NeuroMetrix Quell 2.0 User manual

© 2018 NeuroMetrix, Inc.
User Manual
2.0

Contents
2 Chapter 1: Pain Relief with Quell 2.0
2 Introduction
3 What's Included
4 Chapter 2: Getting Started & Device Basics
4 Getting Started
4 Charging Battery
4 Checking Battery
5 Downloading the App
5 Inserting the Device
5 Attaching the Electrode
6 Device Placement
7 Chapter 3: Calibration
8 Chapter 4: Pain Relief Therapy
8 Preparing for Therapy Session
8 Starting Therapy Session
8 What Therapy Feels Like
9 Adjusting Intensity During Therapy Session
9 Ending Therapy Session
9 Personalizing Therapy
10 Chapter 5: Overnight Therapy
11 Chapter 6: Electrodes
12 Chapter 7: Skin Care
13 Chapter 8: Using the Mobile App
13 Download the App
13 Creating a Health Cloud Account
14 Settings/Personalization Features
15 Tracking
15 About Me
15 Rate Pain
15 Videos
15 Support
15 Store
16 Chapter 9: Maintenance, Safety, and Service
16 Maintenance
16 Cleaning Device
16 Cleaning Band
16 Device Storage
16 Disposal
16 Limited Warranty
17 APPENDIX A: Indicator Lights
18 APPENDIX B: Troubleshooting
23 APPENDIX C: Frequently Asked Questions
25 APPENDIX D: Alternate Placement Sites
26 APPENDIX E: Technical Specifications
28 APPENDIX F: Precautions and Warnings
29 APPENDIX G: Symbols
30 APPENDIX H: Electromagnetic
Compatibility Declaration
33 APPENDIX I: FCC
34 APPENDIX J: Bluetooth®

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Chapter 1: Pain Relief with Quell 2.0
Introduction
Quell Wearable Pain Relief Technology™ is patented, non-invasive nerve stimulation
system that provides relief from chronic pain. It consists of a device, a wearable band,
an electrode that attaches to the device, and the Quell Relief app to control and
customize your therapy.
Quell provides pain relief by comfortably stimulating sensory nerves in your calf. The
nerves carry neural pulses to the brain that trigger a natural response to block pain
signals in your body.
Pain relief is initiated by using the app on your smartphone. Regular therapy sessions
are 60 minutes. After your first session, therapy will automatically restart every other
hour. You have complete control and can start or end therapy anytime.
The more you use Quell, the better the chance of experiencing relief. For best results,
use Quell daily. We recommend that new users wear Quell for a minimum of 3 therapy
sessions per day (up to 24/7) at a strong, but comfortable intensity for at least the
first 30 days.
If you have any questions about how to use Quell, please call Quell Customer Care at
1-800-204-6577 or email us at [e-mail].
Chapter 1
Pain Relief with Quell® 2.0

Chapter 1: Pain Relief with Quell
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What's Included
Upon receiving your Quell 2.0 Starter Kit, you should inspect its contents to make sure
all of the following are included:
Quell Electrode Pack*
(packaging may vary)
Quell 2.0 Device Quell Band
USB Cable AC Adapter
Quick Start Guide
Quick Start Guide
Electrode Use & Skin Care
1. Attach the electrode to the device with the liner in place to
protect the hydrogel. Remove liner before applying electrode
to skin.
2. Only apply the electrode to clean, dry skin. Never apply the
electrode over irritated or damaged skin.
3. Air out your skin every 5 hours, or when you wake up if using
overnight, to minimize the risk of skin irritation. Your device will
pulse at that time as a reminder. Reposition the device on your leg
or switch to the other leg.
4. The electrode gel may show signs of wear with normal use.
Each electrode is designed to last two weeks. Your electrode does
not need to be replaced until stimulation during therapy feels
uncomfortable.
Additional electrode options available at store.quellrelief.com.
Warnings
Quell is contraindicated if you have a cardiac pacemaker,
implanted defibrillator or other implanted electronic device.
Do not use when showering or bathing, or while operating a vehicle.
Commit to Using Daily for at least 30 Days
The more you use Quell, the better the chance of pain relief.
1. Chronic Pain is different for everyone. Please be patient. It
may take several weeks of consistent use before you start
to feel relief.
2. Set a daily therapy goal to stay on track – we recommend
using Quell for a minimum of 3 therapy sessions per day
either during the day or while sleeping.
3. Calibrate your Quell properly during setup to experience
optimal relief. Once calibrated, therapy should feel strong,
but comfortable during use.
4. Track your pain level, activity and sleep through the app.
Many people report improvements in mood, activity, and
sleep when Quell is working for them.
5. Personalize your Quell to meet your needs. Visit the
Settings menu within the app to select from various
Therapy, Stimulation, and Sleep options.
Questions?
Call 1-800-204-6577.
ElectrodesQuell Rel ief App Quell BandQuell De vice
For full User Manual, video tutorials, and FAQs,
visit www.quellrelief.com/quell-user.
2.0 PN 22048 21 Rev A
* Only use electrodes manufactured by NeuroMetrix, Inc.

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Chapter 2: Getting Started & Device Basics
Charging the Battery
A fully charged battery can provide up to 25 hours oftherapy for most
users.
To charge the battery:
Plug the USB cable into the micro-USB port on the side of the device.
Plug the other end of the cable into the AC Adapter.
The AC Adapter should then be plugged into a standard electrical
outlet. We do not recommend using a computer USB port for charging
Quell. The white indicator lights on the device will show that the device is
charging.
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2
Chapter 2
Getting Started & Device Basics
1
2
When the battery is fully charged, the white indicator light will remain solid. It will take approximately 3
hours to charge an empty battery. When the battery is fully charged, unplug the cable from the device.
If the orange light blinks while device is connected to the outlet, charging has failed. Call 800-204-
657 7.
When recharging your device, if the battery is too low to start a therapy session (<10%), you can charge
the device for approximately 20 minutes to provide enough battery life for one therapy session.
Do not use your device with the USB cable connected as this creates a safety harzard.
Checking the Battery
To check battery level, pick up and hold the device in your hand. The
indicator light will blink white if the battery has sufficient charge to run at
least one therapy session. If no indicator light flashes, the battery needs to
be recharged following the steps above.
Getting Started
1. Fully charge your Quell 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 free Quell Relief app to your smartphone or tablet from the App Store or Google Play.
3. Follow the step-by-step setup instructions in the app to pair your device and setup your Quell Health
Cloud account while your device is charging
4. Once your device is fully charged, follow the instructions to calibrate your device and begin therapy.
For additional details on each step, follow instructions below.
Indicator Light

Chapter 3: Device Basics
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Downloading the Quell Relief App
Using your smartphone, open the App Store or Google Play. Search "Quell Relief" and download the app
to your device. Ensure that your smartphone's Bluetooth is turned on and that your device is running
iOS 10 or later, or Android 6 or later. Launch the Quell Relief app and follow the step by step instruction
within the app to pair and setup a Quell Health Cloud account while charging your device. Once your
device is fully charged, you can finish setup and complete calibration.
By signing up for a Quell Health Cloud account, not only do you access unique features and back up your
data so it's never lost, you have an opportunity to be part of something bigger. When you participate,
your de-identified data helps fuel scientific research on chronic pain. For more details, review Chapter 8,
Using the Mobile App.
The instructions below expand upon the setup instructions provided within the Quell Relief app.
Inserting the Device
Place the Quell band with the blue accents face down so that
you are looking at the back of the band. Insert the device into
the opening on the back of the band with the indicator light
facing up. The indicator light should align with the viewing
window on the front of the band, and the snap connectors
should be visible through the opening on the back of the band.
Attaching the Electrode
You will need to attach a new electrode prior to first use of
the device and replace the electrode on average every 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. Align the snaps on the electrode to the snap connections
on the back of the device. Insert snaps until they are
securely fastened to the device.
2. Remove the liner covering the electrode prior to placing the
device on your leg. Remember to save the liner as it should
be re-applied to protect the electrode when it is not in use.
When re-applying the liner to the electrode for storage,
ensure graphics on the liner are facing up so that the paper
side doesn't stick to the gel.
3. The electrode should be replaced approximately 2 weeks
from the date of its first use. You can set a tracking
reminder within the app.
Chapter 2: Getting Started & Device Basics

Chapter 3: Device Basics
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2”
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. Position the device so that it is comfortable. You may
position the device on the inside, outside, or back of the leg. You
should avoid placing the device directly over your shinbone.
If the device cannot be placed in the standard location as shown,
refer to APPENDIX D for alternate site options.
Wrap the band around your leg and adhere the Velcro® end. The band
should fit securely and comfortably around your leg. The electrode
should make smooth contact with the skin. If there is buckling of
the electrode, smooth the electrode and re-secure the band. It is
important that all four electrode pads are in contact with the skin. If
the pads are only partially on the skin, then the stimulation may feel
uncomfortable or your device may not start therapy.
The band was designed to stretch and fit most legs. If the band does
not fit your leg, contact Customer Care at 1-800-204-6577 or visit
www.QuellRelief.com for information on how to get an Extra Small or
Extra Large Quell band.
Back of Calf Inside of Calf
Recommended Positioning On Leg Avoid Positioning
Front of ShinOutside of Calf
Chapter 2: Getting Started & Device Basics

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Chapter 3: Calibration
The calibration process must be completed before first using the device. Watch the Calibration video on
the app or on quellrelief.com/quell-user before you calibrate for the first time.
Calibration allows Quell to learn your sensation threshold. Based on your sensation threshold,
Quell will deliver a customized stimulation level for pain relief
therapy. During the calibration process, Quell will slowly increase
stimulation several times to determine your sensation threshold.
Once you have completed the calibration process, you are ready to
begin your first therapy session.
Follow the instructions in the app to calibrate your Quell for first
use. If needed, you can recalibrate your device at any time within
the app.
Please Note:
• We recommend you sit in a quiet place where you can focus, with your feet flat on the floor during
the calibration process.
• To calibrate Quell, open the Quell Relief 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.
• Wait until you feel the slightest tingle under the electrode, then immediately tap the button within
the app. It may take 20-30 seconds to feel the sensation the first time and the sensation may feel
very light.
• Do not wait until the sensation feels strong before tapping the button.
• You will feel subsequent stimulation slightly faster.
• If you need to stop at any point or feel that you have made a mistake, tap the "Stop Calibration"
button within the app. You can always recalibrate your device at any time.
• Once completed, calibration should set your therapy intensity to the optimal level for you. Therapeutic
stimulation will feel stronger than the sensation you felt during calibration. Therapy should always
feel strong, but comfortable.
Chapter 3
Calibration

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Chapter 4: Pain Relief Therapy
Chronic pain is different for everyone. Please be
patient. It may take several weeks of consistently
using Quell before you start to experience pain
relief. The more you use Quell, the better the
chance of pain relief. For best results, use Quell
daily. We recommend using Quell for a minimum
of 3 therapy sessions every day, but Quell can be
used up to 24 hours per day.
During a therapy session, the device will
comfortably stimulate the nerves in your leg to
provide pain relief. Regular therapy sessions last
60 minutes, and a new session will automatically
restart every other hour. If you prefer to not have
automatic restart turned on, you can change your
Therapy Dose under Settings within the app.
To optimize pain relief, you should feel a strong
but comfortable sensation during therapy. The
intensity that you will require is estimated based
on your sensation threshold determined during
calibration. However, because of differences
among people, this estimated intensity may
be too low and feel weak, or too high and feel
uncomfortable. In either case, you should adjust
the intensity within the app. The greatest pain
relief will be obtained when you set the intensity
to the highest level that is also comfortable.
The device will remember changes made to the
intensity during the first 10 minutes of therapy if
the therapy session is successfully completed, and
you should not need to adjust often. Please follow
the steps below for initiating a therapy session.
Preparing for Therapy Session
Before starting a therapy session make sure you
have an electrode attached to the device. You
should also check the battery to ensure it has
an adequate charge. If the indicator light blinks
Chapter 4
Pain Relief Therapy
white, you have sufficient charge to run a therapy
session. Place the device on your leg as described
in Chapter 2, Getting Started & Device Basics.
Starting a Therapy Session
To start a therapy session, tap the Start Therapy
button on the Dashboard screen in the app. The
indicator light will blink white for the duration of
the therapy session.
Automatic Start
You can also set therapy to start automatically
after attaching the device to your leg. Within
the Settings menu of the app, select Therapy
Automation and turn on Automatic Start. Once
enabled, therapy will begin automatically within
one minute of placing the device on your leg. You
will no longer need to start therapy within the app.
You can always stop therapy by tapping the STOP
button within the app, or by double tapping the
device firmly with your fingers.
What Therapy Feels Like
The intensity will gradually increase during the
first 2 minutes to an intensity that is strong
but comfortable.This strong but comfortable
intensity is based on results of the calibration
process. You may feel a strong sensation at first
but it will typically fade to a comfortable level
after a couple of minutes. If the sensation is
uncomfortable or painful, you should decrease
the intensity within the app. Therapy will continue
for 60 minutes in Regular dose (see Chapter 8 for
personalization options).
Once you have placed the device on your leg,

Chapter 5: Pain Relief Therapy
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the electrode and remember to reapply the
liner (see page 11 for instructions on
removing electrode).
If you leave the device on your leg for long periods
of time, you should check your skin regularly to
make sure that it does not get irritated. We
recommend airing out your skin for 15-30 minutes
after 5 hours or after wearing your device
overnight. You may also switch legs to give your
skin a break. Chapter 7 provides information on
skin care.
If a problem arises during a therapy session,
stimulation will stop and the indicator light will
blink orange for 2 minutes. Refer to APPENDIX B
for troubleshooting assistance.
You should air out your skin after wearing for 5
hours or when you wake up from wearing Quell
overnight. After 5 hours of wear during the
daytime, the device will pulse on and off for 1
minute as a reminder.
Personalizing Therapy
Therapy can be personalized to meet your needs
within the app. Within the Settings menu, you
can choose from a variety of Therapy Dose,
Stimulation, and Therapy Automation options. If
you decide to update any of these settings, the
new selection will take effect at the start of your
next therapy session.
To learn about the different therapy
personalization settings, please review Chapter 8,
Using the Mobile App.
you may cover the device with your clothing. You
should be careful not to dislodge the device and
electrode when covering with clothing. You may
go about your normal activities during a therapy
session. Do not shower, bathe or swim with the
device on your leg.
Adjusting Intensity During a
Therapy Session
Frequent adjustments should not be necessary;
however, if the sensation feels uncomfortable or
is not strong enough, you may make adjustments.
To adjust therapy intensity or to stop therapy, tap
the "+/-" buttons on the Dashboard screen in the
smartphone app.
You may adjust intensity as needed at any time
during a therapy session using the smartphone
app. Optimal pain relief will be obtained at the
highest intensity that is also comfortable.
If you find you are frequently adjusting intensity,
try recalibrating your device.
Ending a Therapy Session
Regular therapy sessions will run automatically
60 minutes on, then 60 minutes off, unless you
turn off therapy during a session or recalibrate
between therapy sessions.
To stop an active therapy session before it ends,
tap the STOP button on the Dashboard screen
in the app. If the app is not readily accessible,
you can manually stop therapy during a session
by double tapping the device firmly with your
fingers. Your leg should be still. You should not
remove the device while it is stimulating, so
make sure that the white indicator light is not
blinking before removing the device and electrode
from your leg. Otherwise you may experience
an uncomfortable sensation while removing the
device.
After ending a therapy session, you may either
leave the device on your leg or remove it. If you
remove the device, be careful to not damage
Double tap the
device firmly with
your fingers to stop
therapy manually.
Chapter 4: Pain Relief Therapy