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| Verification procedure | Purpose | Repeat criteria |
|---|---|---|
| Zero calibration check | Verifies that BpTRU™ accurately measures zero pressure when no pressure is being applied | If value in PULSE display not equal to 0 or if value in READING display >10. |
| Reference gauge calibration check | Compares accuracy of BpTRU™’s pressure transducer against reference pressure gauge (for example, mercury sphygmomanometer) of known accuracy when pressure applied to device | Repeat based on difference between expected and actual readings at each pressure tested as follows: 275 > ± 5.5 mmHg 200 > ± 4 mmHg 50, 100 and 150 > ± 3 mmHg |
| Over pressure test | Verifies BpTRU™’s safety mechanism that automatically releases air in cuff and displays error code should pressure surpass 330 mmHg | Error code E2 should be displayed in SYSTOLIC display window; if not, repeat test. |
| Over infiation time test | Verifies BpTRU™’s safety mechanism that automatically releases air in cuff if it stays pressurized over 10 mmHg for more than 180 seconds | Error code E11 should be displayed in SYSTOLIC display window; if not, repeat test. |