GlucAZone – Blood Glucose Monitoring System

Cutting-edge technologies

HCT Correction

The system detects the hematocrit signal of blood sample then reduces the interference within ±10%

Temperature Compensation

The system detects the temperature signal then compensates the effect within ±5%

Unique Formulation

We use unique formulation in the test strip which is very stable in extreme environments

Unique Algorithm

After detecting signals of various common sources of interferences, the meter runs unique algorithm and gives highly accurate result

Auto-Coding

The system detects the coding info of each test strip automatically

Accurate Results

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Advanced features

8 electrodes

No coding

Can test neonates, pregnant women, anemia people etc.

Wide operating temperature

0.5 pL blood sample

5s testing time

Insufficient sample detection

Strip ejector

900-test memory

Meal markers

Hypo warning

5 test alarms

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Specification

FeatureSpecification

Measurement range10 to 600 mg/dL (0.6-33.3 mmol/L)

Result calibrationPlasma-equivalent

SampleFresh capillary whole blood

Sample volumeAbout 0.5 pL

Test timeAbout 5 seconds

Power sourceOne (1) CR 2032 3.0V coin cell battery

Battery life 12 months or approximately 1,000 tests

Memory900 records with date and time 2 minutes

Automatic shutoff2 minutes after last action

WeightApproximately 44.2g (with battery)

Operating temperature5-45°C

Operating relative humidity 10-90% (non-condensing)

Hematocrit range20-70%

Data portMicro USB

Advanced 8 electrodes

The 8 electrodes on the GLUCAZONE test strips work with the GLUCAZONE meter to deliver highly accurate results. Detailed functions of those electrodes are:

Code calibration (auto-coding)
Eliminating hematocrit interference
Eliminating temperature interference
Checking humidity exposure
Checking if the sample is sufficient
Checking if the sample is blood or control solution
Checking for possible damage of the test strip

A recent independent clinical study conducted by IDK Germany* shows that 98.8% of all results from GLUCAZONE blood glucose monitoring system are within ±15% or 15 mg/dL (0.83 mmol/L) of the YSI plasma results, which is fully complying with the new EN ISo15197:2015 standard.

Proven accuracy

Risk level (CEG zone)	Risk to diabetic patient
A	No effect on clinic action
B	Altered clinical action-little or no effect on clinical outcome
C	Altered clinical action-likely to effect clinical outcome
D	Altered clinical actlon-could have significant medical risk
E	Altered clinical action-could have dangerous consequences

System accuracy results for glucose concerntration
<5.55 mmol/L (100 mg/dL)

Within ± 0.28 mmol/L (5 mg/dL) 78/186 (41.9%)

Within ± 0.56 mmol/L (10 mg/dL) 148/186 (79.6%)

Within ± 0.83 mmol/L (15 mg/dL) 185/186 (99.5%)

System accuracy results for glucose concerntration
* 5.55 mmol/L (100 mg/dL)

Within ± 5% 233/414 (56.3%)

Within ± 10% 360/414 (87.0%)

Within ± 15% 408/414 (98.6%)

System accuracy results for glucose concerntration
between 2.28 mmol/L (40.9 mg/dL)
and 29.4 mmol/L (528.3 mg/dL)

Hematocrit effect study

Over and under estimation of glucose due to the hematocrit effect is a common source of error. Anemia falsely elevates while polycythemia and dehydration falsely depresses blood glucose values. The magnitude of this effect may vary by 4-30% for every 10% change in hematocrit, depending on the systems¹.’^2,3 According to the WHO, anemia affects about 24.8% of the population in the world, about 47.4% of pre-school children and 41.8% of pregnant women worldwide.

With the advanced Hematocrit Correction technology, the GLUCAZONE blood glucose monitoring system could be used for testing patients with hematocrit level within 20-70%, including neonates with very high hematocrit level, as well as anemia people and pregnant women with very low hematocrit level.