Compliance; Components Of The Certified Systems; Component Description; Exceptions - GE Corometrics 250cx Series Service Manual

Compliance

A GE brand Corometrics
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 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
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

• 250cx Series Maternal/Fetal Monitor
• Model 146 Fetal Acoustic Stimulator
• Intrauterine Pressure Transducer
• FECG Cable/Legplate
• Ultrasound Transducers (x2)
• Blood Pressure Hose and Cuff
• MSpO Interconnect Cable and Sensor
2
• 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
®
• Exergen TAT-5000
• External 15" display

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.
xviii
™ 250cx Series Monitor bears CE mark CE-0459 indicating its conformity with the
™
2036947-001
© 2013 by General Electric Company. All rights reserved.