Cleaning And Disinfection - PharmaTech Solutions GenViro! Swift Gebrauchsanweisung

RESULT INTERPRETATION
When the test is complete, the results are clearly
displayed on the instrument screen.
Instrument Display / Follow-up Actions
Interpretation of Results
"Present": Positive results
do not rule out bacterial
infection or co-infection with
other viruses.
COVID-19 Positive
"Not Present": This result does
not rule out co-infections with
other pathogens.
COVID-19 Negative
"Err": The presence or absence
of COVID-19 Virion cannot
be determined. Repeat testing
of the patient using a new test
strip. If repeated Invalid results
are obtained, results should be
confi rmed by another method
prior to reporting the results.
COVID-19 Invalid
If an Invalid result is received, additional tests
may be run using the remaining test strips. The
instructions below should be followed:
• Dispose of the used test strip. The meter will
turn off automatically.
• Insert a new test strip.
• Gently touch the tip of the test strip to the
surface of the sample. If the strip does not fi ll,
remove strip and obtain a new strip and insert
into the meter. Do not apply the sample to
the top surface or underside of test strip. Do
not submerge the strip into sample. Do not
fl ick the test strip.
• When the strip is full, the meter will "beep."
Hold the test strip to sample until you hear
a beep. If you do not hear a beep, you may
get an inaccurate reading or a meter error
message.
• Test result will show up in 10 seconds.
LIMITATIONS
• Do not use with newborns.
• Both viable and non-viable SARS-CoV-2
viruses can be detected using the GenViro!
COVID-19 test
• Positive and negative predictive values are
highly dependent on prevalence. The local
prevalence should be taken into consideration
when interpreting diagnostic test results.
• If the test result is negative and clinical
symptoms persist, additional testing using
other clinical methods is recommended. A
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negative result does not at any time preclude
the possibility of a SARS-CoV-2 infection and
should be confi rmed via molecular assay.
• As with all diagnostic tests, all results must be
combined with clinical observations, patient
history, and epidemiological information
available to the physician.
• The performance of the GenViro! Swift
COVID-19 Professional System was evaluated
using the procedures provided in this product
insert only. Modifi cations to these procedures
may alter the performance of the test.
• False negative results may occur if a specimen
is improperly collected or handled. False nega-
tive results may also occur if inadequate levels
of viruses are present in the specimen.
• The test cannot rule out diseases caused by
other bacterial or viral pathogens.
SETTING METER PARAMETERS
Setting Time & Date
Please set correct time and date before you
begin testing.
How to set time and
date:
1. Press and hold ▲
button to enter the
setting mode.
2. Press ▲ or ▼
button to select
desired year. Press
the power button
to move on to
the next setting,
"Month".
3. Repeat above steps
to set the month,
day, hour and
minute by ▲ or ▼
button and then
power button.
Memory Recall
The GenViro! Swift COVID-19 Meter can
®
automatically store up to 110 results.
When recalling the results, each single result
appears from the latest to the earliest with time
and date.
To recall Results Stored in Memory
1. Turn meter on by pressing power button.
Press ▲ or ▼ button. The fi rst result
displayed on the screen is your most recent
®
test result.
2. Press ▲ or ▼ button to view test records
from the most recent to the oldest.
3. Press the power button to turn off or put
meter aside for auto shut down.

CLEANING and DISINFECTION

"Cleaning" is the general removal of debris (food,
feces, urates, blood, saliva and other body secre-
tions) which helps reduce the amount of organic
matter that contributes to the proliferation of
bacteria and disease.
"Disinfecting" removes most of the organisms
®
present on the surface which can cause infec-
tion or disease. It is useful against a number of
bacterial and viral microorganisms.
The following disinfectant product has been
shown to be safe for use with GenViro! Swift
COVID-19 Meter, but any disinfectant product
with the EPA registration number of 67619-12
may be used on this device.
Clorox Germicidal Wipes
Pathogen Contact Time
TB 2 Minutes
Bacteria 30 Seconds
Viruses 1 Minute
Parvoviruses 5 Minutes
Mold, Mildew, Fungi 5 Minutes
Cleaning Procedures
1. Place device and wipes on a smooth surface.
Be sure there is enough light.
2. Wash hand with soap and water then pat dry.
3. Put on a protective glove.
4. Take a piece of moistened wipe out of canis-
ter. Remember to recap the canister.
5. Wipe entire device until visibly clean.
6. Throw away the used wipe. Please do not
reuse the wipe.
Caution
1. Always clean before disinfect.
2. All parts of devices are considered biohazard.
Disinfect all parts thoroughly.
Disinfect Procedures
1. Prepare wipes and meter.
2. Take a piece of moistened wipe out of canis-
ter. Remember to recap the canister.
3. Put the moistened wipe on a smooth surface.
4. LCD side up, wipe the device from left to
right 3 times slowly. All other sides and
surfaces should be wiped in this way.
5. Make sure the meter stays wet for 1 min.
Please DO NOT get disinfectant liquid into
the test strip slot.
6. Throw away the used wipes. Please do not
reuse the wipe.
7. After disinfection, user's gloves should be
removed and hands should be thoroughly
washed with soap and water before proceed-
ing to the next patient.
Warning:
1. Please use disinfectant with caution.
2. For your own safety, please do not mix
disinfectant with other liquid.
3. Please read the instructions carefully on
the canister before Starting cleaning and
disinfection.
4. Please don't use the wipes on any part of
human.
5. Store disinfectants out of the reach of
children.
6. If any signs of deterioration are noted, stop
using the meter and please contact customer
service. For example: Cloudy Display; ma-
terial cracking, brittle, or softening; meter
buttons malfunction; performance of meter
®
has changed.
NOTE
Where to buy the Disinfectant Wipes.
1. The Clorox Germicidal Wipes can be
purchased on
www.cloroxprofessional.com
www.amazon.com
or call the service number of Clorox (USA)
at 1-800-234-7700
2. If you have any question about the cleaning
and disinfection or need more information,
please contact customer service.
References:
1. Biosafety in Microbiological and Biomedical Labora-
tories (BMBL) found at http://www.cdc.gov/biosafety/
publications/bmb15/
2. "Protection of Laboratory Workers From Occupa-
tionally Acquired Infections; Approved Guideline-Third
Edition" Clinical and Laboratory Standards Institute
(CLSI) M29-A3.
GenViro! Swift COVID-19 User Guide - 7
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