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Instructions for Use
INSTRUCTIONS FOR USE
Noninvasive
UItrasound Device
Customer Service
Toll Free: 888-508-0712
Email: CustomerService@manamed.com
Web: www.manamed.com
Manufactured For:
5240 W Charleston Blvd., #150,
Las Vegas NV 89146
TD-MSPORT02-IFU, Rev. 01
Copyright 2023 ManaMed®, LLC
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Summary of Contents for Manamed ManaSport+ ManaFlow 51
- Page 1 INSTRUCTIONS FOR USE Noninvasive UItrasound Device Customer Service Toll Free: 888-508-0712 Email: CustomerService@manamed.com Web: www.manamed.com Scan QR Code to watch Instructions for Use Manufactured For: 5240 W Charleston Blvd., #150, Las Vegas NV 89146 TD-MSPORT02-IFU, Rev. 01 Copyright 2023 ManaMed®, LLC...
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Page 2: Table Of Contents
Table of Contents Purpose of Device ............Page 3 Indications for Use . -
Page 3: Purpose Of Device
PURPOSE OF DEVICE The ManaSport+ is a portable and rechargeable prescriptive device. It is intended to be used for adults only, under the direction of a medical professional. The ManaSport+ is intended for Home Use. INDICATIONS FOR USE Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. -
Page 4: Precautions
WARNINGS (continued) Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of this device by children or incapacitated persons may be dangerous. To reduce the risk of buns, electric shock, and fire, this device must be used in accordance with the instructions. Do not crush the device and its accessories. -
Page 5: Quick Start Guide
QUICK START GUIDE CAUTION: Federal Law restricts this device CONTENTS: See accompanying documents / User’s Manual. ManaSport+ Device, Applicator, Gel, Adapter, Cap, Strap, Manual to sale by or on the order of a physician. The ManaSport+ provides non-invasive therapy of low-intensity pulsed ultrasound for the treatment of selected medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures. - Page 6 QUICK START GUIDE (continued) The strap can provide you with a hand-free treatment. However, if you prefer to continuously move the transducer applicator throughout your treatment area, you can skip operations 2a to 4c, and only refer to Operation 4a at the bottom of this page. Specifically, please refer to the detailed instructions below for continuously moving the applicator..
- Page 7 QUICK START GUIDE (continued) Use of Ultrasound function: Your physician/doctor may have marked your treatment site with an ‘X’. This is the spot to place the transducer applicator to treat your symptom by using ultrasound. Contact your physician/doctor if you are not sure where to treat your symptom.
- Page 8 Note: Bluetooth LE is an optional feature available on specific versions of ManaSport+ for use with compatible smart devices. For a full list of compatible smart devices, see herein or on our website at www.manamed.com The ManaSport+ provides a Bluetooth LE wireless option to allow connection to a compatible smart device. The Bluetooth communication is only available to smart devices using the Manasport+ App.
- Page 9 QUICK START GUIDE (continued) Use of Ultrasound function via Personal Smart Device: (continued) Step 3: Power on the ManaSport+ device: Power on the device via the power button on the ManaSport+ device. Open the ManaSport+ app on your phone. When the app is paired with the device, a solid Bluetooth symbol will show in the top left corner of the ManaSport+ device.
- Page 10 Irk is mainly used for device authentication; CSRK is mainly used for message signature and verification; The use of multiple keys and CRC verification ensure the encryption and accuracy of BLE data transmission. For more information on the cybersecurity visit our website at www.ManaMed.com. ManaSport+ App Apple™ Compatibility ManaSport+ App Android™...
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Page 11: User Maintenance
The BATTERY icon on the device will keep flashing or steady, Contact ManaMed to receive replacements instructions for any damaged items. depending on the state of the charge. When the battery is charging, the BATTERY icon will keep flashing. -
Page 12: Ultrasound Gel
For the best result, only use the gel supplied. If you need more gel, please email ManaMed at Support@ManaMed.com or contact your DME supplier. The gel is sourced from Hony Medical Co., Ltd. (Reference Gel #K221999). -
Page 13: Troubleshooting
Also, the App can access the data and usage of the device. Currently the optional App is not available. If the optional APP or its update is available, the user may only obtain it from the trusted source instructed by ManaMed. At any time, you can switch to manually operate the subject device by pressing its buttons to deal with any risks and problems that may arise. -
Page 14: Radio Frequency Wireless Description
Radio Frequency Wireless Description Wireless Protocol Characteristics Operation Frequency 2.4 GHz ISM Protocol Type Frequency Hopping Bluetooth Version: V4.2 Frequency modulation GFSK Frequency deviation ± -320 kHz EIRP Measured max -6.2 dBM (0 dBM configured as maximum output power Effective emission power 4.4 [dBm] Data rate 2 Mbps... -
Page 15: Electromagnetic Compatibility Tables
ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES - RF EMISSIONS CLASS B The ManaSport+ is a portable and rechargeable prescriptive device. Warning: Don’t use near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. - Page 16 ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES - RF EMISSIONS CLASS B (continued) GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY The ManaSport+ is intended for use in the electromagnetic environment specified below. The customer or the user of the ManaSport+ should assure that it is used in such an environment. Immunity IEC 60601 Compliance...
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Page 17: Standards
Standards The ManaSport+ complies with current medical standards. The ManaSport+ also complies with the IEC 60601-1 standard on general safety requirements for electro-medical devices, the IEC 60601-1-2 standard on electromagnetic compatibility, the IEC 60601-2-5 standard on basic safety and essential performance of ultrasonic physiotherapy equipment, IEC 61689 field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz, IEC 60601-1-6 General requirements for basic safety and essential performance - Collateral standard: Usability, and the IEC 60601-1-11 standard for use in the home environment.
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