2002938-002E Cardiolab® II Plus Amplifier Manual CE-1
CE Marking Information
Compliance
The CardioLab II Plus Amplifier bears CE mark CE-0459 indicating its
conformity with the provisions of the Council Directive 93/42/EEC
concerning medical devices and fulfills the essential requirements of
Annex I of this directive.
For devices manufactured in the United States, the CE mark is applied
under the authority of Notified Body GMED (0459).
The country of manufacture and appropriate Notified Body can be found
on the equipment labeling.
The safety and effectiveness of this device has been verified against
previously distributed devices. Although all standards applicable to
presently marketed devices may not be appropriate for prior devices (i.e.
electromagnetic compatibility standards), this device will not impair the
safe and effective use of those previously distributed devices.
The CardioLab II meets the requirements of EN60601-1-2 (1993-04)
Medical Electrical Equipment, Part 1: General Requirements for Safety,
2. Collateral Standard: Electromagnetic compatibility - Requirements
and tests.
Exception
ECG Parameter
IEC601-1-2 clause 36.202.1 - Immunity: Radiated Immunity –
The level of compliance is less than 1V/m
If operating under the conditions defined in EMC Standard EN60601-1-2
(Radiated Immunity 3V/m), field strengths less than 1V/m may cause
waveform distortions and erroneous numeric data at various
electromagnetic interference (EMI) frequencies.
Recommendations: –
Review the AAMI EMC Committee technical information report (TIR-18)
titled Guidance on electromagnetic compatibility of medical devices for
clinical / biomedical engineers - Part 1: Radiated radio-frequency
To Next Page
Loading...
