Mains Operation; Battery Operation; Measurement Modes; Measurement Procedure - Chembio Cube Reader Gebrauchsanweisung

EN
| Instructions for use (IFU) – Cube Reader
Attention:
When used correctly, the device does not pose a biological
hazard.
However, careless handling can contaminate the device with
hazardous biological materials. Safety measures of the device
can lose their function through incorrect use.
Therefore, please always follow the instructions listed in this
manual!
Attention:
The device is intended for use on a flat and level surface. It
should not be moved during the measurement and should be
protected from strong lighting, such as direct sunlight.
Attention:
Metallic surfaces can affect the RFID receiver. Always hold the
RFID tag directly over the housing / display of the reader to en-
sure the best possible transfer of the configuration data.
Attention:
The QC set included in the scope of delivery must be stored
under special conditions: light-proof packaging, temperature
18 - 22°C, maximum humidity 40%. The packaging provided
with desiccant guarantees these conditions.
8

Mains Operation

The device can be powered from an electrical outlet using the Reader-spe-
cific USB cable and a standard USB power adapter.
The permanent power supply ensures uninterrupted operation and secure
storage.
If the device is operated with batteries, there is a risk that a measurement
process or result storage process will not be completed if the battery level
is low.
9

Battery Operation

The device can also be operated with three lithium batteries of the type
CR2032 (button cells). When the device is delivered, these may be in-
serted in the device and secured with an insulating strip / pull tab. In this
case, pull out the pull tab to activate battery operation of the device.
To reinsert batteries, open the battery compartment cover by turning it
counterclockwise with a coin as far as it will go.
Tilt the device so that the lid can be removed. Place the three button cells
in the correct orientation (with the "+" sign facing up, as shown) one at a
time into the compartment.
Then place the cover back into the battery compartment while applying
slight pressure and turn it clockwise with a coin until it stops.
Avoid getting the batteries dirty, for example with greasy fingers. Even
slight soiling can lead to faster discharge of the batteries. It is recom-
mended to wear gloves or use plastic tweezers.
2
If the device does not start after inserting the new batteries, check the
correct polarity of the batteries and clean them with a dry cloth.
After the device is started up for the first time, the date and
time must be set. You can find details on this in the "Checking
Date and Time" chapter.

10 Measurement Modes

The device offers two options to perform a measurement.
10.1 Direct Measurement
With this type of measurement, the test-specific incubation time must be
monitored by the user. The user must decide when the test is read out by
the reader. Failure to adhere to the exact incubation time can lead to er-
roneous results.
The measurement starts immediately after pressing the button on the
reader. The result is shown on the display and can be saved internally.
10.2 Timer Measurement
With this type of measurement, the test-specific incubation time is firmly
defined and already stored in the configuration file. The timer for the incu-
bation is started manually by the user. After the timer has expired, e.g. 15
minutes, the reader carries out the measurement automatically and
shows the result on the display. The timer measurement can be canceled
at any time by pressing the operating button. The user is responsible for
triggering the timer immediately after applying the sample to the test cas-
sette. Waiting too long increases the incubation time and can affect the
measurement result.
Details of the measurement process are described in the following chap-
ter.

11 Measurement Procedure

11.1 Off
The device is switched off, nothing is shown on the display.
11.2 Switch-on
Briefly press the button (<1 second) to switch on the device.
11.2.1 Display Test
During start-up, all segments of the display light up briefly to check their
functionality.
Attention: If one or more of the segments do not light up, the
device should not be used for measurements as results may
not be presented correctly. Please contact your distributor im-
mediately to exchange the defective device.
11.2.2 Self-Test
After the display test, the device performs a short self-test to check
memory and measurement-related internal functions.
11.2.3 Checking Date and Time
If the measuring device has been disconnected from the power supply for
longer than one minute (via batteries or cable), the device will display the
date and time after the self-test has been completed. In this case, please
follow the descriptions in the chapter "Date and Time". After setting, the
device will restart automatically.
11.2.4 Last saved Result
If your device has the option to dis-
play the last saved result, this will
now be shown on the display. Con-
firm the result by briefly pressing the
button (<1 sec.). The device will then
display "ON" and is ready for use.
11.3 Ready for Use
"ON" appears on the display and the device is ready for use. Next, the lat-
eral flow rapid test is needed.
11.4 Test Insertion
Place the test cassette into the appropriate adapter, inserting it from ei-
ther the top or bottom depending on the type of adapter.
After inserting the cassette into the adapter, the device is placed on top of
the adapter. The elevation in one of the corners of the adapter surface is
used to position the device correctly.
11.5 Measurement
The device is now ready to start the measurement. Either an immediate
measurement or a timer measurement can be started. Which type of
measurement is started can be determined by the length of the button
press.