Leica ST4020 User Manual
Instructions for Use
Leica ST4020
V1.1, English – 10/2012
Order No. 14 0509 80101 RevB
Always keep this manual with the instrument.
Read carefully before working with the instrument.
Leica ST4020
Small Linear Stainer
NOTE
The information, numerical data, notes and value judgments contained in this documentation
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 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 according
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 information in this manual.
Statements, drawings, illustrations and other information as regards contents or technical details of the present manual are not to be considered as warranted characteristics of our
products.
These are determined only by the contract provisions agreed between ourselves and our customers.
Leica reserves the right to change technical
specifications as well as manufacturing processes without prior notice. Only in this way is it
possible continuously to improve the technology and manufacturing techniques used in our
products.
This documentation is protected under copyright 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, photocopy,
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
Published by:
Leica Biosystems Nussloch GmbH
Heidelberger Str. 17 - 19
D-69226 Nussloch
Germany
Phone: +49 (0) 6224 143-0
Fax: +49 (0) 6224 143-268
Internet: http://www.LeicaBiosystems.de
Leica ST4020
3
Table of Contents
1. Important Information ................................................................................................................ 6
2. Safety ............................................................................................................................................ 7
2.1 Safety notes ........................................................................................................................................ 7
2.2 Warnings ............................................................................................................................................. 7
3. Instrument Components and Specifications....................................................................... 10
3.1 Overview – Instrument Parts .......................................................................................................... 10
3.2 Instrument specifications ............................................................................................................... 11
3.3 Functional Description of Components - System overview....................................................... 12
3.3 Functional Areas of the Slide Carrier ............................................................................................ 14
3.4 Standard delivery ............................................................................................................................. 15
3.5 Technical Data .................................................................................................................................. 16
4. Setting Up the Instrument ....................................................................................................... 17
4.1 Location Conditions ......................................................................................................................... 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 Slides ........................................................................................................... 36
4
Instructions for Use V1.1, RevB – 10/2012
Table of Contents
6. Cleaning and Maintenance .................................................................................................... 38
6.1 Cleaning the Instrument .................................................................................................................. 38
6.2 Maintenance Instructions............................................................................................................... 39
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 .............................................................................................................. 51
Leica ST4020
5
1. Important Information
Symbols in the text and their meanings
Warnings
appear in a gray box and are
marked by a warning triangle
Notes,
i.e. important user information,
appear in a gray box and are
marked by an information symbol
.
Inflammable solvents and reagents
are identified using this symbol.
This warning symbol on the device
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.
Samples processed on this instrument may be biohazard. Appropriate
safety procedures must be followed
to prevent a biohazard.
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 operate 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.
6
(5)
RUN
Numbers in brackets refer to item
numbers in figures.
Function keys to be pressed on the
instrument are written in bold-print
capital letters.
Fig. 1
Instructions for Use V1.1, RevB – 10/2012
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
This Instructions for Use contains important instructions and information regarding the operational safety and maintenance of the instrument.
The Instructions for Use is 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. Safety
This instrument has been built and tested in accordance with the safety regulations for electrical measuring, control, regulating, and laboratory devices.
To maintain this condition and ensure safe operation, the user must observe all notes and
warnings contained in this Instructions for Use.
The Instructions for Use must be expanded by corresponding instructions if this becomes necessary due
to existing national regulations on
accident prevention and environmental protection in the country
where the instrument is operated.
The protective devices located on the instrument and the accessories must not be removed or modified. The instrument must only be opened and repaired by service technicians authorized by Leica.
2.2 Warnings
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 applicable standards, please refer to the
CE declaration for the instrument and
to our Internet site:
http://www.LeicaBiosystems.com
Leica ST4020
7
2. Safety
Hazards – safety regulations on the instrument itself
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
operating 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 – transport and installation
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. The protective effect may not
be eliminated by an extension cable without a protective grounding conductor.
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 temperature 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.
Warnings – Handling reagents
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.
8
Instructions for Use V1.1, RevB – 10/2012
Hazards – working with the instrument
The instrument may be operated by trained laboratory personnel only. It must only be
operated for the purpose of its designated use and according to the instructions contained in this manual.
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.
There is a danger of fire if a 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.
2. Safety
Hazards – cleaning and maintenance
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
containing acetone, chlorine or xylene!
Clean the Hood and the housing with commercial mild household cleaning agents. The
finished 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.
Leica ST4020
9
3. Instrument Components and Specifications
3.1 Overview – Instrument Parts
10
Adjustable
Foot
Reagent
Container
Slide
Carrier
Rinse Station
Lift Bar Hood
(opional)
Exit
Tank
Display
and
Keypad
Platform
Fig. 2
Instructions for Use V1.1, RevB – 10/2012
Instrument rear view
3. Instrument Components and Specifications
Rinsing Water
Connection
Waste Water Hose
Identification Label
Support Bracket
for Stabilizing
2 Screws
Support Bracket
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.
Storage for the
Reagent Container Cover
for
Connector for
Power Cord
Power Switch
Power Supply
Adjustable
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.
Foot
Fig. 3
Leica ST4020
11
3. Instrument Components and Specifications
3.3 Functional Description of Components - System overview
Figure 2 on page 10 shows an overview of the stainer.
The Leica ST4020 Linear Stainer has the following functional areas:
13
4
2
4 6
14
Fig. 4
1
3
Fig. 5
Keypad (14) with Display (13)
A membrane keypad with 6 keys allows the user to set up the
processing 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.
Slide carrier (1) and lift Bar (2)
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.
Reagent container (4) and Rinsing Water Container (6)
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
container or a rinse container present.
12
Fig. 6
The rinse containers allow the slides to be subjected to running
rinse water while the slides are being processed.
Instructions for Use V1.1, RevB – 10/2012
3. Instrument Components and Specifications
Functional Description of Components (continued)
Exit Tank (7)
The exit tank holds the processed slides. It can hold up to 4 slide
carriers.
7
Fig. 7
Fig. 8
9
As soon as the exit tank is full, the stainer pauses processing until
the slide carriers are removed.
Platform (8)
8
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.
Waste Water Drain Hose (9)
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.
11
12
Leica ST4020
10
Fig. 9
Rinsing Water Supply (10)
A connection port for the rinsing water supply is located on the
rear of the stainer. The necessary connecting hose is included in
the equipment supplied.
Fig. 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.
Fig. 11
13
3. Instrument Components and Specifications
3.3 Functional Areas of the Slide Carrier
Side
Support
Locating Slots
for 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
Handle
Slides
Fig. 12
14
Lift Bar
Retainer
Reagent
Container
Fig. 13
Instructions for Use V1.1, RevB – 10/2012
3. Instrument Components and Specifications
3.4 Standard Delivery
The Leica ST4020 standard delivery consists of the following items:
1 Leica ST4020 basic instrument 14 0509 46425
14 Reagent containers (white) 14 0509 46437
3 Water rinse containers (black) 14 0509 46441
3 Slide carrier 14 0509 46438
1 Set of Power cords:
1 Power cord "D" 14 0509 46480
1 Power cord "UK" ST-BU F-5A 14 0509 46481
1 Power cord "US" 14 0509 46479
1 Water inlet hose 14 0509 46532
1 Water drain hose (already installed) 14 0509 46445
1 Rinse Manifold with restrictor (already installed) 14 0509 46533
1 Exit collection tank 14 0509 46450
1 Set with tubings, fittings, tie wraps: 14 0509 46459
1 Water hose 16“ long, Ø1/8“
3 in line fittings
2 plugs
10 tie wraps
1 Support Bracket 14 0509 46570
1 Metal reagent container cover 14 0509 46442
1 Set replacement fuses:
2 Fuses 250 V, T 1.0 A 14 0509 46463
1 Instruction manual for Leica ST4020 “Small Linear Stainer“ 14 0509 80001
Leica ST4020
Please check all delivered parts against the packing list and against your order to verify
whether the delivery is complete! Should you find any discrepancies, please contact your
Leica sales office without delay.
15
3. Instrument Components and Specifications
3.5 Technical Data
General
Admissions: UL, cUL, CE
Nominal voltage: 100 V – 240 V +/- 10% AC
Nominal frequency: 50 to 60 Hz
Power draw: 25 VA
IEC 1010 classification: Protective class 1
Pollution degree 2
Overvoltage installation 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:
Dimensions and weights
Dimensions, (W x D x H): 620 mm x 250 mm x 200 mm
Height with Hood open: 430 mm
Dry weight, unpacked: approx. 16 kg
Instrument with accessories: approx. 19 kg
Weight incl. packing material: approx. 21 kg
< 6500 ft (Ambient pressure. 29 - 31 inch Hg)
Performance
Slide processing rate: Depends on program structure and loading
Loading capacity: max. 4 slide carriers
Stations: max. 14
Reagent stations: max. 14
Washing 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 > 30 sec.
Throughput rate of washing 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
16
Instructions for Use V1.1, RevB – 10/2012
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