Quell Fibromyalgia - User Manual

QUICK START GUIDE
Electrode Use & Skin Care
1. Attach the electrode to the device with the liner in place to protect
the hydrogel. Remove liner before applying electrode to skin.
2. Only apply the electrode to clean, dry skin. Never apply the
electrode over irritated or damaged skin.
3. Air out your skin every 5 hours, or when you wake up if using
overnight, to minimize the risk of skin irritation. Your device will
pulse at that time as a reminder. Reposition the device on your
leg or switch to the other leg.
4. The electrode gel may show signs of wear with normal use.
Each electrode is designed to last two weeks. Your electrode
does not need to be replaced until stimulation during
treatment feels uncomfortable.
Warnings
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.
Do not use when showering or bathing, or while operating a vehicle.
For full User Manual, video tutorials, and FAQs,
visit www.quellfibromyalgia.com/support
PN2205866 Rev A
Quell Device Quell Band ElectrodesQuell Fibromyalgia App
Fibromyalgia
Commit to Using Daily
The more you use Quell Fibromyalgia, the better the chance of
symptom relief.
1. Please be patient. It may take several weeks of consistent use
before you start to feel relief.
2. Set a daily therapy goal to stay on track – we recommend using
Quell for a minimum of 3 treatment sessions per day either during
the day or while sleeping.
3. Calibrate your Quell properly during setup to experience optimal
relief. Once calibrated, stimulation should feel strong, but
comfortable during use.
4. Track your Quell usage, fibromyalgia severity, and sleep through
the app. Many people report improvements in mood, activity, and
sleep when Quell is working for them.
5. Personalize your Quell to meet your needs. Visit the Settings menu
within the app to select from various Treatment, Stimulation, and
Sleep options.
Questions?
Call 1-800-204-6577.

Summary

Commit to Using Daily

Electrode Use & Skin Care

Warnings

Setup Instructions

Treatment

How to Start & Stop Treatment

Start Treatment

Enables automatic treatment start via app or settings menu.

Stop Treatment

Details manual double-tap method to stop treatment.

Indicator Lights

Device On Leg

Explains light signals when device is worn.

Device Off Leg

Explains light signals when device is not worn.

Device Charging

Explains light signals during charging.

Let Us Help

Overview

1. Function Description
2. Usage Features
3. Maintenance Features

The Quell Fibromyalgia device is a wearable therapeutic system designed to provide relief from fibromyalgia symptoms through neurostimulation. It is intended for daily use, with consistent application over several weeks recommended for optimal symptom relief.

Function Description

The Quell Fibromyalgia device delivers neurostimulation to help alleviate fibromyalgia symptoms. Treatment sessions typically last 60 minutes, followed by a 60-minute break. During the initial 2 minutes of a session, stimulation gradually increases until it reaches the user's target level. The device is designed to automatically restart sessions until it is removed from the leg, allowing for continuous therapy. The system includes a wearable device, electrodes, and a mobile application that facilitates setup, calibration, and personalized treatment management.

Usage Features

The Quell Fibromyalgia device is designed for ease of use and personalization.

• Daily Use and Consistency: Users are encouraged to use the device consistently, with a minimum of three treatment sessions per day, either during waking hours or while sleeping. Symptom relief may take several weeks of consistent use to become noticeable.
• Calibration for Optimal Relief: Proper calibration during initial setup is crucial for experiencing optimal relief. The device should be calibrated to deliver strong yet comfortable stimulation.
• Wearability: The device can be worn on the leg, allowing for use during daily activities and while sleeping.
• Treatment Automation: Once set up, treatment can begin automatically within one minute of placing the device on the leg if "Automatic Start" is enabled through the app. This feature eliminates the need to manually start treatment via the app each time.
• Stopping Treatment: Treatment can be stopped by firmly double-tapping the device with fingers while the leg is still. It is important to stop treatment before removing the device from the leg.
• Mobile Application Integration: The Quell Fibromyalgia app is central to the device's functionality. It is required for initial setup and calibration, guiding users through the process to set their optimal therapeutic intensity. The app also allows users to:
  • Track Progress: Monitor Quell usage, fibromyalgia severity, and sleep patterns. Many users report improvements in mood, activity, and sleep when the device is effective.
  • Personalize Treatment: Access the Settings menu within the app to customize various Treatment, Stimulation, and Sleep options to meet individual needs.
  • Start and Stop Treatment: The app provides full control over the Quell device, enabling users to start and stop treatment sessions.
• Indicator Lights: The device features indicator lights to communicate its status:
  • On Leg: A white double blinking light indicates treatment in progress. An orange blinking light signals an error, prompting users to check the electrode connection and skin application.
  • Off Leg (Battery Check): A white blinking light indicates sufficient battery for treatment. No light means the device needs charging.
  • Charging: A white blinking light indicates charging in progress. A solid white light means the device is fully charged. An orange blinking light signifies a charging error, requiring a call to Customer Care.
• No Smartphone Option: While the app is necessary for initial setup and calibration, the device can be programmed for use without the app once these steps are completed.

Maintenance Features

Proper maintenance, particularly concerning electrode use and skin care, is essential for the device's effectiveness and user comfort.

• Electrode Application:
  • Electrodes should be attached to the device with the liner in place to protect the hydrogel, then the liner removed before applying to the skin.
  • Electrodes must only be applied to clean, dry skin. They should never be applied over irritated or damaged skin.
• Skin Care: To minimize the risk of skin irritation, users should air out their skin every 5 hours during daytime use, or upon waking if using the device overnight. The device will pulse at these times as a reminder to reposition it on the leg or switch to the other leg.
• Electrode Lifespan: Each electrode is designed to last two weeks. Electrodes do not need to be replaced until stimulation during treatment feels uncomfortable, even if the gel shows signs of wear with normal use.
• Charging: The device must be charged before its first use and whenever the battery is depleted.
• Support Resources: Users can access a full User Manual, video tutorials, and FAQs online for comprehensive support. Customer Care is available via phone and email for questions, troubleshooting, and assistance.

Quell Fibromyalgia Specifications

General

Connectivity	Bluetooth
Control	Mobile App
Target Condition	Fibromyalgia
Technology	Transcutaneous Electrical Nerve Stimulation (TENS)
Power Source	Rechargeable Battery
Device Type	Wearable Device
Intended Use	Pain Relief
Product Type	Medical Device
Water Resistance	Not Water Resistant