Dentsply Sirona SmartLite Pro Gebrauchsanweisung Seite 9

2005 – Medical electrical equipment - Part 1-2: General requirements for safety and
IEC 60601-1-2 essential 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
EN ISO 10993-1
risk management process
2017– Sterilization of medical devices – Information to be provided by the manufacturer
EN ISO 17664
for the processing of resterilizable medical devices
2012 – applies to the basic safety and essential performance of Dental Units, Dental
IEC 80601-2-60
Patient 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.
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.
6.9 Correspondence
1. The following numbers should be quoted in all correspondence:
• Reorder number
• Serial Number
2. Any serious incident in relation to the product should be reported to the
manufacturer and the competent authority according to local regulations.
Manufactured for
Dentsply LLC
38 West Clarke Avenue
Milford, DE 19963 USA
Made in Switzerland
1-302-422-4511
www.dentsplysirona.com
Dentsply DeTrey GmbH
De-Trey-Strasse 1
78467 Konstanz
Germany
© 2021 Dentsply Sirona Inc. All rights reserved.
109-DV5
544400DFU (R 5-4-21)
EN
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