Leica BIOSYSTEMS HistoCore PEGASUS User manual

HistoCore PEGASUS
Tissue Processor
Instructions for Use
English
Order No.: 14 0488 81101 - Revision J
Always keep this manual with the instrument.
Read carefully before working with the instrument.
Version 1.6, Revision J - 11.2023

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HistoCore PEGASUS
The information, numerical data, notes and value judgments contained in this Instructions for Use
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 this 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 illustrations etc. contained
in this Instructions for Use. In particular, no liability whatsoever is accepted for any nancial loss or
consequential damage caused by or related to compliance with statements or other information in this
Instructions for Use.
Statements, drawings, illustrations and other information regarding the contents or technical details of
the present Instructions 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 document 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
Heidelberger Strasse 17 - 19
69226 Nussloch
Germany
Tel.: +49 - (0) 6224 - 143 0
Fax: +49 - (0) 6224 - 143 268
Web: www.LeicaBiosystems.com
Assembly contracted to Leica Microsystems Ltd. Shanghai
Note

4Version 1.6, Revision J
Table of Contents
1. Important Information ..................................................................................................8
1.1 Naming conventions .................................................................................................................. 8
1.2 Symbols and their meanings....................................................................................................... 8
1.3 Instrument type ........................................................................................................................12
1.4 Intended purpose......................................................................................................................12
1.5 Qualicationofpersonnel .........................................................................................................12
1.6 Statement for user data security and privacy..............................................................................12
2. Safety...................................................................................................................... 13
2.1 Safety notes .............................................................................................................................13
2.2 Warnings..................................................................................................................................14
2.2.1 Markings on the instrument itself ..............................................................................................14
2.2.2 Transport and installation..........................................................................................................14
2.2.3 Operating the instrument...........................................................................................................16
2.2.4 Handling reagents.....................................................................................................................23
2.3 Safety features on the instrument ..............................................................................................23
3. InstrumentComponentsandSpecications ................................................................... 24
3.1 Overview ..................................................................................................................................24
3.1.1 Instrument components ............................................................................................................24
3.1.2 Rear panel ................................................................................................................................25
3.2 Main features of the instrument.................................................................................................25
3.3 Technical data ..........................................................................................................................26
4. Setting up the Instrument ........................................................................................... 30
4.1 Installation site requirements ....................................................................................................30
4.2 Standard delivery - packing list ..................................................................................................30
4.3 Unpacking and installation ........................................................................................................32
4.3.1 Unpacking Instructions..............................................................................................................32
4.3.2 Installing the display .................................................................................................................35
4.3.3 Activecarbonlter....................................................................................................................35
4.3.4 External exhaust system ...........................................................................................................36
4.4 Basic instrument/hardware .......................................................................................................37
4.4.1 Retorts .....................................................................................................................................37
4.4.2 Cassette baskets ......................................................................................................................40
4.4.3 Paranbaths ...........................................................................................................................42
4.4.4 Reagent cabinet........................................................................................................................43
4.4.5 Drip tray ...................................................................................................................................45
4.4.6 Display .....................................................................................................................................46
4.4.7 HistoCore I-Scan (optional) .......................................................................................................47
4.4.8 USB ports.................................................................................................................................48
4.4.9 Alarm connections....................................................................................................................49
4.5 Connecting an uninterruptible power supply (UPS)......................................................................50
4.6 Switching on and off .................................................................................................................51
4.6.1 Switching on.............................................................................................................................51
4.6.2 Switching off ............................................................................................................................52
4.6.3 Emergency shutdown................................................................................................................52
4.6.4 Restart after long time shutdown...............................................................................................52
4.7 Moving the instrument ..............................................................................................................53

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HistoCore PEGASUS
Table of Contents
5. Running Protocol....................................................................................................... 54
5.1 Using the software....................................................................................................................54
5.1.1 Basic operation.........................................................................................................................54
5.1.2 Navigation................................................................................................................................55
5.1.3 Access levels............................................................................................................................57
5.1.4 Help .........................................................................................................................................59
5.2 Quick start................................................................................................................................59
5.3 Cleaning protocols....................................................................................................................66
5.4 Status screen ...........................................................................................................................70
5.4.1 Status area...............................................................................................................................71
5.4.2 Protocol panels.........................................................................................................................75
5.5 Protocol run options .................................................................................................................78
5.5.1 Scheduling protocols ................................................................................................................78
5.5.2 Changing the starting step for a single run.................................................................................80
5.5.3 Changing the step time for a single run......................................................................................81
5.6 Pausing and aborting protocols .................................................................................................83
5.6.1 Recovering from an aborted run.................................................................................................85
5.7 Retort scheduling......................................................................................................................85
5.7.1 Delayedendtimesandinitiallls...............................................................................................86
5.7.2 Unavoidable reagent clashes .....................................................................................................86
5.7.3 Unavailable reagents.................................................................................................................86
6. Protocol Setup .......................................................................................................... 88
6.1 Protocol overview .....................................................................................................................88
6.1.1 Protocol types ..........................................................................................................................88
6.1.2 Reagent selection method.........................................................................................................89
6.1.3 Pre-denedprotocols................................................................................................................90
6.1.4 Protocol validation....................................................................................................................91
6.1.5 Carryover setting ......................................................................................................................91
6.1.6 Protocolles ............................................................................................................................94
6.2 Creating, editing, and viewing protocols .....................................................................................94
6.2.1 Protocol selection screen..........................................................................................................94
6.2.2 Editing protocols.......................................................................................................................94
6.2.3 Creating new protocols .............................................................................................................97
6.2.4 Viewing protocols ...................................................................................................................100
7. Reagent Setup ........................................................................................................ 101
7.1 Overview ................................................................................................................................101
7.1.1 Reagent groups, types, and stations.........................................................................................101
7.1.2 Concentration management ....................................................................................................103
7.1.3 Thresholds .............................................................................................................................104
7.1.4 Recommended reagents..........................................................................................................107
7.1.5 Non-recommended reagents....................................................................................................109
7.1.6 Reagent compatibility .............................................................................................................109
7.2 Managing reagent types..........................................................................................................109
7.2.1 Pre-denedreagents ...............................................................................................................110
7.2.2 Editing active reagent types.....................................................................................................110
7.2.3 Adding, hiding, and deleting reagents.......................................................................................112
7.3 Managing reagent stations......................................................................................................114
7.3.1 Reagent stations screen..........................................................................................................115
7.3.2 Setting reagent station properties............................................................................................116

6Version 1.6, Revision J
Table of Contents
7.4 Replacing reagents .................................................................................................................119
7.4.1 Remotell/drainscreen ..........................................................................................................119
7.4.2 Remotell/drainconnections..................................................................................................120
7.4.3 Replacingreagent–remotellanddrain .................................................................................121
7.4.4 Replacing reagent – manually..................................................................................................124
7.4.5 Replacingparan ...................................................................................................................125
7.4.6 Filling and draining retorts.......................................................................................................127
8. Ancillary Settings & Operations ................................................................................. 128
8.1 Reagents menu.......................................................................................................................128
8.1.1 Manual operations ..................................................................................................................128
8.2 Administration menu...............................................................................................................129
8.2.1 User management...................................................................................................................130
8.2.2 Reports ..................................................................................................................................131
8.2.3 Event logs...............................................................................................................................135
8.3 Settings menu ........................................................................................................................136
8.3.1 Service...................................................................................................................................136
8.3.2 Processing settings ................................................................................................................138
8.3.3 Instrument settings.................................................................................................................140
8.3.4 Tracking options (optional)......................................................................................................142
9. Cleaning and Maintenance ........................................................................................ 144
9.1 Cleaning and maintenance tools..............................................................................................144
9.1.1 Paranscraper ......................................................................................................................144
9.1.2 Paranbathventplug ............................................................................................................144
9.2 Maintenance screen................................................................................................................145
9.3 Cleaning and maintenance schedule........................................................................................146
9.3.1 Daily tasks..............................................................................................................................148
9.3.2 Weekly tasks ..........................................................................................................................152
9.3.3 60–90 Days ............................................................................................................................155
10. Reference .............................................................................................................. 157
10.1 Reagent threshold guidelines...................................................................................................157
10.2 Protocols................................................................................................................................158
10.2.1Specimen type and protocol duration .......................................................................................158
10.2.2ListofPre-denedprotocols....................................................................................................158
10.2.3Xylene protocols .....................................................................................................................159
10.2.4Xylene-free protocols ..............................................................................................................161
10.2.5Cleaning protocol....................................................................................................................162
10.3 Stationcongurations.............................................................................................................162
10.4 Protocol step temperatures .....................................................................................................165
10.5 Reagent compatibility tables ...................................................................................................165
11. Troubleshooting...................................................................................................... 168
11.1 Preliminary questions .............................................................................................................168
11.2 Flowcharts .............................................................................................................................168
11.2.1Under-processed tissue – instrument setup .............................................................................169
11.2.2Over-processed tissue – instrument setup ...............................................................................170
11.2.3Under- or Over-processed tissue – Reagents ............................................................................171
11.2.4Poor processing – Incorrect protocol.......................................................................................172
11.2.5Poor processing – Correct protocol .........................................................................................173
11.2.6Cutting artifact .......................................................................................................................174

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HistoCore PEGASUS
Table of Contents
11.2.7Staining artifact......................................................................................................................175
11.2.8Block artifact..........................................................................................................................176
11.2.9Reprocessing recommendations..............................................................................................177
11.3 Power failure ..........................................................................................................................180
11.4 Crash or freeze of master software..........................................................................................180
12. Ordering Information................................................................................................ 181
A1. DecontaminationConrmation .................................................................................. 182
A2. Warranty and Service ............................................................................................... 183

8Version 1.6, Revision J
1Important Information
1. Important Information
1.1 Naming conventions
Note
• The full name of the device is HistoCore PEGASUS tissue processor. The device is called
HistoCorePEGASUStoensurethattheInstructionsforUsearewelllegible.
1.2 Symbols and their meanings
Symbol: Title of the symbol: Danger
Description: Indicates an imminently hazardous situation which, if not
avoided, will result in death or serious injuries.
Symbol: Title of the symbol: Warning
Description: If this danger is not avoided, then this may result in death
or serious injury.
Symbol: Title of the symbol: Caution
Description: Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
Symbol: Title of the symbol: Note
Description: Indicates information which is important but not related to
any risk.
Symbol: Title of the symbol: Item number
→Fig. 7-1Description: Item numbers for numbering illustrations. Numbers in red
refer to item numbers in illustrations.
Symbol: Title of the symbol: Software designations
Supervisor Description: Software designations that have to be displayed on the
input screen are displayed as bold, gray text.
Symbol: Title of the symbol: Function key
Save Description: Function keys to be pressed on the instrument are
displayed as bold, gray and underlinded text.
Symbol: Title of the symbol: Keys and switches on the instrument
Power switch Description: Keys and switches on the instrument that are supposed to
be pressed by the user in various situations are displayed
as bold, gray and underlinded text.
Symbol: Title of the symbol: Manufacturer
Description: Indicates the manufacturer of the medical product.

9
HistoCore PEGASUS
1Important Information
Symbol: Title of the symbol: Manufacturing date
Description: Indicates the date when the medical device was
manufactured.
Symbol: Title of the symbol: Article number
Description: Indicates the manufacturer's catalog number so that the
medicaldevicecanbeidentied.
Symbol: Title of the symbol: Serial number
Description: Indicates the manufacturer's serial number so that a
specicmedicaldevicecanbeidentied.
Symbol: Title of the symbol: Consult Instructions for Use
Description: Indicates the need for the user to consult the Instructions
for Use.
Symbol: Title of the symbol: Attention
Description: 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.
Symbol: Title of the 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 the symbol: CE Compliance
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 the symbol: Country of Origin
Description: TheCountryofOriginboxdenestheCountrywherethe
nalcharactertransformationoftheproducthasbeen
performed.
Symbol: Title of the symbol: UKCA
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.
Symbol: Title of the symbol: UKRP
Description: The UK Responsible Person acts on behalf of the non-UK
manufacturertocarryoutspeciedtasksinrelationtothe
manufacturer’s obligations.
Symbol: Title of the 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).

10 Version 1.6, Revision J
1Important Information
Symbol: Title of the 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 the symbol: Alternating current
Symbol: Title of the symbol: PE terminal
Symbol: Title of the symbol: ON (Power)
Description: In the position of power on
Symbol: Title of the symbol: OFF (Power)
Description: In the position of power off
Symbol: Title of the symbol: Warning, hot surface
Description: Instrument surfaces which become hot during operation
are marked with this symbol. Avoid direct contact to
prevent the risk of burning.
Symbol: Title of the symbol: Biohazard warning
Description:
Symbol: Title of the symbol: Flammable
Description: Flammable reagents, solvents, and cleaning agents are
labeled with this symbol.
Symbol: Title of the symbol: Fragile, handle with care
Description: The package contents are fragile and must be handled
with care.
Symbol: Title of the symbol: Store dry
Description: The package must be kept in a dry environment.