Leica Autostainer XL Instructions For Use Manual
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Leica Autostainer XL Instructions For Use Manual

Automated slide stainer
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Leica Autostainer XL (ST5010)
Automated slide stainer
Instructions for Use
English
Order No.: 14 0456 80101 - Revision I
Always keep this Instructions for Use with the instrument.
Read carefully before working
near
the instrument.

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  • Page 1 Leica Autostainer XL (ST5010) Automated slide stainer Instructions for Use English Order No.: 14 0456 80101 - Revision I Always keep this Instructions for Use with the instrument. Read carefully before working near the instrument.
  • Page 3 Only in this way is it possible to continuously improve the technology and manufacturing techniques used in our products. This document is protected under copyright laws. All copyrights to this documentation are held by Leica Biosystems Nussloch GmbH.

  • Page 4: Table Of Contents

    Table of Contents Important Information ..........................Symbols in the text and their meaning ......................6 Intended use ..............................10 User group ..............................10 Safety ................................General safety notes ............................. 11 Specific safety notes............................. 11 Instrument Features ..........................General description ............................15 Standard delivery –...
  • Page 5 7.2.2 During editing of programs .......................... 41 7.2.3 During SetUp ..............................41 Warranty and Service ..........................Decommissioning and disposal ......................Decontamination Confirmation ......................Appendix ..............................11.1 Adjustable parameters ..........................45 11.2 Consumables and accessories ........................45 11.3 Compatible staining programs........................47 Leica Autostainer XL (ST5010)

  • Page 6: Important Information

    Be sure to comply with the safety instructions and warnings in (→ p. 11 – 2. Safety). Be sure to read these notes even if you are already familiar with the operation and use of other Leica products. Symbols in the text and their meaning Warning...
  • Page 7 Symbol: Title of the symbol: Label is attached on the transport arm. It indicates a risk Description: of collision between the transport arm and any operator working within the instrument while the transport arm is moving. Leica Autostainer XL (ST5010)
  • Page 8 100-120 VAC or 230-240 VAC (depending on your order). Do not change wiring or voltage selection on your own but contact qualified Leica service personnel in this case. Symbol: Title of the symbol: Caution – Water supply and interfaces...
  • Page 9 The IPPC symbol includes IPPC symbol • Country code to ISO 3166, e.g. DE for Germany • Regional identifier, e.g. NW for North Rhine-Westphalia • Registration number, unique number beginning with 49. • Treatment method, e.g. HT (heat treatment) Leica Autostainer XL (ST5010)

  • Page 10: Intended Use

    Intended use The Leica Autostainer XL (ST5010) is an IVD (in-vitro diagnostics) instrument. The Leica Autostainer XL (ST5010) is a stainer for laboratory applications and intended for the preparation of histological and cytological tissue samples. Danger Any use of the instrument that deviates from the designated use is considered improper.

  • Page 11: Safety

    Vessels not cleaned or cleaned insufficiently before refilling with another reagent Insufficient staining quality, tissue damage or loss of tissue • Always clean the vessels thoroughly and regularly before refilling them ( → p. 38 – 6.2 Reagent containers) Leica Autostainer XL (ST5010)
  • Page 12 Safety Caution Inadequate manual loading of specimen slide holders into vessels Loss of tissue and / or property damage because of crash due to automized loading of another specimen slide holder into the same vessel • Do not manually load specimen slide holders and start any movement of the transport arm Caution Lids not removed from vessel Loss of tissue and / or property damage because of crash due to automized loading of a specimen...
  • Page 13 In Europe, the protection device of the potable water installation to be connected is selected in accordance with the specifications of DIN EN 1717:2011-08 (information status August 2013). Leica Autostainer XL (ST5010)

  • Page 14: Instrument Features

    The Leica Autostainer XL (ST5010) is safe to use and has an integrated system for extracting reagent vapors. The specimen slide holders are loaded and unloaded using two drawers.

  • Page 15: General Description

    Specimen slide holder Hood Container cover The lock for the hood contains a gas pressure spring. This part can wear out. In case of weakening holding force, please contact our after-sales service and ask for replacement. Leica Autostainer XL (ST5010)

  • Page 16: Standard Delivery - Packing List

    Power output Standard delivery – packing list Note To prevent damage to the instrument and specimens, only those accessories and spare parts that have been authorized by Leica may be installed or used with the instrument. Standard delivery: Qty. Designation Order No.
  • Page 17 14 0456 35459 water supply hose with seal 14 0474 32325 drain hose 14 0475 35748 Instructions for Use Leica Autostainer XL (ST5010) German/ 14 0456 80001 English (+ CD) reference manual as appendix, only in English (staining protocols, etc.) The country specific power cord needs to be ordered separately.

  • Page 18: Specifications

    Instrument Features Specifications Dimensions (width x depth x height): 109 cm x 67 cm x 51 cm Weight: 65 kg Nominal supply voltages: 100-120V AC ± 10 % or 230-240V AC ± 10 % Nominal frequency: 50-60 Hz Power draw: 650 VA Fuses: 5 x 20 mm, VDE / UL listed...
  • Page 19 Operating elevation: Max. 2000 m above sea level Storage temperature: +5 to +50 °C Storage relative humidity: 10 % to 85%, non-condensing Transport temperature: -29 °C to +50 °C Transport relative humidity: 10 % to 85%, non-condensing Leica Autostainer XL (ST5010)

  • Page 20: Installing The Instrument

    Warning The user must not alter the voltage selector setting. • The Leica Autostainer XL (ST5010) must be connected to a laboratory water tap with a pressure reducer. Version 3.0, Revision I...

  • Page 21: Setting Up The Instrument

    The hose has a 3/4" connector. Then slowly turn the tap on all the way. Note The water filter must be in place when the water hose is connected, otherwise water can leak out. Leica Autostainer XL (ST5010)

  • Page 22: Battery Backup - Ups (Optional)

    Installing the Instrument Connect the drain hose to the discharge nozzle on the rear side of the instrument. Battery backup – UPS (optional) An interruption of the staining process can be avoided in the event of a temporary power failure by connecting an uninterruptible power supply (UPS).

  • Page 23: Vacuum Extraction System For Reagent Vapors

    To change the filter, remove the cover plate over the filter (→ Fig. 2-19). Use the straps provided to remove filter. Put in a new filter and reattach the cover. Oven Put the wax tray on the oven floor. Leica Autostainer XL (ST5010)

  • Page 24: Operating The Instrument

    In this case, the instrument's cover will have to be opened to remove the holder. The Leica Autostainer XL (ST5010) can accept a new specimen slide holder as soon as the LOAD LED on the load drawer lights up. This makes it possible to process up to 11 specimen slide holders simultaneously.
  • Page 25 Sounds when a key is pressed. • Short double beep: Wrong key pressed or error message received. • Long double beep: Operator action required to remove a fully processed holder. • Continuous tone: Indicates a malfunction. Leica Autostainer XL (ST5010)

  • Page 26: Main Menu

    Operating the Instrument Main menu When the ON/STOP switch has been turned ON, the Main Menu appears and the instrument beeps 3 times. Autostainer XL V2.00 Autostainer XL V2.00 Main Menu Hauptmenü Stain Edit SetUp Färben Programme Geräte- erstellen parameter The instrument has the following operating modes: • Stain: To stain the specimen slides.

  • Page 27: Menu Overview

    Steuerung über PC Fig. 6 Editing programs The Leica Autostainer XL (ST5010) can store up to 15 programs, numbered consecutively from 1 to 15. Programming is easy. The user is guided through a menu and enters all information via the keypad. Caution...

  • Page 28: Entering Program Steps

    Operating the Instrument A program consists of 25 steps, some of which may be blank. A step consists of the following information: • The step number • The station • The incubation time (immersion time) • Whether or not the specified incubation time must be adhered to exactly. The step number defines the order in which the stations are used.

  • Page 29: Deleting Program Steps

    L Steps will then be renumbered in the same sequence as in the original program. 1. Select the program (see items 2 (→ p. 28 – 5.4.1 Entering program steps)). 2. Press Edit. [F2] 3. Press [F1] More. 4. Press [F1] More. Leica Autostainer XL (ST5010)

  • Page 30: Saving A Program

    Operating the Instrument 5. Press [F3] Blank. 6. Press Yes to continue. The blank steps are removed and the subsequent steps are [F1] renumbered. 7. Save the program (→ p. 30 – 5.4.5 Saving a program). 5.4.5 Saving a program When the program is complete, save it as follows: 1.

  • Page 31: Viewing A Program

    In many cases, incompatibility of staining protocols can be traced to assignment of the wash stations. Therefore, these stations can be selected by the user. (→ p. 47 – 11.3 Compatible staining programs) gives some examples of staining protocols that are compatible with each other. Leica Autostainer XL (ST5010)

  • Page 32: User-Adjustable Parameters

    Operating the Instrument User-adjustable parameters The Leica Autostainer XL (ST5010) has multiple parameters that pertain to operation of the instrument regardless of the selected program. These parameters can be set by the user (refer also to (→ p. 45 –...

  • Page 33: Number Of Up/Down Movement (Dips)

    This chapter discusses how to stain specimen slides. The Leica Autostainer XL (ST5010) can accept a new specimen slide holder as soon as the load drawer is empty. Then the specimen slides are stained according to the program selected for the respective holder.

  • Page 34: Reagent Containers

    To use the wash station, slowly open the water tap in the lab all the way. The flow control valve in the Leica Autostainer XL (ST5010) limits the flow rate in the wash stations to an optimum value of 8 liters/ minute.

  • Page 35: Unloading Specimen Slide Holders From The Exit Drawer

    2. Close the drawer and press the [EXIT] key. Then the LED will go out. Note If the [EXIT] key is not pressed, the instrument will be unable to finish processing other holders that require this station. Leica Autostainer XL (ST5010)

  • Page 36: Unloading Specimen Slide Holders From Other Stations

    Operating the Instrument 5.9.6 Unloading specimen slide holders from other stations If the final step in a program is not the exit drawer, the [UNLOAD] LED on the control panel will flash when processing of the holder is complete. To unload: Note For unloading, below steps must be carried out as quickly as possible.

  • Page 37: Aborting The Processing Of A Specimen Slide Holder

    6. To abort the processing of other holders, repeat items 3 to 5. 7. Press [F4] Cancel to exit the Abort screen. 8. Press to continue staining or press to return to the [F1] [F4] Main Menu. Leica Autostainer XL (ST5010)

  • Page 38: Care And Cleaning

    Care and Cleaning Care and Cleaning Clean the interior stainless steel surfaces with a detergent and then rinse them with water. Clean the transport arm surfaces by wiping them with a damp cloth. Warning The transport arm contains sensitive electronic components, therefore do not use any liquid in this area.

  • Page 39: Water Drainage

    6. Check the flow by flushing thoroughly with water. 7. Insert the drainage sieve again, and put the vessels back in their original, defined positions. 8. Remove any lids from vessels before processing specimen slide holders into them. Leica Autostainer XL (ST5010)

  • Page 40: Error Messages And Troubleshooting

    Error Messages and Troubleshooting Error Messages and Troubleshooting Introduction The Leica Autostainer XL (ST5010) has a system that continually monitors the instrument's functions. It displays a corresponding error message if any errors occur. If a minor error occurs during staining, the instrument will first attempt to correct the problem on its own.

  • Page 41: More Information And Warnings

    Caution: increasing dips might extend some station times slides are being processed can result in lengthening of exactly defined incubation periods. If continuous up/down movement was selected, only one specimen slide holder can be processed at a time. Leica Autostainer XL (ST5010)

  • Page 42: Warranty And Service

    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. The following information about the instrument is required: • Model name and serial number of the instrument.

  • Page 43: Decommissioning And Disposal

    These objects must be disposed of via the collection points in accordance with the local regulations. More information on disposal of the instrument can be obtained from your local disposal company or your local Leica support staff. Leica Autostainer XL (ST5010)

  • Page 44: 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 45: Appendix

    11.2 Consumables and accessories Note To prevent damage to the instrument and specimens, only those accessories and spare parts that have been authorized by Leica may be installed or used with the instrument. Consumables Active carbon filter 14 0474 32273...
  • Page 46 14 0456 35434 Plastic rack 30 (specimen slide holder for 30 specimen slides) 14 0475 33750 Specimen slide holder for 30 specimen slides, Type Leica, plastic, 5 pcs. 14 0475 33643 Adapter Sakura (specimen slide holder 140474 33463 14 0475 34515...

  • Page 47: Compatible Staining Programs

    Wash stations 1 to 4 (and the stations in between) are used in the same sequence in both programs. These two programs are compatible with each other, but not with the programs on (→ p. 48 – Compatible staining programs). Leica Autostainer XL (ST5010)
  • Page 48 Appendix Compatible staining programs Program 1 H&E Program 5 Hx Counterstain Reagent Station Step Time Exact Step Time Exact Oven 10:00 Xylene 2:00 Xylene 2:00 100 % alcohol 2:00 100 % alcohol 2:00 70 % alcohol 1:00 Wash medium Wash station 1 2:00 Hematoxylin 5:00...
  • Page 49 OVEN and the number of UP/DOWN MOVEMENTS (DIPS). SOLVENT Organic liquid, such as xylene and ethanol SPECIMEN SLIDE Specimen slides made of glass 25 x 75 x 1 mm Leica Autostainer XL (ST5010)
  • Page 50 Appendix SPECIMEN SLIDE Frame on which the SPECIMEN SLIDES sit to make for easier handling with HOLDER the instrument. STAINING The process in which the tissue sections are stained. STATION Part on the inside of the instrument, where part of the STAINING occurs. Defined by the STATION, IMMERSION TIME and time accuracy for a certain STEP process in the STAINING process.
  • Page 52 Leica Biosystems Nussloch GmbH Heidelberger Str. 17 - 19 D-69226 Nussloch Germany Tel.: +49 - (0) 6224 - 143 0 Fax: +49 - (0) 6224 - 143 268 Web: www.LeicaBiosystems.com...

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St5010

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