Leica AutoStainerXL User manual

Instructions for Use
Leica AutoStainerXL, V2.3 English – 10/2012
Order-No.: 14 0456 80101 RevC
Always keep this manual near the instrument!
Read carefully prior to operating the instrument!
Leica
AutoStainer XL
Automated slide stainer

3
Leica AutoStainer XL – Automated slide stainer
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 follow-
ing thorough investigation in this field.
We are under no obligation to update the present
manual according to the latest technical devel-
opments, nor to provide our customers with ad-
ditional copies, updates etc. of this manual.
For erroneous statements, drawings, technical
illustrations etc. contained in this manual we ex-
clude liability as far as permissible according to
the national legal system applicable in each indi-
vidual case. In particular, no liability whatsoever
is accepted for any financial loss or consequen-
tial damage caused by or related to compliance
with statements or other information in this
manual.
Statements, drawings, illustrations and other in-
formation as regards contents or technical de-
tails of the present manual are not to be consid-
ered as warranted characteristics of our
products.
These are determined only by the contract provi-
sions agreed between ourselves and our custom-
ers.
Leica reserves the right to change technical
specifications as well as manufacturing pro-
cesses without prior notice. Only in this way is it
possible to continuously improve the technology
and manufacturing techniques used in our prod-
ucts.
This document is protected under copyright laws.
Any 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 – includ-
ing 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 name plate at
the back of the instrument.
© Leica Biosystems Nussloch GmbH
NOTE
Published by:
Leica Biosystems Nussloch GmbH
Heidelberger Str. 17 - 19
D-69226 Nussloch
Germany
Phone: [phone]
Fax: [phone]
Internet: http://www.LeicaB iosystems.com

Instructions for Use V 2.3 – 10/2012
4
Table of contents
1. Important information .................................................................................................... 6
1.1 Symbols occurring in the text and ............................................................................................6
1.2 Designated use / improper use of the instrument .................................................................. 7
1.3 Qualification of personnel .......................................................................................................... 7
2. Safety................................................................................................................................. 8
2.1 Safety regulations ....................................................................................................................... 8
3. Instrument features ........................................................................................................ 9
3.1 Overview – instrument .............................................................................................................. 10
3.2 Standard delivery - packing list .............................................................................................. 12
3.3 Technical Data ........................................................................................................................... 13
4. Installation ..................................................................................................................... 14
4.1 Site requirements ...................................................................................................................... 14
4.2 Connection.................................................................................................................................. 14
4.2.1 Power .......................................................................................................................................... 14
4.2.2 Water supply .............................................................................................................................. 15
4.3 Battery backup - UPS (optional)..............................................................................................16
4.4 Remote alarm (optional) ........................................................................................................... 17
4.5 Fume control system ................................................................................................................. 17
4.6 Oven ............................................................................................................................................. 17
5. Operation ........................................................................................................................ 18
5.1 The control panel....................................................................................................................... 19
5.2 The main menu........................................................................................................................... 20
5.3 Menu map ................................................................................................................................... 21
5.4 Edit a program ............................................................................................................................ 22
5.4.1 Entering steps ............................................................................................................................ 23
5.4.2 Erasing steps .............................................................................................................................. 24
5.4.3 Inserting a blank step into a program .................................................................................... 24
5.4.4 Removing blank steps in a program ....................................................................................... 25
5.4.5 Saving a program ...................................................................................................................... 25
5.4.6 Deleting a program.................................................................................................................... 25
5.4.7 Copying a program .................................................................................................................... 26
5.4.8 Viewing a program .................................................................................................................... 27
5.4.9 Checking program compatibility .............................................................................................27
5.5 User-adjustable parameters .................................................................................................... 29

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Leica AutoStainer XL – Automated slide stainer
Table of contents
5.6 Oven ............................................................................................................................................. 29
5.7 Agitation (Dips) .......................................................................................................................... 30
5.8 Rack movement times ............................................................................................................... 31
5.9 Staining ....................................................................................................................................... 31
5.9.1 Reagent containers ................................................................................................................... 32
5.9.2 Wash system .............................................................................................................................. 32
5.9.3 Water saving .............................................................................................................................. 33
5.9.4 Loading slide racks ................................................................................................................... 33
5.9.5 Unloading racks from the exit drawer.................................................................................... 34
5.9.6 Unloading racks from other stations ...................................................................................... 34
5.9.7 Interrupting staining .................................................................................................................. 35
5.9.8 Aborting a rack .......................................................................................................................... 36
6. Cleaning and Maintenance ........................................................................................ 37
6.1 Cleaning the instrument ........................................................................................................... 37
6.1.1 Wash containers ....................................................................................................................... 37
6.1.2 Reagent containers ................................................................................................................... 37
6.1.3 Slide racks .................................................................................................................................. 37
6.1.4 Oven ............................................................................................................................................. 37
7. Trouble shooting ........................................................................................................... 38
7.1 Instrument failures .................................................................................................................... 39
7.2 Information and warnings ........................................................................................................ 40
7.2.1 During staining ........................................................................................................................... 40
7.2.2 During editing programs ........................................................................................................... 41
7.2.3 During SetUp .............................................................................................................................. 42
8. Warranty and service .................................................................................................. 43
APPENDIX 1 ................................................................................................................... 44
User-adjustable parameters ............................................................................................................... 44
APPENDIX 2 ................................................................................................................... 45
Consumables and accessories ........................................................................................................... 45
APPENDIX 3 ................................................................................................................... 46
Compatible staining programs ............................................................................................................ 46
Glossary .......................................................................................................................... 48

6Instructions for Use V 2.3 – 10/2012
1.1 Symbols occurring in the text and
Warnings and cautions appear in a
grey box and are marked by a
warning triangle .
Notes,
i. e. important information for the
user appear in a grey box and are
marked by an information sign .
Numbers in parentheses refer to
positions in the illustrations or to
the illustrations themselves.
Instrument type:
All information in this Instructions for Use applies
only to the instrument type indicated on the title
page.
A nameplate with the instrument serial number is
fixed on the back of the instrument.
Required information:
For all inquiries it is important to state the follow-
ing:
• instrument type
• serial number.
The Instructions for Use for the Leica
AutoStainer XL includes chapters dealing
with the following subjects:
Chapter 1 Manual structure including:
• Table of contents
• Important information
on this handbook.
Chapter 2 Safety
• Read this chapter before you
attempt to operate the
instrument!
Chapter 3 Instrument features
• General description
• Technical data
Chapter 4 Installation
• Site requirements
• Installation
Chapter 5 Operation
• Control elements
• Menu map
Chapter 6 Trouble shooting
Chapter 7 Cleaning and maintenance
Chapter 8 Warranty and service
Appendix 1 User-adjustable parameters
Appendix 2 Consumables
and accessories
Appendix 3 Compatible staining programs
Glossary
1. Important information
(5)
(Fig. 5)
their meaning

7
Leica AutoStainer XL – Automated slide stainer
General
This Instructions for Use includes important information related to the oper-
ating safety and maintenance of the instrument.
The Instructions for Use is an important part of the product. It must be read
carefully and completely before setup and first use of the instrument and
must be kept near the instrument at all times.
If additional requirements on accident prevention and environmental pro-
tection exist in the country of operation, this Instructions for Use must be
supplemented by appropriate instructions to ensure compliance with such
requirements.
Be sure to read and comply with the safety instructions,
warnings and cautions in chapter 2, even if you are already
familiar with the operation and use of other Leica products.
1.2 Designated use / improper use of the instrument
- The AutoStainer XL has been designed for staining applications in medi-
cine, biology and industry.
- The instrument may be operated only according to the instructions con-
tained in this manual.
- Any other use is considered an improper use of the product.
1.3 Qualification of personnel
- The AutoStainer XL may be operated only by trained laboratory person-
nel.
- All laboratory personnel designated to operate the AutoStainer XL must
read this Instructions for Use carefully and must be familiar with all tech-
nical features of the instrument before attempting to operate the
AutoStainer XL.
1. Important information
To prevent damages to the instrument and specimens, only
those accessories and spare parts which have been authorized
by Leica may be installed or used with the instrument.

8Instructions for Use V 2.3 – 10/2012
2. Safety
2.1 Safety regulations
This instrument has been built and tested in accordance with the safety
regulations for electrical measuring, control, regulating and laboratory de-
vices.
In order to maintain this condition and ensure safe operation, the operator
must observe all the instructions and warnings contained in this Instructions
for Use.
For current information about applicable standards, please refer to the CE
declaration of conformity on our Internet site:
www.LeicaBiosystems.com

9
Leica AutoStainer XL – Automated slide stainer
3. Instrument features
The AutoStainer XL is the result of an extensive research program to pro-
vide an innovative stainer which meets the quality requirements of the mod-
ern laboratory, as well as:
• high throughput,
• flexibility,
• safety.
The AutoStainer XL achieves its high throughput by means of an innovative
slide rack transfer mechanism which allows continuous loading of up 11
racks of 30 slides each.
The flexibility of AutoStainer XL also permits simultaneous processing of
slide racks according to different staining protocols so that Papanicolau
and Hematoxylin/Eosin staining can be conveniently performed at the same
time, without reprogramming or reagent changes.
The AutoStainer XL incorporates all of the features which ensure high flex-
ibility, convenience and above all, quality staining. A fan-forced oven is avail-
able to quickly dry slides and optimized wash stations result in rapid re-
moval of excess reagent. The minimum-carryover design of the slide racks
ensures that there are no drips and reagent life is extended.
The AutoStainer XL is safe to use and has an integral fume control system.
Rack loading and unloading is achieved by a unique two-drawer system
which means virtually no exposure to fumes.
The outstanding flexibility, throughput and quality-staining capability of
AutoStainer XL has set a new standard in staining excellence.

Instructions for Use V 2.3 – 10/2012
10
3. Instrument features
Abb. 1
20
19
18
17
15
14
13
12
11
10
9
8
7
1
4
3
2
6
5
16
3.1 Overview – instrument

11
Leica AutoStainer XL – Automated slide stainer
3. Instrument features
Front view
1. Transfer mechanism
2. Wash stations
3. Oven
4. Program pad
5. Program pad recess
6. ON/STOP switch
7. Display screen
8. Keypad
9. LED indicators
10. Slide rack
11. Lid
12. Reagent container
13. Load drawer
14. Load LED and key
15. Exit drawer
16. Slotted lid
17. Exit LED and key
18. Container map on fume filter cover
19. Lid support
20. Lid
Abb. 2
Rear panel
21. Water inlet
22. Drain outlet
23. Serial port
24. Power supply
25. Oven voltage selector
26. Mains switch (ON/OFF)
27. Mains outlet
28. Feet, adjustable
29. Power jumper cable
30. Power supply inlet
31. Rating and serial number plate
32. Remote alarm socket, 50 V 1 A max
33. Accessory port
34. Exhaust air duct
35. Power supply outlet
21
34 22
33
3231
27 26 25 28
30
35 23
24

Instructions for Use V 2.3 – 10/2012
12
3.2 Standard delivery - packing list
Standard delivery:
1 Leica ST5010 basic instrument (100-120 V/50-60 Hz)
1 accessories kit (14 0456 35660) consisting of:
- 22 reagent vessels with lids................................................................................................ 14 0475 33659
- 5 wash vessels ...................................................................................................................... 14 0456 35268
- 5 slide racks, metal............................................................................................................... 14 0456 33919
- 2 lids with slots for reagent vessels .................................................................................. 14 0475 34486
- 1 jumper cable - supply system.......................................................................................... 14 0411 34604
- 1 remote alarm connector................................................................................................... 14 6844 01005
- 1 hose clamp ......................................................................................................................... 14 0422 31972
- 1 angular connecting nozzle for hose ............................................................................... 14 0475 33669
- 1 V filter 3/4 ............................................................................................................................ 14 0456 36101
1 activated carbon filter ............................................................................................................ 14 0474 32273
1 filter cover ................................................................................................................................ 14 0456 35240
1 drip tray for paraffin (heating) (inside the instrument) ...................................................... 14 0456 35216
1 dye log block (attached to the instrument) ......................................................................... 14 0456 35459
1 water supply hose with seal ................................................................................................. 14 0474 32325
1 drain hose ................................................................................................................................ 14 0475 35748
1 power cable USA-C-J ............................................................................................................ 14 0411 13559
1 operating manual Leica AutostainerXL G/E (+ language CD)......................................... 14 0456 80001
- 1 reference manual as appendix, English only (dye logs, etc.)
3. Instrument features
To prevent damages to the instrument and specimens, only those accessories and spare
parts which have been authorized by Leica may be installed or used with the instrument.

13
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 selected program - up to 600 slides per hour)
Loading capacity: ......................................................................................................................... 11 slide racks
Slide rack capacity: .............................................................................................................30 specimen slides
Total number of stations: ................................................................................................................................. 26
Total number of reagent stations: .................................................................................................... at least 18
Reagent container volume: ...................................................................................................................... 450 ml
Number of wash stations: ........................................................................................................................ max. 5
Oven: ..................................................................................................................................................................... 1
Oven chamber temperature: .................................................................................... ambient or 30°C to 65°C
Incubation time setting: ............................................................................... from 0 sec. up to 99 min., 59 sec
Load/unload 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 (W x D x H): ............................................................................................. 109 cm x 67 cm x 51 cm
Weight: .......................................................................................................................................................... 65 kg
Voltages: ..................................................................................................................110 V - 120 V, 50 Hz - 60 Hz
230 V - 240 V, 50 Hz - 60 Hz

Instructions for Use V 2.3 – 10/2012
14
Instructions on how to install the instrument are provided in this chapter. A
diagram and description of components is also given. Finally, the procedure
for replacement of the fume filter is outlined.
4.1 Site requirements
The AutoStainer XL requires a solid bench of dimensions 1.090 mm long and
670 mm deep. The instrument must be located within 3 meters of a tap and
drain.
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 set by the manu-
facturer to suit the country of sale.
The voltage selector setting must not be altered by the user.
The AutoStainer XL requires connection to a laboratory water tap with mains
pressure fitting.
4.2 Connection
4.2.1 Power
• Connect the power cord to the mains outlet ((28) page 11).
• Connect the power jumper cable to the power supply outlet ((30) page
11) and to the power supply inlet ((32) page 11).
Refer to Figure 10 on page 11.
4. Installation

15
Leica AutoStainer XL – Automated slide stainer
How to switch on:
1. Connect the power cord to the mains power socket and, if applicable,
switch power ON at the mains socket.
2. Set the ON/STOP switch at the side of the unit to STOP.
3. Set the ON/OFF switch at the rear of the unit to ON.
4. Set the ON/STOP switch to ON.
The instrument will then sound 3 short beeps and the Main Menu will be
displayed.
When the instrument is not in use set the ON/STOP switch at the side to
STOP.
The ON/OFF switch at the rear of the instrument should be left ON.
The instrument must never be operated without the power
jumper cable.
The instrument must be connected to an earthed mains
power outlet socket only.
4.2.2 Water supply
Connect the water hose to the water inlet at the rear of the unit. Screw the
other end of the hose to the cold water tap. The hose has a 3/4 inch BSP
fitting. Slowly turn the tap on fully.
Ensure that the water filter is present when fitting the water
inlet hose. Failure to do so may result in leakage of water.
Drain hose
Connect the drain hose to the drain outlet on the rear of the unit.
4. Installation

Instructions for Use V 2.3 – 10/2012
16
4.3 Battery backup - UPS (optional)
An uninterruptable power supply (UPS) can be used to permit staining of
slides to continue during brief mains power failures.
A small UPS can be connected using the power jumper lead, as shown in
Figure 15.
The UPS should be rated at 200 VA for 5 minutes. Heating in the oven will not
be maintained by the UPS.
The UPS must be rated for use with the local mains voltage. Your distributor
can recommend a suitable UPS.
4. Installation
Fig. 16

17
Leica AutoStainer XL – Automated slide stainer
4.4 Remote alarm (optional)
The remote alarm option is a latched relay that is voltage-isolated from the
rest of the instrument. When an alarm condition occurs (either a major fail-
ure of the instrument, or loss of mains power during a processing run whilst
a battery backup unit is fitted) the alarm circuit closes, sounding the alarm.
A battery-powered remote alarm must be used if you require
the remote alarm to sound when the mains power fails.
Ensure that the instrument is turned ON and press any key to reset the alarm.
If mains power failed during a run, it may be necessary to put the ON/STOP
switch at the side of the instrument to STOP, and then to ON again.
The remote alarm will only operate during loss of mains power if a battery
backup unit is fitted. Your distributor can provide connection details for the
remote alarm.
The remote alarm connected to the instrument must be rated at less than 1
amp and a maximum of 50 Volts.
Connect the remote alarm to the alarm socket at the rear of the unit, using a
6.25 mm phono jack.
4.5 Fume control system
Fumes are exhausted through the activated carbon filter which must be
changed every three months (with average usage).
To remove a filter, lift out the plate covering the filter. Refer to Figure 2. Re-
move the filter, using the tabs. Replace with a new filter and fit the cover into
place.
4.6 Oven
Fit the wax tray into the bottom of the oven.
4. Installation

Instructions for Use V 2.3 – 10/2012
18
5. Operation
Introduction
This chapter describes how to operate AutoStainer XL. It includes sections
on how to use the control panel functions and other indicators, how to cre-
ate and edit programs and how to stain slides.
AutoStainer XL offers some unique features not available in other stainers
and these are explained in subsequent sections. Firstly, slide racks are loaded
and unloaded by means of drawer, not by opening the lid. If the instrument is
free to accept a rack for staining the Load LED will be on. After loading, the
Load key must be pressed to inform the instrument to begin processing. Simi-
larly, if a rack is finished staining in the Exit drawer the Exit LED will be on.
The Exit key must be pressed to inform the instrument when the rack is re-
moved. Programs can finish at any station. However, if the EXIT drawer is
not the last step then the LCD will inform you of the station to unload from.
In this case, the lid will have to be opened to remove the rack.
AutoStainer XL can accept racks whenever the Load LED is on and process
up to 11 racks simultaneously.
Each rack can be processed according to any of the 15 programs, provided
that the reagents are available and the program chosen is compatible (no
conflicting sequence) with programs already being used.

19
Leica AutoStainer XL – Automated slide stainer
Communication
Communication with AutoStainer XL is via the control panel, load and un-
load keys and associated indicators and audible signals.
5.1 The control panel
The control panel consists of an LCD display, the keypad and four LEDs.
The display
The display is a four-line LCD with backlighting. The fourth line is usually
reserved for commands associated with the function keys [F1] to [F4]. A flash-
ing cursor appears beneath user-changeable settings.
The keypad
The membrane keypad incorporates 4 function keys and 4 arrow keys. The
function keys perform the action indicated immediately above them on the
fourth line of the display. The arrow keys move the cursor in the direction
indicated. They are also used to select digits and other settings.
Contact with solvents, use of sharp instruments or excessive
force may damage the keypad.
The LED indicators
The four LEDs are located below the arrow keys and have the following
functions. The unload LED (yellow flashing) indicates that a rack has been
completed and is ready to be removed from a station other than the exit
drawer. The staining LED (yellow) is lit when staining is in progress. The
alarm LED (red) indicates that an instrument error has occurred. The mains
LED (green) signals that mains power is available (ON at ON/OFF switch, ON
at ON/STOP switch).
5. Operation

Instructions for Use V 2.3 – 10/2012
20
5. Operation
Load and exit keys and indicators
The load and exit keys and associated LED indicators are located adjacent
to the load and exit drawer. For further information, see Pages 32 and 33.
Audible signals
There are four types of audible signals given:
• short single beep: indicates key press;
• short double beep: indicates unacceptable key press
or error message;
• long double beep: operator attention required to remove a
completed rack;
• continuous tone: indicates unit failure.
5.2 The main menu
When the AutoStainer XL is turned ON at the ON/STOP switch, the following
Main Menu will be displayed and the instrument will give 3 beeps.
The modes of operation of the instrument are:
• Stain: to stain slides
• Edit: to create, view or change programs
• Setup: to set, view or alter parameters such as oven temperature
and the number of dips (amount of agitation) upon entering a
reagent station
• PC: for service use only
AutoStainer XL V2.0
Main Menu
Stain Edit SetUp PC