BÜHLMANN Quantum Blue Reader User manual

Quantum Blue®Reader - User Manual Version A1
Quantum Blue®Reader
User Manual

2Quantum Blue ®Reader - User Manual Version A1
Release Date: 2020-11-04
TABLE OF CONTENT
TABLE OF CONTENT
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1 Technical Assistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2 Policy Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.3 Version Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3 Intended use of the Quantum Blue®Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.1 Proper Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.2 Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.3 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.4 Environmental Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.5 Heat Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.6 Maintenance Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.7 Waste Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.8 Symbols on the Quantum Blue®Reader Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4.9 Symbols on the Package of the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
5 Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.1 Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.2 Delivered Content. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
6 Unpacking and Set-up Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
6.1 Unpacking of the Quantum Blue®Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
6.2 Setup and Connection of the Quantum Blue®Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
6.2.1 AC Power Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.1 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.2 Hardware Installation / Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.3 Relocating the Quantum Blue®Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
8 General Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8.1 Powering the Quantum Blue®Reader On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8.2 Instrument Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8.3 First Log In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8.4 Hard Shutdown. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8.5 Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
8.6 Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
9 Instrument Usage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
9.1 The Two Modes of Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
9.2 Starting a Test in the Fail Safe Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
9.3 Starting a Test in the Fast Track Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
10 Review Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
11 System and Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
11.1 Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
11.2 Update Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
11.3 Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
11.3.1 Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
11.3.2 Admin Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

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TABLE OF CONTENT TABLE OF CONTENT
11.4 Menu Structure in the Admin Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
11.4.1 Date & Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
11.4.2 Manage Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
11.4.3 Delete Unsent Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
11.4.4 Export Raw Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
11.4.5 User Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
11.4.6 Update Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
11.4.7 Mode of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
11.4.8 Manufacturer reset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
11.4.9 Communication Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Submenu Network within communication settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Submenu Connect within Communication Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Submenu Security within Communication Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
11.4.10 Shutdown Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
12. Maintenance and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
12.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
12.2 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
12.3 Device Self-Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
13. Technical and Scientific Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
14. Troubleshooting and messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
15. Technical Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
15.1 Dimensions and Weight of the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
15.2 Mechanical Data and Hardware Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
15.3 Software Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
15.4 Optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
15.5 Power requirements of the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
15.6 Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
15.7 Applicable Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
16. Warranty and obligations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
16.1 Product Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
16.2 Obligations of the User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
16.3 Waste Electrical and Electronic Equipment (WEEE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
17. Declaration of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

4Quantum Blue ®Reader - User Manual Version A1
Release Date: 2020-11-04
GENERAL INFORMATION
1INTRODUCTION
Thank you for choosing the Quantum Blue®Reader. We are confident that this product will become an
integral part of your daily work.
Rapid testing enables fast result reporting and thus provides a tool for health care professionals to support
immediate decision making. Using the wealth of experience obtained from providing reflectrometric detection
technology to thousands of customers worldwide, the specialists at BÜHLMANN Laboratories AG have
developed a new generation reader for mobile rapid test applications. The Quantum Blue®Reader is a highly
sensitive, robust, and cost-effective measurement system for lateral flow tests. This flexible and reliable
system, based on a ready-to-use concept, enables the users to easily run lateral flow tests.
This manual describes how to operate the Quantum Blue®Reader. Before using the device, it is essential that
you read this user manual carefully.
2 GENERAL INFORMATION
2.1 Technical Assistance
At BÜHLMANN Laboratories AG, we pride ourselves on the quality and availability of our technical and
scientific support. Our Customer Support Department is staffed by experienced scientists and engineers with
extensive practical and theoretical expertise in the use of BÜHLMANN Laboratories AG products.
For technical and scientific assistance regarding the Quantum Blue®products, contact your local BÜHLMANN
Laboratories AG distributor (see chapter 13. Technical and Scientific Support).
For up-to-date information about the lateral flow reader products of the Quantum Blue® Reader, visit https://
www.buhlmannlabs.ch.
2.2 Policy Statement
It is the policy of BÜHLMANN Laboratories AG to improve products as new techniques and components
become available. BÜHLMANN Laboratories AG reserves the right to change the specifications of products
at any time.
2.3 Version Management
This document is the Quantum Blue®Reader User Manual VA1_EN.
3 INTENDED USE OF THE QUANTUM BLUE®READER
The Quantum Blue®Reader is a rapid test reader for the in vitro detection and/or quantification of target
analytes on lateral flow test cassettes.
The Quantum Blue®Reader is used only in combination with BÜHLMANN lateral flow tests.
SAFETY INFORMATION

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GENERAL INFORMATION SAFETY INFORMATION
4 SAFETY INFORMATION
The instructions and safety information in this user manual must be followed to ensure safe operation of the
Quantum Blue®Reader. Please note that if the equipment is used in a manner not specified by BÜHLMANN
Laboratories AG, the protection provided by the equipment may be impaired.
The following types of safety information appear throughout the Manual. Details are given in the format as
shown below.
The term DANGER is used to inform you about situations that could result in
personal death or serious injury.
The term WARNING is used to inform you about situations that could result in
personal injury to other persons.
The term CAUTION is used to inform you about situations that could result in
damage to the instrument or other equipment.
The term NOTICE is used to indicate information considered important but not
hazard related (e.g. security messages, maintenance and cleaning guidelines).
4.1 Proper Use
The Quantum Blue®Reader must be operated by personnel familiar with BÜHLMANN Quantum Blue® assays
and have the appropriate training.
As potentially infectious patient specimens will be measured with the Quantum Blue®Reader, BÜHLMANN
recommends to use appropriate personal safety equipment such as gloves. Patient specimens should be
handled in accordance with Good Laboratory Practice (GLP) using appropriate precautions. If, despite all
precautionary measures, the Quantum Blue®Reader should come into contact with potentially infectious
material, please follow the instructions provided in chapter 12.1 Cleaning.
Improper use of the Quantum Blue®Reader may cause personal injuries or
damage to the instrument.
The Quantum Blue®Reader must be operated by qualified personnel that has
received the appropriate training.
All instrument-related interventions may only be performed by employees of
BÜHLMANN Laboratories AG.
The advice given in this manual is intended to supplement, not supersede, the
normal safety requirements prevailing in the user’s country.

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SAFETY INFORMATION
4.4 Environmental Hazards
Do not expose the Quantum Blue®Reader to direct sunlight during operation.
Protect the reader from high humidity and contact with liquids.
4.5 Heat Hazard
Do not expose the reader to excessive heat.
4.6 Maintenance Safety
Perform the maintenance as described in chapter 12.2 Maintenance.BÜHLMANN Laboratories AG charges
for repairs that are required due to incorrect handling.
4.7 Waste Disposal
Waste of tests measured with the Quantum Blue®Reader may contain certain hazardous chemicals or
contagious/bio-hazardous materials and must be collected and disposed properly in accordance with all
national, state, and local health and safety regulations and laws.
4.2 Electrical Safety
Any defects which you discover on electrical components / sub-assemblies must
be repaired without delay. Until this is done, the system, sub-assembly or item of
equipment must not be used in its faulty condition. Call your local BÜHLMANN
distributor.
Do not expose the reader to strong electromagnetic radiation. It is the
responsibility of the user to ensure that a compatible electromagnetic environment
is maintained for the instrument in order to guarantee appropriate performance.
This device fulfills the emitted interference and emitted immunity requirements of
the standard DIN EN 61326-2-6.
4.3 Environment
If the Quantum Blue®Reader is to be used in a working environment prone to dirt build-up, clean the device
regularly. For cleaning, please follow the instructions provided in chapter 12.1 Cleaning.
SAFETY INFORMATION

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SAFETY INFORMATION
4.8 Symbols on the Quantum Blue®Reader Instrument
The following symbols appear on the type plate at the rear of the Quantum Blue®Reader instrument.
Symbol Description
CE mark for Europe
In vitro diagnostic mark, device is intended to be used as an
in vitro diagnostic device
Serial number
Legal manufacturer
Date of manufacture
Waste Electrical and Electronic Equipment (WEEE)
Catalog number
Caution - consult instructions before use
IP10 IP Classification
GTIN Global Trade Item Number
SAFETY INFORMATION

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4.9 Symbols on the Package of the Reader
SAFETY INFORMATION
Symbol Description
Transport and Storage
conditions
pKeep package dry!
jHandle package with care!

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Quantum Blue ®Reader - User Manual Version A1
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SAFETY INFORMATION FUNCTIONAL DESCRIPTION
1 Touch display
2 Power button with LED
3 Drawer for lateral flow test cassette
4 Handle
5 Connector for power supply
6Type Plate (for more information refer to chapter 4.8 Symbols on the
Quantum Blue®Reader Instrument)
7 3 USB ports (type A)
8 Ethernet port (RJ-45)
5 FUNCTIONAL DESCRIPTION
5.1 Hardware
2
1
3
8
4
75
6
Figure 1 Figure 2
The drawer can be completely ejected by pushing the button at the bottom of the device (indicated in
Figure 3) while simultaneously pulling out the drawer. Beware, not to touch the white orientation point
(indicated in Figure 4) on the upper right side of the drawer.
Figure 3 Figure 4

10 Quantum Blue ®Reader - User Manual Version A1
Release Date: 2020-11-04
UNPACKING AND SET-UP PROCEDURES
6 UNPACKING AND SET-UP PROCEDURES
6.1 Unpacking of the Quantum Blue®Reader
Take out the Quantum Blue®Reader from its transport case, place it on a stable and leveled surface and
check whether it contains all items as listed in chapter 5.2 Delivered Content.
Carefully examine the instrument to make sure that it has not been damaged during the shipment. In case of
damage or if any parts are missing (refer to chapter 5.2 Delivered Content), contact immediately your local
BÜHLMANN Laboratories AG distributor.
6.2 Setup and Connection of the Quantum Blue®Reader
6.2.1 AC Power Connection
The Quantum Blue®Reader may only be used with the power supply provided with the device.
Plug the power supply cable (low voltage end) into the connector at the rear of the device (pos. 5 in chapter
5.1 Hardware). Plug the power supply cable (mains end) into a power outlet. Make sure that the cable is
plugged in properly on both sides.
Please make sure that the locally available mains voltage matches the voltage
indicated on the type plate of the Quantum Blue®Reader.
INSTALLATION
Please keep the original transport case. It is required when returning or shipping
the device.
5.2 Delivered Content
• Quantum Blue®Reader instrument
• Quick guides Fast Track Mode and Fail Safe Mode
• Instructions for the download of user manuals and additional software tools (eg. Quantum Blue®
Connect Software)
• Power supply including international connection adapter
• Cleaning/ cotton swabs
The drawer must be completely inserted into the instrument for instrument start-
up and for performing measurements.
Do not switch drawers between different Quantum Blue®Reader instruments.