Leica asp6025 User manual

Instructions for Use
ASP6025 - Advanced Smart Processor
Vacuum tissue processor
ASP6025 Tissue ProcessorV 2.4, English 12/2015
Order No.: 14 0495 80101 RevL
Always keep this manual with the instrument.
Read carefully before working with the instrument.

3
ASP6025 Tissue Processor
The information, numerical data, notes and value judgments
contained in this manual represent the current state of scientic
knowledge and state-of-the-art technology as we understand it
following thorough investigation in this eld.
We are under no obligation to update the present Instructions
for Use periodically and on an ongoing basis according to the
latest technical developments, nor to provide our customers
with additional copies, updates etc. of these Instructions for Use.
To the extent permitted in accordance with the national legal
system as applicable in each individual case, we shall not be
held liable for erroneous statements, drawings, technical illus-
trations etc. contained in these Instructions for Use. In particular,
no liability whatsoever is accepted for any nancial loss or other
consequential damage caused by or related to compliance with
statements or other information in these Instructions for Use.
Statements, drawings, illustrations and other information re-
garding the contents or technical details of the present Instruc-
tions for Use are not to be considered 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 specications as well
as manufacturing processes without prior notice. Only in this
way is it possible 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, photocopy, microche, 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 on the back of the instrument.
© Leica Biosystems Nussloch GmbH
NOTE
Leica Biosystems Nussloch GmbH
Heidelberger Str. 17 - 19
D-69226 Nussloch, Germany
Germany
Phone: [phone]
Fax: [phone]
Internet: http://www.LeicaBiosystems.com
Assembly contracted to Leica Instruments (Singapore) Pte. Ltd.

4Instructions for Use V 2.4 RevL - 12/2015
Table of Contents
1. Important Information ..............................................................................................................7
1.1 Symbols in the text and their meanings .................................................................................................................. 7
1.2 Instrument type .................................................................................................................................................... 10
1.3 Qualication of personnel ..................................................................................................................................... 10
1.4 Intended use of instrument................................................................................................................................... 11
2. Safety..................................................................................................................................... 12
2.1 Safety notes........................................................................................................................................................... 12
2.2 Warnings............................................................................................................................................................... 12
2.3 Safety features on the instrument......................................................................................................................... 17
3. Instrument Components and Specications ..............................................................................18
3.1 Standard delivery - packing list............................................................................................................................. 18
3.2 Technical data........................................................................................................................................................ 20
3.3 Compatible reagents ............................................................................................................................................. 23
3.4 Overview............................................................................................................................................................... 24
3.4.1 Instrument components and accessories............................................................................................................... 25
3.4.2 Instrument rear panel - terminals.......................................................................................................................... 26
3.4.3 Instrument specications ...................................................................................................................................... 27
4. Instrument Setup.................................................................................................................... 30
4.1 Unpacking the instrument..................................................................................................................................... 30
4.2 Basic instrument/hardware................................................................................................................................... 37
4.2.1 Installation site requirements................................................................................................................................ 37
4.3 Installing the tube for external exhaust air (optional).......................................................................................................38
4.4 Connecting the power supply................................................................................................................................ 40
4.4.1 The retort .............................................................................................................................................................. 41
4.4.2 Counter area.......................................................................................................................................................... 43
4.4.3 Specimen baskets.................................................................................................................................................. 44
4.4.4 The monitor .......................................................................................................................................................... 45
4.4.5 The paran station ............................................................................................................................................... 46
4.4.6 The paran baths ................................................................................................................................................. 47
4.4.7 Drawer with RTU-bottles....................................................................................................................................... 49
4.4.8 Reagent cabinet with system bottles .................................................................................................................... 52
4.4.9 The drip tray.......................................................................................................................................................... 53
4.4.10 Adhesive labels for system bottles and RTU-bottles .............................................................................................. 54
4.5 Switching the instrument on................................................................................................................................. 56
4.6 Alarm functions..................................................................................................................................................... 58

5
ASP6025 Tissue Processor
Table of Contents
4.7 Touchscreen functions ........................................................................................................................................... 61
4.8 Switching o the instrument correctly .................................................................................................................. 65
5. Operation ............................................................................................................................... 66
5.1 System conguration - conguring the instrument parameters ........................................................................... 66
5.1.1 The Installation menu............................................................................................................................................ 66
5.1.2 System settings ..................................................................................................................................................... 69
5.1.3 User proles .......................................................................................................................................................... 78
5.1.4 The System monitor menu .................................................................................................................................... 80
5.1.5 The Service functions menu................................................................................................................................... 82
5.1.6 System status ........................................................................................................................................................ 84
5.1.7 The Run log ........................................................................................................................................................... 87
5.1.8 The Eternal error log.............................................................................................................................................. 89
5.1.9 Saving or loading data........................................................................................................................................... 90
5.1.10 The Smart Screen .................................................................................................................................................. 95
5.2 Reagents ............................................................................................................................................................... 98
5.2.1 Editing the reagent list.......................................................................................................................................... 98
5.2.2 The RMS system - adjusting warning threshold values........................................................................................ 100
5.2.3 The reagent status............................................................................................................................................... 104
5.2.4 Conguring the stations...................................................................................................................................... 106
5.2.5 The Reagent groups menu................................................................................................................................... 107
5.2.6 Ethanol rotation .................................................................................................................................................. 108
5.2.7 Adjusting the threshold value for ethanol rotation.............................................................................................. 111
5.2.8 Replacing xylene ................................................................................................................................................. 112
5.3 Inltration programs........................................................................................................................................... 113
5.3.1 Display of the program list................................................................................................................................... 113
5.3.2 Adding and modifying programs......................................................................................................................... 114
5.4 Reagent handling................................................................................................................................................ 117
5.4.1 Filling/draining reagents..................................................................................................................................... 117
5.4.2 Relling paran ................................................................................................................................................. 123
5.4.3 Draining a paran bath ...................................................................................................................................... 125
5.5 Running programs............................................................................................................................................... 127
5.5.1 User-dened programs ....................................................................................................................................... 127
5.5.2 Favorites.............................................................................................................................................................. 128
5.5.3 Dening Favorite programs ................................................................................................................................. 129
5.5.4 Starting a program.............................................................................................................................................. 132
5.5.5 Ending a program................................................................................................................................................ 136
5.6 Permanently installed inltration programs........................................................................................................ 137

6Instructions for Use V 2.4 RevL - 12/2015
Table of Contents
5.6.1 Programs with automatic ethanol rotation.......................................................................................................... 137
5.6.2 Preinstalled xylene inltration programs ............................................................................................................ 141
5.6.3 Xylene-free inltration programs ........................................................................................................................ 147
6. Cleaning and Maintenance..................................................................................................... 153
6.1 Cleaning programs .............................................................................................................................................. 153
6.1.1 View cleaning programs...................................................................................................................................... 153
6.1.2 Running cleaning programs ................................................................................................................................ 154
6.1.3 Cleaning protocols............................................................................................................................................... 157
6.1.4 SMART cleaning................................................................................................................................................... 158
6.2 General instrument maintenance........................................................................................................................ 162
6.3 Maintenance overview ........................................................................................................................................ 164
6.3.1 Daily cleaning and maintenance ......................................................................................................................... 166
6.3.2 Periodic cleaning and maintenance..................................................................................................................... 169
6.4 Taking the instrument out of service temporarily................................................................................................ 170
7. Troubleshooting.................................................................................................................... 171
7.1 Troubleshooting .................................................................................................................................................. 171
7.1.1 Power failures...................................................................................................................................................... 171
7.1.2 Instrument procedure in case of power failure..................................................................................................... 172
7.2 Malfunctions in the program sequence ............................................................................................................... 175
7.3 Typical ll or drain problems................................................................................................................................ 176
7.4 Emergency unlock ............................................................................................................................................... 177
7.4.1 Electrical standard emergency unlock ................................................................................................................. 177
7.4.2 Mechanical emergency unlock ............................................................................................................................ 178
8. Optional Accessories .............................................................................................................. 179
9. Warranty and Service............................................................................................................. 180
10. Log for Instrument Status ...................................................................................................... 181
11. Decontamination Certicate (Master)..................................................................................... 182

7
ASP6025 Tissue Processor
1. Important Information
1.1 Symbols in the text and their meanings
(5)
START
Manufacturer: Indicates the manufacturer of the
medical product.
Date of Manufacture: Indicates the date when the
medical device was manufactured.
In vitro diagnostics (IVD) medical device.
ON position of a key with click stop
Indicates the need for the user to consult the
instructions 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.
OFF position of a key with click stop
Observe the Instructions for Use!
This product fulfills the requirements of the
Council’s Directive 98/79/EC concerning in vitro
diagnostics (IVD) medical devices.
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 re-
stricted in China is used in excess of the maximum
permitted limit.
Numbers in parentheses refer to item num-
bers in illustrations.
The instrument is controlled and operated
using a touch-sensitive screen.
Function keys to be pressed on the instrument
touchscreen are written in bold-print capital
letters.
Warning – Dangerous electrical voltage.
Instrument surfaces which become hot during
operation are marked with this symbol.
Avoid direct contact with these surfaces - they
may cause burns.
Inammable solvents and reagents are identi-
ed using this symbol.
Warning instructions on the dust cover of the
instrument.
Notes,
i.e. important user information appears in
a gray box and is marked by an information
symbol .
Warnings
appear in a gray box and are marked by a
warning triangle .

8Instructions for Use V 2.4 RevL - 12/2015
1. Important Information
Indicates the correct upright position of the package.
The package contents are fragile and must be handled with care.
The package must be kept in a dry environment.
It is not permitted to stack packages, and no loads may be placed on top of the package.
The CSA test mark means that a product has been tested and fulfills the applicable safety and/or performance
standards, including the relevant standards dened or administered by the American National Standards Institute
(ANSI), Underwriters Laboratories (UL), the Canadian Standards Association (CSA), the National Sanitation Founda-
tion International (NSF) and others.
Symbol for labeling electrical and electronic equipment in accordance with Section 7 of the German Electrical and
Electronic Equipment Act (ElektroG).
ElektroG is the law regarding the sale, return and environmentally sound disposal of electrical and electronic equipment.
REF Order number for standard delivery or accessories.
Designates the serial number of the instrument.
SN
Symbol for alternating current
~
Symbols in the text and their meanings

9
ASP6025 Tissue Processor
1. Important Information
Indicates the temperature range permitted for storing and handling the package.
Minimum +5 °C
Maximum +50 °C
Indicates the temperature range permitted for transporting the package.
Minimum -40 °C
Maximum +55 °C
In the Shockwatch system, a precision glass tube shows shocks or impacts that are above a specied inten-
sity through red coloration. Exceeding a dened acceleration (g value) destroys the surface tension of the
liquid in the interior of the tube. This causes the indicator tube to change color.
Example of labeling in accordance with IPPC
IPPC symbol
Country code in accordance with ISO 3166, e.g. DE for Germany
Regional identier, e.g. HE for Hessen
Producer/treatment provider code, unique assigned number starting with 49
Treatment code, e.g. HT (heat treatment), MB (methyl bromide), and possibly DB (debarked)
TheTILTWATCH checks in a simple, obvious and irreversible manner whether your product was transported
upright and stored as prescribed.
The indicator eld becomes red if your tipping-endangered product was tilted more than 83 °.

10 Instructions for Use V 2.4 RevL - 12/2015
1. Important Information
1.2 Instrument type
All information provided in these Instructions for Use applies only to the instrument type indicated on the cover page.
A nameplate indicating the instrument serial number is attached to the rear side of the instrument.
The ASP6025Tissue Processor is available in two voltage variants, 120 V and 230 V.
Nameplate for voltage 230 V variant. Nameplate for voltage 120 V variant.
Fig. 1
Fig. 1 is provided as an example only and shows a valid nameplate for this instrument with the necessary infor-
mation about instrument type and power requirement. The precise data for the various versions is specied in
Chapter 3.2 “Technical data”.
1.3 Qualication of personnel
• TheASP6025TissueProcessor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.