Electromagnetic Compatibility - Cardinal Health NPWT PRO Patient User Manual

5.2 Electromagnetic Compatibility

The Cardinal Health™ NPWT PRO family of devices conforms to all pertinent requirements of IEC 60601-1-2.
The EMC summary tables are provided herein below for your reference.
Guidance and Manufacturer's Declaration: Electromagnetic Emissions (IEC 60601-1-2)
Emissions Test
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 14-1
Recommended separation distance between portable and
mobile RF communications equipment and the PRO.
The PRO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the PRO can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the PRO as recommended
below, according to the maximum output power of the communications equipment.
Output Power of
Transmitter in watt(s)
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note: At 80MHz and 800MHz, the separation distance for the higher frequency range applies Note: These guidelines
may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects, and people.
Compliance
Class A
Complies
Complies
Separation distance according to frequency of transmitter in meter(s)
150 kHz to 80 MHz
0.12
0.38
1.2
3.8
12
Electromagnetic Environment
The PRO is suitable for use in all establishments,
including medical facilities, domestic establishments
and those directly connected to the public low-voltage
power supply network that supplies buildings used
for domestic purposes.
The PRO is not suitable for interconnection
with other equipment.
80 MHz to 800 MHz
0.12
0.38
1.2
3.8
12
800 MHz to 2.5GHz
0.23
0.73
2.3
7.3
23
13