Table of Contents
Advertisement
Advertisement
Table of Contents
Summary of Contents for Quell QE-001
- Page 1 User Manual © 2017 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 app. 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 +1-781-890-9989. -
Page 4: What You Should Have Received
• Use your Quell daily, at least 2 to 3 full therapy sessions, for the first month. Can also be used overnight. • Give it time as it may take several weeks to experience optimal pain relief from using your Quell. -
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 connector snaps (not seen in image, port is on bottom of device, not accessible through sports band) Quell... -
Page 6: Chapter 2: Getting Started
Chapter 2 Getting Started The recommended way to get started is is to use the Quell Relief smartphone app. Download the app and follow the set up screens. You may also follow the steps below for manual set up and calibration. For additional details on each step, please review Chapters 3-5 or call Customer Care with any questions at 1-800-204-6577. -
Page 7: Quell User Manual Quell Customer Care 1-800-204-6577 Or +1-781-890-9989
2 minutes until optimal intensity is reached. • Use your Quell daily, at least 2 to 3 full You should feel a strong but comfortable sensation under therapy sessions, for the first month. the electrode. -
Page 8: Chapter 3: Device Basics
The USB The AC Adapter should then be 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. -
Page 9: Attaching Electrode
2 weeks thereafter. You should reseal the package if it contains an 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. -
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
Watch the App Calibration video on the app or on quellrelief.com/quell-user before you use Quell for the first time. 1. Download the Quell Relief app from the App Store or Google Play. 2. Launch Quell Relief app. Follow instructions to pair your smartphone and calibrate your device. -
Page 12: Chapter 5: Pain Relief Therapy
To start a therapy session, tap the start button on the Dashboard screen in the app. Or, briefly click the button on the device. One indicator light will blink white for the duration of the therapy session. Quell User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989 ®... -
Page 13: Adjusting Intensity During Therapy Session
To learn how to control your Quell device with your The easiest way to adjust therapy intensity or smartphone app, please review Chapter 9. -
Page 14: Quell User Manual Quell Customer Care 1-800-204-6577 Or +1-781-890-9989
2 minutes. Refer to APPENDIX B for troubleshooting assistance. Air-out skin after wearing for 4-5 hours or overnight. After 4 hours of wear, device will pulse on and off for 1 minute as a reminder. Quell User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989 ®... -
Page 15: 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. The default sleep setting is "Gentle Overnight."... -
Page 16: Chapter 7: Electrodes
You can order electrodes at www.quellrelief.com/replace or from the location where you purchased your device. Quell User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989 ®... -
Page 17: 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 18: Chapter 9: Using The Mobile App
Using the Mobile App Download the App The Quell App is optional and not required for the use of the device. From your mobile device search for “Quell Relief” by NeuroMetrix, Inc. and download the app. Before proceeding, make sure that Bluetooth® is enabled on your mobile device. - Page 19 You can always stop therapy by clicking the button 4 times in a row. Calibration Recommended method to set up your device the first time you use Quell. Electrode Keep track of how many days you have been wearing your electrodes.
-
Page 20: 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 21: Appendix A: Indicator Lights
(60 min on, 60 min off, automatically). 1 white light indicates Manual dosage; 60 min on and then user has to restart. Regular is the default setting. Quell User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989 ®... - Page 22 With a 10 second press during charging, while button is held all 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 or +1-781-890-9989 ®...
-
Page 23: Appendix B: Troubleshooting
You wait 30-60 minutes so that your leg warms should wait at least 1 hour and preferably 2 up to room temperature before calibrating. hours after a therapy session. Quell User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989 ®... - Page 24 Try the other leg. One leg may be more prone to you feel a strong but comfortable sensation. cramping or soreness than the other leg. Alternatively, calibrate the device again. Quell User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989 ®...
- Page 25 There is no risk associated with soreness. If you Sleep are getting a lot of pain relief from Quell, you may decide it is worth it to keep wearing it, even if you Do I need to do anything to the device on wake have some soreness as a consequence.
- Page 26 If at any time the skin may absorb additional moisture to cause it to begins to feel irritated (itchy) while the device is expand. You may want to try the Quell Sport on, device should be removed and the skin allowed Electrode.
- Page 27 USB outlets on a computer may not have sufficient power to charge the device, so it is not recommended. Using a charger other than the one provided with Quell, i.e., a cell phone charger, isn’t advisable. Quell...
-
Page 28: Appendix C: Frequently Asked Questions
Can I place the device on my arms or lower back? Do I need to set up Quell differently for sleep use? No. Quell is designed to be worn on the upper calf. No, but app users may choose from 4 sleep setting options. - Page 29 Can I use a different manufacturer’s electrode? No. 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.
-
Page 30: 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:... -
Page 31: Appendix E: Therapy Dose
You will see either one or five white lights. 1 light means that it is set to manual restart. 5 lights means it is set to automatically restart at the "Regular" dose. Quell User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989 ®... -
Page 32: 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 or +1-781-890-9989 ®... - Page 33 -25° C to 70° C Atmospheric Pressure Range 70 kPa to 106 kPa Relative Humidity Range 10% to 93% Standards IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62304 Quell User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989 ®...
-
Page 34: 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 35: Adverse Reactions
• Do not apply stimulation across your chest because the introduction of electrical current into the chest may cause rhythm disturbances to the heart, which could be lethal. Quell User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989 ®... -
Page 36: Appendix H: Symbols
Abbreviation for model number Keep dry Manufacturer Mark identifying compliance with council directive 93/42/EEC. Identification mark of the Notified Body. TÜV SÜD responsible for evaluation of the CE Technical File. Quell User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989 ®... -
Page 37: Appendix I: Electromagnetic Compatibility Declaration
Contents | APPENDIX I: Electromagnetic Compatibility Declaration APPENDIX I Electromagnetic Compatibility Declaration Quell 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 38 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.
-
Page 39: Compatibility Declaration
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 electromagnetic interference by maintaining a minimum distance... -
Page 40: 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 or +1-781-890-9989 ®... -
Page 41: 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. Bluetooth is Disabled To turn off Bluetooth: 1. -
Page 42: Appendix L: Declaration Of Conformity
Council Directive 93/42/EEC for Medical Devices until the expiration of the above referenced CE certificate. Company Representative: Rainer Maas Title: Director of QA/RA/Compliance Signature: Date: March 14, 2017 Place: Waltham, Massachusetts Quell User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989 ®... - Page 43 1000 Winter Street Waltham, MA 02451, USA Quell User Manual (800) 204-6577, (781) 890-9989 ©2017 NeuroMetrix, Inc. All Rights www.quellrelief.com Reserved. PN2204482 Rev. B...