Leica BIOSYSTEMS HistoCore SPECTRA CV User manual

HistoCore SPECTRA CV
Coverslipper
Instructions for Use
English
Order No.: 14 0514 80101 - Revision L
Always keep this manual with the instrument.
Read carefully before working with the instrument.
Version 2.2, Revision L - 02.2022

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HistoCore SPECTRA CV
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
Note

4Version 2.2, Revision L
Table of contents
1. Important Notes ..........................................................................................................7
1.1 Symbols and their meanings....................................................................................................... 7
1.2 Instrument type ........................................................................................................................11
1.3 User group................................................................................................................................11
1.4 Intended purpose......................................................................................................................12
1.5 Copyright – Instrument software ...............................................................................................12
2. Safety...................................................................................................................... 13
2.1 Safety notes .............................................................................................................................13
2.2 Hazard warnings.......................................................................................................................14
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 ..........................................................................................................................19
3.3 General overview - front view .....................................................................................................21
3.4 General overview - rear view ......................................................................................................22
3.5 General overview - inside view ...................................................................................................23
4. Installation and Instrument Setup................................................................................. 24
4.1 Installation site requirements ....................................................................................................24
4.2 Electrical connection.................................................................................................................25
4.2.1 Internal battery .........................................................................................................................26
4.2.2 Using an external uninterruptible power supply (UPS) .................................................................26
4.3 Exhaust air connection..............................................................................................................27
4.4 Installing the accessories..........................................................................................................27
4.4.1 Fit the drawer inserts into the unload drawer..............................................................................27
4.4.2 Inserting the waste tray.............................................................................................................28
4.4.3 Filling and inserting the needle cleaning container......................................................................29
4.5 Switching on and shutting down the instrument..........................................................................30
4.6 Rellingconsumables ...............................................................................................................32
4.6.1 Inserting a coverglass cartridge.................................................................................................33
4.6.2 Inserting the mounting medium bottle and prime bottle ..............................................................34
4.6.3 Preparethereagentvessel,llitandinsertitintotheloaddrawer...............................................37
5. Operation ................................................................................................................. 39
5.1 User interface – overview..........................................................................................................39
5.1.1 Grayed out function keys...........................................................................................................40
5.2 Elements of the status display...................................................................................................41
5.3 Process status display ..............................................................................................................42
5.4 Consumables Management System (CMS).................................................................................43
5.5 Displaying the drawers ..............................................................................................................44
5.6 Main menu overview .................................................................................................................45
5.6.1 Entry keyboard..........................................................................................................................46
5.7 User settings ............................................................................................................................48
5.8 Basic settings...........................................................................................................................50
5.8.1 Language settings ....................................................................................................................51
5.8.2 Regional settings ......................................................................................................................51
5.8.3 Date and time ...........................................................................................................................52
5.8.4 Menu for alarm sounds – Error and signal sounds ......................................................................53

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HistoCore SPECTRA CV
Table of contents
5.8.5 Oven settings............................................................................................................................55
5.8.6 Volume calibration....................................................................................................................59
5.8.7 Data management.....................................................................................................................61
5.8.8 Event view ................................................................................................................................63
5.9 Parameter settings....................................................................................................................66
5.9.1 Creating a new parameter set ....................................................................................................67
5.9.2 Assigning a parameter set to a rack handle color........................................................................67
5.9.3 Properties of the mounting medium...........................................................................................70
5.9.4 Properties of the coverglass......................................................................................................70
5.9.5 Adjustment of the application volume........................................................................................71
5.10 Reagent vessels in the load drawer ............................................................................................72
5.11 Module status...........................................................................................................................74
6. Daily Instrument Setup ............................................................................................... 75
6.1 Station overview .......................................................................................................................75
6.2 Switching on and shutting down the instrument..........................................................................76
6.3 Checkingandrellingconsumables...........................................................................................77
6.3.1 Changing the mounting medium bottle.......................................................................................78
6.3.2 Monitoringandrellingoftheneedlecleaningcontainer.............................................................81
6.3.3 Checking and replacing the coverglass cartridge ........................................................................82
6.3.4 Emptying the waste tray ............................................................................................................86
6.3.5 Inspect Pick&Place module .......................................................................................................86
6.3.6 Load drawer .............................................................................................................................87
6.3.7 Unload drawer ..........................................................................................................................88
6.4 Preparing the rack.....................................................................................................................89
6.5 Brief inspection before starting the coverslipping operation........................................................92
6.5.1 Procedure of the coverslipping operation ...................................................................................92
6.6 Starting the coverslipping operation...........................................................................................94
6.6.1 Monitoring the coverslipping operation ......................................................................................97
6.6.2 Coverslippingoperationnished................................................................................................97
6.6.3 Pausing or canceling the coverslipping operation .......................................................................99
6.7 Workstation operation ............................................................................................................101
6.7.1 Notes on workstation mode.....................................................................................................101
6.7.2 Starting the coverslipping operation in workstation mode .........................................................104
7. Cleaning and Maintenance ........................................................................................ 105
7.1 Important notes about cleaning this instrument........................................................................105
7.2 Description of cleaning individual instrument components and areas ........................................105
7.2.1 Exterior surfaces, varnished surfaces, instrument hood ............................................................105
7.2.2 TFT touchscreen.....................................................................................................................106
7.2.3 Load and unload drawers ........................................................................................................106
7.2.4 Interior cleaning......................................................................................................................107
7.2.5 Cleaning the prime bottle ........................................................................................................109
7.2.6 Cleaning the cannulas for the mounting medium bottle.............................................................109
7.2.7 Cleaning the needle.................................................................................................................109
7.2.8 Filling and changing the needle cleaning container ...................................................................110
7.2.9 Removing the complete unit of the needle cleaning container ...................................................111
7.2.10Cleaning the Pick&Place module..............................................................................................114
7.2.11Exchange suction cups............................................................................................................114
7.2.12Cleaning the waste tray ...........................................................................................................115
7.2.13Cleaning the reagent vessels...................................................................................................116

6Version 2.2, Revision L
Table of contents
7.2.14Rack and handle .....................................................................................................................116
7.2.15Changingtheactivecarbonlter..............................................................................................117
7.2.16Cleaning reagent vessels in the load drawer .............................................................................118
7.3 Preparing the hose system for priming and cleaning.................................................................118
7.3.1 Quick Prime............................................................................................................................121
7.3.2 Extended Prime ......................................................................................................................122
7.3.3 Cleaning the hose system........................................................................................................123
7.3.4 Recommissioning after transport or storage.............................................................................127
7.4 Recommended cleaning and maintenance intervals..................................................................127
7.4.1 Daily cleaning and maintenance...............................................................................................128
7.4.2 Weekly cleaning and maintenance ...........................................................................................129
7.4.3 Quarterly cleaning and maintenance ........................................................................................130
7.4.4 Cleaning and maintenance as necessary..................................................................................130
8. Malfunctions and Troubleshooting ............................................................................. 131
8.1 Troubleshooting......................................................................................................................131
8.2 Power failure scenario and instrument failure...........................................................................136
8.3 Manual removal of a rack in the event of instrument malfunctions.............................................138
8.3.1 Malfunction at the coverglass receptacle .................................................................................140
8.3.2 Removing a rack from the elevator of the coverslip line.............................................................142
8.3.3 Removing the rack from the lower area of the left elevator........................................................147
8.3.4 Removing the rack from the oven or from behind the oven ........................................................148
8.3.5 Removal of the rack from the rotator........................................................................................150
8.3.6 Removal of the rack from the gripper of the transport arm above the rotator..............................150
8.3.7 Removal of a rack from the transfer station of the HistoCore SPECTRA ST.................................150
8.4 Replacing main fuses..............................................................................................................152
9. Optional Accessories and Consumables ...................................................................... 153
9.1 Optional accessories ..............................................................................................................153
10. Warranty and Service ............................................................................................... 159
11. Decommissioning and Disposal ................................................................................. 160
12. DecontaminationCerticate...................................................................................... 161

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HistoCore SPECTRA CV
1Important Notes
1. Important Notes
1.1 Symbols and their meanings
Symbol: Title of the symbol: Hazard warning
Description: Warningsaredisplayedinawhiteeldwithan
orangetitlebar.Warningsareidentiedbya
warning triangle.
Symbol: Title of the symbol: Note
Description: Notes, i.e. important information for the user,
aredisplayedinawhiteeldwithabluetitle
bar.Notesareidentiedbyanotication
symbol.
Symbol: Title of the symbol: Item number
→"Fig. 7 – 1"Description: 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: Software symbols that have to be pressed on
the input screen are displayed as bold, gray and
underlined text.
Symbol: Title of the symbol: Keys and switches on the instrument
Main 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 text.
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: Warning, hot surface
Description: Instrument surfaces which become hot during
operation are marked with this symbol. Avoid
direct contact to prevent risk of burning.
Symbol: Title of the symbol: Check display for messages
Description: Messages in the display have to be read by the
user.
Symbol: Title of the symbol: Manufacturer
Description: Indicates the manufacturer of the medical
product.

8Version 2.2, Revision L
1Important Notes
Symbol: Title of the symbol: Date of manufacture
Description: Indicates the date when the medical device was
manufactured.
Symbol: Title of the symbol: CE Label
Description: The CE marking is the manufacturer's
declaration that the medical product meets the
requirements of the applicable EC directives
and regulations.
Symbol: Title of the symbol: UKCA Label
Description: The UKCA (UK Conformity Assessed) marking
is a new UK product marking that is used for
goods being placed on the market in Great
Britain (England, Wales and Scotland). It covers
most goods which previously required the CE
marking.
Symbol: Title of the symbol: CSA Statement (Canada/USA)
Description: CSA Mark shown with adjacent indicators
'C' and 'US' for canada and US (indicating
that products have been manufactured to
the requirements of both Canadian and U.S.
Standards) or with adjacent indicator 'US' for
US only or without either indicator for Canada
only.
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: 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: WEEE symbol
Description: The WEEE symbol, indicating separate
collection for WEEE - Waste of electrical and
electronic equipment, consists of the crossed-
out wheeled bin (§ 7 ElektroG).
Symbol: Title of the symbol: Alternating current
Symbol: Title of the symbol: Article number
Description: Indicates the manufacturer's catalog number
sothatthemedicaldevicecanbeidentied.

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HistoCore SPECTRA CV
1Important Notes
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: UDI
Description: UDIstandsforUniqueDeviceIdentierand
isauniqueproductidenticationnumberfor
medical devices consisting of a QR code and
the GTIN/EAN number of the product.
Symbol: Title of the symbol: UK Responsible Person
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: ON (Power)
Description: The power supply is connected upon pushing
the Power switch.
Symbol: Title of the symbol: OFF (Power)
Description: The power supply is disconnected upon
pushing the Power switch.
Symbol: Title of the symbol: Warning, risk of electric shock
Description: Instrument surfaces or areas which become
energized during operation are marked with
this symbol. Therefore, direct contact is to be
avoided.
Symbol: Title of the symbol: Caution: danger of crushing
Symbol: Title of the symbol: Flammable
Description: Inammablereagents,solventsandcleaning
agents are marked with this symbol.
Symbol: Title of the symbol: Observe the laser beam warning and
Instructions for Use
Description: The product uses a class 1 laser source.
The safety notes for handling lasers and the
Instructions for Use must be observed.

10 Version 2.2, Revision L
1Important Notes
Symbol: Title of the symbol: IPPC symbol
Description: The IPPC symbol includes:
• IPPC symbol
• Country code in accordance with ISO 3166,
e.g. DE for Germany
• Regionalidentier,e.g.HEforHesse
• Registration number, unique number
beginning with 49
• Treatment method, e.g. HT (heat treatment)
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: Fragile, use with care
Description: Indicates a medical device that can be broken
or damaged if not handled carefully.
Symbol: Title of the symbol: Store dry
Description: Indicates a medical device that needs to be
protected from moisture.
Symbol: Title of the symbol: Do not stack
Description: Stacking of the transport package is not
allowed and no load should be placed on the
transport package.
Symbol: Title of the symbol: This way up
Description: Indicates correct upright position of the
transport package.
Symbol: Title of the symbol: Temperature limit for transport
Description: Indicates the temperature limits for transport
to which the medical device can be safely
exposed.

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HistoCore SPECTRA CV
1Important Notes
Symbol: Title of the symbol: Temperature limit for storage
Description: Indicates the temperature limits for storage
to which the medical device can be safely
exposed.
Symbol: Title of the symbol: Humidity limitation for transport and storage
Description: Indicates the range of humidity for transport
and storage to which the medical device can be
safely exposed.
Appearance: Indication: Tilt indicator
Description: Indicator to monitor whether the shipment has
been transported and stored in upright position
according to your requirements. With a pitch
of60°ormore,thebluequartzsand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.
Note
• When delivering the instrument, the recipient must check that the tilt indicator is intact. The
responsibleLeicarepresentativemustbenotiediftheindicatorhasbeentriggered.
• The Instructions for Use are accompanied by a bound "RFID Registration" supplemental sheet. This
supplementalsheetcontainscountry-specicinformationfortheuseraboutthemeaningofthe
RFID symbols and registration numbers available on the packaging or the HistoCore SPECTRA CV
nameplate.
1.2 Instrument type
All information provided in these Instructions for Use applies only to the instrument type indicated on
the title page. A nameplate indicating the instrument serial number is attached to the rear side of the
instrument.
1.3 User group
• The HistoCore SPECTRA CV must only be operated by authorized personnel comprehensively trained in
using lab reagents and their application in histology.
• All laboratory personnel designated to operate this instrument must read these Instructions for Use
carefully and must be familiar with all technical features of the instrument before attempting to
operate it. The instrument is intended for professional use only.

12 Version 2.2, Revision L
1Important Notes
1.4 Intended purpose
TheHistoCoreSPECTRACVisanautomatedcoverslipperspecicallydesignedforapplyingmounting
media between a slide and coverglass. Then a coverglass is applied to preserve the specimen and to
create a uniform visual surface for microscopic research on histological and cytological tissue samples
for medical diagnosis by a pathologist, e.g. for cancer diagnosis.
The HistoCore SPECTRA CV is designed for in vitro diagnostic applications.
Warning
Any use of the instrument that deviates from the intended purpose is considered improper. Failure
to adhere to these instructions may result in an accident, personal injury, damage to the instrument
or accessory equipment. Proper and intended purpose includes compliance with all inspection and
maintenance instructions, along with the observance of all notes in the Instructions for Use as well as
the constant inspection of the media being used for storage life and quality.
1.5 Copyright – Instrument software
The software installed and used on the HistoCore SPECTRA CV is subject to the following license
agreements:
1. GNU General Public License Version 2.0, 3.0
2. GNU Lesser General Public License 2.1
3. additional software not licensed under the GPL/LGPL
Thecompletelicenseagreementsfortherstandseconditemsinthelistcanbefoundontheprovided
language CD (→P. 18 – 3.1 Standard delivery – packing list) in the Software Licenses directory.
Leica Biosystems provides a complete machine-readable copy of the source code to every third party
in compliance with the agreements of the GPL/LGPL applicable for the source code or of the other
applicable licenses. To contact us, go to www.leicabiosystems.com and use the corresponding contact
form.

13
HistoCore SPECTRA CV
Safety 2
2. Safety
2.1 Safety notes
Warning
• 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 instruments.
• 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mayrepairtheinstrumentandaccessits
internal components.
Residual risks:
• The instrument has been designed and constructed with the latest state-of-the-art technology and
according to recognized standards and regulations with regard to safety technology. Operating or
handling the instrument incorrectly can place the user or other personnel at risk of injury or death or
can cause damage to the instrument or property.
• The instrument may be used only as intended and only if all of its safety features are in proper
working condition.
• If malfunctions occur that can impede safety, the instrument must be put out of operation
immediatelyandtheresponsibleLeicaservicetechnicianmustbenotied.
• Only original spare parts and approved original Leica accessories may be used.
• Electromagnetic compatibility, emitted interference and immunity to interference are applicable,
asaretherequirementsinaccordancewithIEC61326-2-6.Therequirementsinaccordancewith
IEC 61010-1, IEC 61010-2-101, IEC 62366 and ISO 14971 with regard to safety information are
applicable.
These Instructions for Use include important instructions and information related to the operating safety
and maintenance of the instrument. The Instructions for Use are an important part of the product, and
must be read carefully prior to startup and use and must always be kept near the instrument.
Note
These Instructions for Use must be appropriately supplemented as required by the existing regulations
on accident prevention and environmental safety in the operator‘s country.
The instrument's EC Declaration of Conformity and UKCA Declaration of Conformity can be found on
the Internet at:
http://www.LeicaBiosystems.com
This instrument has been built and tested in accordance with the safety requirements for electrical
equipment for measurement, control, and laboratory use. To maintain this condition and ensure safe
operation, the user must observe all notes and warnings contained in these Instructions for Use.

14 Version 2.2, Revision L
Safety
2
Warning
• The presence of malware on the system can lead to uncontrolled system behavior. Ensuring that the
behavioroftheinstrumentconformstospecicationsisnolongerpossibleinthiscase!Iftheuser
suspectsmalwareisonthesystem,thelocalITdepartmentmustbenotiedimmediately.
• You must make sure that any data loaded onto the instrument is free of viruses. No anti-virus
software is provided.
• Theinstrumentisonlysuitedforintegrationinarewall-protectednetwork.Leicashallnotassume
any liability for errors due to integration in an unprotected network.
• ONLY technicians trained and permitted by Leica can connect a USB input device (mouse/keyboard,
etc.) for service and application diagnostics only.
In the interest of specimen safety, the HistoCore SPECTRA CV indicates when it is necessary
for the user to intervene using on-screen messages and audible signals. Therefore, the
HistoCore SPECTRA CV robotic coverslipper requires that the user is within hearing distance during
operation.
Warning
The product uses a class 1 laser source.
Attention,laserradiation!Donotlookintothebeam!Thiscancauseinjurytotheretinaoftheeye.
Warning
LASER RADIATION - DO NOT
STARE INTO BEAM
ISO 60825-1: 2014
P<390 µW, λ= 630 to 670 nm
Pulse duration = 500 µs
Class 1 laser product
2.2 Hazard 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, make sure to comply with the following notes and
warnings.
Please note that electrostatic discharges can result due to direct or indirect contact with the
HistoCore SPECTRA CV.
Warning
Markings on the instrument surface showing the warning triangle indicate that the correct operating
instructions(asdenedintheseInstructionsforUse)mustbefollowedwhenoperatingorreplacing
the item marked. Failure to adhere to these instructions may lead to accidents causing personal injury
and/or damage to the instrument or accessories or destroyed, unusable specimens.

15
HistoCore SPECTRA CV
Safety 2
Warning
Certain surfaces of the instrument are hot during operation under normal conditions. They are marked
with this warning sign. Touching these surfaces without suitable safety measures can cause burns.
Warnings - Transport and installation
Warning
• The instrument must only be transported in an upright position.
• Theemptyweightoftheinstrumentis115kg;therefore,fourqualiedpersonsarerequiredtoliftor
carrytheinstrument!
• Usenon-skidglovestolifttheinstrument!
• A Leica service technician must carry out any transport, installation or possible move of the
instrument.
• Retain the instrument packaging.
• Placetheinstrumentonasturdylaboratorybenchwhichhasasucientloadcapacityandadjustit
to a horizontal position.
• A Leica service technician must re-level and recalibrate the instrument after any transport.
• Prevent the instrument from being exposed to direct sunlight.
• Only connect the instrument to a grounded power socket. Do not interfere with the grounding
function by using an extension cord without a ground wire.
• Exposure to extreme temperature changes between storage and installation locations and high air
humidity may cause condensation inside the instrument. If this is the case, wait at least two hours
before switching on the instrument.
• The installation of the instrument at the area of use and a possible transport to a new location can
only take place with the help of a Leica service technician.
• A Leica service technician must carry out the recommissioning of the instrument.
Warnings – Handling reagents
Warning
• Cautionwhenhandlingsolventsandmountingmedia!
• Coverthereagentvesselsduringinstrumentpausestoavoidevaporationofthelledreagent.
Caution!Reagentvapors(e.g.xylene)canbeirritating.
• Always wear protective clothing suitable for laboratory use, as well as rubber gloves and safety
goggles when handling the chemicals and mounting medium used in this instrument.
• The installation site must be well-ventilated. In addition, we highly recommend connecting
the instrument to an external exhaust air extraction system. The chemicals to be used in the
HistoCoreSPECTRACVareammableandhazardoustohealth.
• Do not operate the instrument in rooms with an explosion hazard.
• The user is responsible for monitoring the expiration date of other reagents used with the
HistoCore SPECTRA CV (e. g. xylene in the reagent vessels and the needle cleaning containers).
Expired reagents must be replaced immediately and disposed of. When disposing of consumed,
expired or used-up reagents, the applicable local regulations and the waste disposal regulations of
the company/institution in which the instrument is being operated have to be observed.
• Reagentvesselsmustalwaysbelledoutsideoftheinstrumentincompliancewiththesafety
information.
• Dangerofexplosionandpotentialrespiratorytractirritationduetoammable,evaporativereagents
in the oven.

16 Version 2.2, Revision L
Safety
2
Warnings – Operating the instrument
Warning
• The instrument may be operated by trained laboratory personnel only. It must only be operated for
the purpose of its designated use and according to the instructions contained in these Instructions
forUse.Antistaticprotectiveclothingmadefromnaturalbers(e.g.cotton)shouldbewornwhen
working with the instrument.
• When working with the instrument, wear suitable protective clothing (lab coat, safety goggles and
gloves) for protection against reagents.
• In the event of an emergency, shut down the Main switch (→Fig. 1-8)and unplug the instrument
from the Power supply (→Fig. 2-2)(circuit breaker in accordance with EN ISO 61010-1).
• For severe instrument faults, the warning and error messages on the screen must be followed.
Samples located in the process must be removed from the instrument immediately. The user is
responsible for the safe further processing of the samples.
• Thereisarehazardifworkwithanexposedame(e.g.Bunsenburner)iscarriedoutinthedirect
vicinity of the instrument (solvent vapors). Therefore, keep all ignition sources at least 2 meters
awayfromtheinstrument!
• Beabsolutelycertaintooperatetheinstrumentwiththeactivecarbonlter.Inaddition,wehighly
recommend connecting the instrument to an external exhaust air extraction system because using
theinstrumentmayresultintheformationofsolventvaporsthatarebothammableandhazardous
to health, even when the instrument is used according to its intended purpose.
• The user must stay within earshot during the operation in order to react immediately during
instrument malfunctions.
• The use of Power over Ethernet (PoE) is not allowed using the RJ45 slot (→Fig. 2-1)located at the
back of the instrument.
• The USB 2.0 slot (→Fig. 1-7)at the front of the instrument only accepts passive devices (without
connection to the power supply, e. g. USB sticks).
Note
For instrument fume control, Leica recommends a delivery volume of 50 m3/h and an 8x air exchange
rate (25 m3/m2h) in the lab.
Warning
• Personal protective clothing in the form of a respirator must be worn when working directly with
reagent vessels that contain solvents.
• Opening the hood when one or more coverslipping process(es) are active causes delays, since no
transport movements take place during this time. Tissue samples might dry out.
• Make sure to keep the instrument cover closed while processing is active. Leica assumes no
liability for loss of quality caused by opening the instrument hood during processing.
• ATTENTIONwhenclosingthehood:Crushinghazard!Donotreachintotheswivelrangeofthe
hood!
• Liquid must not get behind covers or in gaps while operating or cleaning the instrument.

17
HistoCore SPECTRA CV
Safety 2
Warnings - Cleaning and Maintenance
Warning
• The instrument should always be cleaned after the end of work, but BEFORE the instrument is
shut down. An exception from this is cleaning the interior (→P. 107 – 7.2.4 Interior cleaning).
Werecommendcleaningwhiletheinstrumentisshutdown.
• When cleaning the instrument, wear suitable protective clothing (lab coat, cut-resistant gloves and
safety goggles) to protect from reagents.
• When using cleaners, please comply with the safety instructions of the manufacturer and the
laboratory safety regulations.
• Do not use any of the following for cleaning the outside surfaces of the instrument: alcohol,
detergents containing alcohol (glass cleaners), abrasive cleaning powders, solvents containing
acetone,ammonia,chlorine,orxylene!
• Cleanthehoodandhousingusingmildcommercial,pH-neutralhouseholdcleaners.Thenished
surfacesarenotresistanttosolventsandxylenesubstitutes!
• Theplasticreagentvesselscanbecleanedinadishwasheratamaximumtemperatureof+65 °C.
Any standard cleaning agent for laboratory dishwashers may be used. Never clean the plastic
reagent vessels at higher temperatures since higher temperatures can cause the reagent vessels to
become deformed.
2.3 Safety features on the instrument
Warning
• Make sure to keep the hood closed whenever coverslipping processes are active. Leica assumes no
liability for loss of quality caused by opening the hood during processing.
• If the hood of the instrument is opened, the movements are stopped for safety reasons as soon as
theslidecurrentlybeingcoverslippedisnishedbeingcoverslippedinordertoavoidanyriskof
specimen damage due to collision with moving parts.
• Opening the hood when one or more coverslipping process(es) is/are active causes delays in the
respective processing steps since no transport movements take place for this time frame.
• To ensure smooth operation of the instrument software, the instrument must be restarted by the
user at least every 3 days.

18 Version 2.2, Revision L
InstrumentComponentsandSpecications
3
3. InstrumentComponentsandSpecications
3.1 Standard delivery – packing list
Qty Designation Order No.
1 HistoCore SPECTRA CV basic instrument (local power cord included) 14 0514 54200
4 Rack for 30 slides (3 pcs. per package) 14 0512 52473
1 Handle for rack for 30 slides (yellow, 3 pcs. per package) 14 0512 52476
1 Handle for rack for 30 slides (light blue, 3 pcs. per package) 14 0512 52477
1 Handle for rack for 30 slides (red, 3 pcs. per package) 14 0512 52480
1 Handle for rack for 30 slides (white, 3 pcs. per package) 14 0512 52484
2 Label cover S 14 0512 53748
2 Label cover, blank 14 0512 47323
2 Reagent vessel, assembly, each consisting of 1 pc.: 14 0512 47086
Reagent vessel 14 0512 47081
Reagent vessel cover 14 0512 47085
Reagent vessel handle 14 0512 47084
1 Prime bottle, assembly, consisting of: 14 0514 53931
1 Lab bottle, 150 ml 14 0514 56202
1 Screw cap 14 0478 39993
1 Prime bottle insert 14 0514 57251
1 28x3 mm O-ring 14 0253 39635
1 Cleaning bottle 14 0514 57248
2 Needle cleaning container, kit (2 pcs. per kit, as reserve) 14 0514 54195
3 Rack storage rails for the unload drawer 14 0514 56165
1 Exhaust air hose set, consisting of: 14 0514 54815
1 Exhaust air hose, 2 m 14 0422 31974
1 Hose clamp 14 0422 31973
1 Pair of cut-resistant gloves, size M 14 0340 29011
1 Tool kit HistoCore SPECTRA CV, consisting of: 14 0514 54189
1 Screwdriver, 5.5x150 14 0170 10702
1 Leica brush 14 0183 30751
2 T16A fuse 14 6000 04696
1Activecarbonlterset,consistingof: 14 0512 53772
2Activecarbonlter 14 0512 47131
4 Suction cups (as reserve) 14 3000 00403
2 Waste trays 14 0514 49461
1 International bundle Instructions for Use (incl. English printout and
additional languages on a data storage device 14 0514 80200)
14 0514 80001
If the local power cord is defective or lost, please contact your local Leica representative.

19
HistoCore SPECTRA CV
InstrumentComponentsandSpecications 3
Note
The delivered components must be carefully compared against the packing list, delivery note, and your
order.Shouldyoundanydiscrepancies,pleasecontactyourLeicasalesocewithoutdelay.
3.2 Technical data
Nominal supply voltages: 100–240VAC+10%
Nominal frequency: 50/60 Hz
Power draw: 1100 VA
Fuses: 2 x T16 A H 250 V AC
IEC1010classication: Protection class 1
Pollution degree in accordance with IEC61010-1: 2
Overvoltage category in accordance with IEC61010-1: II
Exhaust air: Hose length: 2000 mm
Inner diameter: 50 mm
Outer diameter: 60 mm
Exhaust performance: 30 m3/h
Exhaust extraction: Activecarbonlterandexhausthoseforconnectingwithanexternal
exhaust system.
Heat emission: 1100 J/s
A-weighted noise level, measured at 1 m distance: < 70 dB (A)
Connections:
1 x RJ45 Ethernet (rear): RJ45 - LAN (external data management)
1 x RJ45 Ethernet (front): Only for service purposes
2 x USB 2.0 (front): 5 V/500 mA (service & data storage)
International protection class:
1stparameter=Protectedagainstxedforeignbodieswitha
diameter≥12.5mm
2nd parameter = No protection against water
IP20
Ambient conditions:
Operation: Temperature: +18 °Cto+30 °C
Relative humidity: 20 %to80 %,non-condensing
Operating elevation: Up to a max. of 2000 m above sea
level
Storage: Temperature: +5 °Cto+50 °C
Relative humidity: 10 %to85 %,non-condensing
Transport: Temperature: -29 °Cto+50 °C
Relative humidity: 10 %to85 %,non-condensing

20 Version 2.2, Revision L
InstrumentComponentsandSpecications
3
HistoCore SPECTRA CV
Dimensions and weights:
Dimensions
(length x depth x height):
Hood closed: 690 x 785 x 615 mm
Hood opened: 690 x 785 x 1060 mm
Weight, empty (without
reagents and accessories):
115 kg
Weight,lled(withreagents
and accessories):
120 kg
Workstation dimensions
and weights
(HistoCore SPECTRA CV and
HistoCore SPECTRA ST):
Dimensions
(length x depth x height):
Hood closed: 2044 x 785 x 615 mm
Hood opened: 2044 x 785 x 1060 mm
Weight, empty (without
reagents and accessories):
280 kg
Weight,lled(withreagents
and accessories):
335 kg
Performance: Usable slides: In accordance with DIN ISO 8037-1
(76 mm x 26 mm)
Coverglass cartridge capacity: Exclusively Leica consumables with
300 coverglasses per magazine
Coverglasses: Exclusively Leica consumables.
Available size:
50 mm x 24 mm, thickness: No. 1
In accordance with ISO 8255-1
Mounting medium application
quantity:
Preset value corresponding to
coverglass size. Fine adjustment by
users possible.
Types of mounting media: Exclusively Leica consumables:
X1 mounting medium
Capacity of mounting medium
bottle:
At least 1600 slides
Racks: Leica rack for 30 slides
Factory settings: Mounting medium application
volume:
0 (→P. 59 – 5.8.6 Volume
calibration)
Oven temperature: 40 °C(notchangeable)
Oven step: Enabled
Date format: International (DD.MM.YYYY)
Time format: 24 h
Language: English
Note
When using an external uninterruptible power supply (UPS), it should be designed for an output of at
least 1100 VA and ensure operation over a time frame of at least 10 minutes.