E-SOUM-PLUS Rev E
2
Table of Contents
1.
General Safety Statements ................................................................................................................................. 3
3
1.1.
EMC Statement ......................................................................................................................................... 3
1.2.
Electrical Safety Statement ....................................................................................................................... 7
1.3.
Environmental Statement ......................................................................................................................... 8
1.4.
Summary Of Safety Notices ...................................................................................................................... 8
1.5.
Trademark Information ............................................................................................................................. 12
1.6.
Explanation Of Symbols ............................................................................................................................ 13
2.
Indications And Contra Indications.............................................................................................................. 14
2.1.
Indications ................................................................................................................................................. 14
2.2.
Contra Indications ..................................................................................................................................... 14
3.
Adverse Effects ................................................................................................................................................... 14
4.
Considerations During Clinical Use .............................................................................................................. 15
4.1.
SonicOne CLINIC Use ................................................................................................................................. 15
5.
System Overview ................................................................................................................................................ 17
5.1.
Principle Of Operation .............................................................................................................................. 17
5.2.
Reusable System Components ........................................................................................................... 18
5.3.
Single Use, Sterile Components ......................................................................................................... 19
6.
Console ........................................................................................................................................................ 19
6.1.
Receptacles, Controls And Indicators ....................................................................................................... 19
6.2.
Menu Functions ........................................................................................................................................ 21
6.3.
Main Functions.......................................................................................................................................... 23
6.4.
Alerts And Indicators ................................................................................................................................. 25
7.
System Set-Up ..................................................................................................................................................... 27
7.1.
Installation ................................................................................................................................................ 27
7.2.
Console Set-up – Part I (Non-sterile) ......................................................................................................... 29
7.3.
Handpiece Assembly (Sterile) ................................................................................................................... 29
7.4.
Console Set-up – Part II (Non-sterile) ........................................................................................................ 30
7.5.
Perform System Check .............................................................................................................................. 32
8.
Handpiece Assembly And Disassembly ....................................................................................................... 32
8.1.
Handpiece Assembly .......................................................................................................................... 32
8.2.
Handpiece Disassembly ..................................................................................................................... 33
9.
Cleaning And Sterilization............................................................................................................................ 34
9.1.
Disassembly .............................................................................................................................................. 34
9.2.
Cleaning ............................................................................................................................................. 35
9.3.
Sterilizing By Steam Autoclave ........................................................................................................... 38
9.4.
Expected Life, Reusable Components ....................................................................................................... 39
9.5.
Deviations From Decontamination, Cleaning And Sterilization Instructions...................................... 39
10.
Troubleshooting .......................................................................................................................................... 39
11.
Specifications ...................................................................................................................................................... 42
12.
Service, Repair And Technical Correspondence .......................................................................................... 43
12.1.
Fuse Replacement ..................................................................................................................................... 43
12.2.
Pump Head Replacement .................................................................................................................. 45
12.3.
Repair, Service and Replacement Parts .................................................................................................... 46
12.4.
Important Notice ...................................................................................................................................... 47
