RSR-000885-000 (6)
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7.3. Electromagnetic Compatibility (EMC) Tables
This laser system has been tested to comply with the requirements of EN/IEC 60601-1-2 for electromagnetic compatibility (EMC). The following
pages list the tests performed and corresponding test levels. The user, operator, installer, or assembler of this product is advised of the
following:
•
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to
the information provided in this document.
•
Portable and mobile RF communications equipment can affect medical electrical equipment.
•
Use only the power cord provided with this product, or an approved alternate.
Warning:
•
The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased
immunity of this product.
•
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
7.3.3. Recommended Separation Distances
The device is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the
device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications
Equipment and the device as recommended below, according to the maximum output power of the communications equipment.
Below is the table of recommended separation distances between portable and mobile RF communications equipment and the device and
systems that are not life-supporting.
Summary of Contents for LIGHTFORCE XLi
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