Cardinal Health NPWT PRO Patient User Manual page 16

Guidance and Manufacturer's Declaration: Electromagnetic Immunity (IEC 60601-1-2)
IEC 60601
Immunity Test
Test Level
Electrostatic discharge ±6 kV contact
(ESD) IEC 61000-4-2 ±8 kV air
Electrical fast transient/ ±2 kV for power supply lines
burst ±1 kV for input/output
Surge ±1 kV
line to line
IEC 61000-4-5 ±2 kV
line to earth
Voltage dips, short <5 % U T
interruptions and voltage (>95 % dip in
variations on power supply U T ) for 0.5 cycle
IEC 61000-4-11
40 % U T
(60 % dip in
U T ) for 5 cycles
70 % U T
(30 % dip in
U T ) for 25 cycles
<5 % U T
(95 % dip in
U T ) for 5 sec.
Power frequency (50/ 60 3 A/m
Hz) magnetic field IEC
61000-4-8
Guidance and Manufacturer's Declaration: Electromagnetic Immunity (IEC 60601-1-2)
IEC 60601
Immunity Test
Test Level
Conducted RF IEC 61000-4-6 3 V rms
150 kHz ~ 80
MHz
Radiated RF IEC 61000-4-3
3 V/m
800 MHz ~ 2.5
GHz
Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
a 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 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.
ь Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.
14
Compliance Level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output
±1 kV
line to line
±2 kV
line to earth
<5 % U T
(>95 % dip in
U T ) for 0.5 cycle
40 % U T
(60 % dip in
U T ) for 5 cycles
70 % U T
(30 % dip in
U T ) for 25 cycles
<5 % U T
(95 % dip in
U T ) for 5 sec.
3 A/m
Note: U T is the A.C. mains voltage prior to application of the test level.
Compliance Level
Electromagnetic Environment
-
Guidance
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 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
3 V rms
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. ь
3 V/m
Interference may occur in the vicinity of equipment marked with the following symbol:
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%.
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 commercial and/or hospital
environment.
Power frequency magnetic fields should be at levels characteristic of a typical
location in a typical commercial or hospital environment.