Guidance & Manufacturer's Declaration - NeoLight SKYLIFE User Manual

7.6 GUIDANCE & MANUFACTURER'S DECLARATION
Electromagnetic Compatibility (EMC)
The Skylife system is suitable for the electromagnetic environment of typical homes, commercial
or hospital settings.
During the immunity testing described below the Skylife device continued to deliver treatment at a wavelength
of 430-475 nm at an intensity between 25 to 72 µW/cm
WARNINGS:
Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
•
should be used no closer than 30 cm (12 inches) to any part of the Skylife device, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment could result.
The Skylife unit should not be used adjacent to or stacked with other equipment. If adjacent or stacked use
•
is necessary, the device should be observed to verify normal operation. If operation is not normal, the Skylife
device or the other equipment should be relocated.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
•
equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation.
Skylife™ is intended for use in the electromagnetic environment specified below. The customer or the user of Skylife™ should assure that it
is used in such an environment.
Emission Tests
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Skylife™ is intended for use in the electromagnetic environment specified below. The customer or the user of Skylife™ should assure that it is
used in such an environment.
Immunity Test
Electrostatic
± 8kV contact
discharge (ESD) IEC
± 15kV air
61000-4-2
Electrical fast
± 2 kV for power supply
transient / burst IEC
lines
61000-4-4
± 1 kV differential
Surge IEC 61000-4-5
mode
Voltage dips, short
interruptions and 0% .5 Periods
voltage variations 0% 1 Period
on power supply 70% 25 Periods
input lines IEC 0% 5 sec
61000-4-11
Power frequency
(50/60 Hz)
30A/m
magnetic field
IEC 61000-4-8
NOTE: U is the A/C. mains voltage prior to application of the test level.
T
Skylife™ is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that
it is used in such an environment.
IEC 60601 Test
Immunity Test
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF IEC 3 V/m
61000-4-3 80 MHz to 2.5 GHz
Compliance
Skylife™ uses RF energy only for its internal function. Therefore, its RF emissions are
Group 1
very low and are not likely to cause any interference in nearby electronic equipment.
Class B
Skylife™ is suitable for use in all establishments, including domestic establishments and
Class A Class B
those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Complies
Compliance Level
The relative humidity should be at least 5 %
Mains power quality should be that of a typical home commercial or hospital environment.
Mains power quality should be that of a typical home commercial or hospital environment.
Mains power quality should be that of a typical home commercial or hospital environment.
If the user of Skylife™ requires continued operation during power mains interruptions, it is
recommended that Skylife™ is powered from an uninterruptible power supply.
Power frequency magnetic fields from common appliances in the home are not expected
to affect the device.
Power frequency magnetic fields should be at levels characteristic of a typical location in a
typical commercial or hospital environment. Keep Skylife™ away from sources of high
levels of power line magnetic fields (in excess of 30 A/m) to reduce the likelihood of
interference."
Compliance Level
Level
3 Vrms
6 Vrms in ISM and
amateur radio bands
10 V/m
/nm.
2
Electromagnetic Emissions
Electromagnetic Environment – Guidance
Electromagnetic Immunity
Electromagnetic Environment – Guidance
Skylife™ is suitable for the electromagnetic environment of typical
homes, commercial or hospital settings.
Electromagnetic
Environment – Guidance
500007, Rev P, Pg 17