Colibri Cube Reader User manual

Manual Cube Reader

Cube Reader Colibri - EN
1
1Legal References
All rights are protected.
All Information published in this document can be changed by
Chembio Diagnostics GmbH at any time.
Trademark rights
All trademarks mentioned in this document belong to the
proper companies.
Copyright information
Manual Cube Reader
Document version: V2.0, 11-2022
©Copyright by Chembio Diagnostics GmbH, Berlin

Cube Reader Colibri - EN
2
2Contents
1LEGAL REFERENCES ............................................................. 1
2CONTENTS ........................................................................ 2
3SYMBOLS .......................................................................... 5
4INTENDED PURPOSE ............................................................ 7
5SCOPE AND GENERAL INFORMATION........................................ 8
6LIABILITY EXCLUSION ......................................................... 10
7SCOPE OF DELIVERY........................................................... 11
8COMMISSIONING AND SAFETY INSTRUCTIONS.......................... 12
9MAINS OPERATION ........................................................... 15
10 BATTERY OPERATION .................................................... 16
11 MEASUREMENT MODES ................................................ 18
11.1 Direct Measurement.......................................... 18
11.2 Timer Measurement.......................................... 19
12 MEASUREMENT PROCEDURE .......................................... 20
12.1 Off...................................................................... 20
12.2 Switch-on........................................................... 20

Cube Reader Colibri - EN
3
12.3 Ready for Use .................................................... 23
12.4 Test Insertion..................................................... 23
12.5 Measurement .................................................... 25
12.6 Test Configuration Data..................................... 27
12.7 Test.................................................................... 27
12.8 Start Measurement ........................................... 29
12.9 Run .................................................................... 30
12.10 Result................................................................. 30
12.11 Saving Result...................................................... 31
12.12 Switch-off .......................................................... 32
13 QC TEST.................................................................... 33
13.1 QC Test Measurement....................................... 33
14 ERROR MESSAGES........................................................ 35
14.1 Display: “ERR”.................................................... 35
14.2 Display: “DATE” ................................................. 36
14.3 Display: “FAIL” ................................................... 37
14.4 No Function ....................................................... 38

Cube Reader Colibri - EN
4
15 DATE AND TIME........................................................... 39
16 DATA TRANSFER .......................................................... 41
17 DEVICE SPECIFICATIONS................................................. 42
18 MAINTENANCE AND CLEANING OF THE WINDOW ................ 45
19 RETURNING THE READER ............................................... 46
20 DISINFECTION RECEIPT .................................................. 47
21 DISPOSAL OF THE DEVICE ............................................... 49
22 MANUFACTURER’S INFORMATION.................................... 50

Cube Reader Colibri - EN
5
3Symbols
Attention! Important and safety-relevant
information
Manufacturer
Please follow the instructions
In-Vitro-Diagnostics
Date of manufacture (year & month)

Cube Reader Colibri - EN
6
Serial number
Do not dispose in general trash. Please re-
fer to country-specific rules and laws when
disposing if the device
REF
Part number
IP20
Protection class of electronic equipment
CE symbol

Cube Reader Colibri - EN
7
4Intended Purpose
Photometer, intended for the qualitative, semi-quantitative
or quantitative measurement of the optical density of lines
on test strips used in Lateral 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 depends 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 manufacturer of the assay rea-
gents also determines the related target population.
The application is solely performed manually by professional
users. The photometer itself is not a companion diagnostic
device.

Cube Reader Colibri - EN
8
5Scope and general Information
Thank you for choosing this product.
The Cube Reader is a photometer, intended for the qualita-
tive, semi-quantitative or quantitative measurement of the
optical density of lines on test strips used in Lateral Flow As-
says (LFAs) / rapid tests.
The respective test-specific data is transmitted wirelessly be-
fore the measurement using RFID (Radio Frequency Identifi-
cation). 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 measurement 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

Cube Reader Colibri - EN
9
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 “Com-
missioning and Safety Instructions” chapter. The reader can
be used as a portable handheld device or as a stationary
measuring device. It can also be operated remotely using a
Cube Reader specific USB cable and the free Cube Data-
Reader software.
The device can be contaminated by test-specific residues. In
this case, it must be cleaned with appropriate protective
measures using a disinfectant that does not attack the hous-
ing of the device (e.g. Mikrozid® AF Liquid or comparable
products).