Related Manuals for Pelvital Flyte MTI-1
Summary of Contents for Pelvital Flyte MTI-1
- Page 1 Instructions for Use In-Home Pelvic Floor Treatment Model MTI-1 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020...
-
Page 2: Table Of Contents
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 ........................ -
Page 3: Getting Started
Getting Started Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020... -
Page 4: Thank You For Choosing Flyte
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. -
Page 5: How Does Flyte Work
(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 Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020... -
Page 6: What's In The Box
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 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. - Page 7 A. Flyte Wand B. Biofeedback Unit D. Wall Charger C. Charging Cable Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020...
-
Page 8: Contraindications
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. •... -
Page 9: Precautions
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. -
Page 10: General Safety Information
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. - Page 11 This page intentionally left blank. Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020...
- Page 12 This page intentionally left blank. Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020...
-
Page 13: Cleaning & Disinfecting
Cleaning & Disinfecting Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020... -
Page 14: How To Clean & Disinfect Flyte
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. - Page 15 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. 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.
- Page 16 This page intentionally left blank. Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020...
-
Page 17: Preparing To Use Flyte
Preparing to Use Flyte Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020... -
Page 18: Charge The Biofeedback Unit
2.5 hours. Complete the following steps to charge the biofeedback unit: Pelvital recommends that you recharge the battery weekly. 1. Connect the white USB end of the charging cable to the wall charger. 2. Plug the wall charger into an electrical outlet. -
Page 19: Gather Materials
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). - Page 20 This page intentionally left blank. Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020...
-
Page 21: Using Flyte
Using Flyte Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020... -
Page 22: How To Use Flyte
Remove the wand if you encounter excessive discomfort, and then contact Pelvital. See If necessary, apply a small amount of water-based vaginal lubricant to the “Pelvital Customer Care”... - Page 23 4. When the Contract light on the biofeedback unit turns green, squeeze and hold your pelvic floor muscles until the green Contract light turns off and the wand stops vibrating. When the Contract light on the biofeedback unit turns green, squeeze and hold The green light indicates that you should squeeze your pelvic floor muscles as your pelvic floor muscles until the green Contract light turns off and the wand hard as you can.
-
Page 24: End The Day's Session
• Keep Flyte away from children and pets. • Flyte may discolor for various reasons. If discoloration occurs, discontinue using Flyte and contact Pelvital Customer Care. Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020... -
Page 25: Support
Support Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020... -
Page 26: Product Registration & Warranty
Product Registration and Warranty Flyte comes with a 1-year warranty against manufacturer defect-related problems from normal use of the product. Register your Flyte at www.pelvital.com, or fill out and mail the provided registration card to Pelvital. Warranty Exclusions This warranty does not extend to any products (a) that have been subject to misuse, neglect, abuse, improper cleaning, disinfecting, storage, accident, or that have not been properly maintained;... -
Page 27: Frequently Asked Questions
If the discomfort is excessive, consider discontinuing use of Flyte and calling Pelvital Customer Care. How often should I recharge the device’s battery? It is recommended that you recharge the battery weekly. When the battery reaches a low level, the green On light on the biofeedback unit blinks on and off. -
Page 28: Troubleshooting
If problems persist, please contact Pelvital: • Email: support@pelvital.com • Web: www.pelvital.com • Phone: 1-866-PELVITAL About Pelvital USA, Inc. For more information about Pelvital, please visit our website at www.pelvital.com. Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020... -
Page 29: Disposing Of Flyte
To avoid the dissemination of those substances in our environment and to diminish the pressure on natural resources, Pelvital encourages you to use the appropriate systems for product disposal. -
Page 30: Specifications
Technical Specifications Model: MTI-1 Main power: Lithium-ion rechargeable battery, 680-710mAh nominal capacity Electrical class: Internally powered Operational frequency: 30 Hz USB input power: 5 V direct current Training cycle: 5 minutes (DC), 485 mA (455 mA for charging and 30 mA for electronics) Modes: Training mode, Charging Ingress protection: IP22* mode... -
Page 31: Electromagnetic Compatibility
Use. For electromagnetic (EM) compliance, it is important to use only accessories that meet the specifications recommended by Pelvital. (Please refer to the “What’s in the Box?” section.) The following recommendation is for actions to ensure that Flyte remains safe with regard to EM disturbances: •... - Page 32 Guidance and Manufacturer’s Declaration — Electromagnetic Immunity 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. Immunity test IEC 60601 test Compliance...
- Page 33 Guidance and Manufacturer’s Declaration — Electromagnetic Immunity 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 34 Guidance and Manufacturer’s Declaration — Electromagnetic Immunity NOTE: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy.
- Page 35 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.
-
Page 36: Glossary Of Terms
Glossary of Terms Atrophic vaginitis (also known as genitourinary syndrome of menopause - GSM): Thinning, drying, and inflammation of the vaginal walls caused by a reduction in estrogen Intravaginal: Inside the vagina Pelvic floor exercises: Exercises designed to strengthen pelvic floor muscles Pelvic floor muscles: A layer of muscles that, in women, support the bladder, bowel, and uterus Urinary incontinence:... -
Page 37: Explanation Of Symbols
Explanation of Symbols Indicates the medical device manufacturer. Indicates the manufacturer’s serial number so that a specific medical device can be identified. Refer to instruction manual/booklet. DO NOT THROW IN TRASH. Indicates the need for the user to consult the Instructions For Use for important information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. - Page 38 Explanation of Symbols Explanation of Symbols Explanation of Symbols Only use this device with relative humidity between Explanation of Symbols Only use this device with relative humidity between Explanation of Symbols Only use this device with relative humidity between 10% and 90%, non-condensing (that is, no water is 10% and 90%, non-condensing (that is, no water is Only use this device with relative humidity between Only use this device with relative humidity between 10% and...
- Page 39 This page intentionally left blank. Flyte | In-Home Pelvic Floor Treatment Model MTI-1 | © 2020...
- Page 40 Instructions for Use OTC IFU Part #: LBL-0001-01 Last update: July 20, 2020 ©2020 Pelvital USA, Inc. All rights reserved. Pelvital and Flyte are trademarks of Pelvital USA, Inc. Reproduction, adaptation, or translation of this Instructions For Use is prohibited without prior written permission of Pelvital, except as allowed under copyright laws.