Electromagnetic Compatibility - Cogentix Medical Urgent PC Mode D'emploi

» Therapy mode time is automatically set for 30 minutes.
» When the therapy time has elapsed, Therapy mode will
automatically end, the current will be inactive, and the Stimulator
will emit a series of three beeps.
8. Complete Treatment Session
» Turn off the Stimulator by holding down the Power button for
approximately 2 seconds.
» Remove the Needle Electrode Clip from the Needle Electrode.
» Using a smooth, fluid motion, quickly remove the Needle
Electrode from the leg. If bleeding occurs, apply slight pressure
and bandage.
» Disconnect the Lead Wire from the Stimulator and properly
dispose of Lead Set components.
» The treatment session is now complete.
TREATMENT FREQUENCY
» Conduct 12 treatments, typically once per week.
» After the initial 12 treatments, slowly increase the time between
treatments, with the patient closely monitored for the return of
symptoms.
» If symptoms reappear or increase in severity, the patient's treatment
schedule should revert to the last previously effective treatment
schedule.
MAINTENANCE
After each treatment the surface of the Stimulator device should be
wiped down with a soft cloth. The cloth may be slightly dampened, but
not saturated, with water or with a mix of isopropyl alcohol (70%) and
water (30%).
Use only a 9V alkaline battery (e.g., Duracell) to power the Stimulator.
Never operate the Stimulator with any type of line-powered battery
eliminator or other external power source. Battery life is dependent on
the intensity of treatment; a new 9V battery will perform approximately
12 treatments at a current setting of 5mA (level 11). Recycle or
dispose of batteries in compliance with applicable local and/or national
regulations. If the Stimulator is not working properly, contact Cogentix
Medical.
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PERMISSIBLE OPERATING ENVIRONMENT
» Ambient temperature
» Relative humidity
» Atmospheric pressure
MANUFACTURING
The Stimulator is manufactured in accordance with the safety norms set
forth by the International Electrotechnical Commission and Underwriters
Laboratory, IEC/UL 60601, including electromagnetic compatibility.

ELECTROMAGNETIC COMPATIBILITY

Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The Urgent PC Stimulator is intended for use in the electromagnetic environment
specified below. The customer or the user of the Urgent PC Stimulator should assure
that it is used in such an environment.
Emissions Test Compliance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR 11
Harmonic Not applicable
emissions
IEC 61000-3-2
Voltage Not applicable
fluctuations/
flicker emissions
IEC 61000-3-3
10°C to 40°C
30% to 75%
700 hPa to 1060 hPa
Electromagnetic Environment – Guidance
The Urgent PC Stimulator uses RF energy
only for its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
The Urgent PC Stimulator is suitable for use
in all establishments other than domestic and
those directly connected to the public low-
voltage power supply network that supplies
buildings for domestic purposes.
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