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APPENDIX
E N
INTELECT
®
MOBILE 2 ULTRASOUND USER MANUAL
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 Compliance Level Electromagnetic Environment - Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air ± 8 kV contact
± 15 kV air
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.
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.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power supply lines ± 2 kV for power supply lines
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) ± 1 kV differential mode
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 <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
Mains power quality should be that of a typical commercial or hospital
environment. If the user of the Intelect® Mobile 2 requires continued
operation during power mains interruptions, it is recommended that the
Intelect® Mobile 2 be powered from an uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/M 3 A/M
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.