37
Instructions for Use
TNI
soft Flow
50
Clinic System
Guidance and manufacturer’s declaration - electromagnetic immunity
The TNI softFlow system is intended for use in the electromagnetic environment specified below. The user
must ensure that these requirements are met.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic
environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 8 kV contact
± 2, ± 4, ± 8, ± 15
kV air
± 8 kV contact
± 2, ± 4, ± 8, ± 15
kV air
Floors should be made of 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 610004-4
± 2 kV for power
supply lines, 100 kHz
± 1 kV for input/
output lines, 100 kHz
± 2 kV for power
supply lines, 100 kHz
[no input/output
lines with > 3 m
present] 100 kHz
Mains power quality should
comply with that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
± 0.5, ± 1 kV line(s)
to line(s)
± 0.5, ± 1, ± 2 kV
line(s) to earth
± 1 kV line(s) to
line(s)
[no earth present]
Mains power quality should
comply with 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% UT for 0.5 cycle
at 0°, 45°,90°, 135°,
180°, 225°, 270° and
315°
0% UT for 1 cycle
and 70% UT for
25/30 cycles at 0°
0% UT for 250/300
cycles
0% UT for 0.5 cycle
at 0°, 45°,90°, 135°,
180°, 225°, 270° and
315°
0% UT for 1 cycle
and 70% UT for
25/30 cycles at 0°
0% UT for 250/300
cycles
Mains power quality should
comply with that of typical
commercial or hospital
environment. If continuous
operation is critically required,
the use of an uninterruptible
power supply or battery is
recommended.
Rated power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields
should comply with levels in a
typical commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Summary of Contents for 40610021
Page 1: ......
Page 2: ...TNI System ...
