Revision D 170 Series Monitor CE-1
2003023-001
CE Marking Information
0459
CE Marking Information
Compliance
A Corometrics brand 170 Series Monitor 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.
The device is 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 product complies with the requirements of standard EN
60601-1-2 “Electromagnetic Compatibility—Medical Electrical Equipment” and
standard EN 60601-1 “General Requirements for Safety.”
Components of the Certified Systems
The IEC electromagnetic compatibility (EN) standards require individual equipment
(components and accessories) to be configured as a system for evaluation. For
systems that include a number of different equipments that perform a number of
functions, one of each type of equipment shall be included in the evaluation.
The equipment listed below is representative of all possible combinations. For
individual equipment certification, refer to the appropriate declarations of
conformity.
Component Description:
170 Series Fetal Monitor
AC-to-DC Power Supply
Tocotransducer
Ultrasound Transducers (x2)
FECG Cable/Legplate
Model 146 Fetal Acoustic Stimulator
Remote Event Marker
RS-232C Interconnect Cables (x2)
Telemetry Interconnect Cable
Exceptions
The Monitor System EMC: Immunity Performance
None
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