Reagent Remote Fill and Drain You can drain and then refill reagent bottles without removing the bottles from the instrument The process drains each bottle to a retort then drains the retort to the remote fill drain line The reverse procedure is used for the fill If you routinely use remote drain and fill do not forget to check if bottles need cleaning once a week Before you begin a remote fill or drain ensure there is a retort available e the retort must not have a protocol loaded or running
56. Wax System scheduled fill drain operations for the wax chambers Figure 50 Remote fill drain screen Remote Fill Drain Connections The remote fill drain line and the wax drain outlet sit above the carbon filter in the reagent cabinet see Figure 52 A protective flap covers the outlets The wax waste line is heated to ensure that the wax does not solidify during the drain Figure 51 Remote fill drain flap closed Figure 52 Remote fill drain flap open with reagent line left and wax waste line right e Before draining a wax station open the upper reagent cabinet door slide back the fill drain flap then fit the wax waste hose to the wax waste line right connection in Figure 52 Ensure the wax waste hose drains into a suitable container Ensure the hose remains out of the drained wax so that wax can t solidify on the end of hose e Before filling or draining reagent bottles connect the remote fill drain hose see Figure 53 to the remote fill drain line left connection in Figure 53 The hose has a push fit coupling that ensures a secure connection to the line Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 89 Reagent Setup To fit the hose open the upper reagent cabinet door slide back the fill drain flap and push the coupling onto the end of the line To remove the hose slide back the locking ring item 1 in Figure 53 and pull the hose off the remote fill drain line Figure 53
57. Xylene free Protocols Current step Previous step an 2 5 2 v 8 2 s g 010 e 2 compatible al 2 5 o E c To X oO i o x o E O E E z l l d zi O U Fixatives Dehydrants M 1 M M v Clearers Wax v1 v v Cleaning Protocols Current step Previous step gio c o E 15 g 15 g 8 lo S S compatible gt 5 D To X o i o x o f E E E a o Z O Ere Cleaning solvents v1 MiMM MN Cleaning alcohols MiMiM IM Ww Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 138 Troubleshooting If you have processing problems review this chapter to try to identify the cause e 9 1 Preliminary Questions e 9 2 Flowcharts e 9 3 Reprocessing Recommendations 9 1 Preliminary Questions When faced with blocks that are difficult to section first collect as much information as possible to assist in analyzing the problem Some questions to ask are 1 Did the instrument software indicate an error in the run Instrument warnings and alarms will be displayed on screen and in the event log Was there anything different about the run that produced the problem specimens compared to previous successful runs e g a recently changed reagent bottle Is there a possibility that an error was made when replacing reagents on the processor Do a visual check of reagent bottles is the correct reagent in each bottle The Reagent stations screen records
58. a Biosystems Melbourne Pty Ltd 2011 2 Contacting Leica Microsystems For service or support contact your local representative or see www leica microsystems com Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 Software Licence Terms 1 2 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 Defined terms amp interpretation Defined terms In this agreement Leica Microsystems includes Vision BioSystems Pty Ltd ACN 008 582 401 prior to changing its company name and Leica Biosystems Melbourne Pty Ltd ACN 008 582 401 after changing its name Confidential Information means all information a treated by Leica Microsystems as confidential or of its nature confidential and b disclosed by Leica Microsystems to the Licensee or of which the other party becomes aware except information c the other party creates independently of Leica Microsystems or d that is public knowledge otherwise than as a result of a breach of confidentiality by the Licensee or any of its permitted disclosees Designated Computer means the computer or microprocessor controlled unit supplied by Leica Microsystems to the Licensee under the Supply Agreement or otherwise recommended for use by Leica Microsystems Documentation means the manuals user documentation proprietary notices product catalog website notices and bulletins generally supplied by Leica Microsystems with
59. able selected not selectable Tables Tables display configuration information such as reagent station and protocol setup You can edit some table cells but others are locked The background color of locked cells is dimmed Select editable table cells by tapping within the cell boundaries l u r N 0 Figure 3 Table cells editable 1 and locked 2 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 19 1 2 2 Introduction Keypads Keypads appear as needed to allow you to enter text and numbers There are two types of keypad alphanumeric text and numbers and numeric numbers only The keypads are analogous to a computer keyboard with on screen buttons acting as keys 1 Enter text and numbers by tapping the appropriate buttons in order and use the Caps Lock button 4 or Shift button 5 to select upper or lower case characters As you type the characters you select are displayed in the text window 6 The alphanumeric keypad has a Back Space button 7 to delete the last character while all keypads include a Clear button 3 to remove all characters When you have finished tap the Esc button 2 to exit without saving or the Enter button 8 to confirm your entry Enter a name for the protocol Figure 4 Alphanumeric keypad Navigation Navigate the software from the Function bar at the top of the screen A F A gt Sun 15 Nov Protocols Reag
60. amber cell to change Figure 48 Reagent stations screen wax chambers view Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 85 5 3 2 Reagent Setup Setting Reagent Station Properties See sections Assigning New Reagents to Stations e Changing Reagent Concentration e Setting Station States CAUTION Altering reagent station configurations while protocols are running may cause abandoned protocols Assigning New Reagents to Stations If you change the type of reagent loaded in a station you must change the reagent type assigned to the station in the software Follow the steps below to change the reagent type for a station 1 Remove the bottle or drain the wax chamber with the reagent type you are replacing 2 In the Reagent stations screen tap in the station s Type cell to open the Reagent selection dialog box 3 Select the new reagent type from the list The dialog box shows all the current active reagent types see 5 2 3 Managing the Reagent Types Lists 4 When prompted tap Yes to reset the station properties This sets the use history counts to zero and the station concentration to the default for the new reagent type 5 Clean the bottle if necessary and fill with fresh reagent of the new type Load the bottle back onto the instrument or fill the wax chamber 6 Fora bottle in the Inserted bottle configuration dialog box select the bottle in the table and then tap the E
61. amber This is in case fresh cassettes were placed in the retort contaminating the wax residue with formalin A purge under these conditions would contaminate the wax chamber with formalin If you ever place fresh cassettes into a dirty retort in preparation for processing remove the cassettes and then attempt to load a processing protocol before loading the cleaning protocol The 10011 warning raised when you attempt to load the processing protocol causes the cleaning protocol to skip the wax bath purge The retort residue now with formalin in it will not go into the wax bath but into the cleaning solvent After the cleaning protocol finishes replace the cleaning solvent which will now be contaminated with formalin Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 44 Running Protocols In general avoid this situation by always cleaning the retort immediately after a processing run when prompted Do not put fresh cassettes into a retort that is showing residue in it as indicated by the icon at right formalin residue may be acceptable WARNING Do not load unprocessed tissue samples into a retort prior to running a cleaning protocol Formalin in the residue purged to the wax bath at the start of the cleaning run may damage tissue on subsequent runs If you inadvertently load unprocessed samples into a retort prior to running a cleaning protocol remove the samples and attempt to load a processing protocol
62. and e It is denatured with methanol and or isopropyl alcohol IPA e Ethanol containing acetone must not be used Clearing Agents Xylene is the recommended clearing agent Xylene free processing requires the use of isopropyl alcohol as the clearing agent It has been fully tested and validated Paraffin e Use histological wax for histology e Parablocks e Paraplast Cleaning Agents e Use ethanol for the cleaning alcohol solution In xylene processing mode we recommend xylene as the cleaning solvent e Fortrue xylene free processing we recommend Waxsol as the cleaning solvent Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 78 5 1 5 Reagent Setup Tissue Marking Some laboratories have traditionally added eosin or other dyes to formalin or alcohol during tissue processing to aid in the visualization of tissue during embedding This practise is NOT recommended for the Peloris tissue processor The dyes can build up on the liquid level sensors and compromise performance If you need to mark tissue for embedding Leica Microsystems recommends you add the dye at the grossing stage In spite of this recommendation eosin can be used on the Peloris if the customer feels there are strong reasons for doing so and due care is taken If using eosin on the Peloris add the dye to the fixative in preference to the alcohol However rapid turnaround times can mean that tissue is at the
63. and 70 alcohol Push the new seals into the grooves Ensure they are fully seated Figure 70 and Figure 71 show how seals fit into the grooves Figure 70 Cross section of retort seal in lid Figure 71 Cross section of wax bath seal in lid 4 Equalize the tension in each seal by running your finger around the seal to remove any tight or loose sections 7 5 Retort Acid Clean Common fixative reagents for example formalin may cause a build up of precipitate salt crystals on the retort walls If these cannot be removed by wiping with 70 alcohol follow the procedure below 1 If the salt build up is light wipe the retort walls with a lint free cloth dampened with 6 acetic acid 2 If the build up is heavy or is not easily removed fill a reagent bottle with 6 acetic acid solution then fill the retort with the solution using the instrument s remote fill and drain functions 3 Leave the acetic acid solution in the retort for one hour at ambient temperature then drain the acid back to the bottle 4 Remove the acetic acid solution from the instrument and clean the bottle thoroughly before using it for any other reagent 5 Use a clean wax scraper or a lint free cloth dampened with the acetic acid solution to remove any remaining salt build up 6 Run a cleaning protocol in the retort and select a cleaning alcohol as the initial step WARNING Wear suitable protective clothing when handling the acetic acid solution L
64. aning occasionally delays the start of a protocol or other action for up to 30 seconds Global VVax Settings Set the vvax melting and vvax standby temperatures in the Global settings section of the Reagent management screen e wax standby temperature is the temperature the instrument heats the wax to in the wax stations The default temperature is 65 C e wax melting point is the temperature at which the instrument considers the wax molten The default temperature is 56 9C Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 102 6 2 6 2 1 Settings amp Ancillary Operations Control Menu The control screens allow you to alter hardware settings view event logs and system information manage alarms and set the access level The File transfer screen allows you to back up and retrieve log protocol and other system files There are seven screens in the Control menu e 6 2 1 Instrument Settings e 6 2 2 Device Settings e 6 2 3 Service Settings e 6 2 4 Event Log e 6 2 5 Alarms e 6 2 6 Access Level 6 2 7 File Transfer Instrument Settings Use the Instrument settings screen Control menu Instrument settings to configure time display the carbon filter age and threshold reagent fill levels and manual operation drip time Supervisor access is required for all operations except time format configuration You can also close down the instrument from this screen Other settings on t
65. arryover due to cassettes and tissue is calculated using the number of cassettes entered by users at the start of each run in some cases an average number of cassettes may be used see 6 1 2 Reagent Management The amount of carryover on a standard cassette is used in the calculation Drip time is also included The reagent management system calculates carryover from small tissue carriers using the protocol Carryover value you set Carryover values are on a scale from 0 to 100 A setting of indicates that there is no carryover due to small tissue carriers like biopsy pads i e the run has only standard cassettes with no small tissue carriers e A setting of 100 indicates there is carryover equivalent to having all the tissues in a run using biopsy pads biopsy pads have the maximum carryover of all small tissue carriers Because biopsy pads can have up to 10 times the carryover of standard cassettes it is important to set a truly representative Carryover value in your protocols as it is to accurately enter the number of cassettes in each run If you set too high a Carryover value the system calculates too rapid degradation of reagents and requires you to replace them sooner than necessary With too low a setting the system calculates that reagents are more pure than they are You will use reagents beyond their optimal effectiveness resulting in poor processing quality Protocol carryover values are set by supervisors on the Edit protoc
66. as been in the retort CAUTION Do not reuse contaminated dehydrants as cleaning alcohol The contaminated dehydrants will contain formalin or other fixatives and the dry step will cause salts to crystallize on the retort s internal surfaces gt gt BB Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 43 Running Protocols Cleaning Laboratory mplements You can clean metal laboratory implements such as cassette lids and metal molds during cleaning runs but it is important to set reagent purity thresholds that take this into account All the pre defined cleaning reagents have cycle purity thresholds Under these the reagents must be replaced after ten or six cleaning runs if they do not exceed a concentration threshold first But the thresholds are designed for cleaning runs with only cassette baskets in the retorts any additional material increases the rate that the cleaning reagents degenerate requiring lower cycle thresholds If you clean implements other than baskets lower the cycle thresholds for the reagents used so the reagents are replaced more frequently see 5 2 2 Editing Active Reagent Types Depending on the number of implements you typically place in the retorts you may need to reduce the thresholds by half or more Contact your technical support representative for advice if required CAUTION If you clean laboratory utensils metal cassette lids metal molds etc in cleaning
67. as valid making it available to operators for clinical use see 4 1 4 Protocol Validation Use of nonvalidated protocols may result in tissue damage or loss Instructions below describe how to create new protocols from scratch See Copying Protocols below for instructions to create a new protocol by copying another one Creating New Protocols From Scratch 1 Open the Protocol selection screen Protocols in the Function bar and tap New 2 Select the protocol type see 4 1 1 Protocol Types 3 Select a reagent selection method see 4 1 2 Reagent Selection Method Automatic dialog boxes will now guide you through the creation of the first step 4 Tap the next row in the protocol table to add the second step You are prompted to supply the reagent and step duration other step properties pressure stirrer etc are inherited from the previous step Tap the appropriate cell to change any of these values Cleaning protocols automatically have a final dry step You cannot edit this step Add further steps as required Tap the Name button to name your protocol 5 6 7 Optionally tap the Notes button to add any information you want to keep with the protocol 8 Seta carryover value with the Carryover button see 4 1 5 Carryover Setting 9 Tap the Save button to save the protocol 10 Tap the Done button to finish Your new protocol will now be available in the protocol selection list Leica PELORIS User Manual Rev K Lei
68. ation in Severity filters and Non alarmed events in Alarm filters you will see all information events for retort A that do not raise an alarm The Run log entry button in the filter dialog box is only enabled for service personnel e To create a user event select Create user event to open the on screen keyboard Type in the information you want to record and tap Enter to add the message as an event The event severity will be Information e To create an incident report file for a specific event to send to your service representative select the event row in the table and tap Incident report see Transferring Incident Report Files in 6 2 7 File Transfer Event severity There are four event severity levels and each level has a color code as shown in the following table Information A normal event that requires a response e g a protocol Dark green successfully completed or an unusual event that has no detrimental effect e g a user abandoned protocol Warning An error or potential error that does not stop processing ora Orange request for user action For example an out of threshold reagent used in a protocol Error An error that causes an operation to abandon e g a protocol Red abandons because there is no station available Critical error An error that makes part of the instrument e g one retort or Blue the entire instrument unusable 6 2 5 Alarms Peloris uses alarms to alert users when events of
69. before loading the cleaning protocol The purge before the cleaning run will be skipped 3 3 Status Screen Use the Status screen to run protocols and monitor protocol progress The main features of the screen are shown in Figure 25 Retort A protocol panel 4 wax chambers Retort B protocol panel Retort A Retort B te 9 9 e e e D Select Unload leon ZI Select Unload protocol RS rotocol utton to load and unload protocols for retort B button to load and unload protocols for retort A Run Pause 16 reagent bottles Run Pause button for button for retort A retort B Figure 25 Status screen The central area of the screen shows the status of the stations and retorts Panels at either side of the screen show protocols loaded for the retorts e 3 3 1 Status Area e 3 3 2 Protocol Panels Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 45 3 3 1 Status Area Running Protocols The status area provides a visual guide to the status of the bottles wax chambers and retorts as shown below Bottle I cons Bottle number Hatched coloring shows reagent is out of threshold Color coded for reagent group see Groups in 5 1 1 Reagent Groups Types and Stations for color codes Bottles have six possible station states Figure 26 Bottle icons on the Status screen In use A reagent transf
70. ca Biosystems Melbourne Pty Ltd 2011 70 4 2 4 Protocol Setup Copying Protocols You can copy any protocol displayed on the Protocol selection screen in order to create a new one based on it Alternatively copy a pre defined protocol 1 6 Open the Protocol selection screen Protocols in the Function bar and i select a protocol to copy on the Protocol selection screen OR ii tap the New button and then the yellow Pre defined icon Then select the pre defined protocol to copy Tap the Copy button from the control panel Use the keypad to enter a new name for your protocol The Edit protocol screen opens with the copied protocol Modify the protocol as described in 4 2 2 Editing Protocols You cannot edit the final dry step in cleaning protocols Tap the Save button to save the protocol Tap the Done button to finish Your new protocol will now be available in the protocol selection list Viewing Protocols Operator level users cannot create or edit protocols However they can view all protocol details including step details notes and the date and time the protocol was last modified To view a protocol s details select the protocol icon on the Protocol selection screen Protocols on the Function bar and tap the View button Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 71 Reagent Setup This chapter gives an overview of Peloris reagent management as well as providing instr
71. certain types occur These events are mostly for error conditions that require quick intervention but alarms also activate for some normal conditions that it is useful to be informed about such as when a protocol has finished Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 107 Settings amp Ancillary Operations When an alarm activates the associated event is displayed on the Alarms screen Control menu Alarms and one or more of the following occurs depending on how the alarm is configured contact your service representative to reconfigure alarm outputs e instrument s internal alarm sounds e the LOCAL ALARM connection turns on triggering any connected alarm see 2 7 Alarm Connections e the REMOTE ALARM connection turns on triggering any connected alarm see 2 7 Alarm Connections a dialog box popup opens in the software displaying the alarm message Active alarms can be cleared i e turned off on the Alarms screen If an alarm has triggered a popup it can also be cleared from the popup Alarms can also be silenced from the Alarms screen and alarm popups This turns off the instrument internal alarm and closes the popup but the local and remote alarms remain on until the alarm is cleared This allows an operator at the instrument to continue to use the software without the alarm sounding while the external alarms continue in order to bring assistance The internal local
72. ction that requires you to open a retort if the retort contains reagent above its safe temperature threshold WARNING Take extreme care if changing reagent temperature thresholds Raised thresholds can lead to reagents boiling and or the release of large quantities of fumes that can overload the filtering system Boiling reagents can produce excessive pressures within the instrument increasing the chance of reagent contamination and spills Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 77 Reagent Setup 5 1 4 Recommended Reagents While each laboratory is responsible for its choice of reagents and wax using reagents other than those recommended for Peloris can result in poor processing or compromise instrument reliability Compliance with the following guidelines will ensure superior tissue processing The use of alternative reagents must be validated by the end user according to their local or regional accreditation requirements Adequate fixation of tissue samples is required for optimum results and should be achieved prior to placement on Peloris or incorporated into the fixative step of the protocol The following reagents have been validated for use on Peloris Fixatives e 10 Neutral Buffered Formalin NBF Alcohols e Histological grade ethanol Reagent grade ethanol e Absolute ethanol Isopropyl alcohol dehydrant Denatured ethanol is acceptable if e t is at least 99 ethanol
73. ctives can lead to tissue damage or loss WARNING Do not alter the concentration of a used reagent unless you are able to verify the actual concentration If the concentration is incorrect a reduction in tissue processing quality or damage to the tissue sample may result PP Protocol Validation WARNING Do not set new protocols as validated until they have passed the validation procedures for your laboratory Only then should you edit the protocol to set it as valid making it available to operators for clinical use See 4 1 4 Protocol Validation Use of nonvalidated protocols may result in tissue damage or loss gt Basket and Cassette Loading WARNI NG Always ensure the cassettes are correctly inserted into the baskets and that the baskets are correctly placed in the retorts Incorrectly placed cassettes or baskets may lead to samples being damaged as some tissue may not be fully covered by reagent during processing see 2 2 4 Cassette Baskets WARNING Never place three baskets into a retort when the instrument is configured with a two basket fill level If this occurs reagent will not cover the top basket and tissue samples will be damaged PP Cleaning Protocol WARNI NG Remove all tissue from the retort before running a cleaning protocol as the dry step will damage the tissue Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 10 P Safety Notices WARNI NG Do not use cleaning pro
74. decompile decrypt reverse engineer disassemble or otherwise reduce the Software to human readable form to gain access to trade secrets or confidential information in the Software or permit third parties to do the same and i comply with any reasonable directions of Leica Microsystems from time to time in relation to the installation or use of the Software and the Documentation Intellectual property Licensor IP All Licensor IP including but not limited to any images audio video and text in the Software is owned by or licensed to Leica Microsystems and no Licensor IP is transferred to the Licensee under this agreement Proprietary markings The Licensee must not alter or remove any notices of proprietary rights any rights management information or any serial numbers appearing on attached to or incorporated in Licensor IP or any copies thereof and must not use or attempt to register any trademark trade name business name or company name which is confusingly similar to any trademark or trade name of Leica Microsystems Violations of intellectual property The Licensee must a notify Leica Microsystems immediately if it knows of or suspects any unauthorised use or violation of any Licensor IP and 4 4 5 2 5 3 7 2 7 3 Software Licence Terms b provide promptly at its cost all assistance reasonably requested by Leica Microsystems to protect the relevant rights in Licensor IP and prosecute any claims arising f
75. e Use the lid handles to open the lids Always use the handles to close the lids ensuring the lids are properly latched Be sure not to knock the lids when they are open as they may slam shut Figure 16 Opening a wax bath lid Always ensure the wax bath pressure is at ambient pressure before opening the lids If the pressure is not ambient vent the bath first You can do this when you pause a running protocol or from the Manual operations screen View the current temperature of each wax station in the wax chambers view of the Reagent stations screen Depending on the reagents you use you can set the instrument to clean the wax in the bath see Wax Bath Settings in 6 1 2 Reagent Management Drain used wax with commands on the Remote fill drain screen Directly fill with molten or solid wax see 5 4 5 Replacing Wax WARNING Take care when opening the wax bath after a xylene free protocol as the protocol will leave very hot wax in the bath WARNING Never open a wax bath lid when there is wax in a retort or wax is being transferred hot wax may splash out of the bath WARNING Take care not to knock wax bath lids when they are open They could crush fingers or hands gt BB Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 32 Hardware 2 4 Reagent Cabinet Carbon filter 16 reagent bottles Condensate bottle Figure 17 Reagent cabinet The reagent cabinet houses the reagent bot
76. e The retort must be clean or empty e The retort residue if any must be compatible with the reagent in the bottle s Follow the instructions below to replace reagent in a bottle Drain 1 Connect the remote fill drain hose and place the end in a suitable container see 5 4 2 Remote Fill Drain Connections 2 From the Remote fill drain screen Reagents menu Remote fill drain select retort to use Remote icon bottle s to drain multiple bottles must all have reagent in the same group When bottle retort and Fil Drair Remote are selected tap pa Drain from bottle s to Drain from bottle s start the drain Select the retort to use Select the bottle or bottles to drain Wax waste Select Remote icon Remote Figure 54 Remote fill drain setup for draining bottles 3 Tap Drain from bottle s to begin the drain Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 91 Reagent Setup 4 When prompted check that the retort lid is closed and the remote fill drain hose is properly connected Tap OK to begin the drain 5 The instrument will now drain the bottle s via the selected retort Monitor the drain progress in the status panel When the drain completes the retort state will be Empty and the bottle state Dry WARNING Do not remove the remote fill drain hose until the software indicates the process is complete and pressurized air has clear
77. e Water introduced after processing processed Quality of embedding wax correctly Are these all correct Is the lab workflow appropriate Go to 9 2 3 Under or Over processed Tissue Reagents Stop well processed tissue Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 141 Troubleshooting 9 2 2 Over processed Tissue Instrument Setup cooked crispy burnt Are any error codes present If a user warning fix the issue If a service warning contact service tissue processed gt Yes correctly Check How was the tissue submitted to the lab in formalin Was tissue in solution between grossing and processing Was the protocol in dehydrant for too tissue processed out long correctly Was the protocol in solvent for too long Was tissue left in the retort in wax for too long Was the tissue left in the embedding instrument too long Was tissue allowed to dry Yes Check tissue size step times pressure and vacuum temperatures protocol used times Retest Is the tissue processed correctly Yes Are the settings appropriate Optimise the reagent using the pre defined protocols as a guideline correct carryover value number of Cassettes entered Retest Is the tissue processed correctly Enter correct values for Carryover and Cassette
78. e eee eee ens 4 Safety NOtICOS A dBA INE A Raed nek cx 9 Regulatory Approvals ee hh hrs 13 1 ANTOINE Lah A as a ad 17 11 S mmary of Chapters A A ee px SPEO 18 1 2 Using the Software si iaa ir A ERA da ala 18 Basic Operation oeni a eea a A ed eoe A A A RC tes 19 NAVIGATION 30 A A lya AS o ai tig 20 Access Levels rar A a A rd x m ed A dee 22 1 3 OD 2002770220 50200 22 2 Hardwale oras 23 2 5 5 0 AE Delo oo 23 2 1 Switching On and Shutting Down ee 24 22 oc MERIT 25 Opening and Closing Retort Lids nh 25 Fil Levels 7 ane aoc S508 tek 7 7 26 Magnetic StilreE uus nae a ek Ku dane a Ds Bye ae ge RAR ae AL PUR AR ee a 28 Cassette Baskets eee eee eee eens 28 2 3 Wax Bathis say daft Eats Sek A Sead s UR pera TA SONS ate i s 32 2 4 Reagent Cabinet ad ke a a CR RA dea dea 33 Reagent Bottles MITTIT 34 Condensate Bottle a A we uere ob s he 34 Carbon Filter se uulnus kg RR 7 7 34 2 55 TOUCNESCIECA ii A A A AA de 35 2 6 External Vapor Removal Systems ee ees 35 27 Alarm CONNECTIONS 0 oce vu a ha eek dusdu EM haa eke a Skee 38 3 dRUBDBIBO PEROUODGOIS ee dcir te Gat br odi it i he 40 3 1 Quick Start Running a Protocol res 40 3 2 Cleaning Protocols A RAYA a eed 43 3 3 Status Screen s
79. e or wax chamber icons Replace the reagent in hatched stations see 5 4 Replacing Reagents Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 40 Running Protocols 2 Check that the instrument is ready i All 16 bottles are properly installed on the instrument ii There is enough reagent in the bottles and wax chambers Fill to at least the MIN 2 level if you fill retorts to the two basket level or at least the MIN 3 level for the three basket level view the instrument fill level in the Reagent fill levels section on the Instrument settings screen iii Open the retort to use Check that it is clean or that any residue is a reagent compatible with the first reagent in the protocol 3 Prepare your cassettes and load them into baskets see 2 2 4 Cassette Baskets Load Protocol 4 Tap the Select button at the bottom left or right corner of the Status screen depending on the retort you want to use The Protocol selection screen opens 5 Select a protocol and tap Load Only validated protocols can be selected by operator level users see 4 1 4 Protocol Validation The Status screen reopens with the protocol loaded Run Protocol 6 Tap the Run button Review any warnings and rectify as required If necessary cancel the warnings dialog box while you rectify conditions If the first step of the protocol uses a reagent that is incompatible with retort residue you may need to abandon the pro
80. e retort lid seals and to the polished surfaces Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 117 Cleaning and Maintenance Clean Retorts Clean the retort walls daily with a lint free cloth moistened with 70 alcohol 1 gt Figure 64 Retort interior with air hole 1 level sensors 2 stirrer 3 and filter 4 e Ensure the air hole is unobstructed e Carefully wipe the liquid level sensors If you cannot remove stains with the alcohol solution use a lint free cloth moistened with 6 acetic acid or CLR then wipe again with ethanol If still not clean do a retort acid clean see 7 5 Retort Acid Clean Inspect the filter If soiled lift it out and clean with 70 alcohol CAUTI ON Take care not to drop anything into the opening when the filter is removed Foreign material in the line could stop valves operating properly Inspect the stirrer If dirty lift it out and clean with 70 alcohol If damaged or showing signs of rust contact your service representative for replacement To replace the stirrer hold it as indicated in Figure 65 and carefully allow it to slide onto the spindle in the bottom of the retort Figure 65 Stirrer handling correct left and incorrect right WARNING The magnetic coupling will pull the stirrer towards the bottom of the retort To avoid pinching your fingers do not allow them to be trapped between the stirrer and the bottom of the retort
81. e vapor select valve is in the internal position you must ensure the carbon filter is correctly installed or potentially dangerous fumes will be released into the laboratory environment Use the following procedure to reconfigure an externally connected instrument to internal carbon filter use 1 Ensure a new carbon filter is correctly installed see 2 4 3 Carbon Filter 2 Turn the vapor select valve a quarter turn clockwise to direct the vapors to the internal carbon filter see Figure 20 Note to access the valve you may need to remove a blanking plug AA Figure 20 Vapor select valve in the internal filter position 3 If required disconnect the external system from the vapor outlet see item 2 in Figure 18 You may leave the external system connected as the vapor valve effectively isolates this outlet 4 Set the carbon filter threshold to a value appropriate for your instrument s work load We recommend an initial threshold of 60 days with adjustments only if you are sure the carbon filter is becoming saturated earlier or is still in good condition after this time see 6 2 1 Instrument Settings If the carbon filter threshold has been overridden the carbon filter buttons will not be available Arrange for your service representative to cancel the override Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 37 Hardware 2 7 Alarm Connections REMOTE ALARM LOCAL ALARM Figure 21 Rem
82. e when a bottle is removed or if a station contains insufficient reagent This reassignment may use reagents assigned to the other protocol Station selection protocols will fail if an assigned reagent becomes unavailable Type selection protocols will fail if there is only one station with an assigned type and it becomes unavailable Some common causes of station unavailability and ways to avoid them are described below e The station contains insufficient reagent Prior to each run check the reagent level in each station is sufficient for the current fill level see Instrument settings screen for the reagent fill level A bottle scheduled for use is removed from the reagent cabinet For safety reasons you should not remove any bottle whilst a protocol is running However if you choose to do so you must make sure the bottle you intend to remove is not scheduled for use in either retort A wax station is not molten at the time it is required Make sure there is adequate time for the wax to melt and that the correct wax station state is set see 5 3 2 Setting Reagent Station Properties Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 57 Protocol Setup Protocols control all aspects of the tissue processing runs carried out on the Peloris This chapter gives an overview of Peloris protocols and how to create edit and view protocols with the software interface e 4 1 Protocol Overview e 4 2 C
83. ection method see 4 1 2 Reagent Selection Method Type 08 08 00 Y Validation status see 4 1 4 Protocol Validation Protocol duration Figure 38 Protocol icon Icons for the five protocol types see 4 1 1 Protocol Types have different background patterns and colors as shown below Standard Standard white and Standard Reprocessing white with red stripe Cleaning blue NE x Xylene free green and Xylene free Reprocessing green vvith red stripe Editing Protocols To edit an existing protocol open the Protocol selection screen select the protocol then tap Edit to open the Edit protocol screen Steps can be added and removed and step details time temperature etc changed The protocol s name notes carryover setting and validation status can all be changed You cannot change the protocol type or reagent selection method You cannot remove the dry step from a cleaning protocol Only supervisors can edit protocols Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 66 Protocol Setup Figure 39 and Figure 40 show the Edit protocol screen and describe its use Protocol icon updates Each row represents a as protocol is edited protocol step Protocol type cannot change Protocol configuration buttons see Figure 40 Selected step below for details tap the step number to select a step Cells in the step table show the settings for reagent time
84. ed Out but Processed Through to Wax Tissue Insufficiently Infiltrated with Wax Adequately Fixed Under processed Tissue Tissue Affected by Formalin During Clearing or Wax Infiltration 0 N O Ui A UU N Inadequately Fixed Under Processed Tissue 1 Tough Brittle Over Processed Tissue Treat the surface of the exposed tissue in the block with a rehydrating or softening agent e g e Melting ice e 0 2 aqueous Teepol or other wetting agent e Fabric softener at 5 e g Downy Mollifexm e 9 glycerol in 60 ethanol Treat for a few minutes rinse rechill and recut Reprocessing is inappropriate because it will cause further over processing 2 Gritty Tissue due to Calcium Deposits Treat the surface of the exposed tissue in the block with decalcifying agent for 15 30 min the time depends on the decalcifier used Rinse to remove acid rechill and recut Reprocessing tissue that contains calcium or other mineral deposits does not improve its cutting qualities The calcium must be removed 3 Hard Shriveled Tissue Dried Out Before Wax Infiltration Soak in a large volume of reconstitution solution Time 2 24 hr depends on the size and nature of the tissue and the severity of drying Reconstitution solutions include e Neutral buffered formalin e Isotonic saline e Sandison s solution 50 mL 196 aqueous formalin 30mL 96 ethanol Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty
85. ed the hose A cessation of reagent flow is not an indication that the procedure is complete Fill 6 Place the hose into the container of fresh reagent The reagent source must be above 5 C to ensure that all reagent sensors operate correctly 7 From the Remote fill drain screen select retort to use Remote icon bottle s to fill multiple bottles must all be Dry and set to the same reagent type Any bottle residue must be compatible with the new reagent Tap Fill to bottle s to begin filling When prompted check that the retort lid is closed and the remote fill drain hose is properly connected Tap OK to begin the fill 10 The Remote fill drain Reagent details dialog box will now appear Remote fill drain Reagent de Please confirm the delails of the remote fluid you are using to fill the bottle s Figure 55 Reagent details dialog box with reagent type concentration and use history for the new reagent 11 Confirm that the reagent type concentration and use history details are correct or tap in the table cells for any of these values to change the settings If you set a new reagent type the station must have already been set to that type see Assigning New Reagents to Stations in 5 3 Managing Reagent Stations The reagent must be compatible with the retort and bottle residue Tap OK to start the fill Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 92
86. ed with this agreement or the use of the Software to the price paid by the Licensee for the Software or the Goods containing the Software under the Supply Agreement Indemnity The Licensee indemnifies Leica Microsystems against all expenses losses damages and costs on a solicitor and own client basis incurred by or awarded against Leica Microsystems arising directly or indirectly from or in relation to a any use of the Software not in compliance with this agreement b any breach of any Third Party Licence Terms by the Licensee c the Licensee s infringement of Leica Microsystems Intellectual Property rights d clinical including without limitation diagnostic prescription and other treatment errors made while using or otherwise associated with the use of the Software or Documentation Software Licence Terms e any failure by the Licensee to comply with laboratory practices that are consistent with industry practice laws guidelines or decisions in the handling or use of the Software f the Licensee s negligent acts or omissions and ortany other use or misuse of the Software by the Licensee 10 Term and termination 10 1 Term This agreement commences on the Effective Date and continues until terminated in accordance with this agreement 10 2 Termination a The Licensee may terminate this agreement at any time by destroying all copies of the Software and Documentation b The Licensee s rights under this agreement w
87. ee the size of the files transfer selected files to you have configured to the remote device transfer at right of button Figure 59 File transfer screen Refer to the follovving sections for detailed file transfer instructions e Attach or Remove a USB Key e Transferring Protocols e Transferring Instrument Condition Files Service Logs and Event Details e Transferring Incident Report Files e Remote Device File Structure e Archiving Log Files Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 109 Settings amp Ancillary Operations Attach or Remove a USB Key Use a USB key to copy files to Only use the network FTP or RemoteCare options if instructed by a service representative You can use a floppy disk but this may not hold all the files to transfer Prepare the instrument on the File transfer screen before connecting or disconnecting the USB key Any running protocols vvill pause vvhile the instrument is attempting to connect to the USB key Follovv the instructions belovv to either connect or disconnect a USB key 1 2 3 4 Open the File transfer screen Control menu File transfer Tap the Add Remove USB device s button in the Remote connection type section Wait as prompted in the Add Remove devices dialog box When the instrument is ready the message changes You have 30 seconds to add or remove the key before the function automatically times out plug or unplu
88. eica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 123 Reference This chapter has useful reference information to help you set up and operate the instrument e 8 1 Reagent Threshold Guidelines e 8 2 Protocols 8 3 Station Configurations e 8 4 Protocol Step Temperatures 8 5 Reagent Compatibility Tables Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 124 Reference 8 1 Reagent Threshold Guidelines The tables in this section list the recommended thresholds for commonly used reagents There are separate tables for xylene and xylene free processing Xylene Processing For the best results xylene processing reagent changes should be based on concentration thresholds while cleaning reagent thresholds should be based on cycles Thresholds for xylene processing reagents including cleaning reagents using nongraded alcohol are Reagent change Final reagent e thresholds thresholds Max temperatures c Conc Cassettes 96 Cassettes Ambient Vacuum or cycles or cycles 1500 cass N A Type Formalin Ethanol 51 45 Xylene 99 45 Wax 4500 cass 95 0 100 77 Cleaning xylene 10 cycles N A 99 45 Cleaning ethanol 10 cycles N A Xylene free Processing In general xylene free processing reagent changes should be based on concentration thresholds and cleaning reagent changes based on cycles
89. elow for special conditions for initial bottle setup Station Reagent type Reagent group Bottle 1 Formalin Fixative Bottle 2 Formalin Fixative Bottle 3 Ethanol Dehydrant Bottle 4 Ethanol Dehydrant Bottle 5 Ethanol Dehydrant Bottle 6 Ethanol Dehydrant Bottle 7 Ethanol Dehydrant Bottle 8 Ethanol Dehydrant Bottle 9 Ethanol Dehydrant Bottle 10 Ethanol Dehydrant Bottle 11 Xylene Clearer Bottle 12 Xylene Clearer Bottle 13 Xylene Clearer Bottle 14 Xylene Clearer Bottle 15 Cleaning xylene Cleaning solvent Bottle 16 Cleaning ethanol Cleaning alcohol Wax 1 Wax Wax Wax 2 Wax Wax Wax 3 Wax Wax Wax 4 Wax Wax alcohol dehydrants after fixative should be labeled and named in the software Ethanol However if setting up bottles on a new instrument or replacing all the ethanol bottles at once the first and second bottles should be filled with 70 and 90 ethanol respectively As operation continues and you are prompted to replace degraded bottles replace with 100 ethanol Other initially higher concentration bottles will have degraded so there will always be at least one bottle at a low concentration Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 135 Xylene free Configuration Reference This is the suggested station configuration when running xylene free protocols see 8 2 4 Xylene free Protocols See note below for special conditions
90. en 45 stirrer 28 removal 118 supervisor 22 switching on 24 T tables in software 19 Taggart s method 150 temperature thresholds 77 thresholds reagent 76 final reagent 77 purity 76 reagent change 76 temperature 77 time and date format 104 tissue dying 79 tissue marking 79 top surface cleaning 119 touch screen 35 brightness 105 cleaning 119 colors 106 locking 106 transferring service files 112 troubleshooting 139 troubleshooting flowcharts 140 type definition 73 selection method 60 U unavailable reagents 57 under processed tissue instrument problems 141 reagent problems 143 units setting 105 USB key 110 validation protocol 62 vent retort 26 wax bath 32 99 viewing a protocol 71 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 159 WwW wax cleaning 102 heat lines 99 melt temperature 102 preheat 100 standby temperature 102 wax bath 32 cleaning 120 fill level 26 settings 102 vent 99 wax station drain and fill 95 status 47 X xylene free protocols 59 list of pre defined 131 reprocessing 59 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 160
91. ent Medium 10 7 IPA 1 Ambient Ambient Medium 10 8 IPA 25 55 Ambient Medium 10 9 Wax 25 85 Vacuum Medium 10 10 Wax 10 85 Vacuum Medium 10 11 Wax 5 65 Vacuum Medium 10 Processing time 2 11 00 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 131 Reference Xylene free 4 Hour e Pre defined protocol Factory 4 hr Xylene Free e Carryover setting in pre defined protocol 50 Step Reagent type Time min Temp C P V Stirrer on ume 1 Formalin 10 55 Ambient Medium 10 2 85 Ethanol 3 Ambient Ambient Medium 10 3 85 Ethanol 22 55 Ambient Medium 10 4 80 20 Ethanol IPA 10 Ambient Ambient X Medium 10 5 80 20 Ethanol IPA 40 55 Ambient X Medium 10 6 IPA 3 Ambient Ambient Medium 10 7 IPA 10 55 Ambient Medium 10 8 IPA 45 55 Ambient Medium 10 9 Wax 45 85 Vacuum Medium 10 10 Wax 20 85 Vacuum Medium 10 11 Wax 10 65 Vacuum Medium 10 Processing time 4 02 00 Xylene free 6 Hour e Nota pre defined protocol Step Reagent type Time min Temp C P V Stirrer 5 ume 1 Formalin 20 55 Ambient Medium 10 2 85 Ethanol 15 55 Ambient Medium 10 3 85 Ethanol 20 55 Ambient Medium 10 4 80 20 Ethanol IPA 20 55 Ambient Medium 10 5 80 20 Ethanol IPA 45 55 Ambient Medium 10 6 IPA 15 55 Ambient Medium 10 7 IPA 30 55 Ambient Medium 10 8 IPA 60 55 Ambient Medium 10 9 Wax 45 85 Vacuum Medium 10 10 Wax 40 85 Vacuum X Medium 10
92. ents Control Help 03 25 Figure 5 The Function bar The Function bar is always visible so you can always find the screen you want Tap a button in the bar to change screens immediately or open a menu with buttons for a number of related screens Some screens have alternative views to divide the information presented For example the Reagent stations screen has two views one each for bottle and wax chamber information Use buttons on the screens themselves to move between the alternative views Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 20 Introduction The table below lists all the screens in the Peloris software with brief descriptions of the screen functions and links to relevant sections of the manual Function bar button Status Protocols Reagents Control Help Menu button Screen purpose Load and run protocols and view system status Select create edit and manage protocols Set up reagent stations You can also view Refer to 3 3 Status Screen 4 2 Creating Editing and Viewing Protocols 5 3 Managing Reagent Stations the current reagent concentrations and wax Stations bath temperatures T Manage your list of active reagent types 15 2 Managing Reagent ypes Types Remote fill Fill or drain reagent bottles and drain wax 15 4 Replacing Reagents drain stations Manual Manually control individual instrument com 6 1 1 Manual
93. er is in progress or was aban doned The reagent level is between full and empty Empty The bottle has been used to fill a retort There is still reagent in the bottle Dry The bottle has been com pletely drained leav ing only a small amount of residue No bottle The bottle has been removed Reagent type Reagent concentration may not be visible see 6 1 2 Reagent Management Color or other pattern shows station state see below Unknown A previously missing bot tle has been replaced Enter reagent and state details before using this sta tion Icon Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 2 c i 46 Running Protocols Wax Chamber cons Padlock symbol shows Wax concentration there is a vacuum in may not be visible see 6 1 2 the chamber Reagent Management 5 Hatched coloring Wax chamber SS shows Wax is out of SS S t threshold Reagent type Col r code orange for olor or other pattern i e type of wax reagent group Wax shows station state see below Figure 27 Wax chamber icons on the Status screen Wax chambers have four possible station states Means Icon The chamber has enough wax to fill a retort Full to the specified basket level A wax transfer is in progress or has been Part full abandoned The wax level is between full and empty The chambe
94. es the number of cassettes entered here for all processing runs In this case be sure to enter an accurate average value the number is used by the reagent management system to calculate reagent concentrations e Default carryover the default carryover setting used for new protocols until a new value is set see 4 1 5 Carryover Setting e Show conc view only hides or shows the current wax and bottle concentrations on the Status screen Reagent Threshold Check The four buttons in the Reagent threshold check section of the Reagent management screen show which types of reagent thresholds the system is using see 5 1 3 Thresholds By default all four threshold types are enabled Contact your customer support representative to change any of these settings By cassettes the system tracks the number of cassettes processed by the reagent in each station If the reagent type has a cassette threshold set you are alerted when the station goes beyond that threshold By cycles the system tracks the number of processing runs performed by the reagent in each station If the reagent type has a cycle threshold set you are alerted when the station goes beyond that threshold e By days the system tracks the number of days the reagent in each station has been loaded If the reagent type has a days threshold set you are alerted when the station goes beyond that threshold conc the system tracks the concentration o
95. essor uses five protocol types for different processing functions The protocol types allow different reagent sequences and temperature ranges see 8 5 Reagent Compatibility Tables and 8 4 Protocol Step Temperatures Once a protocol is created you cannot change its type The protocol types are Standard conventional tissue processing sequences using a clearer such as xylene Suitable for normal processing requirements These protocols can be constructed with or without defatting steps Standard reprocessing to recover under processed tissue on an instrument configured for standard processing These protocols start with cleaning reagents before moving to a standard tissue processing sequence Xylene free protocols with high temperature wax steps and advanced processing techniques to process tissue without conventional clearing steps Suitable for normal processing requirements Xylene free reprocessing to recover under processed tissue on an instrument configured for xylene free processing These protocols start with cleaning reagents before moving to a xylene free tissue processing sequence Cleaning protocols to clean the retorts and reagent lines Always run a cleaning protocol as soon as possible after wax has been in the retort See 3 2 Cleaning Protocols for further information See Protocol Icons in 4 2 1 The Protocol Selection Screen for the icons used for each protocol type Note the following points Xylene
96. f reagent in each station If the reagent type has a concentration threshold set you are alerted when the station goes beyond that threshold Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 101 Settings amp Ancillary Operations Retorts The Retorts section of the Reagent management screen shows the state of and last reagent used for each retort It also shows the empty access temperature the temperature up to which it is safe to open empty retorts The system warns you if you perform any action that requires you to open an empty or clean retort with a temperature exceeding this value The settings in this section can only be changed by your service representative Wax Bath Settings Turn wax cleaning on and off with the Wax clean button on the Reagent management screen The wax clean function improves the quality of the wax by periodically evacuating the wax bath for approximately 30 seconds to draw off any contaminants You may need to periodically add small amounts of wax to replace solvents that have been removed e Enable wax cleaning for protocols that use xylene and or IPA e Disable wax cleaning for protocols that use xylene or IPA substitutes these clearers are not efficiently removed by the evacuation process By removing contaminants wax cleaning increases wax concentrations The system automatically updates the concentration of each wax station after each wax clean cycle VVax cle
97. free reagent selection xylene free protocols use two sets of dehydrants rather than dehydrant followed by clearer as used in standard protocols This means xylene free protocols cannot use group reagent selection see 4 1 2 Reagent Selection Method Xylene free baskets always use spaced cassette baskets for xylene free protocols Reprocessing carryover during reprocessing protocols there is significant reagent carry over following the cleaning stages After running a reprocessing protocol you should replace the first three processing reagents that are used after the last cleaning reagent Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 59 4 1 2 Protocol Setup Reagent Selection Method All protocols use one of three reagent selection methods group type or station see 5 1 1 Reagent Groups Types and Stations for definitions of these terms Once a protocol is created you cannot change its reagent selection method A protocol s reagent selection method determines the way the system selects reagent stations when the protocol is run With the station selection method you define exactly the station to use for each step so the system makes no choices For group and type selection the system selects a station from a number that are available to it to get the best concentration for the protocol step see Station Selection Rules below In summary e Group selection the system selects from a
98. function attempts to assign reagent stations and start times so that there are no clashes and it may alter your requested end time by starting the protocol early or by inserting a delay time see 3 6 1 Delayed End Times and Initial Fills Also when starting a second protocol you may notice that the reagent stations assigned when a protocol was loaded change as it begins to run This occurs when the instrument must alter the assignment to allow for the first protocol s current reagent requirements It is sometimes not possible to schedule a second protocol This situation and possible remedies are discussed in 3 6 2 Unavoidable Reagent Clashes Also protocols will sometimes fail if a reagent station unexpectedly becomes unavailable 3 6 3 Unavailable Reagents describes the best ways to avoid this situation 3 6 1 Delayed End Times and Initial Fills Protocols do not need to start immediately and it is possible to set a required end time that necessitates a delay before the actual protocol begins This delay period can extend to many days Also when selecting the ASAP As Soon As Possible scheduling option or if you have requested an end time that is not achievable the Peloris tissue processor may be forced to delay the start of the protocol During the protocol delay period the Peloris tissue processor will protect your cassettes by covering them with reagent this process is called an initial fill During the initial fill the retort is filled
99. g bottle lids as fluid spills and vapor leaks will occur Condensate Bottle A separate bottle collects condensate fluid It sits beside the reagent bottles in the lower section of reagent cabinet Empty weekly Do not allow the bottle to overflow as condensate fluid will spill from the instrument or contaminate other reagents WARNI NG SN Never run the instrument with the condensate bottle missing or its lid either loose or missing as fluid spills and vapor leaks will occur Carbon Filter The carbon filter absorbs reagent fumes to prevent them from entering the laboratory atmosphere To ensure the filter is operating effectively it must be replaced periodically Use the Carbon filter threshold button to set the replacement interval see 6 2 1 Instrument Settings The carbon filter can be bypassed and the instrument connected to an external vapor removal system see 2 6 External Vapor Removal Systems WARNING SN Never run the instrument without the carbon filter or an external filter system this will release potentially dangerous fumes into the laboratory The filter must be installed with the direction arrow on the front pointing up and the locking mechanism closed see Change Carbon Filter in 7 4 60 90 Days Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 34 Hardware 2 5 Touch screen A touch screen mounted on the right of the Peloris connects to a computer in the instrument that controls all
100. g your USB key into from the USB port at the front of the instrument To continue either the OK button from the Add Remove devices dialog box or Wait for the auto continue function to activate after 30 seconds The Updating devices dialog box now appears You may also see some additional dialog boxes as the instrument reconfigures Ignore these dialog boxes as they will cease to appear after approximately 10 seconds When all dialog boxes have closed Attach key tap the USB Key button in the Remote connection type section Remove key continue with normal operation You have now completed these instructions If you attached a USB key check the connection status at the bottom of the Remote connection type section If the key is detected proceed to file transfer configuration If the key is not detected tap the Refresh button If this does not work remove the device following these instructions check that it is switched on if required then repeat these installation instructions Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 110 Settings amp Ancillary Operations Transferring Protocols The protocol transfer functions provide an easy way to backup your protocols so they may be restored if lost The functions also allow you to share protocols across instruments 1 Attach a USB device to the instrument see Attach or Remove a USB Key above 2 Tap the Import Export protocol
101. ge thresholds This ensures minimum contamination from the preceding reagent group to the subsequent reagent group Reagents that have exceeded their final threshold are displayed as usual on the Status screen however Peloris displays a warning message Following the warning you are able to process one run default setting that uses reagent that is out of threshold for the final step After this you will not be able to load protocols that require the reagent group affected VVhen you are vvarned that reagent has exceeded the final threshold replace the least pure bottle of the reagent type concerned The bottle that exceeded the final reagent threshold triggering the warning will still have reagent with a relatively high concentration It will still be acceptable for steps in the protocol sequence before the final step so it is inefficient to replace it Temperature Thresholds There are three temperature thresholds for each reagent type e Ambient the highest allowable temperature for the reagent in the retort at ambient and high pressure e Vacuum the highest allowable temperature for the reagent in the retort when the retort is evacuated Safe the highest temperature at which it is safe to open a retort containing the reagent The Peloris software will not allow you to create protocols that put reagents in conditions that exceed their ambient or vacuum temperature thresholds The software warns you if you perform an a
102. ged as some tissue may not be fully covered by reagent during processing WARNI NG Never place three baskets into a retort when the instrument is configured with a two basket fill level If this occurs reagent will not cover the top basket and tissue samples will be damaged Opening and Closing Cassette Baskets The lid is held by two catches and is completely removable to aid cassette access Figure 9 Releasing the lid Figure 10 Replacing the lid e To remove the lid release one catch then swing the lid up and off the basket see Figure 9 To replace the lid insert one end into a catch then swing the other end down so it firmly engages the second catch see Figure 10 e Make sure the lid is firmly held by both catches or the body and cassettes may fall when the basket is lifted High capacity Baskets High capacity baskets include dividers to configure the baskets to hold different numbers of cassettes Use all the dividers to configure the baskets for orderly packing up to 88 cassettes or the long dividers only for tight packing up to 100 cassettes For orderly packing insert both the long and short dividers into the basket This arrangement makes it easier to insert and remove the cassettes see Figure 11 and Figure 12 Six standard Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 29 Hardware cassettes can be placed in the end sections of each row and five in the middle sections gi
103. gent management screen shows the methods enabled for your system these settings can only be changed by customer support representatives The checking methods are configured to monitor two types of purity threshold reagent change thresholds and e final reagent thresholds explained below Reagent Change Thresholds Reagent change thresholds set the limits for any use of reagent on the Peloris system Reagent that has exceeded its change threshold should be replaced with fresh reagent immediately Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 76 Reagent Setup Stations with reagent that has exceeded its change threshold are shown with a hatched icon on the Status screen bottle icon shown at right In addition the system displays a warning message The Peloris system does not use out of change threshold stations unless no other stations are available If no other stations are available out of threshold stations will be used for one run default setting before being locked Locked stations cannot be used at all until the reagent is replaced The system will not allow you to load protocols that require a locked station 7 gt WH Final Reagent Thresholds Final reagent thresholds set limits on reagent purity for use in protocol steps that precede a change to another reagent group or type for protocols configured by type in the next step Final reagent thresholds are set higher than chan
104. gments The Licensee acknowledges that a it has selected the Goods from a range of products and has satisfied itself that the Goods meet the Licensee s requirements b no oral or written information representation or advice given by or on behalf of Leica Microsystems other than as contained in this agreement creates a warranty or in any way increases the scope of this agreement and c unless expressly agreed otherwise in writing the Licensee has not relied on any information representation or advice given by or on behalf of Leica Microsystems in selecting the Goods and d Leica Microsystems makes no representation that the Goods conform to country state or local laws ordinances regulations codes or standards except as may otherwise be agreed to in writing by Leica Microsystems and the Licensee is responsible for complying with all local laws relating to use of the Goods at its own cost Exclusion of implied terms Leica Microsystems excludes from this agreement all conditions warranties and liabilities implied or imposed by law or custom except any liability or implied condition or warranty the exclusion or limitation of which would contravene any statute or cause any part of this clause 8 to be void non excludable conditions Non excludable conditions To the extent permitted by law Leica Microsystems liability for any breach of any Non Excludable Condition is limited to a in the case of services the resupply of
105. grossing stage for only a short time and fixation steps on the Peloris can also be short So some customers prefer to add eosin at the alcohol stage This is also acceptable if due care is taken Recommended eosin concentrations for the different stages are given below Testing was conducted using Surgipath Alcoholic Eosin 1 catalog no 3801600 CAUTION AN If adding eosin to reagents on the Peloris be sure to clean the retorts daily to avoid buildup of dye on the liquid level sensors which can compromise performance See Clean Retorts in 7 2 Daily Tasks Preference 1 At Grossing Use 10mL of 1 liquid eosin per liter of formalin You can vary the concentration to correspond with the length of the processing protocol where some dye will be lost A disadvantage of staining at grossing is that specimens are not immersed in dyed formalin for the same amount of time Preference 2 In Fixative on Peloris Use 50 mL of 1 liquid eosin per 5 L Peloris reagent bottle of formalin Preference 3 In Alcohol on Peloris Xylene Use 10mL to 25mL of 1 liquid eosin per 5 L Peloris reagent bottle of ethanol there are eight ethanol bottles in the recommended bottle configuration for xylene processing Specimens are immersed in the marking reagent for the same amount of time giving consistent staining Protocols longer than two hours may cause overstaining reduce the eosin concentration as required Preference 3 In Alcohol on Pelo
106. gy equipment Congratulations on your purchase of the Leica Peloris rapid tissue processor We trust it will provide you with years of fast efficient high quality tissue processing This chapter has the following sections e 1 1 Summary of Chapters e 1 2 Using the Software e 1 3 Help Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 17 Introduction 1 1 Summary of Chapters e Chapter 1 Introduction general introduction chapter summary general instructions for using the software and help resources e Chapter 2 Hardware descriptions of the main components of the Peloris instrument e Chapter 3 Running Protocols main steps for running protocols further configuration options and scheduling monitoring processing on the Status screen e Chapter 4 Protocol Setup descriptions of protocol types and the reagent selection methods used protocol validation and the carryover setting Creating and editing protocols e Chapter 5 Reagent Setup reagent groups types and stations and reagent management on the Peloris Setting up reagent types and stations in the software Replacing reagents e Chapter 6 Settings amp Ancillary Operations basic instrument settings independent operation of instrument components event monitoring alarms and transfer of system files e Chapter 7 Cleaning and Maintenance daily and as required maintenance accessories available from Leica Microsystems e Chapter 8
107. hamber manually and then update the software See sections below e 5 4 1 Remote Fill Drain Screen e 5 4 2 Remote Fill Drain Connections e 5 4 3 Replacing Reagent Remote Fill and Drain e 5 4 4 Replacing Reagent Manual e 5 4 5 Replacing Wax e 5 4 6 Filing and Draining Retorts Remote Fill Drain Screen Use the Remote fill drain screen Reagents menu Remote fill drain to drain the wax baths and to fill and drain reagent bottles without removing them from the instrument You are able to fill drain stations individually or as a group of compatible stations in a single operation You can also fill and drain retorts from this screen to enable recovery from partially completed fill drain operations All users can perform the functions on the Remote fill drain screen Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 88 5 4 2 Reagent Setup Figure 50 shows the Remote fill drain screen with the main features described Fill to Drain from bottles Drain to waste or Fill Drain retort start fill or drain when appropriate station remote source and retort are selected Retort A scheduled fill drain operations for retort A Abandon stop the drain or fill Wax waste select with a wax chamber to an chamber Remote F select vvith a retort and bottle to fill or drain the bottle Retort B scheduled fill drain operations for retort A DP d d Gn Gn GD 1
108. he Instrument settings screen can be viewed but can only be changed by a service representative e Carbon Filter Settings e Time and Date e Instrument Shutdown Reagent Fill Levels e Manual Drain Drip Time e Language and Unit Settings Carbon Filter Settings Tap the Carbon filter age button to reset the age of the carbon filter to zero days You should do this when replacing the carbon filter so the Peloris tissue processor can track its age and provide proper warnings when it exceeds its age threshold Tap the Carbon filter threshold button to set the number of days a filter can be used before it should be replaced The correct threshold value depends on the average number of protocols you run each day and the type of reagents used We recommend an initial threshold of 60 days with adjustments only if you are sure the carbon filter is becoming saturated earlier or is still in good condition after this time If you are using an external vapor removal system set the carbon filter threshold to either Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 103 Settings amp Ancillary Operations e The inspection interval for the external system e The maximum value 1000 to limit the number of unwanted warnings e Overridden contact your service representative to arrange this setting See 2 6 External Vapor Removal Systems for more information Time and Date Supervisor level users can change the time
109. he rapid wax heating process While in the Not molten state the wax bath chamber temperature is higher than normal to ensure the wax melts quickly You may need to add extra wax as it melts The station s state automatically changes to Full when the wax is ready to use Filling and Draining Retorts The Remote fill drain screen allows you to fill and drain the retorts to assist recovery from incomplete remote fill drain operations The retort fill and drain functions operate with a series of rules designed to avoid reagent contamination reagent overflow spills and reagent overheating You can override some rules but this will often result in reduced reagent concentration You can also fill and drain retorts using the Manual operations screen see 6 1 1 Manual Operations The rules for manually filling and draining retorts are as follows e The retort must be clean or empty before you commence a retort fill operation e Ifthe retort is empty the selected station must have compatible reagent see 8 5 Reagent Compatibility Tables e You cannot fill a retort with a reagent that has a temperature threshold below the set retort temperature e When draining a retort the reagent must return to its original station e When draining a retort the station must have sufficient capacity for the retort contents To avoid fluid spills ensure adequate station capacity before overriding insufficient capacity errors To fill or drain a retort select
110. he size and nature of the specimen see 8 2 1 Specimen Type and Protocol Duration This method is the quickest however it causes wax contamination of the reagents on the processor Change all reagents except wax after direct reprocessing 7 Tissue Affected by Formalin During Clearing or Wax Infiltration This problem can occur if a leaking valve allows backflow of formalin into the wax bath Contact customer support to test your instrument if you see this problem Formalin contamination is characterized by blue hue in the nuclei loss of chromatin detail nuclear shrinkage variable eosinophilia and cytoplasmic swelling and or shrinkage First melt down the blocks blot off excess wax and then place the specimens in new cassettes This minimizes wax contamination of the processing reagents Then reverse process the blocks by any of the methods listed for problem 6 After this soak in a high pH Tris HCl retrieval solution e g Bond Epitope Retrieval Solution 2 for 2 12 hrs at room temperature This treatment improves the staining qualities of the H amp E the cutting qualities of the tissue and the cohesiveness of the section Nuclear detail cytoplasmic swelling and definition are unlikely to improve 8 Inadequately Fixed Under Processed Tissue A possible remedy is to slowly reverse process the tissue see 6C apply additional formalin fixation then reprocess using a schedule suitable for the size and nature of the specimen see
111. he state of the wax chamber Before you begin ensure there is a retort available Draining wax does not fill a retort but it does use retort scheduling resources so at least one retort must be available The retort does not need to be clean The wax to be drained must be molten Follow the instructions below to replace wax in a chamber Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 95 Reagent Setup Drain 1 Connect the wax waste hose and place the end in a suitable container see 5 4 2 Remote Fill Drain Connections 2 From the Remote fill drain screen Reagents menu Remote fill drain select wax stations to drain Wax waste icon When wax chamber and Wax Fil Drair Select the wax chamber or waste icon are selected tap chambers to drain Drain to waste to start the as drain ans Retort A Select VVax vvaste icon Wax waste Figure 57 Remote fill drain setup for draining wax chambers Tap Drain to waste to begin the drain 4 When prompted check that the wax waste hose is properly connected and feeding into a suitable container Tap OK to begin the drain 5 The instrument will now drain the chamber s Monitor the drain progress in the status panel Wax drains may take up to three minutes When the drain completes the chamber state will be Empty WARNING The wax leaving the waste wax line will be hot and may cause burns Make sure the wax dra
112. ill damage any tissue left in the retort Tap Done in the dialog box when you have inserted the baskets and closed the retort Tap Start in the Scheduling dialog box to begin the run If required change the protocol s end time before starting View the progress of the protocol in the Status screen When the protocol is finished the Protocol complete dialog box opens and the alarm sounds tap OK to continue When the Remove baskets dialog box appears open the retort lid and remove the baskets Tap OK to continue Tap Unload protocol in the Status screen so the retort is available for the next protocol WARNING Do not open a retort while a protocol is running as the retort could be pressurized and may contain hot reagent and fumes Always follow the retort access instructions detailed in 3 5 Pausing and Abandoning Protocols if you need to access a retort during processing Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 42 3 2 Running Protocols Cleaning Protocols Cleaning protocols clean the retorts and reagent lines Always run a cleaning protocol as soon as possible after processing runs unless there are specific reasons not to always select the Clean now option when prompted at the end of a run Also clean retorts after replacing reagent by remote fill and drain or if you filled the retorts using manual operations For most laboratories the pre defined Quick Clean protocol should be the o
113. ill terminate immediately without notice from Leica Microsystems if the Licensee fails to comply with any provision of this agreement or if the Licensee does not strictly observe the terms of payment under the Supply Agreement and on termination the Licensee must destroy all copies of Software and Documentation in its possession or control 10 3 Accrued rights and remedies Termination of this agreement under this clause 10 does not affect any accrued rights or remedies of either party 10 4 Survival Clauses 4 Intellectual property 7 Confidentiality and privacy 8 Exclusions and limitations 9 Indemnity 10 3 Accrued rights and remedies 10 4 Survival 11 Force majeure and 12 General continue after termination of this agreement 11 Force majeure Neither party will be liable for any delay or failure to perform its obligations pursuant to this agreement other than on obligation to pay money if that delay is due to Force Majeure If a delay or failure of a party to perform its obligations is caused by or anticipated due to Force Majeure the performance of that party s obligations will be suspended Either party may terminate this agreement if a Force Majeure persists for a continuous period of 90 days 12 General 12 1 Severance Part or all of any provision of this agreement that is illegal or unenforceable may be severed from this agreement and the remaining provisions will continue in force 12 2 Entire agreement This ag
114. ilter when the software indicates that it has expired Running the instrument with an out of date carbon filter may release potentially dangerous fumes into the laboratory Ensure you have the carbon filter threshold set to a suitable number of days to alert you when filter changes are due See Carbon Filter Settings in 6 2 1 Instrument Settings Use the following procedure to replace a used filter 1 Unlock the filter by turning the latch 1 4 turn clockwise and slide the old filter out z enum GIO LA 1 i i i i Figure 66 Unlocking the filter Figure 67 Removing the filter 2 Remove the plastic wrap from the new filter 3 Slide the new filter into the housing with the direction arrow pointing up see Figure 68 Figure 68 Replacing the carbon filter with Figure 69 Locking the filter direction arrow 1 pointing up Turn the latch 1 4 turn anti clockwise to lock the filter in place see Figure 69 Make sure the filter is unwrapped fully inserted and that it is locked into the housing Reset the carbon filter age from the Instrument settings screen see 6 2 1 Instrument Settings Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 122 Cleaning and Maintenance Check Lid Seals Inspect the retort and wax bath lid seals every 60 90 days Replace if worn or damaged 1 Pull the old seals out of the grooves 2 Clean the grooves if necessary with the wax scraper
115. ingle Run Reagent compatibility varies depending on the action or protocol being undertaken Use the reagent tables in 8 5 Reagent Compatibility Tables to check reagent compatibility before creating protocols conducting manual operations or initiating remote fill drain procedures 5 2 Managing Reagent Types The Peloris software uses two lists of reagent types an active list for reagents you use and a dormant list with all reagent types configured in the system Supervisors can edit the default concentrations and purity and temperature thresholds see 5 1 3 Thresholds for active reagents They can easily move reagents on and off the active list and create new reagent types Operators can only view the active list See sections below for editing and managing reagent types e 5 2 1 Pre defined Reagents e 5 2 2 Editing Active Reagent Types e 5 2 3 Managing the Reagent Types Lists 5 2 1 Pre defined Reagents A number of reagent types are pre defined in the Peloris system You can edit the properties of these reagent types but they can cannot be deleted There is no requirement to use the pre defined types however you can leave them on the dormant list If you change the properties of pre defined reagent types you cannot use the software to automatically return them to their original values However the default values for many of the pre defined reagents are shown in 8 1 Reagent Threshold Guidelines Leica PELORIS
116. ins to a suitable container and stand clear while it drains WARNING Do not remove the wax drain container or hose until the software indicates that the drain has A completed A cessation of wax flow is not an indication that the drain procedure is complete If no wax drains it is likely that the wax hose is blocked If you remove a blocked hose before the drain is abandoned hot wax will spurt from the front of the instrument Abandon the drain before removing the hose and melting the wax with hot water 6 To stop wax solidifying in the drain hose promptly remove the hose from the drained wax At any time during the drain you can tap the Abandon button to terminate all current and pending fill drain operations Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 96 5 4 6 Reagent Setup Fill 7 Fill the wax chamber with molten or solid wax 8 Open the Reagent stations screen wax chambers view Reagents menu Stations then tap the Wax chambers button The row for the drained wax chamber shows the default concentration and all use history values set to zero The station state is Dry The reagent type is unchanged from the wax that you drained unless you changed the type assigned to the station after the drain see Assigning New Reagents to Stations 9 Tap the State cell for the chamber If using molten wax set the state to Full using solid wax set the state to Not molten to begin t
117. instrument operations Use the Peloris software on the touch screen to configure the instrument run protocols and perform ancillary operations such as replacing reagents Tap buttons and icons with your finger or a blunt object do not use sharp objects Ensure no strong solvents come into contact with the touch screen Optional stick on peel off touch screen protectors provided by Leica Microsystems can be used to protect to the touch screen In its normal operating position the touch screen sits over the wax bath lid but can be rotated to give clearance to open the lid The screen can be remounted so its normal position is to the right of the mounting stem rather than over the instrument See your service representative if you want to change the touch screen position CAUTION If the touch screen goes blank or is unreadable turn off the instrument immediately 2 6 External Vapor Removal Systems Figure 18 Vapor select valve 1 and vapor outlet 2 The outlet for instrument vapors can be switched between the internal carbon filter and an external vapor extraction system At the rear of each instrument there is a valve that directs vapors to either the carbon filter or to an outlet that can be connected into the external system Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 35 Hardware e For instructions on changing to an external vapor system see Connecting to an External System below
118. ion The use history values are all set to zero If you changed the reagent type in the bottle you cannot update it in the software from this dialog box Tap No change and then remove the bottle again Change the reagent assigned to the bottle in the Reagent stations screen see Assigning New Reagents to Stations then reinsert the bottle e Topped off up select if you did not change all the reagent but added a small amount of fresh reagent of the same type to bring up its level in the bottle With this option the bottle state changes to Full The concentration and use history details do not change No change select if you made no changes to the reagent in the bottle at all Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 94 5 4 5 Reagent Setup With this option you must select the bottle state The concentration and use history details do not change WARNING Always change reagents when prompted Always update station details correctly never update the details without replacing the reagent Failure to follow these directives can lead to tissue damage or loss WARNING Ensure lids are tight and the bottles are correctly plugged into the manifold after replacing reagent to avoid reagent spills Replacing Wax To replace wax 1 drain the wax chamber using the Remote fill drain screen commands 2 refill the wax chamber manually with molten or solid wax and then 3 resett
119. ired end time keep the current end time but the protocol end time you 13 30 Fri 27 Nov 09 change its day have set zt L f Edit end time ASAP iyu Edit end time change the end time for the start the run as soon as run or set a nevv default end possible time for the retort 13 29 Fri 27 Nov 09 Predicted end time the end time predicted by the Peloris system after Start scheduling start the protocol run Figure 31 The Scheduling dialog box Each retort note not each protocol has a default scheduling setting The Scheduling dialog box always opens showing the retort s default setting You can accept the default or change the setting for the run with options to set a different end time or run the protocol as soon as possible the ASAP option Also change the retort defaults from the Scheduling dialog box The system considers the required end time as the latest acceptable protocol completion time To avoid resource clashes protocols may be scheduled to finish earlier than the required end time A red highlight indicates that the required end time is not possible and a later end time has been set The required end time for cleaning protocols is always set to ASAP Always check the predicted end time to ensure it is suitable before starting a protocol Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 50 Running Protocols How To Schedule a Protocol Run When the Scheduling dialog
120. ith minimal management You get maximal use from reagents and with the widest range of stations to select from scheduling conflicts are minimized You must however take some care when using group selection as the Peloris tissue processor may use a reagent type you wished to reserve for a particular purpose In these cases use the type or station selection method or for one off instances temporarily block a station by setting its state to In use see Setting Station States in 5 3 2 Setting Reagent Station Properties Type selection offers the same sorts of benefits as group selection optimal selection of reagents according to concentration minimal reagent management efficient reagent use and minimal scheduling conflicts However provided there is more than one reagent type per group the system selects from a smaller range of stations so the benefits are lessened On the other hand you have greater control over reagent selection Station selection gives you total control over reagent selection However as reagents degrade you need to rearrange bottles between protocols if you want to ensure the most suitable reagents are used This is a significant management burden that opens the possibility for errors Also the station select method does not allow the instrument any flexibility when scheduling protocols and it will not be able to recover from a processing error caused by unexpected reagent unavailability Station selection protocol
121. iving log files 113 artifact block 148 cutting 146 staining 147 ASAP 50 B backup files 109 basket 28 biopsy pad setting in previous software versions 64 biopsy pads cassettes etc carryover from 62 block artifact 148 bottle condensate 34 fill level 26 reagent 34 bottle connectors 121 brightness touch screen 105 C calcium deposits 149 carbon filter 34 change 122 settings 103 carryover default setting 101 general discussion 62 protocol setting 62 cassette basket 28 cassettes default number 101 prompt for number 101 cleaning protocol 43 59 134 reagent bottles 120 retort 118 retort lids 117 top surface 119 touch screen 119 wax bath 120 cleaning and maintenance 60 90 days tasks 122 daily tasks 117 schedule 115 weekly tasks 120 color schemes 106 compatibility reagent 80 tables 137 concentration changing 87 management 74 101 show on Status screen 101 condensate bottle 34 empty 120 consumables 153 Control menu 103 conventional protocols 59 conventional reprocessing protocols 59 copying a protocol 71 creating a new protocol 70 cutting artifact 146 D date and time format 104 default number of cassettes 101 default protocol scheduling time 52 delayed end time 56 deleting a protocol 69 dormant reagent types 80 draining reagent bottles 91 drip time 58 104 dying tissue 79 E edit protocol 66 protocol for single run 53 reagent types 81 emergency shutdown 24 eosin staining of tissue 79
122. l Rev K Leica Biosystems Melbourne Pty Ltd 2011 41 11 Running Protocols View the progress of the protocol in the Status screen You can pause processing to add additional cassettes or abandon protocols completely see 3 5 Pausing and Abandoning Protocols Finish Protocol Run 12 13 14 When the protocol is finished the Protocol complete dialog box opens and the alarm sounds tap OK to continue Tap Drain retort before accessing from the Drain Access retort dialog box You can remove the baskets before draining the retort tap Access retort now this option is not recommended Wait for the Retort accessible dialog box to appear then open the retort and remove the cassettes Tap OK to close the dialog box Run Cleaning Protocol 15 16 17 18 19 20 21 The Run cleaning protocol dialog box appears i Recommended tap Clean now to load a cleaning protocol If you have more than one cleaning protocol use the Prev and Next buttons to select the protocol you want to use ii Not recommended tap Clean later to end the procedure and leave the retort full or with residue in it If you select this option heating continues to keep the wax in the retort and valves molten See 3 2 Cleaning Protocols below for information about cleaning protocols Place the used cassette baskets into the retort when prompted with the Insert baskets dialog box Remove all tissue as the cleaning protocol w
123. l versions modified versions upgrades updates bug fixes and backup copies Supply Agreement means the agreement between the Licensee and Leica Microsystems or where the Licensee is not a direct customer of Leica Microsystems between Leica Microsystems distributor and Leica Microsystems for the sale lease or use of the Goods Third Party Material means any Material owned by a third party that is not a Related Body Corporate as that term is defined in the Corporations Act 2001 Cth of Leica Microsystems Other definitions In this agreement Goods Purchaser and Leica Microsystems have the same meaning as in the Supply Agreement 2 2 4 2 4 3 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 Software Licence Terms Grant of licence Licensee gives consent The Licensee agrees to be bound by all the terms of this Licence by downloading or installing the Software or by agreeing to purchase lease or otherwise use the Software or the Goods containing the Software Leica Microsystems grants licence Subject to this agreement Leica Microsystems grants the Licensee a non transferable non exclusive licence to use the Software and Documentation for its internal business purposes in accordance with the terms of this agreement Restrictions on use The Licensee must a only use the Software on the Designated Computer and in conformity with i laboratory practices
124. ll stations with reagent of the group defined for the protocol step A station s reagent name its type is not used for selection only the reagent group and concentration For example if you have bottles with reagent types Ethanol 70 and Ethanol 90 on the instrument the system will pick an Ethanol 90 bottle for the first dehydrant step if that bottle has the lowest in threshold concentration Both reagent types are dehydrants so are equal candidates for dehydrant steps e Type selection the system selects from all stations with reagent of the type defined for the protocol step Station reagent names i e types and concentration are used for selection Using the example above with Ethanol 70 and Ethanol 90 bottles on the instrument if the first dehydrant step in the protocol specifies Ethanol 70 then the Ethanol 70 bottle with the lowest in threshold concentration will be used even if there is an Ethanol 90 bottle with lower concentration Because Ethanol 70 and Ethanol 90 are different reagent types the system does not consider them both e Station selection the system uses the stations defined in the protocol typically users define the bottles in order bottle 1 first then bottle 2 3 etc Stations are defined by number so the name of the reagent in a station its type nor the reagent group are used for selection Again using the example above if there are two Ethanol 7
125. lso filter events so you can decide which types of event to view You can add a message and save it as a user event or retrieve information relevant to a particular event to send to your service representative In the by time view each event instance is listed ordered with the most recent events at the top of the screen Each event has the event type number the event severity color code see Event severity below the time the event occurred and the event description In the by frequency view there is one row for each event type number e g all the 1000 events protocol completed successfully are represented in one row As well as the event number severity color code and description the number of instances of the event and the dates and times of the first and last instances of the event are shown The event log can only be cleared by service personnel Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 106 Settings amp Ancillary Operations e Toggle the Show by time Show by frequency button to switch between the two views the Filter button to open the Events log filter dialog box where you set filters to select the types of events to view Select buttons in the Retorts filters Severity filters and Alarm filters sections to see the associated types of events You must select at least one button in each section to see any events E g if you select Retort Ain Retorts filters Inform
126. m the instructions may result in sub optimal tissue processing potential loss of the patient sample and the consequent inability to make a diagnosis e Receive sufficient training to ensure that the instrument is used in accordance with this user manual e Be aware of any potential hazards or hazardous procedures before operating the instrument as described in this user manual Warranty claims can be made only if the system has been used for the specified application and operated according to the instructions in this document Damage resulting from inappropriate handling and or misuse of the product will invalidate the warranty Leica Microsystems cannot assume liability for any such damage Due to a policy of continuous improvement Leica Microsystems reserves the right to change specifications without notice Only trained staff are to remove any covers or parts from the processor and only if instructed within this manual Repairs must only be carried out by qualified service personnel authorized by Leica Microsystems The term Leica Microsystems when used in text in this document refers to Leica Biosystems Melbourne Pty Ltd The term Peloris when used in text in this document refers to Peloris and Peloris II Revision Record Detail Updates to Important Information for All Users and Safety Notices Section 5 1 5 Tissue Marking added Chapter 9 Troubleshooting added Rev K02 Leica PELORIS User Manual Rev K Leic
127. management and instrument maintenance However users should validate all protocols including the pre defined protocols for use in their laboratories where different conditions could give different outcomes Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 61 4 1 4 4 1 5 Protocol Setup Pre defined protocols can be copied to appear in the Protocol selection screen where they become available for use They can be copied as they are even keeping the name unchanged or once copied you can modify them to suit your purposes The original versions cannot be changed See Copying Protocols in 4 2 3 Creating New Protocols for directions to copy a pre defined protocol In new Peloris systems the pre defined protocols are all provided ready for use in the Protocol selection screen In case these versions are edited or deleted however the original versions remain available under the Pre defined icon accessed with the New button Protocol Validation Supervisors creating or editing protocols or copying pre defined protocols have the option to validate them in the Peloris software This serves as a sign that the protocols have passed the laboratory s validation tests and can be used for regular clinical processing Supervisors can also make valid protocols invalid Protocols that have been marked as valid can be run by operator level users while invalid protocols cannot Invalid protocols can be run by super
128. manually control the instrument The screen displays the current instrument status including station states the retort states and the retort condition You control the instrument by selecting instrument elements from the status area and control functions from the panels on either side All users can perform manual operations functions You can fill a retort from any station and then set conditions in the retort temperature pressure and stirrer If intending to move wax into a retort preheat the wax path by turning on the wax heater Use the wax vent function to neutralize the pressure in the wax bath so the wax bath lids can be opened easily and safely You cannot override a running protocol from the Manual operations screen and you cannot fill or drain a retort that has a loaded protocol Figure 58 shows the Manual operations screen with function buttons explained Vent wax release pressure or vacuum in wax chambers Fill Drain retort fill or drain the retort from or to the selected station Wax heater turn on off heaters for wax path Stirrer set the retort stirrer to high medium Pressure or low speed or off set the pressure in the retort ambient vacuum pressure or Temp uk vacuum cycle set the retort temperature Abandon stop a fill or drain operation Retort A controls Retort B controls Figure 58 Manual operations screen Retort Temperature Range The retort temperature range is limited
129. mbient Medium 10 7 Ethanol Dehydrants 145 45 Ambient Medium 10 8 Xylene Clearers 1 Ambient Ambient Medium 10 9 Xylene Clearers 10 45 Ambient X Medium 10 10 Xylene Clearers 45 45 Ambient Medium 10 11 Paraffin wax Wax 10 65 Vacuum Medium 10 12 Paraffin wax Wax 10 65 Vacuum Medium 10 13 Paraffin wax Wax 40 65 Vacuum Medium 10 Processing time 4 02 00 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 128 Xylene 6 Hour e Nota pre defined protocol Reference Step Reagent type 7 m i a P P V Stirrer 2 ume 1 Formalin Fixatives 15 45 Ambient Medium 10 2 Ethanol Dehydrants 115 45 Ambient Medium 10 3 Ethanol Dehydrants 115 45 Ambient Medium 10 4 Ethanol Dehydrants 115 45 Ambient Medium 10 5 Ethanol Dehydrants 115 45 Ambient Medium 10 6 Ethanol Dehydrants 130 45 Ambient Medium 10 7 Ethanol Dehydrants 145 45 Ambient Medium 10 8 Xylene Clearers 20 45 Ambient Medium 10 9 Xylene Clearers 20 45 Ambient Medium 10 10 Xylene Clearers 45 45 Ambient Medium 10 11 Paraffin wax Wax 30 65 Vacuum Medium 10 12 Paraffin wax Wax 30 65 Vacuum Medium 10 13 Paraffin wax Wax 45 65 Vacuum Medium 10 Processing time 6 08 00 Xylene 8 Hour Pre defined protocol Factory 8hr Xylene Standard e Carryover setting in pre defined protocol 25 Step Reagent type m i e p P V Stirrer oa ume 1 Formalin Fixatives 2
130. ment is connected to an incorrect power supply voltage WARNING Do not pull out the mains cable whilst the instrument is operating unless there is an emergency situation and both the front panel power button and the mains wall switch are inaccessible Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 11 Safety Notices WARNING Locate the instrument so that either the mains wall outlet or the instrument s appliance inlet socket is accessible You must be able to disconnect the mains power cable without moving the instrument WARNING Do not move the instrument unless the power cable is disconnected gt Reagents WARNING Chloroform vapors may cause severe injury incapacitation or death When using chloroform with the Peloris tissue processor Leica Microsystems recommends that an external fume extraction system be installed Chloroform vapors may accumulate during normal operation or in the unlikely event of a spill The extraction system must keep these vapors below dangerous levels Never open a retort that contains chloroform or chloroform residue WARNING Do not heat reagents above their boiling points Boiling reagents will release large quantities of fumes that may overload the internal carbon filter or if fitted the external filtering system Boiling reagents are also likely to lead to excessive pressures within the instrument increased reagent contamination and reagent spills
131. mode the protocol notes processing time and step details are also shown Hide details Reagent Step duration temperature pressure vacuum and stirrer speed dO e e e Ao D d O Mo MO d Q9 Processing time total time to run protocol Figure 30 Protocol panel extended mode Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 49 3 4 3 4 1 Running Protocols Protocol Run Options You can schedule each protocol run so it finishes at a convenient time You can also modify the protocol for a run to start at the second or later steps and to change step durations e 3 4 1 Scheduling Protocols e 3 4 2 Editing the Protocol for a Single Run Scheduling Protocols Schedule protocol runs in the Scheduling dialog box The dialog box opens automatically for every protocol run after you have loaded the protocol tapped Run cleared any warning messages and placed cassettes in the retort When you tap Start in the Scheduling dialog box there are no further configuration options or warnings and the protocol run starts The Scheduling dialog box also gives access to the Edit protocol instance dialog box where you can edit some protocol features for the run see 3 4 2 Editing the Protocol for a Single Run Edit steps Edit the protocol see 3 4 2 Factory 4hr Xylene Editing the Protocol for a Std jEdit steps Single Run Type Day Requ
132. mote device file structure 113 remote fill drain 88 draining reagent bottles 91 reprocessing protocols rapid reverse cleaning protocol 152 slow reverse cleaning protocol 152 standard 59 xylene free 59 reprocessing recommendations 149 required end time 50 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 158 retort 25 acid clean 123 cleaning 118 cleaning the lids 117 default scheduling 52 empty access temperature 25 102 last reagent used 102 liquid level sensors 27 manual drain drip time 104 manual operations 99 replacing seals 123 set condition 99 stirrer 28 temporary access 55 vent 26 running a protocol 40 S safety notices 9 saving protocol files 65 scheduling protocols 50 seals lid change 123 cleaning 117 selecting reagents for protocol 68 serial number 106 service files transferring 112 Service settings screen 106 setting retort condition 99 shutting down 24 skip protocol steps 53 slow reverse cleaning protocol 152 slow reverse process 151 small tissue carriers carryover from 62 software function bar 20 how to use 18 navigation 20 version 106 sound settings 105 specifications 154 staining artifact 147 standard protocols 59 list of pre defined 127 reprocessing 59 standby temperature 102 state station 87 station 74 assigning a reagent type 86 definition 73 lockout 76 managing 84 selection method 60 selection rules 60 set state 87 station configurations 135 Status scre
133. mptied and refilled button For a wax chamber set the station state to Full on the Reagent stations screen When you change the reagent type for a station on the Reagent stations screen you are always prompted to reset the station s concentration and use history If you select No you will retain the previous reagent s concentration and use history Use this option only if you are correcting a previous error in the identification of the reagent in the station and you are not actually changing the station s contents WARNING Always ensure that the reagents configured in the software are the actual reagents loaded on the instrument A station containing different reagent could damage tissue samples Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 86 Reagent Setup Changing Reagent Concentration You can set a station s calculated concentration value Tap the station s Conc cell Enter the new concentration in the keypad WARNING Do not alter the concentration of a used reagent unless you are able to verify the actual concentration If the concentration is incorrect a reduction in tissue processing quality or damage to the tissue sample may result Setting Station States All users can change station states Full Empty In use Dry and Not molten in the Reagent stations screen For reagent bottles you should not normally need to do this you update the bottle states when you remove and re
134. n Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 53 Running Protocols 3 5 Pausing and Abandoning Protocols To stop a protocol that has started use one of the Pause buttons on the Status screen protocol panels When you tap either Pause button protocols in both retorts stop running and the Paused dialog box opens with a number of options e Abandon all processing or just the protocol in one retort e Access a retort for example to add more cassettes and then resume the protocol running in it Vent the wax baths so you can open them After you pause the instrument you have five minutes to select an option after which processing automatically resumes Instrument paused Emergency stop abandon protocols in both fem retorts 5 minute count down if you do not select an option within 5 minutes processing 00 04 56 automatically resumes Resume continue processing in both retorts Abandon 20 the potona running Access retort in the retort The protocol in prepare the retort to allow you Access retort Access retort the other retort will resume to open it e g to add more cassettes Abandon and Access retort Vent wax Abandon and Access retort buttons for retort A vent the wax chambers to buttons for retort B allow you to open them Figure 34 Paused dialog box WARNI NG Take care if opening a retort or wax chamber after pausing the instrument Retorts may contain very hot
135. n If the protocol uses group reagent selection you can see the protocol types configured for the instrument but can only select by group Select a reagent group Show compatible show only compatible reagent Tap anywhere on the group groups button to select the reagent group Show all show all reagent groups Figure 41 Reagent selection Group dialog box Type Reagent Selection If the protocol uses type reagent selection you can see the protocol types configured for the instrument ordered by group Select specific types Select a reagent type Show compatible show only compatible reagent groups Tap on a type button to select i the reagent type Show all show all reagent groups Figure 42 Reagent selection Type dialog box Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 68 Protocol Setup Station Reagent Selection If the protocol uses station reagent selection you can see the stations configured for the instrument Bottles that are available for selection are drawn in 3D with lids and handles Bottles that are not available because they have already been used or are incompatible are drawn in 2D without lids or handles Wax stations are similarly drawn as 3D buttons available or 2D icons unavailable Select specific stations for your protocol The wax chambers are all unavailable because they are not compatible with the preceding protocol step Show compatible show
136. n fill level tap the Bottle fill level button and select two or three baskets If you increase the fill volume you must visually check each reagent station to ensure it holds sufficient reagent A protocol may be abandoned if a station does not hold sufficient reagent Manual Drain Drip Time Supervisors can change the drip time for manual drain operations on the Instrument settings screen The drip time is the length of time the system waits for reagents to drip from cassettes and retort walls before completing the drain operation the Manual drain drip time button then enter the required number of seconds Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 104 Settings amp Ancillary Operations Language and Unit Settings You can view the instrument s language and temperature and pressure unit settings in the Instrument settings screen Contact your service representative to change either setting 6 2 2 Device Settings The Device settings screen Control menu Device settings allows users to control display settings and lock the screen for cleaning Supervisors can configure instrument sounds and enable and disable power off alarms for the external alarm connectors e Sound Settings e Touch screen Settings e Alarm Power Off Settings e Color Schemes e Screen Lock Sound Settings Supervisors can select from a range of sounds to be heard for particular types of event or have no
137. ne or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio or television technician for help CE Marking and European Union Notice The CE mark on the equipment indicates compliance with the EEC Directives for Electromagnetic Compatibility 89 336 EEC Waste Electrical and Electronic Equipment 02 96 EC Restriction on the Use of Certain Hazardous Substances in Electrical and Electronic Equipment 02 95 EC and In Vitro Diagnostic Medical Devices 98 79 EC Marking of equipment in this manner denotes that the equipment meets the technical standards detailed above Declaration of Conformity A Declaration of Conformity in accordance with the preceding directives and standards has been made and is on file at Leica Biosystems Newcastle Ltd Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom Note To maintain compliance with the above CE and FCC Rules and Regulations use only the cables supplied with the equipment Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 13 Contents Legal os c 2 Contacting Leica Microsystems yy 3 Software Licence Terms ee
138. nformation such as the retort fill level the number of cassettes processed the carryover setting and the reagent groups involved to calculate concentration in each station Concentrations can also be assigned by cycles or by position i e by station These methods rank station concentration by the number of processing runs each station has been used for or the physical order of the stations respectively Leica Microsystems does not recommend the by eycles or by position options vvhich must be set by a technical support representative For consistently high quality processing alvvays replace reagents as soon as you are prompted vvith fresh reagent at the default concentration If you remove a bottle from the instrument alvvays check that you enter the correct reagent information for the bottle when you return it Supervisors can manually change station concentration values in the Reagent stations screen if they believe the value there is incorrect Be sure that you independently verify the concentration if making such a change Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 75 Reagent Setup 5 1 3 Thresholds Each reagent type has a range of thresholds that supervisors can configure on the Reagent types screen The thresholds for the pre defined reagent types should be adequate for most laboratories but alternative settings may suit some laboratories better contact customer su
139. ng time 1 25 00 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 127 Xylene 2 Hour Pre defined protocol Factory 2hr Xylene Standard e Carryover setting in pre defined protocol 75 Reference Step Reagent type 7 5 i o P P V Stirrer iE ume 1 Formalin Fixatives 1 Ambient Ambient Medium 10 2 Ethanol Dehydrants 1 Ambient Ambient Medium 10 3 Ethanol Dehydrants 1 Ambient Ambient Medium 10 4 Ethanol Dehydrants 1 Ambient Ambient Medium 10 5 Ethanol Dehydrants 1 Ambient Ambient Medium 10 6 Ethanol Dehydrants 11 45 Ambient Medium 10 7 Ethanol Dehydrants 130 45 Ambient Medium 10 8 Xylene Clearers 1 Ambient Ambient Medium 10 9 Xylene Clearers 1 Ambient Ambient Medium 10 10 Xylene Clearers 28 45 Ambient Medium 10 11 Paraffin wax Wax 65 Vacuum Medium 10 12 Paraffin wax Wax 65 Vacuum Medium 10 13 Paraffin wax Wax 20 65 Vacuum Medium 10 Processing time 2 14 00 Xylene 4 Hour Pre defined protocol Factory 4hr Xylene Standard e Carryover setting in pre defined protocol 50 Step Reagent type o P P V Stirrer m me 1 Formalin Fixatives 10 45 Ambient Medium 10 2 Ethanol Dehydrants 1 Ambient Ambient Medium 10 3 Ethanol Dehydrants 1 Ambient Ambient Medium 10 4 Ethanol Dehydrants 1 Ambient Ambient Medium 10 5 Ethanol Dehydrants 120 45 Ambient Medium 10 6 Ethanol Dehydrants 120 45 A
140. ning correctly etest Is the tissue processed correctly Yes Stop Well processed tissue Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 143 Troubleshooting 9 2 4 Poor Processing Incorrect Protocol Poor processing incorrect protocol Tissue is over processed soaking the block in a softening agent such Yes Reprocessing will not as fabric softener before cutting help Cutting thinner sections Warming the block slightly before sectioning Was the original protocol too long No engi Tissue is under processed Reprocess NB Do not use the Peloris clean protocol too Yes cycle to reprocess the tissue as the drying step will cause the tissue to dry short Try a longer protocol with less heat and agitation Try a longer protocol with more heat and efficient agitation processing ny a defatting Step of 50 50 xylene and ethanol Put step between ethanols and xylene ensuring that there is a 100 ethanol step after defat before xylene Was wax Tf tissue is dehydrated and cleared infiltration there is no need for reprocessing incomplete Re infiltrate tissue with wax only Is tissue processed adequately Yes Contact customer support Adequately processed tissue Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 144 Troubleshooting 9 2 5 Poor Processing Co
141. nly cleaning protocol required Under normal conditions the protocol purges residue in the retort to the wax bath before the first step see Pre cleaning Purges below Then there are two reagent steps cleaning solvent e g xylene and cleaning alcohol These are followed by a dry step that applies high temperature vacuum and air flow to evaporate all reagent residue At the end of the dry step the heaters turn off but air flow continues to cool the retorts before the next protocol Load and run cleaning protocols like other protocols but never put tissue in the retort the dry step will damage it This means cleaning protocols should never be used for reprocessing runs use a reprocessing protocol instead If required copy the Quick Clean protocol and edit to create your own cleaning protocols You can add delete and edit all the reagent steps as for other protocols but the dry step cannot be deleted or edited Cleaning protocols do not require a water step and work well with conventional cleaning reagents To completely remove xylene from your instrument Leica Microsystems can supply Waxsol a xylene free cleaning solution see 5 1 4 Recommended Reagents WARNING Remove all tissue from the retort before running a cleaning protocol as the dry step will damage the tissue WARNING Do not use cleaning protocols for reprocessing as the dry step will damage the tissue CAUTION Always run a cleaning protocol after wax h
142. nt Remote Fill and Drain 91 Replacing Reagent Manual l rns 94 EA AA ERR Wr a Rad eda 95 Filling and Draining Retorts 97 6 Settings amp Ancillary Operations 98 6 1 Reagents Menu A ewe A Ue aa Aerea t ror A A m 98 Manual Operations Xo ta hd A Pe S 99 Reagent MANAGEMENTS cc ct meo m oa e Ree E ak Seco roe td id mon 101 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 15 6 2 Control M nti v Me A fa ay ee AM ee a eds SRM 103 Instrument SettingS A 103 Device Settirigs i 23 e ai 105 SErviCe SEtliNGS gt ir e ban e ode E A f Be a bd Ab nnd 106 EvE LOG varia a a a AAA ea a a Gre RA RAN 106 Alarmis A A PEINE A AA A dea ie e eot Ra 107 ACCESS Level aia ra ia a rt ra a 108 EAT A A A 109 7 Cleaning and Maintenance 114 7 1 Cleaning and Maintenance Schedule ce ee 115 7 2 Daly Task cia 7 0 0 22 117 7 3 Weekly Tasks wie sais od RR A A A aie ER E s EON AA EON A A as 120 74 4 60 90 sis ros Ae osi OL E Re eg A d s bab ad va E uba Bab duya 122 71 5 RetorteAcid Clean 55 ue aaa ee RR cR a XR ERR ure aza oh is RO SER Sei 123 GO Referenc ssr o s s dc 124 8 1 Reage
143. nt Threshold Guidelines es 125 8 2 Protocols A ma Piva Soh fed agere ier toe eR Su k n sa 126 Specimen Type and Protocol Duration ees 126 List of Pre defined Protocols hh 126 Xylene Protocols tica SEX BAL we eae esee d Ra AC Rex Rea ee RT a e Re Rc 127 Xylene free Protocols hh hah hrs 131 Cleaning Protocol 1 2 aa e AR Ee ee OR LEUR TR 134 8 3 Station Configurations sia cw ed e ae ea eee ee ADR DER aa ATE ee kan 135 8 4 Protocol Step Temperatures eee ees 137 8 5 Reagent Compatibility Tables m hrs 137 9 Troubleshooting 36a pace dex R3 Ex d ar RE AUR S E eles 139 9 1 Preliminary Questions hh hh hans 139 9 2 Flowch atrts x uve RR 3E EGG ere uere ep ea ke lea Y ee ea ea 140 Under processed Tissue Instrument Setup 141 Over processed Tissue Instrument Setup 0000000 0 142 Under or Over processed Tissue Reagents 143 Poor Processing Incorrect Protocol es 144 Poor Processing Correct Protocol lille es 145 Cutting Artifact iria a aa ALA eed aida ala AAA ay et 146 Staining Artifact occa csse weeded ee aa Da A n A PA LA a eee R Ta 147 Block Artifacts
144. of inadequate back up computer viruses or the ongoing functions of computer hardware including backup hardware whether supplied by Leica Microsystems or any other supplier Confidentiality and privacy Use and disclosure The Licensee must in relation to the Confidential Information a keep it confidential b use it only as permitted under this agreement and only disclose it i to employees contractors and agents that have a need to know and who have undertaken to comply with this clause 7 or ii to the extent if any the Licensee is required by law to do so and c promptly comply with any request by Leica Microsystems to return or destroy the Confidential Information unless required by law to be retained Recipient s obligations The Licensee must a safeguard the Confidential Information from unauthorised access or use and b notify Leica Microsystems of and take all steps to prevent or stop unauthorised copying use or disclosure Privacy In performing its obligations under this agreement the Licensee must comply and use all reasonable efforts to ensure that its contractors comply with all applicable legislation relating to privacy of personal information Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 6 8 2 8 3 8 4 8 5 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 Software Licence Terms Exclusions and limitations Acknowled
145. ol Selection Screen annem daai a E EEE E 65 Editing Protocols staan ae adea EG a ARA p 66 Creating NevV Protocols ataa aa Re S a x dac Cad RC a R n a lon Da 70 Viewing Protocols edd suia rac x NR UR RR eer ae 71 5 A 09 3 Oe Pa Oe eke lo ao RE 72 5 1 Reagents OVERVIEW sea oh a a ia a 72 Reagent Groups Types and Stations eee eee 73 Concentration Management ee 74 Thresholds x1 ernie ted kee dk wale wee Ree A Seis eee Pana eee 76 Recommended Reagents used hak eave Walaa ae Roa dard Ade 78 Tissue Marking rt wm ak aed AAA A eae a Dena ay We te Se d 79 Reagent Compatibility ee eee ees 80 5 2 Managing Reagent Types ees 80 Pre defined cba Quad eR A ae Gd ahd 80 Editing Active Reagent TypeS ais siu khe rio rd seek ee ee 81 Managing the Reagent Types Lists 83 5 3 Managing Reagent Stations ees 84 Reagent Stations Screen ees 84 Setting Reagent Station Properties ly ee 86 5 4 Replacing Reagents saa aa x Se ee Rasad Rx CR aa Saad a 88 Remote Fill Drain Screen 88 Remote Fill Drain Connections 89 Replacing Reage
146. ol Setup 4 1 6 Saving Protocol Files Protocols are saved in cfg extension files that you can back up or to send to your service representative for troubleshooting See Transferring Protocols in 6 2 7 File Transfer for instructions to copy protocol files on and off the instrument 4 2 Creating Editing and Viewing Protocols Supervisors can create and edit protocols from the Protocol selection screen Operators cannot create or edit protocols but can view protocol details from the Protocol selection screen 4 2 1 The Protocol Selection Screen 4 2 2 Editing Protocols 4 2 3 Creating New Protocols 4 2 4 Viewing Protocols 4 2 1 The Protocol Selection Screen Tap the Protocols button in the Function bar to open the Protocol selection screen where you access all protocol configuration options Load button load x selected protocol Protocol icons d vex s v m Protocol creation and editing buttons Operators use View button to view protocol configurations Selected protocol Invalid protocol Figure 37 The Protocol selection screen Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 65 4 2 2 Protocol Setup Protocol 1 cons On the Protocol selection screen each protocol is represented by a selectable icon Each icon contains the following protocol details Protocol name 8hr conventional 25 Protocol type indicated by icon pattern and color see below Reagent sel
147. ol screen the default value is set on the Reagent management screen Tap the Carryover button and enter a number between 0 no carryover from small tissue carriers and 100 maximum carryover from small tissue carriers How to Calculate Carryover Values Carryover is dependent on the types of cassettes and other small tissue carriers used e g biopsy pads paper or tissue inserts mini cassettes biopsy cassettes etc It also depends on the proportion of these in each run The carryover setting is a protocol property so it must be set to the average carryover value for runs that use the protocol The following table shows the carryover values that should be used for a range of cassettes and pads etc provided by Leica Microsystems The values in the table apply when all the tissue in the Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 63 Protocol Setup run uses the respective cassette or pad type Carryover value if Leica Microsystems products Generic description of tissue carrier 10096 of tissue uses carrier Surgipath ActivFlo Routine I Standard cassette 0 Surgipath Biopsy Pads in Biopsy pad in standard cassette 100 Surgipath ActivFlo Routine I ActivFlo Mini Cassette in Mini cassette in standard cassette 50 Surgipath ActivFlo Routine I Surgipath Biopsy Wraps in Biopsy wrap in standard cassette 20 Surgipath ActivFlo Routine I Surgipath IP ActivFlo Biopsy I Biopsy cassettes with 1 mm pore
148. or relating to the Software Effective Date means the date the Goods as defined in the Supply Agreement are delivered by Leica Microsystems Intellectual Property means all existing and future intellectual property rights including e patents copyright including all copyright and software software and associated documentation including the specific design and structure of individual programs registered designs trade marks proprietary documentation and notices and any right to have information or know how kept confidential and f any application or right to apply for registration of any of the rights referred to in paragraph e above Licensee means the Purchaser or lessee of the Goods containing the Software or where the Licensee is a distributor of the Goods containing the Software the end user of the Goods containing the Software Licensor IP means all Intellectual Property relating to a the Software and Documentation b any modifications upgrades new versions or new releases of the materials referred to in paragraph a above and c other works created by Leica Microsystems in the course of or as a result of performing this Agreement Release means each release of a new Version of the Software Software means any program firmware or electronic files that provides instructions or data to a computer or microprocessor and shall for the purposes of this agreement include origina
149. ormation to indicate what may have gone wrong 9 2 Flowcharts This section has eight flowcharts for different processing problems e 9 2 1 Under processed Tissue Instrument Setup e 9 2 2 Over processed Tissue Instrument Setup e 9 2 3 Under or Over processed Tissue Reagents 9 2 4 Poor Processing Incorrect Protocol e 9 2 5 Poor Processing Correct Protocol e 9 2 6 Cutting Artifact e 9 2 7 Staining Artifact e 9 2 8 Block Artifact Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 140 Troubleshooting 9 2 1 Under processed Tissue Instrument Setup soft mushy wet Are any error codes present Retest If a user warning fix the Is the tissue es issue If a service warning contact service 1 processed correctly Yes Check tissue size step times pressure and vacuum Retest temperatures Is the tissue drip times processed correctly Was the correct protocol used Yes Are the settings appropriate Optimize the reagent using the predefined protocols as a guideline Retest Is the tissue processed correctly Correct carryovel value number of cassettes entered Enter correct values for carryover and cassettes for the reagent management system to work correctly Yes Check Transfer fluid formal saline Retest Fixation time Is the tissue
150. ort WARNING Take care not to knock retort lids when they are open They could crush fingers or hands PPP Venting a Retort You must ensure there is no pressure or vacuum inside a retort before you open the lid The retorts automatically vent at the start and end of a protocol and also during a pause in a protocol However you may need to manually vent a retort if an automatic vent fails or if you wish to access a pressurized or evacuated retort at other times Use the Manual operations screen to manually vent the retorts Set the Pressure button to Ambient for the retort that you want to open You may need to wait up to one and a half minutes for the pressure to equalize If your instrument has retort latch locks use the Lock Unlock retort button it may take several cycles to successfully vent a retort If you leave a hot retort closed for an extended time the air in the retort will cool and create a vacuum You must then vent the retort before attempting to open the lid Fill Levels Retorts can be filled with enough reagent for two or three cassette baskets Supervisors set the required fill level on the I nstrument settings screen see Reagent Fill Levels in 6 2 1 Instrument Settings The two basket fill volume is 3 8 liters 1 gallon US and the three basket fill volume is 5 liters 1 32 gallon US Use markings on the reagent bottles Figure 3 and wax chambers Figure 4 to ensure you have enough reagent to fill the retor
151. ote alarm 1 and local alarm 2 connectors Each Peloris tissue processor has two external alarm connections a local alarm connection and a remote alarm connection see Figure 21 These connections may be used to control a range of alarm indication devices including audible alarms visual alarms or automatic phone dialers Speak to your service representative to configure the events that will trigger each of the external alarms and to set whether the alarms are a single signal or continuous Alarm Connector Specifications The load connected to either alarm connector must not exceed the following specifications e Maximum voltage e Maximum current e Maximum current 30 VDC 1 A resistive load 0 5 A inductive load Alarm Connector Pins Each alarm connector has three pins as follows see Figure 22 e Pin 1 Normally open item 1 e Pin 2 Normally closed item 2 e Pin 3 Common item 3 Figure 22 Alarm connector pins Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 38 Hardware Pin Schematic During Normal Operation When the instrument is operating normally no alarm the alarm pins connect as shown in Figure 23 e Pin 1 normally open is open e Pin 2 normally closed is connected to Pin 3 common Figure 23 Alarm pins in normal state Pin Schematic During Alarm Conditions When the instrument has an active alarm the alarm pins connect as shown in Figure 24 below
152. otor The stirrer speed can be controlled for each protocol step and is easily removed for cleaning see Clean Retorts in 7 2 Daily Tasks Figure 6 Magnetic stirrer 1 Cassette Baskets There are two Peloris basket types the configurable high capacity basket that accommodates the maximum number and type of cassettes and the spaced basket that ensures optimal reagent flow The high capacity cassette baskets accept most common cassette types and include configurable dividers that allow for different cassette sizes and packing densities The spaced baskets include dividers that ensure optimum reagent flow with minimal carryover This basket type accepts 72 standard cassettes Spaced baskets must be used for all xylene free protocols Cassette baskets stack into the retorts with the lids upwards and handles dropped flat Make sure the first basket sits flat on the rack on the pins at the bottom of the retort Figure 8 Stack additional baskets so they sit flat on the lower ones crooked baskets can leave cassettes exposed damaging the tissue in them Figure 7 Placing a basket into a retort Figure 8 Retort pins Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 28 Hardware correctly placed in the retorts Incorrectly placed cassettes or baskets may lead to samples being WARNING N Always ensure the cassettes are correctly inserted into the baskets and that the baskets are dama
153. own on a decalcifying medium segments Try a softening agent such as fabric softener at sectioning If it is a foreign body such as a staple melt block down remove object and re embed Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 145 9 2 6 Cutting Artifact hard brittle or has chatter Are there breaks in the ribbon or compression sections have disruption holes and tears Is it hard to get the tissue to flatten Are there cracks In the tissue ections Cause Over dehydration Over clearing Cold plate too cold Poor microtomy Inadequate processing Incorrect size mould Poor microtomy Block not cold enough Insufficient dehydration Aggressive trimming or facing of block Poor microtomy Poor wax infiltration Tissue related Is the water bath at correct Troubleshooting Suggestion for fix Decrease time in dehydrant Decrease time in xylene Warm cold plate slightly or wet face of block just prior to cutting Check knife tilt and ensure proper cutting techniques Check protocol and adjust times as neede Re embed tissue in bigger mould Check knife tilt and ensure proper cutting techniques replace blade Allow block to cool longer on cold plate Increase step time in dehydration Change or replace solutions in reagent bottles Trim blocks at a smoother pace and fine trim
154. place bottles and then the software tracks the state automatically Change bottle station states only if the wrong state is displayed or you want to make a full bottle unavailable for use by setting it to In use For wax chambers you must change the station state in the Reagent stations screen as a normal part of wax replacement To change a station state tap the station s State cell and select the appropriate icon in the dialog box Please set the state of wax chamber Please set the state of station HH Cancel c Cancel Cancel Figure 49 Station state dialog box for reagent stations L and wax stations R See 3 3 1 Status Area for detailed information on reagent station states WARNI NG Ensure you set the station state to the actual condition of the station An incorrect reagent station state may cause fluid leaks or abandoned processing runs Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 87 5 4 5 4 1 Reagent Setup Replacing Reagents Always replace reagents as soon as possible after the system alerts you There are two methods to replace reagent in bottles e Remote fill drain pump the old reagent out and new reagent back in without removing the bottle using commands on the Remote fill drain screen e Manually remove the bottle drain and refill then replace on the instrument For wax you must drain the chamber using the Remote fill drain screen fill the c
155. pport for advice before changing threshold settings Validate any threshold changes using the procedures that apply to your laboratory The thresholds fall into two categories e Purity thresholds set usage limits for reagents according to their purity Temperature thresholds set limits on the retort temperatures for reagents to help ensure high processing quality and safety Purity Thresholds Peloris uses purity thresholds to limit the use of reagent as it becomes increasingly contaminated with reagent carried over from other groups When a threshold is exceeded the software warns you that you need to replace reagent Under default settings you are able to use a station with out of threshold reagent for one more run after such a warning Following this the station is locked meaning it cannot be used at all and or you cannot run further protocols until fresh reagent is loaded Your customer support representative can change the number of runs allowed after reagent replacement warnings Reagent purity is assessed using one or more of four different reagent threshold check methods Concentration of the reagent e Number of cassettes processed with the reagent e Number of processing runs cycles the reagent has been used for e Number of days the reagent has been loaded on the instrument By default all of these methods are available for you to configure for individual reagent types The Reagent threshold check section of the Rea
156. prior to cutting Check knife tilt and ensure proper cutting techniques Increase step time in wax Nature of tissue typically seen in brain and bowel temperature Inadequate wax infiltration Tissue over processed Rough trimming Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 o Decrease time in dehydrants xylenes also check the step Increase step time in wax temperatures are appropriate Trim blocks at a smoother pace and fine trim prior to cutting Troubleshooting Artifact ining 9 2 7 Sta Sepnoq juabeal ui suonnjos eoejdaJ Jo abuey c6 cco reo suon s s 5 40 Biq 00 ou 51 nssn eJnsu3 ajenbape ae s uun days 020304d eunsu3 quaned UJO4J Jaye lqissod se UOOS sy aun jo zunowe ayenbape ue 40 uijeuuoJ Jo JUNOWe ajyenbape ue ui peoejd si enssn ains exei s moq juoBea ui suonnjos eoe daJ bupu uoneJpAuep ul aun days enssn Ul 3uesaud 1832M uonexy eyenbapeu passa2oJd S A Z bpnu s Jo any enjd APU anssn BY seog Bupe suy JO 9SJe02 3494 ST uonexy Jeuoz 51 147 suon s s 7 6 226 TUG abuey pue ujeul0J lqenn u ul 55 1 ublu 00 SI Jo Hd quawbid UIJELUIOJ 3194 ST ayenbape
157. ps S26 0822 Bottle connector retaining caps S26 0819 High capacity cassette basket S26 0512 no dividers High capacity basket vvith dividers S26 4506 Spaced basket S26 4505 High capacity cassette basket dividers S26 0516 VVax scraper S26 0027 Reagent fill and drain hose S26 0432 VVax drain hose S26 1400 Drip tray S26 0020 Bottle cap wrench S26 1910 Remote alarm connector S26 4098 Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 11 Specifications Operating Dimensions x W x D rarei a aa ai a aa aaae aaa 1500 x 857 x 721 mm 59 x 33 7 x 28 4 inches Missa EE 331kg 730 lb Weight including reagents ee n R RK YR Ria aaa arayan 430 kg 9501b Work surface height from floor Front 1070 mm 42 1 inches Rear 1110 mm 43 7 inches Cassette capacity standard 15 600 maximum 528 spaced Cassette capacity xylene free protocols nennen nnn nnn 432 Retort vacuum MaX oo danse eo Pe SENE d dl 70 kPa g Retort pressure max e AAA Rx e Ne vun Tue A 45 kPa g Magnetically coupled stirrer user selectable operation Reagent bottles do cite eee va dei debe ded d esa Fe ia RE ERR REGERE rte baee atin 16 Reagent volutmie pde aec a d
158. r Xylene Standard see Xylene 4 Hour e Factory 8hr Xylene Standard see Xylene 8 Hour e Factory 12hr Xylene Standard see Xylene 12 Hour e Factory 1 hr Xylene Free see Xylene free 1 Hour e Factory 2 hr Xylene Free see Xylene free 2 Hour Factory 4 hr Xylene Free see Xylene free 4 Hour e Factory 8 hr Xylene Free see Xylene free 8 Hour e Factory 12 hr Xylene Free see Xylene free 12 Hour e Quick Clean see Quick Clean 8 2 3 Xylene Protocols Reference All the xylene protocols below are designed for use with the xylene bottle configuration in 8 3 Station Configurations Xylene 1 Hour e Pre defined protocol Factory 1hr Xylene Standard e Carryover setting in pre defined protocol 100 Step Reagent type D Hs Stirrer ume 1 Formalin Fixatives 1 Ambient Ambient Medium 10 2 Ethanol Dehydrants 1 Ambient Ambient Medium 10 3 Ethanol Dehydrants 1 Ambient Ambient Medium 10 4 Ethanol Dehydrants 1 Ambient Ambient Medium 10 5 Ethanol Dehydrants 1 Ambient Ambient Medium 10 6 Ethanol Dehydrants 1 Ambient Ambient Medium 10 7 Ethanol Dehydrants 18 45 Ambient Medium 10 8 Xylene Clearers 1 Ambient Ambient Medium 10 9 Xylene Clearers 1 Ambient Ambient Medium 10 10 Xylene Clearers 14 45 Ambient Medium 10 11 Paraffin wax Wax 2 65 Vacuum Medium 10 12 Paraffin wax Wax 1 65 Vacuum Medium 10 13 Paraffin wax Wax 14 65 Vacuum Medium 10 Processi
159. r has been drained to fill a retort Empty There is still wax in the chamber The wax in the chamber has not melted and Not molten is unavailable ELLE Retort I cons Color coded for reagent group Color or other pattern shows currently in the retort retort state see below Drainin E Current retort operation see The number of cassettes in g below the retort 0 kPa Retort pressure temperature 35 C and stirrer speed supervisors Retort name only y Medium A Figure 28 Retort icon on the Status screen Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 47 There are ten operations reported for the retorts e Ready the retort is available for any new action e Reserved a protocol is loaded but has not yet started e Processing the retort is currently running a protocol e Completed the retort has completed the loaded protocol Drying the retort is being dried as the final step of a cleaning protocol Filling the retort is currently filling e Draining the retort is currently draining Running Protocols e Pending drain or fill the retort is waiting for resources to perform a fill or drain e Abandoning the retort is abandoning the current action e Unavailable the retort cannot be used contact your service representative Retorts have five possible states Means The retort contains the correct amount of wax or
160. rants Removes fixative reagents from tissue Blue Defat Removes fat deposits from tissue Yellow Post defat The dehydrant used after a defatting step Purple Clearers Clears the dehydrants from the tissue Pink Wax The embedding medium Orange Cleaning solvents First cleaning reagent Light pink Cleaning alcohols Second cleaning reagent Light blue Cleaning water Third retort cleaning reagent Grey The reagent group determines reagent compatibility see 5 1 6 Reagent Compatibility Types Reagent types are the specific reagents within each group e g formalin xylene Waxsol As well as the chemical constituent reagent type definitions can include concentrations For example 70 Ethanol and 80 Ethanol are reagent types defined in Peloris Reagent types have the following properties Aunique name e Default concentration the concentration of the reagent when fresh e Purity thresholds to ensure you replace degraded reagent see 5 1 3 Thresholds e Temperature thresholds used to ensure processing quality and safe usage of the reagent see 5 1 3 Thresholds The Peloris software includes a number of pre defined reagent types These are adequate for most laboratories however you can create your own reagent types if needed Use the Reagent types screen to define and edit reagent types see 5 2 Managing Reagent Types Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 73 Reagent Setup
161. reagent concentrations and how many cassettes and cycles have been put through a reagent Check to see if these are correct Are any reagents over their recommended purity thresholds Was the intended processing protocol actually used For example is it possible that specimens intended for a longer processing protocol were placed on a shorter processing protocol Were the specimens processed using the usual protocol for specimens of this size and type and that generally produces good results If so the problem is probably not in the protocol parameters Were the specimens at the very top of the retort Is the instrument set up for a two basket level when three baskets were processed Were the baskets placed in the retort correctly Were all the specimens in the batch affected or just some of them Were all the specimens of a similar type Were they all from the same source Answers to these questions may indicate a problem prior to tissue processing 10 Was normal fixation applied to the problem specimens Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 139 Troubleshooting These questions should help you determine what has gone wrong If you remain uncertain as to the cause of the problem you must gather as much information as possible by carefully examining the specimens Close examination of the blocks can confirm what you suspect may have happened Microscopic examination will also provide valuable inf
162. reating Editing and Viewing Protocols 4 1 Protocol Overview Protocols consist of sequences of steps applied to tissue in a retort In each step with one exception the retort is filled with reagent and held for a time under conditions controlled by the protocol Protocol steps have the following properties reagent used e the time the reagent is in the retort temperature of the reagent e the retort pressure ambient pressurized or vacuum or cycling between pressurized and vacuum e retort stirrer speed e the drip time the time allowed for reagent to drip from the cassettes and retort walls before ending a drain Longer drip times reduce carryover The one step type that is an exception is the final dry step of a cleaning protocol where no reagent is used There are five protocol types A protocol s type sets limits on which reagents can be used and the order of their use Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 58 4 1 1 Protocol Setup Other protocol properties are the reagent selection method and a carryover value that must be set for each protocol These and protocol validation pre defined protocols and file saving are described in the sections below 4 1 1 Protocol Types 4 1 2 Reagent Selection Method 4 1 3 Pre defined Protocols 4 1 4 Protocol Validation 4 1 5 Carryover Setting 4 1 6 Saving Protocol Files Protocol Types The Peloris tissue proc
163. reement including any additional terms notified to the Licensee by Leica Microsystems constitutes the entire agreement between the parties and supersedes any prior representations warranties understandings or agreements that relate to the same subject matter 12 3 Variation This agreement may only be amended by agreement in writing between the parties 12 4 Governing law This agreement is governed by the laws of the State of Victoria Australia and the parties submit to the non exclusive jurisdiction of the courts in that State Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 8 Safety Notices The Peloris tissue processor is designed to provide safe trouble free operation when used in accordance with this document Follow all safety precautions to avoid personal injury damage to patient samples and damage to the instrument Clean and maintain the instrument as described in Chapter 7 Cleaning and Maintenance The Safety Notice Types section below describes the types of safety notices in the manual The General Warnings and Cautions section has general warnings for the Peloris instrument other notices appear in relevant sections in the manual Safety Notice Types Safety notices in this manual are either warnings or cautions Warnings Warnings are notifications of hazards that could lead to personal injury to Peloris users or people in the vicinity of the instrument Warnings are also used when
164. resholds buttons to switch views Selected reagent type Add reagent button bring dormant reagent onto the active list Remove reagent button remove selected reagent from the active to the dormant list Defaults Concentration tap cells to change Figure 45 Reagent types screen temperature thresholds view using recommended reagent types for xylene free processing Supervisors can edit the default concentration purity thresholds and temperature thresholds for all active reagent types You edit a type s attributes by tapping the appropriate table cell then entering the required value using the resultant keypad The attributes update immediately and are applied to all reagent stations and protocols that use the reagent type The changes will not affect running protocols Lovvering temperature thresholds may make protocol steps invalid You must lovver the step temperature to comply with the new reagent threshold before you can load or run the protocol Leica Microsystems does not recommend you lovver reagent concentration thresholds Raising thresholds can help to correct poor quality processing due to impure reagents If you no longer use a reagent in the active list you can remove it to the dormant list to keep the active list as small and easy to manage as possible Select the reagent type by tapping in its name cell then tap Remove reagent Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2
165. retorts are as follows e The retort must be clean or empty before you commence a retort fill operation e When filling a retort the selected reagent station must be compatible with the retort residue See 8 5 Reagent Compatibility Tables e You cannot fill a retort with a reagent that has a temperature threshold below the set retort temperature e When draining a retort the reagent should return to its original station e You cannot drain wax to a reagent bottle or non wax reagents to a wax station e When draining a retort the station must have sufficient capacity for the retort contents Always ensure the retort is in a suitable state before filling To fill select the retort and reagent station then tap Fill retort To drain a retort select the retort and the station the retort contents came from Tap the Drain retort button The system will not allow you to drain a retort to a station other than the one the reagent came from You can stop a fill or drain at any time with the Abandon button Recover from an abandoned fill or drain by restarting the operation or return the reagent to the station or retort it came from with the opposite operation WARNING 0 Do not open a retort if it has been filled with hot reagent and pressurized using the manual operations functions Always use the manual operations functions to de pressurize a retort before opening and wear suitable protective clothing including eye protection if the retort
166. rieve samples CAUTION Take care when adding fixed samples to a running protocol The additional fixative will contaminate the reagent used in the current step and this contamination will not be tracked by A the reagent management system CAUTION The further a protocol has progressed before you add more samples the more compromised the processing quality for those samples We therefore recommend that you only add samples during fixative steps or during the first dehydrant step To access a retort while the instrument is processing 1 Pause the instrument with one of the Pause buttons on the Status screen 2 Tap the appropriate Access retort button in the Paused dialog box 3 Select to drain the retort or not in the Temporary access drain dialog box Follow the prompt to wait if draining 4 When the Retrieve samples dialog box opens remove the baskets from the retort and add or retrieve cassettes as required 5 Return the baskets to the retort and tap OK in the Retrieve samples dialog box 6 If prompted enter the new number of cassettes in the Number of cassettes dialog box Follow the prompt to wait if refilling the retort 7 Tap Resume in the Paused dialog to resume the protocol Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 55 Running Protocols 3 6 Retort Scheduling The Peloris tissue processor allows you to simultaneously run protocols in both retorts The automatic scheduling
167. ris Xylene free Use 250 mL of 1 liquid eosin per 5 L Peloris reagent bottle of 85 ethanol there are three bottles of 85 ethanol in the recommended bottle configuration for xylene free processing Specimens are immersed in the marking reagent for the same amount of time giving consistent staining Protocols longer than two hours may cause overstaining reduce the eosin concentration as required Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 79 Reagent Setup 5 1 6 Reagent Compatibility As tissue processing requires the use of incompatible reagents the Peloris tissue processor software uses a set of rules to ensure that only compatible reagents are allowed to mix Reagent mixing usually occurs when a reagent enters a retort of state Empty containing residual amounts of the previous reagent This may happen as part of a protocol during manual operations or during remote and fill drain procedures The software will not allow you to create a protocol that has an incompatible reagent sequence and you are also prevented from mixing incompatible reagents during remote fill drain procedures You cannot run a protocol where the first reagent is incompatible with the retort residue You can however load a protocol with an incompatible first step but the reagent sequence must be edited during scheduling to select a new first step that is compatible with the retort residue see 3 4 2 Editing the Protocol for a S
168. rom such uses or violations Compliance The Licensee must comply at all times with any terms and conditions relating to the Third Party Material notified to the Licensee by Leica Microsystems and or the third party supplier of that Third Party Material Upgrades and support New releases and new versions Leica Microsystems may at its sole discretion provide the Licensee with new Releases or new Versions of the Software Installation If requested by the Licensee to do so Leica Microsystems its designated distributor or agent may at its sole discretion install a new Release or new Version of the Software on the Designated Computer Downloading of data Leica Microsystems or its designated agent may at its sole discretion download data that has been generated by the use of the Software by the Licensee as a means of debugging Software faults and otherwise analyzing the performance of the Software or Goods containing the Software supplied by Leica Microsystems under the Supply Agreement Back up and security of data It is the Licensee s responsibility to a perform regular backups of data and to store these and b provide contingency plans for the event of a failure of any sort eg fire flood and theft and Leica Microsystems has no liability including for negligence for any loss whether direct or indirect that could have been prevented by the Licensee performing the above responsibilities or which occurs as a consequence
169. rrect Protocol correct protocol Did the processor malfunction or error NB Do not use the Peloris clean cycle to reprocess the tissue as the drying step will cause the tissue to dry out Did the tissue dry out completely Reconstitute and then reprocess Is tissue adequately processe Adequately processed Tissue is poorly processed Reverse Yes process to formalin reconstitute and then reprocess dry out during processing Yes Reverse process to formalin reconstitute and then reprocess Over processed Reprocessing will not help Attempt soaking the block before cutting ere steps skipped No Were reagents used Try a longer more gentle process Less heat and agitation No Was the incorrect T Aft reagent used in Yes Ty a longer CTS processing Yes protocol with reprocessing equence more heat and is tissue processed efficient agitation adequately No Adequately processed tissue Try a defatting step of 50 50 xylene and ethanol Put step between ethanols and xylene ensuring that Yes there is a 100 ethanol step after defat before xylene Do blocks contain R Reprocessing will not help Decalcification hard fragment is required Surface decal can be performed by trimming the block in gently and then placing the block face d
170. s n only compatible stations as available This station is hidden because it has already been used for a previous step Show all show incompatible stations as available Hide used show stations that have already been These stations are available selected as unavailable for selection These stations are unavailable because they are not compatible with the preceding protocol step Figure 43 Reagent selection Station dialog box Deleting a Protocol To delete a protocol select the protocol icon on the Protocol selection screen and tap Delete Pre defined protocols can be restored if required with the normal protocol creation procedure Other protocols cannot be retrieved unless you have copied them to an external device using the file transfer functions see 6 2 7 File Transfer Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 69 4 2 3 Protocol Setup Creating New Protocols Create new protocols from scratch or copy an existing or pre defined protocol to modify Make sure you select the right protocol type and reagent selection method when you start or copy a protocol of the right type and reagent selection method because these settings cannot be changed after you have started protocol configuration WARNI NG Do not set new protocols as validated until they have passed the validation procedures for your laboratory Only then should you edit the protocol to set it
171. s also dependent on the protocol type The following sections list the protocol temperature ranges and typical protocol sequences Retort temp range Retort temp range for Wax bath temp Protocol type for reagent wax range Standard 35 9C to 65 9C 2 C above wax melt temp 155 C to 85 C to 77 9C Xylene free 35 C to 65 C 2 C above wax melt temp 155 C to 85 C to 85 C Cleaning 35 9C to 85 9C N A 55 C to 85 C The current wax melting temperature is shown on the Reagent management screen 8 5 Reagent Compatibility Tables The reagent compatibility tables determine the allowable reagent sequences The sequences vary depending on the operation or protocol type Manual Operations Current step Previous step a la o M 2 9 t o Oo compatible 2 g c fo o x oO fo o x o E E MN CU Z O O Fixatives Dehydrants Viv v NM M Clearers v M MI Ww Wax v1 M M M Cleaning solvents v1 M Mu IIM Cleaning alcohols MiMiM M Ww wv Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 137 Reference Standard Protocols Current step Previous step gio 28 i 8 2 9 o 5 v 2 compatible T 9 c fo lt x o x o o Y E E ac a Z O Fixatives Dehydrants MiK v Clearers v M MI Wax v1 M M
172. s are not recommended for overnight processing If a reagent becomes unavailable for any reason then the protocol cannot be completed When running station selection protocols always check the concentration of the assigned stations before starting a run as the concentrations may not be correctly ordered if other protocols have run Your decision about the reagent selection method must be made in combination with decisions about how many and which reagent types you use and the concentration thresholds to set for these Note that all the pre defined protocols in the Peloris system use type selection but with recommended bottle configurations that have the minimal number of reagent types see 8 2 2 List of Pre defined Protocols and 8 3 Station Configurations This combination provides a system that is similar to group selection with all the consequent benefits Pre defined Protocols Each Peloris system includes 11 pre defined protocols 1 2 4 8 and 12 hour protocols for standard and xylene free processing and a cleaning protocol see 8 2 2 List of Pre defined Protocols Access the pre defined protocols from the Protocol selection screen by selecting New and then selecting the Pre defined icon The pre defined protocols are designed for use with the bottle configurations described in 8 3 Station Configurations Leica Microsystems has extensively tested the protocols and found they give excellent results in combination with proper reagent
173. s button on the File transfer screen The Transfer protocol files screen opens Protocols on the instrument are in the left column Local protocols and protocols on the USB key in the right column Remote protocols 3 Select individual protocols in either column to import or export or use the Export all or Import all buttons to copy all of the protocols on the instrument to the USB key or from the USB key to the instrument If when exporting protocols onto the USB key there is a protocol of the same name already on the key you are prompted with the option to overwrite the existing copy or skip the transfer In contrast you cannot overwrite a protocol that is already on the instrument with a protocol of the same name on the USB key 4 Tap Done when finished Protocols transferred to the instrument will now be available in the Protocol selection screen Protocols transferred to the remote device will be stored in the protocols folder on the device Transferring I ncident Report Files Use this procedure to transfer a group of files providing information relating to a specific incident These files can be used by Leica Microsystems or your service representative to aid system health diagnosis The information is compressed into a single file small enough to be emailed 1 Attach a USB device to the instrument see Attach or Remove a USB Key above 2 Open the Event log screen Control menu Event log and select the event that
174. s for the reagent management system to work correctly Yes Check Is the lab Transfer fluid formal saline Fixation time Water introduced after processing Quality of embedding wax Are these all correct workflow tissue processed correctly Go to 9 2 3 Under or Over processed Tissue Reagents Stop Well Processed Tissue Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 142 Troubleshooting 9 2 3 Under or Over processed Tissue Reagents Under over processed tissue reagents Check reagent concentrations with a hydrometer the reagent change and final reagent thresholds No bottles are in their correct stations the reagents in the bottles are correct reagent storage conditions reagent threshold check method Are they all correct Are the reagents physically correct Yes Check reagents are clean Discard incorrect or dirty Factors that could affect reagent purity are reagents Rinse reagent No recycled reagents bottles and fill and drain running reprocessing protocols retort with fresh reagent to failing to clean the retorts before or after clean reagent lines remote drain or fill operations Are the reagents clean Open a service call to have Leica Is the wax Microsystems test the instrument and contaminated repair if required or does it smell like formalin Is the instrument functio
175. temperature pressure or vacuum P V stirrer speed and drip time for each step Tap a cell to open a dialog box to change the setting Figure 39 Edit protocol screen Name change the protocol name Insert f f Notes enter a description or tap to insert a new step above the other notes for the protocol currently selected step W ieee set the carryover value See 4 1 5 Carryover Delete tap to remove the currently Delete Caryover Setting selected step from the protocol protocol Validate l nvalidate protocol set the protocol as valid or invalid see 4 1 4 Protocol Validation Save save changes made to the protocol Done Figure 40 Configuration buttons on the Edit protocol screen Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 67 Protocol Setup Selecting Reagents When you select the Reagent cell in the protocol step table to add or change a reagent the dialog box you see depends on the reagent selection method For all the methods you can show only reagents that are compatible with the preceding protocol step for the protocol s type or all reagents For station selection you can hide stations that have already been selected If you choose an incompatible or hidden reagent it is added to the protocol table with an asterisk to indicate that it is disallowed You cannot load the protocol or run the protocol Group Reagent Selectio
176. that are consistent with industry practice ii all applicable laws regulations guidelines and decisions of judicial or regulatory bodies iii any patent or other proprietary rights of third parties and iv as envisaged by the Documentation and this agreement b not install or procure the installation of any software on the Designated Computer without Leica Microsystems prior written consent c not copy all or part of the Software or Documentation or allow all or part of the Software or Documentation to be copied other than one copy of the Software for backup purposes without obtaining Leica Microsystems prior written permission d not publish distribute or commercialise all or part of the Software or Documentation or any adaptation modification or derivative of the Software or Documentation e not sell rent lease sub license assign or transfer all or part of the Software or Documentation or any of its rights under this agreement f not use the Software or the Documentation for the benefit of any third party or disclose the Software or the Documentation to any third party except with Leica Microsystems prior written consent g not adapt reverse engineer make error corrections or otherwise modify the Software or Documentation or create derivative works based on the Software or Documentation other than to the extent permitted by applicable copyright laws or permit third parties to do the same h not
177. the contamination it receives will be from the previous group A reagent that is used late in a sequence will have a slow concentration decline as most of the contamination it receives will be from the same group Managing Concentrations The Peloris software uses reagent concentrations to select stations when protocols are run unless the protocol uses station reagent selection It selects the station with the lowest in threshold concentration of a reagent group or type for the first step using that group or type then stations of increasing concentration for following steps It always uses the highest concentration reagent for the last step before changing to another reagent group or type The software also uses concentration information amongst other factors to prompt you to change reagents that have exceeded purity thresholds It is very important then for high quality processing and efficient reagent use that the concentration information the software uses is accurate The software automatically tracks the concentration of the reagent in each station updating values after each run For it to do this effectively you must enter accurate information for it to work with e g set realistic protocol carryover values and enter the correct number of cassettes in each run It also means you should update the software properly whenever you change reagents Under default settings the software assigns concentrations by calculation This uses i
178. the retort and the reagent station to fill from or drain to on the Remote fill drain screen Tap the Fill retort or Drain retort button To stop the fill at any stage tap the Abandon button WARNING Never fill a reagent station when its contents are in a retort This may cause fluid spills Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 97 Settings amp Ancillary Operations This chapter describes basic system configuration options and ancillary operations such as manually pressurizing a retort or heating a wax line viewing the event log handling alarms changing user access level and transferring system files onto external media Access reagent related ancillary options from the Reagents menu 6 1 1 Manual Operations 6 1 2 Reagent Management All other ancillary functions are in the Control menu 6 2 1 Instrument Settings 6 2 2 Device Settings 6 2 3 Service Settings 6 2 4 Event Log 6 2 5 Alarms 6 2 6 Access Level 6 2 7 File Transfer 6 1 Reagents Menu Manually control reagent handling components of the instrument or configure or view basic reagents settings in two screens opened from the Reagents menu e 6 1 1 Manual Operations 6 1 2 Reagent Management Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 98 Settings amp Ancillary Operations 6 1 1 Manual Operations The Manual operations screen Reagents menu Manual operations allows you to
179. tions There are two views of the screen one for the 16 reagent bottles and the other for the four wax chambers Change views with the Reagent bottles and Wax chambers buttons Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 84 Reagent Setup See Figure 47 and Figure 48 for descriptions of the information and options on the Reagent stations screen Type reagent type in Since changed the State current state of station Tap cell to use history of each to change station view only Hatched cell indicates change threshold exceeded Out of threshold Reagent bottles and concentration value Wax chambers shown in red buttons to switch views Selected station tap in Station cell to select Station station Conc current number with reagent concentration of group color code reagent in station Tap cell to change Figure 47 Reagent stations screen reagent bottles view Type reagent type in Since changed the State current state of station Tap cell to use history of each station Tap cell to change station view only change Hatched cell indicates change threshold exceeded Out of threshold concentration value shown in red Reagent bottles and Wax chambers buttons to switch views Selected station tap in Station cell to select Station station Conc current Temp current number with reagent concentration of temperature in the wax group color code reagent in station Tap ch
180. tles carbon filter and condensate bottle The cabinet has two glass doors that retract into the cabinet when open WARNING To reduce the risk of fluid spills always keep the reagent cabinet doors closed during instrument operation unless actually changing a reagent or emptying the condensate bottle e 2 4 1 Reagent Bottles e 2 4 2 Condensate Bottle e 2 4 3 Carbon Filter Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 33 2 4 1 2 4 2 2 4 3 Hardware Reagent Bottles The reagent cabinet holds sixteen reagent bottles This is three more than standard tissue processors and it ensures there are sufficient reagents to simultaneously schedule protocols in both retorts while also having ample cleaning reagents on board and ready to use The bottle at each station holds sufficient reagent to fill a single retort To remove a bottle lift open the cabinet door and pull the bottle out Push back in position to return you will feel the bottle pushing into its connection point on the back of the cabinet Replace reagent in the bottles either manually with the bottles removed from the instrument or in position on the instrument using the Remote fill drain screen see 5 4 1 Remote Fill Drain Screen Some chemicals may cause the bottles to expand over time this is normal and does not impact the performance of the instrument WARNING SN Never run the instrument with missing bottles or with loose or missin
181. tocol to run a cleaning protocol Alternatively you may be able to skip the first steps of the protocol see 3 4 2 Editing the Protocol for a Single Run If so tap Continue in the warnings dialog box 7 If prompted enter the number of cassettes in the run in the Number of cassettes dialog box It is important to enter the correct number of cassettes this is used by the reagent management system to calculate reagent concentrations 8 Openthe retort lid and insert the cassettes when directed in the Insert cassettes dialog box Tap Done in the dialog box when you have inserted the cassettes and closed the retort 9 View the protocol end time in the Scheduling dialog box If acceptable tap Start or set a different end time see 3 4 1 Scheduling Protocols Tap Edit steps in the Scheduling dialog box to skip initial protocol steps or change step durations see 3 4 2 Editing the Protocol for a Single Run 10 When you tap Start the system schedules the protocol If the system is unable to schedule the protocol you will see a list of errors Tap OK and correct all errors before attempting to run the protocol again see 3 6 2 Unavoidable Reagent Clashes for a description of possible scheduling difficulties the system was able to schedule the run the protocol will begin If you have set a delayed end time an initial fill condition will occur see 3 6 1 Delayed End Times and Initial Fills Leica PELORIS User Manua
182. tocols for reprocessing as the dry step will damage the tissue WARNING Do not load unprocessed tissue samples into a retort prior to running a cleaning protocol Formalin in the residue purged to the wax bath at the start of the cleaning run may damage tissue on subsequent runs If you inadvertently load unprocessed samples into a retort prior to running a cleaning protocol remove the samples and attempt to load a processing protocol before loading the cleaning protocol The purge before the cleaning run will be skipped Instrument Setup A Eb VVARNI NG Do not use the instrument vvithout installing the drip tray VVARNI NG The instrument must be installed and configured by an approved service representative VVARNI NG Always use suitably rated lifting equipment such as a trolley or forklift when moving a Peloris tissue processor more than a few metres Only use the instrument s castors to reposition an instrument for service access Electrical Hazards gt WARNING The Peloris tissue processor must be connected to an earthed mains power outlet socket WARNING Dangerous voltages are present inside the Peloris tissue processor Only service technicians approved by the Biosystems Division of Leica Microsystems should remove any of the instrument s covers or access the internal components WARNING The instrument s operating voltage is factory set and it must not be changed Severe damage will occur if an instru
183. ts to the required level Always keep the reagent or wax volumes Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 26 Hardware well above the markings but below the maximum MAX level Reagent levels below the minimum will cause protocols to either fail or use a sub optimal reagent sequence MAK MIN 2BABKETR MN 2BANKETB Figure 3 Bottle fill levels Figure 4 VVax chamber fill levels Liquid Level Sensors Figure 5 Liquid level sensors for maximum 1 three basket 3 and two basket 2 retort fill levels Each retort has three liquid level sensors to monitor fluid levels The tvvo lovver sensors monitor the two and three basket levels The top maximum sensor responds to a fluid level of 5 3 liters It serves a Safety function ensuring no more reagent is pumped into the retort if triggered The sensors may occasionally be affected by a buildup of condensation or deposited material If this occurs the software will direct you to wipe the appropriate sensor Always ensure the sensors are kept clean as part of regular retort cleaning see Clean Retorts in 7 2 Daily Tasks Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 27 2 2 3 2 2 4 Hardware Magnetic Stirrer Each retort has as magnetic stirrer that stirs the reagent or wax to ensure temperature consistency and good tissue penetration The stirrer is driven by a magnetically coupled external m
184. tware Supervisors need a password to change to their access level on the access level screen Control menu Access level If a supervisor does not interact with the software for more than 10 minutes the access level automatically reverts to operator An icon on the Function bar indicates your current access level Figure 6 Access level icons with operator 1 and supervisor 2 Help This user manual is provided in PDF format on a CD It is also included in HTML format in the Peloris software Tap the Help button in the Function bar to open Use buttons on the Help screen and links in the text to navigate the online Help Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 22 Hardware The Peloris tissue processor is a free standing processor with two retorts sixteen reagent bottles and four wax chambers A touch screen mounted on the top of the instrument connects to an on board computer for control of all instrument operations Touch screen Wax bath with four wax chambers Y i y SS Two retorts oa Power button 5 PELORIS 4 Reagent cabinet Figure 1 Peloris tissue processor main features Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 23 Hardware This chapter describes the main features of Peloris instrument See sections e 2 1 Switching On and Shutting Down e 2 2 Retorts e 2 3 Wax Bath e 2 4 Reagent Cabinet 2 5
185. uctions to replace reagents and configure them in the software e 5 1 Reagents Overview e 5 2 Managing Reagent Types e 5 3 Managing Reagent Stations e 5 4 Replacing Reagents 5 1 Reagents Overview Using the right reagent at the right time at the right concentration is of utmost importance for high quality tissue processing The Peloris system has an advanced reagent management system that helps ensure consistently high quality processing while allowing you flexibility to fit into your laboratory s workflows The Reagents Overview section describes the main features of reagent management in the Peloris system 5 1 1 Reagent Groups Types and Stations 5 1 2 Concentration Management 5 1 3 Thresholds 5 1 4 Recommended Reagents 5 1 5 Tissue Marking 5 1 6 Reagent Compatibility Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 72 Reagent Setup 5 1 1 Reagent Groups Types and Stations The Peloris tissue processor manages reagents by groups types and stations Groups Groups specify reagent function For example the fixatives reagent group includes all reagents that can be used as a fixative There are nine factory defined groups Each group has a color code used in the Peloris software and on bottle labels Refer to the following table for a list of the groups and their colors and functions Group Function Color Fixatives Tissue preservative Green Dehyd
186. ument CAUTION Do not use any cleaning methods other than the ones described below Use of other methods may damage the instrument Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 114 7 1 Cleaning and Maintenance Schedule Cleaning and Maintenance See the list below for regular cleaning and maintenance tasks and how often they should be carried out The table on the next page is a weekly maintenance and cleaning checklist that you can print to use as a record of maintenance tasks Initial the relevant cells in the table as tasks are carried out Daily Clean Lids and Seals Clean Retorts Check Reagent Levels Clean Top Surface Clean Touch screen Weekly Empty Condensate Bottle Check Reagent Bottles Clean Wax Bath Check Bottle Connectors Clean Exterior Surfaces 60 90 Days Change Carbon Filter Check Lid Seals As Required Retort Acid Clean Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 115 Leica Peloris User Maintenance Chart Week Serial No Cleaning and Maintenance Mon Tues Wed Thurs Fri Sun Date Daily Tasks Clean lids and seals Clean retorts Check reagent levels Initial OK Initial OK Initial Initial Initial Checked OK Topped off up T T C T C T C T C T C Changed C Initial OK T C Initial OK T C Bottle 1 Bottle 2 Bottle 3
187. urement control and laboratory use Part 2 Particular requirements for automatic and semi automatic laboratory equipment for analysis and other purposes IEC 61326 Electrical equipment for measurement control and laboratory use EMC requirements FCC Part 15 Class A B Unintentional Radiators 1SO 13485 2003 Medical Devices Quality management systems Requirements for regulatory compliance FCC Compliance This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference 2 This device must accept any interference received including interference that may cause undesired operation FCC Class B compliance statement This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by o
188. ving 88 cassettes per basket Figure 11 Basket arranged for orderly packing Figure 12 Basket packed with 88 cassettes For tight packing insert only the long dividers This allows you to pack the maximum number of cassettes 25 per row see Figure 13 and Figure 14 Figure 13 Basket arranged for tight packing Figure 14 Basket packed with 100 cassettes For large or unusually shaped cassettes use the baskets with all dividers removed CAUTION Do not use high capacity baskets for xylene free protocols as this may lead to wax build up that will eventually require service intervention Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 30 Hardware Spaced Baskets The spaced baskets include a fixed divider that ensures that the cassettes are correctly spaced for optimal processing Each spaced basket can fit up to 72 standard cassettes inserted into the spacing springs as shown in Figure 15 Figure 15 Detail of cassettes packed into a spaced basket You must use spaced baskets when running xylene free protocols Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 31 Hardware 2 3 Wax Bath The wax bath at the top rear of the instrument has four wax chambers accessed by two lids Each chamber acts independently holding enough wax to fill a retort Although wax does not move between the chambers they are connected for air flow and so always have the same pressur
189. visors Icons for validated protocols have a green check while the icons for invalid protocols have a red cross 2 s 04 02 00 Figure 35 Icon for a valid protocol Figure 36 Icon for an invalid protocol Set protocol validity status on the Edit protocol screen with the Validate protocol I nvalidate protocol button Carryover Setting The Carryover setting is a protocol setting for the additional carryover due to biopsy pads and other small tissue carriers This section has first a general overview of carryover in the Peloris system then describes how to use the Carryover setting in particular Carryover Overview When reagent drains out of a retort and is replaced with reagent from another station a certain amount of the first reagent remains in the retort and mixes with the new reagent The Peloris reagent management system calculates the amount of this carryover and uses it to determine reagent concentrations Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 62 Protocol Setup Carryover has three main components e Reagent on retort walls and baskets e Reagent on cassettes and on and infiltrated into tissue e Reagent on and infiltrated into small tissue carriers e g biopsy pads biopsy cassettes wraps etc The reagent management system automatically calculates the carryover on retort walls and baskets taking into account the retort fill level and drip time The c
190. x Bath Check the wax chambers weekly and note if they are becoming dirty Clean the chambers when next replacing the wax Clean the wax chambers while they are warm after draining spent wax out of the instrument Never attempt to clean a chamber while the wax from the chamber is in the retort Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 120 Cleaning and Maintenance Wipe the bottom and sides of the chamber with a lint free cloth to remove any debris or sludge Do not remove the chimney filters Be careful not to dislodge the filters Take care no material goes into the air hole on the wax bath rim WARNING Never open a wax bath lid when there is wax in a retort or wax is being transferred hot wax may splash out of the bath WARNING Take care when cleaning the wax bath walls The walls could be hot and may cause burns Check Bottle Connectors The bottle connectors that plug into the instrument can become loose Check the connector whenever you pull out a bottle Tighten firmly if necessary Clean Exterior Surfaces Wipe down the exterior surfaces of the Peloris weekly with a damp cloth water or 70 alcohol Do not use strong solvents Dry with a lint free cloth Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 121 Cleaning and Maintenance 7 4 60 90 Days Change Carbon Filter Change the carbon filter every 60 to 90 days WARNING Always replace the carbon f
191. y Ltd 2011 52 Running Protocols 3 4 2 Editing the Protocol for a Single Run You can edit the protocol for an individual run just before the run is started You can make two types of change 1 Skip the first steps of the protocol 2 Change step durations Make both types of change in the Edit protocol instance dialog box opened from the Scheduling dialog box Start a protocol run as normal from the Status screen and continue until the Scheduling dialog box opens Tap the Edit steps button to open the Edit protocol instance dialog box No check in the circle shows Please select the starting step for the protocol this step will be skipped Step Reagent Step time 1 Tap the step that will be the first to run in the protocol Tap on a step time to open the Duration dialog box to set a new step duration JO SACOS Cancel Figure 33 Edit protocol instance dialog box To skip protocol steps tap the step that you want to start the run with Steps prior to this are unchecked to show they will not run The reagent selected as the new first step will be used for an initial fill if required see 3 6 1 Delayed End Times and Initial Fills e To change a step time tap the current step time Set a new time in the Duration dialog box Skipping steps and changing step durations will affect protocol scheduling confirm that the new Predicted end time shown in the Scheduling dialog box is acceptable before you start the ru
192. you want to report Events must be shown by time 3 Tap the Incident report button You are returned to the File transfer screen The Incident report button on that screen is selected and the date and time of the event you selected are entered In an alternative workflow you can manually enter the date and time of the incident with the Incident date and Precise time of incident buttons 4 Tap Transfer files to begin the file transfer Tap OK in the confirmation dialog box to continue with the transfer Tap Cancel to terminate the procedure if there is not room for the files on your USB key Leica PELORIS User Manual Rev K Leica Biosystems Melbourne Pty Ltd 2011 111 Settings amp Ancillary Operations Transferring nstrument Condition Files Service Logs and Event Details There is a range of other file types you can transfer to your service representative for troubleshooting Transfer the following file types if your service representative asks for them e Instrument condition files basic system configuration files e Service logs instrument information up to a specified date and time e Event details more detailed information around a specified date and time Incident report detailed information at the time of a specific event See Transferring Incident Report Files below for instructions for this procedure Use the following procedure to transfer instrument condition files service log files and or event

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