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leva® FAQs

leva is a cutting-edge FDA cleared pelvic floor training 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 urge urinary incontinence (UI), without the risks of surgery or side-effects related to medication. Before using leva, you should read the Instructions for Use, which contains valuable information and visuals to assist with your pelvic floor training.

Before using leva, you should read the Instructions for Use, which contains valuable information and visuals to assist with your pelvic floor training.

ACCESS

Can I get leva without a prescription?

ANSWER

No. leva is only available via a prescription through your doctor.

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

ANSWER

Payment plans are available for the levaes through our durable medical equipment provider, Foundation Care. If you cannot afford your kit, please contact us at 866-PelvicFloor (866-735-8423).

Is there co-pay assistance?

ANSWER

Co-pay assistance is not available at this time.

How will I receive my kit?

ANSWER

Once your prescription is received our distribution partner, Foundation Care, will contact you to process your insurance and coordinate delivery. Upon receipt of the kit, Renovia’s Patient Care and Engagement Team (PCE) 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-PelvicFloor (866-735-8423).

USING LEVA

How will I learn how to use leva?

ANSWER

After your levaes 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. If at any time you have questions or need assistance, Renovia’s Patient Care and Engagement Team (PCE) is available to help. We can be reached at 866-735-PelvicFloor (866-735-8423).

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

ANSWER

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?

ANSWER

No. The leva is small and is inserted into the vagina. Please read the Instructions for Use (IFU) carefully before you use leva, which are located on the USB inside your leva box. If you follow the instructions, you will find that using leva is easy. The instructions show comfortable positions to insert leva. leva is easier to insert and use if you are relaxed and take your time.

Can I use a lubricant with leva?

ANSWER

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?

ANSWER

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?

ANSWER

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?

ANSWER

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?

ANSWER

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?

ANSWER

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?

ANSWER

No. leva is not waterproof. Please read the Instructions for Use (IFU) 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?

ANSWER

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?

ANSWER

No. It is a single-user device. It is your personal system. Do not share leva with anyone.

Can I use leva when I’m pregnant?

ANSWER

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?

ANSWER

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?

ANSWER

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

Can I wear my underwear/undergarments while using leva?

ANSWER

Due to the positioning of the probe and wire, it is recommended to use leva without underwear/undergarments.

Is leva a vibrator?

ANSWER

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

What is leva made of?

ANSWER

leva is made of medical grade silicone.

YOUR LEVA APP

What is the red zone?

ANSWER

In training mode, the red zone is the resting zone.

What is an ideal score?

ANSWER

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 exercises over time.

Should the scores go up or down?

ANSWER

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

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

ANSWER

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?

ANSWER

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 training exercises over.

Why is my app freezing?

ANSWER

Try turning leva and your device off, then turning them on again. If that is unsuccessful, please contact our Patient Care and Engagement Team (PCE) at 866-PelvicFloor (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 exercises?

ANSWER

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 Live Mode. In this mode, you can see the leva moving even if you are bearing down.

I’m in live mode or training mode. Why is the line curved?

ANSWER

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

Why is the Bluetooth® light not on?

ANSWER

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?

ANSWER

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 exercises. Practice lifting in Live 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?

ANSWER

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?

ANSWER

Try turning leva and device off, then turning them on again. If that is unsuccessful, please contact our Patient Care and Engagement Team (PCE) at 866-PelvicFloor (866-735-8423) as they will be able to help you further.

Is the your leva app available for Android™?

ANSWER

The your leva app is now available for Android™ & iOS.

PRIVACY

Is the information on the Renovia database confidential?

ANSWER

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?

ANSWER

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 screen shots 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.

Is the information on the Renovia database confidential?

ANSWER

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.

For more information about Renovia’s Privacy Policy, please view the complete details on our website: https://renoviainc.com/privacy-policy/

IMPORTANT SAFETY INFORMATION

What are the safety warnings for leva?

SAFETY

  • Do not share your leva.
  • leva is a single-user medical device.
  • Do not use leva in any other place in your body. You can keep your leva inside your vagina safely for up to 8 hours.
  • Do not leave leva in your vagina overnight. 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.
  • Keep leva out of reach of children. If left unattended, leva could prove to be a strangulation or choking hazard to a child and could result in death.
  • Do not modify leva in any way or use it in combination with any accessory not mentioned in this document. This could result in deformation of your leva which could cause painful insertion, or could damage the sensors.
  • Be careful not to snag the cable while leva is inserted. This could result in uncomfortable removal of leva.
  • When necessary, leva should be cleaned and recycled as would any other electronic consumer good.

WARNINGS

  • Do not bend leva.
  • Do not twist leva.
  • Do not leave leva in your body for more than 8 hours.
  • Do not leave leva in your body for more than 1 hour during your period.
  • Do not have sexual intercourse while leva is inserted.
  • Do not submerge leva transmitter in any kind of liquid or expose to running water.
  • Do not get leva connector wet.
  • Do not bathe, shower, swim, or submerge yourself in water while leva is inserted.
  • Do not use the toilet while leva is inserted.
  • Do not allow anyone else to use your personal leva.
  • Do not use leva in any other place in your body (vaginal use only).
  • Do not soak leva.
  • Do not put leva in the dishwasher.
  • Do not clean leva with anything but mild soap and water.
  • Do not use oil or petroleum-based lubricants with leva.
  • Use water-based lubricants only.
  • Do not insert leva if there is any damage to it.
  • Do not use leva while pregnant, or if you think you may be pregnant, unless authorized by your doctor.
  • KEEP OUT OF REACH OF CHILDREN.

COMPANY INFORMATION

Who is Renovia?

Renovia Inc acquired the worldwide intellectual property (IP) license of the leva® pelvic floor training system from Remendium Labs. Renovia Inc was formed to discover and deliver innovative medical solutions and technology combined with digital health to help individuals suffering from pelvic floor disorders. The leva system underscores our commitment to bring innovative products to women suffering from specific pelvic floor conditions.

Who is Remendium Labs?

Remendium Labs is the former owner of the leva system.

Who is Foundation Care?

Foundation Care is Renovia’s distribution partner. Foundation Care Pharmacy provides cost-effective, convenient, and trusted pharmacy solutions for patients, physicians, and caregivers

If you have any other questions that we have not addressed, please call our Patient Care and Engagement team at +1 866 735 8423 or visit renoviainc.com

Thank you.