ViroGates suPARnostic GENSPEED R2 User manual

R2
Test System
GENSPEED®
Instructions for Use
suPARnostic®POC+GENSPEED®R2 Test System
Instructions for Use
v 1.0 issued 2022-05-23
www.ViroGates.com
www.genspeed-biotech.com
suPARnostic®POC+ GENSPEED R2
Item n° P001
May 25 2022 May 25 2022 May 25 2022

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Copyright Information
Instructions for Use
suPARnostic®POC+ GENSPEED R2 Test System
© Copyright 2022 by ViroGates
ViroGates A/S
Banevaenget 13
Birkeroed 3460, Denmark
Tel: [phone]
www.virogates.com
GENSPEED Biotech GmbH
Gewerbepark 2
A-4261 Rainbach, Österreich
Tel: [phone]
of[email protected]
www.genspeed-biotech.com
Notice
All rights reserved.
Copying or republication of this document in any form or format is
forbidden without written approval.
Trademark right
The used brand names and labels are the property of the respective
owner.
Important information for the user
For the correct use of the suPARnostic®POC+ GENSPEED R2
Test System, it is necessary to carefully read and follow this instruction
manual.
The manufacturer assumes no liability for any use of this system test
which is not described in this document or for modications by the user
of the Test System.

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Intended Use
Purpose
The suPARnostic® POC+ GENSPEED R2 Test System is an in vitro diag-
nostic system for the analysis of human samples to be used with su-
PARnostic® POC+ test kits and suPARnostic® Report Software by quali-
ed personnel.

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Table of Contents
1. Introduction................................................................................... 7
1.2 Graphic symbols ...................................................................................................................... 9
1.3 Revision history ........................................................................................................................10
1.4 Ambient conditions ................................................................................................................ 11
1.5.1 Installation
............................................................................................................................ 13
1.5.2 Transport and storage ................................................................................................ 13
1.5.3 Operation
............................................................................................................................... 13
1.5.4 Servicing
.................................................................................................................................14
1.5.5 General information .....................................................................................................14
2. The suPARnostic® POC+ GENSPEED®R2 Test System.........15
3. Functional principle & theoretical basics ..........................18
3.1 Overview of the functional principle of the suPARnostic® POC+ GENSPEED
R2 Test System .........................................................................................................................19
3.2 Functional principle & theoretical basics - Test Chips ...................................20
4. Performance data .....................................................................24
4.1 Performance data .................................................................................................................25

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5. Installation...................................................................................26
6. suPARnostic® Report Software overview.............................29
6.1 Login ..............................................................................................................................................30
6.2 User interface.............................................................................................................................31
6.2.1 Workow-Guide ................................................................................................................32
6.2.2 Tabs.............................................................................................................................................33
6.2.3 Toolbar (Quick Access Toolbar)................................................................................. 38
6.2.4 Status bar...............................................................................................................................39
6.2.5 Menu.......................................................................................................................................... 40
7. Hardware overview (GENSPEED® R2) ....................................71
7.1 Integral parts of the suPARnostic® POC+ GENSPEED R2 ...................................72
7.3 Display information on the suPARnostic® POC+ GENSPEED R2 .................... 77
8. Measurement sequence .........................................................79
8.2 Detailed measurement sequence ...............................................................................81
9. Cleaning and maintenance....................................................85
9.1 General care instructions ................................................................................................ 86
9.2 Cleaning of the device ...................................................................................................... 86
9.3 Cleaning of the optical window ....................................................................................87
9.4 Cleaning of the barcode module window...............................................................87

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9.5 System-Check ........................................................................................................................ 88
9.6 System-Care ........................................................................................................................... 90
9.7 Cleaning of uidic system ................................................................................................91
9.8 Stand-by and Off-time period ......................................................................................93
10. Troubleshooting .......................................................................94
10.1 Troubleshooting .................................................................................................................... 95
10.2 Support request ................................................................................................................... 102
11. Appendix ................................................................................... 103
11.1 Sending back / disposal .................................................................................................104
11.2 Technical specications .................................................................................................105
11.3 Manufacturer .........................................................................................................................106
11.4 Standards ................................................................................................................................ 107

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1. Introduction
1

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Chapter Introduction |Abbreviations
Abbreviation Definition
AIS Physician’s Information System (Arzt Informations
System)
CDA Clinical document architecture
DIN German Institute for Standardization
(Deutsches Institut für Normung)
EMV Elektromagnetic Compatibility
EN European Norm
ESD Electrostatic discharge
HL7 Health Level Seven
ISO International Organization for Standardization
IVD In-vitro Diagnostics
LAF “Look and Feel“
LED Light Emitting Diode
LIMS Laboriatory Information Management System
SN Serial number
SW suPARnostic® Report Software
USB Universal Serial Bus
WEEE Waste of Electrical and Electronic Equipment
Table 1: Abbreviations
1.1 Abbreviations

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Chapter Introduction |Graphic symbols
1.2 Graphic symbols
CE Mark In-vitro diagnostics Manufacturer Catalogue number Serial number Protect from
direct sunlight DC (direct current)
Keep in a dry place Temperature
limitation
Consult
Instructions For Use Fragile Handle with care Do not dispose of as unsorted waste Recyclable
Table 2: Graphic symbols

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Chapter Introduction |Revision History
This instruction manual is for users of the suPARnostic® POC+ GENSPEED
R2 Test System, which consists of suPARnostic® POC+ GENSPEED R2
(Item n°: P001) in combination with the suPARnostic® Report Software.
Due to possible suPARnostic® Report Software adaptations (or LAF) of
the different operating systems, dialogue windows, for example, could
differ from the illustrations in this instruction manual.
In spite of all efforts taken in producing this instruction manual, no
guarantee of accuracy or completeness can be given. The man-
ufacturer reserves the right to change the current instruction
manuals without notication.
Charts depicted are examples and may differ depending on test type
performed.
1.3 Revision History
Instruction manual Date of revision
BQ-875-00 May 2022