Table 2.
Colin 8800 validation study sample compared with AAMI requirements
| 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.
a
Required to rate as a ‘pass’ by AAMI standards.
b
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.