14
Impulse Auto Mattress Instructions and Technical Specification
Declaration – electromagnetic emissions and immunity –
for EQUIPMENT and SYSTEMS that are use in the professional healthcare facility
environment or in the home healthcare environment
The Air Pump declaration – electromagnetic immunity
The Air Pump system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Air Pump system should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
3 Vrms ; 6 Vrms
150 kHz to 80 MHz
3 Vrms ; 6 Vrms
150 kHz to 80 MHz
Portable and mobile RF communications equipment should be
used no closer to any part of the EQUIPMENT or SYSTEM
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
Interference may occur in the vicinity of equipment marked
with the following symbol.
Radiated RF
IEC 61000-4-3
3 V/m ; 10V/m
80 MHz – 2.7 GHz
80%
3 V/m ; 10V/m
80 MHz – 2.7 GHz
80%
Proximity fields
from RF wireless
Communications
equipment
IEC 61000-4-3
27 V/m
385 MHz 27 V/m
385 MHz
28 V/m
450 MHz 28 V/m
450 MHz
9 V/m
710 MHz 9 V/m
710 MHz
745 MHz
745 MHz
780 MHz
780 MHz
28 V/m
810 MHz 28 V/m
810 MHz
870 MHz
870 MHz
930 MHz
930 MHz
28 V/m
1720 MHz 28 V/m
1720 MHz
1845 MHz
1845 MHz
1970 MHz
1970 MHz
28 V/m
2450 MHz 28 V/m
2450 MHz
9 V/m
5240 MHz 9 V/m
5240 MHz
5500 MHz
5500 MHz
5785 MHz
5785 MHz
Declaration – electromagnetic immunity
The Air Pump system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Air Pump system should assure 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
±8 kV contact
±2 kV , ±4 kV , ±8 kV , ±15 kV
air
±8 kV contact
±2 kV , ±4 kV , ±8 kV , ±15 kV
air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
±0.5 kV
±1 kV differential mode
±2 kV common mode
±0.5 kV
±1 kV differential mode
±2 kV common mode
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
0 %
U
T
; 0 , 5 cycle
At 0
o
, 45
o
, 90
o
, 135
o
, 180
o
,
225
o
, 270
o
and 315
o
0 %
U
T
; 1 cycle
and
70 %
U
T
; 25/30 cycle
Single phase: at 0
o
0 %
U
T
; 0 , 5 cycle
At 0
o
, 45
o
, 90
o
, 135
o
, 180
o
,
225
o
, 270
o
and 315
o
0 %
U
T
; 1 cycle
and
70 %
U
T
; 25/30 cycle
Single phase: at 0
o
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the EQUIPMENT or SYSTEM
requires continued operation during power
mains interruptions, it is recommended that
the EQUIPMENT or SYSTEM be powered
from an uninterruptible power supply or a
battery.
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 commercial or hospital environment.
