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Ulthera
System
®
Instructions for Use
Featuring DeepSEE
Technology for Ultherapy
®
®
1
Ulthera, Inc.
Page

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Table of Contents
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Summarization of Contents

Introduction to the Ulthera Manual
Manual Purpose and Scope
Explains the manual's content and its role for the user.
Understanding Document Conventions
Details symbols and text conventions used throughout the manual.
Medical Safety and Patient Care
Indications, Contraindications, and Precautions
Lists approved uses, conditions to avoid, and general safety measures.
Patient Safety Guidelines
Critical warnings and actions for patient safety during operation.
Side Effects and Adverse Event Reporting
Describes potential side effects and the process for reporting issues.
Post-Market Surveillance Findings
Lists adverse events identified during routine clinical use.
Ulthera System Overview and Specifications
System Components and Features
Details the control unit, handpiece, and transducers.
Detailed System Specifications
Provides dimensions, monitor, I/O, and transducer specifications.
Essential Accessories and Environmental Needs
Lists required accessories and optimal operating/storage conditions.
System Safety, EMC, and Regulatory Compliance
Electrical, Fire, and Ergonomic Safety
Covers electrical safety, grounding, fire prevention, and injury mitigation.
Ultrasound Safety and ALARA Principle
Emphasizes training, ALARA, acoustic output, and image quality.
Electromagnetic Compatibility and Immunity
Addresses RF emissions, interference, and immunity standards for safe operation.
Safety Symbols and Standards
Explains equipment symbols and lists relevant safety standards.
Setting Up the Ulthera System
Unpacking and Environment Preparation
Instructions for unpacking and preparing the physical environment.
Connecting System Components
Steps to connect the handpiece, transducers, and accessories.
Ultherapy Treatment Guidelines
Preset Guidelines and Transducer Energy
Overview of preset treatment guidelines and energy settings.
Treatment Protocols for Facial Regions
Visual guides for face and neck treatment lines and depths.
Décolleté Treatment and Efficacy
Clinical trial results and efficacy for décolleté treatment.
System Operation and Troubleshooting
Accessing the System and User Interface
Using the Access Key and navigating the main interface tabs.
Performing a Treatment Session
Step-by-step guide for operating the system and delivering treatment.
Adjunctive Functions and Data Management
Features like measuring, annotating, and managing database records.
Resolving System Issues and Warnings
Guidance for troubleshooting system warnings, errors, and poor image quality.
Understanding System Messages
Interpreting System Information Codes
Explains system messages, codes, and their associated descriptions.
System Cleaning and Maintenance
Cleaning Transducers and Handpiece
Procedures for cleaning the transducer and handpiece.
General System Care and Storage
Guidelines for maintaining system performance and longevity.
Re-ordering System Components
Catalog Numbers for System Items
Lists items available for reordering with catalog numbers.
Safety Standards and Regulatory Information
Key Regulatory Classifications and Standards
Lists relevant safety standards and regulatory classifications.

Table of Contents