Leica CV5030 User manual

Instructions for Use
Leica CV5030
Robotic Coverslipper
Leica CV5030 V 3.3, English 04/2019
Order No.: 14 0478 80101 RevK
Always keep this manual with the instrument.
Read carefully before working with the instrument.

3
Leica CV5030 – Robotic Coverslipper
The information, numerical data, notes and value
judgments contained in this manual represent
the current state of scientific knowledge and
state-of-the-art technology as we understand it
following thorough investigation in this field.
We are under no obligation to update the present
manual periodically and on an ongoing basis ac-
cording to the latest technical developments, nor
to provide our customers with additional copies,
updates etc. of this manual.
To the extent permitted in accordance with
the national legal system as applicable in each
individual case, we shall not be held liable for
erroneous statements, drawings, technical illus-
trations etc. contained in this manual. In particu-
lar, no liability whatsoever is accepted for any
financial loss or consequential damage caused
by or related to compliance with statements or
other information in this manual.
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
specifications as well as manufacturing process-
es without prior notice. Only in this way it is pos-
sible 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,
microfiche, web cam or other methods—includ-
ing any electronic systems and media—requires
express prior permission in writing by Leica
Biosystems Nussloch GmbH.
For the instrument serial number and year of
manufacture, please refer to the nameplate on
the back of the instrument.
© Leica Biosystems Nussloch GmbH
NOTE
Leica Biosystems Nussloch GmbH
Heidelberger Str. 17 - 19
D-69226 Nussloch
Germany
Phone: [phone]
Fax: [phone]
Internet: http://www.LeicaBiosystems.com

4Instructions for Use V 3.3 RevK – 04/2019
Contents
1. Important Information ....................................................................................................7
1.1 Symbols and their meanings....................................................................................................... 7
1.2 User group ..................................................................................................................................... 9
1.3 Intended use of instrument......................................................................................................... 9
1.4 Instrument type............................................................................................................................. 9
2. Safety ..............................................................................................................................10
2.1 Safety notes................................................................................................................................. 10
2.2 Warnings...................................................................................................................................... 10
3. Instrument Components and Specifications ...........................................................13
3.1 Overview - instrument components ........................................................................................ 13
3.2 Technical data............................................................................................................................. 14
3.3 Standard delivery—packing list............................................................................................... 15
4. Instrument Setup...........................................................................................................17
4.1 Installation site requirements................................................................................................... 17
4.2 Unpacking the CV5030 ............................................................................................................... 18
4.2.1 Setting up the CV5030 ................................................................................................................ 20
4.3 Preparing and adjusting the instrument ................................................................................. 20
4.3.1 Removing or installing the transport anchors........................................................................ 21
4.4 Leveling the instrument ............................................................................................................. 22
4.5 Exhaust system ........................................................................................................................... 22
4.6 Installing the dispenser group.................................................................................................. 24
4.7 Aligning the dispenser needle height relative to the specimen slide outfeed................. 26
4.8 Dispenser needle cleaner (nozzle cleaner)............................................................................ 29
4.9 Connecting the power supply................................................................................................... 32
4.10 Installing the accessories......................................................................................................... 32
4.11 Refilling consumables................................................................................................................ 34
5. Operation........................................................................................................................36
5.1 Control panel functions.............................................................................................................. 36
5.2 Key functions for instrument operation .................................................................................. 37
5.3 Switching the instrument on or off .......................................................................................... 39
5.4 Brief inspection before starting the coverslipping operation............................................. 41
5.5 The coverslipping operation..................................................................................................... 42
5.6 Interrupting the coverslipping operation................................................................................ 44
5.7 Display indicators and instructions......................................................................................... 50
5.8 Button functions for programming........................................................................................... 56

5
Leica CV5030 – Robotic Coverslipper
Contents
5.9 Setting parameter sets .............................................................................................................. 57
5.10 Menu A – parameter settings................................................................................................... 57
5.11 Menu B – parameter settings................................................................................................... 60
5.11.1 Leaving the parameter and submenu...................................................................................... 62
5.12 Recommendation for parameter setting (beginning with firmware 3.01.04) ................... 63
5.13 Determining the optimum parameter setting (menu A+B)................................................... 66
5.13.1 Procedure .................................................................................................................................... 66
6. Workstation operation.................................................................................................72
6.1 Operation as ST5010 – CV5030 workstation........................................................................... 72
6.2 Operation as ST5020 – CV5030 workstation........................................................................... 74
6.3 Important instructions for operation as workstation............................................................ 76
6.4 Interrupting workstation operation.......................................................................................... 78
7. Cleaning and Maintenance ........................................................................................79
7.1 Notes on cleaning and maintenance ...................................................................................... 79
7.2 Daily cleaning and maintenance - overview.......................................................................... 80
7.3 Weekly cleaning and maintenance......................................................................................... 81
7.4 Cleaning and maintenance as necessary .............................................................................. 82
7.5 Description of the required daily cleaning measures .......................................................... 82
7.5.1 Loading chute and bath transport with transport chain ...................................................... 82
7.5.2 Dispenser needle cleaner (nozzle cleaner)............................................................................ 82
7.5.3 Glass vial in the dispenser rest position................................................................................. 83
7.5.4 Loading bath................................................................................................................................ 83
7.5.5 Dispenser needles...................................................................................................................... 83
7.5.6 Cover slip catch tray .................................................................................................................. 83
7.5.7 Cover slip magazine ................................................................................................................... 83
7.5.8 Skids of the Pick & Place module............................................................................................ 83
7.5.9 Cleaning and replacing the suction cups............................................................................... 84
7.5.10 Cover slip sensor ........................................................................................................................ 84
7.5.11 Specimen slide outfeed............................................................................................................. 84
7.6 Description of the required weekly cleaning measures...................................................... 85
7.6.1 Dispenser group.......................................................................................................................... 85
7.6.2 Dispenser needle cleaner (nozzle cleaner)............................................................................ 86
7.6.3 Specimen slide holder, gripper and output magazines........................................................ 86
7.7 Description for cleaning and maintenance as necessary................................................... 87
7.7.1 Active carbon filter..................................................................................................................... 87
7.7.2 Discharge chute of the TS5015 or TS5025 Transfer Station for workstation operation . 87

6Instructions for Use V 3.3 RevK – 04/2019
Contents
7.7.3 Transfer arm of the TS5015 or TS5025 Transfer Station for workstation operation........ 87
7.8 Procedure for changing the cover slip mountant ................................................................. 88
7.8.1 Changing from one xylene-based coverslip mountant to another..................................... 88
7.8.2 Changing from a xylene substitute coverslip mountant to a xylene-based mountant.... 88
7.8.3 Changing from a xylene-based coverslip mountant to a xylene substitute...................... 88
8. Malfunctions and Troubleshooting...........................................................................89
8.1 Error codes .................................................................................................................................. 89
8.2 Troubleshooting.......................................................................................................................... 91
9. Optional Accessories ..................................................................................................95
9.1 Ordering information.................................................................................................................. 95
10. Warranty and Service................................................................................................106
11. Decontamination Certificate (master) ....................................................................107
Appendix A Application-related notes and recommendations...................................109
A1.1 Leica specimen slide holders, output and coverslip magazines made of plastic ......... 109
A1.2 Specimen slide holders from other manufacturers............................................................ 110
A1.3 Specimen slides and gripper mechanism ............................................................................ 111
A1.4 CV5030 – Validated and recommended specimen slides .................................................. 111
A1.5 Cover slips.................................................................................................................................. 113
A1.6 Labels for specimen slides...................................................................................................... 114

7
Leica CV5030 – Robotic Coverslipper
1. Important Information
1.1 Symbols and their meanings
(5)
START
Manufacturer
In vitro diagnostics (IVD) medical device
This product fulfills the requirements of
the Council's Directive 98/79/EC con-
cerning in vitro diagnostics (IVD) medi-
cal devices.
The CSA test mark means that a product
has been tested and fulfills the appli-
cable safety and/or performance stan-
dards, including the relevant standards
defined or administered by the American
National Standards Institute (ANSI),
Underwriters Laboratories (UL), the
Canadian Standards Association (CSA),
the National Sanitation Foundation Inter-
national (NSF) and others.
Environmental protection symbol of the
China RoHS directive. The number in
the symbol indicates the "Environment-
friendly Use Period" of the product. The
symbol is used if a substance restricted
in China is used in excess of the maxi-
mum permitted limit.
Symbol for labeling electrical and elec-
tronic equipment in accordance with
Section 7 of the German Electrical and
Electronic Equipment Act (ElektroG). Ele-
ktroG is the law regarding the sale, re-
turn and environmentally sound disposal
of electrical and electronic equipment.
Warnings
appear in a gray box and are marked by
a warning triangle .
Notes
i.e. important user information appear
in a gray box and are marked by an in-
formation symbol .
Inflammable solvent and reagents are
marked with this symbol.
Instrument surfaces which become hot
during operation are marked with this
symbol.
Avoid direct contact to prevent risk of
burning.
Numbers and parentheses refer to item
numbers in the illustrations.
Function keys to be pressed on the in-
strument control panel are written in
bold-print capital letters.
Date of Manufacture

8Instructions for Use V 3.3 RevK – 04/2019
1. Important Information
1.1 Symbols and their meanings
REF
SN
Order No.
Serial number
Observe the Instructions for Use
The package contents are fragile and
must be handled with care.
Indicates the correct upright position of
the package.
The package must be kept in a dry en-
vironment.
It is not permitted to stack packages,
and no loads may be placed on top of
the package.
Indicates the temperature
range to which the medical
device can be safely ex-
posed.
Minimum –29 °C
Maximum +50 °C
Indicates the air humidity
range to which the medical
can be safely exposed.
Minimum 10 %
Maximum 85 %
Example of labeling
in accordance with
IPPC
Package labeling in accor-
dance with German Hazard-
ous Freight Ordinance Road
and Rail (GGVSE)/European
Agreement concerning the
International Carriage of
Dangerous Goods by Road
(ADR) for transporting haz-
ardous goods.
Class 3: "FLAMMABLE
LIQUID"
Tip-n-Tell checks whether
the shipment was transport-
ed upright and stored as you
prescribed. With a pitch of
60° or more, the blue quartz
sand flows into the arrow-
shaped indicator window
and sticks there permanent-
ly. Any improper handling of
the shipment is immediately
and definitively detectable.
• IPPCsymbol
• Countrycodein accordance with ISO3166,
e.g. DE for Germany
• Regionalidentifier,e.g.HEforHessen
• Producer/treatmentprovidercode,unique
assigned number starting with 49
• Treatmentcode,e.g.HT(heattreatment),MB
(methyl bromide), and possibly DB (debarked)

9
Leica CV5030 – Robotic Coverslipper
1.2 User group
• 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.
Fig. 1
1.3 Intended use of instrument
The Leica CV5030 is a robotic coverslipper for
coverslipping tissue sections, cells or swabs
mounted on specimen slides with cover slips
made out of glass using a wide variety of differ-
ent cover slip mountants. It may only be used
with instrument accessories approved by Leica
Biosystems Nussloch GmbH.
1.4 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 in-
strument. (The serial number is also displayed
above the loading door on the front side of the
instrument.)
1. Important Information
Any use of the instrument other than
its designated use is considered im-
proper.
Failure to adhere to these instructions
may result in an accident, personal
injury, damage to the instrument or ac-
cessory equipment.
Proper and intended use includes
compliance with all inspection and
maintenance instructions, along with
the observance of all instructions in
the Instructions for Use.
Fig. 1 is provided as an example only
and shows a valid nameplate for this
instrument with the necessary in-
formation about instrument type and
power requirement. The precise data
for the various versions is specified in
Chapter 3.2 "Technical data".

10 Instructions for Use V 3.3 RevK – 04/2019
2. Safety
These Instructions for Use include important instruc-
tions 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.
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, make sure to comply with the following instructions
and warnings.
Please note that electrostatic charge may result through direct or indirect contact with the Leica CV5030.
This instrument was built and tested in accordance
with the safety regulations for electrical measuring,
control, regulating and laboratory devices.
To maintain this condition and ensure safe operation,
the user must observe all notes and warnings con-
tained in these Instructions for Use.
2.1 Safety notes
These Instructions for Use must be ap-
propriately supplemented as required
by the existing regulations on accident
prevention and environmental safety in
the operator's country.
The instrument's CE certificate can be
found on the Internet at:
http://www.LeicaBiosystems.com
• 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 products.
• The protective devices on the instrument and its accessories must not be removed or modi-
fied. Only qualified 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 technol-
ogy 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 can cause damage to the instrument or other property. The instrument may
be used only as intended and only if all of its safety features are in proper working condition.
Malfunctions which could impede safety must be remedied immediately.
• Only original spare parts and permitted original accessories may be used.