viii Rack and Modules Instructions for Use
Regulatory and Safety Specifications
Do not dispose of this product (or any part of it) in industrial or domestic waste. The
system may contain hazardous substances that can cause serious environmental
pollution. The system also contains privacy sensitive information. Philips recommends
that you contact your Philips Service Organization before disposing of this product.
To avoid contaminating or infecting personnel, the environment, or other equipment,
disinfect and decontaminate the monitor before disposing of it in accordance with your
country’s laws. For more information, see the resources listed in the Efficia CM Series
Patient Monitors, Instructions for Use.
Declaration
The Efficia CM10, CM12, CM100, CM120, and CM150 monitors are Class IIb medical
devices and comply with the requirements of the Council Directive 93/42/EEC of 14
June 1993 concerning medical devices and carry CE-marking accordingly.
Note: The CE Mark does not apply to the BIS Module.
Authorized EU Representative
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard Str. 2
71034 Böblingen
Germany
Australian Sponsor
Philips Electronics Australia Ltd.
65 Epping Road, North Ryde, NSW
Australia 2113
Rx Only
Caution United States Federal Law restricts this device to sale by or on the order of a physician.
GMDN code
33586
Global Medical Device Nomenclature NA
Power USB Port mark USB Implementors Forum, Inc.
standard icon.
Symbol Name Standard/Reference
* ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labeling and information to be
supplied - Part 1: General requirements
0123
EC REP
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