METRADO Gluceo ne User Manual

Blutzucker-Teststreifen
Verwendungszweck:
Allgemeines:
Lagerung und Handhabung:
Benutzen Sie den Teststreifen sofort nach der Entnahme.
Gluceo ne®-Teststreifen sind nur zum einmaligen Gebrauch bestimmt.
Wichtige Hinweise:
Messprinzip:
Zusammensetzung der Reagenzien (Jeder Gluceo ne®-Teststreifen enthält):
㎍
㎍
㎍
Ablauf der Blutzucker-Messung:
Gewinnung der Blutprobe:
Um einen Tropfen Blut zu erhalten, beachten Sie folgende Schritte:
Schritt 1: Sauberkeit
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
Schritt 3: Einführen des Teststreifens
automatisch die Teststreifen-Codierung. Überprüfen Sie, ob die angezeigte
Schritt 4: Gewinnen und Auftragen der Blutprobe
Stechen Sie mit der Stechhilfe in die vorgesehene Stelle z.B. in die Fingerbeere. Für ein
Schritt 5: Messergebnis in 5 Sekunden
das Ergebnis angezeigt und automatisch gespeichert. (Zur Mitspeicherung von
den Teststreifenauswurf, um den Teststreifen zu entfernen. Nach Beendigung der
Wichtige Information zu an anderen Körperstellen gewonnenen Blutproben:
Messergebnisse
Bandbreite von Messwerten:
Wichtig:
und Ihnen genaue Messergebnisse liefern.
Hinweis:
Bereiches, wiederholen Sie bitte die Messung mit einem neuen Teststreifen.
-
Fehler in der Durchführung der Messung.
-
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Temperaturbereich (20-25 °C).
Grenzen des Systems:
Mit den Gluceo ne®-Teststreifen erhalten Sie genaue Messergebnisse, wenn Sie die nachfolgenden Dinge beachten:
-
ren Sie bitte umgehend Ihren Arzt.
hyperosmolarem Zustand mit oder ohne Ausscheidung von Ketonen auftreten.
Ärzte und medizinisches Fachpersonal beachten bitte die nachfolgend aufgeführten Wechselwirkungen, die
das Messergebnis beein ussen können:
besonderer Beachtung ausgewertet werden.
Leistungscharakteristika:
Messbereich:
Evaluierung der Systemleistung:
Richtigkeit für Glukose-Konzentrationen <75 mg/dL (4,2 mmol/L)
Innerhalb ± 5mg/dL
(innerhalb ± 0.28 mmol/L) (innerhalb ± 0.56 mmol/L) (innerhalb ± 0.83 mmol/L)
25/26 ) 26/26 ) 26/26 )
Richtigkeit für Glukose-Konzentrationen >75 mg/dL (4,2 mmol/L)
Innerhalb ±5 Innerhalb Innerhalb
) ) )
Präzision:
Mittelwert (mg/dL) 6 2 2 228.2 362.0
-
SD 2. 2. 6. 6
2.8 2.2 2.8 2.
) 0
Mittelwert (mg/dL) 30
SD 8 3. 6
) 0 3.0 2.5
WICHTIG:
-
Unser Engagement für Sie:
Blut auftragen
Richtig
Richtig
Ausreichende Blutmenge
Falsch
-
Falsch
Zu geringe Blutmenge
Bitte beachten Sie die Gebrauchsanweisung!
Zu verbrauchen bis
0483
Achtung - Hinweise beachten!
Chargennummer
Lagerung bei (Temperaturbereich)
METRADO GmbH
Zum Einmalgebrauch bestimmt
GERMANY
Herstellungsdatum
www.metrado.de
Hersteller
Zur Selbstanwendung geeignet
3 M
3 Monate nach dem Ö nen entsorgen
IMPORTANT: Please read this information and your Gluceo ne® operation manual before using the Gluceo ne®
glucose test strips.
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Intended Use:
The Gluceo ne® Glucose Test Strips are used with Gluceo ne® Glucose Test Meter for the measurement of glucose in
your blood. The Gluceo ne® Blood Glucose Monitoring System is plasma-calibrated to allow comparison of results
with the laboratory method. The Gluceo ne® Glucose Test Strips are for testing outside the body (in vitro diagnostic
use only). Gluceo ne® Blood Glucose monitoring system is for self-testing.
General :
Gluceo ne® 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. Gluceo ne® 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 :
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® 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.
container.
results.
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Discard remaining Gluceo ne® Glucose Test Strips 3 months after rst opening the vial.
® Glucose Test Strip.
® Glucose Test Strips are for single use only. Do not re-use.
Warning! To avoid false readings, use only a Gluceo ne® Meter to measure glucose with your Gluceo ne®
Glucose Test Strips.
Care Procedures :
the instructions described in your Gluceo ne® Meter Manual, call your physician.
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 Gluceo ne® meter and displayed as your blood
glucose result.
Reagent Composition :
Each Gluceo ne® glucose test strip contains:
The procedure for Blood Glucose Measurement :
Materials needed: Gluceo ne® Test Strips, Gluceo ne® meter, operation manual, lancing device, sterile lancet
Obtaining Blood Sample :
The Gluceo ne® Glucose Test Strips are designed to be used with fresh capillary whole blood. You may obtain a blood
drop from either a ngertip or an alternative site (see meter manual).
Innerhalb ±20
) 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 a ect the test result).
Step 2: Lancing
Prepare the lancing device. Insert a lancet into the lancing device. The device holds,
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 a ecting 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
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 ashing at the top of the meter display.
You are now ready for testing.
Step 4: Obtain and apply the blood sample
a correct test result, an amount of 0,5µl is necessary. While the symbol for apply is
ashing, place the drop of blood on your nger against the slim end of the test strip
until the window is completely lled. Do not press your nger against the test strip.
Do not try to wipe o the blood with the test strip. A beep sound con rms, when the
window is correctly lled. 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 o .
Important Information About Using Alternate Site Testing :
di er signi cantly from ngertip samples.
samples.
level sooner than a test with a alternate sites sample.
glucose levels may be changing rapidly should be done from the ngertip.
reaction), as forearm testing may fail to detect hypoglycemia.
Test Results :
The results are displayed on the Gluceo ne® meter as either milligrams of glucose per deciliter of blood (mg/dL) or
IMPORTANT NOTE: Blood glucose may be altered by your food, physical activity, and/or stress.
Range of Expected Values :
Self testing of blood glucose levels provides a way to control your diabetes. Consult with your physician to determine
IMPORTANT:
ately. If your blood glucose result is unusually low or high, repeat the test again with a new glucose test strip. If the
Quality Control (System Maintenance) :
Gluceo ne®
together to provide you with the most accurate reading.
Note:
The Gluceo ne® 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.
Gluceo ne® Glucose Control Solution test can only be used with the Gluceo ne® meter and should be used
during the following:
Glucose Test Strips
When the glucose control solution is applied to the top edge of the glucose test strip, you should get results within
outside the range, repeat the test with a new strip. Results that fall out-side the range may be caused by:
IMPORTANT NOTE: If the Gluceo ne® Glucose Control Solution test results continuously falls outside the range
printed on the vial, the Gluceo ne® Blood Glucose Monitoring system may not be functioning properly. DO NOT
use the Gluceo ne® 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 Gluceo ne® Glucose Test Strips provide accurate results when the following constraints are followed:
® Glucose Test Strip.
Physicians - Please note the following interferences that may a ect test results :
results may be lower or higher than actual value.
in normal blood or normal therapeutic concentrations do not signi cantly a ect results. However, abnormally high
concentrations in may cause inaccurately high results.
Performance Characteristics :
The performance of the Glucose Test Strips has been evaluated in laboratory.
Measurement Range:
Accuracy: The accuracy results obtained with the Gluceo ne® Blood Glucose Monitoring system were compared to
System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)
Within ± 5mg/dL
(within ± 0.28 mmol/L)
System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)
Precision:
㎍
- Repeatability Precision Test.
㎍
㎍
Mean (mg/dL)
SD
- Intermediate Precision Test
Mean (mg/dL)
SD
IMPORTANT:
manual.
use of the glucometer.
used test strips properly, to avoid any infection.
We understand that blood glucose levels provide a way to control your diabetes. As a result, the Gluceo ne®
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.
Correct
Completely Filled
Incorrect
Poorly lled
automatically start.
NOTE : Please refer to the table below to identify symbol
Consult Instructions for use
This product ful lls the requirements of Directive
0483
Attention, see instructions for use
Batch code
Catalogue Number
® meter display. Consult with your
Temperature limitation
®
Do not re-use
Date of Manufacture
Manufacturer
For Self-testing
3 M
Discard 3 months after opening
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4)
1), 2), 3)
(within ± 0.56 mmol/L) (within ± 0.83 mmol/L)
228.2 362.0
2.8 2.2 2.8
3.0 2.5
Applying Blood
Correct
Incorrect
METRADO GmbH
GERMANY
www.metrado.de