Instructions For Use Models with serial #’s that begin with FHF SYSTEM-M300 SYSTEM-M360 SYSTEM-M380 IFU-607 Rev D P age 1 of 65 Table of Contents 1. General Safety Statements ........................................................................................................................................................................ 3 1.1. Summary of Safety Notices: Warnings, Cautions and Notes............................................................................................................................. 3 1.2. EMC Statement ...................................................................................................................................................................................................6 1.3 Electrical Safety Statement ............................................................................................................................................................................. 10 1.4 Environmental Statement ................................................................................................................................................................................. 10 1.5 FCC Statement .................................................................................................................................................................................................... 11 1.6 Trademark Information ..................................................................................................................................................................................... 11 1.7 Explanation Of Symbols ..................................................................................................................................................................................... 12 2. Indications And Contraindications ............................................................................................................................................................ 14 2.1. Indications.......................................................................................................................................................................................................... 14 2.2. Contraindications .............................................................................................................................................................................................. 14 3. Adverse Effects ........................................................................................................................................................................................ 14 4. Principle of Operation ............................................................................................................................................................................... 15 4.1. Ultrasonic Theory .............................................................................................................................................................................................. 15 4.2. System Overview............................................................................................................................................................................................... 15 4.3. Reusable System Components ......................................................................................................................................................................... 18 4.4. Single-use, Sterile Components........................................................................................................................................................................ 19 4.5. Optional Accessories for Monopolar COAG .....................................................................................................................................................20 5. Console - Receptacles, Controls and Indicators ..........................................................................................................................................20 5.1. Side Panel Receptacles......................................................................................................................................................................................20 5.2 Front Panel Controls .......................................................................................................................................................................................... 21 5.3 Rear Controls, Labeling, Storage and Receptacles ..........................................................................................................................................24 5.4 Wireless System Receptacles, Controls and Indicators .................................................................................................................................... 27 6. System Set-up .......................................................................................................................................................................................... 31 6.1. Installation ......................................................................................................................................................................................................... 31 6.3 Console Set-up – Part I (In the Non-Sterile Field) ............................................................................................................................................. 32 6.4 Handpiece Assembly .......................................................................................................................................................................................... 32 6.5 Console Set-up – Part II (In the Non-Sterile Field) ............................................................................................................................................ 35 6.6 Perform System Check ...................................................................................................................................................................................... 36 6.7 Operative Use of System................................................................................................................................................................................... 37 6.8 Post-Operative Procedure ................................................................................................................................................................................ 38 7. Handpiece Assembly and Disassembly ..................................................................................................................................................... 39 7.1. Items Required for Handpiece Assembly .......................................................................................................................................................... 39 7.2. Handpiece Inspection ........................................................................................................................................................................................ 39 7.3. Handpiece Assembly – Curved Extended Handpiece (CE) ...............................................................................................................................40 7.4. Electrosurgery Connector Assembly ................................................................................................................................................................ 41 7.5. Handpiece Disassembly – Short Straight Handpiece (SS) ...............................................................................................................................42 7.6. Handpiece Disassembly – Curved Extended Handpiece (CE) ..........................................................................................................................42 8. Monopolar COAG Guidelines .................................................................................................................................................................... 44 8.1. Background........................................................................................................................................................................................................44 8.2. Preparing the System for Monopolar COAG Use ............................................................................................................................................. 45 8.3. Using Monopolar COAG with the SonaStar System ........................................................................................................................................46 9. Cleaning, Sterilization and Maintenance .................................................................................................................................................. 48 9.1. Disassembly .......................................................................................................................................................................................................48 9.2. Cleaning .............................................................................................................................................................................................................48 9.3. Sterilization of Reusable Sterile Field Components ......................................................................................................................................... 51 9.3.1 For Handpiece Disassembled