Chattanooga LIGHTFORCE FXi, Инструкция по эксплуатации

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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