Emc Compliance Table - VQ OrthoCare Avid IF2 Manual Para El Paciente Y Para El Médic

EMC Compliance Table

Medical electrical equipment needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided below.
Portable and mobile RF communications equipment can affect medical electrical
equipment. Shortwave or microwave therapy equipment may produce instability in
the stimulator output if operated in close proximity to the Avid IF2 (e.g. within 1 meter).
- Simultaneous connection of a patient to a high frequency surgical medical
electronic equipment may result in burns at the site of the Avid IF2 electrodes
and possible damage to the stimulator.
- Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy
medical electronic equipment may produce instability in the Avid IF2 output.
Use of lead wires and other accessories other than those supplied by VQ OrthoCare
may result in increased emissions or decreased immunity of the Avid IF2.
Guidance and manufacturer's declaration - electromagnetic emissions
The Avid IF2™ is intended for use in the electromagnetic environment specified below. The
customer or user of the Avid IF2 should assure that it is used in such an environment.
Emissions test
RF Emissions
RF Emissions
Harmonic emissions IEC
61000-3-2
Voltage fluctuations /
flicker emissions IEC
61000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity
The Avid IF2™ is intended for use in the electromagnetic environment specified below. The
customer or user of the Avid IF2 should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Compliance Electromagnetic Environment - Guidance
The Avid IF2 uses RF energy only for its internal
function. RF emissions are very low and are not
Group1
likely to cause any interference in nearby electronic
Class B
Complies
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Complies
IEC 60601
Compliance level
Test Level
± 8 kV contact
± 15 kV air
equipment.
The Avid IF2 is suitable for use in all
establishments, including domestic
± 8 kV contact
± 15 kV air ceramic tile. If floors
the relative humidity
Electromagnetic
environment -
guidance
Floors should be
wood, concrete or
are covered with
synthetic material,
should be at least
30%.
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