Leica ASP300 S Manuale utente

Instructions for Use
Leica ASP300 S -
Advanced Smart Processor
Vacuum
Tissue Processor
Leica ASP300 S, English
Order No.: 14 0476 80101 RevJ
Always keep this manual with the instrument.
Read carefully before working with the instrument.
V 1.9 RevJ - 08/2017


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 Str. 17 - 19
D-69226 Nussloch
Germany
Phone: +49 (0) 6224 143-0
Fax: +49 6224 143-268
Internet: http://www.LeicaBiosystems.com

4Instructions for Use, V 1.9 RevJ – 08/2017
Table of Contents
1. Important Information ............................................................................................................... 6
1.1 Symbols and their meanings....................................................................................................... 6
1.2 Qualification of personnel......................................................................................................... 12
1.3 Intended use of instrument....................................................................................................... 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

5
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.............................................................................................................................................. 92

6Instructions for Use, V 1.9 RevJ – 08/2017
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 Compliance
Description: The CE marking is the manufacturer's declaration
that the medical product meets the requirements of
the applicable EC directives.
Symbol: Title of symbol: CSA Statement (Canada/USA)

8Instructions for Use, V 1.9 RevJ – 08/2017
1. Important Information
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.

10 Instructions for Use, V 1.9 RevJ – 08/2017
1. Important Information
Symbol: Title of symbol: Consult instructions for use
Description: Indicates the need for the user to consult the inst-
ructions for use.
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.
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