Safety And Performance Standards; Emc Details; Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Enraf Nonius Sonopuls 190 Instrucciones De Manejo

48Hz 100%*
100Hz 5%
100Hz 10%
100Hz 20%
100Hz 33%
100Hz 50%
100Hz 80%
100Hz 100%*
* = continuous mode

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

10.4.1 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
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
20.8ms 1
0.5ms 20
1ms 10
2ms 5
3.3ms 3.33
5ms 2
8ms 1.25
10ms 1
: 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.
IEC 60601
test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/output
Lines
±  1 kV line(s)to line(s)
± 2 kV line(s)to earth
<5 %U T
(>95 %dip in U )
T
for 0,5 cycle
40 %U T
(60 %dip in U T)
for 5 cycles
Compliance level
±  6 kV contact
± 8 kV air
± 1 kV for power
supply lines
not applicable
± 1 kV line(s)to line(s)
± 2 kV line(s)to earth
< 5% U
T
for 0,5 cycle
< 5% U
T
for 1 cycle
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
should be that of a
typical computer room.
Mains power quality
should be that of a
typical computer room.
Mains power quality
should be that of a
typical computer room. If
the user of the
Sonopuls 190 requires
continued operation during
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