24
User Guide ProCair Prime
Technical Specifications
Guidance and manufacturer’s declaration – electromagnetic immunity
The ProCair Prime Universal Therapy System M31 control unit is intended for use in the electromagnetic
environment specified below.
The customer or the user of the ProCairPrime Universal Therapy System M31 control unit should ensure that it is
used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment –guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Contact ±8 kV
Contact ±8 kV
Floors should be wood, concrete, or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least 30 %.
Air ±2, ±4, ±8, ±15 kV
Air ±2, ±4, ±8, ±15 kV
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines ±2 kV for power supply lines
Mains power quality should be that of a typical home healthcare
and professional healthcare environment.
±1 kV for input/output lines
Not applicable
Surge
IEC 61000-4-5
± 0.5kV, ± 1kV line(s) to line(s) ± 0.5kV, ±1kV line(s) to line(s)
Mains power quality should be that of a typical home healthcare
and professional healthcare environment.
± 0.5kV, ±1kV, ± 2kV line(s)
to earth
Not applicable
Voltage Dips,
short interruptions
and voltage variations
on power supply
input lines
IEC 61000-4-11
Voltage dips
0 % U
T
; 0.5 cycle
0 % U
T
; 0.1 cycle
70 % U
T
; 25/30 cycles
Voltage dips
0 % U
T
; 0.5 cycle
0 % U
T
; 0.1 cycle
70 % U
T
; 25/30 cycles
Mains power quality should be that of a typical home healthcare
and professional healthcare environment. If the user of the
ProCair Prime Universal Therapy System M31 control unit
requires continued operation during power main interruptions,
it is recommended that the ProCair Prime Universal Therapy
System M31 control unit be powered from an uninterruptible
power supply or a battery.
Voltage interruptions
0 % U
T
; 250/300 cycle
Voltage interruptions
0 % U
T
; 250/300 cycle
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical home healthcare
and professional healthcare environment.
50 Hz or 60 Hz
50 Hz
NOTE UT is the AC mains voltage prior to application of the test level
Conducted RF
IEC 61000-4-6
3 Vrms:
0.15 MHz – 80 MHz
3 Vrms:
0.15 MHz – 80 MHz
Portable and mobile RF communications equipment should
be used no closer to any part of the ProCair Prime Universal
Therapy System M31 control unit, including cables, than
the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2
d = 1.2
√
P 80 MHz to 800 MHz
d = 1.2
√
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 manufacturer and d is the
recommended separation distance in metres (
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.
B
Interference may occur in the vicinity of
equipment marked with the following symbol:
6 Vrms:
in ISM and amateur
radio bands between
0.15 MHz and 80 MHz
6 Vrms:
in ISM and amateur radio
bands between 0.15 MHz and
80 MHz
80 % AM at 1 kHz
80 % AM at 1 kHz
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
A
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur 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 ProCair Prime
Universal Therapy System M31 control unit is used exceeds the applicable RF compliance level above, the ProCair Prime Universal Therapy System
M31control unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the ProCair Prime Universal Therapy System M31 control unit.
B
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.