Frequently Asked Questions

leva is a cutting-edge FDA cleared Pelvic Digital Health System that uses interactive visualization via Bluetooth® to a smartphone and real-time progress tracking to empower women to rehabilitate and strengthen weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence, without the risks of surgery or side-effects related to medication. Before using leva, you should read the Instructions for Use (IFU), which contains valuable information and visuals to assist with your pelvic floor training.

Access

What are the indications for use?

The leva Pelvic Digital Health System (leva PDHS) is intended for: (i) strengthening of the pelvic floor muscles; and (ii) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence in women. This product interacts with the user via smartphone technology.

Can I get leva without a Medical Order?

No. leva is only available via a Medical Order through your doctor.

What if I do not have insurance or my insurance has denied coverage?

Payment plans are available for the levaes through one of our distribution partners. If you cannot afford your kit, please contact us at (866) 735-8423.

Is there co-pay assistance?

Co-pay assistance is not available at this time.

How will I receive my kit?

Once your Medical Order is received one of our distributor partners will contact you to process your insurance and coordinate delivery. Upon receipt of your order, Renovia’s Women’s Center will contact you to set up your leva, provide urinary incontinence/urinary leakage education, ongoing support, and to help schedule a product training session. Additionally, if you have any questions, please call Renovia at (866) 735-8423.

Using leva

How will I learn how to use leva?

After your leva^es prescription has been filled and shipped, you will be contacted by Renovia to help you register your product and download the your leva app, provide urinary incontinence/urinary leakage education and to discuss your options to learn how to use the leva and help schedule leva product training. Training options include in-office training, and at-home individual training using Renovia’s Women’s Center and their resources. If at any time you have questions or need assistance, Renovia’s Women’s Center is available to help. We can be reached at (866) 735-8423.

Why do I need a follow-up appointment at my physician’s office?

It is important that you are provided the proper training in how to use your leva. It is recommended that you receive training by a pelvic floor trainer at your physician’s office or at a pelvic floor physical therapist’s office. This is an important step in starting to use the leva, as recommended by your doctor.

Does using leva hurt?

You should not experience pain when inserting leva into your vagina or when using the leva. Please review the IFU carefully before you use leva. If you experience pain during insertion or during or after use, please contact your health care provider.

Can I use a lubricant with leva?

If you find it difficult to insert, you may use water alone or, if needed, a small amount of waterbased lubricant (NOT petroleum jelly or petroleum based products). Use a very small amount of lubricant on and around the very tip of leva and this should help with insertion. If leva has been inserted correctly, you should not feel any discomfort.

Will using leva cause an infection?

No. If you wash your hands and clean leva properly, as instructed, the product will not cause an infection. The materials used in manufacturing leva have been thoroughly tested and are safe. A small number of people may be sensitive to the materials used in making leva, but most women can use leva without any trouble.

Can leva leave anything behind in my body?

No. All the electronics are completely covered with medical grade silicone, with no exposed parts. Silicone is frequently used in many medical devices for many different purposes and leva has been thoroughly tested for safety.

Can leva get lost inside me?

No. leva goes into the vagina. The opening near the top of the vagina is called the cervix. The cervix is very small, and leva is too large to go through it. The leva will stay in the vagina until you decide to remove it.

Can leva get stuck inside?

No. If you have a hard time removing it, it could be because you are tense and are squeezing your vaginal muscles. Take a deep breath and try to relax. Once you have relaxed, leva should come out easily.

Can I get an electrical shock from leva?

No. The electronics are completely covered in medical grade silicone and leva has gone through rigorous safety testing. If you see an opening or if leva has been punctured or damaged in any way, please discontinue use immediately.

Can leva be submerged in water/liquid?

No. leva is not waterproof. Please read the Instructions for Use manual carefully before you start using leva. Although you must wash the leva probe, you cannot use leva in the shower, bathtub or submerge it in liquid of any kind. leva is not designed to be used underwater.

How should I store my leva?

Always remember to wash your hands and your leva after every use. After washing your leva either allow it to air dry or dry it with a clean towel and store your leva in a clean dry container. It is recommended to store your leva in the supplied box or in a hard case to avoid bending the probe, which may result in damaging the sensors. Do not bend or wrap the wire around the device, as this also may result in damaging the sensors.

Can I share my leva?

No. It is a single-user product. It is for your personal use. Do not share leva with anyone.

Can I use leva when I’m pregnant?

No. Do not use the leva while pregnant, or if you think you may be pregnant, unless recommended by your doctor.

Can I use my leva when I have my period?

Yes. You can use leva when you are menstruating. Do not use leva when wearing a tampon. If using leva during your period makes you uncomfortable, waiting a week will not change anything.

Can I use the leva sitting down or lying down?

No. It is recommended to use leva while standing because it will give you the best reading while performing your pelvic floor muscle training.

Can I wear my underwear/undergarments while using leva?

Yes, if you would like to, you may choose to do so.

Is leva a vibrator?

No. leva is prescribed to help you strengthen your pelvic floor muscles.

What is leva made of?

leva is made of medical grade silicone.

What if I have a latex allergy?

Latex and silicone are two different products. Latex is a natural product and silicone is a man-made product. leva is made of medical grade silicone. Please talk to your healthcare provider if you have any concerns.

your leva APP

What is the red zone?

In Training Mode, the red zone is the resting zone.

What is an ideal score?

There is no ideal score as each person is different. However, the goal is to continue to increase your score as you perform your pelvic floor muscle training over time.

Should the scores go up or down?

Up. The goal is to continue to increase your score as you perform your training.

What does it mean if my scores go down or decrease over time?

There may be some days where your scores go down compared to some of your historical scores. If you find that your scores decrease over time contact your healthcare provider for guidance.

Why do I see flickering when using my app?

Flickering occurs on the app when your pelvic floor muscles get stronger and as a result, your leva may rotate or turn while inserted in the vagina. To correct, remove your leva and re-insert to start your pelvic floor muscle training over.

Why is my app freezing?

Try turning leva and your smartphone device off, then turning them on again. If that is unsuccessful, please contact the Renovia Women’s Center at (866) 735-8423 as they will be able to help you further.

Troubleshooting

Why is the line on the app not moving while I am doing my pelvic floor muscle training?

Check the position of your leva to make sure the line and logo on the probe are facing out. Are you sure you are lifting and not bearing down? An easy way to check is to try leva in Practice Mode. In this mode, you can see the leva moving even if you are bearing down.

Why is the line curved on the visual display?

leva is soft and pliable, and conforms to the shape of your vagina.

Why is the Bluetooth® light not on?

To save battery life the Bluetooth® light only stays on for a few seconds when you first turn the device on.

Why can’t I get out of the red zone?

This could be related to how relaxed you were when you started your training session. To get out of the red zone, you must be relaxed before you start your training. Practice lifting in Practice Mode until your lifts are outside the resting zone range, then return to using the Training Mode.

Why is there a blinking line on the leva app?

The blinking line on the app means you need to reposition the probe to ensure the line is facing out.

I’m still having trouble with my leva and/or app, what should I do?

Try turning leva and device off, then turning them on again. If that is unsuccessful, please contact Renovia Women’s Center at (866) 735-8423 as they will be able to help you further.

Is the your leva app available for Android™?

The your leva app is available for Android™ & iOS. Download the your leva app on Google Play and in the App Store.

Privacy

Is the information on the Renovia database confidential?

Yes. The information that is in the Renovia database that is accessible on the website is confidential. Please do not share your username or password with anyone that you do not want to share your information with.

How can I share the information from the your leva app with my doctor?

You can login to the app during your visit and show your doctor your session history.

You can login to https://leva.renoviainc.com/Account and PDF/print out your session history.
• You can take screenshots of your session history while the app is open.

The your leva app stores up to 300 sessions, so once you have your session history you can either bring it with you to your visit or you can forward it to your doctor electronically.

Important Safety Information

What are the safety warnings for leva?

Contraindications Situations in which the device should not be used because the risk of use clearly outweighs any possible benefit. • No known contraindications.

WARNINGS

Serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that should be taken if they occur. • 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 probe in your body for longer than necessary to complete the training session. Remove the probe after each training session. • Do not use the leva PDHS in any other place in your body. • Do not have sexual intercourse while the probe is inserted. • Do not insert the probe if there is any damage to the leva PDHS. • Keep the leva PDHS out of reach of children. If left unattended, leva PDHS could prove to be a strangulation or choking hazard to a child and could result in death. • Do not share the leva PDHS. The leva PDHS is a single-user medical device. • If you experience odor, fever, vomiting, diarrhea, any signs of infections or any flu-like symptoms, contact your doctor immediately. • If you experience redness or swelling near the insertion area, contact your doctor, as you may have an allergic reaction to the silicone rubber. • Do not use adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the leva PDHS should be observed to verify normal operation in the configuration in which it will be used. • The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Renovia as replacement parts for internal components (if any), may result in increased emissions or decreased immunity of the leva PDHS.

Precautions Information regarding special care to be exercised for the safe and effective use of the device. • Do not bend the probe. Do not twist the probe. • Do not bend or wrap the wire around the probe, as this may result in damaging the sensors. • Do not submerge the probe in water or liquid. • Do not use the leva PDHS in the shower, bathtub or submerge it in liquid of any kind. leva PDHS is not designed to be used underwater. • Do not submerge the transmitter box in any kind of liquid or expose to running water. • Do not get the connector wet. • Do not bathe, shower, swim, or submerge yourself in water while the probe is inserted. • Do not use the toilet while the probe is inserted. • Do not soak the leva PDHS. • Do not put the leva PDHS in the dishwasher. • Do not clean the leva PDHS with anything but mild soap and water. • Do not use oil or petroleum-based lubricants with the leva PDHS. Use water-based lubricants only. • Do not leave the leva PDHS in the sun, near an open fire, or in a hot parked car. Excessive or direct heat can damage the leva PDHS. • Do not modify the leva PDHS in any way or use it in combination with any accessory not mentioned in this document. This could result in deformation of the leva PDHS which could cause painful insertion or could damage the electronics. • Always wash your hands before inserting the probe to prevent harmful bacteria which may be present on your hands from entering your vagina. • Always ensure you can maintain your balance when inserting the probe and operating the leva PDHS.