Related Manuals for Ulthera UC-1
Summarization of Contents
Introduction to the Ulthera Manual
Manual Purpose and Content
Defines the scope of the manual, covering system components, controls, operation, and important user information.
Document Conventions and Symbols
Explains the meaning of notes, cautions, and warnings used throughout the manual for user guidance.
Ulthera Medical Safety Guidelines
Approved Indications for Ulthera Treatment
Lists the approved dermatological aesthetic treatments for the Ulthera System, including lifting and wrinkle improvement.
Contraindications for Ulthera Use
Details patient conditions and factors that contraindicate the use of the Ulthera System for safety reasons.
General Ulthera Safety Precautions
Advises on precautions such as securing the Access Key and avoiding treatment over specific implants or materials.
Critical Patient Safety Warnings
Highlights essential patient safety measures, including avoiding eye areas and the importance of user training.
Expected Side Effects of Ulthera Treatment
Describes potential mild and transient side effects for brow, neck, and décolleté treatments.
Reporting Ulthera Complaints and Adverse Events
Outlines the procedure for handling and reporting complaints and adverse events according to MDR rules.
Post-Market Surveillance of Ulthera System
Lists adverse events identified during routine clinical use after FDA clearance, noting frequency estimation challenges.
Ulthera System Components and Overview
Ulthera System Description and Functionality
Explains how the Ulthera System integrates ultrasound imaging and therapy for aesthetic treatments.
Key Ulthera System Components
Identifies the primary components: control unit, handpiece with cable, and interchangeable transducers.
Ulthera Control Unit Details
Describes the control unit as the system's information center, housing the touchscreen and GUI for user interaction.
Ulthera Handpiece Functionality
Details the handpiece, including its receptacle for transducers and buttons for imaging and therapy.
Ulthera Transducer Technology
Explains how transducers image and treat tissue, creating thermal coagulation points with sound energy.
Essential Ulthera System Accessories
Lists essential accessories such as the power cord, access key, and ultrasound gel required for operation.
Technical Specifications of the Ulthera System
Ulthera System Physical Dimensions and Weight
Provides the physical dimensions and weight specifications for the control unit and handpiece.
Ulthera Monitor Specifications
Details the monitor's size, resolution, and touchscreen capabilities.
Ulthera Input/Output Connections
Lists the available I/O connections, including USB 2.0 ports on the front and rear panels.
Ulthera Transducer Specifications
Details the types of transducers, their frequencies, depths, and contact footprints.
Ulthera Handpiece Model
Specifies the model of the Ulthera handpiece as the Ulthera DeepSEE Handpiece (UH-2).
Ulthera Included System Accessories
Identifies the Ulthera System User Access Key (UK-1) as a standard included accessory.
Ulthera Treatment Control Functions
Outlines the primary treatment controls including Energy, Spacing, Length, and action buttons.
Ulthera Treatment Parameter Settings
Details treatment parameters such as depths, frequencies, energy levels, and line length accuracy.
Ulthera Image Display Specifications
Describes image display features like modes, frequency range, dynamic range, and field of view.
Ulthera Image Measurement Tools
Explains the use of distance calipers for measuring on ultrasound images with precision details.
Ulthera System Power Requirements
Specifies the power input voltage, frequency, current, and fuse requirements for the system.
Ulthera Operating and Storage Environment
Defines the required environmental conditions for system operation, shipping, and storage.
Ulthera System Safety Protocols
Electrical and Fire Safety Precautions
Addresses critical safety measures to prevent electric shock and fire hazards during system operation.
Ulthera Equipment Use and Maintenance
Provides guidelines for proper equipment handling, cleaning, and care to ensure optimal performance and longevity.
Ergonomic Safety for Ulthera Users
Offers advice on ergonomic practices to minimize the risk of repetitive motion injuries during scanning.
Medical Ultrasound Safety Standards
Emphasizes safe use of ultrasound technology, requiring user qualification and adherence to exposure time limits.
ALARA Principle in Ultrasound Usage
Explains the ALARA principle for minimizing ultrasound exposure and bio-effects during scanning procedures.
Ulthera Acoustic Output Measurement Data
Presents technical data on acoustic output parameters and measurements according to industry standards.
Ulthera Safety and Standards References
Lists relevant publications and standards used for safety and acoustic output measurements.
Electromagnetic Compatibility and Immunity
Discusses the system's RF emissions, compatibility with different environments, and immunity to electromagnetic interference.
Electromagnetic Emissions Guidance
Provides guidelines on the electromagnetic environment for system use, noting low RF emissions.
Electromagnetic Immunity Guidance
Details immunity test levels and guidance for portable RF communications equipment in various environments.
RF Equipment Separation Distances
Provides recommended separation distances to prevent interference from portable and mobile RF communications equipment.
Proper Disposal of Ulthera Components
Instructs on the correct disposal procedures for depleted transducers according to regulations.
Ulthera Safety Symbol Definitions
Explains the meaning of various safety symbols found on the Ulthera system components.
Initial Setup of the Ulthera System
Unpacking Ulthera System Components
Details the packaging and shipment of the control unit, handpiece, and transducers for initial setup.
Ulthera System Physical Environment Requirements
Covers placement recommendations, cooling space, and flooring requirements for optimal system operation.
Ulthera System Electrical Specifications
Specifies the system's compatibility with international power supplies (100-240 VAC, 50-60 Hz).
Connecting Ulthera System Components
Provides instructions for connecting the handpiece and transducers to the control unit.
Connecting Ulthera System Accessories
Explains how to connect the Ulthera System Access Key to USB ports for system access and data transfer.
Ulthera Treatment Guidelines and Protocols
Preset Treatment Guidelines and Energy Levels
Describes available preset guidelines and their corresponding energy levels for various anatomical treatment areas.
Face & Neck (Amplify) Treatment Protocol
Illustrates treatment regions and transducer application for Face & Neck (Amplify) procedures.
General Regions (Face & Neck) Protocol
Shows treatment areas and transducer usage for General Regions (Face & Neck) treatments.
Décolleté Treatment Clinical Trial Results
Presents clinical trial findings on the efficacy of Ulthera for improving décolleté lines and wrinkles.
Operating the Ulthera System
Ulthera System Access Key Usage
Details the function and importance of the Ulthera System Access Key for system access and data storage.
Ulthera User Interface Navigation
Guides users through the main screen interface, including DeepSEE, Patient Info, and Setup tabs.
DeepSEE Screen for Imaging and Treatment
Explains the DeepSEE screen layout and its interactive elements for imaging and treatment.
DeepSEE Treatment Control Features
Details controls within the DeepSEE screen, covering line counts, transducer info, energy, length, and regions.
Ulthera Tools Menu Functions
Describes the Tools menu options for volume control, image saving, and adding annotations or measurements.
Creating Custom Ulthera User Regions
Enables users to create and edit custom treatment guidelines and regions for personalized treatment plans.
Ulthera System Operating Procedures
Provides a series of steps for operating the Ulthera system, from activation to treatment delivery.
Ulthera Adjunctive Features
Covers additional features like measuring distances and adding annotations to ultrasound images.
Ulthera System Troubleshooting Guide
Offers guidance on resolving system issues through warning screens, image quality checks, and shutdown procedures.
Ulthera Cleaning and Equipment Care
Cleaning Ulthera Transducers and Handpiece
Details the recommended cleaning procedure using isopropyl alcohol wipes and warnings against solvents.
General Ulthera System Care Guidelines
Provides general care guidelines for maintaining the system, including inspections, proper handling, and gel usage.
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