BÜHLMANN Quantum Blue Reader Bedienungsanleitung

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

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

Quantum Blue ®Reader - User Manual Version A1

Release Date: 2020-11-04

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

Quantum Blue ®Reader - User Manual Version A1

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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!

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

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

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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.

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