KaVo SONICflex seal 45, Instructions For Use Manual

Page: 9 / 20

Instructions for use SONICflex seal
3 Product description | 3.1 Intended use
9 / 20
3 Product description
3.1 Intended use
Indications for use:
This medical device is
▪ Intended for dental treatment only. All other types of use of or modifications
to the product are not permitted and can be hazardous.
The SONICflex seal tip is designed for use in combination with the SONICflex
for exposing and expanding fissures before sealing. Please refer also to the In-
structions for Use.
▪ A medical device according to relevant national statutory regulations.
Proper use:
According to these regulations, the medical device is to be used exclusively for
the described application while complying with
▪ The applicable occupational safety regulations
▪ The applicable accident prevention regulations
▪ And to use these instructions for use by the qualified user.
According to these regulations, the user is required:
▪ exclusive use of equipment that is operating correctly.
▪ compliance with the specified intended use.
▪ Protect themselves, patients and third parties from danger.
▪ Contamination by the product must be avoided.
3.2 SONICflex seal
①
SONICflex seal no. 45 - REF 1.000.8323
① SONICflex seal no. 45 A - REF 1.007.1506
3.3 Technical Specifications
① tip no. 45, conical, diamond-coated D 46
- REF 1.000.8323
①
tip no. 45 A, conical, diamond coated D 46
- REF 1.007.1506
The particle size of the diamond coating is D 46 as per ISO 6106.