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

3
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

5
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

7
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.

11
HistoCore PEGASUS
1Important Information
Symbol: Title of the symbol: Stack limit
Description: Do not stack.
Symbol: Title of the symbol: This way up
Description: Indicates the correct upright position of the package.
Symbol: Title of the symbol: Temperature limit for transport
Description: Indicates the temperature range permitted for transporting
the package.
Symbol: Title of the symbol: Temperature limit for storage
Description: Indicates the temperature range permitted for storing the
package.
Symbol: Title of the symbol: Humidity limitation for transport and storage
Description: Indicates the humidity range permitted for storing and
transporting the package.
Symbol: Title of the symbol: Shockdot Impact Indicator
Description: In the Shockwatch system, the shock dot shows impacts
orshocksthatareaboveaspeciedintensitythroughred
colouration.Exceedingadenedacceleration(gvalue)
causes the indicator tube to change colour.
Symbol: Title of the symbol: Tilt indicator
Description: Tip-n-Tell indicator to monitor whether the shipment
has been transported and stored in an upright position
according to your requirements. With a pitch of 60° or
more,thebluequartzsandowsintothearrow-shaped
indicator window and sticks there permanently. Improper
handling of the shipment is immediately detectable and
canbeprovendenitively.
Symbol: Title of the symbol: CSA symbol
Description: ThisproductfulllstherequirementsoftheCAN/
CSA-C22.2 No. 61010.

12 Version 1.6, Revision J
1Important Information
Symbol: Title of the symbol: Recycle symbol
Description: Indicates the item can be recycled where correct facilities
exist.
1.3 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.
1.4 Intended purpose
TheHistoCorePEGASUSisanautomatedtissueprocessorspecicallydesignedforxation,dehydration,
inltrationwithintermediumandparaninltrationofhumantissuespecimensusedforhistological
medical diagnosis by a pathologist, e.g. for cancer diagnosis.
The HistoCore PEGASUS is designed for in vitro diagnostic applications.
Warning
• Any other use of the instrument is considered Off Label use. Failure to observe these instructions
may result in an accident, personal injury, damage to the instrument, accessories, or specimens.
Proper and intended use includes compliance with all inspection and maintenance instructions,
along with the observance of all instructions in the Instructions for Use.
1.5 Qualicationofpersonnel
• The HistoCore PEGASUS must be operated by trained laboratory personnel only. The instrument is
intended for professional use 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.
1.6 Statement for user data security and privacy
Leica Biosystems respects user data security and privacy. Our statement for user data security and
privacy below will inform you that the below user data will be collected and used by instrument.
• Pictures of baskets with cassettes: Pictures of the baskets including all information on processed
cassettes in baskets will be collected to track the run details of the cassettes and retained for 90 days.
• Use of usernames and user IDs: User account information including user name, password and badge
info for authentication and authorization will be collected, retained till removal by Administrator. And
the database used to store account information will be encrypted.

13
HistoCore PEGASUS
Safety 2
2. Safety
2.1 Safety notes
The Instructions for Use includes important information related to the operating safety and maintenance
of the instrument.
The Instructions for Use is 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 the Instructions for Use.
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
Biosystems products.
The Instructions for Use must be appropriately supplemented as required by the existing regulations on
accident prevention and environmental safety in the operator‘s country.
Warning
• The protective devices located on the instrument and the accessories must not be removed
ormodied.OnlyqualiedservicepersonnelauthorizedbyLeicaBiosystemsmayrepairthe
instrument and access its internal components.
• If the instrument is to be returned to Leica Biosystems for repair, it must be cleaned and
decontaminated in the appropriate manner (→p. 182 – A1. Decontamination Confirmation).
Note
For current information about applicable standards, please refer to the CE Declaration of Conformity
andUKCACerticatesonourInternetsite:
http://www.LeicaBiosystems.com.
Electromagnetic compatibility, emitted interference, and immunity to interference are applicable, as are
the requirements in accordance with IEC/EN 61326-2-6. The requirements in accordance with IEC/EN
61010-1, IEC/EN 61010-2-101, IEC/EN 61010-2-010, and ISO 14971 with regard to safety information are
applicable.
This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may
cause radio interference, in which case, you may need to take measures to mitigate the interference.

14 Version 1.6, Revision J
Safety
2
The electromagnetic environment should be evaluated prior to the operation of the instrument.
Do not use this instrument in close proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these can interfere with the proper operation.
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 instructions and
warnings.
2.2.1 Markings on the instrument itself
Warning
Failuretofollowthecorrectoperatinginstructions(asdenedintheInstructionsforUse)ofthe
corresponding markings and warning triangles on the instrument.
Serious injury of persons and/or damage to instrument, accessories, or specimen.
• Pay attention to the markings on the instrument and strictly follow operating instructions described
in the Instructions for Use when operating or replacing the item marked.
2.2.2 Transport and installation
Warning
Accessories/components may become loose/damaged during transportation.
Sample damage
• The packaging has two indicators, ShockDot Impact Indicator and Tilt Indicator, that indicate
impropertransport.Whentheinstrumentisdelivered,checkthisrst.Ifoneoftheindicators
is triggered, the package was not handled as prescribed. In this case, please mark the shipping
documents accordingly and check the shipment for damage.
Warning
Accessories may fall or drop to users while unpacking.
People injury
• Follow the unpacking instructions carefully to avoid damage to the instrument.
• At least two persons are required when unpacking the instrument.
• Once unpacked, the instrument must be transported only in an upright position.

15
HistoCore PEGASUS
Safety 2
Warning
Theinstrumenttiltswhilemovingduringtherstinstallation.
People injury
• At least two persons are required to hold the instrument when it is rolled off the pallet via the ramp.
Warning
Lift the instrument without tools or equipment.
The instrument may fall or drop on users when being lifted, which causes people injury.
• Always use suitably rated lifting equipment, such as a trolley or forklift, when moving the instrument
upstairs.
Warning
Movetheinstrumentloadedwithreagentsandparan,and/orwithpowercordconnected.
People injury.
• Prior to every transport in which it is possible for the instrument to be shaken, tilted, or lifted, the
instrumentmustbecleanedincludingthetubing,paranbaths,andreagentbottles.Thepower
cord must be disconnected.
Warning
Accessories/components/devices may become loose or damaged during transportation.
Sample damage
• Paranovencoversmustbeclosedduringtransportation.
• Retort lids must be locked during transportation.
Warning
Accessories/components may become loose/damaged during transportation
Sample damage
• Before switching the instrument on, visually check the instrument and accessories for any damages
possibly caused during transportation or while moving the instrument.
Warning
Accessories/components may become loose/damaged during transportation
Sample damage
• Before processing patient tissue samples after transportation or moving the instrument, perform a test
runtoensurethesuitabilityoftheinstrumentandtheprotocolused.Eitheruseapre-denedprotocolor
combine this activity with the validation of your own protocols.
• Only process patient tissue samples for diagnostic purposes, after all the above checks have been
performed successfully. If any of the previous steps failed, do not operate the instrument and
contact your local Leica Biosystems Service Representative.

16 Version 1.6, Revision J
Safety
2
Warning
Insucientornoexhaustsystem/Wrongconnectiontotheexhaustsystem
People injury due to leaked vapor or excessive fumes
• Neverruntheinstrumentwithouttheactivecarbonlteroranexternalexhaustsystem,asthiswill
release potentially dangerous fumes into the laboratory.
• It is recommended to use an external exhaust system.
• Eveniftheinstrumentisconnectedtoanexternalexhaustdevice,theactivecarbonlterprovided
must remain in use.
Warning
The instrument is plugged into a power board with other instruments.
The instrument may work with unstable current/power, which leads to sample damage.
• Do not use an extension cable.
• Plug the instrument only into a grounded power socket. Make sure an obligatory use of a CB (Circuit
breaker).
Warning
Thedriptrayisnotinstalledorisinstalledincorrectlyandliquidowsontotheoor.
People injury.
Environment contamination.
• Do not use the instrument without installing the drip tray.
• Wear PPE (Personal Protection Equipment) when using the instrument.
2.2.3 Operating the instrument
Warning
Theconnectordoesnotmatchthetube/Connectorcorrosion;Reagentbottleoverow(theexternal
reagentquantitydoesnotmatchthereagentbottle,etc.);Bottlefallingduringreagentllorexchange;
The tube becomes loose during draining.
People slip or inhale toxic/dangerous fume.
Biohazard because of waste reagent.
Environment contamination.
• Always wear chemical protective clothing, protective goggles, respirator, rubber gloves, and all
other necessary personal protective equipment, when handling the reagents. Reagents used for
tissueprocessingcanbebothtoxicand/orammable.
• Always use the tube supplied with the instrument.
• Neverllareagentstationthathascontentsalreadyinit.
Warning
Inappropriate carryover settings for the sample types being processed can cause sample damage!
To ensure correct carryover settings:
• For carryover settings, please refer to Chapter 6.1.5 'Carryover setting'.
• Thepre-denedandcustomizedprotocols(carryovervalueincluded)mustbevalidatedbythe
laboratory according to their standard operating procedure.

17
HistoCore PEGASUS
Safety 2
Warning
Thereagentbottleisunderlled(theretortisnotempty).
Sample damage
• Check the retort and make sure nothing is in retort before running a protocol.
Warning
Open/Closeparanbathlid;Fillmeltedparan;Theconnectordoesnotmatchtube/Connector
corrosion;Thetubebecomeslooseduringdraining;Thewasteparancontainerisnotready/not
stable when draining starts via GUI; Pull out the drain tube.
Hands/ngersgetscald.
People slip or inhale toxic/dangerous fume.
Biohazardbecauseofthecontaminatedparan.
Environment contamination.
• Wear chemical protective clothing, protective goggles, respirator, rubber gloves, and all other
necessarypersonalprotectiveequipmentwhenlling/drainingmeltedparan.Usedparancanbe
contaminated.
• Ensureyouusethecorrectsizeparandrainhosetoavoidparanleakage.
• Theparanleavingthetubewillbehotandmaycauseburns.Makesuretheparandrainstoa
suitable container and stand clear while it drains.
• Donotremovetheremotell/draintubeuntilthesoftwareindicatestheprocessiscompleteand
pressurizedairhasclearedthetube.Acessationofreagentowisnotanindicationthatthe
procedure is complete.
Warning
Userdenedprotocolsarenotvalidated.
Sample damage
• Thepre-denedprotocolsandthecustomizedprotocolshavetobevalidatedbytheuserbefore
running the protocol, i.e. tissue processing with patient tissue for diagnostics, according to the
local or regional accreditation requirements.
Warning
The RMS (Reagent Management System) is set to N/A or a wrong value.
The reagent consumption status can not be monitored, which may impact the tissue processing
quality and cause sample damage.
• Do not set the RMS to N/A. Use RMS to monitor reagent consumption status.
• The RMS settings must be validated by the user before running the protocol, i.e. tissue processing
with patient tissue for diagnostics, according to the local or regional accreditation requirements.

18 Version 1.6, Revision J
Safety
2
Warning
Open retort while the instrument is processing/after pausing/after the protocol ends, the user gets
contactwiththehotsurfaceoflid/baskets/uids/hazardousreagents/vaporfromtheretort.
Open the retort and the protocol cannot continue.
People injury/Sample damage/Impaired samples
• Hot surface. Wear chemical protective clothing, protective goggles, respirator, rubber gloves, and all
other necessary personal protective equipment during operation.
• Donotopentheretortlidorremovereagentbottles/paranovencover/paranbathswhena
protocol is running, unless a system message indicates to do so. Whilst a protocol is running, if
you want to remove the specimens from the retort or add specimens to the retort, press the pause
button.
• Takecareifopeningaretortorparanbathafterpausingtheinstrument.Readanywarning
messages—for example, the retort is above safe access temperature—and take appropriate
precautions before continuing.
• Moltenparanishotandmaycauseburns.Becarefulwhenhandlingparanandremoving
baskets.
Warning
Knock retort lids when they are open.
People injury. Fingers or hands are crushed.
• Do not knock retort lids when they are open.
Warning
Processingstartswhenparanisnotcompletelymelted.
Sample damage
• MakesurethattheparanintheparanbathsiscompletelymeltedbeforepressingtheStart
button.
Warning
Samplesarenotcoveredbyreagents/paran.
Samples dried out and got damaged.
• Before running the protocol, check the reagent level in reagent bottles from the outside. Make sure
thatreagentslevelisbetweenMin.andMax.marks.Checktheparanlevelsaswell.
• Do not add samples over the level sensor.
• Do not add specimens more than suggested.
• Always ensure the cassettes are correctly inserted into the baskets and that the baskets are
correctly placed in the retorts.
• Station selection protocols are not recommended for overnight processing. If a reagent becomes
unavailableforanyreason,thentheprotocolcannotnish.

19
HistoCore PEGASUS
Safety 2
Warning
Incorrect setup of the concentrations
Sample damage or reduction in tissue processing quality
• Do not alter the concentration of a used reagent unless you are able to verify the actual
concentration.
Warning
Wrongly set up reagent temperature threshold over its boiling point.
People injury/Sample damage/Environment contamination due to excessive fumes generated during
processing.
• Take extreme care when deciding to change a reagent temperature threshold. Raised thresholds
can lead to reagents boiling. Boiling reagents will release large quantities of fumes that may
overloadtheinternalactivecarbonlteror(iftted)theexternalexhaustsystem.Boiling
reagents are also likely to lead to excessive pressures within the instrument, increased reagent
contamination and reagent spills. Reagent boiling points are lower when in a retort operating with a
vacuum or with pressure/vacuum cycling.
• Neverruntheinstrumentwithouttheactivecarbonlteroranexternalexhaustsystem.Evenifthe
instrumentisconnectedtoanexternalexhaustdevice,theactivecarbonlterprovidedmustremain
in use.
Warning
Wrongdenitionofreagents
SampledamagecausedbyreagentsmismatchbetweenGUIdenitionsandbottlelabels.
• Always update station details correctly.
• Alwayscheckthedenitionofstationsat/beforetheprotocolsstart.
• Never update the details without replacing the reagent.
Warning
Ignore the information provided by the instrument.
Update reagent/station parameters but not replace the reagent.
DonotupdatethereagentstatusonGUIfromEmptytoFullafterllingthebottle.
OrsetthestatustoFullbeforellingthebottle,butnotllingthebottleorunderllingthebottle.
Sampledamagecausedbydirtyorexpiredreagent,orinsucientreagent.
Delay of diagnosis.
• Always change reagents when prompted.
• Always update station details correctly.
• Never update the details without replacing the reagent.

20 Version 1.6, Revision J
Safety
2
Warning
Fill the reagent from an unstable container.
Peopleinjury-Thell/drainfunctionsincludeastrongpurgewhichmaycauseanunstablecontainer
to tip over and spill. The user may slip on the spilled reagent on the ground.
Environment contamination.
• Alwaysensurethatyoullfromordraintoalargestablecontainer.Thecontainermustalsobeof
sucientvolumetoeasilyaccommodateallofthedraineduid.Ifyouuseasmallcontaineryou
mustsupportthecontainerandtubeduringthellordrain.
• Always use the tube supplied with the instrument.
• Always wear chemical protective clothing, protective goggles, respirator, rubber gloves, and all
other necessary personal protective equipment, when handling the reagents. Reagents used for
tissueprocessingcanbebothtoxicand/orammable.
Warning
The instrument runs with a missing reagent bottles or with a loose or missing reagent bottle caps.
People slip or inhale toxic/dangerous fume.
Environment contamination.
• Never run the instrument with missing bottles or with loose or missing bottle caps.
• Neverruntheinstrumentwithoutthecarbonlteroranexternalexhaustsystem,asthiswillrelease
potentially dangerous fumes into the laboratory.
Warning
The instrument runs with a missing condensate bottle or with a loose or missing condensate bottle
cap.
People slip or inhale toxic/dangerous fume.
Biohazard due to the leak of toxic/dangerous fume.
• Never run the instrument with missing bottles or with loose or missing bottle caps.
• Neverruntheinstrumentwithoutthecarbonlteroranexternalexhaustsystem,asthiswillrelease
potentially dangerous fumes into the laboratory.
Warning
Knockparanbathlidswhentheyareopen.
People injury
• Takecarenottoknockparanbathlidswhentheyareopen.Theycouldcrushngersorhands.
Warning
Openaparanbathlidwhenthereisparaninaretortorparanisbeingtransferred.
People injury
• Neveropenaparanbathlidwhenthereisparaninaretortorparanisbeingtransferred.Hot
paranmaysplashoutofthebath.