Glucose Test Strips
IMPORTANT: Please read this information and your Gluceofine® operation manual before using the Gluceofine®
glucose test strips.
Warning! To avoid false readings, use only a Gluceofine® Meter to measure glucose with your Gluceofine®
Glucose Test Strips.
Intended Use:
The Gluceofine® Glucose Test Strips are used with Gluceofine® Glucose Test Meter for the measurement of glucose in
your blood. The Gluceofine® Blood Glucose Monitoring System is plasma-calibrated to allow comparison of results
with the laboratory method. The Gluceofine® Glucose Test Strips are for testing outside the body (in vitro diagnostic
use only). Gluceofine® Blood Glucose monitoring system is for self-testing.
General :
Gluceofine® glucose test strips adopt a new bio-sensor technology composed of electro-chemical components and
require a small 0.5µl volume of blood giving you less pain. Gluceofine® can store 365 readings in memory with date
& time, you can easily store your readings on your PC (optional). This will provide an easier and better way to control
your glucose levels.
Storage and Handling :
t4UPSFUIF(MVDFPöOF® Glucose Test Strip vials in a cool and dry place between 2-30°C(36-86°F). Keep out of direct
sunlight. Do not freeze.
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container.
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results.
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Discard remaining Gluceofine® Glucose Test Strips 3 months after first opening the vial.
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Care Procedures :
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the instructions described in your Gluceofine® Meter Manual, call your physician.
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Test Principle :
Glucose in the blood sample will react to the electrodes in the glucose test strip, generating an electrical current that
will stimulate a chemical reaction. This reaction is measured by the Gluceofine® meter and displayed as your blood
glucose result.
Reagent Composition :
Each Gluceofine® glucose test strip contains:
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The procedure for Blood Glucose Measurement :
Materials needed: Gluceofine® Test Strips, Gluceofine® meter, operation manual, lancing device, sterile lancet
Obtaining Blood Sample :
The Gluceofine® Glucose Test Strips are designed to be used with fresh capillary whole blood. You may obtain a blood
drop from either a fingertip or an alternative site (see meter manual).
To obtain a drop of blood, follow these steps :
Step 1: Cleanliness
Wash your hands and test site with warm water. Dry it thoroughly. (Dirt, oil, lotion, or
sweat may affect the test result).
Step 2: Lancing
Prepare the lancing device. Insert a lancet into the lancing device. The device holds,
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manual for more information).
Step 3: Insert the Glucose Test Strip
Remove a test strip from the vial. Recap the vial immediately to prevent moisture
from affecting the other strips. Insert the test strip into the port of the meter, with
arrow sign facing up and showing towards the meter. The meter will automatically
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matches the code number printed on the test strip vial. If not matching repeat this
step.
The test strip icon with a drop of blood will be flashing at the top of the meter display.
You are now ready for testing.
Step 4: Obtain and apply the blood sample
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a correct test result, an amount of 0,5µl is necessary. While the symbol for apply is
flashing, place the drop of blood on your finger against the slim end of the test strip
until the window is completely filled. Do not press your finger against the test strip.
Do not try to wipe off the blood with the test strip. A beep sound confirms, when the
window is correctly filled. If you have a poor amount of blood: Run a new test whith a
NEW test strip!
Step 5: Measurement result in 5 seconds
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test strip. The meter will automatically turn off.
Important Information About Using Alternate Site Testing :
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differ significantly from fingertip samples.
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samples.
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level sooner than a test with a alternate sites sample.
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glucose levels may be changing rapidly should be done from the fingertip.
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reaction), as forearm testing may fail to detect hypoglycemia.
Test Results :
The results are displayed on the Gluceofine® meter as either milligrams of glucose per deciliter of blood (mg/dL) or
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When the glucose control solution is applied to the top edge of the glucose test strip, you should get results within
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outside the range, repeat the test with a new strip. Results that fall out-side the range may be caused by:
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IMPORTANT NOTE: If the Gluceofine® Glucose Control Solution test results continuously falls outside the range
printed on the vial, the Gluceofine® Blood Glucose Monitoring system may not be functioning properly. DO NOT
use the Gluceofine® Blood Glucose Monitoring system to test your blood until you get a glucose control solution
test result that falls within the range. If you continue to have problems, contact Metrado GmbH or your local
representative immediately.
Limitations of System :
The Gluceofine® Glucose Test Strips provide accurate results when the following constraints are followed:
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Physicians - Please note the following interferences that may affect test results :
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results may be lower or higher than actual value.
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in normal blood or normal therapeutic concentrations do not significantly affect results. However, abnormally high
concentrations in may cause inaccurately high results.
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Performance Characteristics :
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The performance of the Glucose Test Strips has been evaluated in laboratory.
Measurement Range:
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Accuracy:
The accuracy results obtained with the Gluceofine® Blood Glucose Monitoring system were compared to
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System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)
System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)
Precision:
- Repeatability Precision Test.
- Intermediate Precision Test
IMPORTANT:
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manual.
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use of the glucometer.
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used test strips properly, to avoid any infection.
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063$0..*5.&/550:06
We understand that blood glucose levels provide a way to control your diabetes. As a result, the Gluceofine®
Testing System was developed to help you manage your diabetes by the most comfortable and convenient way
possible. Our goal, at Infopia is to provide you the best quality products and superior customer service. If you have
any questions or comments, please contact Metrado GmbH or your local representative.
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IMPORTANT NOTE: Blood glucose may be altered by your food, physical activity, and/or stress.
Within ± 5mg/dL
(within ± 0.28 mmol/L)
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(within ± 0.56 mmol/L)
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Mean (mg/dL)
228.2
362.0
SD
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2.8
2.2
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Mean (mg/dL)
SD
$7
3.0
2.5
Correct
Completely Filled
Incorrect
Poorly filled
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automatically start.
NOTE : Please refer to the table below to identify symbol
Range of Expected Values :
Self testing of blood glucose levels provides a way to control your diabetes. Consult with your physician to determine
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IMPORTANT:
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ately. If your blood glucose result is unusually low or high, repeat the test again with a new glucose test strip. If the
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Quality Control (System Maintenance) :
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together to provide you with the most accurate reading.
Note:
The Gluceofine® Glucose Control Solutions is sold separately. The normal, and high level glucose control solutions
can be obtained through your pharmacy, Metrado GmbH or your local representative.
Gluceofine® Glucose Control Solution test can only be used with the Gluceofine® meter and should be used
during the following:
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Consult Instructions for use
This product fulfills the requirements of Directive
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Attention, see instructions for use
Catalogue Number
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Batch code
Temperature limitation
Date of Manufacture
Do not re-use
For Self-testing
Manufacturer
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METRADO GmbH
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GERMANY
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www.metrado.de
Discard 3 months after opening
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Lagerung und Handhabung:
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Benutzen Sie den Teststreifen sofort nach der Entnahme.
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Gluceofine®-Teststreifen sind nur zum einmaligen Gebrauch bestimmt.
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Wichtige Hinweise:
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Messprinzip:
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Zusammensetzung der Reagenzien (Jeder Gluceofine®-Teststreifen enthält):
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Gewinnung der Blutprobe:
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Um einen Tropfen Blut zu erhalten, beachten Sie folgende Schritte:
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Schritt 1: Sauberkeit
8BTDIFO4JF*ISF)ÊOEFHSàOEMJDINJUXBSNFN8BTTFSVOE
USPDLOFO4JFTJFHVUBC7PSEFS1SPCFOHFXJOOVOHNVTTEJF'JOHFSCFFSFBCTPMVU
USPDLFOVOETBVCFSTFJO "VDI4DINVU[PEFS4DIXFJCFFJOøVTTFOEBT.FTTFSHFC-
nis.)
Schritt 2: Vorbereiten der Stechhilfe
Bereiten Sie die Stechhilfe und Lanzette vor.
Führen Sie eine unbenutzte Lanzette in die Stechhilfe ein. Die Stechhilfe ist eine
TUJGUBSUJHF7PSSJDIUVOH[VS"VGOBINFEFS-BO[FUUF4JFCFJOIBMUFUVOEQPTJUJPOJFSU
CFJN4UFDIFOEJF-BO[FUUF%JF5JFGFEFT&JOTUJDITLBOOBOEFS4UFDIIJMGFFJOHFTUFMMU
XFSEFO /ÊIFSF *OGPSNBUJPOFO öOEFO 4JF JO EFS #FEJFOVOHTBOMFJUVOH EFT
(MVDFPöOF¥#MVU[VDLFS.FTTHFSÊUFT
Schritt 3: Einführen des Teststreifens
&OUOFINFO4JFFJOFO5FTUTUSFJGFOBVTEFN3ÚISDIFO7FSTDIMJFFO4JFEBT3ÚISDIFO
VNHFIFOEXJFEFSVNEBT&JOESJOHFOWPO'FVDIUJHLFJU[VWFSNFJEFO'àISFO4JF
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4FJUFOBDIPCFOVOE[VN(FSÊUIJO[FJHU%BT(FSÊUTDIBMUFUTJDIFJOVOEFSLFOOU
automatisch die Teststreifen-Codierung. Überprüfen Sie, ob die angezeigte
$PEJFSVOHNJUEFSEFT5FTUSÚISDIFOTàCFSFJOTUJNNU*TUEJFTOJDIUEFS'BMMXJFEFSIP-
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VOEEBT(FSÊUJTUNFTTCFSFJU
Schritt 4: Gewinnen und Auftragen der Blutprobe
Stechen Sie mit der Stechhilfe in die vorgesehene Stelle z.B. in die Fingerbeere. Für ein
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Schritt 5: Messergebnis in 5 Sekunden
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das Ergebnis angezeigt und automatisch gespeichert. (Zur Mitspeicherung von
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den Teststreifenauswurf, um den Teststreifen zu entfernen. Nach Beendigung der
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.FTTFSHFCOJT[VFSIBMUFOQVOLUJFSUF4UFMMFOJDIUOBDIRVFUTDIFOTPOEFSOWPSEFN4UFDIFONBTTJFSFO
Wichtige Information zu an anderen Körperstellen gewonnenen Blutproben:
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.FTTFSHFCOJTTFBVT#MVUQSPCFOFJOFT'JOHFSTVOEBVTBOBOEFSFO,ÚSQFSTUFMMFOHFXPOOFOFO#MVUQSPCFOLÚOOFO
TUBSLWPOFJOBOEFSBCXFJDIFO
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.FTTVOHBOBOEFSFO,ÚSQFSTUFMMFOV6FJOF)ZQPHMZLÊNJFOJDIUFOUEFDLUXFSEFO
Messergebnisse
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Bandbreite von Messwerten:
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/àDIUFSOWPSEFN&TTFONHE- NNPM-4UVOEFOOBDIEFN&TTFONHE- NNPM-
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Wichtig:
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GàISFO4JFCJUUFFJOFFSOFVUF.FTTVOHEVSDI*TUEBT&SHFCOJTXFJUFSIJOOJDIU[VGSJFEFOTUFMMFOELPOUBLUJFSFO4JF
CJUUF*ISFO"S[UCFWPS4JFTFMCTU*ISFO.FEJLBUJPOTPEFS5FTUQMBOÊOEFSO
'VOLUJPOTLPOUSPMMFEFT4ZTUFNT
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und Ihnen genaue Messergebnisse liefern.
Hinweis:
%JF(MVDFPöOF¥,POUSPMM-ÚTVOHJTUTFQBSBUFSIÊMUMJDI,POUSPMM-ÚTVOHFOJNOPSNBMFOVOEIPIFO#FSFJDIFSIBMUFO
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%JF,POUSPMM-ÚTVOHEBSGOVSNJU(MVDFPöOF¥.FTTHFSÊUFOWFSXFOEFUXFSEFO&JOF"OXFOEVOHJTUTJOOWPMM
XFOO4JFFJOFOFVF1BDLVOH5FTUTUSFJGFOWFSXFOEFO
XFOO4JFWFSNVUFOEBTT(FSÊUPEFS5FTUTUSFJGFOOJDIUFJOXBOEGSFJGVOLUJPOJFSFO
XFOO*ISF.FTTFSHFCOJTTFTJDIOJDIUNJU*ISFO4ZNQUPNFOEFDLFOPEFS4JFGBMTDIF.FTTFSHFCOJTTFWFSNVUFO
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8FOO4JFEJF,POUSPMM-ÚTVOH BOBMPHFJOFT#MVUTUSPQGFOTBN&OEFEFT5FTUTUSFJGFOTBVGUSBHFOTPMMUFOEJF&SHFCOJT-
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Bereiches, wiederholen Sie bitte die Messung mit einem neuen Teststreifen.
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Fehler in der Durchführung der Messung.
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Temperaturbereich (20-25 °C).
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Grenzen des Systems:
Mit den Gluceofine®-Teststreifen erhalten Sie genaue Messergebnisse, wenn Sie die nachfolgenden Dinge beachten:
7FSXFOEFO4JFLFJOF#MVUQSPCFOWPO/FVHFCPSFOFO
7FSXFOEFO4JF[VS.FTTVOHOVSGSJTDIFTLBQJMMBSFT7PMMCMVU#FOVU[FO4JFLFJO1MBTNBPEFS4FSVN
%FIZESBUJPO 'MàTTJHLFJUTNBOHFMLBOOEBT.FTTFSHFCOJTCFFJOøVTTFO4PMMUFO4JFTFISEFIZESJFSUTFJOLPOUBLUJF-
ren Sie bitte umgehend Ihren Arzt.
%JF5FTUTUSFJGFOTJOEBVTTDIMJFMJDI[VNFJONBMJHFO(FCSBVDIHFFJHOFU7FSXFOEFO4JFTJFOJDIUNFISNBMT
6OHFOBVF.FTTFSHFCOJTTFLÚOOFOVOUFS4DIPDLCFJ#MVUIPDIESVDLQBUJFOUFOJOIZQFSHMZLÊNJTDIFNPEFS
hyperosmolarem Zustand mit oder ohne Ausscheidung von Ketonen auftreten.
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Ärzte und medizinisches Fachpersonal beachten bitte die nachfolgend aufgeführten Wechselwirkungen, die
das Messergebnis beeinflussen können:
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*OTFISIPIFO,PO[FOUSBUJPOFOLÚOOFOTJFKFEPDIVOHFOBVFIÚIFSF.FTTFSHFCOJTTF[VS'PMHFIBCFO
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besonderer Beachtung ausgewertet werden.
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Leistungscharakteristika:
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Messbereich:
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Evaluierung der Systemleistung:
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FJOFN-BCPSJOTUSVNFOUàCFSQSàGU%JF.FTTXFSUFXVSEFOBVTGSJTDIFO,BQJMMBSCMVUQSPCFOFSNJUUFMU
Richtigkeit für Glukose-Konzentrationen <75 mg/dL (4,2 mmol/L)
Richtigkeit für Glukose-Konzentrationen >75 mg/dL (4,2 mmol/L)
Präzision:
t&SHFCOJTTF8JFEFSIPMQSÊ[JTJPO
t&SHFCOJTTF7FSHMFJDITQSÊ[JTPO
WICHTIG:
#JUUFMFTFO4JFGàSTJDIFSFTVOEHFOBVFT.FTTFOWPSEFN(FCSBVDIEFT(MVDFPöOF¥#MVU[VDLFS.FTTHFSÊUFTVOE
EFS5FTUTUSFJGFOVOCFEJOHUBVDITPSHGÊMUJHEBT#FOVU[FSIBOECVDI[VN.FTTHFSÊU
,POTVMUJFSFO4JFJN3BINFOEFS"OXFOEVOHEFT(MVDFPöOF¥(FSÊUFTVOE*ISFNUÊHMJDIFO%JBCFUFT.BOBHFNFOU
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Unser Engagement für Sie:
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Innerhalb ± 5mg/dL
(innerhalb ± 0.28 mmol/L)
*OOFSIBMCNHE-
(innerhalb ± 0.56 mmol/L)
*OOFSIBMCNHE-
(innerhalb ± 0.83 mmol/L)
25/26 )
26/26 )
26/26 )
)
)
)
Innerhalb ±20
Innerhalb
Innerhalb
Innerhalb ±5
)
Mittelwert (mg/dL)
2
6
2
228.2
362.0
SD
2.
2.
6.
6
$7 )
0
2.8
2.2
2.8
2.
Mittelwert (mg/dL)
30
SD
8
3.
6
$7 )
0
3.0
2.5
-FHFOEF6NEJFWFSXFOEFUFO4ZNCPMF[VJEFOUJö[JFSFOWFSXFOEFO4JFCJUUFOBDIGPMHFOEF"VGTUFMMVOH
Zu verbrauchen bis
Bitte beachten Sie die Gebrauchsanweisung!
%JFTFT1SPEVLUFSGàMMUEJF"OGPSEFSVOHFOEFS3JDIUMJOJF
&(àCFSMOWJUSP%JBHOPTUJLB
Achtung - Hinweise beachten!
"SUJLFMOVNNFS
*O7JUSP%JBHOPTUJLVN
Chargennummer
Lagerung bei (Temperaturbereich)
Herstellungsdatum
Zum Einmalgebrauch bestimmt
3 Monate nach dem Öffnen entsorgen
Hersteller
Zur Selbstanwendung geeignet
('4..533FW
METRADO GmbH
"VG1GVIMTU%.FSDIXFJMFS
GERMANY
5FM
'BY
www.metrado.de
Richtig
Blut auftragen
Falsch
Richtig
Falsch
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Zu geringe Blutmenge
5SBHFO4JFEBT#MVUBVGEFO#MVU[VDLFS5FTUTUSFJGFOBVGVOEIBMUFO4JF*ISFO'JOHFSTPMBOHFBOEFO5FTUTUSFJGFOCJT
FJO4JHOBMUPOFSUÚOU%JF.FTTVOHTUBSUFUBVUPNBUJTDI
3 M
0483
1;/
