Misonix sonastar SYSTEM-M200 - Table of Contents

Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 1 of 71
TABLE OF CONTENTS
1. Operating Safety Precautions ................................................................................................... 4
1.1 General ................................................................................................................................ 4
1.2 Conventions: Warnings, Cautions, and Notes ....................................................................... 4
1.3 Safety: Recommendations for the Use of this Device ...................................................... 4-12
1.4 Handling of Handpieces ..................................................................................................... 13
1.5 Explosion and Fire Hazard .................................................................................................. 13
1.6 High Voltage Hazard .......................................................................................................... 13
1.7 Power Receptacle and Plug ................................................................................................ 13
1.8 Grounding the Unit ............................................................................................................ 13
1.9 Using the Proper Fuse ........................................................................................................ 14
1.10 Standards, Classifications and Symbols Used ................................................................. 14-17
2. Installation ............................................................................................................................. 18
2.1 Space Requirements .......................................................................................................... 18
2.2 Environmental Limitations ................................................................................................. 18
2.3 Electrical Requirements .................................................................................................... 19
2.4 Unpacking and Inspection .................................................................................................. 19
2.5 Equipment List ................................................................................................................... 19
3. System Description ................................................................................................................. 20
3.1 Surgical Indications ............................................................................................................ 20
3.2 Contradictions .................................................................................................................... 20
3.3 Ultrasonic Theory ............................................................................................................... 20
3.4 System Overview .......................................................................................................... 21-22
3.5 Vibration System ................................................................................................................ 23
3.6 Irrigation System ................................................................................................................ 23
3.7 Aspiration System .............................................................................................................. 24
3.8 Wireless Footswitch ...................................................................................................... 24-25
4. Controls, Indicators and Connections ........................................................................................ 26
4.1 Overall System .............................................................................................................. 26-27
4.2 Front Panel .................................................................................................................... 28-30
4.3 Components Rear View: Controls & Indicators ...............................................................31-32
4.4 Wireless Indicators ........................................................................................................ 33-34
5. Handpieces ............................................................................................................................. 35
5.1 General .............................................................................................................................. 35
5.2 Handpiece Types ................................................................................................................ 35
5.3 Handpiece Assembly ..................................................................................................... 36-40
5.4 Electrosurgery Connector Assembly .................................................................................. 40
6. System Operating instructions ................................................................................................. 41
6.1 Pre-Operative Preparation ................................................................................................. 41
6.2 Handpiece Preparation .................................................................................................. 42-43
6.3 Preparing the SonaStar for Use: .................................................................................... 44-46
6.4 System Setup ................................................................................................................ 46-47
6.5 Operative Use .................................................................................................................... 48
6.6 Post-Operative Procedure .................................................................................................. 49
7. Monopolar Coag Guidelines...................................................................................................... 50
7.1 Background ................................................................................................................... 50-51
7.2 Preparing the System for Monopolar COAG Use ........................................................... 52-53
7.3 Using Monopolar COAG with the System ...................................................................... 54-55