# of tests left
EN
x
x
Too little
Add more blood
Just right
Too much
Wipe away excess
91146 A 7/2015
Open Plastic Shaker Pouch*
Collect Blood
•
Gently touch blood collector to top of
blood drop to fill.
•
Make sure collector is adequately filled.
Prick Finger
•
Wash hands or clean with alcohol and dry
before testing.
•
Remove cap and press lancet into finger.
•
Gently squeeze finger to get
adequate blood.
Insert Blood Collector
•
Fully insert blood collector into shaker body.
•
Push hard while twisting to fully insert.
3
2
1
4
Insert Cartridge
•
“Click” test cartridge into place.
•
Analyzer and test cartridge codes must match.
•
If codes do not match, call
Customer Service at +1-317-870-5610.
M
% A1C
7
Overview
& Quick
Reference
Guide
PN 91171 Rev. B 02/18
LOT 0628216
EXP 2014 01 27
LOT 0628216
EXP 2014 01 27
LOT 0628216
EXP 2014 01 27
LOT 0628216
EXP 2016 01 27
LOT 0628216
EXP 2016 01 27
LOT 0628216
EXP 2016 01 27
Blood Collector
Shaker body - open end
Shaker base (do not remove!)
6
Open Foil Cartridge Pouch*
AFTER Blood Collection
Insert cartridge into analyzer immediately
and use within 2 minutes.
Tear foil pouch open at the notches on the sides.
A1C
2
A09
LOT 0628216
EXP 2016 01 27
LOT 0628216
EXP 2016 01 27
LOT 0628216
EXP 2016 01 27
1
Do not reuse
Ne pas réutiliser
Use at room temperature
Utiliser à la température ambiante
EN
FR
EN
FR
Usar a temperatura ambiente
Utilizar à temperatura ambiente
ES
PT
No reutilizar
Não reutilizar
ES
PT
DO NOT OPEN until shaker is prepared.
Once opened, use within 2 minutes.
Read the instructions before opening pouch.
Préparer l’agitateur AVANT D’OUVRIR le sachet.
Utiliser dans les 2 minutes suivant l’ouverture.
Lire les instructions avant d’ouvrir le sachet.
EN
FR
ES
PT
NO LA ABRA si el agitador no está preparado.
Una vez abierta la bolsa, utilice el producto antes de
que transcurran 2 minutos.
Lea las instrucciones antes de abrir la bolsa.
NÃO ABRIR até o shaker estar preparado.
Depois de aberto, usar num espaço de 2 minutos.
Leia as instruções antes de abrir a bolsa.
11
12
Dispose of Cartridge /
Save Analyzer
•
Dispose of cartridge n your household
waste.
•
Save analyzer for additional tests. Analyzer
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
Step 12.
•
Analyzer will show result for 60 minutes and
will turn off automatically.
M
+1-317-870-5610
We invite you to call us and we will guide you
through the test.
5 Minutes to Results
10
SAMPLE
SAMPLE
SAMPLE
A09
A09
% A1C
% A1C
SAMPLE
SAMPLE
SAMPLE
A09
SAMPLE
SAMPLE
SAMPLE
A09
A09
% A1C
mmol/mol
Display counts down
QC test result
Result
9
Prepare Shaker
Remove shaker base.
8
% A1C
WAIT
for SMPL to display
Ready for shaker
Mix
•
Shake vigorously 6-8 times (about 5
seconds).
This will mix the blood with the solution.
•
Stand shaker on table while
preparing cartridge.
5
x
Not fully inserted
Fully inserted
Self C
heck
Self Check
A1CN
ow
®
A1CN
ow
+
®
Sist
ema pr
of
essionale
di aut
odiag
nosi
A1CN
ow
®
A1CN
ow
+
®
Sist
ema pr
of
essionale
Self Check
A1CN
ow
®
A1CN
ow
+
®
Sist
ema pr
of
essionale
A1CN
ow
+
®
Sist
ema pr
of
essionale
A1CN
ow
®
Self Check
di aut
odiag
nosi
A1CN
ow
®
A1CN
ow
+
®
Sist
ema pr
of
essionale
•
FIRST,
we strongly recommend you read
all instructions carefully and watch the brief
instructional video on our website at
ptsdiagnostics.com.
THEN
, follow all steps as you
perform the test.
•
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.
Caution:
This device contains material of animal
origin and should be handled as a potential carrier
and transmitter of disease.
For additional information, see the reverse side of
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.
IMPORTANT!
Match Lot Numbers
Use analyzer only with the materials included in
the original kit. The analyzer will expire after the
programmed number of tests have been run. If
another test cartridge is inserted, the analyzer will
display “00TL.”
Open End
Analyzer Front
Analyzer Back
Code
Lot Number
Dispense Sample into Cartridge
•
Ensure analyzer is on level surface.
•
Push down completely to dispense diluted sample
and remove in a continuous motion.
•
Remove sampler from cartridge quickly.
•
“RUN” will appear.
Do not handle analyzer again
until test is complete!
* Pouch illustrations may vary.
Note:
All instances of the box or pouches in this insert
are representative ONLY. Please refer to the packaging
included with your specific kit.
25°C
(77°F)
18°C
(64°F)
Complete test within 15 minutes.
Test S
yst
em
Caution:
Do NOT open foil pouch until this step.
Use within 2 minutes of opening.
If foil pouch is damaged, do not use.
2
DO NOT OPEN until shaker is prepared.
Once opened, use within 2 minutes.
Read the instructions before opening pouch.
Préparer l’agitateur AVANT D’OUVRIR le sachet.
Utiliser dans les 2 minutes suivant l’ouverture.
Lire les instructions avant d’ouvrir le sachet.
1
18-28°C (64-82°F)
A1C
EN
FR
ES
PT
P/N 91069 Rev. C
NO LA ABRA si el agitador no está preparado.
Una vez abierta la bolsa, utilice el producto antes de
que transcurran 2 minutos.
Lea las instrucciones antes de abrir la bolsa.
NÃO ABRIR até o shaker estar preparado.
Depois de aberto, usar num espaço de 2 minutos.
Leia as instruções antes de abrir a bolsa.
Do not reuse
Ne pas réutiliser
Use at room temperature
Utiliser à la température ambiante
EN
FR
EN
FR
Usar a temperatura ambiente
Utilizar à temperatura ambiente
ES
PT
No reutilizar
Não reutilizar
ES
PT
0628216
LOT 0628216
EXP 2016 01 27
LOT 0628216
EXP 2016 01 27
LOT 0628216
EXP 2016 01 27
P/N 91070 Rev. E
A1C
1
Polymer Technology Systems, Inc.
7736 Zionsville Road
Indianapolis, Indiana USA
Manufacturer
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Authorized representative
in the European Community
Do not reuse
Ne pas réutiliser
No reutilizar
Não reutilizar
EN
FR
ES
PT
1
Niet hergebruiken
Non riutilizzare
Nicht wiederverwenden
Nie używać ponownie
NL
IT
DE
PL
EN Read the instructions before opening pouch.
FR Lire les instructions avant d'ouvrir le sachet.
ES Lea las instrucciones antes de abrir la bolsa.
PT Leia as instruções antes de abrir a bolsa.
NL Lees de instructies alvorens de zak te openen.
IT Leggere le istruzioni prima di aprire la busta.
DE Lesen Sie die Anweisungen, bevor Sie den
Beutel öffnen.
PL Przed otwarciem woreczka przeczytać instrukcje.
NOTE: To run another test, use a new shaker, blood
collector, test cartridge, and lancet from the same
kit and return to Step 1.
•
This result cycle remains displayed for
60 minutes or until the next test cartridge
is inserted.
•
If “QCOK” is not displayed, please refer
to the troubleshooting section or
contact Customer Service.
Do NOT open foil cartridge pouch until Step 6.
A1C
1
P/N 91143 Rev. C
A1C
1
Polymer Technology Systems, Inc.
7736 Zionsville Road
Indianapolis, Indiana USA
Manufacturer
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Authorized representative
in the European Community
1
Do not reuse
Ne pas réutiliser
No reutilizar
Não reutilizar
EN
FR
ES
PT
EN Read the instructions before opening pouch.
FR Lire les instructions avant d'ouvrir le sachet.
ES Lea las instrucciones antes de abrir la bolsa.
PT Leia as instruções antes de abrir a bolsa.
Niet hergebruik
en
Non riutilizzar
e
Nicht wiederver
wenden
Nie u
ż
ywa
ć
ponownie
NL
IT
DE
PL
MediPurpose P
te. L
td.
15 Hoe C
hiang Road #12-02
Tow
er Fift
een
089316 Singapor
e
Manufac
turer
Obelis S.A.
Bd. G
éné
ral W
ahis 53
1030 Brussels
, Belgium
Author
ized r
epresen
tativ
e
in the Eur
opean Communit
y
NL Lees de instruc
ties alvor
ens de zak te openen.
IT L
eggere le istruzioni prima di aprir
e la busta.
DE Lesen S
ie die Anweisungen, be
vor S
ie den Beutel öffnen.
PL Pr
zed ot
war
ciem wor
eczka pr
zecz
ytać instrukcje
.
1008
1
Log Result
Chart your progress here.
Record your A1C results here, and bring this
with you when you see your doctor. Mark down
your A1C goal in the space provided.
Date:
A1C Result:
A1C Goal:
Date:
A1C Result:
A1C Goal:
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.
There should be
NO GAP
between the
blood collector and the shaker.
Actual size required
Match codes
Lancet
LOT 0628216
