User's Manual

BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual

1.10 ELECTROMAGNETIC COMPATIBILITY

This medical device is designed for use in the electromagnetic environments

declared in the tables below, in compliance with the IEC 60601-1-2:2001 (second

edition) standard. The operator must assure that the device is used in an

environment compliant to this standard.

This device complies with Part 15 of the FCC Rules. Operation is subject to the

following two conditions: (1) this device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that

may cause undesired operation.

The device is labeled FCC-ID S9NMHBGW1.

Table 1 - Electromagnetic Emissions

Emission Test

Compliance

Electromagnetic Environment

Radiated and

conducted RF

emissions

CISPR 11

Group 1

This medical device use RF energy only for

its internal function. Therefore, the RF

emission is very low and not likely to cause

any interference in nearby electronic

equipment.

Radiated and

conducted RF

emissions

CISPR 11

Class B

This medical device is suitable for use in all

establishments, including domestic directly

connected to the public low voltage power

supply network that supplies buildings used

for domestic purpose.

Harmonic emissions

IEC 61000-3-2

Complies

Class A

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Complies