15
If fluctuations in readings are larger than 15 mmHg, and/or you hear irregular
pulse tones, 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 accordence 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
DIN 58130, NIBP – clinical investigation
ANSI / AAMI SP10, NIBP – requirements
Electromagnetic compatibility:
Device fulfills the stipulations of the
European standard EN 60601-1-2
Clinical testing:
Clinical performance tests were carried out
in the U.S. and Germany according to the
DIN 58130/1997 procedure N6
(sequential) and AAMI standard (US).
The stipulations of the EU-Guidelines 93/42/EWG for Medical Products Class IIa have
been fulfilled.
