91146 A 7/2015
EN
PN 91171 Rev. B 02/18
Overview
IMPORTANT!
FIRST, we strongly recommend you read
•
& Quick
all instructions carefully and watch the brief
instructional video on our website at
Reference
ptsdiagnostics.com. THEN, follow all steps as you
perform the test.
Guide
Do not open pouches until instructed.
•
Make sure lot number on analyzer matches lot
•
numbers on pouches.
•
Use indoors between 18°C - 25°C /64°F - 77°F
•
DO NOT adjust your medication unless
instructed to do so by your doctor or
healthcare provider.
If you have any questions about your A1C result,
•
please contact your doctor or healthcare provider.
25°C
(77°F)
18°C
(64°F)
Complete test within 15 minutes.
6
Open Foil Cartridge Pouch*
Note: All instances of the box or pouches in this insert
AFTER Blood Collection
are representative ONLY. Please refer to the packaging
Insert cartridge into analyzer immediately
included with your specific kit.
and use within 2 minutes.
Tear foil pouch open at the notches on the sides.
2
Caution:
Do NOT open foil pouch until this step.
Use within 2 minutes of opening.
If foil pouch is damaged, do not use.
DO NOT OPEN until shaker is prepared.
EN
Once opened, use within 2 minutes.
Read the instructions before opening pouch.
EN
Use at room temperature
1
FR
Utiliser à la température ambiante
ES
Usar a temperatura ambiente
Préparer l'agitateur AVANT D'OUVRIR le sachet.
FR
PT
Utilizar à temperatura ambiente
Utiliser dans les 2 minutes suivant l' o uverture.
Lire les instructions avant d'ouvrir le sachet.
* Pouch illustrations may vary.
NO LA ABRA si el agitador no está preparado.
EN
Do not reuse
ES
Una vez abierta la bolsa, utilice el producto antes de
que transcurran 2 minutos.
FR
Ne pas réutiliser
Lea las instrucciones antes de abrir la bolsa.
ES
No reutilizar
PT
Não reutilizar
NÃO ABRIR até o shaker estar preparado.
+1-317-870-5610
PT
Depois de aberto, usar num espaço de 2 minutos.
Leia as instruções antes de abrir a bolsa.
LOT 0628216
LOT 0628216
LOT 0628216
EXP 2016 01 27
EXP 2016 01 27
EXP 2016 01 27
We invite you to call us and we will guide you
through the test.
Match Lot Numbers
Caution: This device contains material of animal
Use analyzer only with the materials included in
origin and should be handled as a potential carrier
the original kit. The analyzer will expire after the
and transmitter of disease.
programmed number of tests have been run. If
another test cartridge is inserted, the analyzer will
For additional information, see the reverse side of
display "00TL."
this insert.
If you are not able to access the instructional
video on our website, we encourage you to call
customer service at +1-317-870-5610 to walk
you through the test.
0628216
2
P/N 91069 Rev. C
EN
DO NOT OPEN until shaker is prepared.
Once opened, use within 2 minutes.
18-28°C (64-82°F)
Read the instructions before opening pouch.
FR
EN
Utiliser à la température ambiante
Use at room temperature
1
Préparer l'agitateur AVANT D'OUVRIR le sachet.
ES
Usar a temperatura ambiente
FR
Lire les instructions avant d'ouvrir le sachet.
Utiliser dans les 2 minutes suivant l' o uverture.
PT
Utilizar à temperatura ambiente
ES
Una vez abierta la bolsa, utilice el producto antes de
NO LA ABRA si el agitador no está preparado.
EN
Do not reuse
que transcurran 2 minutos.
Lea las instrucciones antes de abrir la bolsa.
ES
FR
No reutilizar
Ne pas réutiliser
EN Read the instructions before opening pouch.
P/N 91070 Rev. E
PT
Não reutilizar
ES Lea las instrucciones antes de abrir la bolsa.
FR Lire les instructions avant d'ouvrir le sachet.
PT
NÃO ABRIR até o shaker estar preparado.
Depois de aberto, usar num espaço de 2 minutos.
NL Lees de instructies alvorens de zak te openen.
PT Leia as instruções antes de abrir a bolsa.
1
Leia as instruções antes de abrir a bolsa.
IT Leggere le istruzioni prima di aprire la busta.
Authorized representative
in the European Community
DE Lesen Sie die Anweisungen, bevor Sie den
Beutel ö nen.
Schi graben 41
MDSS GmbH
PL Przed otwarciem woreczka przeczytać instrukcje.
30175 Hannover, Germany
LOT 0628216
LOT 0628216
LOT 0628216
EN
Do not reuse
NL
EXP 2016 01 27
EXP 2016 01 27
EXP 2016 01 27
Niet hergebruiken
FR
Ne pas réutiliser
IT
Non riutilizzare
Polymer Technology Systems, Inc.
Manufacturer
Analyzer Front
Analyzer Back
ES
PT
Não reutilizar
No reutilizar
PL
DE
Nicht wiederverwenden
Nie używać ponownie
7736 Zionsville Road
Indianapolis, Indiana USA
LOT 0628216
Code
Lot Number
7
8
Insert Cartridge
Prepare Shaker
"Click" test cartridge into place.
Remove shaker base.
•
Analyzer and test cartridge codes must match.
•
If codes do not match, call
•
Customer Service at +1-317-870-5610.
WAIT for SMPL to display
% A1C
Ready for shaker
% A1C
Match codes
1
2
Open Plastic Shaker Pouch*
Prick Finger
Do NOT open foil cartridge pouch until Step 6.
Wash hands or clean with alcohol and dry
•
before testing.
Remove cap and press lancet into finger.
•
1
Gently squeeze finger to get
•
adequate blood.
P/N 91143 Rev. C
EN Read the instructions before opening pouch.
1
FR Lire les instructions avant d'ouvrir le sachet.
Authorized representative
in the European Community
ES Lea las instrucciones antes de abrir la bolsa.
MDSS GmbH
PT Leia as instruções antes de abrir a bolsa.
Schi graben 41
30175 Hannover, Germany
EN
Do not reuse
FR
Ne pas réutiliser
ES
No reutilizar
PT
Não reutilizar
Manufacturer
Polymer Technology Systems, Inc.
7736 Zionsville Road
Indianapolis, Indiana USA
1
Blood Collector
Shaker body - open end
Shaker base (do not remove!)
LOT 0628216
LOT 0628216
LOT 0628216
Lancet
EXP 2016 01 27
EXP 2016 01 27
EXP 2016 01 27
Actual size required
LOT 0628216
LOT 0628216
LOT 0628216
EXP 2014 01 27
EXP 2014 01 27
EXP 2014 01 27
9
10
Dispense Sample into Cartridge
5 Minutes to Results
Ensure analyzer is on level surface.
•
•
Push down completely to dispense diluted sample
and remove in a continuous motion.
% A1C
Display counts down
Remove sampler from cartridge quickly.
•
"RUN" will appear.
•
A09
% A1C
QC test result
SAMPLE
SAMPLE
SAMPLE
A09
mmol/mol
A09
Result
SAMPLE
SAMPLE
SAMPLE
A09
A09
SAMPLE
SAMPLE
SAMPLE
% A1C
# of tests left
This result cycle remains displayed for
•
60 minutes or until the next test cartridge
is inserted.
If "QCOK" is not displayed, please refer
•
Do not handle analyzer again
to the troubleshooting section or
until test is complete!
contact Customer Service.
3
4
Collect Blood
Insert Blood Collector
Fully insert blood collector into shaker body.
Gently touch blood collector to top of
•
•
Push hard while twisting to fully insert.
blood drop to fill.
•
Make sure collector is adequately filled.
•
Open End
x
x
x
Not fully inserted
Fully inserted
Too little
Just right
Too much
Add more blood
Wipe away excess
NO GAP
There should be
between the
blood collector and the shaker.
11
12
Dispose of Cartridge /
Log Result
Save Analyzer
Chart your progress here.
Dispose of cartridge n your household
•
Record your A1C results here, and bring this
waste.
with you when you see your doctor. Mark down
Save analyzer for additional tests. Analyzer
•
your A1C goal in the space provided.
will display, for example, "01TL" if there is
one test left and "00TL" if you just used your
last test.
•
Record your A1C result in the result log in
Date:
Step 12.
A1C Result:
Analyzer will show result for 60 minutes and
•
will turn off automatically.
A1C Goal:
Date:
A1C Result:
A1C Goal:
NOTE: To run another test, use a new shaker, blood
collector, test cartridge, and lancet from the same
kit and return to Step 1.
5
Mix
•
Shake vigorously 6-8 times (about 5
seconds).
This will mix the blood with the solution.
Stand shaker on table while
•
preparing cartridge.
Result Interpretation
Do not take any decision of medical
•
relevance without first consulting your
healthcare practitioner.
•
When this device is used for monitoring of
an existing disease, adapt the treatment
only if you have received the appropriate
training to do so.
Need help?
Do you have a question about the A1CNow and is the answer not in the manual?
Questions and answers
This is the 4th time using this device. I received a reading of 00TL. The three times it worked perfectly.
A reading of "00TL" on the PTS Diagnostics A1CNow device means that there is one test left and "00TL" will display if you have just used your second-to-last test.
This answer is automatically generated
@Mr. Anderson, I was in the process of using my 4th test when the display showed "00TL." I never received my A1C reading as I did on the previous three tests.
WHAT DOES 00TL MEAN ON MY DEVICE
00TL on the PTS Diagnostics A1CNow device means that all program tests have been used after the A1C result is recorded.
This answer is automatically generated
The analysis device gave an error code QC8 followed by 08TL . What does that mean? Tested a few times with same device, still same codes.