CE
CE- i
0086
Compliance
A GE brand Corometrics 250 Series Monitor bears CE mark CE-0086
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 India; the CE mark is applied under the
authority of Notified Body BSI (0086).
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 equipment
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
• 250 Series Maternal/Fetal Monitor
• Model 146 Fetal Acoustic Stimulator
• Intrauterine Pressure Transducer
• FECG Cable/Legplate
• Ultrasound Transducers (x2)
• Blood Pressure Hose and Cuff
•MSpO
2
Interconnect Cable and Sensor
•MECG Cable
• FECG/MECG Adapter Cable
• Remote Event Marker
• RS-232C Interconnect Cables (x3)
• Central Nurses Station Interconnect Cable
• Model 2116B Keyboard and Interconnect Cable
• Model 1563AAO Telemetry Cable
Exceptions
None
Monitor System EMC:
Immunity
Performance
Be aware that adding accessories or components, or modifying the
medical device or system may degrade the EMI performance. Consult with
qualified personnel regarding changes to the system configuration.
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