Instructions for use INTRA K-LUX 200 – 1.000.6717, INTRA K-LUX 200 F – 1.002.1912
3 Description of the product | 3.1 Intended use
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3 Description of the product
INTRA K-LUX 200 (
Mat. no. 1.000.6717
)
INTRA K-LUX 200 F (
Mat. no. 1.002.1912
)
3.1 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
▪ designed to drive / operate a straight / contra-angle dental 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 only use equipment that is operating correctly
▪ to comply with the specified intended use
▪ to protect him or herself, the patient and third parties from hazards
▪ to prevent contamination from the product
