Contents
1 Documentation
3
1.1 Associated documentation
3
1.2 Electronic documentation
3
2 Required information
5
2.1 Indication for use
5
2.2 Operating principle
5
2.3 Using accessories not supplied by the manufacturer
5
2.4 Connecting and disconnecting accessories during use
5
2.5 Repairing or modifying the medical device
5
2.6 Warranty
5
2.7 Latest document update
5
2.8 Date of first CE marking
5
2.9 Accessory usage conditions
6
3 Unpacking the medical device
7
4 Installing the medical device
9
4.1 Handpiece
9
4.2 Handpiece cord
9
4.3 Connecting the handpiece
9
4.4 Attaching a tip or a file
9
4.5 Install an LED ring
10
5 Dispensing a treatment
11
5.1 Accessory usage conditions
11
5.2 Preparation for use
11
6 Disinfection and sterilising
13
6.1 Clean and disinfect the medical device
13
6.2 Cleaning, disinfecting and sterilising accessories
13
7 Monitoring and routine maintenance
15
7.1 Cleaning the irrigation system
15
7.2 Corrective Maintenance
15
7.2.1 Replacing the handpiece seal
15
8 Identifying incorrect operation
17
8.1 No spray
17
8.2 Ultrasounds not working
17
8.3 Water leakage
17
8.4 No light
17
9 Technical specifications of the medical device
19
9.1 Identification
19
9.2 Handpiece
19
9.3 Light
19
9.4 Length of cords
19
9.5 Irrigation
19
9.6 Environmental characteristics
19
9.7 Environmental restrictions
19
9.8 Main performance characteristics
19
10 Regulations and standards
21
10.1 Applicable standards and regulations
21
10.2 Medical class of the device
21
10.3 Symbols
21
10.4 Quick Start and Quick Clean symbols
23
10.5 Manufacturer identification
24
10.6 Branch addresses
24
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