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.