Blood glucose monitoring system

Basic Information

Measurement method

Electrochemical Biosensor Technology

Enzyme type

GDH-FAD

Intended Use

Home testing or professional use to monitor the blood glucose (β-D-glucose) levels in fresh capillary whole blood from fingertip and venous whole blood. Venous blood tests can only be measured by professionals.

Measuring Principle

Using the latest biosensor technology. It measures the glucose levels of the blood specimen by using a disposable dry reagent strip which can produce an electrical current. And the current will transfer to the meter for measurement. The amount of the current is proportional to the amount of glucose present in the blood sample. Test results are “plasma equivalent”.

Display mode

Reflective TN LCD

Key quantities & functions

3 keys (Mode, forward, backward)

Battery

2*CR2032

Operating environment

Temperature: 10℃～40℃ (50℉~104℉); Control solution: 20℃～30℃

Humidity: 80% R.H.

Storage/ Transport environment

Meter: Temperature: -40℃～55℃ / Humidity: 90% R.H.

Strip: Temperature: 4℃～30℃ / Humidity: 90% R.H.

Control: Temperature: 2℃～30℃ / Humidity: 90% R.H.

Product Life

Meter: 5 years

Strip: Shelf life: 24 months; Shelf life after opening: 180 days (Below 30℃)

Control: Shelf life: 24 months; Shelf life after opening: 90 days (Below 30℃)

Measurement range of glucose

10～600 mg/dl ( 0.5～33.3 mmol/l)

Control solution concentration range

Medium level: 120~164 mg/dl (6.6~9.2 mmol/l)

High level: 362~492 mg/dl (20.1~27.4 mmol/l)

Accuracy range of measurement

If glucose concentration < 100 mg/dl, Bias % (95% CI) ±15 mg/dl

else Bias % (95% CI) ±15% Ref. YSI 2300

System accuracy (ISO 15197)

Criterion A

95% of measured value fall within either ±15 (<100mg/dl) mg/dl or 15% (100 mg/dl) of reference

Criterion B

99% of measured value within CEG zones A and B

Hematocrit Range

0%~70%

Measuring time

5 seconds

Sample volume

1.0 µl

Control solution volume

4 ml

Function

Unit Display

mg/dl and mmol/l

Time display

12h

Memory mode (Sets)

1000

Average display

Last 7 / 14 / 30 / 60 / 90 Days averaging

Talking function

No

Ketone warning / Voice indicator (Beep)

No

Insufficient sample volume detection

Yes

Meal Comment

Yes, Pre/Post Meal Marker

Before / After meals Average of blood glucose

No

Data-Link

AM100 PD-B: Yes (Including sion and mission)

AM100 PD: Yes (Including sion)

Package

Test Strip

vial

25 pcs/vial

50 pcs/vial

box

1 vial/ box, including instruction

2 vials/box, including instruction

Meter

box

Including 1 meter, 1 user’s guide, 1 Logbook, 1 Lancing device, 50 Lancets

Control Solution

Pouch

Including 1 control solution medium level, 1 control solution high level, control solution instruction (Packed in the blood glucose meter pouch)