NeuroMetrix Quell Fibromyalgia User Manual
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NeuroMetrix Quell Fibromyalgia User Manual

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USER MANUAL
© 2022 NeuroMetrix, Inc.

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Summary of Contents for NeuroMetrix Quell Fibromyalgia

  • Page 1 USER MANUAL © 2022 NeuroMetrix, Inc.

  • Page 2: Table Of Contents

    Chapter 2: Getting Started & Device Basics My Information Rate My Fibromyalgia Getting Started Videos Charging Battery Support Checking Battery Downloading the Quell Fibromyalgia App Chapter 9: Maintenance, Safety, and Service Inserting the Device Attaching the Electrode Maintenance Device Placement Cleaning Device Cleaning Band...

  • Page 3: Chapter 1: Symptom Relief

    8 treatment hours per day is not well characterized. If you have any questions about how to use Quell Fibromyalgia, please call Customer Care at 1-800-204-6577 or email us at CustomerCare@quellfibromyalgia.com.

  • Page 4: What's Included

    < Contents | Chapter 1: Symptom Relief with Quell® Fibromyalgia What's Included Upon receiving your Quell Fibromyalgia Starter Kit, you should inspect its contents to make sure all of the following are included: Device Band USB Cable AC Adapter (Adapter may vary)

  • Page 5: Chapter 2: Getting Started & Device Basics

    1. Fully charge your Quell Fibromyalgia device before first use. Once plugged into an outlet, a blinking white light indicates your device is charging. Once the light turns solid, your device is fully charged. 2. Download the Quell Fibromyalgia app to your smartphone or tablet from the App Store or Google Play. Quell Fibromyalgia 3.

  • Page 6: Downloading The Quell Fibromyalgia App

    Ensure that your smartphone's Bluetooth is turned on and that your device is running iOS 14 or later, or Android 8 or later. Launch the Quell Fibromyalgia app and follow the step by step instruction within the app to pair and setup a Quell Health Cloud account. Once your device is fully charged, you can finish setup and complete calibration (See Chapter 3 for more information on Calibration).

  • Page 7: Device Placement

    < Contents | Chapter 2: Getting Started & Device Basics Chapter 3: Device Basics Chapter 2: Getting Started & Device Basics Device Placement Place your Quell band on your upper calf about 1-2 inches below the knee. You may place on either leg. Be sure the electrode is only covering healthy skin that is not irritated and does not have cuts or other wounds.

  • Page 8: Chapter 3: Calibration

    • The first time you use your device with the app, you will automatically be prompted to complete calibration. If at any time you wish to repeat calibration, open the Quell Fibromyalgia app, click the menu icon, select Settings and then Calibration. Read the instructions on the How to Calibrate screen, and then click Start Calibration to begin the calibration process.

  • Page 9: Chapter 4: Treatment

    For best results, use Quell daily. Before starting a treatment session make sure you We recommend using Quell Fibromyalgia for a have an electrode attached to the device. You should minimum of 3 treatment sessions every day. A also check the battery to ensure it has an adequate treatment session (also called treatment hour) charge.

  • Page 10: Adjusting Intensity During Treatment Session

    < Contents | Chapter 4: Treatment Chapter 4: Treatment can manually stop treatment during a of minutes. If the sensation is uncomfortable or session by double tapping the device painful, you should decrease the intensity within the app. Treatment will continue for 60 minutes firmly with your fingers.

  • Page 11: Chapter 5: Overnight Treatment

    Chapter 5 Overnight Treatment You may use Quell Fibromyalgia at bedtime and while you sleep. Before going to sleep, make sure the device is placed securely and comfortably around your leg. All 4 gel pads on the electrode must be making complete contact with the skin. Start a treatment session within the app.

  • Page 12: Chapter 6: Electrodes

    Chapter 6 Electrodes uncomfortable and/or you see the orange error Quell Fibromyalgia electrodes are designed to light on the Quell device blink when you attempt operate consistently for up to 2 weeks. With repeated use, the electrode gel may peel and/or to start treatment.

  • Page 13: Chapter 7: Skin Care

    Chapter 7 Skin Care Quell Fibromyalgia works by electrically stimulating the sensory nerves in the upper calf through your skin. Some people have dry or sensitive skin, and it is important to regularly monitor your skin where it contacts the electrode to ensure that skin irritation does not occur. If your skin becomes irritated, using the device may be uncomfortable.

  • Page 14: Chapter 8: Using The Mobile App

    Chapter 8 Using the Mobile App From your mobile device or tablet, search for “Quell Fibromyalgia” by NeuroMetrix, Inc. and download the app. Before proceeding, make sure that Bluetooth® is enabled on your mobile device or tablet. iOS and Android devices must have Bluetooth Low Energy (LE, also called Bluetooth Smart) compatibility.
  • Page 15 Push Notifications When enabled, you will get notifications with customized insights to exhance your Quell Fibromyalgia experience and to keep you updated on new features. Electrode Replacement When enabled, you will get a notification that it is time to replace your electrodes.

  • Page 16: Tracking

    Sleep Tracking - Fibromyalgia is a common cause of poor sleep, and insufficient sleep may worsen the condition. It is essential that you get as much high quality sleep as possible. Quell Fibromyalgia can help by decreasing your symptoms overnight and monitoring your sleep. Note: Sleep is only tracked when wearing the device overnight.

  • Page 17: Chapter 9: Maintenance, Safety, And Service

    Dispose of the device according to NEUROMETRIX’S OBLIGATIONS FOR ANY FAILURE OF A PRODUCT national, state, and local regulations as the device TO BE AS WARRANTED ARE LIMITED TO, AT NEUROMETRIX contains a Lithium-Ion battery. OPTION, REPAIR OR REPLACEMENT OF THE PRODUCTS SET FORTH IN THIS WARRANTY STATEMENT.

  • Page 18: Appendix A: Indicator Lights

    < Contents | APPENDIX A: Indicator Light APPENDIX A Indicator Light Device on Skin Device State Indicator Light Status Explanation Standby No Light Illuminated Device in standby, no treatment or calibration in progress Calibration Double Blinking White Light Calibration in progress Treatment Double Blinking White Light Treatment session in progress...

  • Page 19: Appendix B: Troubleshooting

    < Contents | APPENDIX B: Troubleshooting APPENDIX B Troubleshooting Calibration I cannot start the calibration procedure. I am trying to calibrate but I don’t feel anything. Within the app, the Calibration option can Confirm electrode liner has been removed and be found under the Settings menu.
  • Page 20 I am not getting symptom relief. your device since your last treatment session. We recommend that you use Quell Fibromyalgia daily for at least 3 treatment sessions per day for The treatment stings or feels uncomfortable.
  • Page 21 < Contents | APPENDIX B: Troubleshooting Sleep If you mostly have cramping/soreness when lying down, make sure that the device is not positioned Do I need to do anything to the device on wake such that it is compressed between the bed and your leg.
  • Page 22 < Contents | APPENDIX B: Troubleshooting The gel is dry and losing its stickiness. What do I do if I have lost the electrode liner? Even when the electrode seems to be losing its Use a piece of wax paper (plain paper will stick to adhesion to the skin, it should still be usable;...
  • Page 23 Using another charger other than the one provided with Quell Fibromyalgia, i.e., a cell phone charger, isn’t advisable. Only use the cable and charger that was provided with your device to ensure proper charging.

  • Page 24: Appendix C: Frequently Asked Questions

    Can I place the device on my arms or lower back? the evenings and while sleeping. Others wear it No. Quell Fibromyalgia is designed to be worn on during the day and at night. We recommend that the upper calf.
  • Page 25 No. The device is calibrated for one person and highest level of safety. should not be shared. How long does it take to recharge the battery? Can I use Quell Fibromyalgia while sleeping? Fully recharging the battery will take Yes. approximately 3 hours when connecting to the charging adaptor plugged into a wall outlet.

  • Page 26: Appendix D: Alternate Placement Sites

    < Contents | APPENDIX D: Alternate Placement Sites APPENDIX D Alternate Placement Sites If you cannot place your Quell device at the recommended location just below the knee, due to situations such as a wound or skin irritation, then you may position it at one of the following alternate sites: At mid-calf Above the knee on the lower thigh You should calibrate the device at the new site before initiating treatment.

  • Page 27: Appendix E: Technical Specifications

    < Contents | APPENDIX E: Technical Specifications APPENDIX E Technical Specifications Output Waveform Biphasic with alternating leading phase, asymmetrical, rectangular Regulated Current or Voltage Current Net Charge per Pulse Nominally 8 μC @ 500 per pulse; nominally 0 μC per sequential pair of pulses;...
  • Page 28 < Contents | APPENDIX E: Technical Specifications APPENDIX E: Technical Specifications User Interface Ability to recognize double-tap to enclosure for stimulation halt Mobile App Control to calibrate, start treatment, stimulation halt, and intensity adjustment Micro USB B socket for charging LEDs 1 white, 1 orange Bluetooth®...

  • Page 29: Appendix F: Precautions And Warnings

    Precautions and Warnings Indications immediately by double-tapping the enclosure and remove the device. Quell Fibromyalgia is a transcutaneous electrical • You may experience skin irritation or nerve stimulation (TENS) device indicated as an hypersensitivity due to the electrical stimulation aid for reducing the symptoms of fibromyalgia in or electrical conductive medium (gel).
  • Page 30 < Contents | APPENDIX F: Precautions and Warnings Adverse Reactions you may experience an uncomfortable sensation when you remove the device. • You may experience skin irritation • Do not use the device if it has been accidentally and burns beneath the stimulation damaged, causing the housing to come electrodes applied to the skin.

  • Page 31: Appendix G: Symbols

    < Contents | APPENDIX G: Symbols APPENDIX G Symbols User Manual/device labeling Type BF Applied Part WEEE (Waste Electronic and Electrical Equipment) symbol in accordance with council directive 2002/96/EC Abbreviation for model number Keep dry Manufacturer Caution: Federal (US) law restricts this device to sale by or on the order of a physician. MR Unsafe IP22 IEC 60529/Degrees of protection provided by enclosures (IP Code).

  • Page 32: Appendix H: Electromagnetic Compatibility Declaration

    Contents | APPENDIX H: Electromagnetic Compatibility Declaration APPENDIX H Electromagnetic Compatibility Declaration Quell Fibromyalgia is intended for use in the electromagnetic environment specified below. The user should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions;...
  • Page 33 APPENDIX H: Electromagnetic Compatibility Declaration Table 1 Manufacturer's declaration - electromagnetic immunity Quell Fibromyalgia is intended for use in the electromagnetic environment specified below. The user should ensure that it is used in such an environment. Immunity test IEC 60601 Test Level Compliance level Electromagnetic environment –...
  • Page 34 Table 2 Recommended separation distances between portable and mobile RF communications equipment and the Quell Fibromyalgia Device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help...
  • Page 35 This transmitter meets both portable and mobile limits as demonstrated in the 2. This device must accept any interference RF Exposure Analysis. Quell Fibromyalgia contains received, including interference that may cause the Nordic nRF52832 pre-qualified design. undesired operation.
  • Page 36 Communication between the Quell Fibromyalgia device and the Smartphone is via Bluetooth. Disabling Bluetooth If Bluetooth is disabled on your smartphone or tablet, then the Quell Fibromyalgia app will not function. Your device will only function if you have previously enabled Automatic Start within the app.
  • Page 37 < Contents | APPENDIX K: Clinical Summary APPENDIX K Summary of Clinical Information Clinical Information from FDA Decision Summary to be provided when published. Quell Fibromyalgia User Manual Quell Customer Care: 1-800-204-6577 or customercare@quellfibromyalgia.com ®...
  • Page 38 4B Gill Street Woburn, MA 01801, USA (800) 204-6577 Quell Fibromyalgia User Manual www.quellfibromyalgia.com ©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205869 Rev.A...

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