Dentsply Sirona SmartLite Pro Manual De Istrucciones página 22

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
a
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the SmartLite® Pro
Curing Light is used exceeds the applicable RF compliance level above, the SmartLite® Pro Curing Light
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the [System Name here].
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
Complies with the following Directives/Standards:
93/42/EEC
2002/95/EC
IEC 60601-1 ed. 3.1
IEC 60601-1-2
IEC 60601-2-57
ISO 10650
EN 62471
IEC 62471
EN 980
EN 1041
EN 1639
EN ISO 10993-1
EN ISO 17664
IEC 80601-2-60
IEC 62366
The SmartLite Pro curing light complies with:
UL 60601-1
CSA C22.2 No. 601.1
E113604
22
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices amended by
directive 2007/47/EC, annex 1
Restriction of the use of hazardous substances in electrical and electronic equipment
2012 – Medical Electrical Equipment (General requirements for basic safety and essential
performance)
2005 – Medical electrical equipment - Part 1-2: General requirements for safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
2011 - Medical electrical equipment - Part 2-57: Particular requirements for basic safety
and essential performance of non-laser light source equipment intended for therapeutic,
diagnostic, monitoring and cosmetic use
2015 – Dentistry - Powered polymerization activators
2008 – Photobiological Safety of Lamps and Lamp Systems
2006 – Photobiological Safety of Lamps and Lamp Systems
2008 – Symbols for use in labeling of medical devices
2008 – Information supplied by the manufacturer of medical devices
2009 – Dentistry – Medical devices for dentistry - Instruments
2009 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process
2017– Sterilization of medical devices – Information to be provided by the manufacturer for
the processing of resterilizable medical devices
2012 – applies to the basic safety and essential performance of Dental Units, Dental Patient
Chairs, Dental Handpieces and Dental Operating Lights.
2015 – Application of usability engineering to medical devices