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Misonix SonaStar SYSTEM-M360-0 Series User Manual

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Instructions For Use
Models with serial #’s that begin with FHF
SYSTEM-M300
SYSTEM-M360
SYSTEM-M380

Table of Contents

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Misonix SonaStar SYSTEM-M360-0 Series Specifications

General IconGeneral
Relative Humidity30% to 75%, non-condensing
IrrigationIntegrated irrigation system
Voltage100-240 VAC
Operating Temperature10°C to 35°C (50°F to 95°F)
Storage Temperature-20°C to 50°C (-4°F to 122°F)

Summary

General Safety Statements

Summary of Safety Notices: Warnings, Cautions and Notes

Summarizes safety notices including warnings, cautions, and notes for user safety during operation.

EMC Statement

Details compliance with FCC regulations and IEC guidelines for electromagnetic compatibility.

Electrical Safety Statement

Provides safety information regarding electrical hazards, grounding, and voltage.

Environmental Statement

Information on material recycling and proper disposal of the equipment.

FCC Statement

States compliance with FCC regulations for conducted and radiated emissions.

Trademark Information

Lists registered trademarks and brand names associated with the system.

Explanation Of Symbols

Defines symbols used throughout the manual for console and general use.

Indications and Contraindications

Indications

Lists surgical specialties and uses for the SonaStar Ultrasonic Aspirator System.

Contraindications

Specifies procedures and conditions where the SonaStar system should not be used.

Adverse Effects

Details potential adverse effects, including airborne acoustic exposure limits.

Principle of Operation

Ultrasonic Theory

Explains the basic principle of ultrasonic tissue ablation using vibration and cavitation.

System Overview

Provides a general overview of the SonaStar system and its components.

Irrigation System

Describes how the irrigation system delivers fluid to the handpiece tip for cooling and cleaning.

Aspiration System

Details the aspiration system for removing fluid and fragmented tissue.

Vibration System

Explains how the vibration system achieves tissue fragmentation via high-frequency oscillation.

Standby Mode

Describes the system's automatic standby mode after a period of inactivity.

Suspend Mode

Explains the suspend mode where aspiration is inactive after prolonged standby.

Wireless Footswitch

Covers the operation and components of the wireless footswitch and IR receiver.

System Components and Accessories

Reusable System Components

Lists the various console configurations and reusable accessories included with the SonaStar system.

Single-use, Sterile Components

Details the single-use sterile components, such as tube sets, required for procedures.

Optional Accessories for Monopolar COAG

Lists optional accessories required for performing monopolar COAG procedures.

Console Controls and Indicators

Side Panel Receptacles

Identifies and describes the receptacles on the side panel of the SonaStar console.

Front Panel Controls

Details the controls and displays on the front panel of the console for system operation.

Rear Controls, Labeling, Storage and Receptacles

Identifies controls, labels, storage, and receptacles located on the rear of the console.

Wireless System Controls and Indicators

Describes controls and indicators for the wireless system, including footswitch.

System Operation

Standard Operation - Foot Pedal Functions

Describes the functions when foot pedals are depressed or released during standard operation.

Lap Mode - Foot Pedal Functions

Explains the foot pedal functions specifically for Lap Mode operations.

System Set-up

Installation

Provides instructions for installing the SonaStar system components.

Pre-Operative Preparation

Outlines the preparatory steps required before operating the SonaStar system.

Console Set-up – Part I

Details the initial console setup steps performed outside the sterile field.

Handpiece Assembly

Explains the procedures for assembling the handpiece.

Console Set-up – Part II

Outlines the second part of console setup performed outside the sterile field.

Perform System Check

Describes the procedure for performing a system check to ensure proper operation.

Operative Use of System

Guides the user on setting up the system for operative use, including selecting levels.

Post-Operative Procedure

Details the steps for tearing down and storing the system after a procedure.

Handpiece Assembly and Disassembly

Items Required for Handpiece Assembly

Lists all items necessary for assembling the handpiece.

Handpiece Inspection

Describes the inspection process for the handpiece and its components before assembly.

Handpiece Assembly – Curved Extended Handpiece (CE)

Provides step-by-step instructions for assembling the Curved Extended Handpiece.

Electrosurgery Connector Assembly

Explains how to assemble the electrosurgery connector on the handpiece.

Handpiece Disassembly – Short Straight Handpiece (SS)

Details the steps for disassembling the Short Straight Handpiece.

Handpiece Disassembly – Curved Extended Handpiece (CE)

Provides step-by-step instructions for disassembling the Curved Extended Handpiece.

Monopolar COAG Guidelines

Background

Provides background information on using the SonaStar system with electrosurgery.

Preparing the System for Monopolar COAG Use

Guides on preparing the system for monopolar COAG function.

Using Monopolar COAG with the SonaStar System

Details how to use the monopolar COAG feature with the SonaStar system.

Cleaning, Sterilization and Maintenance

Disassembly

Details the disassembly of handpiece components for cleaning and sterilization.

Cleaning

Provides validated cleaning procedures for reusable SonaStar system components.

Sterilization of Reusable Sterile Field Components

Outlines sterilization methods and parameters for reusable components.

Troubleshooting

Possible Malfunctions, Not Associated with an Error Code

Lists potential malfunctions not generating error codes and their corrective actions.

Error Code Messages

Explains error code messages that may appear on the display and their corrective actions.

Clearing Faults

Details the method for clearing faults after a problem has been fixed.

Overriding faults

Provides a method for overriding certain persistent E3 error codes if the fault is not critical.

Specifications

Console Specifications

Lists the technical specifications for the SonaStar console.

Wireless Footswitch Specifications

Details the technical specifications for the wireless footswitch.

Handpiece Specifications

Lists the technical specifications for the SonaStar handpieces.

Service, Repair and Technical Correspondence

Fuse Requirements

Details the types, ratings, and locations of fuses for the SonaStar system.

Repair, Service and Replacement Parts

Provides information on obtaining repairs, service, and replacement parts.

Important Notice

Contact information for Misonix regarding system specifications, use, and maintenance.

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