BETACHEK^® C50
Technical Data

Intended use

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

Integrated lancing device

10 penetration depths
Lancet: BETACHEK® lancets

Approx. 5 seconds

Blood sample µl

Testing temperature

Memory

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

Measuring method

Reflex photometry

Blood sample

Fresh capillary blood only

Units of measure

Factory set to: mmol/L or mg/dL

Measurement range

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

Meter dimensions

Allowable humidity during testing

15% to 85% relative humidity

Weight

Safety class

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.