B30 Patient Monitor
1-6
−
The alarm systems of the Monitor conform to IEC 60601-1-8 with the exception of
Sub-clause 6.3.3.1a: An ALARM SYSTEM provided with auditory ALARM SIGNALS shall
have at least one set of ALARM SIGNALS.
−
The characteristics of auditory alarm signals are different from IEC 60601-1-8
requirement. This is only ms quantitative difference that can’t be defected by
human audition, according to the usability study, it has no negative effect in clinical
use.
Comformity according to the Council Directive
93/42/EEC concerning Medical Devices.
0459
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