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Electromagnetic Conformity Declaration
The SmartBag System (model 430) has been built and tested according to IEC60601-1-2 and United States
Federal Communications Commission (FCC) standards.
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 SmartBag System is intended for use in the electromagnetic environment specified below. The
operator and/or patient should assure that it is used in such an environment.
Basic Standards
Test Result
Electromagnetic Environment Guidance
Emissions Testing IEC 60601-1-2
CISPR 11, Radiated Emissions
Compliant –
Class B
The SmartBag System uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
CISPR 11, Conducted Emissions
NT
1
IEC 61000-3-2, Harmonic Current
NT
1
IEC 61000-3-3, Voltage Fluctuation &
Flicker
NT
1
Immunity Testing as Referenced in IEC 60601-1-2
IEC 61000-4-2, Electro-Static Discharge
Compliant
IEC 61000-4-3, Radiated Immunity
Compliant
IEC 61000-4-4, Electric Fast Transients
Immunity
NT
1
IEC 61000-4-5, Surges Immunity
NT
1
IEC 61000-4-6, Conducted Immunity
NT
1
IEC 61000-4-8, Power Frequency
Magnetic Field Immunity
Compliant
IEC 61000-4-11, Voltage Dips &
Interruptions
NT
1
NT
1
– EUT is battery only and therefore required no AC power to test.