R-Biopharm RIDA QUICK SCAN II User manual

User manual
RIDA®QUICK SCAN II
https://r-b.io/15

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RIDA®QUICK SCAN II Version 2.1 | User Manual

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User manual
RIDA®QUICK SCAN II
Item no. ZRQS2-KD: IVD
Version
Version 2.1 (2022-01-21)
Valid for firmware version 44.04 and higher
©Copyright 2022 by R-Biopharm AG
All rights reserved.
It may not be reproduced in whole or in
part or be translated into another language
without our express, prior written consent.
Subject to technical changes.
Technical changes, deviations in
the illustrations, and errors reserved.
©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®QUICK SCAN II Version 2.1 | User Manual
Contents
General information 5
Important information 5
Explanation of symbols used 6
Intended use 6
1 Selection of installation site 7
2 Unpacking and
installation 7
3 RIDA®QUICK SCAN II:
Overview 9
4 Operating the
RIDA®QUICK SCANII 11
4.1 Switching on 11
4.2 Switching off 12
4.3 Main menu 13
4.4 Charge indicator 13
4.5 Submenu “Setup” 14
4.6 Submenu “Management” 16
4.7 Submenu “Measurement” 17
4.8 Submenu “Results” 20
4.9 Submenu “Standby” 22
5 Connecting external
components 23
6 Performing firmware
updates 24
7 LAN access to
RIDA®QUICK SCANII 25
8 Performing a measurement 26
8.1 Creating/selecting a user 26
8.2 Reading in lots and methods 26
8.3 Preparing and initiating a
measurement 27
9 Cleaning and care 29
Notes and annex 30
Technical data, ambient
conditions 30
Safety information 30
EC Declaration of conformity/
CE mark 31
Disposal Information 32
Annex 1: Error messages
and warnings 33
Annex 2: Version history 36

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General information
Please carefully compare the contents of this delivery with the enclosed delivery note, the
package leaet or the invoice. We recommend that you keep a copy of this document
together with the instructions, so that you can quickly access information about the date
and scope of delivery in case of future queries, re-orders or service work.
Please be sure to remove all small parts from the packaging material. We like to inform you
that our devices are adjusted at the factory and can be used immediately after installation.
Before using the RIDA®QUICK SCAN II for the rst time, please read the operating
instruction carefully. We recommend that it always be kept with the
RIDA®QUICK SCAN II.
Important information
The RIDA®QUICK SCANII (item no. ZRQS2-KD) is an invitro diagnostic medical device in
compliance with the German Medical Devices Act (§3 Paragraph4 MPG) when operated
according to the manufacturer’s intended use for examining samples taken from the
human body.
According to the Regulations for Operators of Medical Devices (§2 Paragraph 5
MPBetreibV), users of medical products must ensure that these are functional and in good
condition. In addition, the user must observe the operating instructions as well as other
safety-related information and maintenance information.
The manufacturer of the invitro diagnostic device is not responsible or liable for
information, evaluations, diagnoses, etc. that are obtained through the use of the invitro
diagnostic device.

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RIDA®QUICK SCAN II Version 2.1 | User Manual
Explanation of symbols used
In these operating instructions, special information is highlighted
by the use of symbols:
Warning: Follow the instructions to prevent the risk
of injury.
Warning: Follow the instructions to prevent damaging
the device.
Attention: Possible electric shock!
General safety information: Follow the instructions to ensure
optimum performance of the device.
Intended use
For invitro diagnostic use. The RIDA®QUICK SCANII is a lateral ow reader for automatic
reading of quantitative lateral ow tests. Use the RIDA®QUICK SCANII only in combination
with lateral ow tests for which the use of the RIDA®QUICK SCANII is indicated.
The product is intended for professional use.

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1 Selection of installation site
The RIDA®QUICK SCANII is a high-quality optoelectronic device that can deliver its full
performance only under very clean conditions. To avoid excessive contamination, the
RIDA®QUICK SCAN II should be used in a room that is as free of dust as possible. For dusty
environments, an optional dust protection case is available, in which the device can also
be operated.
If you transport the RIDA®QUICK SCANII between environments with drastically different
temperatures, please note that measurements should not be made until the device has
adjusted to the new ambient temperature.
2 Unpacking and installation
The RIDA®QUICK SCANII is securely packed at the factory for transportation. After
opening the packaging, check to see whether any damage has occurred during transport
and make sure the delivery is complete as stated in the delivery documents.
If there is any cause for complaint about the delivery, please immediately contact
R-Biopharm, Darmstadt, or the supplier from which you obtained the RIDA®QUICK SCAN II.
Warning: Only professional users may operate the
RIDA®QUICKSCANII. The guidelines for working in medical
laboratories must be followed. Follow the user manual
for the RIDA®QUICKSCANII closely.
For installation, rst remove the device from the packaging and place it on an even, rm
and vibration-free surface.
The RIDA®QUICK SCANII comes with a 6-V DC power supply, which was specially
selected for operating the device. The polarity of the plug on the device side was correctly
pre-set at the factory and cannot be changed without forced removal and incorrect
insertion of the plug connector.

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RIDA®QUICK SCAN II Version 2.1 | User Manual
Warning: Only use the power supply provided or an identical type approved
by R-Biopharm to operate the RIDA®QUICK SCANII.
R-Biopharm cannot accept liability for damage to the device or its accessories or
other material damage or personal injury resulting from the use of a power supply
other than the one provided or a type that has not been approved by R-Biopharm.
In these cases, any warranty claims against the manufacturer are null and void.
The same applies to modications to the power supply that are not authorized by
R-Biopharm.
Insert the plug connector of the power supply on the device side into the rear socket of
the RIDA®QUICK SCANII marked “6VDC” and plug the power supply into a wall outlet.
General safety information: Before using the device for the rst time, fully charge
the battery of the device using the power supply provided. The device can be used
during the charging process.
Note: This does not apply to charging via the USB port of a connected PC. The port
does not provide sufcient charging current to enable continuous operation during
the charging process.

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3 RIDA®QUICK SCAN II: Overview
Housing
Touchscreen
display
Test cassette
Status LED
On switch
Drawer for
test cassette
1Supply voltage
2Firmware Button (OPT)
3USB port
4Network Interface
5PC Connection (USB)
Fig. 1: RIDA®QUICK SCAN II general overview
Fig. 2: Connections at the rear of the device
1 2 3 4 5

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RIDA®QUICK SCAN II Version 2.1 | User Manual
Fig. 3: Scope of delivery
1Control strips (ZRQS2-KS-KD) 2 Power supply (ZRQS2-NETZTEIL)
1
2

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4 Operating the RIDA®QUICK SCANII
This section describes the essential operating steps, as well as the menus and submenus.
Refer to section 8 for step-by-step instructions on performing measurements.
General safety information: Some users may nd it more convenient to operate
the RIDA®QUICK SCANII touchscreen using a stylus (“touch pen”). Please use this
option if the device cannot be reliably operated manually.
4.1 Switching on
The drawer of the RIDA®QUICK SCANII must be closed during startup.
Switch on the RIDA®QUICK SCANII by pressing the power switch. Note that when
connected to readers, the RIDA®QUICK SCANII may be operated only when powered
from a wall outlet. Otherwise the RIDA®QUICK SCANII will not start up properly or will
switch off automatically.
During startup, the status LED illuminates orange and a progress bar appears on the
starting screen. After this, a check of the internal calibration is performed and a request to
select the user is displayed. This selection can be skipped by selecting “No User”. Skip this
section when using the device for the rst time and if a user has not been created yet (see
4.5 and 8.1). Immediately after this, the main menu is displayed.
General safety information: The color of the status LED indicates the current
operating state of the RIDA®QUICKSCANII:
Orange: Device starting
Green: Readiness for operation
Flashing green: Standby mode
Off: Battery operation
Flashing red: Charging circuit fault

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RIDA®QUICK SCAN II Version 2.1 | User Manual
Warning: If the status LED illuminates red, the charging circuit is defective.
Please contact your local distributor or R-Biopharm, Darmstadt!
General safety information: If the internal calibration fails, the procedure is
aborted with an error message. The device starts up and displays the main menu,
but activating a measurement causes a failed calibration message to appear.
Ameasurement can no longer be made. Open and close the drawer and restart
the device to try recalibrating.
If the error message persists, switch off the device and contact your local distributor
or R-Biopharm, Darmstadt.
4.2 Switching off
To switch off the RIDA®QUICK SCANII, always select the “Power off” button from the
main menu and select “Yes” to the following prompt.
General safety information: The RIDA®QUICK SCANII can also be switched
off by pressing and holding the power button. However, this method may cause
loss of data, so the device should be switched off in this way ONLY if the rmware
has crashed or the device no longer responds to input.

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4.3 Main menu
Once the RIDA®QUICKSCANII has started, the start screen with the main menu is
displayed.
The header of the main menu shows the date and time, the number of measurements that
have been saved and the number of measurements that are still possible. The date and
time can be changed under “Setup” (see Section4.5).
4.4 Charge indicator
The charge indicator in the top left corner of the start screen shows the charge status of
the built-in battery.
The status LED on the housing ashes red if the charge is too low (see section 4.1). In this
case, connect the mains unit immediately.
When the mains unit is connected, a jagged line is also displayed in the battery symbol.
Fig. 4: Overview main menu

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RIDA®QUICK SCAN II Version 2.1 | User Manual
4.5 Submenu “Setup”
Control measurement
This function performs a control measurement with a control strip. Therefore, please scan
the QR code on the certicate (if existing). The method to be used is loaded automatically.
The RIDA®QUICK SCAN II locks if the control measurement fails or the measurement is
invalid. In this case, please contact your local distributor or R-Biopharm, Darmstadt.
Each control strip has an individual serial number to which a corresponding certicate is
assigned. The traceability of the target value is ensured through the manufacturing
process.
Fig. 5: Overview submenu
“Setup”
Fig. 6: Overview menu item
“control measurement”

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General safety information: Every RIDA®QUICK SCANII comes with a control
strip and certicate that contains a reference value. If the control measurement
does not correspond to this reference value (including the specied tolerances),
repeat the process.
If another deviation occurs, please contact your local distributor or
R-Biopharm, Darmstadt, directly.
General safety information: The control strip must be treated with great care. In
particular, ensure that the surface with the printed reference lines does not become
dirty. Always keep the control strip in a dark place (for example, in a lightproof
drawer) when not in use.
Self test
This function starts an internal test routine to test the camera, illumination, free memory
space and the installed software packages (“Files”).
The RIDA®QUICK SCANII will be locked if at least one item of the self-test fails. In this case,
please contact your local distributor or R-Biopharm, Darmstadt.
Device setup
This function allows the setup of the date and time, user management, screen setup and
language. The language versions German, English, French, Spanish, Italian, and
Portuguese are available.
Users can be created and selected under the menu item “User management”. If at least
one user has been created, the RIDA®QUICK SCANII starts with the prompt to select a
user or to continue without a user.
Device information
Displays the manufacturer, serial number, current user, free memory, model, and rmware
version.

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RIDA®QUICK SCAN II Version 2.1 | User Manual
4.6 Submenu “Management”
Backup
For backup methods and lots, measurements and users can be selected independently of
each other. All of the les in the RIDA®QUICK SCAN II directory “measurements” are
backed up in a directory with the same name and device serial number on a connected
USB ash drive.
The les are saved in the format
[(Method)(Lot No.) – (Date)(Time)].XXX
whereby for a le name the following endings (XXX) are possible:
PGM: Gray-scale image of the test strip
XML: Complete test as XML le
TXT: Complete test result as text le
PDF: Complete test as PDF le
In addition, another XML le is created, which has the character combination “-RES-” (for
“result”) instead of the hyphen in the le name. Only the pure result data are saved in this
le.
Fig. 7: Overview submenu
“Management”

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Fig. 8: Overview menu item
“Backup”
Lot/Method
Selection of the import method: from barcode (with connected reader, see Section5) or
via USB (with USB stick plugged in).
In the “Delete Lot/Method” subitem, individual lots or methods can be selected and
deleted. The RIDA®QUICK SCANII stores only one lot at a time.
4.7 Submenu “Measurement”
To perform a measurement, select a method saved on the RIDA®QUICK SCANII from the
selection list displayed. The sample ID can then either be entered manually or read in via
the barcode.
General safety information: Follow the processing steps for the respective
RIDA®QUICK test and comply with the time window for evaluation according to
the instructions for use for the respective RIDA®QUICK test. If the method to be
used in the RIDA®QUICK test does not appear in the selection eld, it has to be
scanned via “Read Lot/Method” (Section4.6).

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RIDA®QUICK SCAN II Version 2.1 | User Manual
The RIDA®QUICK SCANII then prompts you to insert a test cassette or to conrm that a
test cassette has been inserted. Proceed as follows to insert a test cassette:
• Lightly press in the ribbed surface on the front plate of the drawer until you hear the
drawer unlock.
• Then pull out the drawer as far as the stop.
• Slots are built into the drawer to securely hold the test cassette. Place a prepared test
cassette with test strip facing up into the appropriate slot, and press the cassette down
firmly to ensure it is held securely in place.
Warning: Make sure that no excess uid runs out of the test cassette into the
drawer. If this does happen, clean any residual uid from the drawer before
closingit.
General safety information: If the drawer is open or will be opened for inserting
a test cassette, an image appears on the screen showing the correct orientation of
an inserted test cassette.
Fig. 9: Slightly press the front
plate of the drawer to open it

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• Press the drawer closed until it engages with the housing.
General safety information: If the test cassette is inserted incorrectly, the
measurement process will be aborted with an error message. If a measurement is
started without a test cassette in the device, error message “Test cassette not
inserted” or “Camera out of focus” will appear (see Annex1 on troubleshooting).
Fig. 10: Correct orientation of
the test cassette
Fig. 11: Gently close
the drawer

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RIDA®QUICK SCAN II Version 2.1 | User Manual
General safety information: To close the drawer again immediately after
opening, you must rst pull the drawer a little way out of the housing. Otherwise
it cannot engage!
The measurement now starts automatically. When the measurement is successful, the
result is displayed directly on the screen. The display format corresponds to the illustration
shown in Section4.8 “Samples.”
4.8 Submenu “Results”
It is possible to sort saved measurements by sample ID, method or date by clicking on the
column header.
Fig. 12: Overview submenu
“Results”
Fig. 13: Filter function
for the results