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.

7
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

9
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

11
Leica ST4020
Connector for
Power Cord
3. Instrument Components and Specifications
Fig. 3
Outlet hose
Rinsing Water
Connection
Instrument rear view
Adjustable
Foot
Power SwitchNameplate
Support
Bracket
for stabilizing
Power entry
module
with fuse
Storage for the
Reagent Container
Cover
3.2 Instrument specifications
The Leica ST4020 is an automatic linear stainer
designed for stand-alone use, and can be used
for staining frozen tissue sections in histology
labs as well as anatomical pathology laboratories.
It is ideal for use in staining samples from either
Mohs technique laboratories or sections from
frozen section laboratories or general surgical
pathology. In addition, it is intended to be used
in hematology, cytology, as well as performing
routine H & E stains.
The user loads the slides in a carrier that can
hold up to 4 slides at a time. The stainer provides
14 reagent stations that can be used as reagent
stations or running rinse water stations and has
an Exit Tank that can hold up to four processed
slide carriers.
The slides will remain in each reagent station for
a fixed programmable time that is applicable to all
stations during staining. Station time, number of dips
and start position are programmable.
2 Screws for
Mounting of Support
Bracket

12 Instructions for Use V1.2, RevE – 08/2016
3. Instrument Components and Specifications
3.3 Functional description of components - system overview
A membrane keypad with 6 keys allows the user to set up the pro-
cessing parameters and also allows the user to start and stop the
processing runs.
An LCD display consisting of two rows, each row 16 characters
long, in which the progress of slide processing and the stainer's
processing parameters are displayed. The user is directed to take
various actions as necessary.
Figure 2on page 10 shows an overview of the stainer.
The Leica ST4020 Linear Stainer has the following functional areas:
Keypad (14) with Display (13)
Slide Carrier (1) and Lift Bar (2)
Reagent container (4) and rinsing water container (6)
The user inserts the slides for staining (3) in the slots of the slide
carrier (1). This is then placed onto the Lift Bar (2), by which it is
transferred to the first reagent container.
The Lift Bar moves the slide carriers from one station to the next
station and eventually deposits them in the exit tank.
Each reagent container (4) can hold up to 50 ml of the reagent for
staining and processing.
A total of 14 reagent and rinse containers (6) can be arranged to
customize the stainer to carry out a specific staining protocol.
Each of the 14 processing positions must have either a reagent con-
tainer or a rinse container present.
The rinse containers allow the slides to be subjected to running
rinse water while the slides are being processed.
3
1
24
4 6
Fig. 4
Fig. 5
Fig. 6
14
13

13
Leica ST4020
12
3. Instrument Components and Specifications
The exit tank holds the processed slides. It can hold up to 4 slide
carriers.
As soon as the exit tank is full, the stainer pauses processing until
the slide carriers are removed.
Functional description of the components (continued)
Exit Tank (7)
Platform (8)
Waste Water Drain Hose (9)
Rinsing water supply (10)
Main Switch and (11) Connection to Power Supply (12)
The stainer is connected to the power supply (12) by the power supply
cord, and activated with the main switch (11).
The instrument can be operated with alternating current at 100 to
230 Volt with a power frequency of 50/60 Hz.
A connection port for the rinsing water supply is located on the rear
of the stainer. The necessary connecting hose with clamp is included
in the equipment supplied.
The waste water drain hose must always be inclined downwards so
that the rinsing water drains into a collecting receptacle or drainage
basin, and cannot collect in the stainer.
The platform holds the reagent containers, rinse containers and
the exit tank in fixed locations to ensure the proper operation of the
stainer. All 14 containers and the exit tank must be placed on the
platform to ensure proper operation of the stainer.
Fig. 7
7
9
Fig. 8
Fig. 9
Fig. 10
8
Fig. 11
10
11

14 Instructions for Use V1.2, RevE – 08/2016
3. Instrument Components and Specifications
3.4 Functional Areas of the Slide carrier
Fig. 12
Handle
Locating slots
for slides
Lift Bar
Retainer
Side
Support
Slides
Fig. 12 and Fig. 13 show how the slide carriers are to be positioned
over the reagent containers.
While placing a slide carrier with slides for staining in the Lift Bar,
ensure that the side supports of the slide carrier are aligned so that
the slide carrier is positioned above the container.
Side
Support
Reagent
Container
Fig. 13

15
Leica ST4020
3.5 Standard delivery – packing list
The Leica ST4020 standard delivery consists of the following items:
3. Instrument Components and Specifications
Check the delivery carefully against the packing list, delivery note and your order. Should
you find any discrepancies, please contact your Leica sales office without delay.
Qty Designation Order No.
1 Leica ST4020 basic unit 14 0509 46425
14 Reagent containers (white) 14 0509 46437
3 Wash stations (black) 14 0509 46441
3 Slide carriers 14 0509 46438
1 Water Inlet Hose Assembly
(with hose connectors, 150 cm long, Ø 1/4“)
14 0509 46532
1 Water drain hose 150 cm long (installed on the instrument) 14 0509 46445
1 Hose distributor to rinse stations Ø 1/8“ (installed in the instrument) 14 0509 46533
1 Exit Tank 14 0509 46450
1 Set of tubings, fittings, tie wraps: 14 0509 46459
1 Water hose 40 cm long, Ø 1/8“
3 in line fittings
2 plugs
10 tie wraps
1 Support Bracket for Stabilizing 14 0509 46570
1 Cover for reagent container (made of metal) 14 0509 46442
1 Set of replacement fuses, consisting of
2 Fuses 250 V, T 1.0 A 14 0509 46463
1 Instructions for Use, printed (German/English, with
Language CD 14 0509 80200)
14 0509 80001
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.

16 Instructions for Use V1.2, RevE – 08/2016
3.6 Technical data
3. Instrument Components and Specifications
Dimensions and weights
Dimensions, (W x D x H): 620 mm x 250 mm x 200 mm
Height with Hood open: 430 mm
Empty weight, without packaging: approx. 16 kg
Instrument with accessories: approx. 19 kg
Weight incl. packing material: approx. 21 kg
Performance
Slide processing rate: Depends on program structure and load
Load capacity: max. 4 slide carriers
Stations: max. 14
Reagent stations: max. 14
Wash stations: max. 3 (then only 11 reagent stations are possible)
Reagent container volume: 50 ml
Agitation: 0 to 3 dips per station for dwell times > 4 sec.
Throughput rate of wash stations: 250 ml/min +/-100 ml, depending on number of stations
Dwell time adjustment: 2 to 300 sec. at each station
Capacity of the slide carrier: max. 4 slides
Capacity of the exit tank: max. 4 slide carriers
General
Admissions: UL, cUL, CE
Nominal voltage: 100 V – 240 V +/- 10 % AC
Nominal frequency: 50 to 60 Hz
Power draw: 1 A max.
IEC 1010 classification: Protection class 1
Pollution degree 2
Overvoltage category II
Secondary fuses: Melting fuses 1.0 A T Ø 5.0 x 20 mm
Operating temperature range: 15 °C to 30 °C
Relative humidity: 20 % to 80 %, non-condensing
Altitude for use: < 2000 m (ambient pressure: > 800 hPa)

17
Leica ST4020
• The instrument requires an installation area of approx. 250 x 700 mm. A clearance of at least
25 cm must be left between the instrument and the closest wall or other instruments.
• If the stainer is to be operated with rinsing stations, fresh water and waste water connections
must be no more than 1.2 m from the ports on the back of the instrument.
• It must be ensured that there is sufficient clear space (approx. 30 cm) above the instrument
to allow unobstructed opening of the optional hood.
• Room temperature consistently between +10 °C and +30 °C.
• Relative air humidity maximum 80 %, non-condensing.
• Practically vibration-free floor. Avoid vibrations, direct sunlight and heavy variations in
temperature.
4. Instrument Setup
• Open the packaging.
• Remove foam material.
• Take out all accessories and the instructions for use.
• Check the contents of the delivered pack against the order form to ensure that all components
and accessories are included.
4.1 Installation site requirements
• The chemicals used in the Leica ST4020 are easily inflammable and hazardous to
health.
• The installation site for the Leica ST4020 must be well ventilated, and there must be
no ignition sources of any kind in the area.
• The instrument must not be operated in areas at risk of explosion.
4.2 Unpacking the instrument
First check the shipment for external damages upon arrival. If it is evident that the
shipment was damaged during transport, please make a claim to the carrier imme-
diately.

18 Instructions for Use V1.2, RevE – 08/2016
Unpacking the Instrument (continued)
4. Instrument Setup
These unpacking instructions only ap-
ply if the box is placed with the sym-
bols facing upwards for unpack-
ing.
Fig. 14
35 36
Fig. 15
37 39
Fig. 16
38
Fig. 17
3838 40
1. Cut through the packing tape (35) on the top
edge of the box.
2. Remove the yellow envelope with "Documents
of Conformity" (36) and keep it in a safe place.
3. Remove the accessory carton (37) and remove
the packing material (39).
4. Use the molded foam pads (38) to pull the
instrument out of the inside packaging and
place it on a firm laboratory bench.
5. Pull the molded foam pads (38) away from the
sides of the instrument. Remove the protective
film (40) from the instrument.
6. The instrument must now be prepared for cor-
rect use in accordance with the instructions
in the accompanying Instructions for Use - the
first step is to align the instrument feet.
The packaging must be retained for
the duration of the warranty period.
To return the instrument, follow the in-
structions above in reverse order.
Fig. 18

19
Leica ST4020
25
26
Horizontal Alignment
For safe and accurate work, it is important that
all instrument feet are in uniform contact with the
installation surface.
The stainer is horizontally aligned at the factory.
If a completely level or horizontal surface is not
available at the installation site, the instrument
must be realigned.
For this purpose, the instrument feet (25) are
height-adjustable.
• For alignment, loosen the locknuts (26) using
a size 11 open-end wrench.
• Adjust the instrument feet (25) until the instru-
ment is in a stable position at the installation
location according to requirements.
• Retighten the locknuts.
4.3 Setup
Mounting the Support Bracket
To ensure that the instrument cannot tip over
when its keys are pressed, the support bracket
(27) must be mounted on the rear.
• To do this, first unscrew the two Phillips head
screws (28) with a screwdriver. Place them
together with the two associated washers (29)
• Place the support bracket against the rear of
the instrument (Fig. 20), reinsert but do not fully
tighten the two screws.
• Press the support bracket down onto the sup-
port surface until a face of the plate lies flush
with the bench surface. Tighten the plate in
this position.
Fig. 19
Fig. 20
4. Instrument Setup
28
27
29

20 Instructions for Use V1.2, RevE – 08/2016
4.4 Water Connection
4. Instrument Setup
• Run the drain hose (9) into a suitable collecting
tank or waste basin. Make sure that the hose
is not kinked and that the water is able to drain
freely downwards.
• Then connect the rinsing water supply (35) to
the stainer.
• To do this, push the connector (36) into the
orifice (10) on the instrument until it clicks into
place. To detach the hose, press on the plate
(37) and pull the connector back.
• Secure the hose to the unit using the clamp
(37) at the location shown in Fig. 21.
• Connect the other end of the hose to a suitable
water tap. If necessary an optional connection
kit can be used for this.
• Do not open the water inlet yet!
• Adjustment of the rinsing water flow rate is
described in Chap. 5.4.
4.5 Installing the rinsing water containers
Up to three rinsing stations may be provided on the stainer. The rinsing water containers can
be located at any of the 14 reagent stations.
The equipment supplied includes three hoses with Y-connectors. The cable ties on these Y-con-
nectors must not be removed. Also, do not detach the Y-connectors from the associated hoses.
Watertight, functional rinsing stations in accordance with the desired staining protocol can be
set up with the aid of additional cable ties, hoses, plugs and connectors that are also included
in the scope of delivery.
Fig. 21
While the rinsing stations are being set up, it must be ensured that the rinsing water
containers are positioned horizontally on the platform, and all hoses are lying hori-
zontally on the bottom of the drainage tank, outside of the travel path of the Lift Bar.
The rinsing water hoses must not be subjected to any kind of pulling or stretching
stresses.
9
35
36
37
10
41