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10. Standards
Device standard:
Device corresponds to the requirements of the
standard for non-invasive blood pressure monitors:
AAMI/ANSI/IEC 80601-2-30
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11
Bluetooth sy stem to V4.0
FCC Part 15C
Electromagnetic compatibility:
Device fulfills the stipulations of the International
standard IEC 60601-1-2
Clinical testing:
Clinical performance tests were carried out in
the US according to
ANSI/AAMI/ISO 81060-2
standard.
IP20 Classification:
Protected against solid foreign particles with a
diameter of more than 12.5 mm, no protection
against water. Keep Dry.
The B.H.S. (British Hypertension Society) clinical protocol was used to measure the
accuracy 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.
Please note: According to international standards, your monitor should be checked for
accuracy every 2 years.
Expected Service Life
Monitor
5 years
Cuff
2 years
Trademark Usage:
Apple, the Apple logo, iPad, and iPhone are trademarks of Apple Inc., registered in the
U.S. and other countries. App Store is a service mark of Apple Inc.
Android and Google Play are both trademarks of Google Inc.
The Bluetooth
®
Smart word mark and logos are registered trademarks owned by
Bluetooth SIG, Inc. and any use of such marks in this Blood Pressure Monitor is under
license. Other trademarks and trade names are those of their respective owners.
