8. Reference To Standards
Device standard: Device corresponds to the requirements
of the standard for non-invasive blood
pressure monitors:
AAMI/ANSI SP10
IEC 60601-1
IEC 60601-1-2
Electromagnetic compatibility: Device fulfills the stipulations of the
International standard IEC 60601-1-2
Readings taken by the blood pressure monitor are equivalent to those obtained by a
trained observer using the cuff and stethoscope auscultation method. Clinical performance
were successfully done against ANSI/AAMI SP10 and international protocol, and the
B.H.S has rated this product “recommended for clinical and home use”,this is the highest
grading available for blood pressure monitors. please refer to BHS website http://www.
bhsoc.org/bp_monitors/automatic_wrist.stm.
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