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batteries that are located on the front of the tray. The storage case also
incorporates a push-button open feature and an air vent to circulate air
through the storage case to aid in maintaining a dry storage environment.
Indications for Use
The leva Pelvic Digital Health System (leva PDHS) is intended for:
1. Strengthening of the pelvic floor muscles;
2. Rehabilitation and training of weak pelvic floor muscles for the
treatment of stress, mixed, and mild to moderate urgency urinary
incontinence (including overactive bladder) in women.
This device interacts with the user via smartphone technology.
Caution: Federal law restricts this device to sale by or on the order of a
physician.
Use as Prescribed by Your Physician.
Recommended use: two and one-half minutes, twice daily. Remove after
use.
Contraindications
Situations in which the device should not be used because the risk of use
clearly outweighs any possible benefit:
•
No known contraindications.
Warnings
Please read and understand this section carefully prior to using your leva
PDHS.
Do not use your leva PDHS while pregnant, or if you think you may
be pregnant, unless authorized by your healthcare provider.
Do not share your leva PDHS with other users. The leva PDHS is
intended for use as a single-user medical device.
Do not leave the leva probe in your vagina for longer than
necessary to complete the training session Always remove the leva
probe after each training session and do not exceed 60 minutes of
insertion, including during menstruation.
Do not use the leva probe in any other place in your body. The leva