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General| Device Type | Endometrial Ablation System |
|---|---|
| Anesthesia Requirement | Local or General Anesthesia |
| Ablation Method | Bipolar Radiofrequency energy |
| Technology | Radiofrequency Ablation |
| Indication | Treatment of Abnormal Uterine Bleeding |
| Contraindications | Pregnancy, active pelvic infection |
| Reusable Components | Controller Unit |
| Regulatory Approvals | FDA |
| Handle Type | Single-use Disposable |
| Uterine Cavity Size | 4 cm to 10 cm in length, with no lower limit on width |
| Complications | Pain, Perforation, Infection, Thermal Injury |
| Disposable Components | NovaSure Disposable Device |
| Power Source | Electrical (requires power outlet) |
Details the single-patient use conformable bipolar electrode array for endometrial ablation.
Explains the constant power output generator used for endometrial ablation.
Lists and describes essential system components and initial setup procedures.
Covers critical safety information, patient eligibility, and potential risks.
Presents safety and effectiveness data from a three-year clinical evaluation.
Details the study design, patient criteria, methodology, and key results.
Defines patient selection criteria, counseling guidelines, and pretreatment preparation.
Step-by-step instructions for performing the endometrial ablation procedure.
Instructions for operating the Model 08-09 RF controller, including modes and CIA.
Instructions for operating the Model 10 RF controller, including modes and CIA.
Provides solutions for common system alarms and error messages encountered during operation.
Details recommended periodic maintenance and safety testing for the RF controller.
Offers further solutions for specific procedural issues and system faults.
Lists technical specifications for the disposable device and RF controller.
Provides contact information for technical support, product returns, and warranty details.
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