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Misonix sonicone Clinic User Manual

Misonix sonicone Clinic
52 pages
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Instructions For Use
SonicOne Clinic Powered by Misonix

Questions and Answers:

Misonix sonicone Clinic Specifications

General IconGeneral
BrandMisonix
Modelsonicone Clinic
CategoryMedical Equipment
LanguageEnglish

Summary

General Safety Statements

EMC Statement

Ensures compliance with FCC and IEC guidelines for electromagnetic compatibility...

Electrical Safety Statement

Details compliance with UL and EN standards for electrical safety...

Environmental Statement

Information regarding disposal and environmental impact of the device...

Summary Of Safety Notices

A compilation of all safety precautions, warnings, and cautions from the manual.

Trademark Information

Lists registered trademarks of Misonix and other companies.

Explanation Of Symbols

Defines the various symbols used throughout the operator's manual.

Indications and Contraindications

Indications for Use

Specifies the surgical specialties and applications for which the SonicOne CLINIC system is indicated.

Contraindications

Details situations and procedures where the SonicOne CLINIC system should not be used.

Adverse Effects

Tissue Necrosis and Heat

Discusses risks of tissue necrosis due to tip temperature and insufficient irrigation during use.

Acoustic Pressure and Patient Protection

Addresses potential harmful acoustic pressure and the need for hearing protection.

Clinical Use Considerations

Avoiding Burns and Tissue Damage

Provides guidance on avoiding burns from vibrating elements and managing tip/tissue contact.

Recommended Settings

Offers general guidelines for Amplitude, Pulse, and Flow settings based on clinical scenarios.

System Overview

Principle of Operation

Explains how the SonicOne CLINIC system works, including console, handpiece, and transducer functions.

Reusable System Components

Lists and illustrates the minimum reusable components required for soft and hard tissue procedures.

Autoclavable Debridement Probes

Details the various autoclavable probes available for debridement applications.

Single Use, Sterile Components

Identifies disposable components, including irrigation tubesets and handpiece sheaths.

Additional Probe Tips

Discusses Misonix SonicOne OR and BoneScalpel sterile, single-use disposable probe tips.

Console Operation

Receptacles, Controls, and Indicators

Describes the rear and front panel features, including ports, buttons, and display indicators.

Menu Functions and Navigation

Explains how to navigate through the Main, Options, and Help screens using menu buttons.

Main Functions: Amplitude, Pulse, Flow

Details the control and adjustment of Amplitude, Pulse, and Flow settings on the console.

Alerts and Indicators

Explains system alerts such as Mechanical Limit and Electrical Fault, and their corrective actions.

System Setup and Installation

Installation and Operating Conditions

Guides on inspecting components, installing the unit, and maintaining operating conditions.

Console Setup - Part I (Non-sterile)

Steps for initial console setup, including power, IV pole, and footswitch connections.

Handpiece Assembly (Sterile)

Instructions for assembling the handpiece in the sterile field by trained OR staff.

Console Setup - Part II (Non-sterile)

Completes console setup with handpiece cable, pump, tubing, and initial settings.

Perform System Check

Details the procedure for performing a system check before patient preparation.

Handpiece Assembly and Disassembly

Handpiece Assembly Procedure

Step-by-step guide for inspecting and assembling the handpiece components.

Handpiece Disassembly Procedure

Instructions for disassembling the handpiece components after use.

Cleaning and Sterilization

Disassembly for Cleaning

Procedures for disassembling the console and handpiece for cleaning and sterilization.

Manual Cleaning Procedures

Details manual cleaning steps for reusable components like probe covers and wrenches.

Automated Wash Procedure

Outlines the automated washing and disinfection cycle parameters for handpiece components.

Sterilizing By Steam Autoclave

Provides validated steam sterilization cycles for handpieces and probes.

Troubleshooting Guide

Mechanical Limit Alerts

Explains the mechanical limit alert, its causes, and recommended corrective actions.

Electrical Fault Alerts

Details electrical fault alerts, possible causes, and corrective actions for system issues.

Lack of Irrigant Issues

Troubleshooting steps for symptoms related to insufficient or absent irrigant flow.

System Specifications

Console Specifications

Lists technical specifications for the SonicOne CLINIC console, including power and dimensions.

System Contents and Classification

Details the components included in the system and its UL/IEC classification.

Service and Repair

Fuse Replacement Procedures

Provides instructions for replacing fuses in the SonicOne CLINIC console.

Pump Head Replacement

Guides on the removal and installation of the pump head assembly.

Repair, Service, and Parts

Information on obtaining service, authorized repairs, and using genuine replacement parts.

Important Contact and Return Information

Provides contact details for Misonix, Inc. and information for returning materials for service.

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