BÜHLMANN Quantum Blue User manual

Quantum Blue®Reader
User Manual

Quantum Blue®Reader User Manual V12 02/2021 Page 2 of 43
Notice
All rights reserved.
The information contained in this document is subject to change without
notice.
Trademarks
Trademarks and labels used in this document are property of their
respective owners.
Copyright Information
Quantum Blue®Reader User Manual
Document Version: V12 02/2021
© Copyright 2021 by BÜHLMANN Laboratories AG
Printed in Switzerland

Contents
Quantum Blue®Reader User Manual V12 02/2021 Page 3 of 43
Contents
1Introduction 6
1.1 General 6
1.2 Intended Use 6
1.3 Main Features of the Quantum Blue®Reader 7
2Safety Information 8
2.1 Proper Use 9
2.2 Electrical Safety 10
2.3 Hazardous Substances 10
2.4 Infectious Substances 11
2.5 Waste Disposal 11
2.6 Maintenance 11
2.7 Cleaning and Decontamination 11
2.8 Symbols on the Quantum Blue®Reader 13
3General Description 14
3.1 Hardware 14
3.2 Software 15
3.3 Contents of the Package 15
4Installation 16
4.1 Requirements 16
4.1.1 Site 16
4.1.2 Environment 16
4.1.3 Ambient Temperature 17
4.1.4 Power Requirements 17

Contents
Quantum Blue®Reader User Manual V12 02/2021 Page 4 of 43
4.1.5Power Supply Options 17
4.1.6 Unpacking 17
4.1.7 Connecting Accessories (optional) 17
4.2 Language Setting 18
4.2.1 Overview 18
4.2.2 Installation Procedure 18
5Operation of the Quantum Blue®Reader 19
5.1 Basic Functions 19
5.2 Start Manual Operation and Initialization of the Reader 20
5.3 Main Menu 20
5.4 Scan Test Mode 21
5.4.1 Select and enter Test Parameters 22
5.4.2 Measuring Test Cassette 22
5.4.3 Viewing Results 23
5.5 Memory Mode 23
5.6 Setup / Info Mode 26
5.7 Calibration Check Mode 28
6Maintenance 29
6.1 Replacing the Batteries 29
6.2 Charging the Batteries 30
6.3 Device Calibration 30
6.4 Cleaning 31
6.5 Service Contact Information 31
7Troubleshooting 32
8Technical Data 37

Contents
Quantum Blue®Reader User Manual V12 02/2021 Page 5 of 43
8.1 Environmental Conditions 37
8.1.1 Operating Conditions 37
8.1.2 Transportation Conditions 37
8.1.3 Storage Conditions 38
8.1.4 Dimensions and Weight 38
8.2 Shipment Instructions 38
9Warranty and Customer Services 39
9.1 Warranty 39
9.2 Obligations of the User 40
Appendix 41
Waste Electrical and Electronic Equipment (WEEE) 41
Declaration of Conformity 42

Introduction
Quantum Blue®Reader User Manual V12 02/2021 Page 6 of 43
1 Introduction
1.1 General
Lateral flow assays represent a well-established proven technology for a
variety of near patient and field use applications. Although these simple
diagnostic tests are established in many routine applications, this
technology has not been widely applied when very sensitive, highly
reproducible, quantitative results or electronic data documentation are
required. The Quantum Blue®Reader now makes this possible, by
combining the major advantages of traditional lateral flow assay with
modern technologies to fulfill the requirements for new diagnostic tests.
1.2 Intended Use
The intended use of the Quantum Blue®Reader is to analyze colorimetric
tests by reflectometry. The fast and precise scanning allows the detection
of quantitative results depending on the rapid test and/or the configuration
of the device. The data are stored automatically. All stored data include
measuring time, date, user ID, patient ID, raw data, etc. This mobile
reader is powered by rechargeable batteries or with the external power
supply.
It should only be used according to the safety precautions outlined in
chapter 2.
The Quantum Blue®Reader should only be used with specified tests by
trained and qualified personnel. The reader has to be powered by the
specified rechargeable batteries or by the specified external power
supply. The data can be transferred to a PC via USB port only with the
QB Soft software provided. The Quantum Blue®Reader may be used in
a laboratory or in the field provided that all the environmental and
operating conditions are met.

Introduction
Quantum Blue®Reader User Manual V12 02/2021 Page 7 of 43
1.3 Main Features of the Quantum Blue®Reader
Precision: Excellent repeatability, long term stability of the
detector (optical system), and the powerful controller enable
reliable quantification of lateral flow tests.
High sensitivity: The award winning confocal sensor used
provides unmatched sensitivity.
Ease of use: Load the lot-specific test information by scanning
the RFID card of the kit, insert the test cassette, press start
button and everything else will be done by the reader (scanning,
evaluating, displaying and storing of the results).
Portable: The Quantum Blue®Reader provides all the necessary
requirements of a portable reader: It is small, lightweight, can be
operated as a stand-alone device and stores up to 80 test
results. The reader can be operated by rechargeable batteries
(3 x AA Ni-MH).
Connectivity: Easy connection and transfer of data to a PC via
USB is available, intuitive software allows quick and easy
processing of data. Also, additional equipment such as a
barcode reader and an external RFID-reader can be connected
to the Quantum Blue®Reader.

Safety Information
Quantum Blue®Reader User Manual V12 02/2021 Page 8 of 43
2 Safety Information
This manual contains information about warnings and cautions that must
be followed by the user to ensure safe operation of the Quantum Blue®
Reader and to maintain the Quantum Blue®Reader in a safe condition.
Please note: If the Quantum Blue®Reader is used in a manner not
specified by BÜHLMANN Laboratories AG, the protection provided may
be impaired.
WARNING
The term WARNING is used to inform you about situations
that could result in personal injury to you or other persons.
Details about these circumstances are given in a box like
this one.
CAUTION
The term CAUTION is used to inform you about situations
that could result in damage to the instrument or other
equipment.
Details about these circumstances are given in a box like
this one.
Before using the Quantum Blue®Reader, it is essential to read this
manual carefully and to pay particular attention to any advice it contains
concerning hazards that may arise from the use of the Quantum Blue®
Reader.
The advice given in this manual is intended to supplement, but not
supersede, the normal safety requirements prevailing in the user’s
country.

Safety Information
Quantum Blue®Reader User Manual V12 02/2021 Page 9 of 43
2.1 Proper Use
CAUTION
Improper use of the Quantum Blue®
Reader may
cause personal injuries or damage to the instrument.
The Quantum Blue®Reader must only be operated
by qualified personnel who have been appropriately
trained.
Servicing of the Quantum Blue®Reader must only be
performed by Field Service Engineers
trained by
BÜHLMANN Laboratories AG.
CAUTION
For your own safety do not operate the device without
a test cassette inserted. Do not open the drawer while
measurement is in progress. Only authorized persons
are allowed to service or disassemble the reader.
CAUTION
Do not expose the Quantum Blue®Reader to direct
sunlight.
CAUTION
Protect the Quantum Blue®
Reader from high
humidity and contact with liquids.
CAUTION
Do not expose the Quantum Blue®
Reader to
excessive heat.

Safety Information
Quantum Blue®Reader User Manual V12 02/2021 Page 10 of 43
CAUTION
Take note of the operating conditions of the Quantum
Blue®Reader. Should the device come into contact
with high humidity or temperatures other than +15˚C -
+40˚C
, let it stand overnight at proper operating
conditions before turning it on.
CAUTION
Metal surfaces can interfere with RFID reader function.
2.2 Electrical Safety
CAUTION
Do not expose the Quantum Blue®Reader to strong
electromagnetic radiation.
CAUTION
Use the specified AA rechargeable batteries only!
Do not use alkaline batteries!
Note: Switch off the Quantum Blue®Reader when it is not in use.
Note: Contact your BÜHLMANN Laboratories AG representative or your
local distributor for replacement batteries.
2.3 Hazardous Substances
WARNING
The products used with this instrument may contain
hazardous substances.
When working with chemicals, always wear a suitable
lab coat, disposable gloves, and protective goggles.
For more information, please consult the appropriate
material safety data sheet (MSDS) of a given product.

Safety Information
Quantum Blue®Reader User Manual V12 02/2021 Page 11 of 43
2.4 Infectious Substances
WARNING
Some samples measured in this instrument may
contain infectious agents. Handle such samples with
the greatest care and in accordance with the required
safety regulations.
Always wear safety glasses, 2 pairs of disposable
gloves, and a suitable lab coat.
The responsible body (e.g., laboratory manager)
must take the necessary precautions to ensure that
the surrounding workplace is safe, and that the
instrument operators are suitably trained and not
exposed to hazardous levels of infectious agents.
Venting for fumes and disposal of waste must be in
accordance with all national, state, and local health
and safety regulations and laws.
2.5 Waste Disposal
Waste may contain certain hazardous chemicals, or contagious/bio
hazardous materials and must be collected and properly disposed in
accordance with national, state, and local health and safety regulations
and laws.
For disposal of waste electrical and electronic equipment (WEEE
compliance), see appendix.
2.6 Maintenance
Perform the maintenance procedures described in chapter 6.
2.7 Cleaning and Decontamination
The user is responsible for carrying out appropriate decontamination of
the instrument (according to instructions provided under service and
maintenance, cleaning section, chapter 6.4) if hazardous materials are
spilled on or inside the test cassette holder.

Safety Information
Quantum Blue®Reader User Manual V12 02/2021 Page 12 of 43
Clean the outside of the reader with a mild detergent or a 70% alcohol
solution (isopropanol or ethanol). Avoid the use of aggressive solvents
such as acetone.
Note: Before using any cleaning or decontamination method, except
those recommended in this user manual, check with your local
BÜHLMANN Laboratories AG representative or with the BÜHLMANN
Laboratories AG Customer Support to ensure that the equipment will not
be damaged.

Safety Information
Quantum Blue®Reader User Manual V12 02/2021 Page 13 of 43
2.8 Symbols on the Quantum Blue®Reader
Symbol
Location
Description
Type plate on
the back of the
instrument
CE mark for Europe
Type plate on
the back of the
instrument
In vitro diagnostic (IVD)
medical device
Type plate on
the back of the
instrument
Serial number
Type plate on
the back of the
instrument
Legal manufacturer
Type plate on
the back of the
instrument
Production date
Type plate on
the back of the
instrument
Waste electrical and electronic
equipment (WEEE)
IP21
Type plate on
the back of the
instrument
Degree of Protection
(IP= Ingress Protection)
Type plate on
the back of the
instrument
Consult instructions for use (ie.
this user manual)

General Description
Quantum Blue®Reader User Manual V12 02/2021 Page 14 of 43
3 General Description
3.1 Hardware
1
UP button
2
FORWARD button
3
DOWN button
4
BACK button
5
ENTER and ON/OFF button
6
Display
7
7a
T
est cassette holder (Drawer)
with Calibration Spot
8
Battery compartment
A
Position for placement of RFID Chip Card

General Description
Quantum Blue®Reader User Manual V12 02/2021 Page 15 of 43
3.2 Software
QB Soft software for running and controlling the Quantum Blue®Reader,
reading test results, printing test results, up/downloading test results,
managing test methods and user rights via PC.
3.3 Contents of the Package
Transportation case
Quantum Blue®lateral flow reader
CD-ROM with USB Drivers, Language Updaters, QB Soft
Software and Manuals
Batteries
USB cable
Power supply
Adapter set for power supply
9
I/O port for
barcode reader, USB extension, or
external RFID reader (all optional)
10
I/O port for barcode reader, USB extension, or
external RFID reader (all optional)
11
USB port for
PC-connection
12
Power port

Installation
Quantum Blue®Reader User Manual V12 02/2021 Page 16 of 43
4 Installation
4.1 Requirements
4.1.1 Site
The location of the Quantum Blue®Reader should preferably be on a desk
or stable surface with enough surrounding space in order to easily insert
the test cassettes or unplug the device. In case of emergency or under
abnormal operating conditions the location should provide, at any time,
enough space to allow the easy disconnection of the device.
Note: Please avoid locations of metallic surface that may affect the RFID
reader function.
The Quantum Blue®Reader is a highly sensitive and precise optical
device. The result can be influenced by vibrations (e.g. if the device is
used close to vibrating machines). The device must be used on a stable
and leveled surface.
The Quantum Blue®Reader has an internal correction for normal levels
of ambient light, but highly intense light falling into the insertion port of the
test cassette (holder) can cause serious interference with the
measurement and must be avoided.
4.1.2 Environment
If you plan to use the Quantum Blue®Reader in a working environment
prone to dirt build-up, you will need to clean the device regularly. For
cleaning, use a damp cloth. For more persistent stains, it is also possible
to clean the surface with a cloth dipped in a mild detergent or in a 70%
alcohol solution (isopropanol or ethanol). Avoid the use of aggressive
solvents such as acetone and the like.

Installation
Quantum Blue®Reader User Manual V12 02/2021 Page 17 of 43
4.1.3 Ambient Temperature
The use of the Quantum Blue®Reader in environments prone to large
temperature changes can cause measurement values to deviate from real
values. Please take the environmental conditions into account in case of
trouble shooting (see chapter 7).
Note: Best storage condition for the Quantum®Blue Reader is at ambient
temperature. Avoid storage of the Quantum Blue® Reader at low (-20 °C)
or high (+50°C) temperatures.
4.1.4 Power Requirements
With an external power supply, the Quantum Blue®Reader operates at
100–240 VAC, 0.5 A, and 50–60 Hz.
The Quantum Blue®Reader can also be powered by rechargeable
batteries without an external power supply. The batteries must be
periodically recharged connecting the external power supply for at least 4
hours (the complete charging time is 14 hours).
4.1.5 Power Supply Options
Battery powered: Insert three rechargeable AA batteries (Ni-MH
only) in the battery compartment (refer to chapters 3.1 and 6.1). It
is recommended to regularly check the battery status on the
display.
External power: Connect external power supply to power port
(refer to chapter 3.1).
4.1.6 Unpacking
Take out the Quantum Blue®Reader from its protective transportation
case and place it on a stable and leveled surface.
4.1.7 Connecting Accessories (optional)
External RFID or barcode reader: Connect the device to the
related I/O Port (refer to chapter 3.1).

Installation
Quantum Blue®Reader User Manual V12 02/2021 Page 18 of 43
4.2 Language Setting
4.2.1 Overview
The default language of the Quantum Blue®Reader is English. The
language can be changed by choosing one of the language updaters on
the CD-ROM. Please note that only ONE language can be displayed at a
time on the firmware of the Quantum Blue®Reader (refer to chapter 4.2.2
Installation Procedure).
4.2.2 Installation Procedure
Connect the Quantum Blue® Reader to your PC. Open (double-click) the
language updater of choice on the CD-ROM and follow the instructions
on your PC screen. The firmware will be updated with the language of
choice within less than a minute. Finish the updating process by pressing
“Exit” in the updater menu and then “Finish” in the updater start menu.
The Quantum Blue® Reader is now ready to be used with your language
of choice.
For any further questions regarding installation procedure or language
settings please contact BÜHLMANN Laboratories AG Customer Support.

Manual Operation
Quantum Blue®Reader User Manual V12 02/2021 Page 19 of 43
5 Operation of the Quantum Blue®Reader
5.1 Basic Functions
a) Press ENTER button (5) for 2 seconds to turn on the Quantum Blue®
Reader (see chapter 5.2).
b) Select on the upper right part on any screen in order to go back to
the main menu using the buttons (1), (2), (3) and/or (4). Then press
the ENTER button (5) and the main menu screen will be displayed
(see chapter 5.3).
c) A specific function (for example „Test Method“ or „Patient ID“) is
selected using the ENTER button (5). Specific parameters (for
example „CAL_0“ in the function „ Test Method “ or „User01“ in the
function „User ID“) are selected using buttons (1) and/or (3) and then
confirmed using the ENTER button (5). For the function „Patient ID“
toggle through the characters using buttons (2) and (4) and change
characters using buttons (1) and (3).
d) „N“ and „B“ on the lower part of the display menus mean: power
supply fitted („N“); battery status („B“).
e) Error and other messages from the reader (such as “Error RFID-
2105” or “Initializing Memory”, etc.) are displayed on the lower part
of the display menus where usually the battery status is displayed. In
cases of error messages please refer to chapter 7 “Trouble
Shooting”.
f) Press ENTER button (5) for 3 seconds to switch off the Quantum
Blue®Reader at any time and on any screen.
Key pad with buttons

Manual Operation
Quantum Blue®Reader User Manual V12 02/2021 Page 20 of 43
5.2 Start Manual Operation and Initialization of the
Reader
To turn ON the Quantum Blue®Reader press the ENTER button (5) for 2
seconds.
After turning on the reader the self test,
the detector check, the initialization of
the motor and memory, and the
calibration check is performed
automatically.
After a successful calibration check the
reader turns automatically to the “Test
Selection” screen (see chapter 5.4).
5.3 Main Menu
Select on any screen to switch back to the main menu.
Choose operating mode with buttons
(1) and (3). Select operating mode with
ENTER button (5).
Scan Test mode: see chapter 5.4
Memory mode: see chapter 5.5
Setup / Info mode: see chapter 5.6
Calibration Check mode: see chapter
5.7
Welcome…
Initializing…Self Test
V 2.2.18
BÜHLMANN
Quantum Blue®
Reader
Main Menu
B  15:23:12 01.02.21
CALIBRATION CHECK
SETUP / INFO
MEMORY
SCAN TEST