Dentsply Sirona SmartLite Pro EndoActivator Manual De Instrucciones página 23

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
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 EndoActivator™ System complies with:
UL 60601-1
CSA C22.2 No. 601.1
E113604
6.7 Warranty terms
Dentsply Sirona grants a 2-year warranty on all components of the SmartLite Pro EndoActivator™ System except
the battery and activator tips. The battery is covered by a 1-year warranty. There is no warranty on the activator
tips. 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.
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 base attachment and the handpiece)
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.
6.8 Lot Number, Expiration Date and Correspondence
1. The following numbers should be quoted in all correspondence:
• Reorder number
• Serial Number
• Expiration date
2. Any serious incident in relation to the product should be reported to the manufacturer and the competent
authority according to local regulations.
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