Chembio Cube Reader Gebrauchsanweisung

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| Instructions for use (IFU) – Cube Reader
Instructions for use – Cube Reader (Flat)
1 Legal References
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Diagnostics GmbH at any time.
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All trademarks mentioned in this document belong to the proper compa-
nies.
Copyright information
Instructions for use (IFU) – Cube Reader
Document version: V2.4, 2023-12-15
2 Symbols
Attention! Important and safety-relevant infor-
mation
Manufacturer
Please follow the instructions
In-Vitro-Diagnostics
Time of manufacture (year & month)
Serial number
Do not dispose in general trash. Please refer to
country-specific rules and laws when disposing
if the device
REF Part number
IP20 Protection class of electronic equipment
CE symbol
Var.A Variant info of device configuration
(Factory setting of device functionality as de-
scribed in this manual)
Distributor
Importer
Swiss authorized representative
1
For near patient testing (POCT)
Not for self-testing
Transport and storage between
-30 °C and 80 °C
3 Intended Purpose
Photometer, intended for the qualitative, semi-quantitative or quantita-
tive measurement of the optical density of lines on test strips used in Lat-
eral Flow Assays (LFAs) / rapid tests for in-vitro diagnostics. In particular,
its function is to provide diagnostic assistance in connection with specific
LFA tests, sample material for these tests can be any body fluids and ex-
tracts.
The evidence of a specific disorder, condition, or risk factor of interest de-
pends on the test defined by the manufacturer of the assay reagents, who
brings this test into the photometer via use of an RFID card. The manufac-
turer of the assay reagents also determines the related target population.
The application is solely performed manually by professional users. The
photometer itself is not a companion diagnostic device.
4 Scope and general Information
Thank you for choosing this product.
The Cube Reader is a photometer, intended for the qualitative, semi-quan-
titative or quantitative measurement of the optical density of lines on test
strips used in Lateral Flow Assays (LFAs) / rapid tests.
The respective test-specific data is transmitted wirelessly before the
measurement using RFID (Radio Frequency Identification). Before each
measurement, please ensure that the lot number of the test matches that
on the RFID tag.
The measurement results can be stored internally. In addition to its own
measurement ID (identification number of the measurement), each meas-
urement result contains the test name, lot number, the name of the test
manufacturer, as well as the date and time of the measurement. The
measurement results can be read out via a special USB cable using the
Cube DataReader software. The device is battery operated but can also be
powered via the USB cable.
The use of the device is subject to the provisions in the "Commissioning
and Safety Instructions" chapter. The reader can be used as a portable
handheld device or as a stationary measuring device. It can also be oper-
ated remotely using a Cube Reader specific USB cable and the free Cube
DataReader software.
The device can be contaminated by test-specific residues. In this case, it
must be cleaned with appropriate protective measures using a disinfect-
ant that does not attack the housing of the device (e.g. Mikrozid® AF Liq-
uid or comparable products).
5 Liability Exclusion
The devices are manufactured under strict quality controls, calibrated, and
thoroughly tested before delivery, so that a high level of quality can be en-
sured. The test-specific configurations are created by third-party compa-
nies (test manufacturers/distributors) and made available on the device
using an RFID card for test execution. The manufacturer of the device is
therefore not liable for the accuracy of test-specific measurement results
from tests installed on this device by third-party companies.
The RFID cards are included with the associated tests and, like these, may
be lot specific.
Results obtained from the device shall never be used as the
sole basis for making a diagnosis.
In order to establish a definitive diagnosis and initiate appropriate thera-
pies, reference results shall always be included that were determined us-
ing recognized, comparable methods.
6 Scope of Delivery
Each reader is delivered in a box with the following contents:
•
Reader
•
Test adapter for measurement
•
Three CR2032 batteries (optional)
•
Reader-specific USB data cable (optional)
•
USB Stick with Cube DataReader Software (optional)
•
QC Set (optional)
7 Commissioning and Safety Instructions
Please read the manual carefully before use.
Attention:
Any serious incident that has occurred in relation to the device
must be reported to the manufacturer, the distributor and the
competent authority of the Member State where the user
and/or patient is established.
Attention:
The device must not be opened. Opening the device voids any
warranty on the part of the manufacturer.
Attention:
Protect the device from liquids. Any direct contact with liquids
can cause irreparable damage.