Safety And Regulatory Compliance; Compliance - Philips Lifeline Instructions For Use Manual

Safety and Regulatory

Compliance

IEC regulations
The HomeSafe/GoSafe Help Buttons and Home Communicator comply with the relevant National
and International standards listed in the Technical Section. They are classified as medical electrical
(ME) equipment in the US according to the FDA product classification. According to Health
Canada they are not classified as medical devices. They fall under the Canada Consumer Product
Safety Act.
Medical electrical equipment can either generate or receive electromagnetic interference. This
product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories
according to IEC 60601-1-2:2007, the international standard for EMC for medical electrical equipment.
The HomeSafe/GoSafe Help Buttons and Home Communicator must emit electromagnetic energy in
order to perform its intended function. Nearby electronic equipment may be affected. Medical Electrical
Equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in the accompanying documents.
The use of accessories, transducers and/or cables other than those specified, with the exception of
those sold by the manufacturer as replacement parts for internal components, may result in increased
emissions or decreased immunity of the equipment or system.
The equipment or system should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the equipment or system should be observed to verify normal
operation in the configuration in which it will be used.
System classification
The HomeSafe/GoSafe Help Buttons and Home Communicator are FDA Class II devices. They are
internally powered devices for continuous operation.
Radio specifications
The HomeSafe/GoSafe Help Buttons and Home Communicator have radios with the following
characteristics: 3 channel frequency agility (917 MHz, 919 MHz, 921 MHz); maximum EIRP -1.23 dBm;
FSK digital modulation. It fully complies with FCC Part 15, Section 15.249.
Additionally, the 7100MHB complies with the FCC Part 15, 22 and 24 Subparts B, C and E. Its radio
frequency transmitters have the following characteristics:
Cellular 3G (824-849MHz and 1850-1910MHz transmission bands).

WiFi (a, b, g) 2.4 MHz and 5MHz ISM band; maximum EIRP 15 dBm; OFDM modulation

Bluetooth ISM band 2.4MHz; maximum EIRP 2 dBm; GFSK modulation

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