Chattanooga Vectra Neo, User Manual

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Vectra® Neo Clinical Therapy System
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The Vectra® Neo Clinical Therapy System is intended for use in the electromagnetic environment specifi ed below. The
customer or the user of the Vectra® Neo Clinical Therapy System should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance Level Electromagnetic Environment - Guidance
Electrostatic dis-
charge (ESD) IEC
61000-4-2 ±6 kV contact
±8 kV air ±6 kV contact
±8 kV air Risk assessment on the Vectra Neo Clinical Therapy System
indicates the compliance levels claimed are acceptable when
ESD-precautionary measures are taken.
The Vectra Neo Clinical Therapy System may be susceptible to
Electro-Static Discharge (ESD) at greater than ±4 kV when fi rst
grasping either the Ultrasound or Laser applicator. In the event
of such a discharge, the Vectra Neo Clinical Therapy System
may experience communication loss with the installed mod-
ules. The Vectra Neo Clinical Therapy System will terminate all
active outputs (stim, ultrasound, laser), automatically place the
unit in a safe state, and issue an error message 301 or 307.
To recover from an error message 301 or 307, turn the unit
off and on using the ON/OFF switch located at the top of the
display. Once the system restarts, re-initiate all treatments that
were interrupted.
To prevent Electro-Static Discharge (ESD) at greater than ±4 kV:
- Grasp and hold the Ultrasound or Laser 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
±1 kV for input/output lines ±2 kV for power supply
lines
±1 kV for input/output
lines Mains power quality should be that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5 +1 kV diff erential mode (line
to line)
+2 kV common mode (line
to ground) ±1 kV diff erential mode
±2 kV common 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% U
T
(>95% dip in U
T
) for
0,5 cycle
40% U
T
(60% dip in U
T
) for
5 cycles
70% U
T
(30% dip in U
T
) for
25 cycles
<5% U
T
(>95% dip in U
T
) for
5 sec
<5% U
T
(>95% dip in U
T
) for
0,5 cycle
40% U
T
(60% dip in U
T
) for
5 cycles
70% U
T
(30% dip in U
T
) for
25 cycles
<5% U
T
(>95% dip in U
T
) for
5 sec
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the Vectra® Neo Clinical
Therapy System requires continued operation during power
mains interruptions, it is recommended that the Vectra® Neo
Clinical Therapy System be powered from an uninterrupted
power supply.
Power frequency
(50/60 Hz) magnetic
fi eld
IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fi elds should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
NOTE: U
T
is the AC mains voltage prior to application of the test level.
ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES (CONTINUED)
APPENDIX 2