Leica CV5030 User manual

Leica CV5030
Robotic Cover Slipper
Instructions for Use
English
Order No.: 14 0478 80101 - Revision M
Always keep this manual with the instrument.
Read carefully before working with the instrument.
Version 3.4, Revision M - 04.2021

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
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Leica CV5030

4Version 3.4, Revision M
Table of Contents
Version 3.4, Revision M
4
1. Important Information ..................................................................................................7
1.1 Symbols and their meanings....................................................................................................... 7
1.2 Qualicationofpersonnel ........................................................................................................ 10
1.3 Intended use of instrument....................................................................................................... 11
1.4 Instrument type ....................................................................................................................... 11
2. Safety......................................................................................................................12
2.1 Safety notes ............................................................................................................................ 12
2.2 Warnings................................................................................................................................. 12
3. InstrumentComponentsandSpecications ...................................................................15
3.1 Overview - instrument components ........................................................................................... 15
3.2 Technical data ......................................................................................................................... 16
3.3 Standard delivery – packing list................................................................................................ 17
4. Instrument Setup.......................................................................................................19
4.1 Installation site requirements ................................................................................................... 19
4.2 Unpacking the Leica CV5030 .................................................................................................... 20
4.2.1 Setting up the Leica CV5030..................................................................................................... 22
4.3 Preparing and adjusting the instrument..................................................................................... 22
4.3.1 Removing or installing the transport anchors............................................................................. 23
4.4 Leveling the instrument............................................................................................................ 24
4.5 Exhaust system ....................................................................................................................... 25
4.5.1 Insertingtheactivecarbonlter ............................................................................................... 25
4.5.2 Attaching the exhaust hose ...................................................................................................... 26
4.6 Installing the dispenser group................................................................................................... 26
4.7 Aligning the dispenser needle height relative to the specimen slide outfeed................................ 29
4.7.1 Checking needle height ............................................................................................................ 29
4.7.2 Setting the needle height.......................................................................................................... 30
4.8 Dispenser needle cleaner (nozzle cleaner)................................................................................. 32
4.9 Connecting the power supply.................................................................................................... 35
4.10 Installing the accessories......................................................................................................... 36
4.11 Rellingconsumables .............................................................................................................. 38
5. Operation .................................................................................................................40
5.1 Control panel functions............................................................................................................ 40
5.2 Key functions for instrument operation ..................................................................................... 41
5.3 Switching the instrument on or off............................................................................................ 42
5.4 Brief inspection before starting the coverslipping operation....................................................... 44
5.4.1 Bath insert for HistoCore SPECTRA ST...................................................................................... 44
5.5 The coverslipping operation ..................................................................................................... 46
5.6 Interrupting the coverslipping operation.................................................................................... 48
5.7 Display indicators and instructions ........................................................................................... 53
5.8 Button functions for programming ............................................................................................ 58
5.9 Setting parameter sets............................................................................................................. 59
5.10 MENU A — parameter settings .................................................................................................. 59
5.11 MENU B — parameter settings .................................................................................................. 63
5.11.1Leaving the parameter and submenu......................................................................................... 65
5.12 Recommendationforparametersetting(beginningwithrmware3.01.04)................................. 65

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Leica CV5030
Table of Contents
5
5.13 Determing the optimum parameter setting (MENU A+B)............................................................. 68
5.13.1Procedure................................................................................................................................ 68
6. Workstation operation ................................................................................................74
6.1 Operation as ST5010 — CV5030 workstation............................................................................. 74
6.2 Operation as ST5020 — CV5030 workstation............................................................................. 75
6.3 Important instructions for operation as workstation .................................................................. 78
6.4 Interrupting workstation operation............................................................................................ 80
7. Cleaning and Maintenance ..........................................................................................81
7.1 Notes on cleaning and maintenance ......................................................................................... 81
7.2 Daily cleaning and maintenance - overview................................................................................ 82
7.3 Weekly cleaning and maintenance ............................................................................................ 82
7.4 Cleaning and maintenance as necessary................................................................................... 83
7.5 Description of the required daily cleaning measures .................................................................. 84
7.5.1 Loading chute and bath transport with transport chain .............................................................. 84
7.5.2 Dispenser needle cleaner (nozzle cleaner)................................................................................. 84
7.5.3 Glass vial in the dispenser rest position .................................................................................... 84
7.5.4 Loading Bath ........................................................................................................................... 84
7.5.5 Dispenser needles ................................................................................................................... 84
7.5.6 Cover slip catch tray................................................................................................................. 84
7.5.7 Cover slip magazine................................................................................................................. 84
7.5.8 Skids of the Pick & Place module.............................................................................................. 85
7.5.9 Cleaning and replacing the suction cups ................................................................................... 85
7.5.10Cover slip sensor ..................................................................................................................... 85
7.5.11Specimen slide outfeed............................................................................................................ 86
7.6 Description of the required weekly cleaning measures ............................................................... 86
7.6.1 Dispenser group....................................................................................................................... 86
7.6.2 Dispenser needle cleaner (nozzle cleaner)................................................................................. 87
7.6.3 Specimen slide holder, gripper and output magazines................................................................ 87
7.7 Description for cleaning and maintenance as necessary ............................................................ 88
7.7.1 Activecarbonlter................................................................................................................... 88
7.7.2 Discharge chute of the TS5015 or TS5025 Transfer Station for workstation operation ................. 88
7.7.3 Transfer arm of the TS5015 or TS5025 Transfer Station for workstation operation ...................... 89
7.8 Procedure for changing the cover slip mountant........................................................................ 89
7.8.1 Changing from one xylene-based coverslip mountant to another ................................................ 89
7.8.2 Changing from a xylene substitute coverslip mountant to a xylene-based mountant .................... 90
7.8.3 Changing from a xylene-based coverslip mountant to a xylene substitute ................................... 90
8. Malfunctions and Troubleshooting ...............................................................................91
8.1 Error codes.............................................................................................................................. 91
8.2 Troubleshooting....................................................................................................................... 93
9. Optional Accessories .................................................................................................99
9.1 Ordering information................................................................................................................ 99
10. Warranty and Service .............................................................................................. 109
11. DecontaminationConrmation ................................................................................. 110

6Version 3.4, Revision M
Table of Contents
Version 3.4, Revision M
6
12. Appendix A — Application-related notes and recommendations...................................... 111
12.1 Leica specimen slide holders, output and coverslip magazines made of plastic ........................ 111
12.2 Specimen slide holders from other manufacturers................................................................... 112
12.3 Specimen slides and gripper mechanism ................................................................................ 112
12.4 Leica CV5030 – Validated and recommended specimen slides ................................................ 113
12.5 Cover slips ............................................................................................................................ 114
12.6 Labels for specimen slides..................................................................................................... 114

7
Leica CV5030
1Important Information
1. Important Information
1.1 Symbols and their meanings
Warning
Leica Biosystems Nussloch GmbH assumes no liability for consequential loss or damage due to failure
to observe the following instructions, particularly in relation to transportation and package handling,
and failure to observe the instructions for handling the instrument carefully.
Warning
Leica Biosystems Nussloch GmbH assumes no liability for consequential loss or damage due to failure
to observe the following instructions, particularly in relation to transportation and package handling,
and failure to observe the instructions for handling the instrument carefully.
Symbol: Title of the symbol: Warning
Description: Warnings appear in a box and are marked by a
warning triangle.
Symbol: Title of the symbol: Note
Description: Notes, i. e. important user information, appear ina
gray box and are marked by an information 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: Function key
START Description: Fuction keys to be pressed on the instrument are
displayed as capital letters and bold, black text.
Symbol: Title of the symbol: Software key and/or Display Messages
Ready Description: Software keys to be pressed on the display and/or
messages on the display are displayed as bold, gray
text.
Symbol: Title of the symbol: Attention
Description: Indicates that caution is necessary when operating
the device or control close to where the symbol is
placed, or that the current situation needs operator
awareness or operator action in order to avoid
undesirable consequences. 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ofammablematerial
Description: Inammablereagents,solventsandcleaningagents
are marked with this symbol. Take care to avoid
causingarebyignitingammablematerial.

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8Version 3.4, Revision M
Important Information
Symbol: Title of the symbol: Manufacturer
Description: Indicates the manufacturer of the medical product.
Symbol: Title of the symbol: Manufacturing date
Description: Indicates the date when the medical device was
manufactured.
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.
Symbol: Title of the symbol: CSA Statement (Canada/USA)
Description: The CSA test mark means that a product has
beentestedandfulllstheapplicablesafetyand/
or performance standards, including the relevant
standardsdenedoradministeredbytheAmerican
National Standards Institute (ANSI), Underwriters
Laboratories (UL), the Canadian Standards
Association (CSA), the National Sanitation Foundation
International (NSF) and others.
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.
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.

9
Leica CV5030
1Important Information
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: 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: Fragile, handle with care
Description: Indicates a medical device that can be broken or
damaged if not handled carefully.
Symbol: Title of the symbol: Keep dry
Description: Indicates a medical device that needs to be protected
from moisture.
Symbol: Title of the symbol: Stacking limit by number
Description: To indicate that the items shall not be vertically
stackedbeyondthespeciednumber,eitherbecause
of the nature of the transport packaging or because of
the nature of the items themselves.
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 storage
Description: Indicates the storage temperature limits to which the
medical device can be safely exposed.

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10 Version 3.4, Revision M
Important Information
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.
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.
Symbol: Title of the symbol: IPPC symbol
Description: The IPPC symbol includes
IPPC symbol
• Country code to ISO 3166, e.g. DE for Germany
• Regionalidentier,e.g.NWforNorth
Rhine-Westphalia
• Registration number, unique number beginning with
49.
• Treatment method, e.g. HT (heat treatment)
Symbol: Title of the symbol: 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.
Symbol: Title of the symbol: Maximumllvolume
Description: Indicatesthemaximumallowedllvolumeofthe
rellablerepository(e.g.bottle),intheadjacent
example200ml.
1.2 Qualicationofpersonnel
• The Leica CV5030 may be operated by trained laboratory personnel only.
• All laboratory personnel designated to operate this instrument must read these Instructions for Use
carefully and must be familiar with all technical features of the instrument before attempting to
operate it. The instrument is intended for professional use only.