Renovia leva Manual
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Renovia leva Manual

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  • Page 2: Table Of Contents

    Table of Contents Read This First Contraindications Warnings Smartphone Compatibility Download the leva App Connect and Pair leva Technical Specifications Expected Service Life Maintenance and Servicing Radio Frequency Wireless Technology: Replacing Batteries Replacing the Storage Case Battery: Battery and Device Disposal...
  • Page 3 Symbols Troubleshooting Error Messages Contact...

  • Page 4: Read This First

    Welcome to leva® This instruction manual is intended to provide valuable information about leva® Pelvic Health System (leva PHS) to ensure that your use of the device is safe and effective. As you begin to familiarize yourself with leva Pelvic Health System, it is normal to have questions.
  • Page 5 (i.e., the ability to control your bladder). leva Pelvic Health System helps you exercise and strengthen those muscles, so you can treat your pelvic floor muscle weakness or your urinary incontinence (commonly known as bladder...
  • Page 6 ● Quick Start Guide ● What’s not in the Box? leva Pelvic Health System requires use of a mobile application (leva App) and mobile device (i.e., smartphone) to visualize pelvic floor exercise during device use. The user is required...
  • Page 7 The leva wand is provided with a sturdy storage case. This case serves two purposes: it protects the leva wand during storage and also serves as a communications bridge between your leva wand and your mobile phone (i.e. a relay).
  • Page 8 Indications for Use leva Pelvic Health System is intended for: Strengthening of the pelvic floor muscles; 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.

  • Page 9: Contraindications

    System with other users. leva Pelvic Health System is intended for use as a single-user medical device. Do not leave the leva wand in your vagina for longer than necessary to complete the training session. Always remove the leva wand after each...
  • Page 10 Do not have sexual intercourse while the leva vaginal wand is inserted. Do not insert the leva wand if there is any damage to any of the leva Pelvic Health System components. Keep the leva Pelvic Health System out of reach of children.
  • Page 11 Do not use your leva wand and storage case adjacent to or stacked with other equipment as this may adversely impact normal operation of the device. The modification or use of the leva Pelvic Health System with accessories other than those specified and sold by Renovia Inc.
  • Page 12 Precautions Please familiar yourself with the following information for the safe and effective use of the device: Do not bend the leva wand. Do not twist the • leva wand. Do not submerge the leva wand or case in •...
  • Page 13 Do not use oil or petroleum-based lubricants • with the leva wand. Use water-based lubricants only. Do not leave leva in the sun, near an open • fire, or in a hot parked car. Excessive or direct heat can damage the leva Pelvic Health System.

  • Page 14: Smartphone Compatibility

    Pelvic Health System. To ensure hygienic safety, you should clean • and dry your leva wand before and after each treatment session. Smartphone Compatibility The leva Pelvic Health System is compatible with most iOS and Android™...

  • Page 15: Download The Leva App

    1. Download the free leva App from the App Store® for iOS or from Google Play for Android™. 2. Launch the leva App by pressing the leva App icon on your smartphone 3. Select Sign Up located at the bottom of the screen.
  • Page 16 Submit to finish creating your account. Set Up leva Pelvic Health System The leva App will take you through a series of steps to set up your leva Pelvic Health System. These steps include: 1. Watch the Welcome message.
  • Page 17 Select “Play Video” and watch the educational videos presented. Afterwards, you may choose to watch the videos again or continue to Part 2. 3. Complete Part 2. Select “Next” and proceed through step by step instructions to connect leva and practice your first “lift”.
  • Page 18 4. Connect leva Removing the leva wand from the case will automatically turn on the device. 5. Prepare the leva wand by detaching the battery and removing the battery sticker. 6. Reattach the battery by pressing it toward the vaginal insert and rotating it in the...
  • Page 19 (see below). 7. Search for your leva Pelvic Health System using a Bluetooth signal. The leva App will identify your leva Pelvic Health System and confirm that it is connected and ready to use.
  • Page 20 To ensure connection, verify the leva wand is removed from the case and that the leva wand, case, and smartphone are no more than 3.2 ft (1 meter) away from each other. Preparing for Your Session Wash your hands.
  • Page 21 Another option is standing with one foot propped up on a stool or something of similar height so one leg is higher than the other. Inserting the leva wand is much easier if you are relaxed. The process is much like inserting a tampon.
  • Page 22 If you have trouble inserting the leva wand, use your other hand to separate the skin to give access to the vagina. Gently place the vaginal insert portion of the leva wand into your vagina as far as it will comfortably go.
  • Page 23 (vaginal opening). If you feel resistance, do not force the leva wand in. If you have inserted the leva wand properly, it should be comfortable. Rotate the leva wand until the thumb pad on the grip is facing forward and the leva App informs you that your alignment is correct.
  • Page 24 Try to stand in the same position, standing up straight, and wearing no shoes (or wear similar shoes each time you do your exercises). Practice your first “lift” The leva App will provide a tutorial on how leva works and what to expect when Training. During this tutorial,...
  • Page 25 To begin Training, click on the large “ ” ✓ button at the bottom of the screen. The leva App will remind you to always wash your hands and leva wand prior to use and will indicate how to...
  • Page 26 The app will guide you through a series of 5 lifts with resting periods between. After each lift, you will be shown your Lift and Hold Time results. After all lifts are completed, you will be shown the average of all 5 Lift and Hold Time results from your session.
  • Page 27 Progress screen of the leva App keeps a record of the Training Sessions you completed.
  • Page 28 Relax. Slowly and gently pull the leva wand downward in the same angle as it was inserted. Wash your leva wand with mild, soapy water. Gently dry the leva wand and return it to its storage case to preserve battery life and protect it from damage.
  • Page 29 App Features leva App has several screens that can be reached from the Home screen. leva App Navigation Map Home Support ■ Instructions for Use ■ Progress and Training...
  • Page 30 Learn Video Library ■ Read ■ Tutorials ■ More My Profile ■ My leva ■ Reminders ■ Tests ■...

  • Page 31: Technical Specifications

    Technical Specifications The leva Pelvic Health System uses 6 sensors to provide positional feedback on the shape and movement of your vagina as you perform pelvic floor muscle exercises. In the Practice screen, four measures are reported: Angle, Session Time, Start Angle, and Max Angle.
  • Page 32 Hold Time once you complete all 5 lifts. The Lift result represents the highest angle you reached with leva, from 0˚ to 50˚. The Hold Time result represents the number of seconds, out of 15 total seconds, that you held leva at its highest point.
  • Page 33 Practice and Training Session 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° Lift 0˚ - 50˚ +/- 0.5 1˚...
  • Page 34 Storing Your leva Storage of the leva Pelvic Health System should not exceed the following conditions: Temperature: 5°C to 70°C • Humidity: 15-90% RH non-condensing • Altitude: 70kPa • Operating Your leva Operation of the leva Pelvic Health System should not exceed the following conditions: Temperature: 5°C to 70°C...

  • Page 35: Expected Service Life

    App Store™ or Google Play™. Maintenance and Servicing The leva Pelvic Health System does not have any serviceable parts. Replacement batteries are available per the information provided in this section. Use the following instructions to ensure...
  • Page 36 Excessively bending and twisting the leva wand can damage the device. Gently dry the leva wand and return it to its • storage case. Do not wash the leva wand with alcohol, or •...

  • Page 37: Radio Frequency Wireless Technology

    Bluetooth Low Energy (BLE) radio. The effective RF radiated power output (mW) is: 915 MHz band ISM radio is 3.475 mW 2.4 GHz BLE radio is 1.486 mW The leva wand and case are considered ME ● EQUIPMENT. The operating range for effective transmission ●...
  • Page 38 Info”. Connect to your leva. ● Once connected, the battery level ● information will be displayed. The leva App will also show a pop-up screen when the battery is low, prompting you with instructions on how to order replacement batteries.

  • Page 39: Replacing Batteries

    Replacing Batteries Both the leva wand and case contain batteries that are intended to be replaced as a set. The batteries should be changed when indicated by leva Pelvic Health System on the leva App. To purchase replacement batteries, ●...
  • Page 40 Replacing the leva wand Battery: The leva wand battery is located at the base of the vaginal wand. Step 1. Detach the battery. Hold the base of the vaginal wand and rotate the battery in the direction of the arrow in the picture.

  • Page 41: Replacing The Storage Case Battery

    Step 3. Reattach the battery. Press the battery into the vaginal wand and rotate it in the direction of the arrow as pictured. Replacing the Storage Case Battery The storage case battery is located at the base of the tray component of the storage case. Step 1.
  • Page 42 Step 2. Remove the battery from the case by twisting the end of the tray in the direction of the arrow shown below. Step 3. We recommend waiting 1 minute before connecting the new case battery by twisting it back on.

  • Page 43: Battery And Device Disposal

    (if any), may result in increased emissions or decreased immunity of the leva Pelvic Health System. FCC Compliance The leva Pelvic Health System is compliant with part 15 of FCC regulations for Class B computing devices (47 CFR Part 15).

  • Page 44: Electromagnetic Emissions And Immunity

    Guidance and manufacturer’s declaration – electromagnetic emissions leva Pelvic Therapeutic is intended for use in the electromagnetic environment specified below. The customer or the user of the leva should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 45 Guidance and manufacturer’s declaration – electromagnetic immunity leva Pelvic Health System is intended for use in the electromagnetic environment specified below. The customer or the user of leva Pelvic Health System should assure that it is used in such an environment.
  • Page 46 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the leva Pelvic Health System is used exceeds the applicable RF compliance level above, the leva Pelvic Health System should be observed to verify normal operation.
  • Page 47 System. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
  • Page 48 Guidance and manufacturer’s declaration – electromagnetic immunity The leva Pelvic Health System is intended for use in the electromagnetic environment specified below. The customer or the user of the leva Pelvic Health System should assure that it is used in such an environment.
  • Page 49 UT) for typical commercial or and voltage 0,5 cycle hospital environment. variations on 40 % UT If the user of the leva power supply (60 % dip Pelvic Health System input line IEC in UT) for requires continued 61000-4-11...

  • Page 50: Electromagnetic Interference

    Wireless communications equipment such as wireless home network devices, mobile phones, and cordless telephones and their base stations can affect leva Pelvic Health System. Keep leva away from other wireless equipment based on the table below: The transmitter utilizes a fully certified Class 2 Bluetooth 2.1+ EDR module with a 128-bit...
  • Page 51 The leva Pelvic Health System should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, leva should be observed verify normal operation configuration in which it will be used. The leva Pelvic Health System should not...
  • Page 52 Manufacturer Follow Operating Instructions Type BF Applied Part, Internally Powered Keep Dry The leva-02 device and storage case IP54 are protected from dust. They are also protected against splashing water from all directions, but they should not be submerged in water.
  • Page 53 Humidity Limitation Federal law (USA) restricts the sale of this device by or on the order of a Physician. This product contains electrical and electronic components that may contain materials which, if disposed with general waste, could be damaging to the environment. Dispose or recycle this product in accordance with local laws or regulations that apply.
  • Page 54 Troubleshooting What do I do if my leva will not connect to my mobile device? If your leva will not connect to your mobile device, make sure the batteries on both the leva wand and the case are properly connected.
  • Page 55 Error Messages On occasion the leva App will display a pop-up alert with an error message. The error messages contain information on how to troubleshoot as well as a support phone number to contact. The Error messages are included here.
  • Page 56 Warning: Low Battery Levels This error is displayed when the reported battery levels are below 35% but above 5%: "Batteries Are Getting Low leva batteries are low and will need to be replaced soon. Call Technical Support (833-450-2914) to order batteries.”...
  • Page 57 Floor, Boston, MA 02210 Bluetooth® is a registered trademark of Bluetooth SIG, Inc. leva® is a registered trademark of Renovia Inc. Android™ is a trademark of Google LLC. Google Play and the Google Play logo are trademarks of Google LLC.

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