Quell Wearable Pain Relief User Manual Download Page 36

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APPENDIX F: Technical Specifications

Quell

User Manual Quell Customer Care 1-800-204-6577

Contents |

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)

62 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%

Guidance Documents & Standards

FDA

Draft Guidance for Industry and Staff: Class II Special
Control Guidance Document: Transcutaneous Electrical
Nerve Stimulator for Pain Relief (April 5, 2010)

IEC

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6,
IEC 60601-1-11, IEC 62304

Summary of Contents for Wearable Pain Relief

Page 1: ... 2016 NeuroMetrix Inc User Manual ...

Page 2: ...14 Chapter 7 Electrodes 15 Chapter 8 Skin Care 16 Chapter 9 Using the Mobile App 16 Download the App 16 Install the App and Connect to Your Quell Device 17 The Quell App 22 Chapter 10 Maintenance Safety and Service 22 Maintenance 22 Cleaning Device 22 Cleaning Band 22 Device Storage 22 Disposal 22 Limited Warranty 23 APPENDIX A Indicator Lights 25 APPENDIX B Troubleshooting 30 APPENDIX C Frequentl...

Page 3: ...atically 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 your smartphone You should review this User Manual carefully Chapter 2 shows you how to get started Chapters 3 5 provide detailed inst...

Page 4: ...vice it greatly enhances its functionality Download it by searching for Quell Relief by NeuroMetrix Inc For more tips the complete user manual how to videos reordering electrodes and other supplies please visit our website 1 800 204 6577 www quellrelief com user PN 2204113 Rev A Quick Start Guide Download the App Customer Support Helpful Tips The entire electrode should contact the skin Always pro...

Page 5: ...uell Quell User Manual Quell Customer Care 1 800 204 6577 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 Device Components ...

Page 6: ...sing Quell For additional details please review Chapters 3 8 or you can 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 package and snap it onto the connectors The electrode may be oriented in either dire...

Page 7: ...mes in sequence Each therapy session lasts for 60 minutes with a 60 minute break between sessions Sessions will continue until the device is removed from the leg To learn how to control your Quell device with your smartphone app please review Chapter 9 60 minutes Therapy 60 minutes Therapy 60 minutes Break 60 minutes Break Tips to get the most out of your Quell Calibration This ensures that Quell ...

Page 8: ...C 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 for a short time and then all the lights will turn off I...

Page 9: ...Inc 1 Slide device into band pouch with lights facing up 2 Align the snaps on the electrode to the snap connectors on 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 A white label is affixed to each electrode lin...

Page 10: ...ou should avoid placing one of the 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 device should fit securely around your leg and be comfortable to wear The electrode should make smooth contact with the skin If there is buckling of...

Page 11: ...he connectors 2 Carefully remove liner and place your Quell band directly on your upper calf approximately 1 to 2 inches below knee of either leg Lights should face up 3 Hold the button until you see the lights running back and forth then release the button Every time you feel the slightest tingling sensation click the button once The sensation will pause each time you click the button When the se...

Page 12: ...ice 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 briefly click the button as shown in image below One indicator light will blink white for the duration of the therapy session What Therapy Feels Like The intensity will gradually increase over the first two minutes to a...

Page 13: ...essions 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 yo...

Page 14: ...ce is on your leg and that the therapy session is not running no lights are on You also must have auto restart ON in order to access this menu Then slowly double tap the device outside of the blue oval You should see 1 2 or 3 lights come on in response to your double tap these lights correspond to your current overnight setting Single tap to switch between settings When the desired setting is show...

Page 15: ...removal Do not remove the device while therapy is running Electrode Storage Electrodes should always be stored with the liner covering the gel pads Place the liner with graphic side up so the paper does not stick to the gel You may snap the electrode into the device for convenient storage Electrodes should be stored at room temperature out of direct sunlight Electrode Replacement The electrode sho...

Page 16: ...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 PREP Smi...

Page 17: ...ton at the bottom of your screen 2 Watch the brief introductory video and tap Continue when done 3 To pair the battery needs to be sufficiently charged Check the battery power by clicking the button on your Quell device If a minimum of one of the white LED s lights up your Quell device has sufficient power to proceed Also make sure that Bluetooth is enabled on your mobile device 4 Find the two dig...

Page 18: ...time in the one hour therapy session You may start stop and adjust therapy using the buttons on the Dashboard screen Next Therapy If Auto Restart mode is activated the countdown will tell you how much time until therapy automatically restarts You can always restart therapy at any time by clicking the button on your Quell device You may start therapy using the button on the Dashboard screen Control...

Page 19: ... sleep quality last night Day and Night Screens The screens on the app will automatically adjust to night mode after dark to help in readability This feature is controlled by Location Services on your phone If you choose to not allow this setting night mode will change at 8 00 PM Charging This screen shows when device is charging Please note that your Quell device can only be charged when off your...

Page 20: ... page 21 for more information From the settings menu you can do the following Turn auto restart on and off Select your sleep mode Initiate Sleep Position Tracking Indicate Lights Out and Awake Change the Stimulation Pattern Set your Electrode Replacement date Set Notifications Pair and un pair with your device Modify your account Videos When your mobile device s WiFi is turned on you can access he...

Page 21: ...Therapy Insights Click on a bar to display the number of sessions and percentage of night sessions in that time period Sleep Insights When you are on the Tracking Sleep screen click on any bar to display the Sleep Insights in that time period Time Period By clicking the gear icon from the Tracking screen you may set the desired time period of the display Time Period By clicking the gear icon from ...

Page 22: ...be delivered throughout the night at the same level as during the day Stimulation You may select from two options for Stimulation The Standard stimulation feels like a constant vibration The Alternative Stimulation feels like a gentle pulse Pairing You can use this menu to un pair your mobile device from your Quell device You use this if you want to pair your mobile device with a different Quell d...

Page 23: ...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 NeuroMetrix will repair or replace products that are shown to be other than as warranted above and covered under this limited warranty that are retur...

Page 24: ...py will show the automatic Overnight Therapy setting tap to switch setting Gentle overnight setting is set by default APPENDIX A Indicator Lights Device on 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 bat...

Page 25: ...ice is charging 5 lights on solid Device is fully charged Lights off following 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 Charging ...

Page 26: ...ation 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 Important tips It is a good idea to wait about 5 minutes after putting the electrode on for the skin gel interface to stabilize...

Page 27: ...g without the electrode connected Hold the button down for 10 seconds to toggle between settings 1 white light manual 5 white lights automatic The therapy stings or feels uncomfortable Turn off the device by 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 Pla...

Page 28: ...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 but sessions will continue to run automatically 1 hour on 1 hour off 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...

Page 29: ...o 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 hydrogel movement are much 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 opt...

Page 30: ...n t advisable What if there is no flashing light If the battery has been drained completely and all lights are off allow up to 15 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 after approximately 20 minutes of charging before device has enough charge to provide a single therapy ...

Page 31: ...the knee as described in Chapter 3 Can I place the device on my arms or lower back No Quell is designed to provide widespread relief from chronic pain when worn on the upper calf How long will it take to experience relief We recommend wearing your Quell for 4 6 hours per day for the first month Please be patient because it may take several weeks to experience optimal relief Will pain relief contin...

Page 32: ...ell 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 After charging is complete all of the lights on the device will go out If you leave the device plugged in and miss seeing the entire charge cycle do a ...

Page 33: ...t be placed at its usual location just below the knee due to situations such as a wound or skin irritation then it may be positioned 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 ...

Page 34: ...ctrode attached click and hold the button for at least 10 seconds and you will see either one or 5 white lights One light means that automatic restart is now off 5 white lights mean that automatic restart is now on Note that automatic restart must be on in order to use and change the overnight settings described in Chapter 6 APPENDIX E Automatic Restart Automatic restart is now off Automatic resta...

Page 35: ...to 500Ω load Maximum Average Power Density 7 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 Electrode dislodging from skin Therapy Session Timer 60 minutes Start Therapy Click button once Stop Therapy Click button 4 times Manual Intensity Increase Decrease Increas...

Page 36: ... Dimensions 98 mm x 74 mm x 11 mm Weight without straps 62 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 Guidance Documents Standards FDA Draft Guidance for I...

Page 37: ... 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...

Page 38: ...losure 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 phlebitis t...

Page 39: ...04 6577 Contents 38 APPENDIX H Symbols Abbreviation for model number WEEE Waste 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 ...

Page 40: ...sed for domestic purposes Harmonics Current Emissions IEC 61000 3 2 Class A Fluctuations and Flicker IEC 61000 3 3 Complies Electrostatic Discharge Immunity ESD IEC 61000 4 2 6kV contact 8kV air 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 3 V m 80 MHz to 2 7 GHz 3 V m compliance level Elec...

Page 41: ...e 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 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propa...

Page 42: ...ations equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 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...

Page 43: ...cense 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 transmitter meets...

Page 44: ...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 LED flashes 3 The Bluetooth module is now disabled To reactivate Bluetooth functionality repeat the above steps All six LED s should b...

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