NeuroMetrix Quell Fibromyalgia User manual

USER MANUAL
© 2022 NeuroMetrix, Inc.

Contents
2 Chapter 1: Symptom Relief
with Quell Fibromyalgia
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 Quell Fibromyalgia App
5 Inserting the Device
5 Attaching the Electrode
6 Device Placement
7 Chapter 3: Calibration
8 Chapter 4: Treatment
8 Preparing for Treatment Session
8 Starting Treatment Session
8 Automatic Start
8 What Treatment Feels Like
9 Adjusting Intensity During Treatment Session
9 Ending Treatment Session
9 Personalizing Treatment
10 Chapter 5: Overnight Treatment
11 Chapter 6: Electrodes
11 Electrode Removal
11 Electrode Storage
11 Electrode Replacement
11 Electrode Options
12 Chapter 7: Skin Care
13 Chapter 8: Using the Mobile App
13 Download the App
13 Creating a Health Cloud Account
13 Settings/Personalization Features
15 Tracking
15 My Information
15 Rate My Fibromyalgia
15 Videos
15 Support
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
34 APPENDIX I: FCC
35 APPENDIX J: Bluetooth®
36 APPENDIX K: Clinical Summary

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Chapter 1: Symptom Relief with Quell Fibromyalgia
Introduction
Quell Fibromyalgia is a transcutaneous electrical nerve stimulation (TENS) device indicated
as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity.
It consists of a device, a wearable band, an electrode that attaches to the device, and
the Quell Fibromyalgia mobile app to control and customize your treatment. The device
may be used during sleep. The device is labeled for use only with compatible NeuroMetrix
electrodes.
Quell Fibromyalgia is for prescription use only. The device is contraindicated for use by
patients who have a cardiac pacemaker, implanted defibrillator, other implanted electronic
device, or implanted metal near the device, because this may cause electric shock, burns,
electrical interference, or death. The stimulation electrodes should not be placed across
or through the head, directly on the eyes, covering the mouth, on the front of the neck, on
the chest or upper back, or crossing the heart. The device cannot be used while driving,
operating machinery, or during any activity in which electrical stimulation can put the
patient at risk of injury.
The sale, distribution, and use of Quell Fibromyalgia are restricted to prescription use in
accordance with 21 CFR 801.109.
Many participants in a pivotal clinical study were also taking medication for fibromyalgia
and it was difficult to assess the effects of the device compared to medication.
Quell Fibromyalgia provides symptom relief by comfortably stimulating sensory nerves
in your calf. The nerves carry neural pulses to the brain that trigger a natural response to
reduce your fibromyalgia symptoms.
Symptom relief is initiated by using the app on your smartphone to start treatment
sessions with Quell. Regular treatment sessions are 60 minutes. After your first session,
treatment will automatically restart every other hour. You have complete control and can
start or end treatment anytime.
You should use Quell when you are experiencing symptoms. For best results, use it daily.
We recommend that new users use Quell Fibromyalgia for a minimum of 3 treatment
sessions per day at a strong, but comfortable intensity for at least the first 30 days. A
treatment session (also called treatment hour) represents 1-hour of continuous stimulation.
Therefore, the recommended minimum of 3 treatment sessions per day is equivalent to
3-hours of daily stimulation. To limit skin irritation, please first refer to Chapter 7 (Skin
Care) if you plan to use Quell for long periods of time (e.g., more than 5 hours). Daily use of
the device should not exceed 8-hours of stimulation and 15-hours of wear. The safety and
effectiveness of the device when used for more than 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 [e-mail].
Chapter 1
Fibromyalgia Symptom Relief with Quell® Fibromyalgia

Chapter 1: Symptom Relief with Quell® Fibromyalgia
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What's Included
Upon receiving your Quell Fibromyalgia Starter Kit, you should inspect its contents to
make sure all of the following are included:
Electrode Pack*
(packaging may vary)
Device Band
USB Cable AC Adapter
(Adapter may vary)
Quick Start Guide
QUICK START GUIDE
For full User Manual, video tutorials, and FAQs,
visit www.quellfibromyalgia.com/support
PN2205 866 Rev A
Quell De vice Quell Band ElectrodesQuell Fibromyalgia App
Fibromyalgia
* 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treatment 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.
Only use the cable and AC adapter that was provided with your device to ensure
proper charging. 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 light on the device will show that the device
is charging.
1
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 Customer
Care at 800-204-6577.
If the battery is too low to start a treatment session (<10%), you can charge the device for
approximately 20 minutes to provide enough battery life for one treatment 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
treatment session. If no indicator light flashes, the battery needs to be
recharged following the steps above.
Getting Started
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.
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 treatment.
For additional details on each step, follow instructions below.
Indicator Light
Quell Fibromyalgia

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Downloading the Quell Fibromyalgia App
Using your smartphone, open the App Store or Google Play. Search "Quell Fibromyalgia" and download
the app to your device. 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).
Creating a Quell Health Cloud account is voluntary. The performance and features of your Quell device
are not affected if you do not create an account. By signing up for a Quell Health Cloud account your
utilization, sleep and fibromyalgia severity tracking data are backed up and can be shared among
multiple mobile devices. You can sign up for a Quell Health Cloud account at any time.
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 2: Getting Started & 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 treatment.
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 for
information on how to get a Small or Large 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 before you calibrate for the first time.
Calibration allows the device to learn your sensation threshold.
Based on your sensation threshold, the device will deliver a
customized stimulation level. During the calibration process, the
device 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 treatment session.
Follow the instructions in the app to calibrate your device 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.
• 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.
• Wait until you feel the slightest tingle under the electrode, then immediately tap the button labeled
TAP HERE 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, a screen titled "Calibration Success" will appear in the app and your treatment
intensity should be set to the optimal level for you. Therapeutic stimulation will feel stronger than the
sensation you felt during calibration. Treatment should always feel strong, but comfortable.
Chapter 3
Calibration

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Chapter 4: Treatment
The experience of fibromyalgia is different for
everyone. Please be patient. It may take several
weeks of consistently using Quell Fibromyalgia
before you start to experience symptom relief.
You should use Quell when you are experiencing
symptoms. For best results, use Quell daily.
We recommend using Quell Fibromyalgia for a
minimum of 3 treatment sessions every day. A
treatment session (also called treatment hour)
represents 1-hour of continuous stimulation.
Therefore, the recommended minimum of 3
treatment sessions per day is equivalent to
3-hours of daily stimulation. To limit skin irritation,
please first refer to Chapter 7 (Skin Care) if you
plan to use Quell for long periods of time (e.g.,
more than 5 hours). Daily use of the device should
not exceed 8-hours of stimulation and 15-hours of
wear. The safety and effectiveness of the device
when used for more than 8 treatment hours per
day is not well characterized.
During a treatment session, the device will
comfortably stimulate the nerves in your leg.
Regular treatment 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 Treatment
Schedule under Settings within the app.
To optimize symptom relief, you should feel
a strong but comfortable sensation during
treatment. 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 symptom 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 treatment if the treatment session is
successfully completed, and you should not need
Chapter 4
Treatment
to adjust often. Please follow the steps below for
initiating a treatment session.
Preparing for Treatment Session
Before starting a treatment 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 white, you have
sufficient charge to run a treatment session. Place
the device on your leg as described in Chapter 2,
Getting Started & Device Basics.
Starting a Treatment Session
To start a treatment session, tap the Start button
on the Dashboard screen in the app. The indicator
light will blink white for the duration of the
treatment session.
Automatic Start
You can also set treatment to start automatically
after attaching the device to your leg. Open the app
to the Dashboard, press the Automatic Start icon
(letter A) in the top left corner and select Enable.
You can also go to the Settings menu and select
Treatment Automation to turn on Automatic Start.
Once enabled, treatment will begin automatically
within one minute of placing the device on your leg.
You will no longer need to start treatment within the
app. You can always stop treatment by tapping the
STOP button within the app, or by double tapping
the device firmly with your fingers.
What Treatment 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

Chapter 4: Treatment
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can manually stop treatment 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 treatment session, you may either
leave the device on your leg or remove it. If you
remove the device, be careful to not damage 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 treatment session,
stimulation will stop and the indicator light will blink
orange for 2 minutes. You may also see a message
on the app Dashboard that the last session halted.
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 Treatment
Treatment can be personalized within the app to
meet your needs. Within the Settings menu, you
can choose from a variety of Treatment Schedule
and Treatment Automation options. If you decide
to update any of these settings, the new selection
will take effect at the start of your next treatment
session.
To learn about the different treatment
personalization settings, please review Chapter 8,
Using the Mobile App.
of minutes. If the sensation is uncomfortable or
painful, you should decrease the intensity within
the app. Treatment will continue for 60 minutes
in Regular dose (see Chapter 8 for personalization
options).
Once you have placed the device on your leg, 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 treatment session. Do
not shower, bathe or swim with the device on your
leg.
Adjusting Intensity During a
Treatment Session
The stimulation intensity can range from 0 to
100 milliamps and can be changed in 0.5 milliamp
increments. Frequent adjustments should not
be necessary; however, if the sensation feels
uncomfortable or is not strong enough, you may
make adjustments. To adjust treatment intensity
or to stop treatment, tap the "+/-" buttons on
the Dashboard screen in the smartphone app.
Each time the "+" button is tapped the intensity
will increase by 1.25% (with a minimum increase
of 0.5 milliamps). The device will allow up to 4
such increases each second over the course of a
60-minute treatment session. Each time the "-"
button is tapped the intensity will decrease by 5%.
You may adjust intensity as needed at any time
during a treatment session using the smartphone
app. Optimal symptom 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 Treatment Session
Regular treatment sessions will run automatically
60 minutes on, then 60 minutes off, unless you
turn off treatment during a session or recalibrate
between treatment sessions.
To stop an active treatment session before it ends,
tap the STOP button on the Dashboard screen in
the app. If the app is not readily accessible, you
Chapter 4: Treatment
Double tap the device
firmly with your fingers
to stop treatment
manually.

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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. The default sleep setting is "Gentle Overnight." In this
setting, the first treatment session will stimulate at your regular intensity level. Subsequent
treatment sessions will start automatically every other hour throughout the night at a
reduced intensity.
Within the Settings menu of the app, you will find multiple sleep mode options that you can
choose from. If you decide to change Sleep Modes, the new selection will take effect at the
start of your next nighttime treatment session.
To learn about the different sleep settings, please review Chapter 8, Using the Mobile App.
Chapter 5
Overnight Treatment

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Chapter 6: Electrodes
Quell Fibromyalgia electrodes are designed to
operate consistently for up to 2 weeks. With
repeated use, the electrode gel may peel and/or
dry out thereby losing some of its adhesion, but
the electrode is still usable.
Electrode Removal
You should be careful to not damage the electrode
when you remove it from your upper calf area.
Slowly peel the electrode from your skin, while
making sure that each of the gel pads does not
separate from the electrode. Avoid touching the
gel with your fingers as that can damage the
gel and decrease the life of the electrode. After
removal of the electrode, you should cover it with
the liner.
If you have difficulty removing
the electrode, refer to Chapter
7 for tips on skin care to ease
electrode removal.
Electrode Storage
Electrodes should always be stored with the
liner covering the gel pads. Place the liner with
graphic side up so the paper does not stick to the
gel. You may snap the electrode into the device
for convenient storage. For long term storage,
electrodes should be stored in the electrode pouch
or a sealed bag at room temperature out of direct
sunlight.
Electrode Replacement
The gel pads on the electrodes are primarily water,
so you may observe signs of wear during the
course of normal use, which can include irregular
edges on the gel pads, gel spreading, color fading,
or some of the underlying silver traces becoming
exposed. Your Quell electrode does not need to be
replaced until stimulation during treatment feels
uncomfortable and/or you see the orange error
light on the Quell device blink when you attempt
to start treatment.
The electrode should be replaced prior to 2 weeks
if stimulation becomes painful despite positioning
the device so that the entire electrode is making
smooth contact with the skin. It is recommended
that electrode is replaced at 2 week interval to
maximize treatment comfort and efficacy. A date
can be set in the app to remind you when it is time
to replace the electrode.
Electrode Options
Quell Standard Electrodes are included in the Quell
Fibromyalgia Starter Kit. They are designed to
deliver comfortable, effective symptom relief year
round. The Standard electrode gel is optimized to
provide consistent, comfortable nerve stimulation
in most conditions and is ideal for daily use. Each
individual Quell Electrode is designed to last for
approximately 2 weeks of typical use.
Quell Sport Electrodes are a second type of
electrode designed to work with your device. The
Sport Electrode has a unique gel developed to
be more robust in situations with high levels of
humidity and perspiration. The Sport Electrode
has a gel that absorbs less moisture, but is
otherwise comparable to the Standard Electrode
included in the Starter Kit.
Chapter 6
Electrodes

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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. There are some simple things you can do to take care of your
skin while using Quell Fibromyalgia.
Ensure your skin is clean and dry. Never use the device on open wounds or rashes or over swollen,
red, infected, irritated, or inflamed skin.
Prevent Skin Irritation
Air out Skin
You should air out your skin for 15-30 minutes after 5 consecutive hours of wear during the day, or
after overnight use. You may also switch the device to the other leg every 5 hours, or when you wake
up. After 5 hours of use during the day, the device will pulse on and off for 1 minute as a reminder to
air out your skin.
If you have sensitive skin, you may also want to start slowly. Limit the time the device is on your skin
during the first week. If you do not experience irritation you may increase use while closely monitoring
your skin.
Check for Skin Irritation
Signs of skin irritation can include the following:
• Skin itches while device is on the skin or after removal
• Skin is red where it contacted electrode
• Raised or reddened hair follicles
If skin irritation develops you should not place the device over the irritated area until it completely
heals. You may apply a topical steroid cream to help accelerate healing and reduce irritation. You may
also place the device on the other leg or use different locations as shown in APPENDIX D.
If you experience skin irritation, then you should limit device use for a week to make sure that further
irritation does not occur.
Chapter 7
Skin Care

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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. The Quell Relief app also requires iOS 14 or later, or Android 8 or later.
Create a Quell Health Cloud Account
Creating a Quell Health Cloud account is voluntary. The performance and features of your Quell device
are not affected if you do not create an account. By signing up for a Quell Health Cloud account your
utilization, sleep and pain tracking data are backed up and can be shared among multiple mobile
devices. You can sign up for a Quell Health Cloud account at any time.
Settings/Personalization Features
The tables below and on the next page describe app personalization features and settings, and how
they may help you optimize your Quell Fibromyalgia treatment during the day and at night.
Chapter 8: Using the Mobile App
Chapter 8
Using the Mobile App
Feature Why is it important?
Treatment Schedule You can select the duration and timing of your treatment sessions.
Manual Treatment is 60 minutes and does not restart automatically.
Low Dose Treatment is 30 minutes and restarts every 60 minutes.
Regular Dose Treatment is 60 minutes and restarts every 60 minutes. (Default Setting)
High Dose Treatment is 60 minutes and restarts every 30 minutes.
Treatment Automation
Time of Day Adjustment Enable if stimulation feels particularly strong at a certain time of day. Once
enabled, indicate the time of day when stimulation feels strongest. The device will
automatically compensate so the stimulation feels consistent to you at the time you
selected.
Body Postion Adjustment Enable if stimulation is too strong when you lie down. Treatment intensity will
automatically compensate so stimulation feels consistent when you are lying down.
Automatic Start Enables device to begin treatment automatically within one minute of placing the
device on your leg. When enabled, you do not need the app to start treatment.
Weather When enabled, you will receive an alert when weather conditions may worsen your
pain if your profile indicates weather sensitivity.
Quell Fibromyalgia

Chapter 8: Using the Mobile App
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Electrode Keep track of how many days have passed since you replaced your electrodes.
Calibration Used to determine the optimal treatment stimulation level.
Sleep Position Tracking Enables device to track certain metrics including time slept on back or on sides, and
the number of times position changed while sleeping. Sleep Position Tracking must
be initiated everytime you go to bed in order to track sleep position.
Lights Out Use if device overestimates your 'Time Asleep.' To indicate when you are ready for
sleep, press 'Lights Out.' To indicate when you are awake in the morning despite
remaining in bed, press 'Awake.'
Sleep Onset Detection The default setting detects when you actually went to sleep. Disable 'Sleep Onset
Detection' if device underestimates your time asleep. You should then indicate when
going to sleep using 'Lights Out.' This feature can be found under "Lights Out"
section of the Settings menu on the app.
Sleep Mode This setting may only be used when Treatment Schedule is set to Low, Regular, or
High.
Bedtime only Treatment is only delivered while falling asleep.
Gentle overnight Overnight treatment is delivered at reduced intensity. (Default setting)
Full power Overnight treatment is delivered at daytime intensity.
Account Create an optional Quell Health Cloud Account to backup your data and contribute
de-identified data to fuel scientific research. If you already created an account, it
shows the email you used to create the account. You may change email associated
with your Health Cloud account or the password for the account.
Notifications
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.
Rate My Fibromyalgia When enabled, you will get a notification to remind you to rate your fibromyalgia
symptoms every few days. Tracking your fibromyalgia symptoms helps uncover
patterns and triggers.
Pairing Shows the serial number of the device to which it is paired. To pair with a different
device, tap Un-Pair.
Chapter 8: Using the Mobile App

Chapter 8: Using the Mobile App
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Tracking
Fibromyalgia can decrease your quality of life and impact your sleep and activity levels. Your Quell
Fibromyalgia device and app can track treatment usage, sleep, and fibromyalgia symptoms over time.
This data can be viewed by day, week, month, or in 3 month periods. Reviewing this data over time
can help improve your condition management by identifying patterns and triggers, and by improving
communication with your doctor and other health care professionals.
Treatment Tracking - Your device will track the number of treatment sessions completed per day. For
best results, use Quell Fibromyalgia daily. We recommend wearing Quell Fibromyalgia for a minimum
of 3 treatment sessions per day. The more you use Quell Fibromyalgia, the better the chance of
experiencing symptom relief.
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.
Symptom Severity Rating - You can review your symptom severity rating and see how severe symptoms
have been and its impact on your sleep, activity, and mood in the last 7 days to track your treatment
progress.
My Information
A profile can help Quell Fibromyalgia personalize your treatment. Your profile can include information
including, gender, height, weight, worst symptoms, pain sites, and weather sensitivity. Weather
sensitivity must be completed in order to receive Weather Alerts.
Rate My Fibromyalgia
Inputting your rating is useful to track your fibromyalgia symptoms over time. The app will ask you how
would you describe the severity of your fibromyalgia symptoms and the impact on your life over the
past 7 days.
Videos
View the Videos section of the app menu for useful videos about Calibration, Getting Started and more.
Support
The Support section of the app menu features NeuroMetrix contact info, device info, the Set up
Assistant (repeat of onboarding guidance for putting on the device), important information statement
and links to the Quell Fibromyalgia website.
Chapter 8: Using the Mobile App

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Chapter 9: Maintenance, Safety, and Service
Maintenance
Contact Quell Customer Care at 1-800-204-6577
if the device requires service.
Cleaning Device
Use a damp cloth to clean the exterior of the
device. Do not use any other cleaning solutions
since they may damage the case. Never immerse
the device in water or other liquids.
Cleaning Band
Remove device before washing the band. Handwash
band with a gentle detergent and let it air dry. If
band material is becoming stretched, it may be put
through a gentle dryer cycle; ensure Velcro is adhered
to band before drying. If you have any questions or
need a different size, please contact Customer Care
at 1-800-204-6577.
Device Storage
When device is not in use, store it in a dry location
away from direct sunlight.
Disposal
Used electrodes can be disposed of in normal trash
receptacles. Dispose of the device according to
national, state, and local regulations as the device
contains a Lithium-Ion battery.
Limited Warranty
NeuroMetrix, Inc. manufactures its hardware
products in accordance with industry standard
practices. NeuroMetrix warrants the Quell
Fibromyalgia device to be free from defects
in materials and workmanship at the time of
shipment. The warranty term is one year beginning
on the date of sale to the original purchaser, as
further described in the following text.
This warranty does not cover damage due to
external causes, including accident, abuse, misuse,
problems with electrical power, usage not in
accordance with product instructions, failure to
perform required maintenance, and problems
caused by use of parts or components not supplied
by NeuroMetrix. This warranty does not apply to
any product repaired or altered by anyone other
than NeuroMetrix or an authorized NeuroMetrix
representative. Quell products purchased from
unauthorized resellers are not covered by this
warranty.
NeuroMetrix will repair or replace products that
are shown to be other than as warranted above
and covered under this limited warranty that are
returned to NeuroMetrix under a NeuroMetrix
issued Return Material Authorization (RMA)
Number. To initiate a return, contact Customer
Care at 1-800-204-6577.
All parts removed from repaired products
will become the property of NeuroMetrix. If
NeuroMetrix repairs or replaces a product, the
original warranty is not extended.
NEUROMETRIX MAKES NO EXPRESS OR IMPLIED WARRANTIES
OR REPRESENTATIONS BEYOND THOSE STATED IN THIS
WARRANTY STATEMENT. NEUROMETRIX DISCLAIMS ALL OTHER
WARRANTIES AND REPRESENTATIONS, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
NEUROMETRIX’S OBLIGATIONS FOR ANY FAILURE OF A PRODUCT
TO BE AS WARRANTED ARE LIMITED TO, AT NEUROMETRIX
OPTION, REPAIR OR REPLACEMENT OF THE PRODUCTS SET
FORTH IN THIS WARRANTY STATEMENT.
UNDER NO CIRCUMSTANCES WILL NEUROMETRIX BE LIABLE
FOR ACTUAL OR CLAIMED DEFECTS IN ANY PRODUCT BEYOND
THE REMEDIES SET FORTH IN THIS WARRANTY STATEMENT.
IN NO EVENT SHALL NEUROMETRIX BE LIABLE FOR SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF
OR IN CONNECTION WITH THIS AGREEMENT REGARDLESS OF
THE LEGAL THEORY UPON WHICH SUCH CLAIM IS BASED AND
EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY
THEREOF.
Chapter 9
Maintenance, Safety, and Service
Chapter 9: Maintenance, Safety, and Service

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17
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
Stimulation halted
earlier than expected
Orange Light Blinking Once Per Second Treatment or Calibration has halted due
to an error condition; see Appendix B for
possible causes.
Device off Skin
Device State Indicator Light Status Explanation
Battery Check
(after picking up device)
Single Blinking White Light Once Every
3 Seconds
Battery has adequate charge to run
treatment
No Light Illuminated Battery needs to be charged.
Charging
Device State Indicator Light Status Explanation
Charging Blinking White Light Device is charging
Solid White Light Device is fully charged
Orange Light Blinking Charging issue, call Quell Customer Care
at 1-800-204-6577.
APPENDIX A
Indicator Light

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APPENDIX B: Troubleshooting
Calibration
I cannot start the calibration procedure.
Within the app, the Calibration option can
be found under the Settings menu. To start
calibration, tap "Start Calibration."
You should be sitting down or standing still with
your foot flat on the floor. Make sure the electrode
is snapped onto the device, the liner has been
removed, and your device and band are properly
placed on your leg (on the upper calf, 1-2” below
your knee). All 4 gel pads on the electrode must be
making complete contact with the skin.
I am trying to calibrate but I don’t feel anything.
Confirm electrode liner has been removed and
that the light is blinking. The purpose of the
calibration process is to measure your sensation
threshold, meaning that when you feel even the
slightest sensation, you should tap the button
labeled TAP HERE within the app. Do not wait
until the sensation feels very strong to tap the
screen. It may take 20-30 seconds to feel the
sensation the first time and the sensation may
feel very light. You will feel subsequent stimulation
slightly faster. If you go through the calibration
process and never feel stimulation, the therapeutic
intensity will be set at the maximum possible
intensity.
APPENDIX B
Troubleshooting
Calibration Tips
• It is a good idea to wait about 5 minutes
after putting the electrode on for the skin-gel
interface to stabilize, before you start
calibrating.
• If your leg is cold (for example, if you come in
from the outside during winter), you should
wait 30-60 minutes so that your leg warms
up to room temperature before calibrating.
This is because cold will artificially elevate the
sensation threshold (the same reason cold
makes you feel numb).
• Do not calibrate right after a treatment
session because the sensation threshold will
be artificially elevated. You should wait at
least 1 hour and preferably 2 hours after a
treatment session.

APPENDIX B: Troubleshooting
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19
Treatment
Make sure you initiate treatment only after the
device and electrode are properly placed on the calf.
I am not getting symptom relief.
We recommend that you use Quell Fibromyalgia
daily for at least 3 treatment sessions per day for
the first month. Make sure you feel a strong but
comfortable sensation during treatment sessions
(indicated by single white blinking light). If not, you
can try calibrating the device again or increasing the
therapeutic intensity by using the app.
The treatment stopped and the light is blinking
orange continuously.
A blinking orange light typically indicates poor
contact between the electrode and the skin. This
may occur because the device is not securely
placed on the leg or because the electrode is dry
(e.g., the electrode needs to be replaced). Check
that the electrode is snapped in, the electrode
gel pads are in complete contact with the skin,
and the band is attached snugly (but not too
tightly) on the leg. Start treatment again. If the
problem recurs, remove the device and inspect
the electrode. Place the device back on the leg
and restart the treatment session. If the problem
persists, then replace the electrode.
The light is blinking white but I do not feel
anything.
The intensity may be too low. Use the app to
increase the intensity until you feel a strong but
comfortable sensation. Alternatively, calibrate the
device again.
The device isn’t automatically restarting.
Go to Settings and Treatment Schedule. If
"Manual" is selected, you need to manually restart
treatment. With any other selection (Regular,
Low, or High Dose), treatment will automatically
restart as long as the device is attached to your
leg and all 4 gel pads on the electrode are making
complete contact with your skin.
Treatment may also need to be manually
restarted if your last treatment was manually
stopped/halted, your last treatment was halted
because of a trip condition, you calibrated your
device since your last treatment, or you charged
your device since your last treatment session.
The treatment stings or feels uncomfortable.
Turn off the device by using the app or by firmly
double tapping the device with your fingers.
Remove the device and inspect the electrode,
make sure all four electrode gel pads are in good
condition. If your skin is dry then consider using
skin moisturizer, but wait 20-30 minutes for
the moisturizer to absorb into your skin before
placing the band on your leg. Place the device and
electrode back on your leg, making sure that there
is complete contact between the electrode and
the skin. Sometimes it is helpful to smooth the
electrode onto the skin first and then secure the
sports band. If the discomfort persists, then you
should replace the electrode.
If replacing the electrode doesn’t help, you may
need to recalibrate. One way to check calibration
level is to see how long it takes to feel any
sensation during treatment session. If it is felt
within the first five seconds, it is a good indication
that calibration is too high.
I have leg cramps/muscle contraction during
treatment, or muscle soreness after use.
Confirm that the intensity is appropriate – strong
but comfortable. You can recalibrate. You may also
want to decrease the intensity by using the app, as
long as it remains strong.
Try the other leg. One leg may be more prone to
cramping or soreness than the other leg.
Reposition the device to minimize the amount of
electrode on the back of the calf. This usually means
positioning the device on the inside or outside
rotated towards the front (but not right on top of
the tibia bone).