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Misonix SonaStar SYSTEM-M300-0 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-M300-0 Series Specifications

General IconGeneral
BrandMisonix
ModelSonaStar SYSTEM-M300-0 Series
CategoryMedical Equipment
LanguageEnglish

Summary

General Safety Statements

Safety Notices, Warnings, and Cautions

Summarizes all precaution, warning, and caution statements for safe operation.

EMC Statement and Guidance

Electromagnetic Emissions Guidance

Details emissions test results and guidance for electromagnetic environment.

Electromagnetic Immunity Guidance

Details immunity test results and guidance for electromagnetic environment.

Electrical Safety Statement

Indications and Contraindications

Indications for Use

Lists surgical specialties for which the SonaStar system is indicated for use.

Contraindications for Use

Lists conditions or procedures for which the SonaStar system should not be used.

SonaStar Principle of Operation

Ultrasonic Theory Explained

Explains the ultrasonic technology used for tissue fragmentation and ablation.

System Overview

Provides a general overview of the SonaStar system's functions and components.

System Modes: Irrigation, Aspiration, Vibration

Details the functions of Irrigation, Aspiration, Vibration systems and modes.

Standby and Suspend Modes

Explains the system's automatic standby and suspend modes after inactivity.

Wireless Footswitch Operation

Describes the infrared wireless footswitch and its communication with the console.

Reusable System Components

System Components and Accessories

Single-use Sterile Components

Identifies disposable sterile components necessary for each procedure.

Optional Accessories for Monopolar COAG

Lists optional accessories needed for monopolar COAG functionality.

Console Controls and Indicators

Side Panel Receptacles

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

Front Panel Controls and Displays

Details the controls and displays for Irrigation, Aspiration, and Vibration levels.

Vibration Level Controls and Modes

Details vibration controls, Lap Mode, Preset, and Linear modes.

Setup Key, Display, and Power Switch

Explains Setup key, time/fault display, and power switch functions.

Rear Console Controls and Storage

Rear Panel Controls and Indicators

Covers Fault Override, Volume controls, Receptacles, Fan, Fuse, and Storage.

Lower Console Connections and Components

Details suction, filter, electrosurgery, power connections, and storage.

Filter and Tubing Connections

Describes connections for vacuum ports, filters, and tubing.

Wireless System Controls and Indicators

Wireless System Indicators

Explains the battery and activation indicators for the wireless system.

Wireless Footswitch Operation

Details the functions and components of the wireless footswitch.

Foot Pedal Operation Modes

Standard Operation Foot Pedal Functions

Details functions for Vibration, Vibration+COAG, FLUSH, and COAG pedal modes.

Lap Mode Foot Pedal Functions

Details functions for Lap Mode Vibration, Vibration+COAG, FLUSH, and COAG.

System Setup and Installation

Installation and Requirements

Instructions for installing the system, space, and electrical requirements.

Pre-Operative Preparation

Outlines the steps and items required for preparing the system before surgery.

Console Setup Part I and Handpiece Assembly

Steps for console setup and initial handpiece assembly.

Handpiece Assembly Methods

Detailed procedures for handpiece assembly in sterile and non-sterile fields.

Console Setup Part II

System Check Procedure

Operative Use of System

Setting Operating Levels

How to select desired operating levels for Irrigation, Aspiration, and Vibration.

Mode Selection and Procedure Start

Instructions for enabling Lap Mode, choosing vibration modes, and starting the procedure.

Post-Operative Procedure

Handpiece Assembly and Disassembly

Items and Inspection for Handpiece Assembly

Lists required items and inspection steps for handpiece assembly.

Curved Extended Handpiece Assembly

Step-by-step guide for assembling the Curved Extended Handpiece.

Electrosurgery Connector Assembly

Details on assembling the electrosurgery connector for the handpiece.

Short Straight Handpiece Disassembly

Curved Extended Handpiece Disassembly

Monopolar COAG Guidelines

Background and Approved Generators

Provides background on electrosurgery and lists approved generators.

Monopolar COAG Interface Accessories

Lists accessories needed for connecting to an electrosurgical device.

Preparing for Monopolar COAG Use

Steps for preparing the system for monopolar COAG function.

Using Monopolar COAG with SonaStar

Guidelines for operating the SonaStar system with electrosurgery for COAG.

Cleaning, Sterilization, and Maintenance

Handpiece Disassembly and Single-Use Items

Instructions for disassembling the handpiece and disposing of single-use items.

Cleaning Procedures

Details the cleaning procedures for reusable SonaStar components.

Manual Cleaning Procedures

Step-by-step guide for manually cleaning wrenches and handpiece components.

Automated Wash Procedure

Procedure for automated washing and disinfection of handpieces and components.

Cleaning Console, Footswitch, and IR Receiver

Instructions for cleaning the console, footswitch, and IR receiver.

Sterilization of Reusable Components

Sterilization for Disassembled Handpiece

Sterilization parameters for disassembled handpieces using Misonix trays.

Sterilization for Assembled Handpiece

Sterilization parameters for assembled handpieces without trays.

Decontamination and Maintenance Procedures

Deviations from Sterilization Instructions

Addresses deviations from standard cleaning and sterilization procedures.

Moving the Unit

Instructions for safely moving the SonaStar system.

Periodic Maintenance

Schedule and procedures for periodic maintenance tasks.

Filter Replacement Procedures

Instructions for replacing external, internal filters, and activated carbon filter.

Troubleshooting Common Issues

Malfunctions Without Error Codes

Troubleshooting guide for common issues not generating error codes.

Error Code Messages and Clearing Faults

Lists error codes, causes, actions, and steps for clearing system faults.

Overriding System Faults

Method for overriding persistent faults, provided they are not critical.

System Specifications

Console, Footswitch, and IR Receiver Specs

Technical specifications for the console, footswitch, and IR receiver.

Handpiece and Receiver Specifications

Technical specifications for handpieces and the remote IR receiver.

Service, Repair, and Fuse Information

Fuse Requirements and Locations

Details fuse types, ratings, and locations for the SonaStar system.

Fuse Replacement Procedure

Step-by-step instructions for replacing fuses in the console.

Repair, Service, and Important Notices

Repair, Service, and Replacement Parts

Information on obtaining repairs, service, and replacement parts for the SonaStar.

Important Notice and Contact Information

Provides contact info for Misonix support and important notices.

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