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Summary of Contents for Tissue-Tek AutoTEC

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Page 2: ... 2010 Sakura Finetek USA Inc All Rights Reserved Printed in U S A Manufactured by Sakura Finetek USA Inc Torrance CA 90501 U S A Made in U S A 0003055 02 Rev E ...

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Page 4: ...3 CUSTOMIZATION OF SETTINGS General Information 3 1 Map of Interface Screens 3 5 Access Levels 3 6 Configuring System Settings 3 7 4 OPERATION Initial Start up 4 1 Typical Operating Sequence 4 1 Routine Operation 4 2 5 CARE OF THE INSTRUMENT Introduction 5 1 Routine Maintenance 5 1 Paraffin Reservoir and Filter Cleaning 5 2 Magazine Cleaning 5 4 Output Door Inspections and Cleaning 5 4 Splash Guar...

Page 5: ...des and Messages 6 2 Error Recovery Procedure 6 7 7 SERVICE AND REPLACEMENT PARTS Service 7 1 Replacement Parts 7 1 APPENDIX A Glossary A 1 APPENDIX B Index B 1 APPENDIX C Grossing Procedures for Paraform Sectionable Cassettes C 1 APPENDIX D Microtomy Procedure for Paraform Sectionable Cassettes D 1 ...

Page 6: ...te border Reduce labor requirements Tissue Tek Paraform Cassettes are made of two components an inner sectionable tissue insert and an outer frame that provides support when in the microtome chuck Paraform Cassettes are placed in up to four 32 or 20 cassette input magazines The magazines are loaded with the cassette front surface angled facing up during the embedding process Following a magazine w...

Page 7: ...s 5 Paraffin reservoir lid opens to allow addition of paraffin to the system 6 Paraffin reservoir filter access 7 Rear doors equipped with safety interlocks give access to robotic system 8 External computer system connections for PS2 external pointing device such as a mouse PS2 keyboard to supplement on screen keypads RJ 45 Port USB 2 0 peripherals including USB key drives used to export log files...

Page 8: ...m comprises two main modules a gripper and a stager each with three axes of motion These two modules handle the Paraform Cassettes from the magazine area to the base mold module and finally to the output door area The gripper retrieves Paraform Cassettes from the magazines and moves them through the system Figure 1 F shows the cassette sensor wide beam sensor and beneath it the Paraform recovery c...

Page 9: ...nsing mechanism heated solenoid valve and nozzle over the cassette already placed into the heated base mold It then stages presses down with a tamper the Sectionable Cassette to lower it through the frame until the cassette bottom is pressed against the base mold surface The stager dispenses an even flow of molten paraffin to the correct volume Since the temperature and flow are controlled bubble ...

Page 10: ... the output door to be returned Paraffin Reservoir Figure 1 J The paraffin reservoir stores and heats up to 5 38 liters of paraffin This is enough to embed up to 960 Paraform cassettes or approximately eight hours of operation For superior results and to minimize the production of bubbles only use the Tissue Tek Paraform Processing Embedding Medium Formula 3 product code 7052 The paraffin reservoi...

Page 11: ...tomated Tissue Embedding Console 115 VAC USA 7001 Tissue Tek AutoTEC Automated Tissue Embedding Console 100 VAC Asia 7002 Tissue Tek AutoTEC Automated Tissue Embedding Console 230 VAC Europe Power Ratings and Requirements Model Power Frequency Facility Requirement 7000 115 VAC 10 15A 60 Hz 20A 7001 100 VAC 10 5 15A 50 60 Hz 20A 7002 230 VAC 10 7A 50 Hz 10A We recommend an uninterruptible power sup...

Page 12: ...ician Safety Standards Electrical Safety The Tissue Tek AutoTEC has been tested and it complies with the following standards UL 61010A 1 UL 61010A 2 010 CSA C22 2 1010 1 92 CSA C22 2 1010 2 010 R 1999 IEC 61010 1 IEC 61010 2 010 EMC EN 61326 1998 CE compliance to directive 98 79 EC Regulatory Information FDA registered with ETL evaluation USA complies with requirements of The Pharmaceutical Affair...

Page 13: ...INTRODUCTION 1 8 Revised 5 19 2010 ...

Page 14: ...ment that consumes a high voltage or large current including large refrigerators and ovens For proper operation maintain a six inch 15 24 cm minimum clearance around the sides and back of the instrument For additional stability lower the feet located on the bottom of the instrument To lower the feet turn the nut fastened to the threaded shaft of each foot clockwise until the foot contacts the grou...

Page 15: ...Figure 2 B Main Power Switch 3 Disconnect the power cord from the outlet 4 Raise the feet located on the bottom of the instrument by turning the nut fastened to the threaded shaft of each foot counter clockwise 5 Carefully roll the instrument on its casters to the desired location 6 If desired lower the feet by turning the nut fastened to the threaded shaft of each foot clockwise CAUTION At least ...

Page 16: ...creen and buttons are enabled to allow the initiation of the embedding process MONITOR Screen Monitor screen is displayed when the MONITOR tab is selected Figure 3 C Figure 3 C Time and date are displayed at the top center of the screen Institution name and the current logged in user name are displayed at the top right corner of the screen Tabs to allow screen changes between MONITOR UTILITIES ERR...

Page 17: ...ed INSTRUMENT ACCESS When displayed it allows the user to pause the system operation access the interior of the system by opening the front or rear doors and resume operation by touching OK in an on screen prompt LOAD MAGAZINE When displayed it allows the user to request access to the input door Once the instrument has initialized the door mechanism the ID interlock is released and magazines can b...

Page 18: ...re version SYSTEM SETUP When selected is used to set up alarm volume alarm sound end of process sound current year date and time and institution name SHUT DOWN When selected is used to shut down the AutoTEC Software applications Windows operating system PC and instrument COOL DOWN Mode OR WARM UP Mode When selected will either shut down all AutoTEC heaters or start warming up all AutoTEC heaters W...

Page 19: ...Figure 3 F Figure 3 F Displays information on the cassettes ran based on the following selected criteria Date ranges Today This Week Last Week or this month File Output button When selected will save selected run history to an external memory stick Expand All Columns button When selected toggles the display to show all columns in one screen or to show all information inside each column requires us...

Page 20: ...ised 5 19 2010 3 5 Map of Interface Screens Figure 3 H illustrates the general structure of the interface available for an administrator level clearance showing screens accessible from the Monitor screen Figure 3 H ...

Page 21: ...istory tracking and start up and cool down programming Operator Users with operator status can only navigate the main screens general operational functions and some utilities screens See page 3 7 for details Up to 55 names and passwords can be active at any time 13 Administrators and 42 Operators The type of user currently logged in is identified by an icon that appears in the top right corner of ...

Page 22: ...l Down Mode Warm Up Mode o Clean Gripper Arms Error Log Run History View Only UTILITIES o User Accounts o Software Version o System Setup NOTE Icons unavailable to operator level users or inaccessible during AutoTEC operation are displayed in gray NOTE To avoid data corruption some of the parameters cannot be changed while the AutoTEC is in operating mode running or ready to run These restricted p...

Page 23: ...ered check that they are correct and then touch the SAVE AND EXIT button to return to the System Setup screen Figure 3 L Ready Cool Down Times screen NOTE The times set in this screen will repeat weekly unless Days Off is specified NOTE In Auto At least one ON TIME and one OFF TIME must be set NOTE To control the Ready Cool Down time manually select the MANUAL radial button NO TIME SET appears for...

Page 24: ... from the Utilities Selection screen to initiate system cool down When the Cool Down mode icon is touched a prompt Figure 3 O appears requesting confirmation that the system should cool down and allow the paraffin to cool NOTE In the Cool Down mode the system cannot embed cassettes A warm up time of up to 4 hours will be needed before embedding can start NOTE If a Cool Down time was programmed for...

Page 25: ... AutoTEC will exit the Cool Down mode and begin the 4 hour warm up process when the auto start time begins or when the operator touches the WARM UP mode button in the UTILITIES screen Software Version The Software Version screen displays the software version in use and the serial number of the AutoTEC Record this information at installation and each time the software version is updated Figure 3 R ...

Page 26: ...nd functions are as follows Parameter Default Function Alarm Volume High Sets the volume level for alarms Alarm Sound Alarm 4 Selects alarm sound from seven options End Process Sound End Process 5 Sets sound for end process indication from seven options Date and Time Enables the date and time to be set The following pages review in details each of the user defined parameters Languages Setup As sho...

Page 27: ...nguage Audible Alarm Setup As shown in Figure 3 X System Setup screen there are three alarm attributes that can be modified Select between three volume levels High Middle Low eight different alarm sounds labeled as Alarm 1 though Alarm 8 and eight different end of process sounds labeled as End Process 1 through End Process 8 Select the down arrow to activate the pull down list then scroll to highl...

Page 28: ...ime Select SAVE AND EXIT to save the changes Select EXIT to abort the changes NOTE Time can only be changed when AutoTEC is idling and there is no timer running such as the 4 Hr warming up timer INSTITUTION Setup Select EDIT to bring up CHANGE INSTITUTION NAME keyboard Figure 3 AA Use BACKSPACE to clear current entry Use keypads to enter new name Use SHIFT to change letter fonts Select to ENTER to...

Page 29: ... and user names can only have a maximum of 8 characters NOTE Administrators may change or delete passwords and user names but passwords are never displayed If an operator forgets their password it can be reset Touch the User Name Password Verify Password fields and use the display keyboard to type a name and passwords Figure 3 DD NOTE The user name and passwords are not case sensitive NOTE Each en...

Page 30: ...ror box Figure 3 EE Error Log screen Error log can be sorted in the following ways to help viewing By Date Ranges Select the pull down arrow for the From and To date to activate the date selection calendar Figure 3 FF Figure 3 FF By Error ID Select the Error ID pull down arrow to display the pull down menu Scroll to the selection Figure 3 GG Figure 3 GG By User Select the User pull down arrow to d...

Page 31: ...hree formats HTML PDF or EXCEL to help in organizing the collected data NOTE Internal events are recorded in the Error Log but are not considered errors which require corrective action An example of such an event is the second or third attempt of the gripper to pick up a framed cassette Refer to Section 6 entitled Troubleshooting for error recovery information RUN HISTORY By selecting the RUN HIST...

Page 32: ...s magazines cassettes types of cassettes etc Figures 3 LL and 3 MM Figure 3 LL Summary page Figure 3 MM Summary page By selecting a date from the summary screen details of all the magazines ran on that day are displayed Figure 3 NN Figure 3 NN One day view By selecting a magazine from the summary screen details of all the cassettes in this magazine are displayed Figure 3 OO Figure 3 OO One magazin...

Page 33: ... The run history display can be rearranged by selecting a column dragging it and dropping it at a new location Figure 3 QQ Figure 3 QQ Dragging a column to a new location By selecting the File Output button the selected run history can be transferred to a flash drive Figure 3 RR Figure 3 RR File Output Output files can be saved in any one of the three formats HTML PDF or EXCEL to help in organizin...

Page 34: ... B Figure 4 B Log In screen NOTE Refer to page 3 14 User Accounts to set up the passwords 3 Use the keypad display to type in the password 4 Select ENTER when done 5 The Monitor screen is displayed with a LOG OFF button Figure 4 C Figure 4 C Typical Operating Sequence A typical operating sequence for the Tissue Tek AutoTEC is as follows Warm Up System perform automatic self checks Operation Prelim...

Page 35: ...before the 4 hour period has elapsed At that point the OVERRIDE TIMER button will display Figure 4 D The operator has the choice to either wait for the 4 hour cycle to complete or to touch the OVERRIDE TIMER button to force the system to the ready state In either case the OVERRIDE TIMER button disappears If the input door heaters are at temperature typically 15 to 30 minutes after warm up begins t...

Page 36: ...are parallel none fallen or tipped backward c When holding a magazine filled with frames and viewing from the sides there should be no gap between the frames Any gap found between frames can be an indications of not properly closed cassette lid or cassette is pushed through the frame Open the magazine lid and investigate the causes of the gap and correct if necessary Ensure that cassettes are prop...

Page 37: ...Input Door Activity Acknowledgement 7 Securely close the input door by rotating the knob clockwise and touch CONTINUE in the on screen prompt The Warming Cassettes screen displays and the 15 minute cassette warming process begins This warm up time is required to ensure there is no solid or semi solid paraffin in the magazine that could interfere with the action of the robotic arm If magazines were...

Page 38: ...ue bars with dark border Magazine emptied The number of cassettes processed displays below the graphic Dark blue bars dark border Cassettes are being taken out of the magazine The number of cassettes displayed is incremented each time a cassette is takenfrom themagazine Gray with light border no bars No magazine is detected Base Molds and Output Doors Color Code Information Green Standard Cassette...

Page 39: ...iopsy 7 standard cassettes and 8 13x13 biopsy have been embedded so far The TOTALS are incremented every time a cassette is placed in a base mold They are sorted by cassette type The TOTALS are reset whenever a new user logs in the system shuts down or the count exceeds 9 999 These counts are recorded in the statistics Figure 4 L Run screen Magazines Heated NOTE The input door sensor system is abl...

Page 40: ...code 7052 NOTE When the paraffin reservoir temperature drops below an acceptable range the instrument will restart after the user acknowledges the displayed message Cassette Recovery Chute In certain instances an improperly assembled Paraform frame and cassette will be placed in the cassette recovery chute The chute is located behind a spring loaded hinged door on the left side panel The system wi...

Page 41: ...OPERATION 4 8 Revised 5 19 2010 ...

Page 42: ...ry use Output Door inspection and cleaning Inspection after every use Cleaning every month Splash guards cleaning After 10 000 cassettes Touch screen optional keyboard and Mouse Monthly Gripper Weekly or more often if necessary Exterior Maintenance Keep the exterior of the Tissue Tek AutoTEC cabinet free of dust and clutter Typically wiping the cabinet with a clean wet cloth will keep the instrume...

Page 43: ...ve the gauze slowly around capturing as much of the dirt particles as possible 3 Gently lift the gauze sponges out and discard them Alternatively once a month allow the reservoir to run low toward the end of the day As the paraffin starts to cool and solidify during the cool down period but while it is still pliable use a plastic scraper to remove it from the reservoir Add paraffin pellets to the ...

Page 44: ...ning Figure 5 E Figure 5 E 5 Use a bath of solvent to clean wax and debris out of the filter 6 Dry the filter and reinstall it in the reservoir taking care to tighten the screws down on the tabs of the filter 7 Gently pull the parasitic filter straight out from the center Figure 5 F Figure 5 F 8 Use a bath of solvent to clean the wax filter 9 Dry the filter and reinstall it in the reservoir Figure...

Page 45: ...er to clean accumulated paraffin on splash guard Figure 5 J during the cool down period when the Cleaning Request message Figure 5 I appears or depending on the accumulation of paraffin which could prevent efficient gripper stager traveling CAUTION When cleaning splash guard be careful not to bend any base mold posts NOTE The default setting for the maximum number of cassettes is 10 000 Figure 5 I...

Page 46: ...ime is exceeded the system will resume current operation in 180 seconds To override cleaning at this time select RESUME to let the instrument continue with the current task If operator selects ABORT to clean the gripper arms then the stager will move over standard base mold 1 and gripper will move above base mold 5 giving enough clearance to clean the bottom of the gripper arms Once in the positio...

Page 47: ...n cloth to clean the gripper arms Lint left from cleaning may interfere with the sensors Figure 5 O Figure 5 P After cleaning the gripper close the front door to allow the instrument to resume operation After closing the front door acknowledge message box on screen to continue with the cycle Figure 5 L NOTE Do not load magazines when 4 hours warm up timer is on screen Before loading the magazines ...

Page 48: ...ve above base mold 5 giving enough clearance to clean the bottom of the gripper arms Once in the position wait for the following message to be displayed on the screen before attempting to open the door Figure 5 R Figure 5 R Open the front door to clean the gripper arms Figure 5 S and follow Gripper Arms Cleaning Procedure located on the previous page Figure 5 S After cleaning the gripper close the...

Page 49: ...CARE OF THE INSTRUMENT 5 8 Revised 5 19 2010 ...

Page 50: ...n a pop up window on the control panel but also an audible alarm sounds Error messages are shown in the table below They include Error codes Titles descriptions of errors Messages with instructions on the steps to take for error recovery Actions required to recover from the error Document error codes for reference when contacting Sakura Finetek for service NOTE Internal events are recorded in the ...

Page 51: ...eck the gripper and base mold for excess paraffin and obstructions Once the Paraform has been seated in the base mold close and latch the door then touch OK to resume instrument operation Touch CONTINUE 7 BLOCK NOT REMOVED FROM BASE MOLD 1 8 BLOCK NOT REMOVED FROM BASE MOLD Touch ABORT to open the front door and remove the block from base mold 1 8 and remove any excessive paraffin or obstructions ...

Page 52: ...edding continues 23 HEATER THERMAL FUSE PROBLEM During a check of the system heaters reservoir secondary reservoir copper tube 1 copper tube 2 flex tube valve nozzle drip tray ID A ID B thermal fuse was discovered to be functioning improperly The instrument will not run until this problem is fixed Please contact maintenance for further assistance Perform action s requested 24 25 HEATER TEMPERATURE...

Page 53: ...se mold Once the block has been retrieved close and latch all doors then touch OK to resume instrument operation Touch OK 42 MISSING BLOCK PROBLEM MISSING BLOCK FROM BASE MOLD Touch OK 45 U V STEPPER BOARD PROBLEM U V STEPPER BOARD NOT RESPONDING U V Stepper Board is not responding System is trying to recover the error to resume current operation Error Log 46 W X STEPPER BOARD PROBLEM W X STEPPER ...

Page 54: ...moved Error Log 56 NON RECOVERABLE ERROR INSTRUMENT EXPERIENCES 3 CONSECUTIVE STALLS WITHIN 20 MINUTES The instrument has experienced a non recoverable error with the U V W X Y Z Input Door Stepper Please remove all input magazines and empty all output doors instrument will now shut down Contact Sakura Service Department for further instructions Contact Sakura Service Department 57 MAGAZINE PROBLE...

Page 55: ...HE INSTRUMENT Could not Power On the instrument Clear all base molds and empty output doors while this message is displayed PLEASE DO NOT TURN OFF THE MACHINE Contact Sakura Service Department for further instructions Contact Sakura Service Department 100 AMBIENT TEMPERATURE PROBLEM AMBIENT TEMPERATURE EXCEEDS ACCEPTABLE OPERATING TEMPERATURE Ambient Temperature exceeds operating requirements Embe...

Page 56: ...yboard to enter user name and password 8 Touch the LOG IN button The initial run screen displays with the system start timer visible at upper right 9 The system will home after warming up and move any Paraform cassettes remaining in the base molds to Output Door 1 After that the T E C self test will follow When it appears at the lower left of the screen touch the OVERRIDE TIMER button to override ...

Page 57: ...rompt the operator to remove the block again Figure 6 A After three unsuccessful attempts to remove the block the system will disable the base mold in question NOTE Only users with a service level log in can re enable a base mold once it is disabled Disabling a base mold slows throughput since blocks must be cooled for the same amount of time regardless of how many base molds are in operation Disa...

Page 58: ...ine Problem Figure 6 I Magazine Problem A magazine problem will generate the message shown in Figure 6 I If the problem persists remove the magazine and reseat the cassettes If this action does not correct the problem try a different magazine If the problem cannot be resolved do not use this magazine position and call for service Cassette Lid Open Figure 6 J Cassette Lid Not Closed If the instrume...

Page 59: ...TROUBLESHOOTING 6 10 Revised 5 19 2010 ...

Page 60: ...ent or touch the Software Version icon in the Utilities screen Where to Call for Service If located within the United States contact the Technical Support Department of Sakura Finetek USA Inc by calling toll free 1 800 725 8723 Menu Option 2 In countries other than the United States contact the nearest authorized Sakura Finetek instrument distributor or representative for service information and t...

Page 61: ...Frames are also available stacked for compatibility with the Tissue Tek Autowrite Cassette printer 500 case Stacked 10x40 cs Frame Color Product Code Product Code Aqua 7030 7070 Blue 7031 7071 Gray 7032 7072 Gold 7033 7073 Green 7034 7074 Lilac 7035 7075 Orange 7036 7076 Pink 7037 7077 Red 7038 7078 Tan 7039 7079 White 7040 7080 Yellow 7041 7081 Ancillary Products Ancillary products for the Tissue...

Page 62: ...sue Tek Accu Edge Trimming Blades product code 4785 50 pkg Tissue Tek Accu Edge Scalpel Handle product code 4791 Tissue Tek Accu Edge Scalpel Blades 62 Pointed product code 4793 20 pkg How to Order Replacement Parts In the United States replacement parts can be ordered directly from Order Management Sakura Finetek U S A Inc 1750 W 214th Street Torrance CA 90501 or by calling toll free 1 800 725 87...

Page 63: ...SERVICE AND REPLACEMENT PARTS 7 4 Revised 5 19 2010 ...

Page 64: ...s Input Magazines 32 cassette and 20 cassette magazines that hold Paraform cassette assemblies for loading in the AutoTEC Magazines See Input Magazines Magazine Warm up Time 15 minute period required to bring Input Magazines to temperature before embedding can begin Main Door When closed covers input and output doors when open provides work space for magazines and output doors Output Doors Interlo...

Page 65: ...up but is not embedding System Warm Up The AutoTEC program mode during the four hour period of time required to melt the paraffin in the paraffin reservoir and to bring the instrument to operating temperature Tissue Tek AutoTEC See AutoTEC Tissue Tek Xpress An instrument used to prepare tissue specimens for embedding The Xpress uses low power microwave energy to reduce processing time to one hour ...

Page 66: ...Consumables 7 2 Contact information 2 1 7 1 E Embedding Tracking Color codes 4 5 Run screen 4 5 Environmental Factors 2 1 Error Log 3 15 Error recovery Error code notes 6 4 Error codes and messages 6 7 Procedure 6 7 Exporting Data 3 14 G H I Glossary A 1 Humidity Conditions 1 6 Initial start up 4 1 Input door 1 3 Installation Procedures 2 1 Instrument Access 6 7 Instrument components 1 2 M Magazin...

Page 67: ... order 7 3 Robotic system 1 3 Run history 3 4 3 16 Run Screen Layout 4 5 S Safety Information 1 1 1 7 Screens Cool Down 3 8 3 9 Embedding in progress 4 6 Error Log 3 4 Initial Run 4 2 Initial Start Up 4 1 Log In 3 1 Map of interface 3 5 Monitor 3 1 Password entry 3 14 4 1 Reservoir Temperature 4 2 Run History 3 4 Run screens 4 2 4 5 Service 3 4 Shut Down 3 9 Software Version 3 10 System Setup 3 11...

Page 68: ...Revised 5 19 2010 D 1 ...

Page 69: ...D 2 Revised 5 19 2010 ...

Page 70: ...Revised 08 01 2005 B 3 ...

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