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Manual provides system description, controls, operation, and equipment information for the user.
Explains notes, cautions, warnings, and list conventions used throughout the manual.
Lists non-invasive aesthetic treatments and imaging uses for the Ulthera System.
Lists conditions for which the Ulthera system is contraindicated for patient use.
Advises on securing the access key and areas to avoid during treatment.
Emphasizes trained operation and warns against use near eyes.
Details mild and transient side effects for brow/neck and décolleté treatments.
Outlines procedures for handling complaints and adverse events.
Lists adverse events identified during post-market clinical use.
Integrates ultrasound imaging and therapy for tissue heating and coagulation.
Details the control unit, handpiece, and transducers.
Describes the control unit's functions, ports, and power controls.
Describes the handpiece, its receptacle, and operational buttons.
Describes the image/treat transducer and its specifications.
Lists essential accessories like power cord, access key, and ultrasound gel.
Details physical dimensions, monitor, I/O, and transducer specifications.
Details handpiece, accessories, controls, parameters, image display, and tools.
Details power supply, operating, and storage environmental conditions.
Warns against electric shock and fire hazards; proper grounding and ventilation.
Details cleaning procedures, handling transducers, and general system maintenance.
Warns about repetitive motion injuries and suggests posture improvements.
Emphasizes trained operation and the ALARA principle for ultrasound exposure.
Explains the As Low As Reasonably Achievable principle for ultrasound scanning.
Details acoustic output parameters and tables for transducers.
Discusses RF emissions, immunity tests, and guidance for safe usage.
Advises on proper disposal of depleted transducers according to regulations.
Explains various symbols used on the device for regulatory guidance.
Instructions for unpacking the control unit, handpiece, and transducers.
Discusses system placement and electromagnetic environment considerations.
Details electrical requirements for the system's power supply.
Instructions for connecting the handpiece and transducers.
Instructions for connecting system accessories like the Access Key.
Describes preset treatment guidelines and energy level ranges for transducers.
Illustrates treatment maps and transducer use for face and neck.
Shows treatment maps and transducer usage for general face and neck areas.
Discusses clinical trial results and efficacy for décolleté treatments.
Explains the function and importance of the system's Access Key.
Describes the main screen tabs and overall interface layout.
Details the DeepSEE screen interface, imaging controls, and treatment controls.
Explains the functions available in the Tools menu for image manipulation.
Guides on creating and editing custom treatment guidelines.
Step-by-step guide to activating the system and setting up treatments.
Lists transducer types and instructions for connecting them.
Instructions for scanning treatment areas, applying gel, and delivering treatment lines.
Covers measuring distances and adding annotations to ultrasound images.
Provides guidance on resolving system warnings, errors, and poor image quality.
Instructions for safely shutting down the Ulthera system.
Details the procedure for cleaning transducers and handpiece.
Provides guidelines for maintaining the system's performance and longevity.
General| Frequency | 4 MHz |
|---|---|
| Focal Depth | 4.5 mm |
| Depth of Penetration | 4.5 mm |
| Indications | Skin tightening, lifting, and wrinkle reduction |
| Treatment Areas | Face, neck |
| Technology | Micro-focused ultrasound |
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