InMode EVOLVE X Operator's Manual page 58

Evolve System Operator Manual
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IEC 60601-1-2 Edition 4.0 (2014)
Environment of intended uses:
Professional Healthcare Facility Environment
Summary of Test Results
Test
Emission (IEC 60601-1-2 section 7.1 & 7.2 & IEC 60601-2-2)
Radiated emission
Freq. range: 30 - 1000 MHz
Conducted emission
Freq. range:150 kHz - 30 MHz
Harmonic current emission
test
Voltage changes, Voltage
fluctuations and Flicker test
Immunity (IEC 60601-1-2 section 8.9 & 8.10 IEC 60601-2-2)
Immunity from Electrostatic
discharge (ESD)
Immunity from radiated
electromagnetic fields
Immunity from
Proximity field from wireless
communications equipment
Immunity from Electrical Fast
transient (EFT)
Immunity from Surge
Immunity from conducted
disturbances induced by RF
fields
Immunity from Voltage dips,
short interruptions and
voltage variations
Use of the System with any accessory, transducer or cable other than
those specified may result in increased EMISSIONS or decreased
IMMUNITY than those specified.
The System should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the System should
be observed to verify normal operation in the configuration in which it
will be used.
Standard
CISPR 11
IEC 61000-3-2
IEC 61000-3-3
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-6
IEC 61000-4-11
Section 11: System Specifications
Class/ Severity level
Group 1 Class A
Group 1 Class A
100/ 120/ 230 VAC
AC mains
AC mains
8 kV contact discharges &
15 kV air discharges
3.0 V/m
80 MHz  2.7 GHz, 80% AM, 1kHz
List of frequencies,
from 9 V/m up to 28 V/m,
PM (18 Hz or 217 Hz), FM 1 kHz
± 2 kV on 230 VAC mains,
Pedal, Applicator
Tr/Th – 5/50 ns, 100 kHz
±1.0 kV DM/ 2.0kV CM on 230 VAC
Tr/Th – 1.2/50 (8/20) s
3.0 & 6.0 V on 230 VAC mains,
RMS
Pedal, Applicator
0.15÷ 80 MHz, 80% AM, 1 kHz
230 & 100 VAC mains;
0 % - 10 ms; 70% - 500 ms;
0% - 20 ms; 0% - 5sec
53
Test
result
Complies
Complies
Exempted
Complies
Complies
Complies
Complies
Complies
Complies
Complies
Complies