If fluctuations in readings are larger than 15 mmHg, and/or you hear irregular
pulse tones, and/or the Irregular Heartbeat Detector icon appears frequently,
consult your doctor.
In order to receive market clearance from governmental bodies, this device was subjected
to strict clinical tests. The computer program used to measure blood pressure values was
tested by experienced cardiac specialists in Germany.
The manufacture of your blood pressure monitor is in accordance with the terms of the
European standard for blood pressure measuring devices (see technical data) under the
supervision of the Technical Monitoring Association Essen (RWTüV-Essen).
Never attempt to repair the instrument yourself!
Any unauthorized opening of the instrument invalidates all warranty claims!
10. 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 requirements
(U.S. Standard)
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) has graded this product “Recommended for clini-
cal and home use.” This is the highest grading available for blood pressure monitors.
Please see the B.H.S. web site at www.bhsoc.org.
*Product using the identical measurement algorithm was tested by unaffiliated researches
using B.H.S. study protocol. Results on file and available by request.
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