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APPENDIX
ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES (CONTINUED)
The Intelect® Transport 2 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Intelect® Transport 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
transient/burst
± 2 kV for power supply lines
IEC 61000-4-4
Surge
± 1 kV line(s) to line(s)
IEC 61000-4-5
+/- 2 kV line(s) to ground
Voltage dips, short
0% UT; 0.5 cycle at 0°, 45°, 90°,
interruptions and
135°, 180°, 225°, 270°, 315°
voltage variations on
0% UT; 1 cycle and 70% UT;
power supply input
25/30 cycles Single phase at 0°
lines IEC 61000-4-11
Power frequency
(50/60 Hz)
30 A/M
magnetic field
IEC 61000-4-8
Proximity
CW; 8 AM
magnetic
2.1 KHZ; 65 A/M
fields
50 KHZ; 7.5 A/M
IEC 61000-4-39
NOTE UT is the a.c. mains voltage prior to application of the test level.
47979 INTELECT TRANSPORT 2 COMBO (4778) AND ULTRASOUND (4776) USER MANUAL
Guidance and manufacturer's declaration – electromagnetic immunity
Compliance Level
± 8 kV contact
± 15 kV air
± 2 kV for power supply lines
± 1 kV differential mode
+/- 2 kV line(s) to ground
0% UT; 0.5 cycle at 0°, 45°, 90°,
135°, 180°, 225°, 270°, 315°
0% UT; 1 cycle and 70% UT;
25/30 cycles Single phase at 0°
30 A/M
CW; 8 AM
2.1 KHZ; 65 A/M
50 KHZ; 7.5 A/M
Electromagnetic Environment - Guidance
Risk assessment on the Intelect® Transport 2 indicates
the compliance levels claimed are acceptable when ESD-
precautionary measures are taken.
The Intelect® Transport 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® Transport 2 may display a
permanent error. The Intelect® Transport 2 will terminate
all active outputs (stim, ultrasound), automatically place
the unit in a safe state.
To prevent Electrostatic Discharge (ESD) at greater 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.
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. If the user of the Intelect®
Transport 2 requires continued operation during power
mains interruptions, it is recommended that the Intelect®
Transport 2 be powered from an uninterruptible power
supply or a battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
Test frequency 30 kHz
Test frequency 134.2 kHz
Test frequency 13.56 MHz
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