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General| FDA Cleared | Yes |
|---|---|
| Technology | Radiofrequency (RF) |
| Applications | Skin tightening, body contouring |
| Handpieces | Multiple handpieces |
| Treatment Areas | Face, neck, body |
| Safety Features | Real-time temperature monitoring |
| Treatment Duration | Varies depending on the handpiece and treatment area (typically 15-60 minutes) |
| Downtime | Varies depending on the handpiece and treatment (minimal to several days) |
| Number of Treatments | Varies depending on the handpiece and treatment plan (typically 1-6 sessions) |
| Results Duration | Varies depending on the handpiece and individual factors (months to years) |
| Power Supply | 100-240 VAC, 50/60 Hz |
| User Interface | Touchscreen |
Guidance on system usage and manual review for qualified professionals.
Description of the Optimas System, its technologies, and handpieces.
Explanation of symbols and notes used for clarity and safety warnings.
Details on various symbols used on the system for identification and safety compliance.
Key safety measures and patient information required before and during treatment.
Qualifications and responsibilities for personnel operating or maintaining the system.
Important precautions to follow for safe system operation and handling.
Information on potential eye damage risks from laser and IPL light exposure.
Specific procedures and protective equipment to prevent eye injuries during treatments.
Precautions related to electrical hazards and physical handling of the system.
Identification of flammable materials and conditions that pose fire risks.
Overview of built-in safety mechanisms ensuring safe system operation.
Guidelines for safe connection, handling, and operation of system handpieces.
Essential warnings regarding equipment use, power, patient safety, and fire hazards.
Details of labels on the system console and handpieces, including certification.
Description of labels found on handpieces indicating model, serial number, and compliance.
Classification of the Optimas system and handpieces by regulatory bodies.
Specifications for power supply, grounding, and outlet placement for installation.
Recommended room temperature and humidity for optimal system performance.
List of all components included with the Optimas system package.
Step-by-step instructions for safely removing the system from its packaging.
Steps for physically connecting and setting up the system components.
Instructions for filling the system's water reservoir with distilled water.
Procedures for preparing and moving the system between locations.
Guidelines for disposing of the equipment in compliance with environmental regulations.
Identification and function of connectors and ports on the system's rear panel.
Overview of the system's front panel, including buttons and the touch screen.
Explanation of the system's progress, login, and menu screens.
Detailed descriptions of the DiolazeXL, Vasculaze, Lumecca, Fractora, and Forma handpieces.
Step-by-step instructions for powering on and preparing the system for use.
Instructions for safely turning off and powering down the Optimas system.
General guidance and procedures for performing DiolazeXL hair removal treatments.
Conditions that prevent or advise against performing DiolazeXL treatments.
Potential side effects and reactions from DiolazeXL hair removal treatment.
Recommendations for patient preparation before DiolazeXL treatment.
Instructions for cleaning the DiolazeXL handpiece tip prior to use.
Recommended settings and procedural steps for effective DiolazeXL treatments.
Typical session frequency and timing for DiolazeXL treatment plans.
Advice and care instructions for patients after DiolazeXL treatment.
Conditions and vascular lesions treatable with the Vasculaze handpiece.
Patient conditions that preclude or require caution for Vasculaze treatment.
Potential side effects and skin reactions following Vasculaze treatment.
Patient preparation and recommendations before Vasculaze treatment.
Instructions for cleaning the Vasculaze handpiece tip before use.
Recommended settings and procedural steps for effective Vasculaze treatments.
Typical session frequency and timing for Vasculaze treatment plans.
Advice and care instructions for patients after Vasculaze treatment.
Skin conditions and lesions treatable with the Lumecca IPL handpiece.
Patient conditions that preclude or require caution for Lumecca treatment.
Potential side effects and skin reactions following Lumecca treatment.
Patient preparation and recommendations before Lumecca treatment.
Instructions for cleaning the Lumecca handpiece tip prior to use.
Procedure for performing test spots to assess patient suitability for Lumecca.
Recommended settings and procedural steps for effective Lumecca treatments.
Advice and care instructions for patients after Lumecca treatment.
Typical session frequency and timing for Lumecca treatment plans.
Explanation of the Fractora RF technique for skin resurfacing.
Procedures and applications for Fractora handpieces, including tip types.
Conditions that preclude or require caution for Fractora treatment.
Potential side effects and skin reactions following Fractora treatment.
Patient preparation and recommendations before Fractora treatment.
Instructions for cleaning the Fractora handpiece tip prior to use.
Procedure for performing test spots to assess patient suitability for Fractora.
Recommended settings and procedures for Fractora treatments based on indications.
Typical session frequency and timing for Fractora treatment plans.
Advice and care instructions for patients after Fractora treatment.
Procedures and applications for the Forma handpiece for skin rejuvenation.
Conditions that preclude or require caution for Forma treatment.
Potential side effects and skin reactions following Forma treatment.
Instructions for cleaning the Forma handpiece before use.
Patient preparation and recommendations before Forma treatment.
Recommended settings and procedures for Forma treatments on facial areas.
Typical session frequency and timing for Forma treatment plans.
Advice and care instructions for patients after Forma treatment.
Overview of recommended maintenance tasks and how often they should be performed.
Procedures for cleaning the system and handpieces before and after treatments.
Tasks for routine cleaning and inspection of the system on a weekly basis.
Procedure for replacing the cooling water in the system monthly.
Annual tasks for replacing deionizer cartridges and capsule filters.
Detailed steps for filling the system with distilled water for operation.
Procedure for draining water from the system for shipping or storage.
Using a specialized tool to drain water from handpieces before shipping or storage.
Step-by-step guide for removing and installing a new Deionizer Cartridge.
Step-by-step guide for removing and installing a new Capsule Filter.
Information about the system's air filter, its cleaning, and replacement.
Common system problems, their descriptions, and initial checks for resolution.
Electrical input, operating parameters, and environmental requirements for the system.
Physical size and weight specifications for the system and handpiece cables.
Technical output parameters for DiolazeXL, Vasculaze, Lumecca, Fractora, and Forma handpieces.
Graphs illustrating RF output power versus impedance for Fractora and Forma handpieces.
Information regarding the system's electromagnetic compatibility and safety standards.
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