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Clinical Validation Accuracy
The evaluation of system accuracy revealed that measurements obtained with the monitor fulfill the acceptance criteria as specified by DIN EN ISO 15197:2015.
| Meter Type | HB-201/202 | Storage Environment | -20ºC~55ºC, <90%RH |
| Blood Sample | Capillary and Venous whole blood | Strip Storage | 2ºC ~ 30ºC |
| Blood Volume | 10μL | Dimensions | 126*71*25mm |
| Measuring Range | 4.5-25.6g/dL (45-256g/L) | Response Time | < 10 seconds |
| Power Source | 3*AAA Battery or MiniUSB DC5V | Battery Life | Approx. 2000 tests |
| Memory | 1000 test results | Weight | 113.6g (without battery) |
| Unit of Measure | g/dL, g/L or mmol/L | Service Life | Five years |