Delfi PTS ii - Page 45

OPERATING INSTRUCTIONS
43 OPERATING INSTRUCTIONS
2
EMC GUIDANCE AND DECLARATION - EM IMMUNITY/DISTURBANCES
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The PTS ii Personalized Tourniquet System is intended for use in the electromagnetic environment specified below.
The customer or the user of the PTS ii 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
± 6 kV contact
± 8 kV air
±6 kV Contact
Discharge, VCP, HCP
±8 kV Air Discharge
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 on AC Mains
±1 kV on I/O Ports
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
±0.5 kV, ±1 kV, ±2kV
CM Line-Gnd
±0.5 kV, ±1 kV, DM
Line-Line
NA on I/O Ports
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
<5 % UT (>95 % dip in UT)
for 0,5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in UT)
for 5 s
>95%, 5 periods
(100ms)
30%, 25 periods
(500ms)
60%, 50 periods (1
sec)
>95%, 250 periods (5
sec)
Mains power quality should be that
of a typical commercial or hospital
environment.
If the user of the PTS ii requires
continued operation during power
mains interruptions, it is
recommended that the PTS ii be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60Hz) magnetic
field
IEC 61000-4-8
3 A/m
3A/m @ 50Hz/60Hz
3 orthogonal
orientations
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.