R-Biopharm RIDA qLine ZG2601 User manual

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

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RIDA qLine® Orbital Shaker | User Manual

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User Manual
RIDA qLine® Orbital
Shaker
Item no. ZG2601:
Version 16.00 (2022-03-03)
©Copyright 2022 by R-Biopharm AG
All rights reserved.
No part of this publication may be
duplicated, communicated, rewritten, or
translated into another language or
computer language, regardless of the form
or means, without explicit prior written
permission.
Subject to technical changes, deviations in
figures, and errors.
©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® Orbital Shaker | User Manual
Contents
1 General information 5
1.1 Unpacking the device 5
1.2 Safety information 5
2 Operation and
description of the RIDA
qLine® Orbital Shaker 8
2.1 Description 8
2.2 Intended use 8
2.3 Dimensions and installation of
the RIDA qLine® Orbital Shaker 9
2.3.1 Ventilation requirements
during operation 10
2.4 Scope of delivery 10
2.4.1 Included in the delivery 10
2.4.2 Required accessories, not
included with the device 10
2.4.3 Required consumables, not
included with the device 11
2.5 Operation of the RIDA
qLine® Orbital Shaker 11
2.6 Device malfunctions 12
3 Maintenance and service 13
3.1 Service and repairs 13
3.2 Device cleaning and
decontamination 13
4 Uninstalling
and disposal 14
4.1 Uninstalling the device 14
4.2 Disposal of reagents
and materials 14
4.3 Device disposal 14
5 Packaging and
storing the device 15
5.1 Packaging the device 15
5.2 Storing the device 16
6 Warranty and
exclusion of liability 16
7 Technical data 17
8 Troubleshooting/
information on reporting
to authorities 18
9 Conformity to IEC 61326-2-6
and RoHS3 18
10 Symbols used on
the device 19
11 Version history 19

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1 General information
1.1 Unpacking the device
Examine the outer box containing the instrument. Look for damage, e.g., dented walls,
chemical damage to the box, water marks, or other signs of physical distortion that could
have damaged the package’s contents. If you detect damage, immediately contact the
shipper and ask about the actions that need to be taken.
Note: If all components are undamaged and all parts are complete, you can start
operating the device after reading through the user manual.
1.2 Safety information
1. Read this user manual in its entirety before operating the device. Items that require
special attention within your area of application need to be marked so that they
immediately catch the eye.
Carefully read this manual before using the device, and make the manual
available to all users. Failure to observe the instructions in this manual will void
the manufacturer’s warranty and can pose a risk to users.
Make sure that all users are familiar with the device. When in doubt, contact
R-BiopharmAG if you need additional equipment or training before using the
device.

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RIDA qLine® Orbital Shaker | User Manual
2. This user manual needs to be available at all times, especially to the people who would
like to use this device. Therefore, keep this user manual in the proximity of the device.
Strictly observe this user manual.
3. Use only original spare parts and original accessories from the manufacturer. These
parts are tuned to the tight tolerances of the device and ensure reliability.
4. Always work in accordance with the regulations on good laboratory practice. The
guidelines for working in medical laboratories must be observed. Wear a lab coat and
follow the safety standards in your laboratory.
5. Be careful when working with infectious material, and precisely follow the safety
information. Always wear gloves for your own safety.
Follow the safety regulations of your laboratory if infectious substances come into
contact with your skin.
6. Only professional users may operate this device.
Explanation of the safety information in the user manual
Symbol Description
Warning!
Follow the instructions to avoid the risk of injury.
Warning!
Follow the instructions to avoid the risk of injury.
Warning!
Potential electrical shock
General safety information
Follow the instructions to ensure optimal performance of the device.

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Note:
Failure to follow the safety and operating instructions in the user manual and
improper handling of the device can impact the safety that the device affords and
will void the warranty.
Important:
Only trained users may operate the device.
Important:
Do not use this device in an unsafe environment and especially not in an explosion-
hazardous environment.
Important:
The main switch of the control box does not completely disconnect the device from
its power source. Only one phase is disconnected. To completely disconnect the
device from the electrical grid/power supply, unplug the power plug.
Note:
Make sure that all safety information for the device and on the device itself is clearly
visible during operation.
Important:
Do not open the device. Repairs are reserved to trained service technicians.
Important:
Do not use ammable media together with the device or in its immediate vicinity.

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RIDA qLine® Orbital Shaker | User Manual
2 Operation and description of
the RIDA qLine® Orbital Shaker
2.1 Description
The RIDA qLine® Orbital Shaker is a shaker that has orbital shaking motion. The power
switch on the front side is used to switch on and off the device. The speed is set to
300rpm by default. Users cannot change the speed.
2.2 Intended use
For invitro diagnostic use. The RIDA qLine® Orbital Shaker is a device for shaking the RIDA
qLine® Allergy strips during the incubation steps.
The product is intended for professional use.
Important:
Do not use ammable media together with the device or in its immediate vicinity.
Important:
The user is responsible for determining whether the device is suitable for the user’s
application. If you are in anyway unsure,
talk to your distributor or directly with the manufacturer.
Important:
Always use this device in such a way that neither the user nor any other person
could be endangered.

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2.3 Dimensions and installation of
the RIDA qLine® Orbital Shaker
The following image shows the installation dimensions, such as length × width × height.
Important:
Make sure that the device is resting on all 4 feet. The device must be placed on a
horizontal surface.
Important:
When installing the device, ensure the device has adequate safety distances in its
immediate vicinity. The shaker unit needs to have a safety distance of at least 2cm
away from surrounding objects.
These safety distances refer only to the proper functioning of the device and not to
re hazards.
Do not use ammable media in the immediate vicinity of the device.
90 mm
140 mm
170 mm

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RIDA qLine® Orbital Shaker | User Manual
2.3.1 Ventilation requirements during operation
Ensure adequate and constant ventilation of the RIDA qLine® Orbital Shaker during
operation. The shaker’s ambient temperature should not exceed 40°C. As a user, you are
responsible for providing adequate ventilation to ensure that the device does not overheat.
Users are responsible for the ventilation. It is up to the user to judge whether this
ventilation is damaging to the method/application.
If the instructions are not followed, the safe operation of the device cannot be ensured and
there is a possibility of a risk to people and property.
2.4 Scope of delivery
2.4.1 Included in the delivery
Product
RIDA qLine® Orbital Shaker
User manual
Power supply unit with 4 different power adapters
2.4.2 Required accessories, not included with
the device
Product Item no.
RIDA qLine® Incubation Set ZG1108

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2.4.3 Required consumables, not included with
the device
Product Item no.
RIDA qLine® QC-Kit
(for qLine soft)
ZG2701
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
2.5 Operation of the RIDA qLine® Orbital Shaker
Ensure that the device is operated only under the ambient conditions described in the
“Technical data” section. Read the user manual before operating the device. Follow all
instructions stated in the user manual.
Once the device is connected to a suitable power source and is switched on at the power
switch on the front side, the shaker unit starts moving in its orbital shaking motion. Once
the power switch is switched off, the shaking platform returns to a stop.
Important:
The control unit’s main switch does not completely disconnect the device from the
power supply when the device is switched off. The main switch disconnects only
one phase. To completely disconnect the device, unplug the plug from the power
supply.

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RIDA qLine® Orbital Shaker | User Manual
2.6 Device malfunctions
Func-
tion
Potential
error
Possible
causes
Possible
effects
Possible check
of individual
functions
Possible remedies
Device does
not shake.
1) Not
connected to
power.
2) Shaking
platform is
stuck.
3)
Shaking
platform
overloaded.
Effects
on the
application
itself are
to be
determined
by the user.
External visual
inspection
of the speed
(with the eye
or an external
tachometer)
Once user errors
have been ruled
out, switch off the
device on the power
switch. Check to
make sure the
device is standing
freely so that the
shaking platform
can move freely.
After a short time,
switch on the device
again.
If the device still
does not work as
specified, contact
the manufacturer
or supplier of the
device.
Device
shakes
uncontrol-
lably or at
the wrong
speed.
1)
Shaking
platform is
stuck.
2)
Defective
control
electronics.
Effects
on the
application
itself are
to be
determined
by the user.
External visual
inspection
of the speed
(with the eye
or an external
tachometer)
Shaking of the platform

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3 Maintenance and service
3.1 Service and repairs
If you have any other questions about installation, operation, or maintenance, contact
R-BiopharmAG or your distributor.
Do not make any electronic or mechanical repairs to the device. Inside the device, there
are no parts that users can service or repair. User repairs can cause damage to the
electronics. They can also void the warranty.
Important:
Do not open the device. Repairs are reserved to trained service technicians.
Important:
In the event of a repair: Return the device to the manufacturer or supplier. Make
sure that the device was adequately cleaned/decontaminated before it is returned.
3.2 Device cleaning and decontamination
Use a soft, lint-free cloth moistened with a mild soap solution (water and commercial
detergent) to wipe off the device’s external surfaces and user elements. Do not use a wet
cloth, and use only a small amount of cleaning agent. Do not clean the surfaces with
acids, chlorinated solvents, or saline solutions.
Do not scour or scratch the device; otherwise this causes damage to labels and surfaces. If
you use cleaning agents other than the ones mentioned in this manual, make sure
beforehand that the intended method does not cause damage.

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RIDA qLine® Orbital Shaker | User Manual
4 Uninstalling and disposal
Due to its properties and possible applications, the device needs to be handled properly.
Follow the instructions below for handling the device:
4.1 Uninstalling the device
When uninstalling/removing the device and its components, follow the steps below:
1. First, switch off the RIDA qLine® Orbital Shaker using the power switch.
2. Disconnect the power cord from the power supply.
3. Now you can remove the shaker and its components from the work area.
4.2 Disposal of reagents and materials
Users are responsible for the proper disposal of all reagents and materials after use. Users
are responsible for the proper disposal of instruments at the end of the life cycle. For
disposal, please adhere to national regulations.
4.3 Device disposal
Waste Electrical and Electronic Equipment (WEEE) Directive
of the European Union (EU).
Damaged and/or defective electrical and electronic equipment must be taken to recycling

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center that accepts e-waste. The packaging material also needs to be disposed of in an
environmentally friendly way (separation of materials).
Devices sold in EU countries must be labeled appropriately. The WEEE Directive stipulates
that customers and end users in EU countries may not dispose of electrical and electronic
devices or electrical and electronic accessories in the household waste. Within the EU,
contact your local distributor or the customer service of your device supplier to get more
information on WEEE disposal/returns.
5 Packaging and storing the device
5.1 Packaging the device
Important:
Before packaging, make sure that the device was adequately cleaned/
decontaminated. Users who want to unpack and operate the device at a later time
should not be left unaware of potential risks. Users bear responsibility for direct and
indirect injury to people and damage to property that can result from the media
they used as long as they are not responsible for adequate labeling of possible
hazards.
If possible, use the original packaging to package the device. If you cannot use the original
packaging, label the outside of the package with the following information:
•Glass symbol (caution: fragile)
•Umbrella (protect against moisture)
•Packaging unit (information on the contents)

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RIDA qLine® Orbital Shaker | User Manual
5.2 Storing the device
Follow the instructions below for proper storage of the shaker.
1. Package the shaker in a plastic bag.
2. Ensure the following ambient conditions are met:
Max. ambient temperature: 5°C-40°C
Max. humidity: 80%
6 Warranty and exclusion of liability
The manufacturer is obligated to remedy any errors in the material or processing of this
device experienced by the purchaser that occur within the rst 24months upon delivery
of the device by either repairing or, at the manufacturer’s option, replacing the device. If
the device is replaced, the warranty will still be valid until the end of the 24-month period
from the date of purchase.
Contact the distributor for all customer service.
The warranty becomes void if the defect or malfunction is caused by an accident,
negligence, improper use, improper servicing, or other reasons that are not due to
defective materials or incorrect processing.
All claims to warranty are limited to the professional and proper use of the device under
observance of the general safety regulations and this user manual. The manufacturer is
not obligated whatsoever to any services other than those contained in this declaration of
warranty. In particular, personal injury and property damage resulting from defective
parts or other malfunctions are excluded from liability.
The manufacturer’s obligation is limited in its scope to the repair or replacement of
defective parts. Under no circumstances is the manufacturer required to compensate for
damages for consequential damage of any type that can arise from the use and possession
of this device.

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Important:
If the device fails, do not attempt to repair it. The device does not contain any parts
that can be serviced or repaired by the user. User repairs will void the warranty.
Important:
Do not open the device. Repairs are reserved to trained service technicians.
7 Technical data
Technical data:
Standard conditions: 20°C , 1013mbar
Speed, constant, rpm: 300 +/-10%
Orbit, mm: 3.0
Shaking type: orbital, horizontal
Power supply: 24V DC/15W external power supply unit
Device dimensions, W×H×D, mm: 180×150×90
Installation area, W×D, mm: 170×140
Weight, kg: 1.6
Operating elements:
Power supply: ON/OFF switch lights up
Working conditions:
Ambient temperature, °C: 5 - 40
Max. humidity, %: 80% relative humidity
Safety functions:
Motor thermal cutoff: Integrated into motor electronics

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RIDA qLine® Orbital Shaker | User Manual
8 Troubleshooting/information on reporting to
authorities
For users in the European Union: Report all serious adverse events associated with the
product to R-BiopharmAG and the appropriate national authorities.
9 Conformity to IEC 61326-2-6 and RoHS3
The CE mark on the RIDA qLine® Orbital Shaker conrms that the RIDA qLine® Orbital
Shaker is compliant with Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices).
In addition, the RIDA qLine® Orbital Shaker fullls the protection requirements of EMC
pursuant to IEC61326-2-6. The RIDA qLine® Orbital Shaker is complaint with the current
RoHS Directive.

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10 Symbols used on the device
Symbol Description
RIDA qLine® Orbital Shaker Product designation
For invitro diagnostic use
Item number
Serial number
Important
WEEE
Waste Electrical and Electronic Equipment
Follow user manual
Manufacturer
Date of manufacture
Permissible storage temperature
Permissible storage humidity
11 Version history
Version number Chapter and description
Version 15 (2015-11-15) Previous version
Version 16 (2022-03-03) IVDR changes:
2.3.1 Ventilation requirements during operation
2.4.2 Required accessories, not included with the device
4.2 Disposal of reagents and materials
8 Troubleshooting/information on reporting to authorities
10 Symbols used on the device
11 Version history
SN

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RIDA qLine® Orbital Shaker | User Manual
R-Biopharm •An der neuen Bergstrasse 17, 64297 Darmstadt, Germany
Email: [e-mail] •clinical.r-biopharm.com
2022-03-03 – Version 16.00