Hygiena Cube User manual

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

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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

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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).

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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.

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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

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Device Specifications
6
Device Specifications
Customized cassette adapter
Battery compartment USB data cable connection
Operating buttonDisplay

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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.

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Battery Insertion
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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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Measurement Modes
9
Measurement Modes
The device offers the following options for the test measurement:
a) Immediate measurement
For this type of measurement the test-specific incubation time must be
monitored by the user. The user will decide when to apply the test to the
Hygiena Cube. If the user is not monitoring the incubation time correctly, the
measurement results can be wrong.
When applying the test to the Cube, the measurement starts immediately
after pressing the button if the specific analysis configurations were
previously uploaded via RFID card. The result will be displayed and can be
stored in the internal memory.
b) Timer measurement
This type of measurement follows a test-specifically configured incubation
period, e.g. 10 minutes. The incubation time is implemented in the
configuration file and will be automatically started if chosen by the user. At
the end of the incubation period the measurement starts and displays the
result. The timer measurement procedure can be stopped by pressing the
control button. The user must start the measurement after the lateral flow
test has been activated. Waiting too long will affect the incubation time and
thus the result.
The actual procedure of measuring will be described in the following
chapter.

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Measurement Procedure
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Measurement Procedure
1. Off
The device is turned off, the display is empty.
2. Turn on
To turn on the device, press the button briefly, less than 1 second.
2.1 Display Test
After activation, all display segments flash at once to check the display
functionality.
Attention: If you notice single non-functioning segments,
the reader should not be used for measurements because
result data may be displayed incorrectly. Please contact
your supplier for a replacement in this case.
2.2 Self-test
After the display flash, the reader runs a self-test to check internal functions
important for the measurement process and memory integrity. During the
self-test, WAIT is displayed.
2.3 Setting date and time
In case the reader was without power supply (via batteries or cable
connection) for longer than 1 minute, the reader will show date and time
after the self-test. Please refer to the chapter Setting date and time. After
setting date and time the reader will restart; proceed to point 2.1.

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Reading Data from Memory
11
Reading Data from Memory
3. Ready for operation
The display shows ON and the reader is ready for operation. The rapid test
is now required.
4. Test insertion
Place the test into the adapter. If you use a strip adapter, you have to put the
strip inside the adapter. If you use a cassette adapter, you have to put the
adapter on top of the cassette. Be sure that the adapter is correctly placed.
After the test is placed in the strip/cassette adapter, the reader can be
placed on top. The slanted reader corner and an corresponding counterpart
inside the adapter help to find the correct position of the reader.

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Reading Data from Memory
11
Reading Data from Memory
5. Measurement
The reader is now ready to start a measurement.
5.1 Direct Measurement
Press the button briefly. The display will show RFID or TEST. Proceed to 6.1.
5.2 Timer Measurement
If you want to start the measurement after a certain incubation time has
passed, press the button longer than 1 second. The display will show RFID
or TEST, depending on your reader configuration. Each timer measurement
can be stopped by pressing the button during the measurement.
6. Test configuration data
There are different possibilities of test configuration data transmission
depending on the reader configuration.
6.1 Configuration data via RFID
Test configurations are uploaded via RFID before the measurement. Put
the lot specific RFID card onto the top side of the device or hold the device
against the RFID tag sticking on the test box until the configuration data has
been uploaded (audible signal).

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Remote Measurement
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Remote Measurement
6.2 Transfer of configuration from RFID to reader
Data on the RFID card is transferred and stored to the Cube memory after
being uploaded via RFID. The configuration is still available for further tests
after the measurement.
By briefly pressing the button, the reader will use the stored configuration
and proceed to point 7. If a new RFID card is placed on the reader instead,
the new configuration will be uploaded and will replace the old stored
configuration. Then the reader proceeds to point 7. The configuration is
still stored after turn-off and can be used again after turn-on until it is
replaced with a new RFID transmission.
Attention: The permanent version of the feature bears the
risk that the currently stored configuration is unknown, and
a wrong test is measured with it which can lead to faulty
results.
7. Test
After a successful RFID transmission of the configuration the display shows
TEST. Press and hold the button longer than 1 second to show test and lot
specific information of the test to be run. Briefly press the button to return to
TEST and continue with the measurement process.
8. Start measurement
Start the measurement by briefly pressing the button.

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9. Run
The device measures and the display shows RUN.
10. Result
After a few seconds the result is displayed.
11. Result saving
The reader has an internal memory to store up to 100 readings. If the
internal memory is full and a new result is saved, the reader overwrites the
first saved result. Every new saved result will overwrite the saved results in
chronological order.
There are different possibilities concerning result saving on the reader
depending on the reader configuration. If no saving is required or if data
saving is deactivated on your reader, proceed to 11.3.
11.1 Automatic saving
All results will be saved after the measurement. The reader will not give a
specific display message. Proceed to point 11.2.
11.2 Return to ON state
Press the button again to return to ON. Proceed to point 4 for a new
measurement.
12 Remote Measurement
Remote Measurement

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12 Remote Measurement
Remote Measurement
11.3 No saving
If no result storage is required, or if data saving is deactivated on your
reader, briefly press the button less than 1 second to not store the result.
ON appears in the display; proceed to point 4 if a new measurement will be
started.
12. Turn off
If the device is switched on and will not be activated for about 50 seconds,
the device automatically shuts down. If a new measurement will be started,
proceed to point 2.
Please note: There is no active function to shut off the device.

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If you wish to perform a QC test after a certain amount of measurements,
a QC set consisting of a special QC cassette and a corresponding QC
configuration on the RFID card can be provided for this purpose (please
contact your supplier).
When a QC test is required, please take the provided QC set and insert
the QC cassette into the cassette adapter according to the Test Insertion
point of the measurement procedure and place the reader on top. Briefly
press the button and RFID will be displayed. Put the QC RFID card on top
of the reader and wait until the QC configuration data has been uploaded
(audible signal). Alternatively, select the QC test from the reader memory.
Briefly press the button again to start the QC test. The QC test result will be
displayed afterwards.
Attention: The result of the QC test may be PASS or FAIL.
The reader will be able to measure again after the QC test,
even if the QC result was FAIL. When a QC test fails, the
reader should not be used for measurements because
results could be faulty. The Cube should be switched
off and on again, and the bottom part of the Cube that
performs the reading should be cleaned. If the problem
persists, please contact your supplier for a replacement.
QC-Test
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QC-Test

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Error Messages - Causes and Solutions
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Error Messages - Causes and Solutions
Display: ERR
The device could not read the information from the RFID card.
Elimination
Press the button briefly (<1 second), the display will show ON and continue
with point 5.1 or 5.2. If the error occurs several times, please contact your
supplier.
Display: DATE
The expiry date of the test seems to be exceeded.
Elimination
The device checks the internally set time with the expiration date of the test.
Check the expiration date of the test. If this is actually exceeded, select a
new test from another shipment which has not expired. Briefly press the
button. The display will show ON and repeat point 4a or 4b. If the expiration
date is not exceeded, check the internally set time and date of the device
and adjust it if necessary.

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Display: FAIL
The device could not find a C-line.
Elimination
Check if the test cassette is placed correctly below the Cube and in the
cassette adapter. Press the button briefly (<1 second); the device shows ON
and repeat with 5.1 or 5.2. If the error will not disappar, select a new test
and repeat the measurement procedure. Press the control button briefly (<1
second); the display will show ON and continue with 5.1 or 5.2.
No function
Despite pressing the button no information is visible on the screen.
Cause: The batteries may be discharged.
Elimination
Open the battery compartment and replace the 3 batteries by new ones as
described in section Battery insertion.
Should the device still not react after changing the batteries, please contact
your supplier.
Error Messages - Causes and Solutions
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Error Messages - Causes and Solutions