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-It.Tissue-Tek®VlplM 5

1. Revised 05 16 01 2 5 CIHRT Exhibit P 3624 Page 18 CIHRT Exhibit P 3624 Page 19 Section 3 EXPLANATION OF SOFTWARE CUSTOMIZATION General Information The Tissue Tek VIP 5 Vacuum Infiltration Processor contains software that can be customized for the work routine and procedures used in the individual laboratory This section explains the various operating modes and provides information on customizing the software Many of the procedures in this section will be used upon initial installation and only rarely thereafter However detailed information on the progression of screen displays and prompts is given here therefore this section should be read thoroughly before beginning routine operation Once you are familiar with this information Section 4 Operating Instructions can be used as a quick reference for routine operation When the VIP instrument is first turned on the startup screen shown on page 2 2 is displayed which requires entry of a password entry code to progress further in the displays This screen will also be displayed if the software exits from a processing program such as after the Clean Cycle A default manager password code of 0000 is programmed into the instrument enter this code then press Enter The screen will then display the Main Menu shown below ale SAKURA Tissue Iek VIP Vacuum Infiltration Processor Station Number Retort Operation
2. Retort lid unlocked The retort bar is in the open position to the left Be sure the retort lid is securely clamped No processing operation automatic or manual will then slide the retort bar to the right occur unless the retort bar is closed If the bar is opened while the instrument is operating an alarm will sound for ten seconds repeating every minute Revised 05 16 01 CIHRT Exhibit P 3624 Page 51 ERROR CODE DESCRIPTION POSSIBLE CAUSE REMEDY 1 Retort overflow during a P V cycle 1 A reagent bottle contains too much liquid m There are too many specimens in the retort 3 Fluid from an external source was poured into the retort 4 Overflow bottle is misadjusted or overflow sensor was touched or is misadjusted 1 Fill bottles to the correct level for the instrument model being used 2 Reduce the number of specimens in the retort do not process more than the recommended number 3 Open retort and remove excess fluid to below the fill line etched on either side of retort then close retort Place an empty bottle at the highlighted station and perform a manual pump out of the retort 4 Perform a manua pump out If error repeats contact Customer Support for further information 2 Retort overflow during other than a P V cycle or pump in 3 Power outage 10 Retort overflow during the pump in cycle 11 Pump in not complete after 6 minutes or bottle connec
3. INTRODUCTION Physical Characteristics NOTE All figures in this manual use the floor model Its components are identical to those of the bench model In the bench model however the module that holds the reagent cabinet is located to the right side of the retort and control panel rather than beneath Control Panel Figure 1 3 The control panel contains the screen display 1 and the keypad 2 which the operator uses to communicate with the instrument software A contrast adjustment knob is located behind the left hand side of the display If no keys are pressed for 10 minutes the display will revert to a screen saver mode where the display is dimmed Pressing any key will reinstate full brightness but the action of that key will be ignored otherwise by the software Figure 1 3 Retort Figure 1 4 The retort 3 is the chamber in which processing actually occurs One or more baskets which hold the specimens are placed into the retort if the instrument is used as a 150 samples instrument using a lower reagent volume displacement blocks provided in the accessory kit must be placed in the bottom basket During processing the retort lid 4 is held securely closed by a latch system 5 The retort gasket 6 provides sealing of the retort The retort interlock slide bar 7 when in place over the latch system prevents access to the retort During processing when the retort bar is moved to the open position
4. 4 Unless the process was discontinued it can be restarted simply by pressing Resume from the Hold Menu Processing will continue from the point at which it was interrupted The instrument does NOT adjust the Remain Time for the length of time that elapsed while the instrument was on hold mm m d pu a A PB E 44 Revised 05 16 01 CIHRT Exhibit P 3624 Recommendations for Efficient Operation Specimen Placement Proper placement of tissue specimens into the basket is vital for acceptable processing results Improper placement can result in inadequate reagent penetration and in reagent cross contamination For optimal results 1 Tissue samples must be small enough to allow sufficient clearance between the tissue and the cassette interior This will ensure good flow of reagents on all sides of the tissue 2 Use the vertical divider in the specimen basket 3 Place cassettes in the basket with their slanted end facing up rather than laying them flat 4 Cover the baskets with their lids to prevent cassettes from floating free in the retort Page 39 Solution Replacement and Exchange The schedule for replacement and or exchange of reagents varies from one laboratory to another the volume of processing is the best indicator of the timing Solution replacement can be done either manually by physically emptying and filling the bottles or automatically through the Exter
5. Error information function can be utilized to help determine the cause of the error Press any key the processing run will end and the display will return to the Main Menu m P nn A M QM NNNM NAAR 3 4 Revised 05 16 01 CIHRT Exhibit P 3624 Page 23 1 From the Main Menu press Utility and then Error Information It can also be entered during a processing run through the Stop Menu See Interrupting the Run in Section 4 To view the current error or to review up to 100 errors that previously occurred press Error List In each case the following information is displayed Display Explanation Error Error number Sta Station number at which error occurred Time Time at which the error occurred Retort C Temperature of the retort Oven C Temperature of the paraffin oven Rotary Valve C Temperature of the rotary valve Gate Valve C Temperature of the gate valve 2 Refer to Section 7 TROUBLESHOOTING for a complete explanation of each error code that is displayed 3 Record or print the screen information Press Error Description to obtain an explanation for each error code Press Exit to return to the Error List screen The error list can be cleared using the Clear function key only if a Manager Password has been entered in the Startup Screen The error codes will also clear automatically on
6. F Safety Standards Tested and listed by Inchcape Testing Services ITS Complies with UL3101 1 1st ed CAN CSA C22 2 No 1010 1 92 M M LL 1 8 Revised 05 16 01 CIHRT Exhibit P 3624 INSTALLATION Page 13 Section 2 General Information This section provides information on selecting a proper location unpacking and installing the Tissue Tek VIP 5 instrument A Tissue Tek instrument representative or a certified Biomedical Equipment Technician should perform the installation The instrument must be installed correctly to ensure proper operation and service Read this Operating Manual carefully before attempting to operate the instrument Follow all instructions carefully The VIP processor is a precision instrument and must be handled accordingly Rough handling or dropping of the instrument will disturb or damage internal components Always handle the instrument with care Environmental Factors Environmental factors influence the selection of a proper location for the VIP instrument As with all sensitive electronic instruments prolonged exposure to excessive humidity and temperature should be avoided Temperature and humidity should be held relatively constant to obtain the highest degree of operating stability The ambient temperature range for operating the instrument is 10 C to 40 C 50 F to 104 F The ambient operating humidity range is 30 io 85 relative hum
7. ____ Retort Temp 35 C Rotary Valve Temp 70 C Oven Temp 61 C Gate Valve Temp 24 C On most screen displays the date and time are displayed in the upper right corner and the software routine or operating mode in the upper left corner The retort oven rotary valve and gate valve temperatures the station number selected the instrument operation and the retort condition are displayed in the bottom section of the display in the Main Menu and in some other screen displays When applicable the bottom two lines of the screen are reserved for the display of messages and warnings The right hand side of the display has room for up to six function keys A software label describes the function of the key and the function can be enabled by pressing the button adjacent to it A blank key signifies that there is no associated function The Main Menu is the starting point for the routine operation of the instrument Each menu item is explained below in a logical order of usage during the initial setup Pressing the Exit function key will display the previous screen Any information not saved before pressing this Exit function key would be lost Jun 3 6 04pm FT Exit Tissue Processing Edit Programs Cleaning E Solution Contro E D Main Menu Revised 05 16 01 3 1 CIHRT Exhibit P 3624 EXPLANATIO
8. and there is no need to clear the counters However if runs have been performed and you plan to exchange the solution at this station the Clear Used count key can be pressed to clear the Used count and begin again at 0 To access the Clear Used Count key the cursor must be located in the Solution column The operator has the option to clear all counters at once only the ones that have reached the Set number or line by line 5 Repeat Steps 1 4 above for each station from 2 to 10 and Steps 1 3 and 4 for each station from 11 to 14 the concentration of the paraffin in these stations is not set Revised 05 16 01 3 7 CIHRT Exhibit P 3624 EXPLANATION OF SOFTWARE Page 26 6 When the cursor reaches the lines for Stations 15 through 17 and for the Activated Carbon only the Set column can be accessed ONLY the reagenis listed should be used at these stations and they should always be changed after the listed number of cycles in order to ensure adequate cleaning and fume control The three cleaning reagents must be changed at least every 5 cleaning cycles To ensure proper fume control the carbon filter cartridge must be changed on a regular basis depending upon usage refer to Section 6 Since there is no economical way to specifically monitor the remaining absorption capacity and or capability of the Activated Carbon changing the Activated Carbon after every 20 runs is recomm
9. located behind the door on the left side of the instrument next to the paraffin oven Push gently on the lower right of the door where indicated to get access to the port b Insert the other end of the drain fill hose into a reagent container with at least 5 liters of reagent left Make sure the reagent in the container is the same as the one programmed for that station c From the Main Menu press the Solution Control function key then press the Exchange function key d Press the Fill function key e As instructed on the screen input the station number io be filled and press Enter L Press the function key Select Vol Normal Full to select the appropriate fill volume When the instrument is used for 300 cassette processing the Normal fill volume will pump in 3 7L of reagent and the Full fill volume will pump in 4 5L of reagent When used for 150 cassette processing the Normal fill volume will pump in 2 7 L and the Full fill volume will pump in 3 5 L of reagent NOTE The Full fill volume is selected when a higher ratio of reagent to tissue specimens is desired g Verify once again the connection the reagent and the station number Press the Start function key when ready The pump in action will be automatically stopped when the fill level is reached h If desired the drain fill port can be rinsed using the Rinse function Page 16 Figure 2 3 24 Revised 05 16
10. Cycle press Exit The software will then require you to enter the password in order to bypass the Clean Cycle After entering the password and pressing Enter the Main Menu will be displayed Wipe out the retort with a dry cloth before performing another processing run if the Clean Cycle was not performed this will help prevent contamination of the reagents from remnants of the final reagent pumped out of the retort Interrupting the Run A processing run can be interrupted for example in order to edit the program or discontinue the run ff the run is not discontinued processing can be started again after the editing function by pressing Resume Revised 05 16 01 1 To interrupt a run that is either processing or in the Delay mode press the Hold key If a pump in or pump out operation is in progress the instrument will complete the operation before stopping and returning the retort to an ambient condition The message line will then prompt ENTER PASSWORD OR PROCESSING WILL RESUME IN 30 SECONDS You must enter the password within 30 seconds or processing will begin again Enter the password and press Enter or press Resume to continue the run NOTE The instrument does not adjust for the length of time of the interruption The Time Left will not count down if a run was in progress NOTE A processing run can also be interrupted by pressing the STOP key or sliding the retort lock lever
11. Error Information If an error occurs during a processing run information about each error is displayed through the Error information function Each occurrence of an error is stored in sequential order for later display the Warning line on the display will flash the message ERRORS XX XX with each error number listed When errors occur during a processing run the run will be affected in one of three ways depending upon the type of error The instrument corrects the error and the processing run continues however the occurrence may have delayed the scheduled end time The processing run is stopped the error can be corrected by the operator and the run continued by following the prompts given on the message line of the display The processing run is stopped and the error cannot be corrected without ending the run Errors that stop the run will cause an alarm to sound for 10 seconds every minute until the instrument is attended and will set off the external alarm in five minutes if one is connected Pressing the ALARM OFF key will silence the internal alarm moving the retort bar to the left then to the right will silence the external alarm if a critical error has occurred that causes the run to be aborted the display will flash the message OPERATION INTERRUPTED PRESS ANY KEY the station line at which processing stopped will be highlighted and the error numbers will be displayed on the warning line The
12. ON or OFF for each station Using the arrow keys move the cursor into the Time or Temp column at the desired station Press the P V Cycle key to turn it off or on Using the Mix Cycle key you can select either slow fast cont or off for each station When mixing is slow the reagent will be pumped out of and back into the retort every 20 minutes When fast the cycle will occur every 12 minutes The cycle will repeat until the Remain Time shows 30 minutes or more when slow is selected or 22 minutes or more if fast is selected If continuous mixing is selected partial pump in and pump out cycles will be initiated followed by fast mixing cycles The mixing action can also be turned OFF The Mix Cycle key allows the selection of one of the four options Revised 05 16 01 5 Repeat Steps 1 4 above for each station from 2 through 14 All prompts will be identical with exception of the prompt for processing temperature Step 2 for Stations 11 14 The prompt for these stations will show an allowable range of 45 70 C 113 158 F rather than 35 50 C 95 122 F also the heat cannot be turned OFF for these stations NOTE Check the melting temperature of the paraffin to be used before programming the processing temperature for Stations 11 14 to ensure an appropriate entry 6 If the program is used with a delayed starting time the End Date and Time are selected The end time is the time at which you want
13. Revised 05 16 01 CIHRT Exhibit P 3624 Page 29 Mir PPP IER E a 4 2 Program Copy This function which is also a subfunction of the Edit Programs screen can be used to copy one program to another This is a convenient and quick way to set up a second program that will be very similar to another with only a change for example in the end time or in the processing times To use this function you must be in the Edit Programs screen with the old program to be copied from on the display To highlight the program move the cursor to the desired program code line using the and v key Press Enter and then Copy 2 Two message boxes will appear The top box will have the message line COPY PROGRAM FROM NUMBER The cursor will move to the box next to the prompt COPY PROGRAM TO NUMBER and the message line will prompt ENTER PROGRAM NUMBER TO BE COPIED TO PRESS COPY Enter the program number that you want to copy to and press Copy The program will then be immediately copied and the display will change to Edit Programs showing the newly created program Press the Save function key to store this program into memory 4 3 Name Programs To name a program press Edit Programs in the Main Menu Display Enter a program number or select one from the list using the arrow keys Then press Enter Press the Name Programs function key to name that program number Use the
14. Tek VIP Tissue Processors and Tissue Tek TEC Tissue Embedding Centers To be used with Product Code 5267 To be used with Product Code 5268 Allows the partitioning all VIP 5 baskets even further Six per package Complete with cap and connector Color coded labels for 150 cassette or 300 cassette oper ation Reagent information can be inscribed using a felt pen Contains either 2 7L or 3 7L of molten paraffin Used in the 150 cassette operation Must be put into a 150 cassette basket and placed underneath the basket containing tissues Three per package Used to perform an external drain or fill operation TTT TET a 9 2 Revised 05 16 01 CIHRT Exhibit P 3624 Page 43 Printer Product No 4397 Not Shown A printer can connect to the VIP 5 instrument 1 Figure 5 3 Once installed the printer will provide a hard copy printout of the program being used and any errors that occur as well as several other screens Uninterruptible Power Supply UPS not sold through Sakura An Uninterruptible Power Supply can be connected to the UPS Connector 2 Figure 5 3 on the rear of the VIP 5 Note that the UPS connector is a signal connector only Figure 5 3 The UPS unit supplies power to the VIP 5 in case of power outage occurrence Revised 05 16 01 5 3 4 CIHRT Exhibit P 3624 Page 44 CIHRT Exhibit P 3624 CARE OF THE INSTRUMENT Page 45 Section 6 General Mainte
15. following procedure Tools Required None Parts Required Retort Gasket Part No 1520 LUCHAS Figure 8 1 Once a small portion of the gasket is fitted into the groove slowly run your thumb along the gasket pressing Procedure it into the groove all the way around the lid Figure 8 2 1 Remove the old gasket from the groove around the Check carefully to ensure that the entire length is fully underside of the retort lid inserted inside the groove with no edges sticking out If excess remains apply pressure along the gasket in the 2 Thoroughly clean the groove using a cloth moistened with opposite direction of insertion to take up any slack alcohol or xylene Be sure all debris and moisture are removed Then check the groove carefully for any flaw or CAUTION Do not tear or break the gasket with irregularity If any exists do not operate the instrument fingernails or sharp objects contact Customer Support immediately Figure 8 2 Revised 05 16 01 8 1 CIHRT Exhibit P 3624 Page 56 CIHRT Exhibit P 3624 Page 57 Section 9 SERVICE AND REPLACEMENT PARTS Service Information When You Have a Problem With the Instrument When problems arise during operation of the Tissue Tek VIP 5 Vacuum Infiltration Processor first refer to Section 7 TROUBLESHOOTING Avoid problems by carefully following proper operating and cleaning procedures If the problem cannot be s
16. in the designated work area Be sure that each leveling foot fully contacts the bench top and that each foot has been properly adjusted so the instrument is level CIHRT Exhibit P 3624 INSTALLATION 3 included with the instrument Operating Manual 1 including Warranty Registration U S customers only Reagent Bottles 15 E Paraffin Containers 4 Front Anti Splash Inserts 4 already inserted in the paraffin containers Back Anti Splash Inserts 4 already inserted in the paraffin containers Activated Carbon Cartridges 2 Cassette Baskets 2 Blank Bottle Labels 150 samples 1 set Blank Bottle Labels 300 samples 1 set Drain amp Fill Hose 1 Displacement Blocks 3 Basket Transport Tray 1 If any of these items are missing contact your Customer Support Representative refer to Section 9 If there is visible shipping damage to any item immediately file a complaint with the carrier Then notify your nearest Tissue Tek instrument distributor or call Sakura directly Plug the instrument power cord into a dedicated grounded electrical power source of the proper voltage and amperage als 4 SAKURA Tissue Iek VIP Vacuum Infiltration Processor Page 14 Confirm that all of the following accessories have been Move the main power switch located on the rear of the instrument behind the control panel to the ON posit
17. memory and to return to the Main Menu or press Exit if you do not want to save the changes 3 10 Page 28 4 1 Program All Stations This subfunction of the Edit Programs screen allows the user to quickly make the same change to all stations It can be used for each of the four parameters that can be set in each program time temperature P V and mixing If only a few of the stations will be different you can use this function to change them all then modify those few stations as necessary h To use this function the display must be in the Edit Program screen Then press All Stations The cursor will be located at the bottom of the column in which it was previously located or under Time if it was located at the End time selection and All Stations will be displayed at the left side of that line Use the and arrow keys to move the cursor to select the Time or Temp for change Press the P V Cycle or Mix Cycle function keys to change those selection Then press the Enter function key All stations will then be changed to the values shown in the All Stations row NOTE The entry for Temp C column will affect only Stations 1 10 Stations 11 14 must be set individually through the normal Edit Program screen After the Save key is pressed the display will return to the normal Edit Programs screen Make any changes to specific stations at this time
18. the oven When the door is closed it will push against the containers making sure they are properly connected Close the oven door Precautions There are several precautions that must be observed before operating the instrument 1 Check the fill level of each reagent bottle to ensure the specified volumes Bottle levels will be specified by labels Over filling the bottles may cause an overflow in the retort resulting in an error condition and halted processing Check the screw caps of each bottle io ensure tightness Check each connection to ensure that it is properly seated Check the paraffin containers for proper fill level Use only paraffin with the same melting point not to exceed 70 C 158 F DO NOT overfill the paraffin containers Ensure that all tanks are properly seated in their connections NEVER open the retort lid if VACUUM or PRESSURE is being displayed for the retort atmosphere Open the lid only when AMBIENT is being displayed NOTE The pressure and vacuum are released automatically through a safety relief valve when ihe retort bar is moved to the left Wait for AMBIENT to be displayed before opening the lid Do not obsiruct the ventilation louvers in the top of the control panel This area must be kept clear to ensure proper ventilation Also do not place any containers of liquid on the top of the control panel spillage could cause extensive damage to the instrument
19. to the left The instrument would then stop immediately and return the retort to an ambient condition Any pump in or pump out operation in progress will be stopped immediately If a valid password is entered the display will change to the Hold screen NOTE If the run was interrupted while the instrument was in the standby position of the delayed start routine an Immediate Start key will also be shown allowing to bypass the delay Press the appropriate function key for the desired action Each function is explained below The screens displayed and the operation of each function are identical to those seen in the routine operation when it is selected from the Main Menu Hold E Ei d 8l E 9 0 0 0 0 mu List OoOoouoocouo A A 1 di Hold d Display 4 8 CIHRT Exhibit P 3624 OPERATING INSTRUCTIONS Edit Programs If Edit Programs is selected the display will change to the Edit screen for the program being used for the processing run The time retort temperature P V or mixing selections can be changed for any station not yet completed in addition the end time can be changed When all necessary changes have been made press Save to return to the Hold screen If Exit is pressed changes are not kept NOTE The changes made affect only the current processing run they do not affect the parameters stored in memory for the program Error List The Error List scre
20. 01 CIHRT Exhibit P 3624 Page 17 5 Remove the cartridge of activated carbon from its plastic bag Open the door located on the left side of the paraffin oven by gently pushing where indicated With the vent holes to the top and the connecting hole towards the instrument slide the cartridge into the receptacle Figure 2 4 When a slight resistance is felt push firmly on the cartridge to ensure a proper connection Figure 2 4 6 Monitor the temperature of the oven the default tem perature is 62 C 143 6 F If this temperature is not suitable for the paraffin being used set the appropriate temperature as described in Section 3 Edit Programs If it is suitable the paraffin containers can be filled with melted or unmelted paraffin Remove each paraffin container from the oven and install the front and back anti splash inserts in each one of them if not already done Then fill to the embossed line with molten or unmelted paraffin Make sure the anti splash inserts are in place these will prevent excessive splashing when the paraffin containers are inserted or removed When filling with unmelted paraffin it may be necessary to add more paraffin later to reach the fill level DO NOT overfill the tanks doing so may cause an overflow in the retort WARNING USE EXTREME GARE WHEN FILLING THE PARAFFIN CONTAINERS MOLTEN PARAFFIN IS VERY HOT AND CAN CAUSE BURNS 7 CAREFULLY replace each paraffin container into
21. 723 U S only If located outside the United States contact the nearest Tissue Tek instrument distributor or representative for information and assistance Page 49 Section 7 When an error is detected an alarm sounds for about 10 seconds repeating every minute until the error is cleared The error number or warning message is flashed repeatedly on the Warning line of the display If the instrument is left unattended for longer than five minutes an external alarm if connected is activated To stop the internal alarm press the ALARM OFF key To turn off the external alarm slide the retort bar to the left and then to the right To view a description of the error messages press the Utility key from the Main Menu Press Error Information then Error List then Error Description eegend Revised 05 16 01 7 1 CIHRT Exhibit P 3624 Page 50 TROUBLESHOOTING TROUBLESHOOTING CHART WARNING MESSAGE DESCRIPTION REMEDY Battery voltage low All user selected programming such as reagents and Contact Customer Support to have a new battery programs are maintained by the backup battery if a installed Do not turn your instrument OFF until power outage occurs If power is lost and the battery the battery is replaced to ensure that your voltage is insufficient to provide this backup then programming remains in memory all user selected programming will be lost Paraffin not melted Displayed w
22. CIHRT Exhibit P 3624 Page 1 We Tissue Tek VIP 5 SAKURA WINNNINNNANANNNN NANA NR NN RR AAAAALALAAMAALLAAAAAA Vacuum Infiltration Processor MODEL NUMBERS Zus Bench 115 VAC North America EER nw n 8219 Bench 220 240 VAC Asia SE evan 5222 Floor 100 VAC Asia Wan pera WO CIHRT Exhibit P 3624 Page 2 IMPORTANT NOTICE If this equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired 2001 Sakura Finetek USA Inc All Rights Reserved Printed in U S A y Manufactured for qe d Sakura Finetek USA Inc Torrance CA 90501 U S A Sakura Finetek Japan Co Ltd Tokyo 103 0023 Japan Sakura Finetek Europe B V 2382 AT Zoeterwoude NL SAKURA Made in Japan 0001193 01 Rev B CIHRT Exhibit P 3624 Page 3 TABLE OF CONTENTS Section Page 1 INTRODUCTION General Description MNT PH 1 1 Physical Characteristics nic ected vetta Rak era bui ENEE aere eins 1 2 Principles of Operation IO E Une me ea nennen 1 6 Safety 01D fT 1 6 DPS CHICANOS A 1 7 2 INSTALLATION General fom ORE ua is ove ec ta UE nari ER REX Dix Eq a taa ne lee aaa EROS dad ERA Rate 2 1 Environmental FAO as oes ie eee tee ii 2 1 scar mee UU 2 1 Instrument SER KEE IRR ER WADE KE Ra dA RRKE ERA EA ge ORE SENE geg 2 3 FRECHE ace
23. E DEP pMD PEN M STU DEM 6 3 DEMO E 6 3 7 TROUBLESHOOTING General MOM ANON E 2 Troubleshooting AAA PF EEEE EETA 7 2 8 MINOR REPAIR General MANO EE 8 1 Replacement of Retort GAskel EE 8 1 g SERVICE AND REPLACEMENT PARTS Service Information REENEN 9 1 When You Have a e d ET 9 1 Where to Call renge see opes ee Eae REA Rad 9 1 Huc itle C 9 2 Replacement Accessory OMS uo idees s ore ese Fea Fev geed Er seis dy up vera d Vb Vaga 9 3 FIODISCOMGCNT FONG e 9 3 Appendix Page A EXAMPLE PROCESSING PROGRAMS Sample PrograMS AO ern een A1 Routine Overnight Run EE A2 R sh r Biopsy RUN Mme e POE o Eo OE AA A2 individual Programs nee Sege bane eege ee dee ERE MU M RE A3 VIP 5 Menu Map A Operator Mode AA VIP 5 Menu Map A Operator ERR eege deed en Abee heeten eege A5 iv Revised 05 16 01 CIHRT Exhibit P 3624 INTRODUCTION Page 5 Section 1 General Description The Tissue Tek VIP 5 Vacuum Infiliration Processor is an automatic self contained tissue processor which holds up to 150 tissue cassettes or up to 300 cassettes as selected by the user The VIP 5 is available as a floor model Figure 1 1 and bench top model Figure 1 2 The VIP software is programmable for up to twenty different programs for use in the fixation dehydration clearing and paraffin infiltration of a variety of human animal or plant tissue specimens The operator can program th
24. Fill the bottle with the appropriate reagent to the proper fill line 2 Reconnect the tank at the station listed ensuring a secure connection at the back of the tank 3 Contact Customer Support Refer to Error 13 Refer to Error 13 Reconnect the bottle or tank at the station listed ensuring a secure connection nm Clean the filter as instructed in Section 6 Daily Maintenance 3 Contact Customer Support for further information 23 Pump out not complete after 2 attempts of 6 minutes each Refer to Error 22 Refer to Error 22 31 Oven thermistor malfunction Connector 9 32 Rotary valve thermistor malfunction Connector 11 33 Retort thermistor malfunction Connector 10 Connector is not connected the connector pin has come off or the thermistor wire is disconnected Refer to Error 31 Refer to Error 31 Contact Customer Support for further information Refer to Error 31 Refer to Error 31 Revised 05 16 01 CIHRT Exhibit P 3624 Page 53 HE DESCRIPTION POSSIBLE CAUSE REMEDY 34 Oven temperature too high The thermistor circuit has been Contact Customer Support for further tripped information 35 Oven temperature too low Refer to Error 34 Refer to Error 34 36 Rotary valve temperature too high Refer to Error 34 Refer to Error 34 37 Rotary valve temperature too low Refer to Error 34 Refer to Error 34 38 Retort temperature too h
25. IP Paraffin 30 0 15 58 On Cont 13 VIP Paraffin 30 0 15 58 On Cont 14 VIP Paraffin 30 Q15 58 On Cont Total Processing Time 5 hours LL LLL A yr pe yf A2 Revised 05 16 01
26. N OF SOFTWARE Page 20 1 System Setup To perform the initial setup press the Utility function key in the Main Menu If a user password was entered in the Startup Screen the System Setup menu will not be available To access all the functions of the Utility Menu a manager password has to be entered The User Utility Menu allows the operator to perform manual operations to view or print the error information and to check paraffin status The Manager Utility Menu allows the operator to perform the initial setup NOTE The Print functions will not be shown unless the Printer option is selected as ON in the System Setup menu NOTE The Check Paraffin function will not be shown until the oven has reached a temperature of 57 C Utility Manual operations Error List Manual operation Detailed information Transmit Print error list Print ng information System Setup Date and Tim Dei Clock Format Password Entry Print system setup data Valve Heating Sensor i adf Number Audible Signals Check Paraffin Confirmation of molten paraffin Manager Utility Menu The system setup screen is accessed by pressing on the System Setup function key SystemSerup_ _______ Month AS Day Time Dite format Clock format Printer Fon Instrument mmber 71 Rotary Valve Heating on Level Sensor Lo Alarm adjustment Tone Volume Low Loud Low Mid sound es3 More Functions System Set
27. a first in first out basis after 100 errors have occurred 4 To print the screen information press the Exit function key to return to the Error Information screen then press the Print Error Log or Print Keystroke function keys 5 If the processing run was ended prematurely return to the Main Menu then select the Edit Programs function Enter and Edit the program that was being used entering a processing time of 0 00 for all stations for which processing was complete Press the Save function key This will return you to the Main Menu To start the run over press the Tissue Processing function key select the program number press the Enter function key then the immediate Start function key After processing is complete reedit the program to the original processing times eegend Revised 05 16 01 3 5 CIHRT Exhibit P 3624 EXPLANATION OF SOFTWARE 2 3 Check Paraffin Although the instrument will not allow paraffin pump in to begin until 24 hours have elapsed after the power is initially turned ON the following routine will override this function H the retort and oven temperatures have reached the specified limit and you verify to the instrument that the paraffin is molten you will be allowed to begin processing 1f the oven temperature is below 57 C an OVEN TEMPERATURE IS TOO LOW warning is given and tissue processing is
28. alphanumeric keypad to create or modify a name Use the right arrow key to insert a space and the left arrow key to backspace Press Caps Lock to toggle between lower case and upper case characters Press Enter when completed The display will go back to the Edit Programs screen Press the Save function key to store the name into memory Revised 05 16 01 3 11 CIHRT Exhibit P 3624 Page 30 EXPLANATION OF SOFTWARE 9 Start Process This menu selection is the starting point of each processing run You cannot gain access to this operation unless the oven and retort temperatures are at the specified values the retort is empty the clean cycle has been completed if necessary and no errors exist If any of these conditions are not met four rapid beeps will sound and an appropriate message will be displayed on the Warning line at the bottom of the display 1 To begin processing press Tissue Processing from the Main Menu 2 If the solution Control method selected is Number of Cassettes you will be prompted to enter a number from 1 to 300 If not the instrument will display a Tissue Processing screen The screen will display the program number that was last used If this is the desired program press Enter If it is not enter the desired program number and press Enter The Tissue Processing display will appear Tissue Processing BottleCheck oN OA Solution Manag
29. ar If a bottle connection check is not required press the Bottle Check key to turn it off If reagents need to be automatically transferred during the run press the Auto Transfer key This key will not appear if the Solution Manager is turned ON for that program Section 8 Exchange Solutions Press the Experiment Number key to input a number if desired Then select either Delay Start or Immediate Start 6 a If Immediate Start was selected the Tissue Processing Screen will appear The current time will be displayed as the Start Time and the predicted End time will be calculated and displayed on the line above the system status area The rotary valve will turn to Station 1 if necessary and processing will begin immediately starting with Station 1 or the first station for which time is programmed Station 1 or the first station for which time is programmed will be pumped into the retort to prevent deterioration of the samples When the Start Time is reached processing will begin the screen display will change to the Process Monitor Screen 7 When processing is complete the message line will display PROCESS COMPLETED PRESS DRAIN RETORT AFTER BASKETS ARE REMOVED The instrument will beep intermittently for approximately 30 seconds The highlighted bar will remain on the final station for which time was entered in the program After removing the baskets the message l
30. articular chemical exposure to or infiltration of the specimens This process can be done manually by physically changing the bottle locations or it can be done automaiically by the instrument through the Auto Transfer Mode In this mode the reagent solution will be rotated automatically during a processing run or on request If a Set count was entered through the Solution Setup screen the software will automatically notify you when it is time to exchange solutions When the number of runs performed or the number of cassettes processed Used equals the number of runs or cassettes selected Set the Solutions screen will be displayed with each station requiring exchange denoted by asterisks at both the beginning and the end of the display line The Solutions screen is identical to the Identity Solutions screen except for the message line and the asterisks This notification includes Stations 11 16 and the active carbon even though automatic transfer cannot be done for these stations To use the automatic transfer feature during a processing run follow these steps 1 From the Main Menu press Edit Programs and turn the Solution Manager box to OFF Save the modified program 2 From the Main Menu press Tissue Processing and enter a program number The Select Processing display will appear 3 Press the Auto Transfer key The cursor will access the Automatic Transfer box and the message line will prom
31. ch door 2 The reagent bottles are connected to the instrument by quick release connectors that enable the bottles to be securely connected or removed with one hand Remove each bottle from the reagent cabinet by pulling the bottle toward you Figure 2 1 S Figure 2 1 3 Color coded labels are provided for both 150 or 300 cassette operation Affix a label and mark each one according to the desired solution type Figure 2 2 Bottles can be filled manually or through the external drain and fill port If filled bottles need to be moved to another location flip loose the small dark colored cap 1 located on top of the bottle screw cap Affix the small cap to the connector end of the bottle 2 To fill the bottles manually be sure the bottles are placed on a level surface Figure 2 2 Remove the bottle cap by turning it counterclockwise Replace the cap when finished Ensure that the bottle is securely connected by gently pulling it out It should not budge If there is any movement try connecting the bottle again To fill or top off the bottle using the external drain and fill port use the procedure that follows A more complete description of the solution exchange function is given in Section 3 Exchange Solutions A SS e PHP Bg Revised 05 16 01 CIHRT Exhibit P 3624 INSTALLATION a Connect the drain fill hose to the external drain port 3 figure 2 3
32. ch Model Depth 60 0 cm 23 6 in Width 120 0 cm 47 2 in Height 70 0 cm 27 5 in Weight Approximately 160 kg 252 Ib without accessories and reagents Revised 05 16 01 1 7 CIHRT Exhibit P 3624 Page 12 INTRODUCTION Canacity Fill Volumes Cassettes 150 or 300 Cassette Baskets 1 2 or up to 4 optional 65 cassette baskets Processing Reagent Stations 10 Paraffin Stations 4 Cleaning Reagent Stations 3 Fume Control Stations 2 Waste Station 1 Reagent Bottles 2 7 L for 150 cassettes or 3 7 L for 300 cassettes each Cleaning Bottles 3 5 L each for 150 cassettes or 4 5 L for 300 cassettes Paraffin Containers 2 7 L for 150 cassettes or 3 7 L for 300 cassettes each Operating Conditions Temperature 10 C to 40 C 50 F to 104 F Relative Humidity 30 to 85 RH Fluid Transfer Pressures Pump In 0 35 kg cm nominal Pump Out 0 24 kg cm nominal PA Cycle Pressure 0 35 kg cm Vacuum 0 71 kg cm 90 Seconds Pressure 30 Seconds Ambient 90 Seconds Vacuum 30 Seconds Ambient Mixing Pump Out and Pump In every 12 or 20 minutes continuous or OFF User selectable for each processing station Temperature Capabilities Retort Solutions 35 C to 50 C 95 F to 122 F Paraffin 45 C to 70 C 113 F to 158 F Paraffin Oven 47 C to 72 C 116 6 F to 161 6
33. ding with paraffin The Process Embedding Cassettes are designed for use with reusable metal lids such as Tissue Tek Process Covers Tissue Tek Cassettes are available in a variety of colors and styles Tissue Tek VIP Activated Carbon Cartridge Product no 4899 The Tissue Tek VIP Activated Carbon Cartridge Figure 5 2 is made specifically for use with the Tissue Tek VIP Vacuum Infiltration Processor It is self contained for easy insertion and disposal Two per package Figure 5 2 Revised 05 16 01 5 1 CIHRT Exhibit P 3624 Page 42 ACCESSORIES Paraffin Scraper Product Code 1550 Basket Transport Tray Product Code 5264 150 Cassette Basket with Dividers and Handles Product Code 5265 65 Cassette Basket with Dividers and Handles Product Code 5266 150 Cassette Basket with Dividers Product Code 5267 75 Cassette Basket with Dividers Product Code 5268 Basket Hook Product Code 5269 Basket Hook Product Code 5270 Individual Basket Dividers Product Code 5271 Reagent Bottle Product Code 5272 Reagent Bottle Labels Product Code 5273 Paraffin Container Product Code 5274 Displacement Blocks Product Code 5275 Drain Fill Hose Product Code 5276 Used to scrape paraffin off the retort Convenient to transport cassette baskets to and from the Tissue Tek VIP 5 without dripping reagents Choose between four different styles to fit your workflow Compatible with all models of Tissue
34. e instrument to begin processing either immediately or in a delay mode In delay mode the operator enters a desired end time and the instrument then automatically calculates the program start time Figure 1 1 Revised 05 16 01 The instrument consists of four major components the control panel through which all operations are controlled the retort an enclosed chamber that holds the tissue specimens and in which all processing occurs the paraffin oven which maintains molten paraffin at the appropriate temperature for use in the paraffin infiltration steps the reagent cabinet which holds the bottles of reagents The operator places baskets containing tissue cassettes into the retort The instrument then sequentially moves processing reagents and molten paraffin into and out of the retort through the use of vacuum and pressure The heat of the paraffin oven causes the evaporation of clearing reagent from the paraffin A degassing feature aspirates the air from the oven after every automatic pump in cycle This action sends the vapor laden air through the VIP s air filtration system The closed system design along with the air filtration system ensure a sealed moist environment for the tissues and an essentially fume free environment outside the VIP Reagent bottles can be filled either manually or through the external drain and fill port Figure 1 2 1 1 CIHRT Exhibit P 3624 Page 6
35. e pumped back into the retort and the audible alarm sounds When selected the solution manager function will allow the instrument to complete a processing run even if a faulty pump in or pump out condition occurs if certain safeguard conditions are met Level sensors are provided to ensure positive fluid level sensing during special procedures such as continuous mixing The instrument contains an alarm that sounds whenever there is an error condition that stops processing The instrument can also be connected to an external alarm that will alert personnel in case of an error during the night or weekend when the laboratory is not occupied Two levels of password manager and user can be entered into the software to prevent access to the program settings and processing function by unauthorized personnel Revised 05 16 01 CIHRT Exhibit P 3624 Page 11 Specifications Power Required Model Numbers 5214 Bench 4no i 5245 Floor 115 VAC 10 60 Hz 11 0 A North America Model Numbers 5216 Bench 5217 Floor 230 VAC 50 Hz 6 0 A Europe Model Numbers 5218 Bench 220 240 VAC 10 50 Hz 6 0 A Asia 5219 Floor Model Numbers 5220 Bench 115 VAC 10 50 Hz 11 0 A Asia 5221 Floor Model Numbers 3i 5222 Floor 100 VAC 10 50 60 Hz 10 0 A Asia Dimensions Floor Model Depth 60 0 cm 23 6 in Width 60 0 cm 23 6 in Height 136 0 cm 53 5 in Ben
36. en can be displayed by selecting Error List from the Hold Menu Th s allows the user to determine what errors may have occurred and with certain errors to correct the condition causing the error before processing is delayed further Refer to Section 7 TROUBLESHOOTING for complete information on the displayed errors Press Exit to return to the Hold Menu Processing will continue from the point at which it was interrupted The instrument does not adjust the Remain Time for the length of time that elapsed while the instrument was on Hold Immediate Start If the instrument was put on Hold during the delay portion of a Delay Start process an immediate start can be forced by pressing the Immediate Start key Page 38 Ahort Processing The processing run can be discontinued by selecting this option The message line will prompt DO YOU WANT TO ABORT THE PROCESS A response of No returns the display to the Hold Menu with the original message line prompt of THE DELAYED START HAS BEEN INTERRUPTED Responding YES will end the processing run and return the display to the Main Menu If the retort is not empty the message RETORTIS NOT EMPTY will be flashed on the Warning line and the alarm will sound for 10 seconds repeating every minute To silence the alarm press ALARM OFF The retort must then be drained using the Drain Retort function of the Manual Operations screen Section 2 Utility Functions
37. ended 7 The entries made on this screen are used as the basis for all Program screens so examine the completed screen to ensure its correctness The display will appear similar to the following example Solution Setup Solutions F i E Clear H Used Count Xylene Alcohol Water Activated Carbon To select a solution name press Assign Solutions Solution Setup 8 When all reagent information has been properly entered press the Save key to save the information into memory then press Exit twice to return to the Main Menu Edit Programs Up to twenty different processing programs can be entered into the software The processing time and temperature can be set and the P V cycle and Mix options turned ON or OFF for each station The reagents and concentrations displayed for each station are determined by the selections previously made in Solution Setup To edit any or all of the twenty programs press Edit Programs from the Main Menu and then select one program using the arrow keys or the keypad Then press Enter You can either edit a program copy a program section 4 2 or name a program section 4 3 If the printer function is ON you can also print the programs To edit an existing program or to create a new one press the Edit key The default conditions for the selected program will be displayed initially the reagents and concentrations displayed are determined by those e
38. er kn Zac M posed uml 109 M 7004 700 BO 00 HO 00 00 700 200 00 Tissue ues Display 3 If you wish to use an experiment number press Experiment Number An experiment number of up to 8 alphanumeric characters can be entered Then press Enter 4 If you want the instrument to perform an automatic transfer during the processing run for a series of compatible reagents press Auto Transfer NOTE Auto Transfer is not allowed if the Solution Manager has been turned ON The Auto Transfer function key will not be displayed To turn the Solution Manager OFF go back to the Main Menu and select Edit Programs Section 4 Edit Programs 5 A bottle connection check is automatically performed whenever a delay start or an immediate start is selected To disable that function for the next run press Bottle Check The Bottle Check box will change to OFF When either start function is pressed the first reagent of the program is pumped into the retort The same program screen will be displayed The highlighted station indicates which reagent is in current processing use If the Start Mode was selected as Immediate the message line will indicate the instrument is in process and the program will begin to time down The Operation Pump In Pump Out Move Station and condition under which the retort is operating Vacuum Ambient or Pressure are displayed as are the Start time and Predicted End ti
39. evised 05 16 01 3 3 CIHRT Exhibit P 3624 EXPLANATION OF SOFTWARE 2 Utility Functions 2 1 Manual Operations The Manual Operations Mode is not used during normal operation of the instrument however manual operation may sometimes be necessary Three functions can be achieved through the Manual Operations Mode Drain Retort Pumps out a reagent from the retort Fill Retort Pumps in a reagent into the retort Change Station Moves the rotary valve to the next station 1 To enter the Manual Operations Mode press Utility and then Manual Operations in the Utility Menu 2 Select the desired function by pressing the appropriate function key The function begins immediately either pumping the reagent into the retort from the station number displayed pumping the reagent out of the retort into the station displayed or moving the rotary valve to the next station 3 When the operation is complete you can select another operation by pressing the appropriate key or repeat the Change Station operation To abort the operation press the STOP key NOTE If a Fill Retort function was performed that is fluid was pumped into the retort you must perform a Drain Retort before you will be allowed to change stations or to exit the Manual Operations Mode 4 Press Exit twice to return to the Main Menu when you no longer require manual operation of the instrument Page 22 2 2
40. h tap water then fill each to the appropriate line with warm tap water Reinstall the bottles into the appropriate stations NOTE Stations 1 through 5 can be selected for a warm water flush procedure b From the main Menu press the Cleaning key and then the Warm Water Flush key The message line will prompt IF THE WARM WATER BOTTLE IS IN PLACE PRESS START If desired the program can be modified by pressing the Edit key If Start is pressed the warm water from the first station in the program will be pumped in the retort and pumped back out in the same bottle The same action will take place automatically for all programmed stations c When water has been pumped from all appropriate stations discard the water from each bottle and fill with the appropriate concentration of fresh reagent Replace the bottles into their appropriate stations ensuring a secure connection The xylene alcohol and water used in the Clean Cycle will quickly become contaminated with residual paraffin therefore these reagents need to be replaced after every five uses If local regulations require the use of a xylene substitute it should be replaced more often also extra cleaning cycles may be needed to attain proper cleaning Discard the contents of each bottle in an appropriate manner then fill with fresh reagent to the appropriate line Reinstall the bottles into their proper stations ensuring a secure connection Periodic Main
41. he processing run the operator will be alerted of the need to fill station 6 and empty station 18 This can be accomplished manually or using the external drain and fill feature Revised 05 16 01 3 15 CIHRT Exhibit P 3624 Page 34 CIHRT Exhibit P 3624 OPERATING INSTRUCTIONS Page 35 Section 4 Routine Operation Once the instrument software has been customized for your laboratory needs the Tissue Tek VIP 5 Vacuum Infiltration Processor is ready for use in routine processing The instrument is designed to be left on at all times as this maintains the oven temperature to prevent solidification of the paraffin This section provides the steps to follow for each processing run Ensure that the retort is drained and the Clean Cycle has been run if paraffin was pumped into the retort during the 1 previous run see Steps 7 and 8 below These steps must be performed before the instrument will allow a new processing run to be performed Prepare the specimens for processing as follows a Properly fill and seal the Tissue Tek Cassettes ensuring that there is a sufficient ratio between the size of the specimen and the volume of the cassette Place the divider into the sample basket then load the cassettes with the slanted end up Figure 4 1 Each partition holds up to ten cassettes Cover the basket with the basket lid Fill the other baskets if applicable F
42. hen the instrument is first turned ON or When the oven temperature reaches its set when there has been a power outage in which the temperature this warning can be overridden oven temperature has dropped by greater than 10 through the Utility Menu option of Check from the set temperature Will continue to be Paraffin see Section 3 Ensure that the paraffin displayed for a preset length of time up to 24 hours in each tank is completely melted before overriding the warning Power out Power to the instrument has been interrupted because Power has already been restored when this of a power outage the power switch was turned to warning is displayed Operation continues OFF or the line cord was unplugged immediately unless the oven or retort tempera tures have fallen below the acceptable limit in which case an additional delay may occur See Paraffin not melted above The end time for the processing run may be or have been delayed To clear the warning from the display slide the retort bar to the left and then to the right Retort dirty Clean retort The retort has not yet been cleaned following a Perform a Clean Cycle by selecting Cleaning from the processing run in which reagent from Stations 11 14 Main Menu was pumped in Retort is not empty Processing was discontinued while there was reagent Drain the retort by selecting Manual Operations from in the retort the Utility Menu and then Drain Retort
43. idity Locate the instrument in a well ventilated area avoiding exposure to corrosive vapors or temperature extremes Avoid proximity to direct sunlight open windows sinks ovens open flames hot plates radiators and dry ice baths It should also be located away from any instrument that consumes a high voltage or large current including large refrigerators and ovens If installing a floor model the floor must be solid and level for bench models the bench must have a firm level surface capable of supporting at least 181 kg 400 Ibs of weight Be sure the instrument will be located near a power source that meets the electrical requirements voltage and amperage specified on the rating label located on the rear of the instrument The power receptacle must be grounded and should be a clean noise free dedicated line Revised 05 16 01 Unpacking 1 Unpack the instrument by lifting the shipper off Carefully lift the instrument off the wooden base CAUTION The instrument is very heavy and large therefore it is strongly recommended that it be lifted and transported by af east two people 2 Floor Model After the instrument is unpacked roll it to a firm level surface in the designated work area Once in its final position and all installation steps are complete lock the front casters to prevent instrument movement Bench Motel After the instrument is unpacked carefully lift it into place on a firm level surface
44. igh Refer to Error 34 Refer to Error 34 39 Retort temperature too low Refer to Error 34 Refer to Error 34 40 1 Astrong external source of light 1 Turn the instrument OFF or move it away to Instrument malfunction is interfering with the photo from any source of very bright light 88 interrupter in the instrument that shines into the rear of the instrument Revised 05 16 01 Overhead lights will generally not affect the instrument 2 instrument malfunction 2 if Step 1 does not correct the occurrence of the error contact Customer Support CIHRT Exhibit P 3624 Page 54 CIHRT Exhibit P 3624 Page 55 MINOR REPAIR Section 8 H 3 Replace the new gasket into the groove 1 The wider General Information P 9 groove D side of the gasket goes into the groove with the narrower side 3 facing out see Figure 8 1 This section is provided as an aid for performing minor repairs on the Tissue Tek VIP 5 instrument The only procedure that can be performed without direct interaction with a Customer Support Representative is the replacement of the retort gasket For any repairs other than the one given in this section refer to Section 9 SERVICE AND REPLACEMENT PARTS for instructions on service for your instrument Replacement of Retort Gasket lf the retort gasket is worn or cracked the instrument will be unable to maintain pressure or vacuum in the retort The gasket can be replaced by the
45. igure 4 1 c Open the retort by sliding the retort bar to the left and unhooking the retort laich Place the basket s into the retort rotating the handles so they lay flat against the retort sides Close and latch the retort lid then slide the retort bar to the right Make sure the message RETORT LID UNLOCKED has disappeared from the display NOTE Before loading the retort check that it is empty of any liquid and that the inside is clean NOTE The instrument can be loaded with either up to 150 cassettes or up to 300 cassettes per load To run the instrument for up to 150 cassettes Figure 4 2 two displacement blocks must be placed inside the bottom basket 1 Reagent volumes in stations 1 through 14 should be atleast 2 7 L When running up to 300 cassettes the displacement blocks are not used and the reagent volumes must be at least 3 7 L NOTE The operator has the option of selecting one of two reagent fill volumes for all applicable stations The operator can select the Normal fill volume at 3 7 L or the Full fill volume at 4 5 L when used for 300 cassette processing When used for 150 cassette processing the Normal fill volume is 2 7 L and the Full volume is 3 5 L of reagent The Ful fill volume is selected when a higher ratio of reagent to tissue specimens is desired Figure 4 2 Revised 05 16 01 4 1 CIHRT Exhibit P 3624 Page 36 3 Press Tissue Processing from the Ma
46. ime the Clean Cycle is performed However if a malfunction of the pump occurs and normal pumping cycles cannot be accomplished the instrument can be disinfected if necessary by the following procedure 1 Spray or wipe a thick coating of 70 to 85 ethanol or isopropanol onto the walls and base of the retort and the inside of the retort lid Do not use absolute 100 alcohol as this is a less effective disinfectant than is a concentration of 70 to 85 NOTE The use of sodium hypochlorite i e bleach is not recommended since any residue in the retort can contaminate the reagents and tissues 2 Allow the alcohol to air dry before closing the retort lid Revised 05 16 01 6 3 CIHRT Exhibit P 3624 Page 48 CIHRT Exhibit P 3624 TROUBLESHOOTING General Information The following Troubleshooting Chart lists the warning messages and error codes that could occur during operation of the Tissue Tek VIP 5 instrument Possible problems could be electrical mechanical or operational Probable causes and recommended remedies are also included so that many isolated problems can be quickly corrected If additional assistance is required concerning an instrument problem or if the problem cannot be isolated or is beyond the scope of this manual complete the Preservice Checklist in Section 9 Then contact the Customer Support Department of Sakura Finetek U S A Inc by calling toll free 1 800 725 8
47. in Menu The b If Delay Start was selected the screen will show Program Selection screen will be displayed If the Delay Start at the top and the Start Time and Control Method used is of cassettes you will be predicted End Time will be displayed The rotary valve prompted to enter a number from 1 to 300 Use the will turn to Station 1 if necessary and the reagent in Deleted Input key to correct any error Enter the desired program number The Start Processing screen will be displayed NOTE If any solution has been used for the set number of runs or cassettes the Solution Control screen will be displayed a dash placed to the left side of the solution name for those stations that are due for exchanging The message line will prompt PRESS EXCHANGE SOLUTIONS TO EXCHANGE UPDATE SOLUTION CONTROL INFORMATION a To exchange the solutions using the External Drain and Fill Mode press Exit twice to return to the Main Menu then press Solution Control and then Exchange Solutions Be sure to remove the specimen baskets before starting ihe exchange b If you wish to begin processing without exchanging the solutions press Exit the used count will continue incrementing Again the Tissue Processing screen will be displayed however the used count will not be cleared Select the number of the program you want to use or enter its number then press Enter Tissue Processing Screen will appe
48. in the Code column of the selected station and the message line will prompt SELECT NEW SOLUTION FROM SOLUTION LIST AND ENTER ITS NUMBER PRESS ENTER You can also select a solution by pressing the right arrow key and then using the up and down arrow keys to highlight the desired reagent Press the Enter function key to select it If no reagent name is needed for a given station press the Not Used function key When all stations have been assigned press the Exit key to continue the setup 2 Use the right arrow key to select Conc The message line will prompt ENTER SOLUTION CONCENTRATION 0 1 100 0 Enter the concentration up to one decimal place The concentration column can be set to any number from 0 1 100 0 or left blank using the Blank key 3 Enter the Set count for each solution Press No Limit if you do not want to use this option for a given station If you do wish to use the option determine how many processing cycles or how many cassettes you want to run using the reagent at this station before exchanging or replacing the reagent Enter this number from 1 99 for runs and from 1 9999 for Cassettes NOTE For Stations 15 through 17 a Set between 1 and 5 can be input For the Activated Carbon the range is from 1 to 99 The No Limit function cannot be used for these four stations 4 If there have been no processing runs on this instrument the Used column will all be 0
49. ine will display PRESS DRAIN RETORT A pump out cycle will begin immediately after pressing the Drain Retort key em A AAA PUY 42 Revised 05 16 01 CIHRT Exhibit P 3624 Page 37 L M O CODO O CON 9 The display will then show the screen for the Clean Retort Cycles with the prompt PRESS START TO BEGIN CLEANING OR PRESS EDIT TO MODIFY THE CLEANING PROGRAM If not already done open the retort and remove the basket s of specimens Use the plastic scraper to scrape any solidified paraffin from the sides and lid of the retort If desired replace the empty baskets into the retort for cleaning Close the retort then press Start Cleaning 1 or Start Cleaning 2 to begin the Clean Cycle When the Clean Cycle is complete the screen will request entry of the password to prevent unauthorized access to the instrument after the password is entered the Main Menu will be displayed NOTE 1 Metal items such as base molds and forceps may also be placed in the retort for cleaning However if additional items are cleaned in this manner the cleaning reagents Stations 15 16 and 17 may have to be replaced more often NOTE 2 If reagent from any of Stations 11 14 was pumped into the retort the Clean Cycle must be performed before another processing run can be started However if paraffin has not been used and you do not wish to perform the Clean
50. ion A small green light on the control panel will illuminate NOTE The instrument will not begin automatic operation until approximately 24 hours after the power is turned on This ensures that the oven temperature has reached and stabilized at its set temperature Refer to Section 3 Check Paraffin to override this delay The screen on the control panel should be displaying the Startup Screen shown below requesting entry of the Password Press 0 0 0 0 on the keypad and the Enter function key the display will change to the Main Menu which includes an instrument status area located at the bottom of the display Up to two different passwords can be programmed Refer to Section 2 Passwords to change the default password Connect the external alarm and optional printer if desired Locate the serial number label found on the left side of the instrument control panel Write the installation date and instrument serial number on the Warranty Registration Card found in the front of this manual Also write the installation date and serial number in the Preservice Checklist in Section 9 Completely fill out the Warranty Registration Card and mail it Jun 3 6 23pm f Startup Screen 22 Revised 05 16 01 CIHRT Exhibit P 3624 Page 15 Instrument Setup 1 Open the doors on the front of the reagent cabinet by pulling the handle on the upper inside corner of ea
51. is ON a Print function key will appear on page one of the Setup screen and in other screens NOTE The printer is an optional item 1 4 Instrument Number An instrument number from 0 default value through 99 can be programmed by pressing the Instrument Number function key 1 5 Valve Heating The rotary and gate valves can be constantly heated at a temperature of 70 C Even if the setting is OFF no heating heat will be applied to the valves before station 11 to 14 are used paraffin and during the heating portion of the cleaning cycle To heat the valves continuously press the Valve Heating function key once if the current setting is OFF 1 6 Level Sensors By default the level sensors are OFF To enable the level sensors press the Level Sensor function key once 1 7 Alarm Tone The alarm tone can be changed between two levels High and Low Each time the Alarm Tone function key is pressed the tone will be changed the initial default setting being High 1 8 Alarm Volume The alarm volume can be changed between two levels Loud and Low Each time the Alarm Volume function key is pressed the volume will be changed the initial default setting being Loud 1 9 Keystroke Sound By default every time a key is pressed a sound will be heard By pressing the keystroke sound function key the keystroke sound can be turned OFF The initial default setting is ON R
52. is identical to the Solution Control screen except for the message line and the presence of asterisks to denote which stations need to be exchanged The message does not prevent the run from continuing if bypassed the Used counter will continue to increment and the message will be displayed again with the next run The Solution Usage feature is optional and may be bypassed entirely by leaving the Set counts blank or pressing No Limit to clear any previously set numbers Press the Save key when finished If desired up to 50 solution names can be created In the Solution Control Menu press the Name solutions function key to create solution names Enter a code and then use the alpha numeric keypad to enter each character to create the name Pressing each key repeatedly will cycle through the characters shown Use the right arrow key to insert a space and the left arrow key as backspace Press Caps Lock to toggle between lower case and upper case characters Determine the reagents and concentrations that are to be located in each of the 14 processing stations and enter them into the instrument software as instructed in the following steps Note that the names for stations 15 through 17 and for the Activated Carbon cannot be changed If desired you can also input usage limits in the Set column 1 Press the Solution Setup function key and then the Assign Solutions key The cursor will initially be located
53. lean cycle will be displayed Remove the specimen baskets from the retort before starting the Clean Cycle Revised 05 16 01 3 13 CIHRT Exhibit P 3624 EXPLANATION OF SOFTWARE Page 32 7 Clean Retort Any time reagents from Stations 11 14 paraffin have been pumped into the retort or a pump in from these stations was attempted the retort must be cleaned before any additional processing cycles can be started However the instrument will not require that a cleaning cycle be performed unless a station higher than Station 10 has been used NOTE If paraffin was not pumped into the retort the retort should be wiped out with a dry cloth regardless of whether or not a Clean Cycle is performed This will ensure that remnants of the final reagent in the retort do not contaminate other reagents Clean Retort Start aning 1 C 2 h P b mum Feet en 15 Xylene 9 H i A 16 Alcohol 5 E nm EM y f ing2 aimed Sim Jun uses Edit i Cleaning 1 Edit Cleaning 2 Station Number 14 Operation jRetortTemp 35 C Rotary Valve Temp Dr Retort ETC Sate Valve Tem fale 72 58 o bes r clearing o he cl y the cleciuny program Reprint 1 Verify that the number of cycles for the cleaning program you want to use is correct If not use the Edit function to modify either progra
54. m The range of cycles allowed are as follows Station 15 Xylene 5 15 Cycles Station 16 Alcohol 2 15 Cycles Station 17 Water 0 15 Cycles 2 From the Clean Retort Display press Start Cleaning 1 or Start Cleaning 2 3 If cleaning is not necessary or if you wish to delay performing the Clean Cycle press Exit You will be prompted to enter the password to prevent unauthorized personnel from starting a run or changing the processing parameters After entry of the password the display will return to the Main Menu 4 Upon pressing START the following will occur a A warming time of 10 00 minutes begins during which time the retort is heated to 65 C 149 F in order to melt the paraffin remaining in the retort The display constantly updates the amount of time remaining b After the warming time has elapsed the instrument pumps out the melted paraffin from the retort into the last paraffin station for which processing time was programmed generally Station 14 NOTE If paraffin had not been pumped into the retort the instrument performs the pump out cycle into the cleaning xylene Station 15 c The instrument then begins the first of the user defined numbers of pump in pump out cycles with xylene Station 15 The number of cycles remaining is displayed on the screen NOTE 1o interrupt the cleaning cycle in progress press the STOP key or move the retort lock lever to the leit d After all
55. me If the Delay Start Mode was selected Tissue Processing Delayed Start will display in the upper left corner of the screen until the VIP time of day display upper right screen matches the program Start time The message line will then change to In Process and the conditions applied to the program time temperature pressure vacuum mixing will be active Until that time match occurs and if the control method selected is number of cassettes the operator can add remove or update the number of cassettes 3 12 Revised 05 16 01 CIHRT Exhibit P 3624 Page 31 B Drain Retort Once the processing run is complete the retort will remain filled with the reagent from the last station for which time was entered in the program generally this will be paraffin The retort must be drained and the specimen baskets removed If paraffin has been pumped into the retort the retort must also be cleaned see Clean Retort below If any processing mode or manual operation is attempted while the relort is not empty the instrument will emit four rapid beeps and the warning RETORT IS NOT EMPTY will be shown 1 The display returns to the Process screen when a processing run is complete and the message DRAIN RETORT is displayed The last station at which processing was done is highlighted 2 Press Drain Retort 3 The Pump Out cycle will begin immediately After the retort has been drained the selected c
56. mmediately The following conditions will activate the external alarm five minutes after they occur the retort bar remains in the open position during any automatic operation including a DELAY cycle a condition leading to an error or warning display is left unattended or power has been restored following an outage The rear panel can accommodate optional interfaces for an optional printer and uninterruptible power supply UPS The printer connection allows the printing of reports automatically and on demand The UPS option allows the instrument to be connected to a backup generator A serial port Q3 is also supplied to transmit data to an external device Figure 1 10 Revised 05 16 01 15 CIHRT Exhibit P 3624 INTRODUCTION Principles of Operation As soon as a start command is issued by the operator the rotary and gate valves in the instrument open the passage to the retort from the first reagent station for which a processing time is programmed The rotary valve will then cycle through all bottle positions to verify proper connection The operator will be alerted of any faulty condition If desired the bottle connection check feature can be bypassed Reagent movement is effected as follows the rotary and gate valves move to open the passage to the retort A vacuum is created in the retort and it draws the reagent from the bottle into the retort All reagents are introduced from
57. nal Drain and Fill mode Rotation of reagents can also be done either manually by physically moving the bottles from one station to another or automatically through the Auto Transfer Mode Paraffin Replacement The paraffin containers are designed to be removed from the oven for filling and should be filled with previously melted paraffin or unmelted paraffin flakes or chips Carefully observe the fill line and do NOT overfill When transferring paraffin from one container to another hook the lip of the pouring container over the edge of the receiving container Pour molten paraffin slowly and carefully WARNING OVEN AND PARAFFIN CONTAINERS ARE HOT USE EXTREME CARE Replacement of Fume Control System Materials The water in the water bottle absorbs formalin and alcohol vapors from the exhaust fumes Change the water daily to maintain efficient fume control The activated carbon in the carbon cartridge absorbs the remaining xylene and alcohol vapors present in the exhaust fumes To maintain a high level of fume control change the cartridge at least once a month after 20 processing runs AS Revised 05 16 01 45 CIHRT Exhibit P 3624 Page 40 CIHRT Exhibit P 3624 Page 41 ACCESSORIES Section 5 Tissue Tek Uni Cassette Tissue Tek Process Embedding Cassettes The Tissue Tek Uni Cassette cassettes Figure 5 1 are self contained units with an attached lid that is removed prior to embed
58. nance Keep the exterior of the instrument free of dust Remove hardened paraffin using a plastic scraper If needed gently clean the remaining paraffin with a cloth lightly moistened with xylene then wipe with a dry cloth Do not use solvents of any kind on the front of the contro panel however if disinfection of the keypad is desired 70 to 85 ethanol or isopropanol can be wiped on and allowed to air dry The glass doors may be cleaned with a glass cleaner and soft cloth Keep the inside of the reagent cabinet clean by wiping with a clean cloth Daily Maintenance Retort 1 Clean the inside of the retort lid the rim of the retort and the retort lid gasket by wiping with a clean cloth After cleaning inspect the gasket carefully for cracks splitting tearing or other signs of deterioration that could cause leaks Replace the gasket if necessary as instructed in Section 8 MINOR REPAIR 2 Clean the outlet filter in the retort floor as follows a Grasp the protruding part of the filter and unscrew it counterclockwise Figure 6 1 then remove it from the retort Figure 6 1 b Remove any debris then thoroughly clean the filter by soaking in xylene Clean the retort floor by wiping with a cloth moistened with xylene Reinstall the filter Fume Control System Water Bottle Remove the WATER bottle from the storage cabinet and dispose of its contents Refill to the proper level 2 5 L to 3 0 L with tap water and
59. ne will momentarily display CHECK PROGRAM PROCESSING CANNOT BE COMPLETED AS PROGRAMMED This message is dependent upon the current time If you are editing the program for later use simply verify that the times are all appropriate for your use and continue the programmed end time will be accepted regardless However if the program is being edited during a processing run or this message appears when attempting to start a new run either the end time or one or more of the processing times must be changed in order to process in the Delay Mode For each program the Solution Manager can be set ON or OFF Use the arrow keys to access the Solution Manager Box Then press the On Off function key to select the desired operation When turned ON the Solution Manager will monitor pump in error condition and try to use any compatible solution if a given reservoir station cannot be used This allows to automatically bring a program to completion even if one of the station is not responding Compatible solutions are solutions using the same name code as defined in the Name Solutions screen Section 3 Solution Control NOTE To allow for an automatic transfer of reagents during the processing run the Solution Manager must be turned OFF Review the program carefully to ensure that all information is correct Use the arrow keys to move the cursor to correct any errors When finished either press Save to store the information into
60. nector to the bottle Contact Customer Support for further information nw Revised 05 16 01 73 14 Unable to establish vacuum from reagent bottle or paraffin tank 20 Pressure cannot be achieved in 1 minute with the rotary valve closed 21 Pressure cannot be achieved after 3 attempts of 1 minute each with the rotary valve closed 22 Pump out not complete after 2 attempts of 6 minutes each A Instrument malfunction 1 Reagent bottle is empty 2 Paratfin tank Stations 11 14 is not securely connected 3 Instrument malfunction Refer to Error 13 Refer to Error 13 1 Reagent bottle or paraffin tank is not securely connected 2 Retort inlet outlet filter is plugged 3 Air line or reagent transfer line is plugged CIHRT Exhibit P 3624 Page 52 gp DESCRIPTION POSSIBLE CAUSE REMEDY 12 Pump in not complete after Refer to Error 11 Refer to Error 11 3 attempts of 6 minutes each 13 Unable to establish pressure or 1 Retort clamp is notin position 1 Close the Clamp by pushing firmly on the vacuum inside the retort handle refer to Section 2 Instrument Setup 2 Retort gasket is leaking 2 Clean and reposition the retort gasket as instructed in Section 6 if gasket appears cracked or worn replace as instructed in Section 8 3 Aline connection or union is loose 3 Contact Customer Support for further information 4 Contact Customer Support
61. ng the example programs are several pages on i which you can write your own individual programs Revised 05 16 01 A 1 CIHRT Exhibit P 3 EXAMPLE PROCESSING PROGRAMS To he used as a guide only Routine Overnight Run Station Code Time Set No Solution No Conc hr min Temp P V Mix 1 Neutral Buffered Formalin 05 10 2 00 40 On Slow 2 Neutral Buffered Formalin 05 10 2 00 40 On Slow 3 Ethanol 12 65 0 30 40 On Slow 4 Ethanol 12 80 0 30 40 On Slow 5 Ethanol 12 95 0 45 40 On Slow 6 Ethanol 12 95 0 45 40 On Slow 7 Ethanol 12 100 0 45 40 On Slow 8 Ethanol 12 100 0 45 40 On Slow 9 Xylene 20 100 0 45 40 On Slow 10 Xylene 20 100 0 45 40 On Slow 11 VIP Paraffin 30 0 30 58 On Slow 12 VIP Paraffin 30 0 30 58 On Slow 13 VIP Paraffin 30 0 30 58 On Slow 14 VIP Paraffin 30 0 30 58 On Slow Total Processing Time 12 7 hours Rush or Biopsy Run Station Code Time Set No Solution No Conc hr min Temp P V Mix 1 Neutral Buffered Formalin 05 10 0 30 40 On Cont 2 Neutral Buffered Formalin 05 10 0 30 40 On Cont 3 Ethanol 12 65 0 10 40 On Cont 4 Ethanol 12 80 0 10 40 On Cont 5 Ethanol 12 95 0 10 40 On Cont 6 Ethanol 12 95 0 15 40 On Cont 7 Ethanol 12 100 0 15 40 On Cont 8 Ethanol 12 100 0 15 40 On Cont 9 Xylene 20 100 0 15 On Cont 10 Xylene 20 100 0 15 On Cont 11 VIP Paraffin 30 0 15 f 58 On Cont 12 V
62. not allowed 1 From the Main Menu press Utility and then Check Paraffin The display will change to display the prompt VERIFY PARAFFIN HAS MELTED AND PRESS YES PARAFFIN MAY NOT BE MELTED 2 l the paraffin in all containers is melted press Yes and the warning line will disappear You will be allowed to begin processing when the display returns to the Utility screen If it is not melted press Exit and the display will return to the Utility screen with the Warning line still displayed CAUTION Do NOT attempt to begin processing unless the paraffin is completely melted To do otherwise could cause extensive damage to the instrument 3 Solution Control One of the first steps in setting up the instrument is to identify which solutions will be used at each station To do this press the Solution Control function key in the Main Menu The Solution Control screen will be displayed until reagents are entered the default screen is nearly empty Page 24 ed 50 50 me sonion EF fesses EH kessi Sol Activated Carbon Solution Control The columns display or allow entry of in order the station number solution or reagent name and the concentration of the reagent The column titled Set represents how many processing cycles or cassettes each reagent should be used up to before being replaced The next column Used shows the actual number of cycles performed or cassette
63. ntered through the Solution Setup screen For example 00 00 00 00 00 00 00 700 00 Solution Manager Save Edit Programs TT AAA a a M 3 8 Revised 05 16 01 CIHRT Exhibit P 3624 Page 27 NOTE The default settings for each program are identical If the same change is to be made to most or all stations you can make the change in one step using the All Stations function see instructions below Also after editing one program you can copy that program to another then make modifications to the copy see Copy below The message line displays the prompt ENTER PROCESSING TIME 00 00 99 59 Enter the desired processing time in hours and minutes for Station 1 A leading zero does not have to be entered for a single digit hour however it does have to be entered for minutes of less than 10 NOTE If a time of 0 00 is entered or Clear is pressed for a station that station will be skipped during the processing run fluid will not be pumped into the retort Using the arrow keys move to the Temp column The prompt on the message line will display ENTER PROCESSING TEMPERATURE 3550 C Enter the desired retort temperature for processing from 35 to 50 C 95 122 F NOTE If you do not want to have added heat at a station press Clear The P V cycle alternating pressure and vacuum can be turned
64. olved and an instrument failure is apparent our Customer Support Department is available to assist you Before calling for instrument service collect the information requested in the Preservice Checklist in this section This information will help the Customer Support Representative to identify the probable cause of your instrument malfunction The instrument should be disinfected prior to being serviced If the pump is functioning performing a Clean Cycle will provide sufficient disinfection If it is not functioning the retort should be disinfected as described in Section 6 CARE OF THE INSTRUMENT Where to Call for Service If located within the United States contact the Customer Support Department of Sakura Finetek U S A Inc by calling toll free 1 800 725 8723 In countries other than the United States contact the nearest authorized Tissue Tek instrument distributor or representative for service information and assistance A E EAA AAA Revised 05 16 01 9 1 CIHRT Exhibit P 3624 Page 58 SERVICE REPLACEMENT PARTS Tissue Tek VIP 5 Ce Preservice Checklist For reference record the following information Model Serial Number installation Date 1 Has Section 7 Troubleshooting been reviewed C 0 7 Do the oven and retort temperatures regulate C C YES NO properly YES NO 2 When the power is turned ON does the screen O Oven Temperature ___ C Retort Temperature _ show an ap
65. placement Parts may be ordered directly from CUSTOMER SERVICE Sakura Finetek USA inc 1750 West 214th Street Torrance CA 90501 or by calling toll free 1 800 725 8723 Outside of the United States contact the nearest authorized Tissue Tek instrument distributor EE Product No Description 4899 Tissue Tek VIP Activated Carbon 2 Cartridges Replacement Parts Product No Description 1520 Retort Gasket 1550 Paraffin Scraper 5264 Basket Transport Tray 5265 150 Cassette Basket with Dividers and Handles 5266 65 Cassette Basket with Dividers and Handles 5267 150 Cassette Basket with Dividers 5268 75 Cassette Basket with Dividers 5269 Basket Hook for Product No 5267 5270 Basket Hook for Product No 5268 5271 individual Basket Dividers 6 pkg 5272 Reagent Bottle 5273 Reagent Bottle Labels 1set 5274 Paraffin Container 5275 Displacement Blocks 3 Pkg 5276 Drain Fill Hose B4 00 0230 Overflow Boitle 999 489 08 Service Manual 0001193 01 Operating Manual Revised 05 16 01 9 3 CIHRT Exhibit P 3624 Page 60 CIHRT Exhibit P 3624 Page 61 EXAMPLE Appendix A PROCESSING Sample Programs Following are two examples of programs one for a routine overnight run and the other for a rush or biopsy run Example reagents and concentrations are shown also The programs are intended to be used as a guide only modify them to satisfy the individual needs of your laboratory d Followi
66. processing stops immediately and an alarm sounds until the retort bar is moved to the closed position Solutions are introduced from the top of the retort 8 and drained from the bottom Level sensors 9 detect proper solution levels during pump in If desired level sensing can be disabled Fluid level control would then be D O Fi 14 8 accomplished through the detection of a pressure drop or a igure vacuum change condition in the retort The air port 9 is connected to an overflow sensor and bottle 12 Revised 05 16 01 CIHRT Exhibit P 3624 Page 7 Revised 05 16 01 e ES Figure 1 6 iB Paraffin Oven Figure 1 5 The paraffin oven OD maintains a set temperature to hold molten paraffin at the proper temperature for use in the infiltration step The oven holds four paraffin containers 2 that are easily removed by the operator for refilling These containers are designated as stations 11 through 14 Each container accepts one front and one back anti splash insert to reduce splashing when containers are removed or inserted Reagent Cabinet Figure 1 6 The reagent cabinet 3 holds ten bottles of processing reagents designated as stations 1 through 10 4 located in the first two top rows In the third row three additional stations 15 through 17 hold bottles for xylene alcohol and water 5 used during the cleaning cycle The final two spaces hold a waste bottle used when an automa
67. propriate display YES NO If NO is the unit plugged into a live AC E 8 Which station number is being highlighted electrical outlet YES NO 9 Is an Operation being displayed g DJ 3 Are all reagent bottles securely connected If YES which YES NO to the quick release connectors YES NO Pump In 7 Pump Out 1 Move Station 4 Are all reagent bottles filled to their proper leves 7 Il 10 Does the Retort display show an operation L L YES NO f YES which YES NO 5 Are any warnings being displayed OO Vacuum C Ambient Pressure C YES NO lf so have they all been corrected and cleared 7 7 11 Is there fluid in the retort E un YES NO If YES how much CAUTION Do NOT YES NO If you are unable to clear a warning what does it say attempt to onen the retort if the display shows either Vacuum or Pressure 12 Does the pump operate L LI YES NO 6 Are any errors listed in the Error information LI 8 13 Whatis the level of vacuum and or pressure screen uc NO Pressure kg cm Vacuum cm Hg If so please list the information from that screen 14 Are the time and date being displayed accurately G g display r UI Retort Oven Valve i Error Sta Temp Temp Temp Time eee M ee ee aa eme 9 2 Revised 05 16 01 CIHRT Exhibit P 3624 Page 59 Replacement Accessory Items Where 16 Order in the United States the above Replacement Accessory Items and Re
68. pt Enter ihe first station number to be transferred Press Enter 4 The message line will then prompt ENTER THE LAST STATION NUMBER TO BE TRANSFERRED PRESS ENTER H the selected first and last stations are compatible the Automatic Transfer box will display these station numbers and the display will go back to the Start Processing display NOTE Verify that the waste bottle in station 18 is empty before proceeding 5 To perform an automatic transfer when a processing run has not been started select Solution Control from the Main Menu Press Exchange Solutions and then Auto Transfer The process is as previously described above 6 During a processing run when an immediate or a delayed start is selected the transfer cycle will be automatically performed as in the following example a Assume that the first station selected is 3 and the last one is 6 During the run reagent in station 3 will be pumped in the retort according to the program When the Set Time for that station has reached zero the solution will be pumped out in station 18 the Waste station The bottle in station 3 will then be empty b The reagent in station 4 will then be pumped in the retort as programmed At the end of the Set Time the reagent will then be pumped out in Station 3 The same scenario will happen for stations 5 and 6 c Atthe end of the transfer cycle station 6 will be empty and station 18 will be full At the end of t
69. replace into the reagent cabinet Exterior Surfaces Daily clean the control panel plastic and painted areas by wiping with a clean cloth moistened with mineral oil Daily clean the inside of the reservoir storage compartment by wiping with a clean cloth gd Revised 05 16 01 6 1 CIHRT Exhibit P 3624 Page 46 CARE OF THE INSTRUMENT Weekly Maintenance Clean Cycle Reagents Stations 15 16 and 17 Reagent Exchange and Warm Water Flush 1 All the reagents should be replaced or exchanged on a weekly basis If replacing empty each bottle and refill it with the appropriate concentration of fresh reagent If exchanging empty the first bottle of each reagent type then move the remaining reagents up one station each see Auto Transfer in Section 3 2 Unless the Tissue Tek VIP Formalin reagent is used other commercial formalin generally in Stations 1 and 2 and the first alcoho generally Station 3 become contaminated with precipitated formalin salts These salts also create blockages in the lines and in the rotary valve Therefore the formalins and the first alcohol should be replaced rather than exchanged on a weekly basis While replacing these reagents a warm water flush should be performed to dissolve any salt buildup in the lines and on the rotary valve a Discard the contents of each bottle of formalin and the first bottle of alcohol generally Stations 1 3 Rinse each bottle wit
70. s processed The last column Left indicates how many additional runs or cassettes can be processed before reaching the Set Value With each processing cycle the number in the Used column increments by one for each reagent or by the number of cassettes processed If usage control is through the cassette count the operator will be prompted to enter the number of cassettes being processed whenever a Start command is entered The Left column will automatically be adjusted To select the control method press the Solution Setup key followed by the Control Method key The message line will prompt CONTROL METHOD WILL BE CHANGED TO THE NUMBER OF CASSETTES PROCESSED DO YOU WANT TO CHANGE or CONTROL METHOD WILL BE CHANGED TO THE NUMBER OF RUNS COMPLETED DO YOU WANT TO CHANGE depending on the current control method Press Yes to change or No to keep the same control method Note that the cleaning stations 15 through 17 and the Activated Carbon are only controlled using the number of runs method That feature cannot be turned off to ensure that they will be refreshed regularly beem 3 6 Revised 05 16 01 CIHRT Exhibit P 3624 Page 25 When the number in the Used column equals the number in the Set column a screen labeled Solutions will be displayed along with a message alerting the user to the need to replace one or more reagents The Solutions screen
71. s bain nn veg o d bv aud Fa Queue IRE eene 25 3 EXPLANATION OF SOFTWARE AND CUSTOMIZATION OF SETTINGS General WO ur EE 3 1 I VEN a e 3 2 n r EE 3 2 Eo PA E EAE EAE E E ETA 3 3 ES Pinte NEQUIT TEE TENE EE Era aE 93 1 4 Instrument EE 3 3 AR 3 3 1 6 Level SA ii 3 3 1 7 Alarm A Bee 3 3 1 8 Alarm Volume en sia ENEE ANEREN n one pene pix d dog eR RN RR S EES 3 3 as oro MM A o 3 3 2 Utility FUNCIONS osos PO rd ua Se ua oe cUm US Ca EUR TOES NH UU 34 2 3 ET he nen ee en 3 4 2 2 Error HOME are 3 4 2 3 Check TEE 3 6 3 SOTO COM une 3 6 2 Edit PO ink 3 8 At Program All Stan en 340 4 2 Program COpY ee ee PPNA nEEEE EE EEEEE EEEE E EEEren 341 4 3 Name POIs A ex EF EFE PE VAS EE REES 3 11 5 Start FISCHE E 3 12 B Dram ReO raiione O O 0 3 13 7 Clean GION EEN 3 14 miei li pL A ES EEE S 3 15 Revised 05 16 01 lii CIHRT Exhibit P 3624 Page 4 Section Page 4 OPERATING INSTRUCTIONS A SP een 4 1 Interrupting A een 4 3 Recommendations for Efficient Operation u nungen 4 5 5 ACCESSORIES u en sea 5 1 6 CARE OF THE INSTRUMENT General Maintenance acesse disc een 6 1 Daily Malena ne een 6 1 PPP nO E E 6 1 Water EE 6 1 EXIBHOI QU EE 6 1 Weekly Maintenance RP 6 2 Reagent Exchange and Warm Water Fluch 6 2 Clean Cycle ET 6 2 Periodic Maintenance EE 6 2 Activated Carbon Cane EE 6 2 Overflow BO Eee REN GR EEN 6 2 Bolle DORBIeCIDISL o ceteri pn O UU Eg ART
72. strument only including tissue processing cleaning warm water flush solution exchange manual drain of the retort and access to the error log The Manager Password allows access to all instrument functions and setup Both passwords are set up in the same manner as follows First press the desired function key 1 The message line will prompt you to ENTER NEW USER PASSWORD Or ENTER NEW MANAGER PASSWORD Enter the new password pressing Enter when complete Passwords must be 4 digit or more 2 The prompt will change to REENTER NEW PASSWORD FOR VERIFICATION 3 Enter the new password a second time and press Enter If the second entry matches the first entry the display will return to the System Setup Menu and the new password will be stored in memory for future use If it does not agree the message line will prompt THE PASSWORD ENTERED DOES NOT MATCH TRY AGAIN Enter the new entry code again taking care to enter the same code both times Pressing Exit at any time before a successful reentry of the new code will reinstate the former password Pressing the More Functions function key allows user to access the following setup options 1 3 Printer From the System Setup Screen select the More Functions function key and then the Printer function key By default the printer selection is OFF Press the Printer function key to turn the printer interface to ON 1f the printer selection
73. ted reagent transfer procedure is performed and a bottle for water 7 which is an essential component of the fume control system of the instrument The first two top rows have cutouts for the placement of one drain shelf each Waste trays 8 are located below the paraffin oven and below the reagent cabinet 1 8 CIHRT Exhibit P 3624 Page 8 INTRODUCTION Activated Carbon Cartridge and External Drain and Fill Figure 1 7 The activated carbon filter is part of the fume control system The external drain and fill port allow for the replacement of reagents 1 through 10 and 15 through 18 directly from external containers Figure 1 7 Leveling Feet Casters Figures 1 8 and 1 9 The bench model has eight adjustable feet to ensure proper leveling of the instrument The floor model has four casters for instrument mobility positive locks on the front casters hold the instrument securely in place for stationary use dn 0 Figure 1 9 14 Revised 05 16 01 CIHRT Exhibit P 3624 Page 9 Rear of the Instrument Figure 1 10 The line cord is permanently attached to the instrument The other end of the cord attaches to an appropriate AC electrical outlet or to an Uninterruptible Power Supply UPS unit The instrument is turned on and off with the circuit interrupter The panel also contains a connector for an external alarm A power outage will activate the external alarm i
74. ted to the pro grammed temperature for the duration of the immersion time for that station After compietion of a processing run the instrument 1 6 Page 10 automatically prompts for a cleaning cycle This can be overridden ONLY if no reagents from Stations 11 14 paraffin were pumped into the retort In the Clean Cycle the retort heats and the remaining melted paraffin is pumped into the last paraffin station for which a processing time was programmed Xylene is then repeatedly pumped into and out of the retort This is followed by multiple rinses with alcohol and or water Up to two different cleaning cycles can be programmed by the user Safety Features The VIP instrument is designed as a closed system tissue processor to minimize the release of reagent fumes into the environment It also contains a fume control system consisting of water and an activated carbon filter to purify the air that it releases The retort slide bar prevents access to the retort during processing If the bar is slid to the left open processing stops immediately any vacuum pressure in the retort is released and the audible alarm sounds A reagent bottle connection check is automatically performed by the instrument when a start process is initiated unless disabled by the user If the instrument is unable to pump a reagent into the retort e g the bottle is empty or not properly connected the reagent from the previous station will b
75. tenance Fume Control System Activated Carbon Cartridge Replace the activated carbon cartridge on a regular basis The recommended schedule is once a month assuming five processing runs per week however this will vary depending upon the frequency and duration of your runs and on the reagents used Remove the old cartridge located behind the panel on your left and replace with a new cartridge Product No 4898 Press the cartridge firmly into place to ensure a proper seal Dispose of the used cartridge according to your local regulations CAUTION The used carbon cartridge contains xylene fumes dispose of these cartridges with proper care Overflow Bottle The overflow bottle located behind the rear left panel on the control module when viewed from the front should be inspected periodically once or twice a year for fluid buildup 6 2 Revised 05 16 01 CIHRT Exhibit P 3624 Page 47 a E Bottle Connectors Carefully inspect all bottle caps for cracks and worn threads Inspect the bottle connection fitting for cracks and deterioration An initial indication of a connection problem will be the loss of bubbling in the WATER bottle during fluid transfer operations and or failure of the bottle connection check Replace bottles that are cracked or deteriorated see Section 9 Replacement Parts Disinfection Under normal operating conditions the instrument is effectively disinfected each t
76. the processing to be completed The instrument then determines the start time by adding the processing times entered in the program and the times required for pumping each solution in and out then subtracting the total from the selected end time NOTE Time continues to count down during the pump in and pump out operations of the mix cycle a Use one of the three function keys Today Tomorrow or Day after Tomorrow or enter the number of days using the numerical keypad b Using the arrow keys access the End Time box The message line will change to the prompt ENTERTHE DESIRED COMPLETION TIME Enter the time at which you want the run to be completed c If the 12 hour format has been selected in the System Setup screen use the am pm key to select either AM or PM Example f you want to program a run in which the retort is loaded on Monday and you want processing to be completed on Tuesday at 8 00 am you must enter 1 for the days or press Tomorrow and 8 00 am for the time For a run placed into the instrument on Friday to be completed on Monday at 1 30 pm you must enter 3 for the days and 1 30 pm for the time The end date will be shown 39 CIHRT Exhibit P 3624 EXPLANATION OF SOFTWARE NOTE If the processing times that were programmed earlier cannot be achieved by the end time just entered the instrument will beep three times and the message li
77. the top of the retort This action is called a pump in The gate valve then closes and the specimens are immersed in the reagent for the selected length of time After this time pressure is created in the retort and the gate valve opens again forcing the reagent from the retort back into the reagent bottle All reagents are drained from ihe bottom of the retort A mesh prevents debris from being transferred to the bottle This action is called a pump out The rotary valve then rotates to the next station for which a processing time is programmed and the procedure is repeated During the immersion time three additional options are available as histologic choices for the treatment of the specimens Application of any of these three physical conditions can increase the reagent infiltration of the Specimens These three options may be programmed into individual and or all stations P V Cycle The instrument alternates applying pressure and vacuum to the retort During the Pressure portion of the P V cycle paraffin is automatically cleansed Mixing Depending on which option slow or fast has been selected pump out and pump in of the same reagent is repeated every 12 or 20 minutes or continuous cont mixing can be selected In that mode partial pump in and pump out cycles are effected to promote optimum infiltration during short immersion steps If desired mixing can be turned OFF Heat The surfaces of the retort are hea
78. tion check has failed The instrument was moved while fluid was in the retort causing a false overflow Overflow bottle is misadjusted or overflow sensor was touched or is misadjusted hv There was a power outage at some point during the processing cycle Areagent bottle contains too much liquid m There are too many specimens in the retort eo Fluid from an external source was poured into the retort pers Reagent bottle is not securely connected to quick release connector m Air line or reagent transfer line is plugged 1 Do not move the instrument when there is fluid in the retort 2 Perform a manual pump out If error repeats contact Customer Support for further information Refer to Power Ouf warning above Before continuing the run check that the paraffin is molten after the retort and oven temperatures have stabilized 1 Perform a manual pump out then fill ail bottles to the correct level for the instru ment model being used Reduce the number of specimens in the retort do not process more than the recommended number Open retort and remove excess fluid to below the fill line etched on either side of retort then close retort Place an empty bottle at the highlighted station and perform a manual pump out of the retort Mi w Reconnect the bottle at the station listed ensuring a secure connection of the quick release con
79. up 1 1 Date and Time The date and time can be programmed by pressing the Date and Time function key from the System Setup screen The display will show the year month day and time that are currently programmed and the related formats Each can be changed as described below if an entry is correct as displayed simply press one of the arrow keys to continue to the next entry 1 The blinking cursor will initially be on the last digit of Year with the prompt of ENTER YEAR DATE AND TIME AND SELECT DATE AND CLOCK FORMATS PRESS SAVE on the message line If the year being displayed is incorrect enter the correct four numerical digits then use the arrow keys to move the cursor to the Month Day and Time fields 2 Enter the correct month day and time if necessary 3 Using the Date Format and Clock Format function keys configure the date and clock formats as needed Press the Save function key when finished or the Exit function key if you do not want to save the changes ee 9 09 OO 0 O OO DO 3 2 Revised 05 16 01 CIHRT Exhibit P 3624 Page 21 beem 1 2 Passwortis The default manager password entered into the instrument is 0000 This eniry code can be changed using up to two codes of four digits or more The password can be added by pressing the User Password or the Manager Password function keys The User password limits access to routine operations of the in
80. xylene cycles have been completed the first of the user defined number of alcohol cycles begins Station 16 Again the number of cycles remaining is displayed e After all alcohol cycles have been completed the first of the user defined number of water cycles begins station 17 The number of cycles remaining is also displayed f After the final cleaning cycle has been completed the display returns fo one of two screens i to the Solutions screen if there are any solutions that need to be exchanged see Exchange Solutions below or to the Main Menu if no solutions require exchanging LGL LLNWEILLAPCOSXQGJLEEXSLLS LABEPL b K L mnw sdms RB EM e 3 14 Revised 05 16 01 CIHRT Exhibit P 3624 Page 33 6 Exchange Solutions Reagents gradually become diluted and deteriorate after repeated use To keep reagent purity consistent some users may wish to rotate their reagents discard the first reagent of a particular group or set and then move the following reagents nearer to the beginning of the cycle or to be the first used reagent of that particular set The reagent container which held the discarded reagent should be cleaned and or rinsed with clean reagent Then a full bottle of new reagent is placed at the end of that particular set of reagents or that reagent grouping The freshest reagent or purest of a group will always be the final reagent to complete that p

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