Pelvic Digital Health System
Table of Contents Read This First ................................................................................................. 3 Welcome to leva® ............................................................................................. 3 Indications for Use .......................................................................................... 5 Contraindications ............................................................................................ 5 Warnings ..............................
Read This First Please read all instructions in this manual before you begin using your device. This warning symbol appears next to information about possible safety risks. Please be sure to follow all warning and safety information. Save these instructions for future reference. Welcome to leva® This instruction manual is intended to provide valuable information about the leva® Pelvic Digital Health System (leva PDHS) to ensure that your use of the device is safe and effective.
What’s in the Box? Your leva PDHS includes the following: • Storage case and battery Vaginal probe and battery • • Quick Start Guide What’s not in the Box? The leva PDHS requires use of a mobile application (Renovia App) and mobile device (i.e., smartphone) to visualize pelvic floor exercise during device use. The user is required to download the Renovia App onto their mobile device. What Features does the leva PDHS have? Your leva PDHS was designed as a soft, flexible vaginal device.
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. 2.
probe is only intended to be used in the vagina. Do not have sexual intercourse while the leva probe is inserted. Do not insert the probe if there is any damage to any of the leva PDHScomponents. Keep the leva PDHS out of reach of children. If left unattended, the leva PDHS could prove to be a choking hazard to a child and could result in death. Ifyouexperienceodor,fever,vomiting,diarrhea,any signs of infections, or any flu-like symptoms, contact your doctor immediately.
• 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.
Smartphone Compatibility The leva PDHS is compatible with iOS and Android™ smartphones. App Download The Renovia App is free and can be downloaded from either the App Store or from Google Play.
App Features The Renovia App has several screens that can be reached from the Dashboard. Renovia App Dashboard Practice Mode Training Mode Tests Support Frequently Asked Questions (FAQs) More About You Device Information Education Reminders Figure 1.
Inserting the leva Probe Wash your hands. Always wash your hands immediately prior to inserting the leva probe to prevent harmful bacteria, which may be present on your hands, from entering your vagina. Wash Your leva Probe Wash your leva probe with mild, warm soapy water and gently dry. Get Comfortable Find a comfortable standing position and relax. If this is your first-time using leva PDHS, standing with your knees slightly bent is a very comfortable and easy way to reach your vagina.
Insert the probe into your vagina at a slight upward angle toward the small of your back. If you have trouble inserting the probe use your other hand to separate the skin to give access to the vagina. Gently place the probe into your vagina as far as it will comfortably go. Stop inserting the device if you feel uncomfortable or when the probe is flush with the perineum (vaginal opening). If you feel resistance, do not force the probe in. If you have inserted the probe properly, it should be comfortable.
Starting Your Session The Renovia App has two modes to help you visualize your pelvic floor muscle movements; a Practice Mode and a programmed Training Mode. Both modes can be accessed from the Dashboard. Open Practice Mode first. Unlike the Training Mode, the Practice Mode allows access for as long as you need so you can learn how to properly lift and relax your pelvic floor. Training should be used during your daily sessions. Each training session can be completed in 2.5 minutes.
The Dashboard in the Renovia App keeps a record of the sessions you have completed in Training Mode. Your leva PDHS session history is automatically stored on the Renovia database and is available to you right from the Dashboard. You can view a shorter or longer period of progress time by selecting different timepoints in the Progress view. You can also click on the plot to see the daily average for any given day.
it was inserted. Wash your leva probe with mild, warm soapy water, gently dry the device, and return the device to its storage case. Technical Specifications The leva PDHS uses 6 sensors to provide positional feedback on the shape and movement of your vagina as you perform pelvic floor muscle exercises. In Practice Mode, four measures are reported: Angle, Session Time, Start Angle, and MaxAngle. The Angle measure refers to the average angle of the device with respect to the floor.
Practice Mode and Training Mode Measurements Measure Range Accuracy Precision Angle 0-180° +/- 0. 2° 1° Start Angle 0-180° +/- 0. 2° 1° Max Angle 0-180° +/- 0.2° 1° Session Score 0-100 +/- 0.5 1 Final Score 0-100 +/- 0.
• Do not wash the leva probe with the battery removed. • Care should be taken to not excessively bend or twist the probe during the cleaning and handling process. Excessively bending and twisting the probe can damage the device. • Gently dry the leva probe and return it to its storage case. • Do not wash the leva probe with alcohol, or other chemical cleaners. • Do not submerge the device in water or liquid. Cleaning the Case: Do not wash or submerge the leva case.
• Select “Device Info” • Connect to your leva device • Once connected, the battery level information will be displayed The device will also show a pop-up screen when the battery is low, prompting you with instructions on how to order replacement batteries. See below for reorder and replacement steps. Replacing Batteries Both the probe and case contain battery packs that are intended to be replaced as a set. The batteries should be changed when indicated by the leva PDHS on the Renovia App.
Step 3. Attach the replacement battery pack by pressing it toward the vaginal insert and rotating it clockwise.
Replacing the Storage Case Battery: The storage case battery is located at the base of the tray component of the storage case. Step 1. Open the case by pressing the ejection button on the side the device. Step 2. Detach the battery from the storage case by rotating the base of the battery counterclockwise. Step 3. Attach the replacement battery pack by pressing it toward the vaginal insert and rotating it clockwise.
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. FCC Compliance The leva PDHS is compliant with part 15 of FCC regulations for Class B computing devices (47 CFR Part 15).
Guidance and manufacturer’s declaration – electromagnetic immunity The leva PDHS is intended for use in the electromagnetic environment specified below. The customer or the user of the leva PDHS should assure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic immunity The leva PDHS is intended for use in the electromagnetic environment specified below. The customer or the user of the leva PDHS should assure that it is used in such an environment. IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
The transmitter utilizes a fully certified Class 2 Bluetooth 2.1+ EDR module with a 128-bit encryption. The leva PDHS should not be used 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.
Symbols Model Number Serial Number Date of Manufacture Manufacturer Follow Operating Instructions Type BF Applied Part, Internally Powered Keep Dry IP54 The leva-02 device and storage case are protected from dust. They are also protected against splashing water from all directions, but they should not be submerged in water. Non-Ionizing Electromagnetic Radiation Temperature Limitation Humidity Limitation Federal law (USA) restricts the sale of this device by or on the order of a Physician.
Troubleshooting What do I do if my leva will not connect to my mobile device? If your leva PDHS will not connect to your mobile device, make sure the battery pack on both the probe and the case are properly connected. If it still does not connect, make sure Bluetooth is enabled in your mobile device’s settings. For troubleshooting assistance please contact the Renovia Technical Excellence Center at (833) 450-2914. Error Messages On occasion the App will display a pop-up alert with an error message.
Replace Battery This error is displayed if the actual battery level reported is 5% or below: "Low Battery: Please replace the battery pack on your leva. Contact support at 1 (833) 450-2914 to order a replacement battery pack." Sensor Error "Probe Sensor Error: Please close your app and wait a few minutes, then reopen the app and try to proceed with your exercises with leva. Contact support at (833) 450-2914 if this issue persists." FAQs Please see the Frequently Asked Questions section of the Renovia App.
©2019 Renovia Inc. All Rights Reserved.
