CEFLA VENUS PLUS - Intended Use; Classification; Environmental Conditions; Warranty

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EN
OPERATOR’S MANUAL
1.2. INTENDED USE
• The operating light is part of a dental surgery equipment and is used to illuminate the operating area.
• The operating light is designed for continuous operation.
• DEVICE FOR PROFESSIONAL USE: the use of the device is strictly reserved to qualied dental
professionals. Under no circumstances it can be used or handled by unskilled and/or unauthorised
persons.
1.2.1. CLASSIFICATION
• MEDICALDEVICESclassication
EquipmentclassicationaccordingtotherulessetoutinAnnex VIII of Reg. (EU) 2017/745: Class I.
• ELECTRICALMEDICALEQUIPMENTclassication.
 ClassicationofthedentalunitinaccordancewithstandardIEC60601-1onsafetyofmedicalequipment:
- VENUS PLUS / VENUS PLUS -L version / VENUS PLUS MCT version / VENUS PLUS E version:
Class II - Type B.
- VENUS PLUS CL version / VENUS PLUS CL -L version / VENUS PLUS CL MTC version:
Class I - Type B.
• PHOTOBIOLOGICALSAFETYclassication.
 • ClassicationoftheequipmentinaccordancewithstandardsEN62471:2008andIEC62471:2006:
- VENUS PLUS -L version / VENUS PLUS CL -L version / VENUS PLUS CL MCT version / VENUS PLUS
Eversion:Riskgroup1.
1.2.2. ENVIRONMENTAL CONDITIONS
The equipment is to be installed in rooms that satisfy the following requirements:
• temperature: +5 to +40° C;
• relative humidity from 25 to 75% (non-condensing);
• atmospheric pressure ranging from 700 to 1060 hPa;
• the electric system in the room in which the equipment is installed must conform to IEC 60364-7-710 V2
(standards for electric systems in medical and dental surgeries) or equivalent standards in force in the
country where the equipment is installed.
1.2.3. WARRANTY
The manufacturer stands behind its products warranting safety, reliability and performance.
The warranty is valid only under the following terms:
• Conditionsgivenonthewarrantycerticateareobserved.
• Yearly scheduled maintenance is performed.
• The equipment is only to be used as instructed in this manual.
• Equipment installation, expansion and technical support must be performed exclusively by personnel
authorised by the manufacturer to carry out these operations.
• The equipment must be installed only in rooms that follow the requirements specied in paragraph
“Environmental conditions”.