Novoxel Tixel2 - Typical Patient Response to Treatment

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User Manual TXLD0012

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P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 53

Typical Patient Response to Treatment

Example # 1

Before Treatment (Left) / Immediately After Treatment (Right)

Crusting, 3 Days After Treatment; on the Right - An Enlarged View of the Left Cheek

Main Page

Table of Contents2
Scope6
Introduction6
This Manual6
Specifications of this Manual6
Glossary, Conventions, Abbreviations, Signs and Symbols7
Glossary7
Abbreviations8
Signs and Symbols9
Operating State, Location and Position10
Electrical Safety Information10
Electrical Medical Equipment Classification10
Environmental Protection12
Applicable Standards13
The Tixel2 Device - Overview13
System Layout and Components14
Principle of Operation and System Components16
The Novoxel® Tip16
The Standard Tip16
The Periorbital Tip17
The Tixel2 Console19
The Tixel2 Handpieces19
Handpiece/S Receiving Inspection - Content and Functionality Verification22
Installation23
Turning on the Tixel2 Device & Operating the Touchscreen27
The Home Screen27
The Operating Screen29
Pulse Credit & the Pulse Credit Screen32
Purchasing of Pulse Credit32
Entry of Credit Codes Via the Device's Pulse Credit Screen - Via the Home Screen33
The Novoxel Application34
System Shutdown35
Tip Cleaning38
Prepare the Following38
Tip Cleaning Screen38
Tip Sterilization43
Intended Use44
Indication for Use44
Contraindications for Use44
Intended User45
Intended Treatment Areas45
Pre-Treatment Patient Preparation45
Patient Pre-Treatment Preparation and Guidance45
In-Clinic Pre-Treatment Patient Preparation46
Determination of Treatment Parameters46
First Treatment46
Single Pulse Treatment Characteristics for Caucasian Fitzpatrick I-IV Skin Phototypes48
Comfort Level During Treatment48
Post-Treatment Heat Sensation48
Protrusion Level48
Device Preparation49
Routine Treatment49
Criss-Cross Mode50
Frame Segments51
Specific Skin Irregularities: Moles/Open Sores53
Post-Treatment53
Typical Patient Response to Treatment54
Example # 154
Example # 256
Post-Treatment Patient Guidance57
Safety Guidelines57
General Safety: Supervising Physician57
Warnings and Precautions: Patient & Operator Routine Operation Safety57
Expected Possible Complications and Adverse Effects58
Maintenance60
Product Lifetime60
Technical Device Service60
Cleaning60
Cleaning the Tixel2 Handpiece Distance Gauge (the DG)60
Storage and Packaging61
Device Storage61
Disposal61
Periodic Inspection & Service Instructions61
Annual Inspection by Certified Local Representative62
Essential Performance64
Electromagnetic Emissions & Immunity64
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Device67
BLE Module with Chip Antenna Manufactured by Laird, Model BL652-SA67

Novoxel Tixel2 - Typical Patient Response to Treatment

Table of Contents