10. EMC - Related Notication
1616
Manufacturer’sdeclaration–electromagneticimmunity
The Steiss™ Universal Therapy System (UTS) is intended for use in the electromagnetic environment specied
below. The customer or the user of the Steiss™ Universal Therapy System (UTS) should assure that it is used in
such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnectic
environment - guidance (for home
healthcare and professional healthcare)
Electrostatic
discharge (ESD)
IEC 61000-4-2
Contact:±8 kV
Air±2 kV,±4 kV,±8
kV,±15 kV
Contact:±8 kV
Air±2 kV,±4 kV,±8
kV,±15 kV
Floors should be wood, concrete, or
ceramic tile.
If oors 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
Not applicable
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+ 0.5kV, +1kV line(s) to
line(s)
+ 0.5kV, +1kV,+ 2kV
line(s) to earth
+ 0.5kV, +1kV line(s) to
line(s)
Not applicable
Mains power quality should be that
of a typical home healthcare and
professional healthcare environment.
Voltage Dips, short in
-
terruptions and voltage
variations on power
supply input lines IEC
61000-4-11
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Voltage interruptions:
0 % UT; 250/300 cycle
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Voltage interruptions:
0 % UT; 250/300 cycle
Mains power quality should be that
of a typical home healthcare and
professional healthcare environment.
If the user of the Steiss™ Universal
Therapy System (UTS) requires
continued operation during power
mains interruptions, it is recommended
that the Steiss™ Universal Therapy
System (UTS) be powered from an
uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz
The Steiss™ Universal Therapy
System (UTS) power frequency
magnetic elds should be at levels
characteristic of a typical location
in a typical home healthcare and
professional healthcare environment.
NOTE: UT is the AC mains voltage prior to application of the test level.