CGH11 Digital Glucometer for Blood Glucose Measurement

The CGH11 Digital Glucometer is an in vitro diagnostic device designed to perform quantitative measurement of glucose in fresh capillary whole blood quickly and easily.
It incorporates advanced electrochemical biosensor technology, providing results in approximately 5 seconds. Its compact, lightweight, and ergonomic design facilitates both home self-monitoring and use by healthcare professionals in clinical settings.

In addition, it features an LCD screen, memory for up to 600 records, automatic shut-off, and a test strip ejection system, offering convenient and practical use.

Strengths

- Glucose measurement in approximately 5 seconds.

- Electrochemical biosensor technology.

- Memory for up to 600 records.

- Wide measurement range from 20 to 600 mg/dL.

- Easy-to-read LCD screen.

- Test strip ejection system.

- Automatic shutdown.

- Compact, lightweight and ergonomic design.

- Compatible with CGH100 test strips.

Perfect for

- Home self-monitoring of glucose levels.

- Use by healthcare professionals.

- Measurement of glucose in fresh capillary blood.

- Users looking for a compact, fast and easy-to-carry glucometer.

Instructions:

Technical specifications

- Classification : In vitro diagnostic (IVD) medical device, Class C.

- Sample type: Fresh capillary whole blood.

- Technology : Electrochemical biosensors.

- Compatibility : Exclusively with CGH100 glucose test strips.

- Screen : LCD.

- Memory : Up to 600 records.

- Measurement range: 1.1-33.3 mmol/L (20-600 mg/dL).

- Measurement time: Approximately 5 seconds.

- Automatic shutdown: Yes.

- Test strip ejection: Yes.

- Power supply : 2 AAA batteries.

- Dimensions : 95.5 × 60.5 × 23 mm.

- Use temperature: 5-40 °C.

- Relative humidity of use: 10-80% RH.

- Storage temperature: -20 to +55 °C.

- Relative humidity for storage: 10-90% RH.

- Conditions for use of the test strips: 5-40 °C and 10-90 % RH.

- Accuracy for concentrations <5.55 mmol/L (<100 mg/dL): maximum deviation of ±0.83 mmol/L (±15 mg/dL).

- Accuracy for concentrations ≥5.55 mmol/L (≥100 mg/dL): maximum deviation of ±15%.

- Standard deviation: SD <0.42 mmol/L (7.7 mg/dL) for concentrations <5.55 mmol/L.

- Coefficient of variation: CV <7.5% for concentrations ≥5.55 mmol/L.

- Contents : 1 glucose meter, 1 user manual, 1 carrying bag and 2 AAA 1.5V batteries.

Regulations:

- In accordance with Regulation (EU) 2017/746 (IVDR), Annex IX, Chapter II.

- Regulatory classification: In vitro diagnostic (IVD) medical device, Class C.