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Novoxel Tixel2 - User Manual

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69 pages
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Table of Contents

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Summary

Chapter 1: Introduction

Scope

Description of the manual's purpose and content.

Introduction

General introduction to the manual and its importance.

Copyrights and Declaration

Before You Begin

General cautionary notes and operator responsibility.

Specifications of This Manual

Glossary, Conventions, Abbreviations, Signs and Symbols

Glossary

Defines terms used in the manual.

Abbreviations

Lists abbreviations and their meanings.

Signs and Symbols

Explains symbols used in the manual.

Operating State, Location and Position

Operating State, Location and Position

Describes required operating conditions and environment.

Electrical Safety Information

Provides safety guidelines related to electrical aspects.

Environmental Protection

Discusses proper disposal of electronic waste.

Applicable Standards

Lists relevant industry standards.

The Tixel2 device - Overview

System Layout and Components

The Tixel2 Console

Details the main console unit.

The Tixel2 Handpieces

Describes the handheld components.

Principle of Operation and System Components

The Novoxel Tip

Discusses the treatment tips.

The Standard Tip

Details the standard tip configuration.

The Periorbital Tip

Details the periorbital tip configuration.

Chapter 3: Package Contents & the Unboxing Process

Package Contents & the Unboxing Process

Lists items included and unboxing steps.

Installation

Chapter 4: Operating Instructions

Turning on the Tixel2 device & Operating the Touchscreen

Guides on powering up and using the interface.

The Home Screen

Describes the initial screen and its features.

The Operating Screen

Explains the screen for selecting treatment parameters.

Preparing the Second Handpiece for Operation

Instructions for preparing the second handpiece.

Switching between Handpieces

How to switch active handpieces.

Automatic Hibernation;End of Session

Describes system behavior after use.

Pulse Credit & the Pulse Credit Screen

Explains pulse credit system.

Purchasing of Pulse Credit

How to buy more pulse credits.

The Novoxel Application

Using the mobile app for pulse credit.

System Shutdown

Procedure for turning off the device.

Chapter 5: Troubleshooting

Troubleshooting

General overview of troubleshooting.

Displayed Screen

Shows error screens and their comments.

Chapter 6: Caring For the Tips

Tip Cleaning

Instructions for cleaning the treatment tips.

Tip Sterilization

Describes the dry-heat sterilization process.

Chapter 7: Clinical Information and Guidelines

Intended Use

Describes the device's purpose and application.

Indication for Use

Specifies the conditions the device treats.

Contraindications for Use

Lists conditions where the device should not be used.

Intended User

Defines who can operate the device.

Intended Treatment Areas

Specifies areas suitable for treatment.

Pre-Treatment Patient Preparation

Guidelines for preparing patients.

In-Clinic Pre-Treatment Patient Preparation

Specific preparation steps within the clinic.

Determination of Treatment Parameters

How to set treatment settings.

First Treatment

Guidance for initial patient treatments.

Single vs. Double Pulse Mode

Explains pulse mode options.

Protrusion

Discusses protrusion settings.

Device Preparation

Steps before operating the device.

Routine Treatment

Guidelines for regular treatments.

Criss-Cross Mode

Technique for wrinkled areas.

Area Specific Treatment guidelines

Tailoring treatment to different body areas.

Frame Segments

Specifics for facial areas.

Boney Facial Treatment Areas

Identifies specific facial areas.

Specific Skin Irregularities: Moles;Open Sores

Advice on treating these conditions.

Post-Treatment

Recommendations after treatment.

Typical Patient Response to Treatment

Shows examples of patient outcomes.

Post-Treatment Patient Guidance

Advice for patients after treatment.

Safety Guidelines

General safety rules.

General Safety: Supervising Physician

Role of the supervising physician.

Chapter 8: Maintenance, Service and Storage

Maintenance

General maintenance procedures.

Product Lifetime

Information on device lifespan.

Technical Device Service

When and how to get service.

Cleaning

Instructions for cleaning.

Storage and Packaging

How to store and pack the device.

Disposal

Guidelines for disposing of the device.

Periodic Inspection & Service Instructions

Instructions for periodic checks.

Chapter 9: General Guidance and Manufacturers Declaration: Essential Performance & Electromagnetic Emissions & Immunity

Essential Performance

Key performance characteristics.

Electromagnetic Emissions & Immunity

EMC information and compliance.

Novoxel Tixel2 Specifications

General IconGeneral
TechnologyThermo-Mechanical Ablation (TMA)
Tip Temperature400°C
Treatment Area1 cm²
DisplayTouchscreen
Tip MaterialTitanium
Cooling SystemNot required
Treatment AreasFace, neck, décolleté
IndicationsSkin rejuvenation, acne scars, wrinkles
Treatment TimeVaries by area
Number of TipsSingle-use tip
Power SupplyMains powered
Pulse DurationAdjustable (typically 5-15 ms)