Leica TP1020 Instructions For Use Manual
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Leica TP1020 Instructions For Use Manual

Tissue processor
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Leica TP1020
Tissue Processor
Instructions for Use
English
Order No.: 14 0422 80101 – Revision M
Always keep this manual with the instrument.
Read carefully before working with the instrument.

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  • Page 1 Leica TP1020 Tissue Processor Instructions for Use English Order No.: 14 0422 80101 – Revision M Always keep this manual with the instrument. Read carefully before working with the instrument.
  • Page 3 These are determined only by the contract provisions agreed between ourselves and our customers. Leica reserves the right to change technical specifications as well as manufacturing processes without prior notice. Only in this way is it possible to continuously improve the technology and manufacturing techniques used in our products.

  • Page 4: Table Of Contents

    Description of the instrument ........................15 Standard delivery – packing list ........................16 Overview of the Leica TP1020 – with additional wax bath (optional accessory) ....... 20 General overview Leica TP1020 – with fume control system ..............22 Accessories supplied together with the instrument ................23 3.6.1 Standard tissue basket ..........................
  • Page 5 13.3 Basket holder for second tissue basket ....................70 13.4 Connecting the fume outlet tube (optional accessory for instruments with fume control system) 72 13.5 Inserting the activated carbon filters (optional on instruments with fume control system) ..... 73 Leica TP1020...
  • Page 6 Table of contents Ordering Information ..........................14.1 Accessories ..............................74 Appendix ..............................15.1 Modifying the instrument configuration ....................75 15.2 Reagents appropriate for use with the instrument .................. 77 15.3 Factory-set programs ............................ 78 Warranty and Service ..........................Decontamination Confirmation ......................Version 3.5, Revision M...

  • Page 7: Important Information

    Indicates the manufacturer's serial number so that a specific medical device can be identified. In vitro diagnostic medical device Symbol: Title of the symbol: Description: Indicates a medical device that is intended to be used as an in vitro diagnostic medical device. Leica TP1020...

  • Page 8: Instrument Type

    A nameplate indicating the instrument serial number is attached to the rear side of the instrument. Qualification of personnel • The Leica TP1020 may be operated only by trained laboratory personnel. The instrument is intended for professional use only. • All laboratory personnel designated to operate the Leica instrument must read these Instructions for Use carefully and must be familiar with all technical features of the instrument before attempting to operate it.

  • Page 9: Intended Purpose

    Important Information Intended purpose The Leica TP1020 is an automated tissue processor specifically designed for fixation, dehydration, infiltration with intermedium and paraffin infiltration of human tissue specimens used for histological medical diagnosis by a pathologist, e.g. for cancer diagnosis. The Leica TP1020 must be operated exclusively with the reagents listed in chapter (→...

  • Page 10: Safety

    Make sure to comply with the safety instructions and warnings in this chapter. Make sure to read these instructions, even if you are already familiar with the operation and use of other Leica products. Safety notes These Instructions for Use includes important information related to the operating safety and maintenance of the instrument.

  • Page 11: Warnings

    • Make sure to observe the level indicators on the reagent containers and wax baths. • Warning! Use caution when handling solvents! Make sure the premises are adequately ventilated! Explosion hazard! Leica TP1020...
  • Page 12 Safety Working with the instrument (continued) Warning • Spilled reagents have to be wiped away immediately. In case of long-term exposure, the instrument surfaces are only conditionally resistant to solvents. • Always observe worker's protection rules and use adequate protective gear (gloves, laboratory coats).
  • Page 13 Wax baths Warning • If the excess temperature repeatedly – please call Leica Technical Service. DO NOT continue to use the wax bath. • Check if the wax bath works trouble-free. Use of defective wax baths has to be discontinued for safety reasons! • Empty the wax baths completely before the paraffin cools! When cooling down, the paraffin...

  • Page 14: Instrument Components And Specifications

    Instrument Components and Specifications Instrument Components and Specifications Technical data Type TP1020 Approvals UL / cUL / VDE Electrical data Nominal voltage 100 / 120 / 230 / 240 V AC ±10 % Rate frequency 50 - 60 Hz Power fuses (Type MDA; Bussmann) 2x T 10.0 A L250 V, UL listed...

  • Page 15: Description Of The Instrument

    500 hPa ±10 % (approx. 0.5 bar) Description of the instrument The Leica TP1020 is an automatic tissue processor designed for laboratory applications. It is used for the fixation, dehydration and infiltration of histological tissue samples with fixatives, alcohol, solvents and paraffin wax.

  • Page 16: Standard Delivery - Packing List

    After a long-term power failure, critical excess immersion time in a station will be visually displayed. Standard delivery – packing list The Leica TP1020 is available in eleven different configurations, which are described below. All variants also include accessories as described in the table (→ p.
  • Page 17 Basic instrument 14 0422 31412 Aluminum reagent containers for vacuum 14 0422 42545 Reagent container carriers 14 0422 42545 Wax baths, (1.8 liters) 14 0422 30665 Standard tissue basket 14 0422 30585 Tubing band clamp 14 0422 31973 Leica TP1020...
  • Page 18 Instrument Components and Specifications Order No. Variant 8 Two basket operation (double-loading) / standard tissue baskets. With vacuum / without fume control system. Connection for optional third wax bath includes second tissue basket carrier. Basic instrument 14 0422 31414 Aluminum reagent containers for vacuum 14 0422 42545 Reagent container carriers 14 0422 42545...
  • Page 19 Activated carbon filter for formaldehyde 14 0422 30674 Exhaust hose, diameter 50 mm, 4 m long 14 0422 31975 All instrument variants of the Leica TP1020 come with the following accessories: Replacement fuses T 10.0 A L250 V 14 0600 00759 Screwdriver 5.5 x 200...

  • Page 20: Overview Of The Leica Tp1020 - With Additional Wax Bath (Optional Accessory)

    Instrument Components and Specifications Overview of the Leica TP1020 – with additional wax bath (optional accessory) Fig. 1 Carousel cover Tissue basket holder Reagent station lid Standard tissue basket Glass container with holder Wax bath Beaker carrier with fill level...
  • Page 21 Instrument Components and Specifications Leica TP1020 – rear side Fig. 2 Voltage selector Connections for wax baths (connection socket for Mains switch station 10 with cap (not Socket for power cable pictured) closed) Wax bath plug Leica TP1020...

  • Page 22: General Overview Leica Tp1020 - With Fume Control System

    Instrument Components and Specifications General overview Leica TP1020 – with fume control system Fig. 3 Plexiglas fume containment shield Fig. 4 Hose clamp Activated carbon filter receptacle Fume outlet tube (optional accessory) Version 3.5, Revision M...

  • Page 23: Accessories Supplied Together With The Instrument

    The wall of the beaker has two marks (Min, Max) that specify the minimum and maximum level in the container. The level must not exceed the Max mark or fall below the Min mark during filling. Fig. 6 Leica TP1020...

  • Page 24: Aluminum Container With Holder

    Instrument Components and Specifications 3.6.3 Aluminum container with holder (instruments with vacuum function only or as an optional accessory) Holding capacity: 1.8 l Instruments equipped with vacuum function are supplied with aluminum containers instead of glass containers. In aluminum containers the level indications marks are located on the inside of the container.
  • Page 25 • If the excess temperature switch-off mechanism reacts several times, call Technical Service without delay. DO NOT continue to use the wax bath. • Empty the wax baths completely before the paraffin cools! When cooling down, the paraffin contracts, which can cause damage to the wax bath. Leica TP1020...

  • Page 26: Initial Operation

    Initial Operation Initial Operation Unpacking instructions Note When the instrument arrives, check the tilt indicator (→ Fig. 9) on the package. If the arrowhead is blue, the shipment was transported laying flat, was tilted at too great an angle or fell over during transport. Note this on the shipping documents and check the shipment for possible damage.
  • Page 27 Plexiglas plates (→ Fig. 11-15). (not visible) Fig. 11 Warning When transporting the instrument, do NOT lift it up by the carousel cover! Note For safe transport of the instrument, we recommend keeping the original packaging. Leica TP1020...
  • Page 28 Initial Operation • To lift up the instrument take it by the reagent container platform or by the lower end of the housing (→ Fig. 12) and lift it from the base plate (→ Fig. 11-10). • Place the instrument on a stable laboratory table.

  • Page 29: Installation Site Requirements

    • Grounded wall outlet near enough so it can be reached with the power cable supplied together with the instrument. Note If you wish to install the basket holder for a second tissue basket, you should do that now. For mounting instructions, see (→ p. 70 – 13.3 Basket holder for second tissue basket). Leica TP1020...

  • Page 30: Electrical Connection

    Initial Operation Electrical connection 4.3.1 Checking the voltage selector setting The voltage selector is located in a shell (→ Fig. 14-3) above the power switch (→ Fig. 14-2) at the rear of the instrument. The actual selected voltage can be seen in the window (→...

  • Page 31: Adjusting The Voltage Selector

    (→ Fig. 16-6) and fuses (→ Fig. 16-7) back into the receptacle in the instrument and press lightly until it locks. • Check again if the right setting shows in the window (→ Fig. 16-1). Fig. 16 Leica TP1020...

  • Page 32: Connecting The Power Cable

    Initial Operation 4.3.3 Connecting the power cable Note The instrument is supplied together with various country-specific power cables. Warning The instrument may only be connected to the power with the cable supplied together with the instrument and it may only be connected to grounded sockets. • Before connecting the power cable, check if the power switch (→...

  • Page 33: Setting The Time

    Fig. 18 • Press to lift the carousel. Arrow Up Note To install and remove the reagent containers and wax baths, the instrument can be rotated on the bench. This ensures good access to all stations at any time. Leica TP1020...

  • Page 34: Installing The Wax Baths

    4.6.1 Installing the wax baths Note The Leica TP1020 basic instrument is delivered with two wax baths (no. 11 and 12). Optionally a third wax bath can be connected to station no. 10. • Insert the wax bath connection cable (→...

  • Page 35: Fastening The Wax Bath Connection Cables (Instruments With Fume Control System Only)

    4.6.4 Installing the reagent stations Fig. 20 • Mount the reagent containers (→ Fig. 20-1) (glass or aluminum) onto the station holders (→ Fig. 20-2) of the platform. Leica TP1020...

  • Page 36: The User Interface

    The User Interface The User Interface Control panel Fig. 21 The control panel is an easy-care key pad. The individual keys are organized in four functional groups. Pressing any key will be acknowledged by an audible signal. This function can be disconnected if required, see (→...
  • Page 37 – which is indicated through hyphens and colon – and indication of duration (holding time of the tissue basket in a particular station, total duration of process) – which is indicated through the letters and h. Leica TP1020...
  • Page 38 The User Interface Three Arrow key for Three Arrow key is used to start and stop the carousel carousel up and down (tissue basket) up and down movement. movement When this function is activated, the tissue basket is lifted and lowered in three-second intervals within the processing stations.
  • Page 39 To halt an up or down movement while still in progress, push one of the two keys again. The movement will stop immediately when pressing the key. Vacuum function (variant To connect/disconnect the vacuum function in the manual 2 and 4) processing mode. Leica TP1020...
  • Page 40 The User Interface Note The Leica TP1020 is available with and without a vacuum function. The instrument versions without vacuum functions do have the key in the control panel; however it is not functional is not displayed. Of course a vacuum function cannot be activated with the key in those cases.

  • Page 41: Programming The Instrument

    Alcohol 80 % 1h30 parameters are memorized immediately. Alcohol 96 % 1h30 The Leica TP1020 has a memory capacity of Alcohol 100 % 1h00 9 programs. Each program can be set up and edited by the user. Alcohol 100 % 1h00 Programs nos.

  • Page 42: Setting-Up/Editing Programs

    Programming the Instrument Setting-up/editing programs 6.2.1 Selecting programming mode • To select the programming mode, push the Prog key. The following parameters are displayed: • Number of baskets • Number of processing station - 12, • Vacuum "ON" or "OFF", • Tissue infiltration time in the displayed station min, 0 h 50...

  • Page 43: Selecting The Starting Station

    • To activate the vacuum, press Plus. • To deactivate the vacuum, press Minus. Warning The Leica vacuum accessories for enhanced tissue infiltrations may ONLY be used with aluminum containers. Glass beakers used in combination with the vacuum accessories have a high hazard potential when damaged! 6.2.6 Selecting infiltration times per station...

  • Page 44: Displaying Total Program Duration

    Programming the Instrument The cursor flashes on both digits destined for entering the minutes. • Press Plus Minus to enter the minutes. Setting range: 0 hrs. 05 min. to 99 hrs. 59 min. Note For stations you wish to leave out of your program, select an infiltration time of 0 h 00 min. • Press Arrow Right to quickly jump to the next station for...

  • Page 45: Leaving The Programming Mode

    While operating the instrument, no liquid may enter in contact with any of the electrical connections or the interior of the instrument. Note To remove and reinstall the reagent containers and wax baths, the instrument can be rotated thus ensuring easy access to all stations at any time. Leica TP1020...

  • Page 46: Preparations For Tissue Processing

    Preparations for Tissue Processing Preparations for Tissue Processing Filling the reagent stations • Lift the carousel cover. • Fill all stations with the corresponding reagents. Make sure to observe the minimum and maximum level indication marks. Warning Spilled reagents have to be wiped away immediately. In case of long-term exposure, the instrument surfaces are only conditionally resistant to solvents.
  • Page 47 The wax bath rims and sealing rings of the lids always have to be clean and undamaged. The covers must close tightly, as for instruments with vacuum function, the vacuum would not be able to be built up. Leica TP1020...

  • Page 48: Inserting The Tissue Basket

    Preparations for Tissue Processing Inserting the tissue basket Warning Use caution when lowering the carousel! Keep your fingers out of the space between the container lid and the upper rim of the container! • Fill the tissue cassettes or capsules into the tissue basket.

  • Page 49: Operating The Instrument In The Manual Processing Mode

    If yes, you may carry on and lower the basket into or lift it out of the wax bath. • To lower the basket press Arrow Down simultaneously. • To lift the basket, press Arrow Up simultaneously. Leica TP1020...

  • Page 50: Moving The Tissue Basket To The Next Station

    Activating the vacuum function (instruments with vacuum function only) Note The Leica TP1020 is available with and without a vacuum function. Instruments without vacuum function also have the key for vacuum on the control panel, however this key is not functional.

  • Page 51: Operating The Instrument In The Automatic Processing Mode

    While the basket is being moved, the display reads the numbers of the container stations the carousel is rotating past. Instead of the infiltration time will be displayed. As soon as the basket has arrived at the programmed starting station, it will be lowered into that station. Leica TP1020...

  • Page 52: Delayed Start

    Operating the Instrument in the Automatic Processing Mode From that point on, the remaining infiltration time of the basket in the current station is displayed. While processing time is running, the display reading is updated in one-minute intervals; i.e. you can always see exactly the remaining infiltration time for each station.
  • Page 53 • To override the warning codes and start processing, press simultaneously. Start The program will be started at the selected delay time. • To quit the display indication, press Clock again. Leica TP1020...

  • Page 54: Editing And Modifying Programs While A Processing Cycle Is In Progress

    Operating the Instrument in the Automatic Processing Mode Locking the key functions Note To protect program settings against unintended deletion or alterations, the key functions of the control panel can be locked. • To lock the panel, press for 5 seconds. LOCKED will be displayed.

  • Page 55: Display End Of Processing Time

    When in PAUSE, the keys for manual operation become functional, e.g. to lift the tissue basket out of a station to add specimens. The carousel can also be rotated to move the basket to any processing station, see (→ p. 49 – 8. Operating the Instrument in the Manual Processing Mode). Leica TP1020...

  • Page 56: Resuming A Paused Process

    Operating the Instrument in the Automatic Processing Mode Resuming a paused process • To reassume processing press Pause/Cont again. Pressing this key will lower the basket into the station. Processing continues as programmed. While a run is paused, the infiltration time countdown in the actual station will also be interrupted.

  • Page 57: End Of An Automatic Process

    • Clean the edges of the reagent containers and wax baths as well as the seals of the lids, see (→ p. 64 – 11. Cleaning). • Wipe the control panel clean. • Press to lock the panel and that way protect program settings against accidental alteration or misuse. Leica TP1020...

  • Page 58: Warning And Error Codes - Troubleshooting

    Warning and Error Codes – Troubleshooting Warning and Error Codes – Troubleshooting 10.1 Warning codes The warning codes W:01 - W:06 may be displayed. W:01, W:02, W:03 – paraffin in station no. 10, 11, 12 is still solid. W:04, W:05, W:06 – paraffin in station no. 10, 11, 12 may still be solid when basket no.

  • Page 59: Error Codes

    10 seconds reinforce the visual error code. • To quit the error codes, press any key. Note On the next page you will find a complete list of all error messages, their meaning and how to troubleshoot them. Leica TP1020...
  • Page 60 Warning and Error Codes – Troubleshooting List of error codes Code Possible root cause Troubleshooting Cache memory defective Call Technical Service Error code "E:01" Error code "E:03" – "E:04" – "E:05" Drive malfunction • Switch off the main switch and next switch it back on. Try again.

  • Page 61: Power Failure" And "Wrong Station" Messages

    Once the power is restored, processing will be resumed as programmed. The basket will be moved from the wrong station to the next station that is part of the current program. Leica TP1020...

  • Page 62: Measures To Remove Specimen Material In Case Of Prolonged Power Failure

    Warning and Error Codes – Troubleshooting 10.4 Measures to remove specimen material in case of prolonged power failure Note In case of a prolonged power failure the tissue can be removed from the instrument manually and also be relocated to the next station by entirely manual operation. • Switch the instrument off at the main power switch.

  • Page 63: Abort" Message

    Circle Arrow where processing was aborted. • Press to lower the basket. Arrow Down • To leave the manual processing mode, press Pause/Cont again. Processing will then continue where it had previously been aborted. Leica TP1020...

  • Page 64: Cleaning

    Cleaning Cleaning • Lift the carousel in the manual processing mode. • Remove all station containers from the platform. Warning Spilled reagents have to be wiped away immediately. In case of long-term exposure, the instrument surfaces are only conditionally resistant to solvents. The interior containers of the wax baths become very hot when the heating function is activated! Do not touch the gray upper rim of the containers with your hands! Burn hazard! Caution when handling hot paraffin! Burn hazard!
  • Page 65 • Use a soft plastic spatula for removing residual paraffin from the surface of the shields to avoid scratches. • Apply some alcohol or xylene on a cloth and wipe off the surfaces previously cleaned with the plastic spatula. Do not allow xylene or alcohol to react on the surfaces! Leica TP1020...

  • Page 66: Maintenance

    • Have a preventive maintenance done once a year by a service engineer authorized by Leica. • Enter into a service contract at the end of the warranty period. For details please contact your local Leica Service Organization.

  • Page 67: Reset After Excess Temperature Shutdown

    • Measure if the actual temperature of the paraffin corresponds to the standard working temperature. If there is any doubt whether the wax bath is functioning trouble-free, it has to be exchanged. Leica TP1020...

  • Page 68: Replacing The Fuses

    Maintenance 12.3 Replacing the fuses Warning Turn the instrument off and disconnect the power plug before replacing the fuses! Burnt-out fuses may only be replaced by fuses of the same type and specification. (→ p. 14 – 3.1 Technical data). Fig.

  • Page 69: Optional Accessories

    • Lock the hook (→ Fig. 28-2) into the upper rim of the tissue basket and release the spring. • Lift the basket slightly and remove it from the basket holder in a horizontal movement. Fig. 28 Leica TP1020...

  • Page 70: Basket Holder For Second Tissue Basket

    Optional accessories 13.3 Basket holder for second tissue basket Note To increase the specimen throughput the instrument can be retrofitted with a basket holder for a second tissue basket. A second tissue basket (standard or three-level type) has to be ordered separately. Standard delivery Basket holder for second tissue basket Wax bath...
  • Page 71 Note The instrument standard configuration will then have to be changed accordingly to acknowledge that a third wax bath has been connected, see (→ p. 75 – 15.1 Modifying the instrument configuration). Fig. 31 Leica TP1020...

  • Page 72: Connecting The Fume Outlet Tube (Optional Accessory For Instruments With Fume Control System)

    Optional accessories Installing the station holder • Use a screw driver to lift the reagent station holder out of the platform. • Insert the wax bath holder and drive in with a plastic hammer. Connecting the third wax bath • Pull off the cover cap from the socket no. 10. • Insert the plug (→...

  • Page 73: Inserting The Activated Carbon Filters (Optional On Instruments With Fume Control System)

    If a filter becomes saturated with solvent, there is a potential fire risk! It is important that the activated carbon filters are changed at factory recommended intervals. Generally the activated carbon filters have to be replaced every four months. Leica TP1020...

  • Page 74: Ordering Information

    Ordering Information Ordering Information 14.1 Accessories Qty. Designation Order No. Standard tissue basket 14 0422 30585 Three-level tissue basket 14 0422 30547 Single-level compartment for three-level tissue basket 14 0422 30622 Lid for three-level tissue basket 14 0422 30623 Basket removal device with drip tray 14 0422 30637 Glass container, 1.8 l capacity 14 0424 60429...

  • Page 75: Appendix

    Editing the configuration menu • Switch the instrument off at the main power switch. • Turn the power switch back on. While the display still reads TP1020 V x.xx press Prog for a short while. The first configuration menu item is displayed.
  • Page 76 Appendix The next standard setting is displayed. 3. wax bath = do you wish to use a third wax bath? Note In station no. 10 you can install a third wax bath instead of the reagent station. If you do so, you have to modify the configuration menu accordingly; otherwise the instrument will not function properly.

  • Page 77: Reagents Appropriate For Use With The Instrument

    Warning Important! Using other than the reagents listed below can cause damage to the instrument or to parts of the instrument. The following reagents are safe for use with the Leica TP1020: Formalin, buffered or unbuffered Fixation Picric acid Dehydration...

  • Page 78: Factory-Set Programs

    Appendix 15.3 Factory-set programs Program no. 6 - 1 basket Program no. 8 - 2 baskets Station Reagent V AC Duration Station Reagent V AC Duration 0h15 0h15 0h15 0h15 0h15 0h15 0h15 0h15 0h15 0h15 0h15 0h15 0h15 0h15 0h15 0h15 0h15...
  • Page 79 Appendix Leica TP1020 – Programming Worksheet Program no. ––––––––––– Name: ––––––––––––––––––––– Date: –––––––––––––––––––––– Written by: –––––––––––––––––––––– Station Reagent V AC Duration Notes Paraffin Paraffin Leica TP1020...
  • Page 80 Appendix Leica TP1020 – Programming Worksheet Program no. ––––––––––– Name: ––––––––––––––––––––– Date: –––––––––––––––––––––– Written by: –––––––––––––––––––––– Station Reagent V AC Duration Notes Paraffin Paraffin Version 3.5, Revision M...

  • Page 81: Warranty And Service

    Leica sales organization or the organization from which you have purchased the contractual product shall apply exclusively. Technical service information If you are in need of technical customer support or spare parts, please contact your Leica representative or the Leica dealer where you purchased the instrument. Please provide the following information: • Model name and serial number of the instrument.

  • Page 82: Decontamination Confirmation

    Decontamination Confirmation Decontamination Confirmation Every product that is returned to Leica Biosystems or that requires on-site maintenance must be properly cleaned and decontaminated. You can find the dedicated template of the decontamination confirmation on our website www.LeicaBiosystems.com within the product menu. This template has to be used for gathering all required data.
  • Page 84 Leica Biosystems Nussloch GmbH Heidelberger Strasse 17 - 19 69226 Nussloch Germany Tel.: +49 - (0) 6224 - 143 0 Fax: +49 - (0) 6224 - 143 268 Web: www.LeicaBiosystems.com...

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