Ulthera, Inc. Page 5
Table of Contents
1. Introduction to Manual .......................................................................................... 7
1.1. Purpose ........................................................................................................... 7
1.2. Conventions.................................................................................................... 7
2. Medical Safety......................................................................................................... 8
2.1. Indications for Use........................................................................................... 8
2.2. Contraindications ........................................................................................... 8
2.3. Precautions ..................................................................................................... 8
2.4. Patient Safety.................................................................................................. 9
2.5. Potential Side Effects .................................................................................... 10
2.6. Complaints and Adverse Events .................................................................. 11
2.7. Post- Market Surveillance ............................................................................. 12
3. System Overview ................................................................................................... 13
3.1. System Description........................................................................................ 13
3.2. System Components and Features.............................................................. 13
3.3. System Specifications ................................................................................... 18
4. System Safety ......................................................................................................... 21
4.1. Electrical and Fire Safety .............................................................................. 21
4.2. Equipment Use and Care............................................................................. 22
4.3. Ergonomic Safety ......................................................................................... 22
4.4. Medical Ultrasound Safety ........................................................................... 22
4.5. Electromagnetic Compatibility and Immunity ............................................ 25
4.6. Disposal ......................................................................................................... 29
4.7. Safety Symbols .............................................................................................. 30
5. Setting Up for First-Time U se ................................................................................. 32
5.1. Unpacking..................................................................................................... 32
5.2. Physical Environment .................................................................................... 32
5.3. Electrica l R equ irements ................................................................................ 33
5.4. Connecting Components ............................................................................ 33
6. Treatment Guidelines ........................................................................................... 35
6.1. Preset Guidelines and Energy Levels ........................................................... 35
7. System Operation.................................................................................................. 43
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