15
If fluctuations in readings are larger than 15 mmHg, and/or you hear irregular
pulse tones, and/or the Heartbeat Interval Irregularity Indicator 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 warrantee claims!
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
ANSI / AAMI SP10, NIBP – requirements
Electromagnetic compatibility:
Device fulfills the stipulations of the
International standard IEC60601-1-2
Clinical testing:
Clinical performance tests were
successfully completed against AAMI
SP10-1992 and British Hypertension
Society protocol B.H.S.: 1993.
Studies available on request.
The B.H.S. (British Hypertension Society) has rated this product “Recommended for clinical
and home use.” This is the highest grading available for blood pressure monitors. Please
see the B.H.S. web site. (Uses the same algorithm as B.H.S. graded “AA” model number
3BT0-1)
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