Pelvital Flyte MTI-1 User manual

Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
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Instructions for Use
In-Home Pelvic Floor Treatment Model MTI-1

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Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
Table of Contents
Getting Started .............................................................................................................................. 3
Thank You for Choosing Flyte .................................................................................................... 4
Indications for Use ......................................................................................................................... 4
How Does Flyte Work? ................................................................................................................ 5
What’s in the Box? ......................................................................................................................... 6
Contraindications ........................................................................................................................... 8
Precautions ..................................................................................................................................... 9
General Safety Information ....................................................................................................... 10
Potential Adverse Events ............................................................................................................ 10
Cleaning & Disinfecting ............................................................................................................... 13
How to Clean & Disinfect Flyte .................................................................................................. 14
Preparing to use Flyte ................................................................................................................ 17
Charge the Biofeedback Unit .................................................................................................... 18
Gather Materials .......................................................................................................................... 19
Visually Inspect ............................................................................................................................ 19
Find a Comfortable Position ...................................................................................................... 19
Using Flyte ..................................................................................................................................... 21
How to Use Flyte .......................................................................................................................... 22
End the Day’s Session ................................................................................................................. 24
Store and Handle Flyte ............................................................................................................... 24
Support ......................................................................................................................................... 25
Product Registration & Warranty ............................................................................................. 26
Warranty Exclusions ................................................................................................................... 26
Frequently Asked Questions ..................................................................................................... 27
Troubleshooting ............................................................................................................................28
Pelvital Customer Care ............................................................................................................... 28
Disposing of Flyte ........................................................................................................................ 29
Federal Communications Commission (FCC) Power Input Technical .............................. 29
Specifications ............................................................................................................................... 30
Electromagnetic Compatibility .................................................................................................. 31
Glossary of Terms ........................................................................................................................ 36
Explanation of Symbols .............................................................................................................. 37
Getting Started

Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
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Getting Started

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Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
Thank You for Choosing Flyte
Physical changes (for example, pregnancy, childbirth, aging, obesity, and
menopause) can result in weakening of the muscles responsible for controlling
urination. When these pelvic floor muscles become weak, actions such as
coughing, laughing, and exercising can result in urine leakage, or urinary
incontinence.
Flyte was designed by physicians who are experts in urogynecology, muscle
rehabilitation, and urinary incontinence to help strengthen pelvic floor muscles
and decrease urinary incontinence in women.
Indications for Use
Flyte is intended for the strengthening of the pelvic floor muscles, which has been
found to help women with stress urinary incontinence.

Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
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How Does Flyte Work?
Flyte helps women strengthen weak pelvic floor muscles to reduce bladder leaks
— both the frequency and volume of urine.
The Flyte wand is placed in the vagina and delivers a series of mechanical pulses
while you contract (squeeze or tighten) your pelvic floor muscles during a 5-minute
per day, six week treatment. This is called mechanotherapy.
For more information about how it works, please visit www.pelvital.com

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Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
What’s in the Box?
Flyte consists of the following components:
A. Flyte wand: Measures the contraction strength of pelvic floor muscles and
applies mechanical stimulus to amplify the eects of each contraction.
B. Biofeedback unit: A handheld device that controls the delivery of mechanical
stimulus by the wand and provides visual feedback to guide your pelvic floor
muscle contractions.
C. Charging cable: Connects the biofeedback unit to the wall charger.
D. Wall charger: AC adapter that allows you to plug the biofeedback unit into a wall
outlet for charging.
Other Accessories (not included with Flyte):
Mild Soap: For cleaning Flyte.
Disinfecting wipes: For disinfecting the surface of the device.
Clean cloths: For wiping the device surfaces.
Water-based vaginal lubricant: Makes insertion of the wand easier.
Lubricated condoms: Make wand insertion and cleaning easier.

Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
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A. Flyte Wand
C. Charging Cable
B. Biofeedback Unit
D. Wall Charger

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Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
Contraindications
Do not use Flyte if you:
• Are under 21 years of age.
• Have given birth in the past 6 weeks.
• Have had genitourinary or pelvic surgery in the past 6 weeks.
• Have had vaginal surgery within the past 3 months.
• Have experienced unusual or unexpected vaginal bleeding in the past 6 months.
• Experience pain or a burning sensation when you urinate, which could indicate a
urinary tract infection.
• Experience vaginal discharge that has an odor, irritation, soreness, or itching,
which could indicate a vaginal infection.
• Have been diagnosed by your doctor with a severely dry (atrophic) vagina, also
known as genitourinary syndrome of menopause (GSM).
• If you have a sensitivity or allergy to silicone.
Ask your doctor before using Flyte if you:
• Are pregnant.
• Experience pain during sexual intercourse or when inserting a tampon or
tampon-like device, which could indicate atrophic vaginitis.
• Often have trouble keeping in a tampon or tampon-like device, which could
indicate vaginal prolapse.
Do not use Flyte:
• If insertion of the Flyte wand causes excessive discomfort.
• With a tampon, a tampon-like device, a diaphragm, a pessary, or other
intravaginal product.
• During sexual intercourse.
• On rare occasions when the wand causes irritation.
• For any reason other than its intended purpose.

Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
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Precautions
• Flyte is not sterile. Please follow the cleaning instructions prior to use.
• Use Flyte only as described in this Instructions For Use.
• Do not disassemble any component of Flyte.
• Do not use Flyte if any component appears to be damaged.
• Do not store or use Flyte in excessively hot, cold, or humid environments.
Please refer to “Technical Specifications” for approved operating temperature
and humidity.
• Do not share your Pelvital System with others. It is for individual use only.
• Do not clean the wand in the dishwasher. The wand is not dishwasher safe.
• Do not submerge the biofeedback unit, the charging cable, the wall charger or
the wand in water.
• Let the wand dry before replacing it in the box.
• No part of Flyte is designed to be repaired or modified by the user. Attempting
to repair or modify system components will void any applicable warranty and
could lead to injury or further damage to components.
If you suspect that the integrity of any component of Flyte has been
compromised, please contact Pelvital. See page 30 for contact information.
WARNING: Do not use a charging system other than the one provided
with Flyte. Use of the wrong charging system can damage Flyte.

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Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
General Safety Information
• Keep Flyte out of the reach of children.
Potential Adverse Events
• As with all intravaginal devices, a foreign-body response(response of biological
tissue to any foreign material in the tissue) may occur.
• Tissue responses to the wand can include vaginal irritation or discharge,
irritation to the urethra or other surrounding tissue, pain, and inflammation. If you
experience these responses, you may need to stop using Flyte.
• Improper placement or use of the wand may cause temporary or permanent
injury.
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Cleaning & Disinfecting

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Cleaning & Disinfecting

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Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
How to Clean & Disinfect Flyte
Pelvital recommends that you clean and disinfect Flyte before you use it the first time
and after each use.
Cleaning and disinfecting are not the same thing. Cleaning simply removes bodily
fluids and dirt. Disinfecting kills germs and provides an extra level of safety. Be sure
to follow the disinfection process provided in this Instructions For Use.
Clean Flyte with mild soap and disinfect the exterior of the wand only with products
such as Dispatch® Cleaner Disinfectant Towels or equivalent wipes that contain
no more than 1% sodium hypochlorite. Dispatch Towels have been tested and
are shown to be safe for use with your wand. In the procedure provided in this
Instructions For Use, you will use the mild soap and water for cleaning and a
hypochlorite wipe for disinfection.
WARNING: Note the following warnings when cleaning and disinfecting
the wand:
Do not use glass or household cleaners on the wand.
Stop using the wand and contact Pelvital Customer Care immediately if
you notice any signs of deterioration, such as a change in color, or any
indication of damage.

Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
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To clean the wand, complete the following steps:
1. Wash your hands.
2. Use a clean, damp cloth to remove any obvious residue from the wand.
To disinfect the wand and biofeedback unit, complete the following
steps:
1. Dispense a hypochlorite wipe from its container.
2. Use the wipe to disinfect the wand and biofeedback unit, wiping all outside
surfaces thoroughly according to the instructions included with the wipes.
3 Discard the wipe.
4. Allow the wand’s surface to remain wet for 5 minutes.
5. Use a clean, damp cloth to wipe the wand clean and remove residual
disinfectant.
Use only a soft cloth or wipe to clean the wand. Abrasive materials such
as scouring pads and steel wood can damage the wand’s silicone covering,
reducing its reliability and adding to the risk of contamination and infection.
Use a cleaning/disinfecting wipe that contains no more than a 1% dilution of
sodium hypochlorite.
WARNING: Do not submerge the biofeedback unit, the charging cable,
the wall charger, or the wand in water.
3. Hands wash the wand with mild soap and warm water.
4. Rinse the device thoroughly with warm water.

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Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
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Preparing to Use Flyte

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Preparing to Use Flyte

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Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
Charge the Biofeedback Unit
Before you can use your Flyte for the first time, you must charge the biofeedback
unit for at least 2.5 hours.
Complete the following steps to charge the biofeedback unit:
1. Connect the white USB end of the charging cable to the wall charger.
2. Plug the wall charger into an electrical outlet.
3. Connect the black connector end of the charging cable to the biofeedback unit.
4. Allow the biofeedback unit to charge for at least 2.5 hours.
5. When charging is complete, disconnect the charging cable from the biofeedback
unit by pressing the tabs on both sides of the connector and gently pulling the
cable.
6. Disconnect the charging cable from the wall charger.
7. Store the charging cable and wall charger in the box for later use, if not ready to
use the device. If ready to use, proceed to the next set of instructions.
Pelvital recommends that you recharge the battery weekly.
The solid yellow Charging light on the biofeedback unit indicates that the
device is charging. When this light turns o, the biofeedback unit is fully
charged.

Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
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Gather Materials
Before you start your session, please have the following materials available:
• Clean cloths for cleaning the wand and biofeedback unit.
• Mild soap
• Disinfecting wipes (choose a wipe that contains no more than 1% dilution of
sodium hypochlorite).
• Optional. A water-based vaginal lubricant or a lubricated, non- latex probe cover
or condom to make the wand insertion more comfortable.
Visually Inspect
Prior to each use, visually inspect all Flyte components. In particular, make sure that
there are no cracks or tears in the silicone cover of the wand or the charging cable
that could expose the component’s interior wires or electronics.
Find a Comfortable Position
You can use Flyte either lying down or standing up. Choose a private area where you
can concentrate on your pelvic floor exercises for 5 continuous minutes. To achieve
optimal results, you should remain in the same position for the full 5 minutes of the
session.

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Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020
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Using Flyte