Lifeline Systems Inc. 7100MHB ユーザーズマニュアル

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Safety and Regulatory 

Compliance

IEC Regulations

The GoSafe

 Lite Pendant complies with the relevant National and International standards listed in  the 

Technical Section. It is classified as medical electrical (ME) equipment in the USA according to the 

FDA product classification. According to Health Canada GoSafe Lite Pendant is not classified as a medical 

device. It falls 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.

 Refer to EMC section on page xx for details.

The GoSafe Pendant 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.

Device classification

The GoSafe Lite pendant is a FDA Class II device. It is an internally powered device for 

continuous operation.

Radio specifications



 WiFi (a, b, g) ISM bands 2.4 MHz and 5MHz; maximum  EIRP 15 dBm; OFDM modulation

 Bluetooth ISM band 2.4MHz; maximum EIRP 2 dBm, GFSK modulation