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9. Certifications
Device standard: This device is manufactured to meet the
European and United States standards for
non-invasive blood pressure monitors:
EN1060-1 / 1995
EN1060-3 / 1997
EN1060-4 / 2004
AAMI/ANSI SP10
Electromagnetic compatibility: Device fulfills the stipulations of the
International standard IEC60601-1-2
Clinical testing: Clinical performance tests were carried out
in the U.K. “Association Protocol and
British HTP Protocol.”
The B.H.S. (British Hypertension Society) clinical protocol was used to measure the accu-
racy of this product. Blood pressure units using the same measurement technology are
graded “AA” for systolic/diastolic accuracy by independent investigators using the BHS
protocol. This is the highest grading available for blood pressure monitors. Please see
bhsoc.org for more information. (Uses the same algorithm as B.H.S. graded “AA” model
number 3BT0-A)
US patents:
6,485,429 (Irregular Heartbeat Feature)
6,447,457 (Averaging Mode)