Leica BIOSYSTEMS ASP300S User manual

Instructions for Use
Leica ASP300 S -
Advanced Smart Processor
Vacuum
Tissue Processor
Leica ASP300 S, English
Order No.: 14 0476 80101 RevN
Always keep this manual with the instrument.
Read carefully before working with the instrument.
V 2.1 RevN - 06.2021

3
Leica ASP300 S
The information, numerical data, notes and value
judgments contained in this manual represent
the current state of scientific knowledge and
state-of-the-art technology as we understand it
following thorough investigation in this field.
We are under no obligation to update the present
manual periodically and on an ongoing basis ac-
cording to the latest technical developments, nor
to provide our customers with additional copies,
updates etc. of this manual.
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 information
in this manual.
Statements, drawings, illustrations and other
information as regards contents or technical
details of the present Instructions for Use 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 process-
es without prior notice. Only in this way is it pos-
sible to continuously improve the technology and
manufacturing techniques used in our products.
This documentation is protected under copyright
laws. All copyrights to this documentation are
held by Leica Biosystems Nussloch GmbH.
Any reproduction of text and illustrations (or
of any parts thereof) by means of print, 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 name plate at
the back of the instrument.
© Leica Biosystems Nussloch GmbH
WARNING
Leica Biosystems Nussloch GmbH
Heidelberger Strasse 17 - 19
69226 Nussloch
Germany
Phone: [phone]
Fax: [phone]
Internet: http://www.LeicaBiosystems.com

4Instructions for Use, V 2.1 RevN – 06.2021
Table of Contents
1. Important Information ............................................................................................................... 6
1.1 Symbols and their meanings....................................................................................................... 6
1.2 Qualification of personnel......................................................................................................... 12
1.3 Intended purpose........................................................................................................................ 12
1.4 Instrument type........................................................................................................................... 13
1.5 Microsoft software license terms............................................................................................ 13
2. Safety ......................................................................................................................................... 14
2.1 Safety notes................................................................................................................................. 14
2.2 Warnings...................................................................................................................................... 15
2.3 Safety features on the instrument ........................................................................................... 19
3. Instrument Components and Specifications....................................................................... 20
3.1 Overview – instrument components........................................................................................ 20
3.2 Specific instrument options...................................................................................................... 22
3.3 Standard delivery – packing list............................................................................................... 22
3.4 Technical Data............................................................................................................................ 24
3.5 Compatible reagents.................................................................................................................. 26
3.6 Recommended reagent handling............................................................................................. 27
3.6.1 Cycle for changing reagents..................................................................................................... 28
4. Initial Operation ....................................................................................................................... 29
4.1 Installation site requirements................................................................................................... 29
4.1.1 Moving the instrument............................................................................................................... 29
4.2 Electrical connection................................................................................................................. 30
4.2.1 Connecting the power supply................................................................................................... 30
4.2.2 Connecting an uninterruptible power supply (UPS) ............................................................. 31
4.3 Installing accessories................................................................................................................ 32
4.4 Making the data connections................................................................................................... 34
4.5 Anti-reflection clip – Function.................................................................................................. 35
4.6 Alarm functions........................................................................................................................... 36
4.7 Switching the instrument on..................................................................................................... 37
4.8 Touchscreen functions.............................................................................................................. 39
4.9 Checklist for initial operation.................................................................................................... 40
4.10 Switching off the instrument..................................................................................................... 41
5. Operation................................................................................................................................... 42
5.1 Setting up the instrument parameters .................................................................................... 42
5.1.1 System setup............................................................................................................................... 42
5.1.2 Access levels .............................................................................................................................. 45

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Leica ASP300 S
Table of Contents
5.1.3 INSTALLATION menu................................................................................................................. 47
5.1.4 Editing the reagent list............................................................................................................... 50
5.1.5 Viewing the program list............................................................................................................ 53
5.1.6 Adding and/or modifying programs......................................................................................... 54
5.1.7 Favorites....................................................................................................................................... 57
5.1.8 Configuring the stations............................................................................................................. 59
5.1.9 Reagent groups........................................................................................................................... 60
5.2 Reagent handling........................................................................................................................ 61
5.2.1 Draining/filling reagents (other than paraffin)....................................................................... 61
5.2.2 Replacing the paraffin................................................................................................................ 63
5.3 Running programs ...................................................................................................................... 66
5.3.1 Editing a program that has been called up............................................................................. 67
5.3.2 Starting a program...................................................................................................................... 69
5.3.3 Opening the retort....................................................................................................................... 70
5.3.4 Retort emergency release......................................................................................................... 70
5.4 Reagent status ............................................................................................................................ 72
5.5 System monitor ........................................................................................................................... 73
5.6 The online help............................................................................................................................ 74
6. Troubleshooting ....................................................................................................................... 75
6.1 General......................................................................................................................................... 75
6.2 Power failure............................................................................................................................... 75
6.3 Troubleshooting.......................................................................................................................... 76
6.4 Typical fill or drain problems .................................................................................................... 77
7. Cleaning and maintenance .................................................................................................... 78
7.1 Clean programs........................................................................................................................... 78
7.1.1 Retort cleaning programs.......................................................................................................... 78
7.1.2 Paraffin cleaning......................................................................................................................... 80
7.1.3 Smart clean.................................................................................................................................. 81
7.2 General cleaning steps.............................................................................................................. 82
7.2.1 Daily cleaning and maintenance.............................................................................................. 84
7.2.2 Periodic cleaning and maintenance........................................................................................ 86
7.3 Checklist for preventive maintenance .................................................................................... 88
8. Warranty and Service ............................................................................................................. 90
9. Decontamination Confirmation............................................................................................. 91
Appendix 1 - Notes on Specimen Preparation ............................................................................. 92
Appendix 2 - Exhaust Hose (Optional) Installation...................................................................... 93

6Instructions for Use, V 2.1 RevN – 06.2021
1.1 Symbols and their meanings
1. Important Information
Leica Biosystems GmbH assumes no liability for consequential loss or damage due to failure to
observe the following instructions, particularly in relation to transportation and package han-
dling, and failure to observe the instructions for handling the instrument carefully.
Symbol: Title of symbol: Caution
Description: Indicates the need for the user to consult the inst-
ructions for use for important cautionary information
such as warnings and precautions that cannot, for
a variety of reasons, be presented on the medical
device itself.
Symbol: Title of symbol: Caution
100 - 120 V
Description: Unit wired for 100 - 120 V alternating current (label
attached at the rear of the instrument, close to the
input socket of the power supply, see fig. 4 (41))
Symbol: Title of symbol: Caution
230 - 240 V
Description: Unit wired for 230 - 240 V alternating current (label
attached at the rear of the instrument, close to the
input socket of the power supply, see fig. 4 (41))
Symbol: Title of symbol: Caution
Description: Filtered air outlet – do not obstruct, may connect to
fume extraction (label attached at the rear of the
instrument, close to the filtered air outlet)
Symbol: Title of symbol: Caution
Description: Carbon filter – do not operate the instrument without
filter in place (label attached to the right of the active
carbon filter slot)
Symbol: Title of symbol: Notes
Description: This symbol indicates important information for the
user. The notes appear in a gray box and are marked
by this symbol.

7
Leica ASP300 S
1.1 Symbols and their meanings (continued)
1. Important Information
Symbol: Title of symbol: Item numbers
Description: Numbers and parentheses refer to item numbers in
the illustrations.
Symbol: Title of symbol: Function keys
Description: Function keys that must be pushed on the touch-
screen or activated in the software are shown in
BOLD.
Symbol: Title of symbol: Warning, hot surface
Description: Instrument surfaces which become hot during
operation are marked with this symbol. Avoid direct
contact to prevent risk of burning.
Symbol: Title of symbol: Manufacturer
Description: Indicates the manufacturer of the medical product.
Symbol: Title of symbol: Date of Manufacture
Description: Indicates the date when the medical device was
manufactured.
Symbol: Title of symbol: CE Label
Description: The CE marking is the manufacturer's declaration
that the medical product meets the requirements of
the applicable EC directives and regulations.
Symbol: Title of symbol: UKCA Label
Description: The UKCA (UK Conformity Assessed) marking is a
new UK product marking that is used for goods being
placed on the market in Great Britain (England, Wales
and Scotland). It covers most goods which previously
required the CE marking.

8Instructions for Use, V 2.1 RevN – 06.2021
1. Important Information
Symbol: Title of symbol: CSA Statement (Canada/USA)
Description: The CSA test mark means that a product has been
tested and fulfills the applicable safety and/or perfor-
mance standards, including the relevant standards
defined or administered by the American National
Standards Institute (ANSI), Underwriters Laborato-
ries (UL), the Canadian Standards Association (CSA),
the National Sanitation Foundation International
(NSF) and others.
Symbol: Title of symbol: In vitro diagnostic medical device
Description: Indicates a medical device that is intended to be used
as an in vitro diagnostic medical device.
Symbol: Title of symbol: Alternating current
Symbol: Title of symbol: Stack limit
Description: The largest number of identical packages allowed to
be stacked; "2" stands for the number of permitted
packages.
Symbol: Title of symbol: Network connection
Symbol Title of symbol: USB Port

9
Leica ASP300 S
1. Important Information
Symbol: Title of symbol: ON / STOP (Power)
Description: ON: The electronic power supply is connected upon
pushing the power switch.
STOP: The electronic power supply is disconnected
upon pushing the power switch.
Label is attached close to the electronic power
supply switch.
Symbol: Title of symbol: China ROHS
Description: Environmental protection symbol of the China RoHS
directive. The number in the symbol indicates the
"Environment-friendly Use Period" of the product in
years. The symbol is used if a substance restricted
in China is used in excess of the maximum permitted
limit.
Symbol: Title of symbol: WEEE Symbol
Description: The WEEE symbol, indicating separate collection
for WEEE - Waste of electrical and electronic
equipment, consists of the crossed-out wheeled bin
(§ 7 ElektroG).
Symbol: Title of symbol: Article number
Description: Indicates the manufacturer's catalogue number so
that the medical device can be identified.
Symbol: Title of symbol: Serial Number
Description: Indicates the manufacturer's serial number so that a
specific medical device can be identified.
Symbol: Title of symbol: Consult instructions for use
Description: Indicates the need for the user to consult the inst-
ructions for use.

10 Instructions for Use, V 2.1 RevN – 06.2021
1. Important Information
Symbol: Title of symbol: Caution: danger of crushing
Symbol: Title of symbol: Inflammable
Description: Inflammable reagents, solvents and cleaning agents
are marked with this symbol.
Symbol: Title of symbol: IPPC symbol
Description: The IPPC symbol includes
• IPPC symbol
• Country code to ISO 3166, e.g. DE for Germany
• Regional identifier, e.g. HE for Hesse
• Registration number, unique number beginning
with 49.
• Treatment method, e.g. HT (heat treatment)
Symbol: Title of symbol: Fragile, handle with care
Description: Indicates a medical device that can be broken or
damaged if not handled carefully.
Symbol: Title of symbol: Keep dry
Description: Indicates a medical device that needs to be protected
from moisture.
Symbol: Title of symbol: Country of Origin
Description: The Country of Origin box defines the country where
the final character transformation of the product has
been performed.

11
Leica ASP300 S
1. Important Information
Symbol: Title of symbol: This way up
Description: Indicates correct upright position of the transport
package.
Symbol: Title of symbol: Temperature limit for transport
Description: Indicates the temperature limits for transport to
which the medical device can be safely exposed.
Symbol: Title of symbol: Temperature limit for storage
Description: Indicates the temperature limits for storage to which
the medical device can be safely exposed.
Symbol: Title of symbol: Humidity limitation for transport and storage
Description: Indicates the range of humidity for transport and
storage to which the medical device can be safely
exposed.
Appearance: Title of symbol: Tilt indicator
Functional description: Indicator to monitor whether the shipment has been
transported and stored in upright position according
to your requirements. With a pitch of 60° or more, the
blue quartz sand flows into the arrow-shaped indica-
tor window and sticks there permanently. Improper
handling of the shipment is immediately detectable
and can be proven definitively.

12 Instructions for Use, V 2.1 RevN – 06.2021
1. Important Information
The Leica ASP300S is an automated tissue processor specifically designed for fixation, dehydra-
tion, infiltration with intermedium and paraffin infiltration of human tissue specimens used for
histological medical diagnosis by a pathologist, e.g. for cancer diagnosis.
The Leica ASP300 S is designed for in vitro diagnostic applications.
The Leica ASP300 S must be operated exclusively with the reagents listed in Chap. 3.5 – "Com-
patible reagents".
The Leica ASP300 S is intended for indoor use only.
• TheLeicaASP300Smaybeoperatedbytrainedlaboratorypersonnelonly.
• AlllaboratorypersonneldesignatedtooperatethisinstrumentmustreadtheseInstructions
for Use carefully and must be familiar with all technical features of the instrument before
attempting to operate it. The instrument is intended for professional use only.
1.2 Qualification of personnel
1.3 Intended purpose
Any other use of the instrument is considered improper.
Failure to adhere to these instructions may result in an accident, personal injury, damage
to the instrument or accessory equipment.
Proper and intended purpose includes compliance with all inspection and maintenance
instructions, along with the observance of all instructions in the Instructions for Use.
When delivering the instrument, the recipient must check that the ShockWatch impact indica-
tor and tilt indicator are intact. The responsible Leica representative must be notified in the
case that one or all indicators have been triggered.

13
Leica ASP300 S
1. Important Information
All information provided in these Instructions for Use applies only to the instrument type in-
dicated on the cover page. The precise data for the various versions is specified in Chap. 3.4
"Technical Data".
A nameplate indicating the instrument serial number is attached to the rear side of the instru-
ment. (The serial number is also displayed above the loading door on the front side of the instru-
ment.)
Your instrument is working with an embedded Windows 7 operating system. Terms of the
so-called End User License Agreement (EULA) apply. For details, please refer to the language
CD where you can find the entire content of this agreement.
1.4 Instrument type
1.5 Microsoft software license terms

14 Instructions for Use, V 2.1 RevN – 06.2021
2. Safety
These Instructions for Use include important
information related to the operating safety and
maintenance of the instrument.
The Instructions for Use are an important part of
the product, and must be read carefully prior to
startup and use and must always be kept near
the instrument.
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
operation, the user must observe all notes and
warnings contained in these Instructions for Use.
These Instructions for Use must be ap-
propriately supplemented as required
by the existing regulations on accident
prevention and environmental safety in
the operator‘s country.
For current information about appli-
cable standards, please refer to the CE
Declaration of Conformity and UKCA
Declaration of Conformity on our Inter-
net site:
http://www.LeicaBiosystems.com
• The safety and caution notes in this chapter must be observed at all times.
• Be sure to read these notes even if you are already familiar with the operation and use of
other Leica products.
• The protective devices located on the instrument and the accessories must not be removed
or modified. Only qualified service personnel authorized by Leica may repair the instrument
and access its internal components.
Residual risks
• The instrument has been designed and constructed with the latest state-of-the-art technol-
ogy and according to recognized standards and regulations with regard to safety technology.
Operating or handling the instrument incorrectly can place the user or other personnel at
risk of injury or can cause damage to the instrument or other property. The instrument may
be used only as intended and only if all of its safety features are in proper working condition.
Malfunctions which could impede safety must be remedied immediately.
• Only original spare parts and permitted original accessories may be used.
• Electromagnetic compatibility, emitted interference and immunity to interference are appli-
cable, as are the requirements in accordance with IEC 61326-2-6. The requirements in accor-
dance with IEC 61010-1, IEC 61010-2-101 and ISO 14971 with regard to safety information are
applicable.
2.1 Safety notes

15
Leica ASP300 S
2. Safety
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, be sure to comply with the following instruc-
tions and warnings.
Warnings – Markings on the instrument itself
Markings on the instrument showing the warning triangle indicate that the correct operat-
ing instructions (as defined in these 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.
Some instrument surfaces become hot during operation. They are marked with this
warning label. Touching these surfaces may cause burns.

16 Instructions for Use, V 2.1 RevN – 06.2021
• Only qualified personnel may install the instrument.
• At least 2 qualified persons are required when lifting and transporting the instrument. Caution!
The instrument weighs approximately 160 kg when empty. Once unpacked, the instrument may
be transported only in an upright position.
• Wear non-slip gloves when moving the instrument to prevent the instrument from slipping.
• Follow the unpacking instructions carefully to avoid damage to the instrument!
• Prior to every transport in which it is possible for the instrument to be shaken, tilted, or lifted, it
must be cleaned for transport – otherwise the interior of the instrument can be severely dam-
aged.
• Plug the instrument only into a grounded power socket. Do not interfere with the grounding
function by using an extension cord without a ground wire.
• Make sure to observe the voltage settings! The set voltage CANNOT be changed by the user.
Severe damage may occur if the instrument is connected to a power supply voltage other
than that to which it was originally set.
• The installation location must be well-ventilated; there should be no ignition sources there
of any kind. The chemicals to be used in the Leica ASP300 S are both flammable and noxious.
• Do not operate the instrument in rooms with explosion hazard.
• Do not operate without having an active carbon filter installed.
• Extreme temperature fluctuations between storage facility and setup site as well as high hu-
midity may cause condensation to form. If this is the case, wait at least two hours before
switching on the instrument. Failure to comply with this may cause damage to the instru-
ment.
2. Safety
Transport and Installation
2.2 Warnings (continued)

17
Leica ASP300 S
• The instrument may only be operated by trained laboratory personnel. It must only be operat-
ed for the purpose of its designated use and according to the instructions contained in these
Instructions for Use.
• It is highly recommended to connect the instrument to an external extraction device using
the optional exhaust air hose.
• The instrument may be operated only with an active carbon filter in place.
• The active carbon filter used in the instrument must be changed regularly in accordance
with the cleaning specifications.
• When working with the instrument, wear suitable protective clothing (lab coat, safety gog-
gles and gloves) for protection against reagents and potentially infectious micro-biological
contaminations.
• Exercise caution when opening and closing the retort and paraffin tank cover! Risk of crush-
ing or other injuries!
• In an emergency, the instrument can be switched off while working with specimens via the
ON/STOP switch located on the side of the instrument.
• If human tissue is being processed, the instrument is connected to a local and/or remote
alarm system (see Chap. 4.6) to prevent the possibility of the specimen being lost in case of a
malfunction.
• Before opening the retort when an infiltration process is in progress, always press the
PAUSE button so that the retort is ventilated or vented.
• The paraffin drain hose and the hose for remote filling/draining are cleaned with com-
pressed air after the filling or draining process. Therefore, never remove the hoses before a
filling or draining process has been completed.
• After refilling/replacing reagent containers, close the container covers again tightly.
• The reagent containers must be properly pushed home into the connection manifolds at the
rear inner wall of the reagent module.
• Failure to plug the reagent containers into the manifold correctly will interrupt the infiltra-
tion process and may also result in spilling of reagents.
• Fixing solutions that contain mercury salts, acetic acid, or picric acid can cause corrosion
on metal components.
• After each paraffin step a retort clean cycle must be run.
Warnings – Operating the instrument
2. Safety
2.2 Warnings (continued)

18 Instructions for Use, V 2.1 RevN – 06.2021
Warnings – Handling reagents
2. Safety
Warnings – Cleaning and maintenance
• Take care when handling solvents!
• Always wear rubber gloves and safety goggles when handling the chemicals used in this
instrument.
• Reagents used for tissue infiltration can be both toxic and/or flammable.
• To prevent damage to the instrument, use only the reagents listed in Chap. 3.5!
• Reagents must be checked for sufficient storage life. Never use expired reagents!
• Do not use acetone, benzene or trichlorethane!
• Use caution when handling paraffin wax or removing baskets – molten paraffin is hot and
may cause burns.
• Also, avoid personal contact with paraffin reservoirs and retort walls – they can be very hot
as well.
• 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 clean reagent containers (bottles) in a dishwasher; the containers are NOT dishwash-
er-proof.
• Switch off the instrument each time before servicing and pull out the power plug.
• Do not use inflammable cleaning agents to clean hot surfaces!
• Do not clean the instrument with solvents containing acetone or xylene. No liquid may be
spilled into the internal components of the instrument – neither during operation nor during
cleaning.
• When using cleaners, please comply with the safety instructions of the manufacturer and the
laboratory safety regulations.
• Check the condensate container at least once a week and, if necessary, drain it.
2.2 Warnings (continued)
Material safety data sheets can be obtained from the supplier of the chemicals.
Alternatively, they can be downloaded from the following website:
http://www.msdsonline.com

19
Leica ASP300 S
2.3 Safety features on the instrument
In the case of power failures or other processing problems the Leica
ASP300 S incorporates specimen protection features such as a fluid level
sensor and sophisticated software controls which ensure that processing
can be completed successfully without damage to the tissue specimens.
Overpressure protection
• Whenpowerisofftheairpumpandairvalvesdefaulttoasafecondition
(retort vented, no pressure generation).
• Ifthepumpisnotstoppedatthecorrectmomentduringthepressuriza-
tion, the power supply is interrupted by a separate electronic circuit.
• Inaddition,thereisasafetyreliefvalvethatventsallexcessairpump
output to atmosphere.
Overcurrent protection
• Overcurrentconditionsareprotectedagainstbyboththemainfuseand
the separate heating power fuses.
Overheating protection
An error is indicated and all heating is stopped by the microprocessor
–control if the instrument detects any of the following conditions:
• Abnormallyhightemperature(>75°C)
• Contradictoryresultsofthetemperaturesensors
• Failureofoneormoreheatingpowercontrolcomponents
• Ifthemicroprocessorfailstointerruptheatingpower,independenttem-
perature limiting hardware circuits limit the temperature rise to a safe
level.
• Ifthetemperaturelimitingcircuitsmalfunction,anindependenthard-
ware thermal fuse circuit cuts power to the heating elements.
Over vacuum protection
• Thevacuumsystemisnotcapableofgeneratingadangerousvacuum
condition.
2. Safety

20 Instructions for Use, V 2.1 RevN – 06.2021
3.1 Overview – instrument components
3. Instrument Components and Specifications
2
34
5
11
6
7
12
13
14
15 16
17
18
19
20
10
9 8
1
Fig. 2
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