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Important Safety Information for the leva Pelvic Digital Health System (leva PDHS): Do not use the leva PDHS while pregnant, or if you think you may be pregnant, unless authorized by your doctor. Do not leave the leva in your body for longer than necessary to complete the training session. Do not use the leva PDHS in any other place in your body or have sexual intercourse while the leva is inserted. If you experience odor, fever, diarrhea, any signs of infection, or of an allergic reaction, contact your doctor immediately. For a complete summary of the risks and instructions for leva PDHS, see its Instructions for Use available here.
EmbaGYN Contraindications Should not be used if you have any of the following conditions: If you have a heart pacemaker or a heart rhythm problem. If you are pregnant or trying to become pregnant. If you have been diagnosed or treated for cervical or any pelvic cancer. If you have or had had epilepsy. While driving or during any activity in which involuntary muscle contractions may put the user at undue risk of injury. If you have: An active urinary tract infection. Recent history of vaginal bleeding between menstrual periods. Infections or lesions in the area of the electrode placement. Diminished sensory perception. Inability to understand the directions of use or operate the device correctly. History of urinary retention or post-void residual volume greater than 200 cc. If any discomfort occurs when inserting the trainer consult your treating physician. For more information regarding the EmbaGYN product, see the Instructions for Use available here, or please visit its manufacturer’s website, TensCare Limited.