Table 2.
AAMI SP10: 2002 standards | Colin 8800C validation study | ||
---|---|---|---|
|
|||
Sample size | n ≥ 85 (255 data points) | n = 96 (288 data points) | |
Blood pressure | |||
< 100 mmHg systolic | At least 10% of sample | 10% | |
> 160 mmHg systolic | At least 10% of sample | 18% | |
< 60 mmHg diastolic | At least 10% of sample | 10% | |
> 100 mmHg diastolic | At least 10% of sample | 10% | |
Mean SBP (SD) | 134 (28) | ||
Mean DBP (SD) | 76 (15) | ||
Range for SBP | 89–222 | ||
Range for DBP | 50–120 | ||
Arm sizes | |||
< 25 cm | At least 10% of sample | 11% | |
> 35 cm | At least 10% of sample | 16% | |
Observer agreement | |||
Within ± 10 mmHg | 100% of sample | 100% | |
Within ± 5 mmHg | At least 90% of sample | 98% | |
Mean (SD) of differences between | 5 mmHg ± 8 mmHga | SBP 3.9 (6.7) | |
Electronic device and average of the observers | DBP – 2.1 (6.1) | ||
Percentage of differencesb | ≤ 5 | ≤ 10 | ≤ 15 |
SBP | 58 | 85 | 95 |
DBP | 71 | 91 | 96 |
AAMI, Association for the Advancement of Medical Instrumentation; BHS, British Hypertension Society; DBP, diastolic blood pressure; SBP, systolic blood pressure.
Required to rate as a ‘pass’ by AAMI standards.
For an ‘A’ rating for the BHS standards, 60% of differences between electronic device and manual must fall within 5 mmHg, 85% within 10 mmHg, and 95% within 15 mmHg; for a ‘B’ rating, 50% of differences between the electronic device and the manual must fall within 5 mmHg, 75% within 10 mmHg, and 90% within 15 mmHg.