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Quell QE-001 User Manual Download Page 22

APPENDIX A: Indicator Lights

Quell

®

 User Manual    Quell Customer Care 1-800-204-6577 or +1-781-890-9989

< 

Contents |

21

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.

Summary of Contents for QE-001

Page 1: ... 2017 NeuroMetrix Inc User Manual ...

Page 2: ...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 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 F...

Page 3: ...es 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 s...

Page 4: ...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 Important Guidelines The electrode should be making good contact with the skin Remove electrode briefly during the day to reduce risk of skin irritation A...

Page 5: ...ll Customer Care 1 800 204 6577 or 1 781 890 9989 Contents 4 Push button Adjustable sports band Two electrode connector snaps Indicator lights Micro USB port not seen in image port is on bottom of device not accessible through sports band Device Components ...

Page 6: ... 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 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 pack...

Page 7: ...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...

Page 8: ...g 1 2 Chapter 3 Device Basics 1 2 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 appr...

Page 9: ...nto 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 ...

Page 10: ...e 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...

Page 11: ...me 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 Ste...

Page 12: ...r 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 ligh...

Page 13: ...erience 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 damage the electrode and remember to reapply the liner see page 15 for instructions on removing electrode Adjusting Intensity During Therapy Session Frequent adjustments should not be necessary however i...

Page 14: ...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 remin...

Page 15: ...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 di...

Page 16: ...trode 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 sti...

Page 17: ...ion 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 Protectants that work well include 3M Cavilon No Sting Barrier Film Smith Nephew SKIN ...

Page 18: ...ow they may help you optimize your Quell therapy during the day and at night Not all features available on all devices Chapter 9 Using the Mobile App Chapter 9 Using the Mobile App 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 overesti...

Page 19: ...ticularly 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...

Page 20: ...ems 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 cover...

Page 21: ...lted due 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 Singl...

Page 22: ...ng 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 ...

Page 23: ...rying 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 ma...

Page 24: ...ton 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 ma...

Page 25: ...n 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 My device is pulsing at the end of therapy Pulsing serves as a reminder that you have being wearing the device on the same p...

Page 26: ...ightly 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 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 som...

Page 27: ...at 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 dev...

Page 28: ...ition 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 ...

Page 29: ... 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 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 How long should the battery last Battery life is heavil...

Page 30: ...on 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 APPENDIX D Alternate Placement 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 ...

Page 31: ...lect 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 automat...

Page 32: ... burst 4 pulse bursts randomly 15 25 Hz with mean 20 Hz 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 Output Trips No Load Device not connected to patient Insufficient Charge Delivered charge below target Over Load Delivered charge above target Electrode Peeling Electr...

Page 33: ...arging 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 k...

Page 34: ...t 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...

Page 35: ...ting in closure of the airway difficulty in breathing or adverse effects on heart rhythm or blood pressure 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 Do not apply stimulation over open wounds or rashes or over swollen red infected or inflamed areas or skin eruptions e g ph...

Page 36: ... Electronic and Electrical Equipment symbol in accordance with council directive 2002 96 EC Type BF Applied Part User Manual device labeling APPENDIX H Symbols 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 ...

Page 37: ...atic Discharge Immunity ESD IEC 61000 4 2 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 Radiated RF IEC 61000 4 3 10 V m 80 MHz to 2 7 GHz 10 V m compliance level Electric Fast Transient Burst Immunity IEC 61000 4 4 2kV power leads Mains power quality should be that of a typical domestic establis...

Page 38: ...of equipment marked with the following symbol 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 amat...

Page 39: ...mitter 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 Table 2 Recommended separation distances between portable and mobile RF communications e...

Page 40: ...Canada license exempt 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 transmit...

Page 41: ...er 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...

Page 42: ...Products Only Name of company Address Telephone email TÜV SÜD Product Service GmbH Notified Body Number 0123 Zertifizierstelle Ridlerstrasse 65 80339 München Germany 49 89 5008 4477 phone 49 89 5008 4327 fax medical_devices tuev sued de Conformity Assessment Device classification Route to compliance Standards applied QE 001 QE 002 Class IIa Rule 9 Annex II w o 4 of MDD 93 42 EEC Council Directive ...

Page 43: ...Quell User Manual 2017 NeuroMetrix Inc All Rights Reserved PN2204482 Rev B 1000 Winter Street Waltham MA 02451 USA 800 204 6577 781 890 9989 www quellrelief com ...

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