Greiner Bio-One CheckScanner 2.0 User manual

Your Power for Health
www.gbo.com/diagnostics
CheckScanner™ 2.0

Made in Germany
Greiner Bio-One GmbH
Maybachstr. 2
72636 Frickenhausen
Germany 862 070
Your Power for Health
Revision: BQ-686-01 / March 2017
For in-vitro diagnostic use
by professional laboratory personnel only
CheckScanner™ 2.0
Instructions for Use

Made in Germany
Greiner Bio-One GmbH
Maybachstr. 2
72636 Frickenhausen
Germany 862 070
Your Power for Health
CheckScanner™ 2.0 - Instructions for Use
Revision: BQ-686-01 /March 2017
3
GLOSSARY OF SYMBOLS
en Consult
Instruc-
tions for
Use
Catalog
Number
Manufac-
turer
In Vitro
Diagnostic
Medical
Device
Waste
Disposal
GHS pictograms
with signal words
DANGER or
WARNING
Impor-
tant Note
Warning
Label on
instru-
ment
Warning
label laser
beam
Warning
label elec-
tric shock
en Biological
Risks
Functio-
nal Earth
Contact
!

Made in Germany
Greiner Bio-One GmbH
Maybachstr. 2
72636 Frickenhausen
Germany 862 070
Your Power for Health
CheckScanner™ 2.0 - Instructions for Use
Revision: BQ-686-01 /March 2017
4
TABLE OF CONTENTS
1. TRADEMARKS .............................................................................................................. 6
2. CONTENT OF SALES PACKAGE ................................................................................ 6
3. ENVIRONMENTAL CONDITIONS & SHIPMENT ......................................................... 7
3.1 Environmental Conditions.................................................................................................. 7
3.2 Repacking before Shipment .............................................................................................. 7
4. SAFETY INSTRUCTIONS AND PRECAUTIONS.......................................................... 7
4.1 Operator Qualifi cation ........................................................................................................ 7
4.2 Safety Information ............................................................................................................. 8
4.3 Protection against Laser Power......................................................................................... 8
4.4 Safety Precautions ............................................................................................................. 8
4.5 Warning Messages ............................................................................................................ 9
4.5.1 Electric Shock Precautions....................................................................................................9
4.5.2 Mechanical Safetz Precautions .............................................................................................9
4.6 Caution Messages ............................................................................................................. 9
4.6.1 Lasers ....................................................................................................................................9
4.6.2 Spillage, infectious materials and infl ammable liquids ..........................................................9
4.7 Electromagnetic Compatibility .......................................................................................... 9
5. INTENDED USE........................................................................................................... 10
6. APPROVALS................................................................................................................ 10
7. ABBREVIATIONS......................................................................................................... 10
8. DEFINITIONS............................................................................................................... 11
9. CONVENTIONS ........................................................................................................... 11
10. PREFACE..................................................................................................................... 11
11. SCOPE AND AUDIENCE ............................................................................................ 11
12. INTRODUCTION.......................................................................................................... 12
13. SYSTEM OVERVIEW................................................................................................... 12
14. INSTALLATION............................................................................................................ 12
14.1 Removing Transit Support Screws ................................................................................. 13
14.2 Connections..................................................................................................................... 13

Made in Germany
Greiner Bio-One GmbH
Maybachstr. 2
72636 Frickenhausen
Germany 862 070
Your Power for Health
CheckScanner™ 2.0 - Instructions for Use
Revision: BQ-686-01 /March 2017
5
14.3 Software Installation ....................................................................................................... 14
15. OPERATING................................................................................................................. 15
15.1 LED Color Description .................................................................................................... 15
16. REPACKING BEFORE SHIPMENT............................................................................. 16
16.1 Installing Transit Support Screws ................................................................................... 16
16.2 Repackaging.................................................................................................................... 17
17. SUMMARY................................................................................................................... 19
18. APPENDIX ................................................................................................................... 19
18.1 Technical Data ................................................................................................................. 19
18.2 Maintenance .................................................................................................................... 20
18.3 Waste Disposal ................................................................................................................ 20
18.4 Product Warranty............................................................................................................. 20
19. MANUFACTURER ADDRESS..................................................................................... 21

Made in Germany
Greiner Bio-One GmbH
Maybachstr. 2
72636 Frickenhausen
Germany 862 070
Your Power for Health
CheckScanner™ 2.0 - Instructions for Use
Revision: BQ-686-01 /March 2017
6
1. TRADEMARKS
All trademarks mentioned in these Instructions for Use are the property of their respective trademark
holders. Microsoft®and Windows®are registered trademarks of the Microsoft®Corporation.
These Instructions for Use are written for operators of the CheckScanner™ 2.0 using CheckReport™
Software version 1.1 or higher. Due to software evolution slight changes in the dialog boxes
displayed in this manual may occur. When a modifi cation is made that may have adverse effects on
the system using this manual, an update or amendment will become available.
Every effort has been made to ensure that the information contained in this manual is updated
and accurate as of the date of issue or revision and it is consistent with the product described.
However, no guarantee is given or implied that the document is error-free or accurate with regard to
any specifi cations. The instrument manufacturer reserves the right to make changes to this manual
without notifi cation.
2. CONTENT OF SALES PACKAGE
Equipment Greiner Bio-One Cat.No. Quantity
CheckScannerTM 2.0 862 070 1
power supply 1
line cord 1
Ethernet cable 1
transit support screws and caps 2 of each
CheckScanner™ Verifi cation Kit 862 030 1
Use solely the specifi c external power supply (AC adapter) included in the sales package
of your scanner!
Generally use only accessory parts which are specifi cally provided by Greiner Bio-One
for your instrument type!
All packing material including the transport pallet and transit support mounted at the
instrument are very specifi c. These materials must be kept in case the instrument has
to be shipped!
!

Made in Germany
Greiner Bio-One GmbH
Maybachstr. 2
72636 Frickenhausen
Germany 862 070
Your Power for Health
CheckScanner™ 2.0 - Instructions for Use
Revision: BQ-686-01 /March 2017
7
3. ENVIRONMENTAL CONDITIONS AND SHIPMENT
3.1 Environmental Conditions
To ensure trouble-free running of the CheckScanner™ system, it is important to locate the
instrument in an appropriate environment.
Environmental conditions Specifi cation
Temperature Operating: 15 to 30 °C
Storage: 0 to 40 °C
Humidity 20 - 80 %, non-condensing
Sunlight No direct sunlight or other intensive light sources
Altitude Up to 2000 m above mean sea level
Storage: as required for air travel
Dust Preferred dust-free environment
Mains power Wall socket with grounding providing
110/230 V (for external power-supply provided with the instrument)
LAN Connection of PC to LAN (optional)
3.2 Repacking before Shipment
If it is necessary to ship the CheckScanner™ 2.0 special care has to be taken concerning the
packaging. Please refer to chapter 16 for further details.
4. SAFETY INSTRUCTIONS
4.1 Operator Qualifi cation
The CheckScanner™ 2.0 should be operated by or under the supervision of a technician or operator
who is suffi cient qualifi ed to perform laboratory work.
Before operating the CheckScanner™ the operator should:
• Read and understand these Instructions for Use
• Be aware of all relevant laboratory procedures
• Be aware of all relevant safety rules and regulations
Carefully follow the procedures specifi ed in these Instructions for Use for the operation and
maintenance of the system. Maintenance which is not described in these Instructions for Use should
be performed by qualifi ed service engineers only.
DO NOT open the instrument housing.
Electronic equipment can be the source of electrical shocks.
DO NOT attempt to repair any electrical parts.
Service and repair should only be carried out by authorized and qualifi ed personnel of the
manufacturer.

Made in Germany
Greiner Bio-One GmbH
Maybachstr. 2
72636 Frickenhausen
Germany 862 070
Your Power for Health
CheckScanner™ 2.0 - Instructions for Use
Revision: BQ-686-01 /March 2017
8
4.2 Safety Information
It is essential that the warnings, cautions and safety requirements contained in this manual are
read and understood by the operator before operating the system. If the equipment is used in
a manner not specifi ed by the manufacturer, the protection provided by the equipment may be
impaired.
Warning symbols have been placed on the instrument to draw your attention to areas of potential
hazards.
Familiarise yourself with the following icons and their meanings:
4.3 Protection against Laser Power
Laser class 1:
Outside label for the classifi cation of the CheckScanner™. Safe under all
conditions of normal use.
Laser class 3B:
Inside label for the classifi cation of the lasers used within the device.
Hazardous if the eye is exposed directly.
4.4 Safety Preauctions
Particular attention must be paid to the following safety precautions. If these safety precautions are
ignored, the operator may suffer injury. Each individual precaution is important.
This label warns that there is a danger of hazardous situations within the vicinity of this
label which may result in serious injury.
This label warns that there is a danger of electric shock when gaining access to parts of
the system marked with this label.
Avoid looking directly into any refl ected laser light potentially leaking from the instrument,
as this may damage your eyesight.
Wear safety glasses while working with open housing.
!
This label warns that there are lasers operating within the vicinity of this label. Do not look
directly into the beam.
Complies with 21CFR1040.10 except Laser Notice No. 50.
CAUTION!
Use of controls, adjustments or performance of procedures other than those specifi ed
herein may result in hazardous radiation exposure.
!

Made in Germany
Greiner Bio-One GmbH
Maybachstr. 2
72636 Frickenhausen
Germany 862 070
Your Power for Health
CheckScanner™ 2.0 - Instructions for Use
Revision: BQ-686-01 /March 2017
9
4.5 Warning Messages
4.5.1 Electric Shock Preauctions
The protection classifi cation of the instrument is IP20.
4.5.2 Mechanical Safety Preauctions
4.6 Caution Messages
4.6.1 Lasers
4.6.2 Spillage, infectious materials and infl ammable liquids
Any liquid spilled on the instrument may result in the malfunctioning of the system. If liquid is spilled
on the instrument, wipe it up immediately.
4.6.3. Biological Risk
4.7 Electromagnetic Compatibility
The CheckScanner™ 2.0 is a class A system with respect to Electromagnetic Compatibility (EMC)
requirements for industrial areas. It fulfi ls the emission limits for class A equipment according to
EN 61326-1. It does not fulfi l the emission limits for class B equipment.
The LAN output insulation fulfi lls the requirement according to IEC60601-1- of 4 kV.
Electronic equipment can be the source of electrical shocks. DO NOT attempt to gain
access to parts of the instrument marked with this label.
DO NOT attempt to repair any electrical parts.
DO NOT open the instrument housing.
Service and repair should only be carried out by authorised and qualifi ed personnel of the
manufacturer.
This is a Class 1 laser product - the operator will not be exposed to laser radiation during
normal operation. When the instrument is undergoing maintenance or service (with panels/
guards removed and interlocks defeated), exposure to Class 3B radiation may occur. Make
sure proper safeguards and related PPE are employed at that time.
As with any mechanical system, certain precautions must be taken when operating the
scanner.
The instrument has a loading lid intended to prevent contact of the operator with any
moving parts.
DO NOT raise the lid when the scanner is in operation.
DO NOT tamper with the safety sensors of the lid.
DO NOT load humid or wetted HTA™Slides. Besides non-reproducible measuring data,
the fast scanning movement of the slide might lead to contamination of optical components
of the scanner, which can only be cleaned by a service technician.
DO NOT use easily infl ammable liquids in the vicinity of the instrument.
Equipment that can be potentially infectious due to the samples or reagents used shall be
prominently marked with symbol 101 of Table 1. At minimum, a biohazard symbol shall
be placed near the sampling area and visible in NORMAL USE.

Made in Germany
Greiner Bio-One GmbH
Maybachstr. 2
72636 Frickenhausen
Germany 862 070
Your Power for Health
CheckScanner™ 2.0 - Instructions for Use
Revision: BQ-686-01 /March 2017
10
Electromagnetic Devices: Devices that emit electromagnetic waves may affect measurement data,
or cause the instrument to malfunction. DO NOT operate the following devices in the vicinity of the
instrument when it is in use: mobile or cordless phones, transceivers or other electrical devices that
generate intensive electromagnetic waves.
5. INTENDED USE
The CheckScanner™ 2.0 is a PC-controlled biochip fl uorescence scanner for the daily general
laboratory use in combination with the CheckReport™Software. Hazardous samples must not be
measured. It is designed to scan with high performance ready-to-use microarrays on HTA™Slides
manufactured by Greiner Bio-One. It is important that the operator reads this manual thoroughly
before using the instrument. The scanner must be operated by professionals only.
The manufacturer does not assume any liability for any use of the instrument not described in this
manual, or for any customer modifi cations made to the instrument.
6. APPROVALS
This instrument is in compliance with the following directives of the Council of the European
Community and the according standards:
98/97/EC,89/336/EEC,73/23EEC,2006/95/EC(EN61010-1),2009/95/EC(EN61010-1),2004/108/EC
(EN 61326, EN 61000-3-2, EN 61000-3-3), ISO 13485:2007, ISO 9000, part3ISO/IEC90003,
DIN EN ISO 9001:2000, EN 591, EN 980, EN 13612, ISO 14971, ISO 17050-1, EN 1041,
ISO 15223-1, EN 61010-2-101, ISO/IEC 10007:2003, ISO/IEC 12207:1995, Amd 2:2004, IEC
68025-1.
7. ABBREVIATIONS
Abbreviation Meaning
EN European Standard
DIN Deutsches Institut für Normung = (German Standard)
IEC International Electrotechnical Commission
ISO International Organisation for Standardisation
EMC Electromagnetic Compatibility
LAN Local Area Network
PC Personal Computer (Windows-based)
AC Alternating Current
IP 20 protection class according DIN EN 60529
TIFF Tagged Image File Format
PMT Photo Muliplier
VAC Voltage in Alternating Current
VDC Volts of Direct Current