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Related Manuals for Flyte MTI-1
Summary of Contents for Flyte MTI-1
- Page 1 Instructions for Use #FLYTEISMYSUPERPOWER 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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Page 2: Table Of Contents
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 .......................... -
Page 3: Getting Started
Getting Started... -
Page 4: Thank You For Choosing Flyte
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. In-Home Pelvic Floor Treatment Model MTI-1... -
Page 5: How Does Flyte Work
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... -
Page 6: What's In The Box
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... - Page 7 Getting Started A. Flyte Wand B. Biofeedback Unit D. Charging Block C. Charging Cable In-Home Pelvic Floor Treatment Model MTI-1...
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Page 8: Contraindications
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. -
Page 9: Precautions
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. -
Page 10: General Safety Information
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. - Page 11 Getting Started This page intentionally left blank. In-Home Pelvic Floor Treatment Model MTI-1...
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Page 13: Cleaning
Cleaning... -
Page 14: How To Clean Flyte
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. - Page 15 Cleaning This page intentionally left blank. In-Home Pelvic Floor Treatment Model MTI-1...
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Page 17: Preparing To Use Flyte
Preparing to Use Flyte... -
Page 18: Charge The Biofeedback Unit
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: We recommed that you recharge the battery weekly or as needed. -
Page 19: Gather Materials
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. - Page 20 This page intentionally left blank. In-Home Pelvic Floor Treatment Model MTI-1...
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Page 21: Using Flyte
Using Flyte... -
Page 22: How To Use Flyte
Remove the wand if you encounter excessive discomfort, and then contact Flyte. See “Flyte Customer Care” for contact information. On the biofeedback unit, firmly squeeze the ON/OFF button for about 1-2 seconds until the device turns on. - Page 23 Using Flyte Flyte starts your treatment with an 8 second rest cycle with NO CENTER LIGHT on. Relax, rest, and breathe normally. Do not squeeze during this rest period. The center light will then turn ORANGE for 2 seconds. You will start to feel the vibration of the wand.
- Page 24 When the center light turns off and the wand stops vibrating, release, and relax your pelvic floor muscles. You will then return to the 8 second rest cycle. Repeat steps 4-6 for the full 5-minute session. When the session is done, Flyte automatically turns off. Each session consists of 20 repetitions.
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Page 25: End The Day's Session
Keep away from strong magnetic fields because they can turn Flyte off and on. Store Flyte in the box provided and out of direct sunlight when not in use to avoid device damage and maintain cleanliness. - Page 26 This page intentionally left blank. In-Home Pelvic Floor Treatment Model MTI-1...
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Page 27: Support
Support... -
Page 28: Product Registration & Warranty
Product Registration & Warranty Flyte comes with a 1-year warranty against manufacturer defect-related problems from normal use of the product. Please register your Flyte by providing us the following information in one of 3 ways: 1. Online at https://flytetherapy.com/register-your-product/ 2. By calling Flyte Customer Care at 1-866-735-8482 (press 1 when prompted) 3. -
Page 29: Frequently Asked Questions
My wand is slipping out. What do I do? If you find your Flyte wand is being pushed out during your treatment, it is likely that you are not using your pelvic floor muscles properly or using the right muscles. -
Page 30: Troubleshooting
Troubleshooting Refer to the below table if you have problems with any component of Flyte. Problem Probable Cause and Solution The most likely cause is a depleted The biofeedback unit does not turn on battery. Try charging the biofeedback when I press the ON/OFF button. -
Page 31: Flyte Customer Care
Phone: 1-866-735-8482 Flyte Customer Care is staffed by Doctors of Physical Therapy that specialize in pelvic floor physical therapy. You can be confident in connecting with us that we can help answer your questions and guide you towards success. -
Page 32: Technical Specifications
*Protected from touch by fingers and objects > 12mm. Protected from water spray < 15 degrees from vertical. EXPECTED SERVICE LIFE When proper care is taken, and maintenance instructions are followed, the expected service life of Flyte is 1 year. In-Home Pelvic Floor Treatment Model MTI-1... -
Page 33: Electromagnetic Compatibility
The following recommendation is for actions to ensure that Flyte remains safe with regard to EM disturbances: If Flyte is used in a location near (for example, less than 1.5 km [1 m] from) AM, FM, or TV broadcast antennas, it may be necessary to take preventative actions to reduce the EM interference level (for example, by physically moving to a different location). - Page 34 Flyte is intended for use in the electromagnetic environment specified below. The customer or user of Flyte should ensure that it is used in such an environment. When Flyte is exposed to EM disturbances, the system may show abnormal behavior.
- Page 35 Flyte is intended for use in the electromagnetic environment specified below. The customer or user of Flyte should ensure that it is used in such an environment. When Flyte is exposed to EM disturbances, the system may show abnormal behavior.
- Page 36 TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Flyte is used exceeds the applicable RF compliance level above, Flyte should be observed to verify normal operation.
- Page 37 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and Flyte Flyte is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Flyte can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Flyte as recommended below, according to the maximum output power of the communications equipment.
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Page 38: Glossary Of Terms
Unexpected, unintentional urine leakage, such as during normal physical activities Urogynecologist: A doctor who specializes in disorders of the pelvic floor, such as incontinence Vagina: The passage leading from the uterus to the outside of the female body In-Home Pelvic Floor Treatment Model MTI-1... -
Page 39: Explanation Of Symbols
Only store and transport system components in places where +35˚ C the temperature ranges between −20°C (−4°F) and 35°C (95°F). -20˚ C Only use this system when the room temperature is between +35˚ C 5°C (41°F) and 35°C (95°F). 5˚ C In-Home Pelvic Floor Treatment Model MTI-1... - Page 40 Indicates the date when the medical device was manufactured. Do not expose to sunlight. Indicates the manufacturer’s catalogue number so the medical device can be identified. Type BF Applied Part. In-Home Pelvic Floor Treatment Model MTI-1...
- Page 41 Support This page intentionally left blank. In-Home Pelvic Floor Treatment Model MTI-1...
- Page 42 Instructions for Use #FLYTEISMYSUPERPOWER OTC IFU Part #: LBL-001-04 ©2022 Pelvital USA, Inc. All rights reserved. Pelvital and Flyte are trademarks of Pelvital Pelvital USA, Inc. USA, Inc. 860 Blue Gentian Rd. Suite 200 Reproduction, adaptation, or translation Eagan, MN 55121...