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ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES (CONTINUED)
Guidance and manufacturer's declaration – electromagnetic immunity
The Intelect® Mobile 2 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Intelect® Mobile 2 should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Electrostatic
± 8 kV contact
discharge (ESD)
± 15 kV air
IEC 61000-4-2
Electrical fast
± 2 kV for power supply
transient/burst
lines
IEC 61000-4-4
Surge
± 1 kV line(s) to line(s)
IEC 61000-4-5
0% UT; 0.5 cycle at
Voltage dips, short
0°, 45°, 90°, 135°,
interruptions and
180°, 225°, 270°,
voltage variations
315°
on power supply
0% UT; 1 cycle and
input lines
70% UT; 25/30 cycles
IEC 61000-4-11
Single phase at 0°
Power frequency
(50/60 Hz)
30 A/m
magnetic field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
CW; 8 A/M
Proximity magnetic
2.1 kHz; 65 A/M
fields IEC 61000-4-39
50 kHz; 7.5 A/M
Compliance Level
Electromagnetic Environment - Guidance
Risk assessment on the Intelect® Mobile 2 indicates
the compliance levels claimed are acceptable when
ESD-precautionary measures are taken.
The Intelect® Mobile 2 may be susceptible to
Electrostatic Discharge (ESD) at greater than ±7 kV when
first grasping the Ultrasound applicator. In the event of
such a discharge, the Intelect® Mobile 2 may display a
permanent error. The Intelect® Mobile 2 will terminate
all active outputs (stim, ultrasound), automatically place
the unit in a safe state.
± 8 kV contact
To prevent Electrostatic Discharge (ESD) at greater
± 15 kV air
than ±7 kV:
• Grasp and hold the Ultrasound applicator prior to
starting treatment. If the applicator must be put down
prior to completion of treatment, stop the current
treatment first and then place the applicator in the holder.
• Maintain humidity in the use environment to at least
50% relative humidity.
• Floors should be wood, concrete, or ceramic tile. If floors
are covered with synthetic material, DJO recommends
implementing additional controls to maintain relative
humidity to at least 50%.
• Communicate these ESD-precautionary procedures to
healthcare staff, contractors, visitors and patients.
± 2 kV for power supply
Mains power quality should be that of a typical
lines
commercial or hospital environment.
Mains power quality should be that of a typical
± 1 kV differential mode
commercial or hospital environment.
0% UT; 0.5 cycle at
Mains power quality should be that of a typical
0°, 45°, 90°, 135°,
commercial or hospital environment. If the user of the
180°, 225°, 270°,
Intelect® Mobile 2 requires continued operation during
315°
power mains interruptions, it is recommended that the
0% UT; 1 cycle and
Intelect® Mobile 2 be powered from an uninterruptible
70% UT; 25/30 cycles
power supply or a battery.
Single phase at 0°
Power frequency magnetic fields should be at levels
30 A/m
characteristic of a typical location in a typical commercial
or hospital environment.
CW; 8 A/M
Test Frequency 30 kHz
2.1 kHz; 65 A/M
Test Frequency 134.2 kHz
50 kHz; 7.5 A/M
Test Frequency 13.56 MHz
INTELECT
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MOBILE 2 USER MANUAL
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