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

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Chapter Introduction |Ambient conditions
1.4 Ambient conditions
Please adhere to the ambient conditions specied here in order to ensure a proper analysis of the measuring data.
Transport and storage:
Temperature -20 °C to 50 °C
Humidity relative humidity: ≤ 70 % (non condensing)
Operation:
Installation site Indoor use as a desktop unit
No direct sunlight, horizontal surface,
no great uctuations in temperature and humidity
Temperature Please refer to the test-specic requirements in the user manual for the respective test
Humidity Relative humidity: ≤ 70 % (non condensing)
Power supply Via a USB port (2.0 or higher) of an EN60950-1: 2006-compliant computer
Should the suPARnostic® POC+ GENSPEED R2 be used outside the specied temperature range, the suPARnostic® Report Software
automatically gives a warning (dialogue box) before the measurement. In this case, please check the ambient temperature and,
if necessary, take appropriate measures to get the room temperature within the specied range. Should the ambient temperature
still be outside the specied temperature range after the measurement is completed, this will be noted in the report.
Should the device be disconnected and reconnected, the temperature values may deviate from the real temperature, which may
lead to an unfounded temperature warning.

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Chapter Introduction |Warnings and precautionary measures
1.5 Warnings and precautionary measures
Important safety regulations!
Conventions CAUTION indicates a potentially dangerous situation
which, if not avoided, can result in low or medium
harm to people or devices.
NOTES offer additional practical tips.
Safety information It is required that warning notices, such as CAUTION, and
other safety requirements contained in this manual have
been read and understood by the user BEFORE using the
suPARnostic® POC+ GENSPEED R2 Test System.

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Chapter Introduction |Warnings and precautionary measures
Please only transport the suPARnostic® POC+ GENSPEED R2
in the packaging in which it was delivered to prevent any
damage.
Place the suPARnostic® POC+ GENSPEED R2 on a solid, clean,
horizontal surface where it will not be exposed to any direct
sun light, large temperature uctuations or high humidity.
1.5.1 Installation
Prior to starting-up the suPARnostic® POC+ GENSPEED R2
(connecting of the device to the computer), the suPARnos-
tic® Report Software has to be installed by a system ad-
ministrator.
Before startup of suPARnostic® POC+ GENSPEED R2 please
prepare the device according to chapter “5.1 Installation of
suPARnostic® POC+ GENSPEED R2”
1.5.3 Operation
(For details, see chapter „Installation of the suPARnostic® POC+ GENSPEED R2“)
(For details, see chapter “1.4 Ambient conditions”)
The suPARnostic® POC+ GENSPEED R2 Test System may not be
use for other (non-dened) purposes. (see “Intended Use“ on
page 3 )
Only start operating the suPARnostic® POC+ GENSPEED R2 with
the supplied USB cable.
If the suPARnostic® POC+ GENSPEED R2 or parts of
it are used in another way or manner than speci-
ed by GENSPEED Biotech, the function of the
installed safety devices can be impaired.
The suPARnostic® POC+ GENSPEED R2 Test System is solely for
use with original Test Chips from GENSPEED Biotech.
(The Test Chips of the GENSPEED line are included with the
Test Kits of the respective products).
The suPARnostic® POC+ GENSPEED R2 may only be operated
together with a computer that demonstrably meets the con-
ditions according to EN 60950-1 and has the technical speci-
cations.
(see chapter “11.2 Technical specifications”)
The tray opens/closes automatically after pushing the but-
ton. Please open/close the tray by hand only in exceptional
case e.g. if inhibition or similar problems occur.
The cover is only opened in case of GENSPEED Cartridge
change. Please do not open the cover during System-Check
or during test procedure in the device respectively.
Do not dismantle the suPARnostic® POC+ GENSPEED R2.
The suPARnostic® POC+ GENSPEED R2 meets the standards

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Chapter Introduction |Warnings and precautionary measures
1.5.4 Servicing
After every measurement, check whether liquid has leaked
into the suPARnostic® POC+ GENSPEED R2 and in particular
whether the optical window has been contaminated.
Remove leaked liquids immediately with a microbre cloth
(included in delivery of the suPARnostic® POC+ GENSPEED R2).
Regularly clean the suPARnostic® POC+ GENSPEED R2 (espe-
cially the optical window) (see chapter „9 Cleaning and maintenance“)
1.5.5 General information
To prevent unauthorised manipulation of your data, we rec-
ommend that you activate the automatic locking of the com-
puter if this is not going to be used for a certain time (can be
found in the control panel of your computer).
(For details, see chapter „9 Cleaning and maintenance“)
according to EMC and ESD. (also see chapter “11.2 Techni-
cal specifications”)
PLEASE DO NOT REMOVE THE GENSPEED CARTRIDGE IN USE
FROM THE DEVICE! (In particular NOT after a measurement
or at the end of the working day!)
Only remove in case the lling level is zero and GENSPEED
Cartridge exchange is requested by the software. If you
don’t have a new GENSPEED Cartridge available at that
time, please keep the empty cartridge in the device until
you have a new one at hand.
During idle time leave the suPARnostic® Test System con-
nected to power supply in stand-by-mode. Also insert
In case of mechanical damage to the housing, it is imperative
that a System-Check is carried out before the next measure-
ment and, if necessary, technical support must be contacted.
(see chapter „10 Troubleshooting“)
In case of reoccuring invalid tests or prolonged periods of in-
activity System-Care procedure is initiated automatically by
the suPARnostic® Report Software.
Therefor it is necessary to insert a GENSPEED SC Chip (System-
Care). System-Care can also be started manually any time.
At least every 14 days the software requests a manual clean-
ing procedure of the nozzles. This time interval can be ad-
justed in the software settings (device management).

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2. The suPARnostic® POC+ GENSPEED®R2 Test
System
2

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Chapter The suPARnostic® POC+ GENSPEED® R2 Test System |System components
In this section the components of the suPARnostic® POC+ GENSPEED R2
Test System are briey explained.
The suPARnostic® POC+ GENSPEED R2 Test System consists of:
Test Chips
The Test Chips are provided in the respective Test Kits. They are
printed with capture probes. These probes are used on the one
hand for detection of specic analytes and on the other hand for
checking of the test performance.
Fig. 1: Symbolic photo
Test Chip
suPARnostic® POC+ GENSPEED R2
The device is an electronic CE/IVD device which automati-
cally dispenses the reagents required during the test pro-
cedure into the Test Chip inlet, detects target analytes by
means of spatially-resolved light detection and evaluates
it using the suPARnostic® Report Software. It is a desktop
device that is connected via USB port to the computer.

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Chapter The suPARnostic® POC+ GENSPEED® R2 Test System |System components
The device is delivered with a GENSPEED
Transport Cartridge (Item n° 453242)
inserted. The package also includes the following components:
-USB cable to connect the suPARnostic® POC+ GENSPEED
R2 with the computer for power supply as well as
communication with the suPARnostic® Report Software
- Cloth to clean the optical window and the the window of the
barcode module of the suPARnostic® POC+ GENSPEED R2
- Graphical instruction manual for installation
- Two GENSPEED SC Chips for System-Care procedure
- Accessories for cleaning (4 brushes, 1 mL syringe with Luer-
adapter, 3 substitute seal ring)
suPARnostic® Report Software
The software is used to control the suPARnostic® POC+ GENSPEED
R2, to guide the user through the test-procedure, to analyse the
measurement data and to nally present the measurement report.
The Computer
The suPARnostic® POC+ GENSPEED R2 device is connected to the
computer with the pre-installed suPARnostic® Report Software via
USB.
Fig. 2: suPARnostic® Report Software

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3. Functional principle & theoretical basics
3

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Chapter Functionalprinciple&theoreticalbasics|OverviewofthefunctionalprincipleofthesuPARnostic®POC+GENSPEEDR2TestSystem
3.1 Overview of the functional principle of the suPARnostic®
POC+ GENSPEED R2 Test System
The following chapter explains and illustrates the functional principal
of the suPARnostic® POC+ GENSPEED R2 Test System.
To carry out a test, the Test Chip is inserted in the suPARnostic® POC+
GENSPEED R2 analyzer.
The barcode on the Test Chip identies the chip as a particular test
type and is automatically recognised by the suPARnostic® POC+
GENSPEED R2 analyzer.
By dripping the patient sample, which has been prepared accord-
ing to the test type, into the Test Chip, the suPAR molecule will bind
to specic antisuPRA antibodies of certain micro organisms will bind
to the oligonucleotide probes. After application of different reagents
stored in the Cartridge and dispensed automatically into the Test
Chip inlet by the suPARnostic® POC+ GENSPEED R2, an enzymatic re-
action generating light is initialized.
This light is detected in the device by means of a highly sensitive op-
toelectronic sensor system and eventually analyzed by the software.
Fig. 3: suPARnostic® POC+ GENSPEED R2

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Chapter Functional principle & theoretical basics |Functional principle & theoretical basics - Test Chips
3.2 Functional principle & theoretical basics - Test Chips
Top view:
Fig. 4: different views of the Test Chip
Illustration of the test chip on the left
(Top view and side view, see Fig. 5).
The Test Chip consists of:
• Test chip upper part including:
- an inlet to apply the sample and necessary reagents,
- the reaction channel through which the liquids are drawn
by capillary action and which facilitates the binding of the
analytes to the probes by the resulting shear forces
- as well as a waste container, which acts as a capillary
action pump and as a reservoir for excess liquid.
• Film
On the lm, the strips with specic probes are located, which bind
the target analytes.
Side View:
zoom in:
above Test Chip top-part,
below the foil with printed
capture oligonucletides,
in the middle the
reaction channel
(I) GENSPEED Test chip top-part
Foil with printed capture-oligonucleotides
Test Chip top-part
Foil with printed capture-oligonucleotides
Rection channel
Reaction channel
GENSPEED Test chip inlet (I)
Waste