Colibri Cube Reader User manual

Manual Cube Reader

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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

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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

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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

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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

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

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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

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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.

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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

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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).

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6Liability 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 companies (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 in-
stalled 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 should never be used as the
sole basis for making a diagnosis. In order to establish a defin-
itive diagnosis and initiate appropriate therapies, reference
results should always be included that were determined using
recognized, comparable methods.

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7Scope of Delivery
Each reader is delivered in a box with the following contents:
•Reader
•Three CR2032 batteries
•Reader-specific USB data cable (optional)
•USB Stick with Cube DataReader Software (op-
tional)
•QC Set (optional)

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8Commissioning 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 manufac-
turer, 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 de-
vice voids any warranty on the part of the manufac-
turer.
Attention:
Protect the device from liquids. Any direct contact
with liquids can cause irreparable damage.

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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 meas-
urement and should be protected from strong lighting, such
as direct sunlight.

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Attention:
Metallic surfaces can affect the RFID receiver. Al-
ways hold the RFID tag directly over the housing /
display of the reader to ensure 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 con-
ditions.

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9Mains Operation
The device can be powered from an electrical outlet using the
Reader-specific USB cable and a standard USB power adapter.
The permanent power supply ensures uninterrupted opera-
tion 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.

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10 Battery Operation
The device can also be operated with three lithium batteries
of the type CR2032 (button cells). These must be removed
from their packaging and placed in the battery compartment
of the device. To do this, open the cover of the battery com-
partment 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 fac-
ing 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 fin-
gers. Even slight soiling can lead to faster discharge of the
batteries. It is recommended to wear gloves or use plastic
tweezers.

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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.

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11 Measurement Modes
The device offers two options to perform a measurement.
11.1 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 erroneous results.
The measurement starts immediately after pressing the but-
ton on the reader. The result is shown on the display and can
be saved internally.

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11.2 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 incubation 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 re-
sult on the display. The timer measurement can be canceled
at any time by pressing the operating button. The user is re-
sponsible for triggering the timer immediately after applying
the sample to the test cassette. Waiting too long increases
the incubation time and can affect the measurement result.
Details of the measurement process are described in the fol-
lowing chapter.