Quell QE-001, QE-P02, QE-P01, QE-002 User Manual

User Manual

© 2017 NeuroMetrix, Inc.

Contents

2 Chapter 1: Pain Relief with Quell

2 Introduction
3 What You Should Have Received
4 Device Components

5 Chapter 2: Getting Started

7 Chapter 3: Device Basics

7 Checking Battery
7 Charging Battery
8 Attaching Electrode
9 Device Placement

10 Chapter 4: Calibration

10 Option A: App Calibration (Recommended)
10 Option B: Manual Calibration

11 Chapter 5: Pain Relief Therapy

11 Preparing for Therapy Session
11 Starting Therapy Session
11 What Therapy Feels Like
12 Adjusting Intensity During Therapy Session
12 Ending Therapy Session

19 Chapter 10: Maintenance,

Safety, and Service

19 Maintenance
19 Cleaning Device
19 Cleaning Band
19 Device Storage
19 Disposal
19 Limited Warranty

20 APPENDIX A: Indicator Lights

22 APPENDIX B: Troubleshooting

27 APPENDIX C: Frequently Asked Questions

29 APPENDIX D: Alternate Placement Sites

30 APPENDIX E: Therapy Dose

31 APPENDIX F: Technical Specifications

33 APPENDIX G: Precautions and Warnings

14 Chapter 6: Overnight Therapy

15 Chapter 7: Electrodes

16 Chapter 8: Skin Care

17 Chapter 9: Using the Mobile App

17 Download the App
17 Create an Account
18 Personalization Features

35 APPENDIX H: Symbols

36 APPENDIX I: Electromagnetic

Compatibility Declaration

39 APPENDIX J: FCC and IC

40 APPENDIX K: Bluetooth®

41 APPENDIX L: Declaration of Conformity

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Chapter 1

Chapter 1: Pain Relief with Quell

Pain Relief with Quell

®

Introduction

Quell Wearable Pain Relief Technology™ is patented, non-invasive nerve stimulation
technology that provides relief from chronic pain. It consists of a device and an
electrode that attaches to the device. The device is worn on your upper calf, a few
inches below the knee, and is controlled by a single button on the device or by the
"Quell Relief" smartphone app.

Quell provides pain relief by comfortably stimulating the nerves that carry normal,
non-painful sensations to your brain, which decreases the perception of pain.

Pain relief is initiated by simply clicking a button on the device or using the app on
your smartphone. Regular therapy sessions are 60 minutes. After your first session,
therapy will automatically restart every other hour. Pain relief may begin in as little
as fifteen minutes after the start of a therapy session and may last up to an hour
following the end of a session. You have complete control and can start or end therapy
anytime from your device or smartphone.

You should review this User Manual carefully. Chapter 2 shows you how to get started.
Chapters 3-5 provide detailed instructions on device use. Chapter 6 describes device
use during sleep. Chapter 7 offers tips for taking care of the electrodes. Chapter 8
provides information on preventing skin irritation, particularly if you have sensitive
or dry skin. 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 [phone].

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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

USB Cable AC Adapter

Quick Start Guide

Quell Electrode Pack*

(packaging may vary)

* Only use electrodes manufactured by NeuroMetrix, Inc.

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ElectrodesOptional App Sports BandQuell Device

Travel Bag (available separately) Quick Start Guide

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Chapter 1: Pain Relief with Quell

Device Components

Adjustable sports band

Indicator lights

Push button

(not seen in image, port is on bottom of device,

not accessible through sports band)

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Micro-USB port

Two electrode
connector snaps

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Chapter 2

Chapter 2: Getting Started

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.

1. Check Battery

Click the button and check the indicator

lights. The number of white lights indicates
the charge remaining in the battery. A
single orange light indicates the unit needs
charging. If the battery needs to be recharged,
use the USB cable and AC adapter.

2. Insert Device

Slide your device into the band pouch so that
the button is visible inside the blue-rimmed
window, with the lights facing up.

3. Attach Electrode

Remove an electrode from the package,
and snap it onto the connectors.

The electrode may be oriented in either
direction. Carefully remove the liner and save
it for storing the electrode between uses.

4. Place Device

Place your Quell band directly on your upper
calf approximately 1 to 2 inches below the
knee of either leg. Lights should face up.

2”

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Chapter 2: Getting Started

5. Calibrate

Perform this step when using the device for the first time.

Option A: App Calibration (Recommended)

Once you have downloaded and launched the app, follow
instructions to set up and calibrate.

Option B: Manual Calibration

Sit with foot flat on the floor and leg at a 90 degree angle.
Calibration won't start if leg is extended horizontally.

Press and hold the button until you see the lights running
back and forth, then release the button. Lights will continue
running.

Wait until you feel the slightest tingle under the band, then
immediately click the button one time.

When the sensation starts again, click the button again. You
will typically click the button 3-6 times.

When the lights go off, calibration is complete. If you need
to recalibrate, simply repeat the calibration steps. See next
step to begin therapy.

6. Start Therapy

Click the button. One indicator light will blink. The sensation

will increase for 2 minutes until optimal intensity is reached.
You should feel a strong but comfortable sensation under
the electrode.

Decrease Intensity: Click the button to reduce intensity.
Repeat if needed.

Increase Intensity: Hold button down. Intensity increases
until you release the button.

Turn off: To stop therapy, click the button four times in

sequence.

Regular therapy sessions last for 60 minutes with a 60
minute break between sessions. Sessions will continue until
the device is removed from the leg. You may go about your
normal activities during a therapy session.

Tips for Success

• Calibrate properly so Quell delivers
the right stimulation level for optimal
pain relief.

• 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.

To learn how to control your Quell device and personalize
your therapy with the smartphone app, please review
Chapter 9.

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Chapter 3

Chapter 3: Device Basics

Device Basics

Checking Battery

Your Quell will arrive fully charged. To check battery
level, hold the device in your hand and briefly click
the button. The indicator lights will flash white if
the battery has sufficient charge. The number of
illuminated white lights corresponds to the level
of battery charge. Five white lights indicate a fully
charged battery. If orange indicator light flashes,
the battery needs to be recharged (see below for
charging instructions).

Charging Battery

A fully charged battery can provide up to 50 hours
oftherapy for most users.

To charge the battery:

Plug the USB cable into the micro-USB port on

1

the bottom of the device.

Plug the other end of the cable into the AC

2

Adapter. The cable should not be plugged into a
computer USB port for charging.

The AC Adapter should then be plugged into a standard electrical outlet. 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. 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.

If the battery is too low to start a therapy session, you can charge the device for
approximately 20 minutes to provide enough battery life for one therapy session.
To confirm, disconnect the USB cable from the device and briefly click the button. If
at least 1 white indicator light flashes, battery has enough charge for one therapy
session. If the orange light flashes, reconnect the USB cable and continue charging.

1

2

Do not use your device with the USB cable connected.

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Chapter 3: Device Basics

Attaching Electrode

You will need to attach a new electrode prior to first use of the device and 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. Slide device into band pouch with lights
facing up.

2. Align the snaps on the electrode to the snap
connectors on the back of the device. Insert
snaps until they are securely fastened.

3. Remove the liner covering the electrode prior
to placing the device on your leg. Remember

to keep the liner as it should be re-applied to
protect the electrode when not in use.

4. The first time you use a new electrode, write
the date on the liner. When placing liner on the
electrode when it is not in use, ensure graphics
on liner are facing up so that the paper side
doesn’t stick to the gel. The electrode should be
replaced approximately 2 weeks from this date.

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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. Position the device so that it
is comfortable and the button is accessible. You
may position the device with the button on the
inside, outside, or back of the leg. You should avoid
placing one of the device compartments 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 attach it
with the Velcro®. 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 your skin.

If the pads are only partially on the skin, then the
stimulation may feeluncomfortable.

2”

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.

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Chapter 4

Chapter 4: Calibration

Calibration

Option A: App Calibration (Recommended)

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.

3. Start Therapy.

If you do not have a smartphone, please follow Option B: Manual
Calibration.

Option B: Manual Calibration

Watch the Manual Calibration Video on quellrelief.com/quell-user before you use Quell
for the first time.

Read through all the steps below before you begin calibration. You
must calibrate the first time you use Quell, so Quell will learn your
nerve sensitivity. Sit in a quiet place where you can focus, with your
foot flat on the floor and knee bent at 90° angle as shown.

Step 1:

Press and HOLD button until you see lights running back and forth,
then release button. Lights will continue running.

Step 2:

Wait until you feel the slightest tingle under the band, then
immediately CLICK the button one time.

Step 3:

Repeat Step 2 until the lights go off, meaning calibration is
complete. People typically click the button 3-6 times during
calibration.

You are now ready to begin therapy.

You do not need to stay seated during therapy. You may move
around and be as active as you can be while wearing your Quell.

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Chapter 5

Chapter 5: Pain Relief Therapy

Pain Relief Therapy

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, consult APPENDIX E
to learn how to turn it off.

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 device 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 as described on page 12. 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 after the first two minutes
of therapy and you should not need to adjust
often. Please follow the steps on the following
pages for a therapy session.

What Therapy Feels Like

The intensity will gradually increase during the
first two 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 as
described in the next section. Therapy will continue
for 60 minutes in Regular dose (see page 18 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 therapy
session. Do not shower, bathe or swim with the

device on your leg.

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. Place the device on your leg as
described in Chapter 3.

Starting Therapy Session

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.

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Chapter 5: Pain Relief Therapy

Adjusting Intensity During
Therapy Session

Frequent adjustments should not be necessary;
however, if the sensation feels uncomfortable or
is not strong enough, you may make adjustments.
The easiest way to adjust therapy intensity or
to stop therapy is to tap the buttons on the
Dashboard screen in the smartphone app. For
manual adjustments, please follow the directions
below.

click

Decrease Intensity: Click the button. Each click

decreases intensity. Lights will flash and then go
down to indicate intensity has decreased.

Increase Intensity: Press and hold button to
increase the intensity. Intensity increases until

You may adjust intensity as needed at any
time during a therapy session using the
button on the device or the smartphone app.

Optimal pain relief will be obtained at the highest
intensity that is also comfortable.

To learn how to control your Quell device with your
smartphone app, please review Chapter 9.

Ending Therapy Session

Regular therapy sessions will run automatically
60 minutes on, then 60 minutes off, unless you
manually turn off therapy during a session or
recalibrate.

To manually stop therapy during a session, click
the button four times in sequence. You should

not remove the device while it is stimulating, so

make sure that the indicator light is not blinking
white before removing the device and electrode
from your leg. Otherwise you may experience an
uncomfortable sensation when you remove the
device.

After completing a therapy session, you may
either leave the device on your leg or remove
it. If you remove the device, be careful to not

press and hold

you release the button or for a maximum of 20
seconds. If you still need to increase intensity after
20 seconds, hold the button down again.

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4x

damage the electrode and remember to reapply
the liner (see page 15 for instructions on
removing electrode).

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Chapter 5: Pain Relief Therapy

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. Chapter 8
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.

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.

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Chapter 6

Chapter 6: Overnight Therapy

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." In this setting, the first therapy session will stimulate at
your regular intensity level. Subsequent therapy sessions will start automatically every
other hour throughout the night. If you are asleep during these sessions, the device will
automatically lower the intensity.

App users have multiple sleep mode options. To learn about the different sleep
settings, please review Chapter 9, Using the Mobile App.

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Chapter 7

Chapter 7: Electrodes

Electrodes

The 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 8 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. Electrodes should be stored in a sealed bag
at room temperature out of direct sunlight. You
may also snap the electrode into the device for
convenient storage.

Electrode Replacement

The electrode should be replaced prior to two
weeks if stimulation becomes painful despite
positioning the device so that the entire electrode
is making smooth contact with the skin. You can
order electrodes at www.quellrelief.com/replace
or from the location where you purchased your
device.

Helpful Tips

• The entire electrode should contact the
skin.

• To get the most use of your electrode,
put the liner back on the gel pads when
electrode is not on skin.

• Air-out skin or switch legs during the
day or after overnight use. After 4
hours of wear, device will pulse on and
off for 1 minute as a reminder.

• Change the electrode every 2 weeks.

• Do not use while showering or bathing.

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Chapter 8

Chapter 8: Skin Care

Skin Care

Quell works by electrically stimulating your sensory nerves 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.

Never use the device on open wounds or rashes or over swollen, red, infected, or
inflamed skin.

Prevent Skin Irritation

Air-out Skin

Air-out skin after 4-5 hours of wear during the day
or after overnight use. Many users simply switch
the device to the other leg every 4-5 hours.

If you have sensitive skin, you may also consider
the following:

Start Slow

Limit the time the device is on your skin to 3-4
hours per day in the first week. If you do not
experience irritation you may increase use while
closely monitoring your skin.

Use Skin Protectant

Apply a skin protectant before placing the device
on your leg. Skin protectants are available as
wipes, swabs, or sprays. They are safe and may
reduce the likelihood of irritation. They also
increase adhesion of the electrode to your skin.

Check for Skin Irritation

Check for signs of irritation, including:

• 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 then 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 to 3-4 hours per day for a week to
make sure that further irritation does not occur.

Protectants that work well include:

• 3M Cavilon™ No Sting Barrier Film

• Smith & Nephew SKIN-PREP®

• Smith & Nephew No-Sting SKIN-PREP®

• Coloplast Prep™ Protective Skin Barrier

These products are available online or at selected
retailers.

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Chapter 9: Using the Mobile App

Chapter 9

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.

iOS and Android devices must have Bluetooth Low Energy (LE, also called Bluetooth
Smart) compatibility.

For more insights on the data tracked with the app, visit www.quellrelief.com/
how-quell-works/app/ and select Sleep, Therapy, Activity, or Pain.

Create a Health Cloud Account

Creating a Health Cloud account from the app provides a secure backup of your data
and allows you to view data across multiple devices.

The tables below and on the next page describe app features and how they may help
you optimize your Quell therapy during the day and at night.*

*Not all features available on all devices.

Feature Why is it important?

Sleep Position Tracking Enables device to track sleep metrics including time slept on back or on sides, and

the number of times position changed while sleeping.

Lights Out Use if Quell 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 Let Quell itself figure out when you actually went to sleep. Disable 'Sleep Onset

Detection' if Quell underestimates your time asleep. You should then indicate when
going to sleep using 'Lights Out.'

Sleep Mode

Bedtime only Therapy only while falling asleep.

Gentle overnight Overnight therapy at reduced intensity.

Full power Overnight therapy at daytime intensity.

As needed Therapy only when Quell detects poor sleep quality.

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Chapter 9: Using the Mobile App

Stimulation Select the type of stimulation Quell will provide during therapy sessions. Standard

and Alternate are equally effective, but one may feel more comfortable. Sensitive
is an option if Standard and Alternative feel uncomfortable. Your selection will take
effect with the next therapy session.

Standard Feels like a constant vibration.

Alternative Feels lke a fast gentle pulse.

Sensitive Feels like a low vibration.

Therapy Dose You can select the duration and timing of your therapy sessions.

Regular Therapy is 60 minutes and restarts every 60 minutes.

High Therapy is 60 minutes and restarts every 30 minutes.

Low Therapy is 30 minutes and restarts every 60 minutes.

Manual Therapy is 60 minutes and does not restart automatically.

Time of Day Adjustment Enable if stimulation feels particularly strong at certain times of day. If enabled,

indicate the time of day when stimulation feels strongest. The device will then
automatically compensate so the stimulation feels consistent to you.

Device Button Disable device button to prevent unintended button presses, such as while sleeping.

If the device button is disabled, then you must use the app to start therapy and
control the intensity. 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.

Notifications

Electrode Replacement When enabled, you will get a notification that it is time to replace your electrodes.

Rate Pain When enabled, you will get a notification to remind you to rate your pain.

Intensity Display When enabled, the stimulation intensity will be displayed on the Dashboard during

therapy sessions.

Pairing If paired, shows the serial number of the device to which it is paired. To pair with a

different device, tap Un-Pair.

Account Create a Health Cloud account.

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Chapter 10: Maintenance, Safety, and Service

Chapter 10

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.

Device Storage

When device is not in use, store it in a dry location
away from direct sunlight.

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.

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
device to be free from defects in materials and
workmanship at the time of shipment. The
warranty term is two years beginning on the
date of sale to the original purchaser, as further
described in the following text.

Quell® User Manual Quell Customer Care 1-800-204-6577 or [phone]

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.

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APPENDIX A: Indicator Lights

APPENDIX A

Indicator Lights

Device on Skin

Device State Indicator Light Status Explanation

Standby No lights illuminated Device in standby, no therapy or

calibration in progress

Calibration Waterfall White (lights running back

and forth)

Therapy Single Blinking White Light Therapy session in progress

Lights running one direction or the other Intensity increase or decrease as a result

Stimulation halted
earlier than expected

Orange light blinks for 2 minutes Therapy or Calibration has halted due

Calibration in progress

of button press or adjustment via app.

to an error condition; see Appendix B for
possible causes.

Device off Skin

Device State Indicator Light Status Explanation

Battery Check Single blink of 1 white light Adequate charge for one therapy session

Single blink of 2, 3, or 4 white lights The number of illuminated white lights

correspond to the level of battery
charge. The higher the number, the closer
it is to being fully charged.

Single blink of 5 white lights Fully Charged Battery

Single blink of orange light Battery needs to be charged.

Therapy Dose 1 white light or 5 lights illuminate while

button is held

With a 10 second press off-skin, 5
white lights indicate Regular therapy
dose is selected (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.

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APPENDIX A: Indicator Lights

Charging

Device State Indicator Light Status Explanation

Charging 1, 2, 3, or 4 lights solid, one light blinking Device is charging

5 lights on solid Device is fully charged

Orange light blinking Charging issue

Outer 2 lights on or all 6 lights illuminate
while button is held

With a 10 second press during charging,
all 6 lights indicate Bluetooth being
enabled, outer 2 lights indicate Bluetooth
being disabled. Bluetooth is enabled by
default.

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APPENDIX B

APPENDIX B: Troubleshooting

Troubleshooting

Calibration

I cannot start the calibration procedure (the
lights are not running waterfall motion).

If you are using the app, the Calibration option
can be found under the Settings menu. To start
calibration using the app, tap "Start Calibration."

If you are calibrating manually, you should be
sitting down with your lower leg at a 90° angle (or
perpendicular to the floor) with your foot flat on
the floor. Make sure the electrode is snapped onto
the device, the liner has been removed, and the
device is properly placed on your leg (on the upper
calf, 1-2” below your knee). Electrode should be
making complete contact with the skin. Click and
hold the button on the device down for at least 5
seconds until you see the white waterfall pattern.

I can start calibration and see the waterfall lights
briefly, but then they turn off.

Check your positioning (seated with leg at 90°
angle) and device (upper calf, 1-2” below the knee).
Electrode should be making complete contact
with the skin. Try smoothing the electrode over
your skin (while it is snapped to the device), before
securing the sports band.

I am trying to calibrate but I don’t feel anything.

Confirm electrode liner has been removed and
that the lights have been running back and forth
for at least 30 seconds. The purpose of the
calibration process is to measure your sensation
threshold, meaning that when you feel even the
slightest sensation, you should click the button. Do
not wait until the sensation feels very strong to
click the button. 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 (or press the
button), the therapeutic intensity will be set at the
maximum possible intensity.

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.

Quell® User Manual Quell Customer Care 1-800-204-6577 or [phone]

The reason is that cold will artificially elevate
the sensation threshold (the same reason cold
makes you feel numb).

• Do not calibrate right after a therapy session
(of >30 minutes) because the sensation
threshold will be artificially elevated. You
should wait at least 1 hour and preferably 2
hours after a therapy session.

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APPENDIX B: Troubleshooting

Therapy

Make sure you initiate therapy only after the device
and electrode are properly placed on the calf.

I am trying to start therapy with the app (or
by pressing the button) and getting a short
(2-second) blink of an orange light.

Recharge battery.

I start therapy and a white light blinks once and
stops.

Your device has not been calibrated. You need to
calibrate device at least once before therapy.

I am not getting pain relief.

Make sure you feel a strong but comfortable
sensation during therapy 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 or pressing
and holding the button.

The therapy 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. Check that the electrode is snapped in, the
electrode is in complete contact with the skin,
and the band is attached snugly (but not too
tightly) on the leg. Start therapy again. If the
problem recurs, remove the device and inspect
the electrode. Place the device back on the leg
and restart the therapy 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 or press
and hold the button to increase the intensity until
you feel a strong but comfortable sensation.
Alternatively, calibrate the device again.

The device isn’t automatically restarting.

If you are using the app, go to Settings and
Therapy Dose. If "Manual" is selected, you need
to manually restart therapy. With any other
selection (Regular, Low, or High Dose), therapy will
automatically restart.

You can check and change settings manually
by holding the device off your leg without the
electrode connected. Hold the button down for 10
seconds to toggle between settings.

1 white light = Manual. 5 white lights = Regular

The therapy stings or feels uncomfortable.

Turn off the device by using the app or clicking the
button 4 times. 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. 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
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 therapy 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
therapy, 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, as long as it
remains strong.

Try the other leg. One leg may be more prone to
cramping or soreness than the other leg.

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APPENDIX B: Troubleshooting

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).

If you mostly have cramping/soreness when lying
down, make sure that the device is not positioned
such that it is compressed between the bed and your
leg. Compressing the device forces the electrodes
closer to the muscle, making it more likely to activate
it. If this is happening, position the device so that it
will not be compressed between the bed and your
leg in your preferred sleep position to minimize any
discomfort.

There is no risk associated with soreness. If you
are getting a lot of pain relief from Quell, you may
decide it is worth it to keep wearing it, even if you
have some soreness as a consequence.

The device increased intensity on its own.

If the increase was rapid and intense, you may
have inadvertently pressed the button. This can
sometimes happen if you have your legs crossed
or are resting your legs against an object, like a
piece of furniture or the car door while driving.
App users can disable the button to prevent
unintentional changes.

My device is pulsing at the end of therapy.

Pulsing serves as a reminder that you have being
wearing the device on the same place for at least
4 hours. You should consider removing the device
to allow the covered skin to breathe. You may also
move the device to the other leg if more therapies
are desired. A “long term wear” alert will pulse for
one minute at the conclusion of the 3rd therapy
session (at least 4 hours of wear).

If you don’t remove the device, it will pulse again at
the conclusion of each subsequent session until the
device is removed. Sessions will still continue to run
automatically. The device will not pulse after four
hours of overnight wear, or while you are sleeping.

Sleep

Do I need to do anything to the device on wake
up?

No, you do not need to do anything special. Once
you are up and moving about for more than a
few minutes, the device will automatically revert
to normal daytime therapeutic intensity the next
time it restarts therapy. We do recommend you
remove your device or switch legs after waking up
to prevent skin irritation. When you put your Quell
back on and start therapy, the device will restart
at normal intensity.

If intensity is increasing on its own and waterfall
pattern is shown, calibration is running. Pressing
the button 4x in a row will stop calibration. If this
was accidental, the device will remember your
previous calibration settings.

If the increase was noted toward the latter half
of the therapy session, the habituation ramp
is too steep for you. The device is designed to
increase intensity throughout a therapy session
to compensate for nerve habituation. For some
people, this ramp is too steep, in which case the
therapy intensity should be decreased during the
therapy session. If you allow therapy to run the
full 60 minutes, the device will remember the
adjustment for future therapy sessions.

Quell® User Manual Quell Customer Care 1-800-204-6577 or [phone]

The device is waking me up when therapy restarts
overnight.

Check sleep settings on smartphone app. You may
have inadvertently changed sleep mode setting
or may need to change the settings to "Gentle
Overnight," "Bedtime," or "As Needed" mode.

My device doesn’t “wake up”/restart in the
morning.

Make sure you wait 60 minutes to see if device will
restart on its own. If you had the device off your
skin for more than 60 minutes or charged it while
it was off, you will need to restart manually.

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APPENDIX B: Troubleshooting

Use the app to check Sleep Mode. If Sleep Mode
was set to “Bedtime,” the first session in the
morning will need to be manually started.

Electrodes

The gel sticks to my skin when I am removing the
electrode.

Be sure to peel the electrode from the skin very
carefully. If, despite this, the gel is coming off the
electrode, then try applying a light lotion on the
skin area where electrodes will make contact at
least thirty minutes to an hour prior to therapy,
giving enough time for the lotion to fully absorb
into the skin.

The gel is dry and losing its stickiness.

Even when the electrode seems to be losing its
adhesion to the skin, it should still be usable; the
band will help to keep contact with the skin.

The electrodes should last approximately 2 weeks
with typical use. Be sure to store electrodes
properly between uses as described in Chapter 7.

Minimize use outdoors during hot, humid weather,
when possible.

Be mindful about where the device and electrode
are stored in hot and humid weather, i.e., a hot car.

In some cases, it may also help to alternate
between two electrodes (if you switch the device
at the 4-hour or “long-term wear” alert, for
example) to minimize the amount of gel migration
that may result from extended sessions.

Issues with gel spread are less frequent during
cooler, drier months.

What do I do if I have lost the electrode liner?

Use a piece of wax paper (plain paper will stick to
the hydrogel).

Another option is to place the electrode in a plastic
zipper bag laid flat or loosely folded (if a larger
bag is unavailable) with the gel facing out.

Gel will stick to itself if pads are allowed to touch.

The gel on my electrode is coming off and/or
spreading.

The electrode should still function and can be used
safely as long as the stimulation feels comfortable
and the device does not repeatedly blink orange
during therapy sessions. Gel spread is more likely
to occur in hot, humid weather since the hydrogel
may absorb additional moisture to cause it to
expand. You may want to try the Quell Sport
Electrode.

How can I minimize gel spread?

Ensure that the sport band isn’t wrapped too
tightly around the leg, as that will contribute to
gel spread. Electrode shouldn’t leave an imprint on
the leg after it is removed. If it does, you need to
loosen the band slightly.

Remove the device when not in use to allow the gel
to cool.

Skin Care

My skin is irritated (redness or rash) or itches
where the device was worn.

Skin irritation may occur. The skin should be aired
out after wearing for 4 hours and after overnight
use by removing the device and electrode from
the leg or switching legs. If at any time the skin
begins to feel irritated (itchy) while the device is
on, device should be removed and the skin allowed
to breathe.

Consider using light skin moisturizer if skin is dry.

Ensure that the strap is not being placed too
tightly; this can cause the strap/electrode to
create indents in the skin and lead to irritation.

Alternate leg on which Quell is worn, if possible.

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APPENDIX B: Troubleshooting

Reorient the device so the electrode is covering
another part of the leg, i.e., button faces in toward
the other leg or the back of the leg or the outside
of the leg.

If skin is irritated, do not place device or electrode
over the irritated area until it has fully healed.
See Chapter 8 for ways to reduce your risk of skin
irritation.

Charging

My device isn’t charging.

Confirm the charging adapter is plugged into a
functioning wall outlet that is on. 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.

What if there is no flashing light?

If the battery has been drained completely and all
lights are off, allow at least 20 minutes for the 1st
white light to begin flashing after connecting the
device to the charging adaptor plugged into a wall
outlet. The 1st light needs to be solid white before
device has enough charge to provide a single
therapy session.

What if there is a flashing orange light?

If the orange light continues to blink after
the device has been plugged in, there is a
charging issue. Please call Customer Care at
1-800-204-6577.

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APPENDIX C

APPENDIX C: Frequently Asked Questions

Frequently Asked Questions

What should therapy feel like?

You should feel a vibrating or light pressure
sensation. You may reduce the intensity if it feels
uncomfortable.

How often should I use Quell?

You may run therapy as often (even 24 hours a
day) or as little as needed for pain relief. Some
users only wear the device in the evenings and
while sleeping. Others wear it during the day and
at night. We recommend that you use your Quell
for at least 2-3 therapy sessions per day for the
first month.

When do I need to calibrate my device?

You must calibrate the device before first use.
You may repeat calibration if pain relief has
diminished, or if therapy sensation becomes
uncomfortable/too strong.

Do I need to calibrate the device before each
therapy session?

No. Once your device is calibrated you do not
need to calibrate it again unless pain relief has
diminished.

Do I need to recalibrate when I switch legs?

No.

If I have foot pain, should I position the device
closer to my foot?

No, you should position the device on your upper
calf 1-2 inches below the knee as described in
Chapter 3.

Can I place the device on my arms or lower back?

No. Quell is designed to be worn on the upper calf.

How long will it take to experience relief?

We recommend wearing your Quell for 2-3 therapy
sessions per day for the first month. Please be
patient because it may take several weeks to
experience optimal relief.

Will pain relief continue beyond the end of the
therapy session?

Pain relief may last up to an hour after the session
ends.

How often do I need to change the electrode?

Every 2 weeks.

Can I use my device while showering or bathing?

No.

Are there side effects?

No. You may experience some mild skin irritation
under the electrodes with prolonged use.

Can I use it with pain medications?

Speak to your doctor about your pain medication
use in conjunction with Quell.

Can multiple people share the device?

No. The device is calibrated for one person and
should not be shared.

Can I use Quell while sleeping?

Yes.

What does Quell do while I am sleeping?

It starts 60 minute therapy sessions every other
hour throughout the night or as needed to help
control your pain.

Do I need to set up Quell differently for sleep use?

No, but app users may choose from 4 sleep setting
options.

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APPENDIX C: Frequently Asked Questions

What if I only want a single 60 minute therapy
session when going to sleep?

Set the sleep mode to Bedtime Only.

What should I do before going to sleep?

Make sure the device is securely and comfortably
placed around your leg. Start the first therapy
session by clicking the button.

Will wearing Quell overnight irritate my skin?

Skin irritation may occur in some cases (see
APPENDIX B, Troubleshooting, Skin Care).

Can I use Quell every night?

Yes.

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.

How long should the battery last?

Battery life is heavily dependent on your particular
therapy intensity and frequency of use but a
fully charged battery can last up to 50 therapy
sessions.

Like most rechargeable batteries, the charging
capacity will start to taper off over the course of
years, so there is not a specific time when it will
completely stop working.

The battery in Quell was designed for years of
problem-free use and is covered by our 2 year
warranty.

How long does it take to recharge the battery?

Fully recharging the battery will take 2-3 hours
when connecting to a charging adaptor plugged
into a wall outlet.

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APPENDIX D

APPENDIX D: Alternate Placement Sites

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 therapy.

If you place the device on your thigh, you must stand straight up to perform
calibration.

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APPENDIX E

APPENDIX E: Automatic Restart

Therapy Dose

Therapy Dose settings determine whether therapy
will restart automatically or must be restarted
manually.

The easiest way to check and change therapy dose
is to use the app. Go to Settings -> Therapy Dose
to select dosage. Regular is the default setting,
which delivers 60 minutes of therapy followed by a
60 minute break, automatically.

You may also check the setting manually. With
the device in your hand, without an electrode
attached, click and hold the button for at least 10
seconds. 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.

Manual restart is on

Regular dose will restart automatically

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APPENDIX F: Technical Specifications

APPENDIX F

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; zero net current

Maximum Output Voltage (±10%) 100 V

Maximum Output Current
(<1KΩ load) (±10%)

Pulse Duration (±4%) 280 µsec

Pulse Frequency (±4%) 60-100 Hz, randomly varying, or 30-50 Hz, randomly varying.

Pulse Pattern Continuous or burst (4 pulse bursts, randomly 15-25 Hz with

Maximum Phase Charge 18 µC

Maximum Current Density 0.6 mA/cm2 into 500Ω load

Maximum Average Current 2.8 mA into 500Ω load

Maximum Average Power Density 5 mW/cm2 into 500Ω load

100 mA

Alternate pattern has uniform frequency distribution of 4 pulse
sequences at 15-25 Hz; each pulse sequence lasts 8.6 msec with
pulses evenly spaced; mean frequency is 80 Hz.

mean 20 Hz)

Output Trips

No Load Device not connected to patient

Insufficient Charge Delivered charge below target

Over Load Delivered charge above target

Electrode Peeling Electrode dislodging from skin

Therapy Session

Timer 30 minutes or 60 minutes

Start Therapy Click button once or via app

Stop Therapy Click button 4 times or via app

Manual Intensity Increase/Decrease 0.5-2 mA / sec

Habituation Compensation Adaptive stepwise increase in intensity during session

Electrode

Type Self-adhering, single-patient use, multiple applications

Materials Mylar substrate, silver electrode pads

Number of Electrodes 2, outer electrode area 28 cm2, inner electrode area 33 cm

Connector Medical snap (male)

Dimensions 0.2 cm x 5.3 cm x 28.3 cm (exterior)

2

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APPENDIX F: Technical Specifications

Power

Source Permanent rechargeable battery

Battery Type Rechargeable 3.7V Lithium-Ion battery

Battery Life 400 Charge Cycles

Charging Source AC line adapter

Line Current Isolation Patient disconnected when charging

Patient Leakage Current, DC < 10 µA

Patient Leakage Current, Enclosure < 100 µA

Physical

Dimensions 98 mm x 74 mm x 11 mm

Weight (without straps) 66 g

Environmental

IP Classification IP20

Operating Temperature Range -5° C to 40° C

Atmospheric Pressure Range 70 kPa to 106 kPa

Relative Humidity Range 15% to 93%

Transport and Storage Temperature Range -25° C to 70° C

Atmospheric Pressure Range 70 kPa to 106 kPa

Relative Humidity Range 10% to 93%

Standards

IEC IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC

60601-2-10, IEC 62304

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APPENDIX G

APPENDIX G: Precautions and Warnings

Precautions and Warnings

Indications

Quell is intended for use as a transcutaneous
electrical nerve stimulation device for the
symptomatic relief and management of chronic
intractable pain.

The device may be used during sleep. The device
is only labeled for use and compatible with
NeuroMetrix Quell brand electrodes.

Contraindications

Do not use this device if you have a cardiac
pacemaker, implanted defibrillator, or other
implanted metallic or electronic device. Such
use could cause electric shock, burns, electrical
interference, or death.

Precautions

• Transcutaneous electrical nerve
stimulation is not effective for pain of
central origin, including headache.

• Transcutaneous electrical nerve stimulation
is not a substitute for pain medications
and other pain management therapies.

• Transcutaneous electrical nerve stimulation
devices have no curative value.

• Transcutaneous electrical nerve stimulation
is a symptomatic treatment and, as such,
suppresses the sensation of pain that would
otherwise serve as a protective mechanism.

• The long-term effects of electrical
stimulation are unknown.

• Since the effects of stimulation of the brain
are unknown, stimulation should not be applied
across the head, and electrodes should not
be placed on opposite sides of the head.

• The safety of electrical stimulation during
pregnancy has not been established.

• You may experience skin irritation or
hypersensitivity due to the electrical stimulation
or electrical conductive medium (gel).

• If you have suspected or diagnosed heart
disease, you should follow precautions
recommended by your physician.

• If you have suspected or diagnosed
epilepsy, you should follow precautions
recommended by your physician.

• Use caution if you have a tendency to bleed
internally, such as following an injury or fracture.

• Consult with your physician prior to using the
device after a recent surgical procedure, because
stimulation may disrupt the healing process.

• Use caution if stimulation is applied over
the menstruating or pregnant uterus.

• Use caution if stimulation is applied over
areas of skin that lack normal sensation.

• Keep this device out of the reach of children.

• Use this device only with electrodes and
accessories recommended by the manufacturer.

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APPENDIX G: Precautions and Warnings

Adverse Reactions

• You may experience skin irritation
and burns beneath the stimulation
electrodes applied to the skin.

• You may experience headache and other
painful sensations during or following the
application of electrical stimulation near
the eyes and to the head and face.

• You should stop using the device and should
consult with your physician if you experience
adverse reactions from the device.

Warnings

• If you are in the care of a physician, consult
with your physician before using this device.

• If you have had medical or physical
treatment for your pain, consult with your
physician before using this device.

• If your pain does not improve, becomes
more than mild, or continues for more
than 5 days, stop using the device
and consult with your physician.

• Do not apply stimulation over your neck because
this could cause severe muscle spasms resulting
in closure of the airway, difficulty in breathing, or
adverse effects on heart rhythm or blood pressure.

• 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.

• Do not apply stimulation in the presence
of electronic monitoring equipment (e.g.,
cardiac monitors, ECG alarms), which
may not operate properly when the
electrical stimulation device is in use.

• Do not apply stimulation when
in the bath or shower.

• Do not apply stimulation while driving, operating
machinery, or during any activity in which
electrical stimulation can put you at risk of injury.

• Consult with your physician before
using this device, because it may cause
lethal rhythm disturbances to the
heart in susceptible individuals.

• Apply stimulation only to normal,
intact, clean, healthy skin.

• No modification of this device is allowed.

• Do not use the device on children.

• 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.

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APPENDIX H

APPENDIX H: Symbols

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

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.

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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; CISPR 11 Group 1 Quell uses RF energy only for its internal function. Its

RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.

RF emissions; CISPR 11 Class B Quell is suitable for use in all establishments,

including domestic establishments and those directly
connected to the public low voltage power supply
network that supplies buildings used for domestic
purposes.

Harmonics Current
Emissions IEC 61000-3-2

Fluctuations and Flicker
IEC 61000-3-3

Electrostatic Discharge
Immunity (ESD);
IEC 61000-4-2

Radiated RF;
IEC 61000-4-3

Electric Fast Transient
Burst Immunity
IEC 61000-4-4

Fast Surge Immunity
IEC 61000-4-5

Radio Frequency
Common Mode Immunity
IEC 61000-4-6

Power Frequency
Magnetic Field Immunity
IEC 61000-4-8

Voltage Dip and Interrupt
Immunity IEC 61000-4-11

Class A

Complies

+/- 15kV air; +/- 8kV contact Floors should be wood, concrete or ceramic tile.

If floors are covered with synthetic material, the
humidity should be at least 30%

10 V/m; 80 MHz to 2.7 GHz 10 V/m compliance level

±2kV power leads Mains power quality should be that of a typical

domestic establishment.

±2kV Common mode

3 VRMS (80% AM at 1 kHz);
150 kHz to 80 MHz

30 A/m 50 Hz

Complies Mains power quality should be that of a typical

domestic establishment.

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APPENDIX I: Electromagnetic Compatibility Declaration

Table 1

Manufacturer's declaration - electromagnetic immunity

Quell 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 – guidance

Portable and mobile RF communications
equipment should be used no closer to any part
of the Quell Device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter. Recommended separation

distance

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. 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.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

3 Vrms
150 kHz to 80 MHz

10 V/m 3 V/m d = 1.2√P 80 MHz to 800 MHz

3 Vrms d = 1.2√P

d = 2.3√P 800 MHz to 2.5 GHz

where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b

Interference may occur in the vicinity of
equipment marked with the following symbol:

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APPENDIX I: Electromagnetic Compatibility Declaration

Table 2

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 electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
Quell Device as recommended below, according to the maximum output power of the
communications equipment.

Rated maximum output power of

transmitter W

0.01

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz

d = 1.2√P

0.12 0.12 0.23

80 MHz to 800 MHz

d = 1.2√P

800 MHz to 2.5 GHz

d = 2.3√P

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APPENDIX J

APPENDIX J: FCC and IC

FCC and IC

This device complies with Part 15 of the FCC Rules.
Operation is subject to the following conditions:

1. This device may not cause harmful interference,

and

2. This device must accept any interference

received, including interference that may cause
undesired operation.

This device complies with Industry Canada license­exempt RSS standard(s). Operation is subject to
the following two conditions:

1. This device may not cause interference, and

2. This device must accept any interference,

including interference that may cause undesired
operation of the device.

FCC RF Radiation Exposure Statement

This equipment complies with FCC radiation
exposure limits set forth for an uncontrolled
environment. 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

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APPENDIX K: Bluetooth®

APPENDIX K

Bluetooth®

The Bluetooth word mark and logos are owned by
the Bluetooth SIG, Inc. and any use of such marks
by NeuroMetrix, Inc. is under license.

Communication between the Quell Device and the
Smartphone is via Bluetooth.

Disabling 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. Plug the Quell device into the charger/wall

outlet,

2. Click and hold the button on the Quell Device

for approximately 10 seconds until the one
orange and one white indicator light flashes.

3. The Bluetooth module is now disabled.

To reactivate Bluetooth functionality, repeat
the above steps. All six indicator lights should be
illuminated.

Bluetooth is Enabled

Bluetooth is Disabled

Bluetooth Specifications

Bluetooth Module: Bluegiga BLE 113 Bluetooth® Module with Bluetooth® 4.0 low energy radio
Transmit Power: +0 dBm
Receiver Sensitivity: -93 dBm
FCC Rules: Part 15C
Frequency Range: 2402.0 - 2480.0
Output Watts: 0.0011
Security: Encryption

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APPENDIX L: Declaration of Conformity

APPENDIX L

Declaration of Conformity

Product Identification

Product name Model/number

QUELL Transcutaneous Electrical Nerve Stimulator QE-001 Quell 1 Device

QE-002 Quell 2 Device
QE-P01 Electrode
QE-P02 Sport Electrode

Manufacturer

Name of company Address Representative CE Certificate Number

NeuroMetrix, Inc. 1000 Winter St.

Waltham, MA 02451
U.S.A.

European Authorized Representative

Name of company Address Telephone/email

EMERGO Europe Prinsessegracht 20

2514 AP The Hague
The Netherlands

Notified Body (Annex II Products Only)

Name of company Address Telephone/email

TÜV SÜD Product Service GmbH
Notified Body Number 0123

Conformity Assessment

Device classification Route to compliance Standards applied

QE-001
QE-002

QE-P01
QE-P02

Class IIa
Rule 9

Class 1
Rule 1

Zertifizierstelle
Ridlerstrasse 65
80339 München, Germany

Annex II w/o (4) of MDD
93/42/EEC Council Directive

Annex VII of MDD
93/42/EEC Council Directive

Rainer Maas G1 16 10 40014 014

+31.70.345.8570 – phone
+31.70.346.7299 – fax
[e-mail]

+49.89.5008.4477 – phone
+49.89.5008.4327 – fax
[e-mail]

IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-11
IEC 60601-2-10
IEC 62304
ISO 14971

ISO 10993

NeuroMetrix, Inc. declares, under our exclusive responsibility, that the above mentioned products meet
the provision of the 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

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1000 Winter Street

Waltham, MA 02451, USA

[phone], [phone]

www.quellrelief.com

Quell User Manual

©2017 NeuroMetrix, Inc. All Rights

Reserved. PN2204 482 Rev. B