Hygiena Cube Manuale utente
Hygiena Cube
ASY3206
2
Table of Contents
Table of Contents
1Contents ................................................................................3
2Symbols used in the Manual and on the Cube .......................4
3Scope of Application and Safety Instructions..........................5
4Liability Exclusion ...................................................................6
5Scope of Delivery ...................................................................7
6Device Specifications .............................................................8
7Commissioning and Safety Insructions ...................................9
8Battery Insertion ...................................................................10
9Measurement Modes ...........................................................11
10 Measurement Procedure......................................................12
11 Reading Data from Memory .................................................13
12 Remote Measurement..........................................................15
13 QC-Test ...............................................................................18
14 Error Messages - Causes and Solutions...............................19
15 Setting Date and Time..........................................................21
16 Data Transfer........................................................................22
17 Cube Specifications .............................................................23
18 Maintenance and Cleaning of the Window ...........................24
19 Disposal of the Device..........................................................25
3
Contents
Hygiena Cube
USB Cable
Strip/Cassette Adaptor
3 Lithium Batteries
Contents
1
4
Symbols used in the Manual and on the Cube
Symbols used in the Manual and on the Cube
2
Attention! Very important and
safety relevant information
Manufacturer’s instructions
Consult instructions for use
Date of manufacture
(year & month)
Serial number
Don’t dispose in general trash.
For disposal of device please
refer to country specific rules
and laws
Part number
Protection class of electronic
equipment
CE-symbol
2004-06
5
Scope of Application and Safety Instructions
Scope of Application and Safety Instructions
3
The Hygiena Cube is a mobile measuring device for colorimetric tests based
on reflectance measurements to capture the optical density. The built-in
techniques allow a quantitative and qualitative evaluation of every lateral
flow assay. The test specific data is transferred wirelessly by radio-frequency
identification (RFID) before each measurement. Please check before each
measurement if the batch number of the lateral flow test matches the
one printed on the RFID tag. In case different shaped cassette/strip types
will be used, always ensure using the correct cassette/strip adapter with this
particular cassette/strip. A wrong cassette adapter or using it incorrectly can
affect the measurement result.
The measurement data can be stored internally. Every saved result includes
a unique measurement ID, test name, lot number, manufacturer, and date
and time. The measurement data can be extracted via USB using a special
USB cable and the Hygiena Cube DataReader Software. The device is
powered by battery but can also be powered via USB.
The use of the monitoring device is only allowed by following the instructions
stated in Chapter 7 Commissioning and Safety Instructions. The Cube can
be used as a mobile handheld device or as a desktop measuring device
remotely controlled via USB cable and the free-to-use Cube DataReader
Stoftware.
The device and cassette adapter can get contaminated by any test specific
residues. In this case, cleaning with a disinfectant solution and protective
equipment which does not affect the housing or the cassette adapter has to
be conducted (e.g. alcohol-based disinfectant or similar products).
6
Liability Exclusion
Liability Exclusion
4
The devices are produced, calibrated and checked before shipping under
strict quality control measures in order to guarantee a high degree of quality.
Test-specific analysis configurations are provided via RFID card for running
the tests on the Hygiena Cube.
Results determined with the device should not be the sole base of analysis.
The test should be compared to reference values obtained from approved
and comparable methods.
7
Scope of Delivery
Scope of Delivery
5
Every Hygiena Cube comes with 3 batteries (type CR2032) and a lid for the
battery compartment. Depending on the shape of the test, each Hygiena
Cube also includes a specific cassette adapter (for tests provided as a
strips/cassette, a specific strip/cassette adapter must be used). A USB
cable is included to download the data to a PC. The reader contains a QC
set consisting of QC cassette and RFID card with QC configuration. Test
specific analysis configurations are uploaded via RFID card included in the
kit.
Manual of use as well as the software to download the results on a PC can
be downloaded from our website www.hygiena.com
8
Device Specifications
6
Device Specifications
Customized cassette adapter
Battery compartment USB data cable connection
Operating buttonDisplay
9
Commissioning and Safety Instructions
7
Commissioning and Safety Instructions
Attention: The device is designed for use on a straight and
horizontal surface area. During the measurement it should
not be moved and not be exposed to any bright light (e.g.
sunlight).
Attention: Always ensure that the Hygiena Cube is attached
correctly and tightly to the cassette adapter. A wrong or
improper attachment can lead to faulty results.
Attention: Protect the device from any liquids. Be aware that
direct contact with any liquid can damage the Hygiena Cube.
Damages caused by liquids can be irreparable.
Attention: The device shall not be opened. Otherwise the
warranty of the manufacturer is terminated.
Attention: With proper usage, there are no biological
hazards coming from the device. However, when not handled
properly, contamination due to biological dangerous material
is possible. Safety measures of the device can become
ineffective with improper usage.
Therefore, please follow all instructions in this manual.
Attention: Concerning test disposal of cassettes containing
hazardous or infectious material, please follow the instructions
of the test manufacturer.
Attention: Metal surfaces can influence the RFID scanner.
Always place the RFID tag on top of the housing/display to
ensure best readability of the configuration information.
Prior to commissioning, please read the instruction manual carefully.
10
Battery Insertion
8
Battery Insertion
The device works with 3 lithium batteries (button cells) called CR2032.
These have to be removed from the packaging and inserted into the battery
compartment of the device. Turn the battery cover with a smooth-edged
coin counter-clockwise until it stops.
Turn the device slightly down, so that the battery cover can be removed.
Place the 3 button cell batteries with correct polarity (+ side up, see Fig.) into
the tray one by one. Then place the battery cover on and press slightly with
a coin, turning clockwise until it stops.
Natural oils found on hands should not come in contact with batteries during
insertion. Contamination can lead to a more rapid discharge of the batteries.
Therefore, gloves or plastic tweezers are recommended.
In case the device does not start after putting in new batteries, please check
the polarity and clean the batteries by using a dry cloth.
After turning on the device for the first time or changing the
batteries, date and time need to be set. Please refer to chapter
Setting Date and Time.
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