Table of Contents
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Table of Contents
Summary of Contents for Quell Wearable Pain Relief
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Page 1: User Manual
User Manual © 2016 NeuroMetrix, Inc. -
Page 2: Table Of Contents
Contents Chapter 1: Pain Relief with Quell Chapter 10: Maintenance, Safety, and Service Introduction What You Should Have Received Maintenance Device Components Cleaning Device Cleaning Band Chapter 2: Getting Started Device Storage Disposal Limited Warranty Chapter 3: Device Basics Checking Battery... -
Page 3: Chapter 1: Pain Relief With Quell
Chapter 9 provides information about the optional smartphone apps. APPENDIX C gives answers to frequently asked questions. If you have any questions about how to use Quell please call Quell Customer Care at 1-800-204-6577 or, if calling from outside the US, please call 781-890-9989. -
Page 4: What You Should Have Received
Contents | Chapter 1: Pain Relief with Quell What You Should Have Received Upon receiving your Quell Wearable Pain Relief System you should inspect its contents to make sure all of the following are included and undamaged. Quell Device Sports Band... -
Page 5: Device Components
< Contents | Chapter 1: Pain Relief with Quell Device Components Indicator lights Push button Adjustable sports band Micro-USB port Two electrode (not seen in image, port is on bottom of device) connector snaps Quell User Manual Quell Customer Care 1-800-204-6577... -
Page 6: Chapter 2: Getting Started
Contents | Chapter 2: Getting Started Chapter 2 Getting Started The following instructions will help you start using Quell. For additional details, please review Chapters 3-8 or you can call Customer Care with any questions at 1-800-204-6577. 1. Check Battery... -
Page 7: Start Therapy
Break weeks to experience optimal relief. Let us help: For questions or to troubleshoot To learn how to control your Quell device with your issues, contact Customer Care at smartphone app, please review Chapter 9. 1-800-204-6577 or via email at CustomerCare@quellrelief.com. -
Page 8: Chapter 3: Device Basics
The USB connector on many computers is not powerful enough to charge Quell. The white indicator lights on the device will show that the device is charging. The number of lights shown will increase as the battery charges. When the battery is fully charged, all 5 lights will be lit for a short time and then all the lights will turn off. -
Page 9: Attaching Electrode
Improper storage of the electrode will reduce its life. Only use Quell electrodes manufactured by NeuroMetrix, Inc. 1. Slide device into band pouch with lights facing up. 2. Align the snaps on the electrode to the snap connectors on the device. -
Page 10: Device Placement
Chapter 3: Device Basics Chapter 3: 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 11: Chapter 4: Calibration
If you halt the calibration process before it is completed, you will have to re-start and fully complete the calibration process before using your device. Device is calibrated for a single person and should not be shared. Quell User Manual Quell Customer Care 1-800-204-6577 ®... -
Page 12: Chapter 5: Pain Relief Therapy
Do not shower, bathe or during a therapy session. adequate charge. Place the device on your leg as swim with the device on your leg. described in Chapter 3. Quell User Manual Quell Customer Care 1-800-204-6577 ®... -
Page 13: Adjusting Intensity During Therapy Session
After 4 hours of wear, device will pulse highest intensity that is also comfortable. on and off for 1 minute as a reminder. To learn how to control your Quell device with your smartphone app, please review Chapter 9, Using the Mobile App. -
Page 14: Chapter 6: Overnight Therapy
Chapter 6 Overnight Therapy You may use Quell at bedtime and throughout the night. Before going to sleep, make sure the device is placed securely and comfortably around your leg. Start a therapy session by briefly clicking the button. This first therapy session will stimulate at your regular intensity level. -
Page 15: Chapter 7: Electrodes
You can www.quellrelief.com/replace order electrodes at or from the location where you purchased your device. Quell User Manual Quell Customer Care 1-800-204-6577 ®... -
Page 16: Chapter 8: Skin Care
There are some simple things you can do to take care of your skin while using Quell. Never use the device on open wounds or rashes or over swollen, red, infected, or inflamed skin. -
Page 17: Chapter 9: Using The Mobile App
Check the battery power by clicking the button on your Quell device. If a minimum of one of the white LED's lights up, your Quell device has sufficient power to proceed. Also make sure that Bluetooth is enabled on your mobile device. -
Page 18: The Quell App
Please note that not all features are available on all devices. Time to Calibrate Your Device This message will appear if your Quell device has not yet been calibrated. Refer to the Quick Start Guide that came with your device for calibration instructions. - Page 19 This screen shows when device is Tap the User icon to see a charging. Please note that your dashboard of current activity. Quell device can only be charged This shows how many therapy when off your leg. sessions you had today, the...
- Page 20 Videos When your mobile device’s WiFi is turned on, you can access helpful how-to videos that walk you through common procedures including calibrating your Quell device, pairing with your mobile device, and much more. Support Support includes important Contact, Legal, and Device related information.
- Page 21 Sleep screen, click on any bar to the Tracking screen, you may set previous nights. display the Sleep Insights in that the desired time period of the time period. display. Quell User Manual Quell Customer Care 1-800-204-6577 ®...
- Page 22 You can use this menu to options for Stimulation. The un-pair your mobile device from Standard stimulation feels your Quell device. You use this like a constant vibration. The if you want to pair your mobile Alternative Stimulation feels device with a different Quell like a gentle pulse.
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Page 23: Chapter 10: Maintenance, Safety, And Service
Maintenance, Safety, and Service Maintenance This warranty does not cover damage due to external causes, including accident, abuse, Contact Quell Customer Care at 1-800-204-6577 misuse, problems with electrical power, usage if the device requires service. not in accordance with product instructions,... -
Page 24: Appendix A: Indicator Lights
Auto-Restart being enabled, 1 white light indicates Auto-Restart being disabled.* Auto-Restart is enabled by default. *Note: You must have Auto-Restart enabled in order to access the Overnight Therapy Settings. Quell User Manual Quell Customer Care 1-800-204-6577 ®... - Page 25 Outer 2 lights on or all 6 lights With a 10 second press during charging, all illuminate while button is held 6 lights indicate Bluetooth being enabled, outer 2 lights indicate Bluetooth being disabled. Bluetooth is enabled by default. Quell User Manual Quell Customer Care 1-800-204-6577 ®...
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Page 26: Appendix B: Troubleshooting
(or press the calibrating the device again or increasing the button), the therapeutic intensity will be set at the therapeutic intensity by clicking and holding the maximum possible intensity. button. Quell User Manual Quell Customer Care 1-800-204-6577 ®... - Page 27 If this is happening, the device should be placed to to toggle between settings. the inside or outside to minimize any discomfort. 1 white light = manual. 5 white lights = automatic Quell User Manual Quell Customer Care 1-800-204-6577 ®...
- Page 28 Sleep There is no risk associated with soreness. If you are getting a lot of pain relief from Quell, you may Do I need to do anything to the device on wake decide it is worth it to keep wearing it, even if you have some soreness as a consequence.
- Page 29 Remove the device when not in use to allow the gel to cool. Alternate leg on which Quell is worn, if possible. Minimize use outdoors during hot, humid weather, Reorient the device so the electrode is covering when possible.
- Page 30 Using a charger other than the one provided with Quell, i.e., a cell phone charger, isn’t advisable. What if there is no flashing light?
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Page 31: Appendix C: Frequently Asked Questions
No. Quell is designed to provide widespread relief from chronic pain when worn on the upper calf. Do I need to set up Quell differently for sleep use? No, but there are 3 sleep setting options (see Chapter 6). - Page 32 Yes. Can I use a different manufacturer’s electrode? The Quell electrode is the only electrode cleared by the FDA for use on the Quell device. The Quell electrode was designed to ensure optimal performance and the highest level of safety.
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Page 33: Appendix D: Alternate Placement Sites
APPENDIX D Alternate Placement Sites If your Quell device cannot be placed at its usual location just below the knee, due to situations such as a wound or skin irritation, then it may be positioned at one of the following alternate sites:... -
Page 34: Appendix E: Automatic Restart
Note that automatic restart must be on in order to use and change the overnight settings (described in Chapter 6). Automatic restart is now on Quell User Manual Quell Customer Care 1-800-204-6577 ®... -
Page 35: Appendix F: Technical Specifications
Mylar substrate, silver electrode pads Number of Electrodes 2, outer electrode area 28 cm , inner electrode area 33 cm Connector Medical snap (male) Dimensions 0.2 cm x 5.3 cm x 28.3 cm (exterior) Quell User Manual Quell Customer Care 1-800-204-6577 ®... - Page 36 Draft Guidance for Industry and Staff: Class II Special Control Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief (April 5, 2010) IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62304 Quell User Manual Quell Customer Care 1-800-204-6577 ®...
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Page 37: Appendix G: Precautions And Warnings
Indications • The long-term effects of electrical stimulation are unknown. Quell is intended for use as a transcutaneous • Since the effects of stimulation of the brain electrical nerve stimulation device for the are unknown, stimulation should not be applied... -
Page 38: Adverse Reactions
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins). • Do not apply stimulation over, or in proximity to, cancerous lesions. Quell User Manual Quell Customer Care 1-800-204-6577 ®... -
Page 39: Appendix H: Symbols
APPENDIX H: Symbols APPENDIX H 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 Quell User Manual Quell Customer Care 1-800-204-6577 ®... -
Page 40: Appendix I: Electromagnetic Compatibility Declaration
Compliance Electromagnetic environment – guidance RF emissions; Group 1 Quell uses RF energy only for its internal function. Its CISPR 11 RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions;... - Page 41 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 the Quell Device is used exceeds the applicable RF compliance level above, the Quell Device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Quell Device.
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Page 42: Compatibility Declaration
Recommended separation distances between portable and mobile RF communications equipment and the Quell Device The Quell Device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Quell Device can help prevent... -
Page 43: Appendix J: Fcc And Ic
This transmitter meets both portable and mobile limits as demonstrated in the RF Exposure Analysis. The Bluegiga BLE Bluetooth Module contains Transmitter Module: FCC ID: QOQBLE113 IC: 5123A-BGTBLE113 Quell User Manual Quell Customer Care 1-800-204-6577 ®... -
Page 44: Appendix K: Bluetooth
While all sensitive data transmission is encrypted, Bluetooth functionality can be turned off for increased privacy. If Bluetooth is disabled, then the Quell Relief App will not function, but all other functions of the Quell device will operate normally. To turn off Bluetooth: 1. - Page 45 1000 Winter Street Waltham, MA 02451, USA Quell User Manual (800) 204-6577, (781) 890-9989 ©2016 NeuroMetrix, Inc. All Rights www.quellrelief.com Reserved. PN2204111 Rev. B...