Electromagnetic Compatibility - Cardinal Health ALLY TO GO NPWT Patient User Manual

Negative pressure wound therapy
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6.1 Electromagnetic Compatibility

Guidance and Manufacturer's Declaration – Electromagnetic Emissions
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
Immunity test
IEC 60601 test level
Electrostatic discharge (ESD)
± 6kV contact
IEC 61000-4-2
± 8kV air
Electrical fast transient/burst
± 2kV for power supply lines
IEC 61000-4-4
± 1kV for input/output lines
Surge
± 1kV line(s) to line(s)
IEC 61000-4-5
± 2kV line(s) to earth
Voltage dips, short
<5% U
interruptions and voltage
(>95% dip in U
variations on power supply
input lines
40% U
IEC 61000-4-11
(60% dip in U
70% U
(30% dip in U
<5% U
(>95% dip in U
Power frequency (50/60 Hz)
3A/m
magnetic field
IEC 61000-4-8
The ALLY TO GO™ is intended for use in the electromagnetic environment specified below.
The customer or the user of the ALLY TO GO™ should assure that it is used in such an environment.
Compliance
Group 1
Class B
Class B
Complies
The ALLY TO GO™ is intended for use in the electromagnetic environment specified below.
The customer or the user of the ALLY TO GO™ should assure that it is used in such an environment.
Compliance level
± 6kV contact
± 8kV air
± 2kV for power supply lines
± 1kV for input/output lines
± 1kV line(s) to line(s)
± 2kV line(s) to earth
<5% U
T
) for 0.5 cycle
(>95% dip in U
T
40% U
T
) for 5 cycles
(60% dip in U
T
70% U
T
) for 25 cycles
(30% dip in U
T
<5% U
T
) for 5 s
(>95% dip in U
T
3A/m
Note: U
is the A.C. mains voltage prior to application of the test level.
T
Electromagnetic environment – guidance
The [ME EQUIPMENT or ME 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.
The
is suitable for use in all establishments, including
ALLY TO GO™
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Electromagnetic environment –
guidance
Floors 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 or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
T
) for 0.5 cycle
commercial or hospital environment. If the user of the
T
ALLY TO GO™ requires continued operation during
power mains interruptions, it is recommended that
T
) for 5 cycles
the ALLY TO GO™ be powered from an uninterruptible
T
power supply or a battery.
T
) for 25 cycles
T
T
) for 5 s
T
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
31

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