R-Biopharm RIDA qLine Scan User manual

User Manual
RIDA qLine®Scan
https://clinical.r-biopharm.com

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RIDA qLine® Scan | User Manual

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User Manual
RIDA qLine® Scan
Art. No. ZG1109:
Version 2022-04-08
© Copyright 2022 by R-Biopharm AG
R-Biopharm AG reserves the right to
modify its products and services at any
time. This guide is subject to change
without notice. Although prepared to
ensure accuracy, R-Biopharm AG assumes
no liability for errors or omissions, or
for any damages resulting from the
application or use of this information.
The content of this manual is the property
of R-Biopharm AG and is copyrighted.
Except as specified in the End User License
Agreement, any reproduction in whole
or in part is strictly prohibited.
© 2022 R-Biopharm AG, Darmstadt
R-Biopharm AG
An der neuen Bergstraße 17
64297 Darmstadt, Germany
+49 (0) 61 51 - 8102-0
+49 (0) 61 51 - 8102-40
[e-mail]
www.r-biopharm.com

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RIDA qLine® Scan | User Manual
Content
Warnings, Cautions and notes 5
Labels 6
1 Safety instructions 7
2 General information 8
2.1 Intended purpose 8
2.2 Functions 8
2.3 Device specications
and requirements 9
2.3.1 Specications 9
2.3.2 Requirements 10
3 Start up 10
3.1 Introduction 10
3.2 Device and accessories 10
3.3 Unpacking and positioning
of the device 11
3.4 Environmental conditions 12
3.5 Environmental parameters 12
3.6 Transport and storage
conditions 13
4 Installation and
connection of
RIDA qLine® Scan 14
4.1 Transportation lock 14
4.2 Preparation 15
4.2.1 Connection 15
4.3 Installation 16
5 QC test using
RIDA qLine® Soft 17
6 Image creation with
RIDA qLine® Scan 18
6.1 Placing the test 18
7 Erroneous image
acquisition 19
8 Turn off the reader 20
9 Cleaning and
maintanance 20
9.1 Outside 20
9.2 Inside 20
9.3 Cleaning of the glass sheet 21
9.4 Maintenance 21
9.5 Return and repair 21
10 Disposal 22
11 Corrective action/
Notication to authorities 23
12 Conformity IEC 61326-2-6
and RoHS3 23
13 Version Number 23

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Please read this manual carefully before using the instrument and make it
accessible to all users. Failure to comply with the instructions in this manual
will void the manufacturer’s warranty and may pose a risk to the user.
Ensure all users are conversant with the instrument - contact R-Biopharm AG
for any further instrument or training requirements if in any doubt before
using the instrument. Consult User Manual where symbol (left) is seen on
the instrument
Warnings, Cautions and notes
Special notes in these operating instructions are highlighted by symbols
Symbol Description
Warning!
Follow the instructions to avoid the risk of injury.
Warning!
Follow the instructions to avoid damage to the device.
Warning!
Possibility of electric shock!
General safety instructions!
Follow the instructions to achieve optimum device performance.

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RIDA qLine® Scan | User Manual
Labels
Symbol Description
RIDA qLine® Scan Product branding
In vitro diagnostic medical device
Reference number
Caution
WEEE
Waste Electrical and Electronic Equipment
WEEE
Waste Electrical and Electronic Equipment
Refer to user manual
Manufacturer
Date of manufacturing
RIDA qLine® Scan serial number
RIDA qLine® Scan serial number
Acceptable storage temperature range
Acceptable storage humidity range
SN

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1 Safety instructions
• The device is intended for use by professional users only.
• The guidelines for work in medical laboratories must be observed.
• The operating instructions for the devices must be strictly observed.
• Please handle this equipment carefully at all times.
• Follow basic safety precautions to reduce the risk of injuries, fire and electrical shock.
• Read all information in this document attentively. Failures in understanding and
following the instructions may result in damage to the product, injury to operating
personnel and poor instrument performance.
• Electrostatic discharges can damage the device and affect the behavior and stability
of laboratory equipment. Therefore, avoid any electrostatic charge.
• Pay attention to all WARNING, CAUTION and STOP statements in this publication.
• Never open the electrical compartment while the equipment is plugged into
a power source.
• When using the RIDA qLine® Scan, Good Laboratory Practice (GLP) must be observed.
• Use a lab coat and pay attention to the safety standard procedures in you laboratory.
• Please be careful while working with infectious material and pay attention to the safety
instructions thoroughly. Always wear gloves for your own safety. Proceed according to
the safety instructions of your laboratory when infectious substances get in contact
with your skin
Warning:
If the RIDA qLine® Scan or corresponding pieces are damaged, the system
cannot work correctly and therefore the warranty will no longer be valid!
Warning:
Always pay attention to the safety instructions while working with infectious
material

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RIDA qLine® Scan | User Manual
2 General information
2.1 Intended purpose
For in-vitro diagnostic use. The RIDA qLine® Scan reader creates scanned images of the
RIDA qLine® Allergy test membranes. RIDA qLine® Soft must be used for operation in
compliance with in-vitro diagnostic use and for further processing of the images.
The product is intended for professional use.
2.2 Functions
RIDA qLine® Scan allows RIDA qLine® Allergy tests to be scanned after manual processing.
The images are then quantitatively analyzed with RIDA qLine® Soft.
Instrument features:
• Generation of pictures within a few seconds
• Picture handover in Bitmap format
• Control through Imaging-Software with Twain-Interface
• Easy to use
Caution:
If the directions given in this manual are not followed, the system may not work
correctly and it can be damaged!
Warning:
Warranty void if any changes or modications are made to the product.

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2.3 Device specifications and requirements
Fig. 1: Open Drawer
2.3.1 Specifications
Parameter Specifications
General weight 2.9 kg
Plastic contents 2 parts of body housing
Drawer mechanical drawer
Power Supply 1 x external power supply
Mod. 3A-183WP24
Input 100V – 240V 50-60 Hz, 0.6 A
Output 24V – 0.75 A
Dimensions 300 x 300 x 80 mm
Throughput 10 membranes within 20 seconds
Calibrating Self calibrating

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RIDA qLine® Scan | User Manual
2.3.2 Requirements
Hardware minimum requirements:
• PC according DIN EN 60950
• USB 2.0 port (3.0 possible)
Software requirements:
• Microsoft Windows Version 7,8,10
• RIDA qLine® Soft
3 Start up
3.1 Introduction
This chapter describes how to install and start this device. This includes unpacking,
accessories, the software installation and PC connections.
Note:
Make sure you do not drop the scanner, this could injure someone
or damage the device.
3.2 Device and accessories
Accessories provided with the instrument:
Product Accessory
RIDA qLine® Scan •Power supply (100-240V Input and 24V,
0.75A Output)
•USB cable, ca. 1.2 - 2 m
•Instruction manual

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Accessories required but not provided with the instrument:
Product Art. No.
RIDA qLine® Soft
RIDA qLine® Incubation Set
Z9995
ZG2701
Product Art. No.
RIDA qLine® QC-Kit
(for RIDA qLine® Soft)
ZG1108
RIDA qLine® Allergy A6442, A6242, A6342, A6142, A6142EC2, A6142VIET,
A6142PSMI, A6442UA1, A6242H, A6242PA, A6342UY,
A6142UZ, A6442TZA, A6342MENA, A6442UZ, A6442BY,
A6342KE, A6342BY, A6142HVEN, A6142UY, A6442UA2,
A6242GR, A6342PH, A6242PH, A6142BY, A6242BY,
A6242UY, A6142ZW2, A6142EAWU, A6242EAWU,
A6342EAWU, A6442EAWU, AW2001, AW2002,
AW2003, AW2004
3.3 Unpacking and positioning of the device
Place the instrument on a at, horizontal surface. Remove all indicated safeguarding and
adhesive tape. Put no heavy objects onto the reader.
Warning:
Please, pay attention to the temperature. During winter season, the instrument
can be delivered very cold because of shipment. After positioning, wait until the
instrument has reached the environmental temperature. Only then start the
instrument.
Check all parts supplied according to the above-mentioned list. Compare the serial
number of the instrument with the enclosed shipping documents. Please store all
packaging material. It should be used for a return transport in case of damage or
complaint. The instrument should be shipped in the original packing.

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RIDA qLine® Scan | User Manual
3.4 Environmental conditions
Place the instrument on a at, horizontal surface with sufcient amount of space around
it. Avoid setting up at places where it can fall down.
Warning:
Please, pay attention that the pulled out drawer doesn’t reach out over the
working place. This might lead to injuries of the employees and can damage
the instrument.
Avoid vibrations, strong electromagnetic waves (not computer), sources of heat and the
exposure to direct sunlight.
Keep the workplace surrounding the instrument free of any aggressive liquids.
3.5 Environmental parameters
Operation temperature: 15 °C to 35 °C
Working height: 0 to 2.000 m above sea level
Relative humidity: 20 % - 80 %, no condensing
Caution:
Before turning the instrument on, acclimatize the instrument at room temperature
to let all condensed water evaporate from the inside.

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3.6 Transport and storage conditions
Transport
Environmental temperature: -40 °C to 65 °C
Relative humidity: 0 % to 95 %
Storage
Environmental temperature: -20 °C to 30 °C
Relative humidity: 20 % to 30 %
It is recommended to choose the transport and storage conditions in the medium range of
the conditions specied above. Before moving or transporting the device unplug it and
use exclusively the original packaging for transport.

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RIDA qLine® Scan | User Manual
4 Installation and connection of RIDA qLine® Scan
4.1 Transportation lock
The device is locked for transportation. Please read the note attached to the device
attentively. Turn the device upside down and proceed upon instruction.
Caution:
Before turning on the instrument, remove transportation lock.
Using the device in a locked state might cause irreversible damage.
The device is delivered in a locked state.
The dark screw locks the scanning unit whereas the light
colored screw seals a second opening.
In order to unlock the device, please unscrew both screws
completely, remove the note slip and exchange the
positions of the screws.
Please tighten both screws
properly to keep the device
free of dust.
After exchanging the screws,
the device is unlocked and
ready to use.
Fig. 2: How to remove the transportation lock
The device can be placed in an upright position and the drawer can be inserted
completely now.
Caution:
Please tighten both screws properly to prevent any contaminations with dust.

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4.2 Preparation
Please plug the supplied cables into the respective sockets at the rear of the scanner.
4.2.1 Connection
The RIDA qLine® Scan features two sockets at the rear.
1. Power Plug
2. USB Port
Connect the black power plug with socket at the rear of the scanner.
Use only the external power adapter provided with the instrument.
Caution:
Only use the original power adapter of the RIDA qLine® Scan.
The plugs cannot be mixed up due to their different t. The device has a power switch at
the rear to turn it on. If the RIDA qLine® Scan is not in use it will automatically enter the
standby mode after 15 minutes. An input signal of the software can reactivate the scanner.

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RIDA qLine® Scan | User Manual
4.3 Installation
Note:
Please install the RIDA qLine® Soft software rst in order to install the driver
of the RIDA qLine® Scan.
Please disconnect the computer from the Internet in order to speed up
the installation process of the driver
The Driver for RIDA qLine® Scan is integrated in
RIDA qLine® Soft and will be installed during
installation of RIDA qLine® Soft. When the driver
installation is completed successfully please connect
the RIDA qLine® Scan to the PC using the provided
USB cable.
The plugs t into the dedicated sockets only and you
cannot mix them up. Please switch on the RIDA qLine®
Scan. You will nd the switch at the rear of the device.
The small blue lamp on the right front side indicates
that the reader is switched on.
Note:
If an older version was previously installed you must execute the
program „SetRIDAqLineScanner.exe“. This program is stored in the folder
„C:\Program Files (x86)\R-Biopharm\qLine“
Note:
Please keep the manual of the RIDA qLine® Soft software at hand to support you
working correctly with the reader. In this manual, you will nd all the functions
described in detail for controlling the RIDA qLine® Scan.
Fig. 3: The device is ready
to use as soon as the PC
has identied the reader

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5 QC test using RIDA qLine® Soft
In order to check the perfect function of the RIDA qLine®
Soft it is recommended to use the RIDA qLine® QC kit
(ZG1108).
Start the RIDA qLine® Soft software on the connected PC.
To perform the QC test, click the down arrow in
Settings menu item, and select Perform QC test.
Place 10 QC strips (Art. No. ZG1108) in the strip holder,
included in the RIDA qLine® Incubation Set.
Insert it into the upper position (1) of the RIDA qLine® Scanner template. When using two
strip holders, you must simultaneously insert them into the (1) and (2) position in the
RIDA qLine® Scanner template.

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RIDA qLine® Scan | User Manual
Place the scanner template on the scanner, close the cover and click Measure .
You will be shown a QC report immediately after a successful measurement.
You can either print it, save it as a PDF, or simply close the preview.
All reports are automatically saved as PDF in this directory:
C:\R-Biopharm\Database\qLine\QCArchive.
This report consists of a total of either 11 or 21 pages: the rst page of the report shows
you an overview of the QC measurement, and subsequent pages show the results for each
individual strip.
6 Image creation with RIDA qLine® Scan
6.1 Placing the test
Pull out the drawer at the front side of the
RIDA qLine® Scan.
Open the drawer until you see the complete pad
to place the strips (see Fig.4).
Position the strip holder including RIDA qLine® Allergy
strips (RIDA qLine® Incubation Set) into the cavity of
the pad (see Fig 5).
Pay attention that the test membranes are
positioned facing up.
Close the drawer as far as it will go. The drawer is
completely held in place by a magnet.
Start the scan-process now using the software.
Open the drawer after scanning and remove
the strips.
Fig. 4: RIDA qLine® Scan
with opened drawer
Fig. 5: RIDA qLine® Scan
with placed strip holder

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7 Erroneous image acquisition
If any image does not reect the visual perception, please check the correct proceeding
upon the instructions and restart the image acquisition again. If you are not able to receive
a correct image please contact the manufacturer.
Warning:
After scanning please check, if the membranes were evaluated with good quality.
Repeat the scan, if necessary.
8 Turn off the reader
At the rear of the device you can nd a switch to turn the device on and off.
When you turn off the device, it is not disconnected from the power source.
The device is only disconnected from the power source completely if it is unplugged.
Please position the scanner in such a way that you can easily access the rear
to disconnect the device from the power source.

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RIDA qLine® Scan | User Manual
9 Cleaning and maintanance
Optimal results will be obtained when the device is operated virtually dust-free.
Clean the drawer and the insert from time to time, depending on the level of
contamination
9.1 Outside
Clean the device only with water and a mild detergent. For external cleaning, use a moist
cloth and wipe the device evenly.
9.2 Inside
The cleaning of the interior is limited to the drawer area.
Warning: Wear rubber gloves when cleaning the scanner.
Slight contaminations
Pull out the drawer and then wipe the drawer with a damp cloth carefully.
Heavy contaminations
In case of heavy contaminations of
the drawer, pull it out completely.
In order to pull out the drawer
completely the clamps on the
bottom side must be drawn
outwards. Then the drawer can
be pulled out completely.
Caution:
Never use acetone or concentrated alcohol to clean the plastic components
in the device.
Fig. 6: Open the drawer completely