Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Hutchinson Technology InSpectra StO2 650 Manual Del Usuario

Technical Addendum
Guidance and Manufacturer's Declaration — Electromagnetic Immunity
The InSpectra
StO Tissue Oxygenation Monitor is intended for use in the electromagnetic environment
™
2
specified below. The customer or the user of the InSpectra StO
it is used in such an environment.
IEc 60601
Immunity test test Level
Electrostatic
±6 kV contact
discharge (ESD)
IEC 61000-4-2 ±8 kV air
Electrical fast ±2 kV for power
transient/burst supply lines
IEC 61000-4-4 ±1 kV for input/
output lines
Surge
±1 kV differential mode
IEC 61000-4-5 ±2 kV common mode
Voltage dips, short <5 % U
(>95 % dip in U
interruptions and
voltage variations for 0,5 cycle
on power supply
input lines 40 % U
(60 % dip in U
for 5 cycles
IEC 61000-4-11
70 % U
(30 % dip in U
for 25 cycles
<5 % U
(>95 % dip in U
for 5 seconds
Power frequency 3 A/m
(50/60 Hz
magnetic field
IEC 61000-4-8

NotE: U is the a.c. mains voltage prior to application of the test level.
T
compliance
Level
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV differential mode
±2 kV common mode
<5 % U
T T
) (>95 % dip in U
T
for 0,5 cycle
40 % U
T T
) (60 % dip in U
T
for 5 cycles
70 % U
T T
) (30 % dip in U
T
for 25 cycles
<5 % U
T T
) (>95 % dip in U
T
for 5 seconds
3 A/m
Tissue Oxygenation Monitor should assure that
2
Electromagnetic
Environment – Guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
) typical commercial or hospital environment.
T
If the user of the InSpectra StO
Oxygenation Monitor requires continued
operation during power mains interruptions,
) it is recommended that the InSpectra StO
T
Monitor be powered from an uninterruptible
power supply or a battery.
)
T
)
T
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
Tissue
2
2
table 202
35
Technical Addendum