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Invasix InMode User Manual

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wT
System
InMode
Operator Manual
Version: DO606736C
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Invasix InMode Specifications

General IconGeneral
RF Frequency1 MHz
FDA ClearedYes
TechnologyRadiofrequency (RF)
ApplicationsBody contouring, skin tightening, cellulite reduction
Treatment AreasFace, neck, body (abdomen, thighs, arms)
Safety FeaturesTemperature monitoring

Summary

Section 1: Introduction

Before You Start

Guidelines for qualified medical professionals and safety requirements.

System Overview

Describes the InMode System technologies and applications.

Conventions Used in the Manual

Explains symbols and notes used throughout the manual for clarity.

Explanation of the Symbols used on the System

Details various symbols and their meanings related to device operation and safety.

Section 2: Safety

The Patient

Safety considerations for the patient, including history and protective measures.

Treating Attendant

Safety requirements for personnel operating the system.

Cautions

Important warnings and precautions for safe system use.

Ocular Hazards

Risks associated with laser and IPL light exposure to the eyes.

Ocular Safety Considerations

Measures and requirements for eye protection during treatments.

Electrical and Mechanical Safety

Precautions related to the system's electrical components and physical handling.

Fire Hazards

Identifies substances and conditions that pose fire or explosion risks.

Safety Features of the System

Outlines built-in safety mechanisms of the InMode System.

Safe Use of the Active Accessories

Guidelines for safely connecting and using handpieces and accessories.

Warnings

General warnings regarding equipment usage, connections, and cleaning.

Device Labels

Explains warning and information labels found on the InMode device console.

Handpiece Labels

Details certification and identification labels affixed to the handpieces.

Equipment Classification

Lists equipment classifications for shock protection, liquid ingress, and usage environments.

Section 3: System Installation

Electrical Requirements

Specifies power supply, voltage, frequency, and grounding requirements.

Environmental Requirements

Outlines necessary room temperature and humidity for optimal operation.

Equipment List

Lists all components included with the InMode System.

Unpacking

Step-by-step instructions for safely unpacking the device.

Installation

Procedures for setting up the system in a clinic environment.

Filling Water

Instructions for filling the system with distilled water, crucial for warranty.

Moving the System

Guidelines for safely transporting the system, including precautions.

System Disposal

Regulations and instructions for proper disposal of the equipment.

Section 4: Device Description

Rear Panel

Details components and connectors located on the rear of the system.

Front Panel and Operator Control Panel

Describes the user interface, including the LCD screen and buttons.

Software Screens

Illustrates key software interfaces like Splash, Login, and Menu screens.

Sound Indicator

Explains audible signals emitted by the system during operation.

Cut-Off Temperature Control

Describes the safety feature that manages skin temperature during RF treatments.

Handpieces

Provides an overview of the different types of handpieces used with the system.

Section 5: System Operation

Device Start-Up

Step-by-step guide for powering on and preparing the InMode System for use.

System Shutdown

Procedures for safely turning off the InMode System.

Section 6: Diolaze Treatment Information

Indications for Use

Specifies the intended applications for the Diolaze handpiece, focusing on hair removal.

Contraindications

Lists conditions and situations where Diolaze treatment is not recommended.

Possible Adverse Effects

Describes potential side effects patients may experience post-treatment.

Pre-treatment Recommendations

Guidelines for preparing patients before Diolaze treatments.

Tip Cleaning Instructions Prior to Use

Procedures for cleaning the Diolaze handpiece output window.

Treatment Recommendations

Details typical treatment parameters and steps for Diolaze hair removal.

Treatment Schedule

Information on the typical number and frequency of Diolaze treatment sessions.

Post Treatment Recommendations

Advice for patients on post-Diolaze treatment care.

Section 7: DiolazeXL Treatment Information

Indications for Use

Specifies the intended application of DiolazeXL handpieces for hair removal.

Contraindications

Lists conditions where DiolazeXL treatment is contraindicated.

Possible Adverse Effects

Details potential side effects from DiolazeXL treatments.

Pre-Treatment Recommendations

Guidelines for patient preparation before DiolazeXL treatments.

Tip Cleaning Instructions Prior to Use

Instructions for cleaning the DiolazeXL handpiece output window.

Treatment Recommendations

Provides parameters and steps for DiolazeXL hair removal treatments.

Treatment Schedule

Information on the typical frequency and number of DiolazeXL sessions.

Post-Treatment Recommendations

Guidance for patients on post-DiolazeXL treatment care.

Section 8: Lumecca Treatment Information

Instructions for Use

Specifies the intended use of Lumecca handpieces for skin rejuvenation.

Contraindications

Lists conditions where Lumecca treatment is not advised.

Possible Adverse Effects

Describes potential side effects of Lumecca treatments.

Pre-Treatment

Guidelines for patient preparation before Lumecca treatments.

Tip Cleaning Instructions Prior to Use

Instructions for cleaning the Lumecca handpiece light guide.

Treatment Recommendations

Provides parameters and steps for Lumecca treatments.

Post-Treatment Recommendations

Guidance for patients on post-Lumecca treatment care.

Treatment Schedule

Information on the typical number and frequency of Lumecca sessions.

Section 9: Fractora Treatment Information

Fractional Skin Resurfacing

Explains the mechanism of RF energy delivery for skin resurfacing.

Instructions for Use

Specifies the intended use of the Fractora handpiece for skin ablation and resurfacing.

Contraindications

Lists conditions where Fractora treatment is contraindicated.

Possible Adverse Effects

Details potential side effects of Fractora treatments.

Pre-Treatment Recommendations

Guidelines for patient preparation before Fractora treatments.

Tip Cleaning Instructions Prior to Use

Instructions for cleaning the Fractora handpiece tip.

Test Spots

Procedures for performing test spots to assess patient suitability and response.

Treatment Recommendations

Provides parameters and steps for Fractora treatments.

Treatment Schedule

Information on the typical number and frequency of Fractora sessions.

Post-Treatment Recommendations

Guidance for patients on post-Fractora treatment care.

Section 10: Forma/Plus Treatment Information

Instructions for Use

Specifies the intended use of Forma and Plus handpieces for skin rejuvenation.

Contraindications

Lists conditions where Forma/Plus treatment is contraindicated.

Possible Adverse Effects

Details potential side effects of Forma/Plus treatments.

Handpiece Cleaning Instructions Prior to Use

Instructions for cleaning Forma/Plus handpieces.

Pre-Treatment Recommendations

Guidelines for patient preparation before Forma/Plus treatments.

Treatment Recommendations

Provides parameters and steps for Forma/Plus treatments.

Treatment Schedule

Information on the typical number and frequency of Forma/Plus sessions.

Post-Treatment Recommendations

Guidance for patients on post-Forma/Plus treatment care.

Section 11: BodyFX/MiniFX Treatment Information

Indications for Use

Specifies intended uses for BodyFX/MiniFX handpieces for body contouring and pain relief.

Contraindications

Lists conditions where BodyFX/MiniFX treatment is contraindicated.

Possible Adverse Effects

Details potential side effects of BodyFX/MiniFX treatments.

Handpiece Cleaning Instructions Prior to Use

Instructions for cleaning BodyFX/MiniFX handpieces.

Pre-Treatment Recommendations

Guidelines for patient preparation before BodyFX/MiniFX treatments.

Treatment Recommendations

Provides parameters and steps for BodyFX/MiniFX treatments.

Treatment Schedule

Information on the typical number and frequency of BodyFX/MiniFX sessions.

Post-Treatment Recommendations

Guidance for patients on post-BodyFX/MiniFX treatment care.

Section 12: System Maintenance

Maintenance & Frequency

Outlines recommended maintenance procedures and their frequency.

Before and after each treatment

Daily cleaning and disinfection procedures for the system and handpieces.

Once a Week

Weekly cleaning tasks for the system and dust cover.

Once a Month

Monthly procedure for replacing cooling water.

Once a Year

Annual replacement of deionizer cartridge and capsule filter.

Filling Water for Diolaze, DiolazeXL and Lumecca

Step-by-step guide for filling the system with distilled water.

Draining Water for Diolaze, DiolazeXL and Lumecca

Procedures for draining water from the system and handpieces for storage.

Draining the Laser/IPL Handpieces with the Water Draining Tool

Specific instructions for using a tool to drain handpieces.

Replacing the Deionizer Cartridge

Guide for removing and installing a new deionizer cartridge.

Replacing the Capsule Filter

Instructions for replacing the capsule filter.

Air Filter

Information on cleaning and maintaining the air filter.

Section 13: Troubleshooting

Description of Faults with All Handpieces

Lists common problems, their descriptions, and initial troubleshooting checks.

Section 14: System Specifications

Input Power

Details electrical input requirements like voltage and current.

Operating Parameters

Specifies ambient temperature, humidity, and pressure for operation.

Transport and Storage

Conditions for transporting and storing the system.

Dimensions

Physical size specifications of the system and handpiece cables.

Weight

Lists the weight of the system and various handpiece applicators.

Diolaze Output Parameters

Technical output specifications for Diolaze handpieces.

DiolazeXL Output Parameters

Technical output specifications for DiolazeXL handpieces.

Lumecca Output Parameters

Technical output specifications for Lumecca handpieces.

Fractora Output Parameters

Technical output specifications for Fractora handpieces.

Forma Output Parameters

Technical output specifications for Forma handpieces.

Plus Output Parameters

Technical output specifications for Plus handpieces.

BodyFX Output Parameters

Technical output specifications for BodyFX handpieces.

MiniFX Output Parameters

Technical output specifications for MiniFX handpieces.

Output Power Curves

Graphical representation of power output versus impedance for RF modes.

EMC Safety

Information regarding electromagnetic compatibility and interference.