Leica ST4020 User manual

Instructions for Use
Leica ST4020
Small Linear Stainer
Leica ST4020, English
Order No.: 14 0509 80101 RevE
Always keep this manual with the instrument.
Read carefully before working with the instrument.
V 1.2 RevE - 08/2016

3
Leica ST4020
The information, numerical data, notes and val-
ue judgments contained in this documentation
represent the current state of scientific knowl-
edge and state-of-the-art technology as we un-
derstand it following thorough investigation in
this field.
We are under no obligation to update the pres-
ent manual periodically and on an ongoing basis
according to the latest technical developments,
nor to provide our customers with additional
copies, updates etc. of this manual.
For erroneous statements, drawings, technical
illustrations etc. contained in this manual we
exclude liability as far as permissible accord-
ing to the national legal system applicable in
each individual case. In particular, no liability
whatsoever is accepted for any financial loss
or consequential damage caused by or related
to compliance with statements or other infor-
mation in this manual.
Statements, drawings, illustrations and other
information as regards contents or techni-
cal details of the present manual are not to be
considered as warranted characteristics of our
products.
These are determined only by the contract pro-
visions agreed between ourselves and our cus-
tomers.
Leica reserves the right to change technical
specifications as well as manufacturing pro-
cesses without prior notice. Only in this way is
it possible continuously to improve the technol-
ogy and manufacturing techniques used in our
products.
This documentation is protected under copy-
right laws. All copyrights of this document are
retained by Leica Biosystems Nussloch GmbH.
Any reproduction of text and illustrations (or
of any parts thereof) by means of print, photo-
copy, microfiche, web cam or other methods —
including any electronic systems and media —
requires express prior permission in writing by
Leica Biosystems Nussloch GmbH.
For the instrument serial number and year of
manufacture, please refer to the nameplate at
the back of the instrument.
© Leica Biosystems Nussloch GmbH
NOTE
Leica Biosystems Nussloch GmbH
Heidelberger Str. 17 - 19
D-69226 Nussloch
Germany
Phone: [phone]
Fax: [phone]
Internet: http://www.LeicaBiosystems.com

4Instructions for Use V1.2, RevE – 08/2016
Table of Contents
1. Important Information ............................................................................................................... 6
1.1 Symbols in the text and their meanings.................................................................................... 6
2. Safety ........................................................................................................................................... 7
2.1 Safety notes................................................................................................................................... 7
2.2 Warnings........................................................................................................................................ 7
3. Instrument Components and Specifications....................................................................... 10
3.1 Overview - instrument components ........................................................................................ 10
3.2 Instrument specifications.......................................................................................................... 11
3.3 Functional description of components - system overview.................................................. 12
3.4 Functional Areas of the Slide carrier ...................................................................................... 14
3.5 Standard delivery – packing list............................................................................................... 15
3.6 Technical data............................................................................................................................. 16
4. Instrument Setup...................................................................................................................... 17
4.1 Installation site requirements................................................................................................... 17
4.2 Unpacking the instrument......................................................................................................... 17
4.3 Setup............................................................................................................................................. 19
4.4 Water Connection....................................................................................................................... 20
4.5 Installing the rinsing water containers................................................................................... 20
4.6 Remedy if hose is too short....................................................................................................... 24
5. Operation................................................................................................................................... 25
5.1 Switching on the instrument..................................................................................................... 25
5.2 Control panel functions.............................................................................................................. 25
5.3 Setting the Operating Parameters........................................................................................... 27
5.4 Setting the rinsing water flow rate.......................................................................................... 30
5.5 Processing slides........................................................................................................................ 31
5.5.1 Starting a staining run................................................................................................................ 32
5.5.2 Adding more slide carriers during a staining run.................................................................. 33
5.5.3 Temporarily pausing a staining run......................................................................................... 34
5.5.4 Ending a staining run prematurely........................................................................................... 35
5.5.5 Removing processed specimen slides.................................................................................... 36
6. Cleaning and Maintenance.................................................................................................... 38
6.1 Cleaning the Instrument ............................................................................................................ 38
6.2 Maintenance Instructions......................................................................................................... 39

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Leica ST4020
Table of Contents
7. Troubleshooting ....................................................................................................................... 40
7.1 General......................................................................................................................................... 40
7.2 Alarms........................................................................................................................................... 40
7.3 Fault detection and correction list........................................................................................... 41
7.4 Power failure............................................................................................................................... 43
8. Optional Accessories.............................................................................................................. 44
8.1 Ordering information.................................................................................................................. 44
9. Warranty and Service............................................................................................................. 50
10. Decontamination Declaration (master)............................................................................... 51

6Instructions for Use V1.2, RevE – 08/2016
1. Important Information
Fig. 1
1.1 Symbols in the text and their meanings
Warnings
appear in a gray box and are marked
by a warning triangle .
Numbers in parentheses refer to item
numbers in illustrations.
(5)
Function keys to be pressed on the in-
strument are written in bold-print capi-
tal letters.
RUN
Samples processed on this instrument
may be biohazardous. Appropriate
safety procedures must be followed to
prevent a biohazard.
This warning symbol on the de-
vice notifies users of the danger of
electric shock. To avoid the risk of
injury from electric shock, a panel
bearing this marking, or this housing,
must not be opened.
Inflammable solvents and reagents
are identified using this symbol.
Notes,
i.e. important user information ap-
pears in a gray box and is marked by
an information symbol .
Intended use
The Leica Small Linear Stainer ST4020 is used
for the automated preparation of routine histo-
logical and cytological stains. It is intended for
use in pathology laboratories to assist with the
following tasks:
• Stainingthin tissue sectionsorcytological
specimens on slides. Frozen sections can also
be stained.
• Theinstrumentmaybeoperatedonlyaccording
to the instructions contained in this manual.
Any other use of the instrument is considered
improper!
Qualification of personnel
• TheLeicaST4020maybeoperatedbytrained
laboratory personnel only.
• Alllaboratory personneldesignatedtoop-
erate the Leica instrument must read this
Instructions for Use carefully and must be
familiar with all technical features of the
instrument before attempting to operate it.
Type
All information contained in this Instructions for
Use applies solely to the instrument type listed
on the cover page. A nameplate indicating the
instrument serial number is attached to the rear
side of the instrument.
The CE marking is the manufacturer’s
declaration that the medical product
meets the requirements of the appli-
cable EC directives.

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Leica ST4020
2. Safety
These Instructions for Use include important
instructions and information related to the oper-
ating 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.
2.2 Warnings
This instrument has been built and tested in
accordance with the safety requirements for
electrical equipment for measurement, control
and laboratory use.
To maintain this condition and ensure safe opera-
tion, the user must observe all notes and warnings
contained in this Instructions for Use.
The safety devices installed in this instrument by the manufacturer only constitute the basis for
accident prevention. Operating the instrument safely is, above all, the responsibility of the owner,
as well as the designated personnel who operate, service or repair the instrument.
To ensure trouble-free operation of the instrument, make sure to comply with the following
instructions and warnings.
For current information about appli-
cable standards, please refer to the
CE declaration for the instrument and
to our Internet site:
www.LeicaBiosystems.com
The protective devices located on the instrument and the accessories must not be removed
or modified. Only service personnel qualified by Leica may repair the instrument and
access the instrument's internal components.
Material safety data sheets for reagents can be requested from the respective manufac-
turer of the chemical.
Alternatively, they can be downloaded from the following website:
http://www.msdsonline.com
These Instructions for Use must be
appropriately supplemented as re-
quired by the existing regulations on
accident prevention and environmen-
tal safety in the operator‘s country.
The safety and caution notes in this chapter must be observed at all times.
Be sure to read these instructions, even if you are already familiar with the operation and
use of other Leica products.
2.1 Safety notes

8Instructions for Use V1.2, RevE – 08/2016
2. Safety
Warnings – Handling reagents
Hazards – transport and installation
Take care when handling solvents!
Always wear rubber gloves and safety goggles when handling the chemicals used in this
instrument.
The reagents used can be both toxic and/or flammable.
When disposing of spent reagents, observe the applicable local regulations and the waste
disposal regulations of the company/institution in which the instrument is being operated.
Do not smoke near the stainer or the reagents.
The stainer should be operated under an extractor hood.
Once unpacked, the instrument may be transported only in an upright position.
Place the instrument on a laboratory bench and align it horizontally.
The instrument must not be placed in direct sunlight (e.g. next to a window). Avoid
impacts, bright direct light, and excessive temperature fluctuations.
Only connect the instrument to a grounded power socket. Do not interfere with the ground-
ing function by using an extension cord without a ground wire.
The instrument will automatically detect the voltage/frequency of the power source.
The installation location must be well ventilated, and must contain no sources of ignition
of any kind. The chemicals used in the Leica ST4020 are easily inflammable and hazardous
to health.
Do not operate the instrument in rooms with explosion hazard.
Condensation water may form in the instrument, if there is an extreme difference in tem-
perature between the warehouse and the installation site and if air humidity is high at the
same time. In this case, a two-hour waiting period must be maintained before switching
on the instrument.
Warning labels on the instrument marked with a warning triangle indicate that the correct
operating instructions (as defined in this Instructions for Use) must be followed when op-
erating or replacing the item marked. Failure to adhere to these instructions may result in
an accident, personal injury, damage to the instrument or accessory equipment.
Hazards – safety regulations on the instrument itself

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Leica ST4020
Warnings – Operating the instrument
2. Safety
Warnings – Maintenance and cleaning
Before any maintenance, switch off the instrument and unplug it from power supply.
When using cleaners, please comply with the safety instructions of the manufacturer and
the laboratory safety regulations.
Do not use any of the following for cleaning the outside surfaces of the instrument: alcohol,
detergents containing alcohol (glass cleaners), abrasive cleaning powders, solvents con-
taining acetone, chlorine or xylene!
Clean the Hood and the housing with commercial mild household cleaning agents. The fin-
ished surfaces are not resistant to solvents!
Prevent liquids from entering the interior of the instrument while the instrument is being
cleaned or during operation.
Do not use any attachments or accessories not recommended by the product manufacturer
as such attachments and accessories may cause hazards, damage the instrument and void
the warranty.
The instrument may be operated by trained laboratory personnel only. It must only be oper-
ated for the purpose of its designated use and according to the instructions contained in
these Instructions for Use.
In the event of an emergency, switch off the power switch and unplug the instrument from
the power supply.
The instrument must be positioned so that the connection socket and the power switch are
easily accessible at all times.
The power supply cord must be routed so that it is not likely to be walked on or pinched by
items placed on or against it.
Suitable protective clothing (lab coat, gloves, protective goggles) must be worn when
working with reagents and specimen slides.
There is a danger of fire if an open flame (e.g. Bunsen burner) is used directly beside the
instrument (solvent fumes). Therefore, keep all ignition sources at least 2 meters away
from the instrument!
While the stainer is not in use, keep the reagent containers covered with the reagent cover
provided with the stainer.

10 Instructions for Use V1.2, RevE – 08/2016
3.1 Overview - instrument components
3. Instrument Components and Specifications
Fig. 2
Adjustable
Foot
Reagent
Container
Specimen side
carrier
Lift Bar Hood
(optional)
Rinsing Water
Container
Display
and
Keypad
Exit Tank Platform