Safety And Performance Standards; Emc Details; Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Sportec Sonopuls 190 Manual De Uso

10.3 Safety and Performance standards

IEC 60601-1
Safety class according to IEC 60601-1
IEC 60601-2-5
Medical device classification
21 CFR 1050.10

10.4 EMC details

Guidelines and manufacturer's declaration – electromagnetic interference
The Sonopuls 190 intended for operation in an electromagnetic environment as indicated below.
The customer or user of the Sonopuls 190 should ensure that it is operated in such an
environment.
Interference tests
RF emissions according to CISPR 11 Group 1
RF emissions according to CISPR 11 ClassB
Harmonic emissions according to
IEC 61000-3-2
Voltage fluctuation emissions and
flicker according to IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The Sonopuls 190 is intended for use in the electromagnetic environment specified below. The customer
or the user of the Sonopuls 190 should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
56
Electrical fast
: General requirements for the safety of electrical medical
systems, including Annex I, national differences for Australia,
Canada and the United States.
: class I type BF
: Particular requirements for the safety of ultrasonic therapy
equipment.
: This equipment complies with all requirements of the Medical
Device Directive (93/42/EEC).
: IIa
: This equipment complies with all requirements of 21 CFR
1050.10, Performance Standard for Ultrasonic Therapy
devices.
Conformity
Class B
Conforms
IEC 60601
test level
 6 kV contact
 8 kV air
 2 kV for power
Electromagnetic environment
guideline
The Sonopuls 190 uses RF energy
solely for its internal functioning. Its
RF emission is therefore very low and
it is unlikely that this will cause
interference to neighbouring
electronic equipment.
The Sonopuls 190 is suitable for use
in all installations including those in a
residential environment and those
which are directly connected to the
public mains network which also
supplies buildings which are used for
residential purposes.
Compliance level
 6 kV contact
 8 kV air
 1 kV for power
Electromagnetic
environment –
guidance
Floors should be wood,
concrete or
ceramic tile. If floors are
covered with
synthetic material, the
relative humidity
should be at least 30 %.
Mains power quality