Warranty Terms - Dentsply Sirona SmartLite Pro Instrucciones De Uso

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].
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Complies with the following Directives/Standards:
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices amended by
93/42/EEC
directive 2007/47/EC, annex 1
2002/95/EC Restriction of the use of hazardous substances in electrical and electronic equipment
2012 – Medical Electrical Equipment (General requirements for basic safety and essential
IEC 60601-1 ed. 3.1
performance)
2005 – Medical electrical equipment - Part 1-2: General requirements for safety and essential
IEC 60601-1-2
performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
2011 - Medical electrical equipment - Part 2-57: Particular requirements for basic safety
IEC 60601-2-57 and essential performance of non-laser light source equipment intended for therapeutic,
diagnostic, monitoring and cosmetic use
ISO 10650 2015 – Dentistry - Powered polymerization activators
EN 62471 2008 – Photobiological Safety of Lamps and Lamp Systems
IEC 62471 2006 – Photobiological Safety of Lamps and Lamp Systems
EN 980 2008 – Symbols for use in labeling of medical devices
EN 1041 2008 – Information supplied by the manufacturer of medical devices
EN 1639 2009 – Dentistry – Medical devices for dentistry - Instruments
2009 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
EN ISO 10993-1
management process
2017– Sterilization of medical devices – Information to be provided by the manufacturer for
EN ISO 17664
the processing of resterilizable medical devices
2012 – applies to the basic safety and essential performance of Dental Units, Dental Patient
IEC 80601-2-60
Chairs, Dental Handpieces and Dental Operating Lights.
IEC 62366 2015 – Application of usability engineering to medical devices
The SmartLite Pro curing light complies with:
UL 60601-1
CSA C22.2 No. 601.1
E113604

6.8 Warranty terms

Dentsply Sirona grants a 2-year warranty on all components of the SmartLite Pro Curing Light
except the battery . The battery is covered by a 1-year warranty . The warranty commences on the
date of purchase . Within the warranty period, Dentsply Sirona will eliminate free of charge any
defects in the appliance resulting from faults in material or workmanship either by repairing or
exchanging parts or exchanging the whole device at Dentsply Sirona's discretion .
Not covered by this warranty: Damage arising from improper use (operation with incorrect current/
voltage, unsuitable power point, breakage, cleaning by other than the recommended methods),
normal wear and defects which have a negligible effect on the value or operation of the appliance .
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This warranty becomes void if repairs are undertaken by unauthorized persons .
This warranty extends to every country where this device is supplied by Dentsply Sirona or its
appointed distributor and where no import restrictions or legal regulations hinder or prevent service
being given under warranty .
Service under this warranty does not affect the expiration date of the warranty . The warranty on
parts or entire devices which are exchanged ends when the warranty on this device expires .
In the event of a claim of this device, return the complete device (charging unit and the LED curing
light) together with the invoice to your dealer or send it to your nearest Dentsply Sirona Service
Center .
All other claims including those for damages resulting from this warranty are excluded unless our
liability is legally mandatory .
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