RSR-000886-000 (1)
Page
33
of
40
Warning:
Equipment should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, this device should be observed
to verify normal operation in the configuration in which it will be used.
All medical electronic devices must conform to the requirements of EN/IEC 60601-1-2.
Precautions, adherences to the EMC guideline information provided, and verification of all
medical devices in simultaneous operation are required to ensure the electromagnetic
compatibility and coexistence of all other medical devices prior to a laser therapy treatment.
7.3.1. Emissions Test Summary
Specification
Frequency Range
Compliance Status
CISPR 11/EN 55011
Group 1, A
Conducted Emissions
0.15 MHz
– 30 MHz
PASS
CISPR 11/EN 55011
Group 1, A
Radiated Emissions
30.0 MHz
– 1,000 MHz
PASS
EN 61000-3-2
Power Line Harmonics
Up to the 40
th
Harmonic
PASS
EN-61000-3-3
Power Line Flicker
Less than or equal to 4% Maximum Relative
Voltage Change; Value of d(
t
) less than or
equal to 3.3% for more than 500 ms
PASS
7.3.2. Immunity Test Summary
Specification
Minimum Test Level Required per
EN 60601-1-2, 4
th
Edition
Test Level Completed
Compliance
Status
EN 61000-4-2
- Electrostatic
Discharge
Immunity
Air discharge up to ± 15 kV;
Contact discharge up to ± 8 kV
Air discharge up to ± 15 kV;
Contact discharge up to ± 8 kV
PASS
EN 61000-4-3
- RF Radiated
Fields Immunity
Radiation field strength of 3V/m from
80
– 2700 MHz
(80% AM, 1 kHz)
Radiation field strength of 3V/m
from 80
– 2700 MHz
(80% AM, 1 kHz)
PASS
EN 61000-4-4
-Electrical Fast
Transient
Immunity
Power line pulses of ± 2kV direct;
I/O line pulses of ± 1kV
Power line pulses of ± 2kV
direct;
I/O line pulses of ± 1kV
PASS
EN 61000-4-5
-Lightning Surge
Immunity
Power line surges of ± 2kV common,
± 1kV differential mode
Power line surges of ± 2kV
common, ± 1kV differential
mode
PASS
EN 61000-4-6
-RF Common
Mode Immunity
150 kHz - 80 MHz at 3 Vrms
1 kHz 80% amplitude modulated
150 kHz - 80 MHz at 3 Vrms
1kHz 80% amplitude modulated
PASS
EN 61000-4-8
-Power Frequency
Magnetic Field
Immunity
Inductive loop at 50 Hz or 60Hz, to
30 amps (rms) per meter
Inductive loop at 50 Hz, to 30
amps (rms) per meter
PASS
EN 61000-4-11
- Voltage Dips and
Short Interruptions
Voltage Dips of
100% for 0.5 cycles (0, 45, 90, 135,
180, 225, 270 and 315)
100% for 1 cycle
30% for 25 cycles
10% for 250 cycles (5s)
Voltage Dips of
100% for 0.5 cycles (0, 45, 90,
135, 180, 225, 270 and 315)
100% for 1 cycle
30% for 25 cycles
10% for 250 cycles (5s)
PASS
