Data Transfer; Device Specifications; Manufacturer's Information - Chembio Cube Reader Gebrauchsanweisung

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| Instructions for use (IFU) – Cube Reader
The update of all values is finally confirmed with the display message
"OK".
By briefly pressing the button again (<1 sec.), you can return to the "ON"
state, the device is now ready for measurements again. If necessary, re-
peat this process after replacing the battery.

15 Data Transfer

The device offers the possibility of transferring data to a PC or laptop. This
requires a Cube Reader specific USB cable and the Cube DataReader soft-
ware.
This package consisting of cable and software (USB stick) may be included
in the scope of delivery. To install and use the software, follow the instruc-
tions in the software manual, which can also be found on the USB stick.

16 Device Specifications

Description: Reader for standard lateral flow assays
User: Professional Use; Lab and POCT
Test format: Test cassette or test strip
Measurement: Device for quantification, semi-quantifica-
tion, or qualification of test-line intensity
– also adaptable for multiple test-line
measurements
Dimensions L x W x H: Approx. 1.6 x 1.6 x 1.6 in. (41 x 41 x 40
mm)
Weight: Approx. 1.4 oz (40 g)
Operation: One button operation
Display: 14-segment LCD
Storage capacity: Several hundred test results
Measurement period: Approx. 3 sec.
Power supply: 3 batteries CR2032 (3 V/230 mAh) or
Cube Reader specific power cord (optional
article) also usable for data transfer to
PC/laptop
Interface: 4 pole – 0.1 in. (2,5 mm) jack plug for
power supply and USB data transfer to
PC/laptop, Wi-Fi Connection 4.0 class 2
Configuration: Specific configuration program; RFID tech-
nology
Measuring field: Min. 0.2 in. (4 mm) width; max. 0.7 in. (18
mm) length
Lighting: Wavelength 525 nm
Signaling device: Buzzer
Operating conditions: Between 50°F (+10°C) and 95°F (+35°C);
Between 20% and 85% humidity
Transport / Storage con- Between +20 % and +85 % humidity
ditions:
Storage QC Set Storage with lightproof packaging
Storage at room temperature
(65°F..72°F / 18°C..22°C)
4
Maximum relative humidity 40%
Degree of protection: IP 20
Color of housing: Customizable
17 Maintenance and Cleaning of the Window
The device does not require regular maintenance. Before each measure-
ment, the bottom of the glass window should be checked for dirt. A com-
mercially available textile cloth suitable for glass and a cleaning agent are
recommended for cleaning of the window.
A disinfectant suitable for laboratory equipment can be used to clean the
surface of the housing, e.g. Mikrozid® AF Liquid or comparable products.
The battery voltage is continuously monitored. Replace the batteries as
soon as the battery icon starts flashing. Never recharge empty batteries
and ensure that they are disposed of properly.
18 Returning the Reader
In the event of a defect, it may be necessary to return the device to the re-
tailer. In such a case, first contact your distributor for further coordina-
tion.
Due to potential contamination with infectious material during use, disin-
fection is required prior to return.
For complete disinfection, all must be cleaned with a suitable agent. The
disinfectant should be suitable and approved for laboratory devices and
should not affect the housing material of the device. Suitable for this are,
for example, Mikrozid® AF Liquid or comparable products.
The template on the following page can be used as proof of the disinfec-
tion of the device. Please enclose the disinfection slip with the delivery pa-
pers.
19 Disinfection Receipt
Attention: A reader sent in cannot be accepted without a signed disin-
fection receipt and will be returned unopened!
Device type: Cube Reader
Reason for transmittal:
Customer/company:
Date of disinfection:
Disinfection operator:
Serial numbers of disinfected devices:
The following disinfecting measures were executed on the above-men-
tioned devices: (please checkmark):
Cleaning of every surface of the device with paper tissue and dis-
infection solution suitable for laboratory devices
(for instance Mikrozid® AF Liquid or comparable product)
Place and date Signature
20 Disposal of the device
Since the device is exposed to potential contamination during use, it must
be properly disinfected using suitable protective equipment.
Then dispose of the device separately from the batteries in accordance
with the respective country-specific regulations.
Alternatively, you can send the device back to your distributor or directly
to the manufacturer for disposal. Please note the specifications in chapter
18 for the return.

21 Manufacturer's Information

Chembio Diagnostics GmbH
12489 Berlin, Germany
Schwarzschildstraße 1
CDGInfo@chembio.com
www.chembiogermany.de
For support when using with specific tests, please contact the distributor
first.