Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
3 Product description | 3.1 Purpose – Intended use
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3 Product description
INTRA K-LUX 200 (
Mat. no. 1.000.6717
)
INTRA K-LUX 200 F (
Mat. no. 1.002.1912
)
3.1 Purpose – Intended use
Indications for use:
The motor is:
▪ An electrical low-voltage motor for dental purposes according to DIN EN ISO
14457 and classified as a type B applied part according to IEC 80601-2-60
▪ Intended to drive / operate a dental handpiece / contra-angle handpiece
equipped with a handpiece connection according to DIN EN ISO 3964
▪ not approved for use in areas at risk of explosion
▪ intended only for dental treatment by a dental professional, the product
must not be modified or used for any other purpose since this may be haz-
ardous
▪ a medical device according to relevant national statutory regulations
Proper use:
According to these regulations, this product may only be used for the described
application by a properly trained user. You need to comply with the following:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
▪ these Instructions for use
According to these regulations, the user is required to:
▪ to only use equipment that is operating correctly
▪ adhere to the specified intended use
▪ to protect him or herself, the patient and third parties from hazards
▪ to prevent contamination from the product
3.2 Technical data
Note
The INTRA K-LUX 200 / K-LUX 200 F motor may only be combined with the
specified motor electronics.
Содержание 1.000.6717
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