Flyte MTI-1 User manual

Instructions for Use
In-Home Pelvic Floor Treatment Model MTI-1
support@flytetherapy.com | 1-866-735-8482 | www.flytetherapy.com
860 Blue Gentian Rd. Suite 200, Eagan MN 55121
©2022 Pelvital USA. Inc. All rights reserved. Pelvital and Flyte are trademarks of Pelvital USA, Inc.
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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 ...................................................................................................................................................... 13
How to Clean 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 .................................................................................................................................. 25
Store and Handle Flyte ................................................................................................................................. 25
Support ........................................................................................................................................................ 27
Product Registration & Warranty ........................................................................................................... 28
Warranty Exclusions .................................................................................................................................... 28
Frequently Asked Questions .................................................................................................................... 29
Troubleshooting .............................................................................................................................................. 30
Flyte Customer Care ...................................................................................................................................... 31
Disposing of Flyte ............................................................................................................................................ 31
Federal Communications Commission (FCC) Power Input ........................................................ 31
Technical Specifications ............................................................................................................................. 32
Electromagnetic Compatibility ................................................................................................................. 33
Glossary of Terms .......................................................................................................................................... 38
Explanation of Symbols ............................................................................................................................... 39

Getting Started

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Thank You for Choosing Flyte ®
We’re excited you’re beginning your journey with us. Flyte is designed to
improve weak pelvic floor muscles. When 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.

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Getting Started
How Does Flyte Work?
Flyte focuses on promoting quality pelvic floor movement to help women
strengthen weak pelvic floor muscles to reduce bladder leaks — both in terms of
the frequency of urine leakage and the volume of urine leakage.
Once placed in the vagina and turned on, the Flyte wand delivers a series of
mechanical pulses while the biofeedback unit guides you through a series of
contractions (squeeze and lift) and relaxations of your pelvic floor muscles
during a 5-minute per day, six-week treatment. This is called mechanotherapy.
IMPORTANT: To achieve the best results, it is important that you
read these Instructions for Use thoroughly and understand the
contraindications, precautions, and directions for use before using Flyte.

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What’s in the Box?
FLYTE CONSISTS OF THE FOLLOWING COMPONENTS:
A. Flyte wand: Measures whether the pelvic floor muscles are contracting
properly, applies load through a mechanical stimulus to amplify the effects 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. Charging block: 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.
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.

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Getting Started
A. Flyte Wand
C. Charging Cable
B. Biofeedback Unit
D. Charging Block

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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.
Often have trouble keeping in a tampon or tampon-like device.
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.

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Getting Started
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 Flyte 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 charging block
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 Flyte Customer Care. See page 31 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.
WARNING: Do not use Flyte while in the bath, swimming, or otherwise
submerged.

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General Safety Information
Keep Flyte out of reach from 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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Getting Started
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Cleaning

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How to Clean Flyte
We recommend that you clean Flyte before you use it the first time and after each
use.
Clean Flyte with mild soap and water. The procedure provided in this Instructions
For Use manual explains how to use mild soap and water for cleaning.
WARNING: Note the following warnings when cleaning the wand:
Do not use glass or household cleaners on the wand.
Stop using the wand and contact Flyte Customer Care immediately if
you notice any signs of deterioration, such as a change in color, or any
indication of damage.
TO CLEAN THE WAND, COMPLETE THE FOLLOWING STEPS:
1. Wash your hands.
2. Use a clean, wet cloth to remove any obvious residue from the wand.
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.
WARNING: Do not submerge the biofeedback unit, the charging cable,
the charging block, or the wand in water.
3. Wash with mild soap and warm water for 20 seconds.
4. Rinse the wand thoroughly and dry with a clean dry cloth.

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Cleaning
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Preparing to Use Flyte

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Charge the Biofeedback Unit
Before using Flyte for the first time, you must charge the biofeedback unit for at
least 2.5 hours or until the yellow charging light turns off.
Complete the following steps to charge the biofeedback unit:
1. Connect the black connector end of the charging cable to the biofeedback unit
until you hear a click.
2. Connect the white USB end of the charging cable to the charging block.
3. Plug the wall charger block into an electrical outlet.
4. Allow the biofeedback unit to charge for at least 2.5 hours, or until the charging
light turns off.
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 charging block.
7. Store the charging cable and charging block in the box for later use. If ready to
use, proceed to the next set of instructions.
We recommed that you recharge the battery weekly or as needed.
The solid yellow charging light on the biofeedback unit indicates that the
device is charging. When this light turns off, the biofeedback unit is fully
charged.

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Preparing to Use Flyte
Gather Materials
Before you start your session, please have the following materials available:
A clean cloth for cleaning the wand and biofeedback unit.
Mild soap
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 Place and Position
Find a comfortable and private place for your treatment session where you can
concentrate on your pelvic floor exercises for 5 continuous minutes.
You can use Flyte either lying down, sitting, or standing up. We recommend
using Flyte lying on your back when you first begin but choose a position that is
comfortable for you.
As you continue with your treatments and gain strength and tone, you may choose
to change your position. To achieve optimal results, you should remain in the
same position for the full 5 minutes of the session. Feel free to contact our Ask a PT
service for options on positions.

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