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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App Features
The Renovia App hasseveralscreensthatcanbereached from the
Dashboard.
Renovia App Dashboard
Practice Mode
More
Training Mode
About You
Tests
Device Information
Support
Education
Frequently Asked Questions (FAQs)
Reminders
Figure 1. Renovia App Screenshots

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Inserting the leva Probe
Wash your hands. Always wash your hands immediately priortoinserting
thelevaprobeto preventharmfulbacteria, whichmaybepresentonyour
hands,fromentering 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.Ifthisisyourfirst-timeusing
levaPDHS,standingwith yourkneesslightlybentisaverycomfortableand
easy way to reach your vagina.
Another option is standing with one foot propped up on a stool or
something of similar height soonelegishigherthantheother.Insertingthe
probe is much easier if you are relaxed. The process is much like inserting
a tampon.
Always ensure you are able to maintain your balance when
inserting the vaginal probe and operating the leva PDHS.
Insert the leva Probe.
Hold the leva probe lightly by placing your thumb on the grip and your
index and middle finger on the opposite side.
Remembertokeeptheprobealignedwiththeraised line and logo facing
forward.
Grip
Note: If you have problems with vaginal dryness, applying a very small
amount of water-based lubricant to the tip of the probemaymake
insertioneasier.Donotuseoilorpetroleum-basedlubricants.

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Insert the probe into your vagina at a slight upward angle towardthesmall
ofyour back.Ifyouhavetroubleinsertingthe probe use your other hand to
separate the skin to give access to thevagina.
Gentlyplacetheprobeintoyourvaginaasfarasitwill comfortablygo.
Stop inserting the device if you feel uncomfortable or when
the probe is flush with the perineum (vaginal opening).
Ifyoufeelresistance,donotforcetheprobein.Ifyouhave insertedthe
probeproperly,itshould becomfortable.
Beforebeginningyourexercises,pullupyourunderwearuponlyenough
to gently hold the leva in place.
Trytostandinthesameposition,standingupstraight,and wearingno
shoes(orsimilarshoes) eachtimeyoudoyour exercises.

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Starting Your Session
The Renovia App hastwomodestohelpyouvisualize 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
longasyou needsoyoucanlearnhowto properly
liftandrelaxyour pelvic floor.
Training should be used during your daily sessions. Each training session can
be completed in 2.5 minutes. To access the Training mode, click on the large
“+” button at the bottom of the screen. The app will remind you to always
wash your hands and leva prior to use and will indicate how to insert the
device.
Theappwillthenguideyouthroughaseriesofexercisesand restperiods.
Aftereachexercise,youwillbeshownaSession Score and after all sessions
are completed, you will be shown a Final Score.

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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. Youcanalsoclickonthe plottoseethedailyaverage
foranygiven day.By clicking on the
Sessions link, you can see the scores
foreachsessioncompletedona givenday.
Removing the leva Probe
Relax. Slowly and gently pull the probe downward in the same angle as

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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 ,fourmeasuresarereported:Angle,Session Time, Start
Angle, and MaxAngle.
The Angle measure refers to the averageangle of the devicewithrespect
tothefloor.Ifthedeviceismoreparallel with the floor, the Angle will be
smaller. As you lift your pelvic floor muscles and the device rises, the
Angle will increase. When the device is pointing straight up (perpendicular
to thefloor),theAngleis90°.TheAnglemeasureisupdatedat a rate of 10
times per second and the value displayed is the currentAngle.
The SessionTime referstothe duration of your Practice session.
The Start Angle refers to the angle of the device when you start your session.
The MaxAngle referstothehighestangleyoureachduring thesession.
In Training Mode, you will see a Session Score after each session and a Final
Score once you complete all 5 sessions.
The Session Scores are calculated using an algorithm that considers how
high you lift your pelvic floor and for how long you sustain that lift.After
completingallfivesessions,aFinal Scoreisshownwhichistheaverageofall
fiveSessionScores.
The table below summarizes the range, accuracy, and precision of each
measure when the device is operated under the conditions defined in the
section titled Operating Your leva.

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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
+/- 0.5
1
Storing Your leva
Storage of the leva PDHS should not exceed the following conditions:
• Temperature: +5°C to +40°C
• Humidity: 90% RH non-condensing
• Pressure/Altitude: 3000m or 70kPa
Operating Your leva
Operation of the leva PDHS should not exceed the following
conditions:
• Temperature: +5°C to +40°C
• Humidity: 90% RH non-condensing
• Pressure: 700hPa to 1060hPa
• Operating Range: <3.2 ft (1 meter)
Expected Service Life
• The expected service life of the leva PDHS is 1 year.
• The leva PDHS requires periodic battery changes to maintain
reliability (see Replacing Batteries in the Maintenance Section).
• App updates will be pushed to users periodically as needed
through the App Store™ or Google Play™.
Maintenance
Use the following instructions to ensure proper care and maintenance of
your leva PDHS.
Cleaning the Probe:
Toensure hygienic safety, you should clean and dry your leva probe before
and after each treatment session.
• Clean the leva probe with mild, warm, soapy water.

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• Donotwashthelevaprobewiththebatteryremoved.
• 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 storagecase.
• Donotwashtheleva probewith alcohol,orother chemicalcleaners.
• Donot submergethedeviceinwater orliquid.
Cleaning the Case:
Do not wash or submerge the leva case. If the case needs cleaning, wipe
the case with a damp cloth.
Radio Frequency Wireless Technology:
•The leva-02 probe includes a microcontroller with a 915 MHz band ISM
radio. The effective RF radiated power output (mW) associated with the
915 MHz radio is 2.582 mW.
•The leva-02 case includes two microcontrollers: a 915 MHz band ISM radio
and a 2.4 GHz band Bluetooth Low Energy (BLE) radio. The effective RF
radiated power output (mW) associated with the:
o915 MHz band ISM radio is 3.475 mW
o2.4 GHz BLE radio is 1.486 mW
•The leva-02 device and leva-02 case are considered ME EQUIPMENT.
•The operating range for effective transmission for both the 915 MHz and
BLE transmitters are no more than 3.2 ft (1 meter) away from each other.
Batteries
The leva is powered by two (2) custom battery packs:
• Probe: One (1) Device battery pack containing four 393 silver oxide
button cell batteries that powers the probe.
• Case: One (1) Relay battery pack containing one 2032 Lithium button
cell battery that powers the relay device on the case.
Note: Batteries are non-rechargeable and require periodic replacement
To view the current battery level of your leva:
• Open the Renovia App
• Login
• Select “More” on the dashboard

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• 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.
• To purchase replacement batteries, please contact Renovia at (833)
450-2914 .
Replacing the Probe Battery:
The probe battery is located at the base of the probe.
Step 1.
Detach the battery pack from the vaginal insert by holdingthe
baseof thevaginalinsertfirmlyandrotatingthe battery pack counter-
clockwise.
Step 2. Remove the sticker at the top of the replacement battery pack.

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Step 3. Attach the replacement battery pack by pressing it toward the
vaginal insert and rotating it clockwise.
Step 1
Step2 Step 3
Attach
replacement
battery pack
Remove
sticker
Remove
battery pack