Regulatory Compliance - Philips lifeline AutoAlert Help Button FD100 User Manual

Regulatory Compliance

Safety Standards
The AutoAlert Help Button complies with the following safety standards for medical devices and
home health care equipment:
UL1637 – Home Health Care Signaling Equipment
IEC60601-1 2005 (3rd Edition) – Medical Electrical Equipment - General Requirements for Basic
Safety and Essential Performance
IEC60601-1-1 – System Safety
IEC60601-1-2 – Electromagnetic Compatibility
IEC Regulations
The AutoAlert Help Button is Medical Electrical (ME) Equipment. 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-
2:2003, the international standard for EMC for medical electrical equipment.
The AutoAlert Help Button must emit electromagnetic energy in order to perform its intended
function. Nearby electronic equipment may be affected.
FCC Regulations
The AutoAlert Help Button complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions: (1) the AutoAlert Help Button may not
cause harmful interference, and (2) the AutoAlert Help Button must accept any interference
received, including interference that may cause undesired operation. Pursuant to Part 15.21 of
the FCC Rules, any changes or modifications to this equipment not expressly approved by Philips
Lifeline may cause harmful interference.
Essential Performance
The AutoAlert Help Button provides Essential Performance (EP) under normal operating
conditions (includes EMC exposure) only as a complete system, consisting of the AutoAlert Help
Button and the DT1000 or 6900 Communicator. The system achieves its Essential Performance
by generating help messages to the Philips Lifeline Response Center Responders. If the system is
incapable of communicating help messages, it will generate an alarm that will be communicated
periodically to the Philips Lifeline Responders.
System Classification
The AutoAlert Help Button is an FDA Class II device. It is an internally powered device for
continuous operation, with a water resistance classification of IPX7.
For assistance, call 1-800-635-6156 in the U.S. and 1-800-387-1215 in Canada. 19