Novoxel Tixel2 User Manual page 3

User Manual TXLD0012
TABLE OF CONTENTS
Determination of Treatment Parameters .................................................................................................. 45
First Treatment ......................................................................................................................................... 45
Single Pulse Treatment Characteristics for Caucasian Fitzpatrick I-IV Skin Phototypes ....................... 47
Comfort Level during Treatment ............................................................................................................. 47
Post-Treatment Heat Sensation ................................................................................................................ 47
Protrusion Level ....................................................................................................................................... 47
Device Preparation ................................................................................................................................... 48
Routine Treatment .................................................................................................................................... 48
Criss-Cross Mode ..................................................................................................................................... 49
Frame Segments ....................................................................................................................................... 50
Specific Skin Irregularities: Moles/Open Sores ....................................................................................... 52
Post-Treatment ......................................................................................................................................... 52
Typical Patient Response to Treatment ................................................................................................... 53
Example # 1 ............................................................................................................................................. 53
Example # 2 ............................................................................................................................................. 55
Post-Treatment Patient Guidance ............................................................................................................. 56
Safety Guidelines ..................................................................................................................................... 56
General Safety: Supervising Physician .................................................................................................... 56
Warnings and Precautions: Patient & Operator Routine Operation Safety ............................................. 56
Expected Possible Complications and Adverse Effects ........................................................................... 57
Maintenance ............................................................................................................................................. 59
Product Lifetime ...................................................................................................................................... 59
Technical Device Service ......................................................................................................................... 59
Cleaning ................................................................................................................................................... 59
Cleaning the Tixel2 Handpiece Distance Gauge (the DG) ...................................................................... 59
Storage and Packaging ............................................................................................................................. 60
Device Storage ......................................................................................................................................... 60
Disposal .................................................................................................................................................... 60
Periodic Inspection & Service Instructions .............................................................................................. 60
Annual Inspection by Certified Local Representative ............................................................................. 61
Essential Performance .............................................................................................................................. 63
Electromagnetic Emissions & Immunity ................................................................................................. 63
Recommended Separation Distances between Portable and Mobile RF Communications
Equipment and the Device ....................................................................................................................... 66
BLE Module with Chip Antenna Manufactured by Laird, Model BL652-SA ........................................ 66
P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 2