Vista Apex pinkwave Mode D'emploi page 21

APPENDIX – ELECTROMAGNETIC
COMPATIBILITY AND SAFETY INFORMATION
The PinkWave™ Curing Light is tested according to IEC 60601-1-2, Edition 4.0.
Medical electrical devices are subject to particular preventive action and must be installed
and operated according to the EMC guidelines in the accompanying documents.
Guidance and Manufacturer's Declaration – Electromagnetic Emission
The following tables are guidelines according to the 4th edition of the medical
standard IEC 60601-1-2.
The PinkWave™ Curing Light is intended for use in the electromagnetic environment
specified below. The customer or the user of the PinkWave™ Curing Light should assure that
it is used in such an environment.
EMISSION TEST
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC
61000-3-2
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Table: According to IEC 60601-1-2, Edition 4.0
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The PinkWave™ Curing Light is intended for use in the electromagnetic environment
specified below. The customer or the user of the PinkWave™ Curing Light should assure that
it is used in such an environment.
IMMUNITY TEST
TEST LEVEL
Electrostatic
± 8 kV contact
discharge (ESD) IEC
61000-4-2
± 2 kV for power
Electric fast transient
/ burst IEC 61000-4-4 ± 1 kV for input/
Surge IEC
61000-4-5
COMPLIANCE
Group 1
Class B
Complies
Complies
IEC 60601 COMPLIANCE
LEVEL
± 8 kV contact
± 15 kV air ± 15 kV air
supply lines ± 2 kV for power
supply lines
output lines
± 1 kV line to line
± 2 kV line to earth
ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
PinkWave™ uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electrical equipment.
PinkWave™ is suitable for use in all establishments, including
domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes.
ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
Floors should be concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity
should be at least 30%.
Mains power quality should be that of typical
commercial or dental environment.
Mains power quality should be that of typical
commercial or dental environment.
N/A
N/A
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