Misonix neXus - Default Chapter; Table of Contents

Instructions For Use – neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 3
Table of Contents
1. General Safety Statements .............................................................................................................................................................. 4
1.1. EMC Statement ...................................................................................................................................................................... 4
1.2. Electrical Safety Statement .................................................................................................................................................... 9
1.3. Environmental Statement ...................................................................................................................................................... 9
1.4. Summary of Safety Notices .................................................................................................................................................. 10
1.5. Explanation of Symbols ...................................................................................................................................................... 15
2. Indications and Contraindications ............................................................................................................................................... 18
2.1. Indications for Use ............................................................................................................................................................... 18
2.2. Intended Use Environment .................................................................................................................................................. 19
2.3. Contraindications ................................................................................................................................................................. 19
3. Adverse Effects .............................................................................................................................................................................. 19
4. Considerations During Clinical Use .............................................................................................................................................. 20
4.1. Hard Tissue Applications/Use (e.g. BoneScalpel Applications) ............................................................................................... 20
4.2. Wound Debridement Applications / Use (e.g. SonicOne applications) .................................................................................. 22
4.3 Soft Tissue Applications / Use (e.g. SonaStar Applications) ................................................................................................. 22
5. System Overview .......................................................................................................................................................................... 23
5.1. Principle of Operation .......................................................................................................................................................... 23
5.2. Reusable, Non-Sterile Components ..................................................................................................................................... 23
5.3. Single Use, Sterile Components ......................................................................................................................................... 23
6. Console Setup and Use ................................................................................................................................................................ 24
6.1. Installation ........................................................................................................................................................................... 24
6.2. Initial Setup .......................................................................................................................................................................... 25
6.3 Power Up and Setup ............................................................................................................................................................ 26
6.4 Tubing Connection ................................................................................................................................................................... 28
6.5 Handpiece Assembly & Disassembly ....................................................................................................................................... 30
6.6 Priming Irrigation Tubing ..................................................................................................................................................... 31
6.7 Main Screen with a Standard Handpiece (e.g. BoneScalpel or SonicOne)........................................................................... 32
6.8 Main Screen with a Sonastar Handpiece (e.g. SonaStar Short or SonaStar Long) ............................................................... 34
6.9 Mode Selection & Functionality ........................................................................................................................................... 36
6.10 System Check ....................................................................................................................................................................... 36
6.11 Footswitch Connectivity & Functionality ............................................................................................................................. 37
6.12 Powering Down the Console ................................................................................................................................................ 40
7. Cleaning Console .......................................................................................................................................................................... 41
7.1 Console & Footswitch Cleaning ............................................................................................................................................. 41
7.2 Single-Use Item Disposal ....................................................................................................................................................... 41
8. Faults, Indicators & Troubleshooting .......................................................................................................................................... 42
8.1 Electrical Faults ....................................................................................................................................................................... 43
8.2 Mechanical Faults ................................................................................................................................................................... 44
8.3 Power Supply Faults ............................................................................................................................................................... 45
8.4 Communication Faults ........................................................................................................................................................... 45
8.5 Temperature Faults ................................................................................................................................................................ 46
8.6 Footswitch Faults ................................................................................................................................................................... 46
8.7 Handpiece Faults .................................................................................................................................................................... 47
8.8 Aspiration Troubleshooting ................................................................................................................................................... 48
8.9 Irrigation Troubleshooting ..................................................................................................................................................... 48
9. Specifications ................................................................................................................................................................................ 50
10. Service, Repair and Technical Correspondence .......................................................................................................................... 51