GlucoZen.auto AGM-4000 User manual

AGM-4000
BLOOD
GLUCOSE
MONITORING
SYSTEM
User Manual
Blood Glucose Monitoring System
GlucoZen_AMG-4000 Test Meter Manual (A812DE601).indd 1 2016-10-12 오전 9:20:49

This User Manual will tell you all you need to know
about the system and how it works.
Please read this carefully before using the meter.
QUICK START GUIDE
Apply the blood drop
to the side edge of
the yellow window of
the test strip.
Wait for the blood
drop to completely ll
the yellow window of
the test strip, then the
meter will begin the
countdown.
5
The blood glucose
result will be
displayed on the
meter in just
5 seconds.
Insert a test strip.
The meter will
automatically turn on.
Check the code number.
The code number
displayed on the meter
must match the one on
the test strip vial.
This summary is intended only as a quick reference and is not a substitute
for GlucoZen.auto Blood Glucose Monitoring System User Manual.
Please read the entire User Manual before you begin testing.
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This User Manual will tell you all you need to know
about the system and how it works.
Please read this carefully before using the meter.
GlucoZen_AMG-4000 Test Meter Manual (A812DE601).indd 3 2016-10-12 오전 9:20:50

Test Principle
The blood sample is drawn into the test strip's reaction chamber through capillary action. Glucose in the
sample reacts with glucose dehydrogenase and mediator in the test strip. This reaction creates electrical
currents. The electrical currents produced are proportional to the glucose concentration in the blood
and converted to the equivalent glucose concentration values calculated based on the algorithm
programmed in GlucoZen.auto Meter.
- The GlucoZen.auto Meter is designed for use with GlucoZen.auto Test Strips
(manufactured by All Medicus Co., Ltd.) only.
- The GlucoZen.auto Blood Glucose Monitoring System is calibrated to produce values equivalent to results
on plasma specimens obtained from a laboratory analyzer (YSI 2300 STAT Plus).
- The GlucoZen.auto Blood Glucose Monitoring System should not be used for the diagnosis of diabetes.
Precautions for Use
For Self-testing: GlucoZen.auto Blood Glucose Monitoring System is for quantitative blood glucose testing
in fresh capillary whole blood drawn from the ngertips. The GlucoZen.auto Blood Glucose Monitoring
System is for testing outside the body (in vitro diagnostic use). The GlucoZen.auto Blood Glucose
Monitoring System is
intended for use by diabetic lay users for self testing to improve management of their
blood glucose level. The GlucoZen.auto Blood Glucose Monitoring System should not be used for the
diagnosis of or screening of diabetes mellitus, or for neonatal use.
For professional use: GlucoZen.auto Blood Glucose Monitoring System is for quantitative blood glucose
testing in venous whole blood and fresh capillary whole blood drawn from the ngertips.
The GlucoZen.auto Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use).
The GlucoZen.auto Blood Glucose Monitoring System is intended for use by healthcare professionals to
improve management of patient’s blood glucose level. The GlucoZen.auto Blood Glucose Monitoring
System should not be used for the diagnosis of or screening of diabetes mellitus, or for neonatal use.
Intended Use
*
PRECAUTIONS
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Precautions for Test Strip
- Store test strip vials in dry place with temperature ranging between 1~32ഒ (34~90ഘ).
- Avoid direct sunlight, heat and excessive humidity.
-
Always close the vial cap immediately after removing a test strip from the vial. If the test strip vial is left
open for a long time, the test strips will become unusable.
- Use the test strip immediately after removing it from the vial.
- Use all the test strips within 4 months after the rst opening.
- Store your test strips only in their original vial and do not transfer them to a new bottle or any other
container.
- Do not handle the test strip with wet hands.
- Do not use the test strip after the expiration date printed on the vial.
- Do not bend, cut, or alter the test strips.
- Do not insert the same test strip into the test port multiple times. It can lead to an improper operation.
Safekeeping
- Store the GlucoZen.auto Meter at a temperature between 0~40ഒ (32~104ഘ).
- Store the GlucoZen.auto Meter at a place where relative humidity is less than 85%.
- Keep the GlucoZen.auto Meter in sanitary environment.
- Keep the meter away from direct sunlight.
- Keep the test port away from dirt, blood or water.
- Do not store your meter and test strips in the car, the bathroom, or the refrigerator.
(sensitive to temperature and humidity)
- Keep the meter, test strip vials and lancing materials away from children.
- Clean the outside of the meter using a moist (not wet) cloth or tissue with isopropyl alcohol or mild
detergent with water. Do not immerse the meter in water or other liquid.
-
Rapid change in temperature may cause inaccurate test results in reading. When taking the meter from
cold to warm area or from warm to cold area, let the meter sit for about 30 minutes to adjust to the
room temperature.
- Do not drop the meter.
-
Do not disassemble, repair or remodel without consultation. The sensitive parts could be damaged and
the warranty will then become invalid.
- A hematocrit that is either very high (above 60%) or very low (below 20%) can cause false test results.
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