Philips Lifeline FD100 Instructions For Use Manual page 23

System classification
The AutoAlert Help Button is an FDA Class II device. It is an internally
powered device for continuous operation.
Radio specifications
The AutoAlert Help Button has a radiofrequency transmitter with the
following characteristics: maximum power over an antenna load: 12 dBm,
frequency: 312 MHz ± 75 KHz, modulation: OOK. It fully complies with
FCC Part 15, Section 15.231 for periodic operation above 70 MHz.
Collateral standards for IEC 60601-1
60601-1-2:2007 Electromagnetic Compatibility (EMC)
1. 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.
2. Portable and Mobile RF Communications Equipment can affect Medical
Electrical Equipment.
3. 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.
4. 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.
For assistance, call 1-800-635-6156
23