Renovia leva User manual

Pelvic Digital Health System

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Table of Contents
Read This First ................................................................................................. 3
Welcome to leva® ............................................................................................. 3
Indications for Use .......................................................................................... 5
Contraindications ............................................................................................ 5
Warnings .......................................................................................................... 5
Precautions ...................................................................................................... 6
Getting Started ............................................................................................... 7
Smartphone Compatibility ........................................................................... 9
App Download ............................................................................................... 9
Device Registration ....................................................................................... 9
Pairing Your Device............................................................................................ 9
Inserting the leva Probe ................................................................................12
Starting Your Session .....................................................................................14
Removing the leva Probe ..............................................................................15
Technical Specifications .................................................................................16
Expected Service Life .....................................................................................17
Maintenance ...................................................................................................17
Radio Frequency Wireless Technology:..............................................................18
Replacing Batteries ........................................................................................19
Replacing the Storage Case Battery: .............................................................21
Battery and Device Disposal ............................................................................21
FCC Compliance ................................................................................................22
Electromagnetic Emissions and Immunity..........................................................22
Electromagnetic Interference .......................................................................24
Symbols ...........................................................................................................26
Troubleshooting .............................................................................................27
Error Messages ...............................................................................................27
FAQs ................................................................................................................28
Contact ...........................................................................................................28

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Read This First
Pleasereadallinstructionsinthismanualbeforeyoubegin using your
device.
Thiswarningsymbolappearsnexttoinformationabout possible
safetyrisks.
Pleasebesuretofollowallwarningandsafetyinformation. Savethese
instructionsforfuturereference.
Welcome to leva®
This instruction manual is intended to provide valuable information about
the leva® Pelvic Digital Health System (levaPDHS)toensurethatyouruse
ofthedeviceissafeand effective.
As you begin to familiarize yourself with the leva PDHS, it is normal to
have questions. If at any time you have questions or need assistance,
contact the Renovia’s Women’s Center at [phone].
Why leva?
Healthy pelvic floor muscles are a key part of overall pelvic health,which
includesmaintainingurinarycontinence (i.e.,the ability to control your
bladder).
Your leva PDHS helps you exercise and strengthen those muscles, so you
can treat your pelvic floor muscle weakness or your urinary incontinence
(commonly known as leakage).

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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?
ThelevaPDHSrequiresuseofamobileapplication( Renovia App )
and mobile device (i.e., smartphone) to visualize pelvic floor
exercise during device use. The user is required to downloadthe
Renovia App onto theirmobiledevice.
What Features does the leva PDHS have?
YourlevaPDHSwasdesignedasasoft,flexiblevaginaldevice. The leva
PDHS has a raised indicator line along the front of thevaginalprobeto
ensureproperpositioning.Theleva PDHS operatesonbatterieslocatedin
thebaseof both the case and the probe.
Theleva PDHSisprovidedwitha sturdystoragecase.This caseservestwo
purposes:itprotectsthedeviceduring storageandalso servesasa
communicationsbridgebetween yourlevaandyourmobilephone(i.e.a
relay).Becauseofits communication function, the case also operates on

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batteries thatare locatedonthefront ofthetray.Thestoragecasealso
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 thinkyoumay
bepregnant,unlessauthorizedbyyour 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
necessarytocompletethetrainingsession Always remove the leva
probe after each training session and do not exceed 60 minutes of
insertion, including during menstruation.
Donotusetheleva probe inanyotherplacein your body. Theleva

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probeisonlyintendedtobeusedin the vagina.
Donothavesexualintercoursewhilethelevaprobe isinserted.
Donotinserttheprobeifthereisanydamagetoany ofthe leva
PDHScomponents.
Keep the leva PDHS out ofreach of children. If left unattended, the
leva PDHS could proveto be a choking hazard to a child and could
result in death.
Ifyouexperienceodor,fever,vomiting,diarrhea,any signsof
infections,oranyflu-likesymptoms,contactyour doctor immediately.
Ifyouexperiencerednessorswellingneartheinsertion area,contact
yourdoctor,as
youmay haveanallergic reactionto the device material.
Donotuseyourleva PDHSadjacenttoorstackedwith other
equipment.Ifadjacentorstackeduseis necessary,the leva PDHS
should be observed to verify normal operation in the configuration in
which it will be used.
The useof accessories,transducers, and cables, other thanthose
specified,withtheexceptionoftransducers and cables sold by Renovia
Inc. as replacement parts forinternalcomponents(ifany), mayresultin
increasedemissionsordecreasedimmunityoftheleva PDHS.
Precautions
Informationregardingspecialcaretobeexercisedforthesafe and effective
use of the device.
• Donotbendthedevice.Donottwistthedevice.
• Donot submergethedeviceinwater orliquid.
• Do not use the leva PDHS in the shower or bathtub, and do not
submergeit inliquidofanykind. leva PDHSisnot designed to be
usedunderwater.
• Do not submerge the battery pack in any kind of liquid or expose
torunningwaterwhendetachedfromvaginalinsert.
• Donotbathe,shower,swim,orsubmergeyourselfinwater while the
device is
inserted.
• Donot usethetoiletwhilethedeviceisinserted.
• Do not soak the leva PDHS.
• Donot puttheleva PDHSinthedishwasher.
• Donotclean the leva PDHSwithanything but mildsoap andwater.

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• Do not use oil or petroleum-based lubricants with the leva PDHS.
Usewater-basedlubricantsonly.
• Donotleavetheleva PDHS in the sun, near an open fire, or in a hot
parked car.Excessiveor directheatcandamagetheleva PDHS.
• Do not modify the leva PDHS in any way or use it in combination
with any accessory not mentioned in this document.Thiscould
result in deformation oftheleva PDHS which couldcause painful
insertion or could damage the electronics.
• Always wash your hands before inserting the device to prevent
harmfulbacteria,whichmaybepresentonyour hands, from
entering your vagina.
• Always ensure there are no obstructions present when inserting the
device.
• Alwaysensureyoucanmaintainyourbalancewheninserting the
device andoperatingtheleva PDHS.
• Toensure hygienic safety, you should clean and dry your leva probe
before and after each treatment session.
Getting Started
Before handling your leva, wash your hands. This is an
important step to prevent harmful bacteria,whichmaybe
presentonyourhands, from contaminating the
probe.

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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.
Device Registration
• Open the Renovia App
• Select Sign Up located at the bottom of the login screen
o Enter the following information:
§ First Name
§ Last Name
§ Email
§ Password
§ Indicate if you want to opt out of emails
§ Indicate if you want to be kept logged in
o Click Register to create your account
Note:
Thestoragecasecontainsrelayelectronicsthatallow
communicationbetweenyourlevaPDHSandsmartphone.
To ensure
connection, verify the probe is removed from the case and that the
probe, case and smartphone are no more than 3.2 ft (1 meter) away
from each other.
Pairing Your Device
Login to the app using the account email and password that you created.
Then follow the pairing process as indicated on the app by first selecting the
“leva-02” device, then selecting “Connect leva.” The app will search for the
leva-02 Bluetooth signal and when found will show the device ID. Once found
select “proceed.” See below screenshots of the pairing process.

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