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  9. aptitude Metrix Reader User manual

aptitude Metrix Reader User manual

The above two pages should be printed (doublesided) on 38 lb glossy white paper.
The prints should be cut to size accoridng to the dimensions on this document (15.81 x 3.93”).
The prints should also be folded in thirds along the dotted lines shown above like an accordion fold.
The dotted lines are not to be printed.
The dark blue panel that says “Metrix Reader” with the helix is the front.
THIS PAGE IS NOT TO BE PRINTED
Scan QR code for
interactive instructions
and video demonstration.
Start Here
Connect reader to power supply.
The center light will turn solid
(not flashing) when ready.
Open the Metrix COVID-19 Test kit (available separately) if you
have not done so already.
The Metrix COVID-19 Test kit will guide you through how to
collect and run your sample.
Power Up
Collect Sample
01
02
Quick Start Guide
MetrixTM Reader
™
Starting Up
The reader is starting up. Wait
until the center light is solid
white before inserting a sensor.
Ready
The reader is ready to start a
test.
Test Running
The reader is running a test.
DO NOT remove the sensor or
unplug the reader.
Positive Result
The test is complete and
SARS-CoV-2 was detected in
the sample.
Negative Result
The test is complete and
SARS-CoV-2 was NOT
detected in the sample.
Invalid Result
The test is complete and the
result is invalid. Repeat with a
new Metrix COVID-19 Test kit.
Indicates
flashing light
Reader Statuses
For use with the Metrix COVID-19 Test kit (available separately).
For use under Emergency Use Authorization (EUA) only.
IVD
Test Error
Remove sensor and firmly press down
on collector. Firmly reinsert sensor
into reader. If error persists, discard
sensor and use a new test kit.
Hardware Failure
There is an error with the reader.
Disconnect and reconnect the
power.
Canceled Test
The test did not complete. Discard
the sensor and run the test with a
new test kit.
If troubleshooting fails to resolve any
problem persist please contact support.
If your Metrix Reader needs to be disposed
of, please place in electronic waste.
For support, please contact us at:
1.888.934.2253
[email protected]
Or visit: AptitudeMetrix.com.
Troubleshooting
UG-00001 Ver 2
The Metrix COVID-19 Test kit and Metrix Reader are
for FDA Emergency Use Authorization (EUA) only.
This home test kit is only authorized for the duration
of the declaration that circumstances exist justifying
the authorization of emergency use of IVDs for
detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner.
Aptitude, Metrix, and the Aptitude logo
are trademarks of Aptitude Medical Systems, Inc.
All Rights Reserved.
Certification that the electromagnetic
interference from the device is under
limits approved by the Federal
Communications Commission.
REF
Manufacturer’s catalog number
IVD
For vitro diagnostic use
Keep dry
Date of manufacture
Manufacturer of device
Please consult the instruction manual
Dispose of in electronic waste
Do not use if packaging is damaged
Temperature limitations of the product
Direct current (DC) voltage
No Power
Check all electrical
connections. The reader is
not receiving power.
Indicates
flashing light Warnings and Precautions
∙ Do not use components that are visibly
damaged.
∙ The Metrix Reader can be cleaned by wiping the
exterior with disinfectant. Do not spray
disinfectant into or onto the reader.
∙ If a power failure occurs or if the Metrix Reader is
unplugged while the Sensor is inserted, the test
result is invalidated. The test should be redone
with a new test kit.
∙ Use only the provided power cable and power
adapter.
∙ This device complies with Part 15 of the FCC
Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any
interference received, including interference that
may cause undesired operation.
Legend of Symbols
™
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. This equipment should be installed and operated with minimum distance
20cm between the radiator & your body.
FCC Warning:
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions:
(1) This device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
NOTE 1: This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following
measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
NOTE 2: Any changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user's authority to operate the equipment.

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