BETACHEK® C50
Technical info.
 
 

Meter name

Betachek® C50

Intended use

For self testing of blood glucose.
Not suitable for multi patient testing.

Integrated lancing device

Single patient use only
10 penetration depths
Lancet: Betachek® lancets or Softclix® lancets

Test time

Approx. 5 seconds

Measuring method

Reflex photometry

Assay method

FAD GDH

Blood sample

Fresh capillary blood

Sample size

Minimum: 0.3μl / Maximum: 5μl

Haematocrit range

25% – 55%

Units of measure

Factory set to: mmol/L or mg/dL

Memory

500 results with time and date
Averages for 7, 14, 30 and 90 days

Measurement range

20 – 600 mg/dL (1.1 – 33.3 mmol/L)

Power supply

1 battery (type CR2032)

Battery life

Approx. 1000 tests or 1 year

Auto power off

After 60 or 120 seconds depending on operating status

Temperature

During testing:
+10°C to +40°C (+50°F to +104°F)
During storage without battery and test cassette:
-25°C to +70°C (-13°F to +158°F)
During storage with battery, without test cassette:
-20°C to +50°C (-4°F to +122°F)
During storage with battery and test cassette:
+2°C to +30°C (+35.6°F to +86°F)

Atmospheric humidity

During testing:
15% to 85% relative humidity
During storage:
15% to 93% relative humidity

Altitude

Sea level to 4000m

Meter dimensions

105mm x 58mm x 19.5mm

Cassette dimensions

22.2mm x 13mm x 48.2mm

Meter interface

Bluetooth for connection to smart phone
RFID for connection between meter and test cassette

Cassette interface

RFID to connect to meter

Weight

Meter only: 60g
Meter with battery and cassette: 70g

Model/Serial Number

Located on meter label

Safety class

III

LED

Class 1

Electromagnetic compatibility

This blood glucose meter meets the electromagnetic immunity requirements as per EN 61326-2-6 and EN ISO 15197 Annex A. The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000-4-2. Its electromagnetic emission is thus low. Interference on other electrically-driven equipment is not anticipated.

Performance analysis

Performance data for the Betachek C50 system was obtained using capillary blood from diabetic patients (method comparison, accuracy), oxygenated venous blood (repeatability) and control solution (reproducibility).

Calibration and traceability

The system is calibrated with freshly obtained capillary blood, containing various glucose concentrations. The glucose values used as reference values are obtained using the YSI method. The YSI method is traceable to a primary NIST standard.
Betachek C50 blood glucose monitoring system meets the requirements of EN ISO 15197 (2013).
Freshly obtained capillary blood is the only allowable sample. Results displayed are the plasma equivalent. See the instructions for use supplied with the test cassette for further information.

 

Softclix® is a registered trademark of Roche Diagnostics which is in no way affiliated with Betachek Europe or National Diagnostic Products Pty Limited