Novoxel Tixel2 - Chapter 1: Introduction; Scope; Introduction

TABLE OF CONTENTS
User Manual TXLD0012
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P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 1
Scope .......................................................................................................................................................... 5
Introduction ................................................................................................................................................ 5
This Manual ............................................................................................................................................... 5
Specifications of This Manual ................................................................................................................... 5
Glossary, Conventions, Abbreviations, Signs and Symbols ...................................................................... 6
Glossary ..................................................................................................................................................... 6
Abbreviations ............................................................................................................................................. 7
Signs and Symbols ..................................................................................................................................... 8
Operating State, Location and Position ...................................................................................................... 9
Electrical Safety Information ..................................................................................................................... 9
Electrical Medical Equipment Classification ............................................................................................. 9
Environmental Protection ........................................................................................................................ 11
Applicable Standards ............................................................................................................................... 12
The Tixel2 device – Overview ................................................................................................................. 12
System Layout and Components .............................................................................................................. 13
Principle of Operation and System Components ..................................................................................... 15
The Novoxel® Tip ................................................................................................................................... 15
The Standard Tip ...................................................................................................................................... 15
The Periorbital Tip ................................................................................................................................... 16
The Tixel2 Console .................................................................................................................................. 18
The Tixel2 Handpieces ............................................................................................................................ 18
Handpiece/s Receiving Inspection – Content and Functionality Verification ......................................... 21
Installation ................................................................................................................................................ 22
Turning on the Tixel2 device & Operating the Touchscreen ................................................................... 26
The Home Screen ..................................................................................................................................... 26
The Operating Screen ............................................................................................................................... 28
Pulse Credit & the Pulse Credit Screen ................................................................................................... 31
Purchasing of Pulse Credit ....................................................................................................................... 31
Entry of Credit Codes via the device’s Pulse Credit Screen - via the Home Screen ............................... 32
The Novoxel Application ......................................................................................................................... 33
System Shutdown ..................................................................................................................................... 34
Tip Cleaning ............................................................................................................................................. 37
Prepare the Following .............................................................................................................................. 37
Tip Cleaning Screen ................................................................................................................................. 37
Tip Sterilization ........................................................................................................................................ 42
Intended Use ............................................................................................................................................ 43
Indication for Use ..................................................................................................................................... 43
Contraindications for Use ........................................................................................................................ 43
Intended User ........................................................................................................................................... 44
Intended Treatment Areas ........................................................................................................................ 44
Pre-Treatment Patient Preparation ........................................................................................................... 44
Patient Pre-Treatment Preparation and Guidance .................................................................................... 44
In-Clinic Pre-Treatment Patient Preparation ............................................................................................ 45