Product-Specific - KaVo Poly One Instructions For Use Manual

Polymerisation light
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Instructions for use KaVo polymerisation light Poly One
2 Safety | 2.2 Purpose – Proper use
The overarching guidelines and/or national laws, national regulations and the
rules of technology applicable to medical devices for start-up and use of the KaVo
product for the intended purpose must be applied and followed.
The applicable national legal regulations must be observed during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and start-up of medical devi‐
ces.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
Users have a duty to:
▪ Only use equipment that is operating correctly
▪ to protect himself, the patient and third parties from danger.
▪ to avoid contamination from the product

2.2.2 Product-specific

The curing light Poly One is designed for the curing of dental materials in the oral
cavity of a patient in the course of a dental treatment. For installation on dental
treatment centres; the use is restricted to medical specialist staff in rooms used
for medical purposes.
The user must ensure that the device works safely and is in a satisfactory condi‐
tion before each use.
Information on electromagnetic compatibility
Note
Based on IEC 60601-1-2 (DIN EN 60601-1-2) concerning the electromagnetic
compatibility of electrical medical devices, we must draw your attention to the fol‐
lowing points:
• Electrical medical devices are subject to special precautionary measures re‐
garding electromagnetic compatibility and must be operated in accordance with
the KaVo installation instructions.
• Portable and mobile high-frequency communications devices can affect the op‐
eration of electrical medical devices.
Further details on the technical EMC description are available on request.
See also: For "Specific details concerning electromagnetic compatibility in accord‐
ance with EN 60601-1-2", see the instructions for use of the respective treatment
centre
Note
KaVo cannot guarantee the compliance of accessories, enclosed cables, and
other components not supplied by KaVo with EMC requirements of IEC
60601-1-2 (DIN EN 60601-1-2).
7/22

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