Cardinal Health PRO Patient User Manual page 27

Guidance and Manufacturer's Declaration: Electromagnetic Immunity (IEC 60601-1-2)
Immunity Test IEC 60601 Test Level
Electrostatic discharge (ESD) IEC ±6kV contact
61000-4-2 ±8kV air
Electrical fast transient/burst ±2kV for power supply lines
±1kV for input/output
Surge ±1kV line to line
IEC 61000-4-5 ±2kV line to earth
Voltage dips, short interruptions <5% U
and voltage variations on power (>95% dip in U
supply
40% U
IEC 61000-4-11
(60% dip in U
70% U
(30% dip in U
<5% U
(95% dip in U
Power frequency (50/60Hz) 3A/m
magnetic field
IEC 61000-4-8
Conducted RF IEC 61000-4-6 3V rms
Radiated RF IEC 61000-4-3 150kHz ~ 80MHz
3V/m
800MHz ~ 2.5GHz
Note 1: At 80MHz and 800MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast and TV
a
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the PRO is used exceeds the applicable RF compliance level above, the PRO should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the PRO.
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
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Compliance Level
±6kV contact
±8kV air
±2kV for power supply lines
±1kV for input/output
±1kV line to line
±2kV line to earth
<5% U
T T
) for 0.5 cycle (>95% dip in U
T
40% U
T T
) for 5 cycles (60% dip in U
T
70% U
T T
) for 25 cycles (30% dip in U
T
<5% U
T T
) for 5 sec. (95% dip in U
T
3A/m
Note: U is the A.C. mains voltage prior to application of the test level.
T
3V rms
3V/m
Electromagnetic
Environment-Guidance
Floor should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30 percent.
Mains power quality should be that of a typical
commercial and/or hospital environment.
Mains power quality should be that of a typical
commercial and/or hospital environment.
Mains power quality should be that of a typical
) for 0.5 cycle commercial and/or hospital environment.
T
) for 5 cycles
T
) for 25 cycles
T
) for 5 sec.
T
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
Portable and mobile RF communications equipment should be used no
closer to any part of the PRO including cables, than the recommended
separation distance calculated from the equation appropriate to the
frequency of the transmitter.
Recommend separation distance
d = 1.2 √P
d = 1.2 √P 80MHz to 800MHz
d = 2.3 √P 800MHz to 2.5GHz
where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF transmitters as determined by an
electromagnetic site survey, a should be less than the compliance level in
each frequency range.
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Interference may occur in the vicinity of equipment marked with the
following symbol:
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