Leica AutoStainerXL User manual

Instructions for Use
Leica AutoStainerXL
Automated slide stainer
Leica AutoStainerXL, V2.5, English – 01/2017
Order No.: 14 0456 80101 RevH
Always keep this manual with the instrument.
Read carefully before working with the instrument.

3
Leica AutoStainer XL – Automated slide stainer
Leica Biosystems Nussloch GmbH
Heidelberger Str. 17 - 19
D-69226 Nussloch
Germany
Phone: [phone]
Fax: [phone]
Internet: http://www.LeicaBiosystems.com
These are determined only by the contract
provisions agreed between ourselves and our
customers.
Leica reserves the right to change technical spec-
ifications as well as manufacturing processes
without prior notice. Only in this way is it pos-
sible 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.
Any reproduction of text and illustrations (or of
any parts thereof) by means of print, photocopy,
microfiche, web cam or other methods – includ-
ing any electronic systems and media – requires
express prior permission in writing by Leica Bio-
systems Nussloch GmbH.
For the instrument serial number and year of
manufacture, please refer to the nameplate on
the back of the instrument.
© Leica Biosystems Nussloch GmbH
The information, numerical data, notes and value
judgments contained in this manual represent
the current state of scientific knowledge and
state-of-the-art technology as we understand it
following thorough investigation in this field. We
are under no obligation to update the present
manual periodically and on an ongoing basis ac-
cording to the latest technical developments, nor
to provide our customers with additional copies,
updates etc. of this manual.
To the extent permitted in accordance with the
national legal system as applicable in each indi-
vidual case, we shall not be held liable for errone-
ous statements, drawings, technical illustrations
etc. contained in this manual. In particular, no
liability whatsoever is accepted for any financial
loss or consequential damage caused by or
related to compliance with statements or other
information in this manual.
Statements, drawings, illustrations and other infor-
mation regarding the contents or technical details
of the present Instructions for Use are not to be con-
sidered warranted characteristics of our products.
Note

4Instructions for Use V2.5 – 01/2017
Table of Contents
1. Important Information ............................................................................................................... 6
1.1 Symbols in the text and their meanings.................................................................................... 6
1.2 Intended use/improper use......................................................................................................... 8
1.3 User group ..................................................................................................................................... 8
2. Safety........................................................................................................................................... 9
2.1 General safety notes.................................................................................................................... 9
2.2 Specific safety notes.................................................................................................................... 9
3. Instrument Features................................................................................................................. 10
3.1 Overview and instrument components................................................................................... 12
3.2 Standard delivery – packing list............................................................................................... 14
3.3 Technical data............................................................................................................................. 15
4. Installing the Instrument ........................................................................................................ 16
4.1 Installation site requirements................................................................................................... 16
4.2 Connections on the instrument ................................................................................................ 16
4.2.1 Power supply............................................................................................................................... 16
4.2.2 Water supply ............................................................................................................................... 17
4.3 Battery backup – UPS (optional).............................................................................................. 18
4.4 Remote alarm (optional) ............................................................................................................ 19
4.5 Vacuum extraction system for reagent vapors ..................................................................... 19
4.6 Oven.............................................................................................................................................. 19
5. Operating the Instrument........................................................................................................ 20
5.1 The control panel........................................................................................................................ 21
5.2 Main menu................................................................................................................................... 22
5.3 Menu overview ........................................................................................................................... 23
5.4 Editing programs......................................................................................................................... 24
5.4.1 Entering program steps ............................................................................................................. 25
5.4.2 Deleting program steps ............................................................................................................. 26
5.4.3 Inserting a blank step into a program ..................................................................................... 26
5.4.4 Removing blank steps from a program ................................................................................... 27
5.4.5 Saving a program........................................................................................................................ 27
5.4.6 Deleting a program..................................................................................................................... 27
5.4.7 Copying a program ..................................................................................................................... 28
5.4.8 Viewing a program ..................................................................................................................... 29
5.4.9 Checking the compatibility of programs................................................................................. 29
5.5 User-adjustable parameters..................................................................................................... 31
5.6 Oven.............................................................................................................................................. 31

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Leica AutoStainer XL – Automated slide stainer
Table of Contents
5.7 Up/down movement (dips) ........................................................................................................ 32
5.8 Number of up/down movement (dips)..................................................................................... 33
5.9 Staining......................................................................................................................................... 33
5.9.1 Reagent containers.................................................................................................................... 34
5.9.2 Wash system............................................................................................................................... 34
5.9.3 Water-saving function............................................................................................................... 35
5.9.4 Loading specimen slide holders............................................................................................... 35
5.9.5 Unloading specimen slide holders from the exit drawer..................................................... 36
5.9.6 Unloading specimen slide holders from other stations ....................................................... 36
5.9.7 Interrupting staining................................................................................................................... 37
5.9.8 Aborting the processing of a specimen slide holder............................................................ 38
6. Care and Cleaning ................................................................................................................... 39
6.1 Cleaning the instrument............................................................................................................. 39
6.1.1 Wash containers......................................................................................................................... 39
6.1.2 Reagent containers.................................................................................................................... 39
6.1.3 Specimen slide holders ............................................................................................................. 39
6.1.4 Oven.............................................................................................................................................. 39
7. Error messages and troubleshooting................................................................................... 40
7.1 Warning messages for instrument errors .............................................................................. 41
7.2 More information and warnings............................................................................................... 42
7.2.1 During staining............................................................................................................................ 42
7.2.2 During editing of programs ....................................................................................................... 43
7.2.3 During SetUp ............................................................................................................................... 44
8. Warranty and Service............................................................................................................. 45
APPENDIX 1......................................................................................................................................... 46
Adjustable parameters.......................................................................................................................... 46
APPENDIX 2......................................................................................................................................... 47
Consumables and accessories............................................................................................................ 47
APPENDIX 3......................................................................................................................................... 50
Compatible staining programs............................................................................................................. 51
Glossary................................................................................................................................................ 52

6Instructions for Use V2.5 – 01/2017
General information
These Instructions for Use include important instructions and information
related to the operating safety and maintenance of the instrument.
The Instructions for Use are an important part of the product, and must be
read carefully prior to startup and use and must always be kept near the
instrument.
If additional requirements for accident prevention and environmental protection
apply in the country of operation, these Instructions for Use must be supplement-
ed by appropriate instructions to ensure compliance with such requirements.
Make sure to read all of these Instructions for Use before you work on or
operate the instrument.
1.1 Symbols in the text and their meanings
Warnings appear in a gray box and are marked by a warning
triangle .
Useful tips, i.e. important information for the user, appear in
gray boxes and are marked by an .
(5)
(Fig. 5) Numbers in parentheses refer to item numbers in illustrations
or to the illustrations themselves.
Instrument type:
All information in these Instructions for Use applies only to the Leica Auto-
Stainer XL described here.
A nameplate indicating the instrument serial number is attached to the rear
side of the instrument.
Fig. 1 is provided as an example only and shows a valid name-
plate for this instrument with the necessary information about
instrument type and power requirement. The precise data for the
various versions is specified in Chapter 3.3 "Technical data".
Be sure to comply with the safety instructions and warnings
in Chapter 2. Be sure to read these notes even if you are already
familiar with the operation and use of other Leica products.
1. Important Information

7
Leica AutoStainer XL – Automated slide stainer
1. Important Information
Symbol Title of the symbol Description
In vitro diagnostic
medical device
Indicates a medical device that is intended to be used as an in
vitro diagnostic medical device.
Consult Instructions
for Use
Indicates the need for the user to consult the Instructions for
Use.
China ROHS Environmental protection symbol of the China RoHS directive.
The number in the symbol indicates the "Environment-friendly
Use Period" of the product in years. The symbol is used if a
substance restricted in China is used in excess of the maximum
permitted limit.
WEEE Symbol The WEEE symbol, indicating separate collection for WEEE -
Waste of electrical and electronic equipment, consists of the
crossed-out wheeled bin (§ 7 ElektroG).
Caution Indicates the need for the user to consult the Instructions for
Use for important cautionary information such as warnings and
precautions that cannot, for a variety of reasons, be presented
on the medical device itself.
CE Compliance The CE marking is the manufacturer's declaration that the
medical product meets the requirements of the applicable EC
directives.
Fig. 1

8Instructions for Use V2.5 – 01/2017
1. Important Information
Symbol Title of the symbol Description
Serial number Indicates the manufacturer's serial number so that a specific
medical device can be identified.
Article number Indicates the manufacturer's catalog number so that the medi-
cal device can be identified.
Date of manufacture Indicates the date when the medical device was manufactured.
Manufacturer Indicates the manufacturer of the medical product.
When making inquiries, it is important to specify the instrument type and
serial number correctly.
1.2 Intended use/improper use
- The AutoStainer XL has been designed for staining in medical, biological
and industrial applications.
- The instrument must be used exclusively according to the instructions
contained in these Instructions for Use.
- Any other use of the instrument is considered improper.
1.3 User group
- The AutoStainer XL should be operated by trained laboratory personnel
only.
- All laboratory personnel designated to operate the AutoStainer XL must
read these Instructions for Use carefully and must be familiar with all
technical features of the instrument before attempting to operate the
AutoStainer XL.
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.

9
Leica AutoStainer XL – Automated slide stainer
2. Safety
2.1 General safety notes
This instrument has been built and tested in accordance with the safety
requirements for electrical equipment for measurement, control, and labo-
ratory use.
To maintain this condition and ensure safe operation, the user must observe
all notes and warnings contained in these Instructions for Use.
For current information about applicable standards, please refer to the CE
Declaration of Conformity on our Internet site:
www.LeicaBiosystems.com
2.2 Specific safety notes
In accordance with national rules and regulations, the opera-
tor may be obligated to provide long-term protection of the
public water supply from contamination due to backflowing
water from the building installation. In Europe, the protec-
tion 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).

10 Instructions for Use V2.5 – 01/2017
3. Instrument Features
General description
The AutoStainer XL was developed with the goal of satisfying the quality
requirements of modern laboratories:
• highspecimenthroughput,
• flexibility,
• safety.
The AutoStainer XL achieves its high throughput by means of a specimen
slide transport system, which allows for simultaneous processing of up to
11 specimen slide holders, each with 30 slides.
The flexibility of AutoStainer XL permits simultaneous processing of speci-
men slide holders according to various staining protocols.
An oven is integrated into the instrument for quickly drying specimen slides.
Optimized wash stations provide for rapid removal of reagent residue. The
design of the specimen slide holders ensures minimal reagent displacement
and prevents the reagents from being contaminated by liquid dripping into
them and needing to be replaced prematurely.
The AutoStainer XL is safe to use and has an integrated system for extract-
ing reagent vapors. The specimen slide holders are loaded and unloaded
using two drawers.

11
Leica AutoStainer XL – Automated slide stainer
This page is intentionally left blank.
3. Instrument Features

12 Instructions for Use V2.5 – 01/2017
3. Instrument Features
Fig. 2
20
19
17
15
14
13
12
11
10
9
8
7
1
4
3
2
6
5
16
3.1 Overview and instrument components
18a
18b

13
Leica AutoStainer XL – Automated slide stainer
3. Instrument Features
Front side of instrument
1. Transport arm
2. Wash stations
3. Oven
4. Notepad for staining protocols
5. Recess for notepad
6. ON/STOP switch
7. Display screen
8. Keypad
9. LED indicators
10. Specimen slide holder
11. Container cover
12. Reagent container
13. Load drawer
14. LED indicator and key for load drawer
15. Exit drawer
16. Cover with cut-outs (for container transportation)
17. LED indicator and key for exit drawer
18a. Schematic diagram of the stations
18b. Cover plate
19. Lock for hood
20. Hood
Fig. 3
Rear side of instrument
21. Water inlet
22. Drain outlet
23. Serial port (service computer)
24. Power supply (electronics)
25. Voltage selector and fuses for heater
26. Power switch (ON/OFF)
27. Power input
28. Feet, adjustable
29. Power supply input
30. Nameplate
31. Remote alarm socket, max. 50 V, 1 A
32. Accessory port
33. Exhaust air duct
34. Power output
21
33 22
32
313027 26 25 28
29
34 23
24

14 Instructions for Use V2.5 – 01/2017
3. Instrument Features
3.2 Standard delivery – packing list
Standard delivery:
1 Leica ST5010 basic unit (230-240 V / 50-60 Hz).................................................................... 14 0456 35136
- or -
1 Leica ST5010 basic unit (100-120 V / 50-60 Hz).................................................................... 14 0456 35340
1 accessories kit (0456 35660) consisting of:
- 22 reagent vessels with lids................................................................................................. 14 0475 33659
- 5 wash vessels....................................................................................................................... 14 0456 35268
- 5 specimen slide holders, metal.......................................................................................... 14 0456 33919
- 2 covers with slots for reagent vessels ............................................................................. 14 0475 34486
- 1 jumper cable, power supply ............................................................................................. 14 0411 34604
- 1 remote alarm connector.................................................................................................... 14 6844 01005
- 1 tubing band clamp.............................................................................................................. 14 0422 31972
- 1 angular connecting nozzle for hose ................................................................................ 14 0475 33669
- 1 V filter 3/4 ............................................................................................................................. 14 0456 36101
1 active carbon filter................................................................................................................... 14 0474 32273
1 filter cover ................................................................................................................................. 14 0456 35240
1 collecting tray for paraffin (heater) (inside the instrument) ............................................. 14 0456 35216
1 staining protocol notepad (attached to instrument) .......................................................... 14 0456 35459
1 water supply hose with seal .................................................................................................. 14 0474 32325
1 drain hose.................................................................................................................................. 14 0475 35748
1 Instructions for Use Leica AutoStainer XL German/English (+ CD) ................................ 14 0456 80001
- 1 reference manual as appendix, only in English (staining protocols, etc.)
The country specific power cord needs to be ordered separately. Please find a list of all power cords
available for your device on our website www.LeicaBiosystems.com within the product section.
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.

15
Leica AutoStainer XL – Automated slide stainer
3. Instrument Features
3.3 Technical data
Specimen slide throughput:.................at least 200 specimen slides per hour
(depending on the program, up to 600 specimen slides per hour)
Load capacity:............................................................11 specimen slide holders
Holding capacity:................................................................... 30 specimen slides
Stations: ................................................................................................................ 26
Reagent stations:................................................................................... at least 18
Volume of reagent containers:................................................................... 450 ml
Number of wash stations:...........................................................................max. 5
Oven:........................................................................................................................ 1
Oven temperature:.......................................................ambient or 30 °C to 65 °C
Incubation time setting:..........................from 0 sec. up to 99 min. and 59 sec.
Loading/unloading stations:....................................................................... 1 each
Permanent memory capacity: 15 programs, up to 25 program steps each
Operating temperature range:....................................................... 15 °C to 35 °C
Relative humidity: ....................................................max. 80 %, non-condensing
Dimensions and weights:
Dimensions (W x D x H):................................................109 cm x 67 cm x 51 cm
Weight:............................................................................................................. 81 kg
Voltages: .................................................................... 100 V - 120 V, 50 Hz - 60 Hz
230 V - 240 V, 50 Hz - 60 Hz

16 Instructions for Use V2.5 – 01/2017
This chapter provides instructions on how to install the AutoStainer XL. It also
includes a diagram and detailed description of the instrument's components.
The procedure for replacing the active carbon filter for protection against
reagent vapors is outlined as well.
4.1 Installation site requirements
The AutoStainer XL must be installed on a stable bench (dimensions: 1090 mm
long, 670 mm deep) with a water tap and drain no more than 3 meters away.
The power requirements for the AutoStainer XL are:
8 amps at 110 volts
4 amps at 240 volts
The voltage selector and other internal components are preset by the
manufacturer to meet the power requirements of the respective country of
destination.
The AutoStainer XL must be connected to a laboratory water tap with a
pressure reducer.
4.2 Connections on the instrument
4.2.1 Power supply
• Connectthepowercabletothepowerinput(Fig. 3, 27).
• Connectthepowersupply jumper cable tothepowersupply output
(Fig. 3, 34) and power supply input (Fig. 3, 29).
The user must not alter the voltage selector setting.
4. Installing the Instrument

17
Leica AutoStainer XL – Automated slide stainer
4. Installing the Instrument
How to switch on:
1. Plug the power plug into the power socket.
2. Set the ON/STOP switch on the right side of the instrument to STOP.
3. Set the ON/OFF switch on the rear side of the instrument to ON.
4. Set the ON/STOP switch on the side to ON.
Then the instrument will emit 3 short beeps and the Main Menu will be
displayed.
When the instrument is not in use, set the ON/STOP switch on the side to
STOP.
The ON/OFF switch on the rear side of the instrument should be left ON.
4.2.2 Water supply
Connect the water hose to the water connection on the rear side of the in-
strument. Attach the other end of the hose to the cold-water tap. The hose
has a 3/4" connector. Then slowly turn the tap on all the way.
Connect the drain hose to the discharge nozzle on the rear side of the
instrument.
The instrument must never be operated without the power
supply jumper cable.
The instrument must be connected to a grounded power
socket.
The water filter must be in place when the water hose is con-
nected, otherwise water can leak out.

18 Instructions for Use V2.5 – 01/2017
4.3 Battery backup – UPS (optional)
An interruption of the staining process can be avoided in the event of a tem-
porary power failure by connecting an uninterruptible power supply (UPS).
A compact UPS can be connected easily as shown in Fig. 4 via the power
supply jumper cable.
The UPS should be designed for an output of 200 VA for a duration of 5 min-
utes. However, the UPS will not maintain operation of the oven.
The UPS must be designed for power supply voltage at the installation loca-
tion. Your distributor will gladly recommend a UPS that is suitable for you.
4. Installing the Instrument
Fig. 4

19
Leica AutoStainer XL – Automated slide stainer
4.4 Remote alarm (optional)
The optional remote alarm is an interlock relay that is voltage-isolated
from the rest of the instrument. When there is an alarm condition (a major
operational malfunction or a power failure during a staining run with a UPS
connected), the alarm circuit closes and the alarm sounds.
Ensure that the instrument is still turned ON and press any key to turn off
sound of the alarm. If the power failed during a staining run, you may first
need to turn the ON/STOP switch on the side to STOP and then back to ON.
The remote alarm will only operate during a power failure if a UPS is connect-
ed. For details on how to connect a remote alarm, contact your distributor.
The remote alarm must be designed for less than 1 A and a maximum of 50 V.
Connect the remote alarm to the connection socket on the rear side of the
instrument using a phono jack (6.25 mm).
4.5 Vacuum extraction system for reagent vapors
Fumes are extracted through the active carbon filter, which must be changed
every three months (with average usage).
To change the filter, remove the cover plate over the filter (see Fig. 2, 18b).
Use the straps provided to remove a filter. Put in a new filter and reattach
the cover.
4.6 Oven
Put the wax tray on the oven floor.
If you need a remote alarm that sounds even if there is a power
failure, you have to use a battery-operated remote alarm.
4. Installing the Instrument

20 Instructions for Use V2.5 – 01/2017
5. Operating the Instrument
Introduction
This chapter describes how to operate AutoStainer XL. It includes informa-
tion on how to use the function keys and displays in the control panel. It
also describes how to create and edit programs as well as how to stain
specimen slides.
AutoStainer XL offers many features not found in other stainers. In particu-
lar, the specimen slide holders are loaded and unloaded not by opening
the cover, but by means of drawers. Once the instrument is able to accept
a new specimen slide holder, the LED by the load drawer lights up. After a
specimen slide holder has been loaded, the LOAD key must be pressed for
the instrument to begin the staining run. Similarly, if the staining run for a
specimen slide holder has finished, the LED by the exit drawer lights up. After
the specimen slide holder has been removed, the EXIT key must be pressed
so that the instrument knows this has been done. Programs can be ended at
any station. However, if the exit drawer is not the program's last step, then
the LCD will display which station to unload the holder from. In this case,
the instrument's cover will have to be opened to remove the holder.
The AutoStainer XL 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.
Each specimen slide holder can be processed according to any of the
15 programs, provided that the corresponding reagents are available and the
program chosen is compatible (no conflicting sequence) with the programs
already being used.