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Regulatory compliance
Safety standards
The AutoAlert Help Button complies with the following safety standards
for medical devices and home healthcare equipment:
UL1637 – Home Healthcare Signaling Equipment
CSA C22.2 NO 205-M1983 – Signal Equipment
IEC60601-1:2005 (3rd Edition) – Medical Electrical Equipment –
General Requirements for Basic Safety and Essential Performance
CA/EN/US National Differences
IEC60601-1-2 – Electromagnetic Compatibility
RSS-210 - Low-Power License-Exempt Radiocommunication Device
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 60601-1-2:2007, 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.
