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Declaration of Conformity
Chapter 11 - Accessories and Technical Specifications
These medical devices comply with the requirements of the Medical
Devices Directive (93/42/EEC) concerning medical devices.
This symbol defines Class 2 radio equipment per 1995/5/EC for which
Member States may apply restrictions on putting the device into service
or placing it on the market. This device is intended to be connected to
the publicly available interfaces (PAI) for use throughout the EEA.
These medical devices comply with the Radio and Telecommunications
Terminal Directive (1999/5/EC).
This product is classified as Class IIb in accordance with Annex IX of the
Medical Devices Directive (93/42/EEC).
Manufactured by:
Product Name and
Model Number:
Standards complied with:
Safety, Performance
Systems
Radio
EMC
Philips Medizinsysteme Boeblingen GmbH
Hewlett-Packard Str. 2, Boeblingen,
Germany
Series 50 T (M1310A) Fetal Telemetry
System (all options)
EN 60601-1:1990
EN 60601-1-1:1993
EN 300 220-3:2000
EN 60601-1-2:1997
Declaration of Conformity
67
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