Renovia leva User manual

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Table of Contents
Read This First 4
Contraindications 9
Warnings 9
Smartphone Compatibility 14
Download the leva App 14
Connect and Pair leva 17
Technical Specifications 30
Expected Service Life 34
Maintenance and Servicing 34
Radio Frequency Wireless Technology: 36
Replacing Batteries 38
Replacing the Storage Case Battery: 40
Battery and Device Disposal 42
FCC Compliance 42
Electromagnetic Emissions and Immunity 43
Electromagnetic Interference 49
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Symbols 51
Troubleshooting 53
Error Messages 54
Contact 56
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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 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. If at any time you have questions or
need assistance, contact the leva Women’s
Center at [phone].
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Why leva?
Healthy pelvic floor muscles are a key part of
overall pelvic health, which includes maintaining
urinary continence (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
leakage).
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What’s in the Box?
Your leva includes the following:
●Storage case and case battery
●leva vaginal wand with battery
●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
to download the leva App onto their mobile
device.
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What features does leva have?
The leva vaginal wand was designed as a soft,
flexible vaginal device. The leva wand has a
raised indicator line along its front to help ensure
proper positioning. leva Pelvic Health System
operates on batteries located in the base of both
the case and the leva wand.
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).
Because of its communication function, the case
also operates on 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.
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Indications for Use
leva Pelvic Health System 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 the vaginal wand after use.
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Contraindications
leva Pelvic Health System is contraindicated for
uses other than those described by the
indications for use.
Warnings
Please read this section carefully prior to using
your leva Pelvic Health System.
Do not use your leva Pelvic Health
System while pregnant, or if you
think you may be pregnant, unless
authorized by your healthcare
provider.
Do not share your leva Pelvic Health
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
training session and do not exceed 60
minutes of insertion, including during
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menstruation.
Do not use the leva wand in any
other place in your body. The leva
wand is only intended to be used in
the vagina.
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. If left
unattended, the leva Pelvic Health
System could prove to be a choking
hazard to a child and could result in
death.
If you experience redness or swelling
near the insertion area, contact your
doctor, as you may have an allergic
reaction to the device material.
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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. as replacement parts
may result in increased emissions or
decreased immunity of the leva
Pelvic Health System.
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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
water or liquid.
•Do not use the leva Pelvic Health System in
the shower or bathtub, and do not
submerge it in liquid of any kind. The leva
Pelvic Health System is not designed to be
used underwater.
•Do not submerge the battery in any kind of
liquid or expose to running water when
detached from vaginal wand.
•Do not bathe, shower, swim, or submerge
yourself in water while leva wand is
inserted.
•Do not use the toilet while leva wand is
inserted.
•Do not soak the leva Pelvic Health System.
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•Do not put the leva Pelvic Health System in
the dishwasher.
•Do not clean leva with anything but mild
soap and water.
•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.
•Do not modify the leva Pelvic Health System
in any way or use it in combination with any
accessory not mentioned in this document.
This could result in deformation of the leva
which could cause painful insertion or could
damage the electronics.
•Always wash your hands before inserting the
leva wand to prevent harmful bacteria,
which may be present on your hands, from
entering your vagina.
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•Always ensure there are no obstructions
present when inserting the leva wand.
•Always ensure you can maintain your
balance when inserting the leva wand and
operating the leva 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™smartphones.
Contact Technical Support at [phone] for
more information about smartphone
compatibility.
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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.
4. Enter the following information:
●First and Last Name
●Email
●Password (minimum of 8 characters)
●Indicate if you want to receive emails or stay
signed in
●Click Sign Up
●Then:
oAccept the Renovia Privacy Policy
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oEnter the 4-digit code which was sent to
your email, then click 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.
Log in to the leva
App using the email
and password that
you created.
Select “Play Video”
and watch the
Welcome Message.
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2. Complete Part 1.
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”.
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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
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direction of the arrow (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.
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Note: The storage case contains relay
electronics that allow communication
between your leva wand and smartphone.
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. Always wash
your hands immediately prior to
inserting the leva wand to prevent
harmful bacteria, which may be
present on your hands, from
entering your vagina.
Wash Your leva wand
Wash your leva wand.Wash your leva Motion
wand with mild, warm soapy water and gently
dry.
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