User Manual - SENSUS Pain Management
Contents
1. t Intensity Hold button down intensity will increase while button is down S Therapy Press button 4 times to stop therapy A therapy session lasts 1 hour After starting your first Session therapy will automatically restart every other hour RS Air out skin after wearing several hours or overnight device will pulse on and off for 1 minute as a reminder Helpful Tips e Entire electrode should contact skin e Every few hours make sure device fits securely around your leg e Run electrode under water if it stops adhering to skin e Change electrode every 2 weeks If you need assistance call 1 888 786 7287 SENSUS Pain Management User Manual Chapter 3 Device Basics Figure 3 Checking Battery With the device in your hand briefly press the button to check the battery Figure 3 The indicator light will flash green if the battery has sufficient charge If indicator light flashes red or does not flash at all the battery needs to be recharged see below for charging instructions eo charged recharge Charging Battery A fully charged battery typically provides 20 40 hours of use To charge the battery 1 Plug the USB cable into the USB port on the side of the device The USB port is protected by a rubber cover To access the USB port rotate the cover until the connector is exposed Figure 4 Figure 4 SENSUS Pain Management User Manual 9 2 Plug the other end of the cable int2. Adjusting Intensity During Therapy Session Frequent adjustments should not be necessary however if the sensation is not strong if it feels uncomfortable or your calf muscle is twitching please follow the instructions below Intensity Briefly press the button each press decreases intensity t Intensity Hold button down intensity increases while button down SENSUS Pain Management User Manual 15 You may adjust the intensity at any time during a therapy session Maximum pain relief will be obtained at the highest intensity that is also comfortable Ending Therapy Session A therapy session stops after 60 minutes Figure 14 If the device is on your leg a new therapy session will automatically restart 60 minutes following the end of prior session To end a therapy session early press the button 4 times Figure 14 You should not remove the device while it is stimulating so make sure that the indicator light is not blinking green before removing the device and electrode from your leg After completing a therapy session you may either leave the device on your leg or remove it If you remove the device be careful not to damage the electrode and remember to reapply the liner See page 18 for instructions on removing electrode If you leave the device on your leg for long periods of time you should check your skin frequently to make sure that it does not get irritated Chapter 8 provides information on ski
3. Turn the device so that Align the snaps on the electrode to the the snap connectors snap connectors on the device Insert are visible snaps until they are securely fastened Remove the liner covering the electrode Figure 8 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 A white label is affixed to each electrode liner Figure 9 The first time you use a new electrode write the date on the label The electrode should be replaced 2 weeks from this date can be extended up to Figure 8 Figure 9 3 days if anew electrode is not available SENSUS Pain Management User Manual 11 Device Placement Place the device on your upper calf about Figure 10 1 2 inches below the knee Figure 10 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 the button is accessible and you experience a comfortable sensation during therapy You may position the device with the button on the inside outside or back of the leg You should avoid placing the center compartment directly over your shinbone If the device cannot be placed in the standard location as shown in Figure 10 then refer to Appendix D for alternate site options Loop the strap through the buckle and attach it with the Velcro fastener
4. healing process e Use caution if stimulation is applied over the menstruating or pregnant uterus e Use caution if stimulation is applied over areas of skin that lack normal sensation e Keep this device out of the reach of children e Use this device only with the leads electrodes and accessories recommended by the manufacturer SENSUS Pain Management User Manual APPENDIX G Prescribing Information CONT e Use this device only under the continued supervision of a licensed medical professional e Accessory equipment connected to the USB port must be certified to the respective IEC standards e g IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Most computers manufactured by major suppliers meet the IEC 60950 standard If in doubt consult with your local information technology support Adverse Reactions e Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin e Patients may experience headache and other painful sensations during or following the application of electrical stimulation near the eyes and to the head and face e Patients should stop using the device and should consult with their physicians if they experience adverse reactions from the device Warnings e Do not apply stimulation over the neck because this could Cause severe muscle spasms resulting in closure of the airway difficulty in breathing or adverse effects on h
5. prescribed two devices do I need to match devices and legs No unless the stimulation feels dramatically different between legs Will pain relief start immediately after I press the button Pain relief usually starts within 15 minutes 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 be extended up to 3 days if a new electrode is not available 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 Your doctor may decide to prescribe both SENSUS and pain medications SENSUS Pain Management User Manual APPENDIX C Frequently Asked Questions CONT Can multiple people share the device No The device is configured for one person and should not be shared Will get pain relief in just the leg that has SENSUS You may experience relief in both legs with placement on one leg Will SENSUS just provide pain relief in the legs You may experience relief in other body locations Can use SENSUS while sleeping Yes have chronic pain will SENSUS help me sleep better It may reduce your pain as you fall asleep and while you are sleeping What does SENSUS do while am sleeping It starts 60 minute therapy sess
6. SENSUS PAIN MANAGEMENT User Manual GET RELIEF GET ACTIVE GET SLEEP NE i e Rea NEUROMetrix TABLE OF CONTENTS Chapter 1 Pain Relief with SENSUS nrnaunaunnnunaunnnnnannnnnnnunnnunnur 3 HAINAN 3 What You Should Have Heceived 4 DEVICE COMPO MS sveesacerscesecnsenecentecnesdozeawesateysacivedseusseeaseueeaatned 6 Chapter 2 Getting Started anrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnunn 7 Chapter 3 Device BasiCsS a annnnnnannnnnnannnnnnannnnnnnnnnnennnnnnennnnnnennnnnnr 9 Fe EE 9 CARON Banery EE 9 Attaching Electrode Ak 11 Device Place EEN 12 Chapter 4 Configuration suser EEN ES 13 Chapter 5 Pain Therapy anvnnnnanennnnnnnnnnnnnnnnnnnnennennnnnnennnnnnnnnnen 14 Preparing for Therapy Session Lasaesnemmmenesdumnsteen 14 Starting Therapy Session EE 15 Adjusting Intensity During Therapy Geseion 15 Ending fa 1 EO 16 Chapter 6 Overnight Therapy anrnanvnnnnnnnnnnnnnnnnenannnnennnennnnnnen 17 Chapter 7 Electrodes saavaessijsmsdveseemmmisamninnn 17 Chapter 8 Skin Gare an sarnananannnnnnnnnannnnnnnnennnnnnennennnnnnnnnnennennnnnr 18 SENSUS Pain Management User Manual 1 TABLE OF CONTENTS CONT Chapter 9 Maintenance Safety and ServiCe ar arxnaxvanrnnnrn 21 Maintenance EN 21 Cleaning EE ett kk E REE ERE REE E RE ERE REE REE ERE ERE L ERE EL ERE R EL EER 21 BE 6 ee 22 DEN 22 Limited E e EEN ER APPENDIX A Indicator Light n nanennvnnnnnnvnnnennvnnnnnnennnnnnennnenn
7. able Velcro strap oa Two electrode connector snaps O USB port not seen in image port is on side of device oggLOpB WII 6 SENSUS Pain Management User Manual Chapter 2 Getting Started The following instructions will help you start using SENSUS For additional details please review Chapters 3 8 These instructions are also available in video format at www SENSUSRx com Instructional video html Step 1 Check Battery Briefly press the button eo charged recharge Step 2 Attach Electrode Snap in a new electrode Step 3 Place Device Remove liner and place the device on the upper calf of either leg 1 2 inches below knee The exact position is not critical Step 4 Configure First Use Only You must configure your device before first use Press and hold button for 10 seconds until the indicator light is steady green Briefly press the button whenever you feel a sensation under the electrode The sensation will pause with each button press You will typically press 3 6 times When the light turns off you are done configuring your device SENSUS Pain Management User Manual 7 Step 5 Start Therapy Briefly press the button The indicator light will blink green and the intensity will automatically increase to your therapeutic level over 2 minutes You should feel a strong but comfortable sensation Intensity Briefly press the button each press decreases intensity
8. angular Current 0 1 uC into 5000 load 100 V 100 mA 200 400 usec 60 100 Hz randomly varying Continuous 20 uC 0 71 mA cm into 5000 load 4 mA into 500Q load 7 mW cm into 5000 load Device not connected to patient Delivered charge below target Delivered charge above target Low impedance Electrode dislodging from skin SENSUS Pain Management User Manual 35 APPENDIX F Technical Specifications CONT Therapy Session Timer Start Therapy Halt Therapy Manual Intensity Increase Decrease Habituation Compensation Electrode Type Materials Number of Electrodes Connector Dimensions Power Source Battery Type Charging Source 60 minutes Briefly press button Press button 4 times within 10 seconds Increase 1 25 per second decrease 5 Adaptive stepwise increase in intensity of during session Self adhering single patient use multiple applications Mylar substrate silver electrode pads 2 outer electrode area 28 cm inner electrode area 33 cm Medical snap male 0 2 cm x 5 3 cm x 28 3 cm exterior Permanent rechargeable battery Rechargeable 3 7V Lithium Ion battery AC line adapter SENSUS Pain Management User Manual Power continued Line Current Isolation Patient Leakage Current DC Patient Leakage Current Enclosure Physical Dimensions Weight without straps Environmental Operating Temperature Range Atmospheric Pressure Range Rela
9. as shown in Figure 11 The device should fit securely around your leg and be comfortable to wear However the strap should not be so tight that the device and electrode substan tially indent the skin The electrode should make smooth contact with the skin If there is buckling of the electrode loosen the strap smooth the electrode and re secure the strap 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 Figure 11 12 SENSUS Pain Management User Manual Your device comes with small medium and large straps It is shipped with the medium strap attached If you require a different strap remove the medium strap and attach either the small or large strap Chapter 4 Configuration Before you begin using your device for the first time you will need to configure You should also reconfigure your device if you are no longer experiencing pain relief Otherwise you do not need to reconfigure your device including when you switch electrodes and alternate legs You should carry out the configuration process in a quiet area without distractions It is best to configure using a new electrode Configuration Procedure STER I Snap in a new electrode STER Remove liner and place the device on the upper calf of either leg 1 2 inches below knee The exact position is not critical Press and hold button for 10 se
10. che e Transcutaneous electrical nerve stimulation is not a substitute for pain medications and other pain management therapies e Transcutaneous electrical nerve stimulation devices have no curative value e Transcutaneous electrical nerve stimulation is a symptomatic treatment and as such suppresses the sensation of pain that would otherwise serve as a protective mechanism SENSUS Pain Management User Manual e Effectiveness is highly dependent upon patient selection by a licensed medical professional qualified in the management of pain patients e The long term effects of electrical stimulation are unknown e 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 e The safety of electrical stimulation during pregnancy has not been established e Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium gel e Patients with suspected or diagnosed heart disease should follow precautions recommended by their physicians e Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians e Use caution when the patient has a tendency to bleed internally such as following an injury or fracture e Use caution following recent surgical procedures when stimulation may disrupt the patient s
11. conds until the indicator light is steady green Briefly press the button whenever you feel a sensation under the electrode The sensation will pause with each button press You will typically press 3 6 times When the light turns off you are done configuring your device SENSUS Pain Management User Manual 13 If your doctor prescribed two devices configure one device at a time If you have difficulty with configuration call 888 786 7287 Device is configured for a single person and should not be shared Chapter 5 Pain Therapy During a therapy session the device will comfortably stimulate the nerves in your leg to provide pain relief Each therapy session lasts 60 minutes and a new session will automatically restart every other hour See Appendix E to turn automatic restart off To maximize pain relief you should feel a strong but comfortable sensation The intensity that you will require is estimated based on your device configuration 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 15 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 to the intensity and you should not need to adjust often Please follow the steps on the following pages for a therapy session Pr
12. d hydrate the electrodes as described in Chapter 7 Skin Care My skin is irritated redness or rash or itches after I remove the device 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 Legs should be alternated Chapter 8 provides information on skin care If you need assistance call 888 786 7287 SENSUS Pain Management User Manual 27 APPENDIX C 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 can use SENSUS You may start a therapy session whenever you need pain relief However it is best to wait one hour between sessions When do I need to configure my device You must configure the device before first use You may repeat configuration if pain relief has diminished Do I need to configure the device before each therapy session No Once your device is configured you do not need to configure it again unless pain relief has diminished Do I need to reconfigure 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 SENSUS Pain Management User Manual If I was
13. eart rhythm or blood pressure e Do not apply stimulation across the chest because the introduction of electrical current into the chest may cause rhythm disturbances to the heart which could be lethal SENSUS Pain Management User Manual e 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 e Do not apply stimulation over or in proximity to cancerous lesions e 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 e Do not apply stimulation when in the bath or shower e Do not apply stimulation while driving operating machinery or during any activity in which electrical stimulation can put the patient at risk of injury e Consult with the patient s physician before using this device because it may cause lethal rhythm disturbances to the heart in susceptible individuals e Apply stimulation only to normal intact clean healthy skin e No modification of this device is allowed SENSUS Pain Management User Manual APPENDIX H Symbols User Manual device labeling Type BF Applied Part WEEE Waste Electronic and Electrical Equipment symbol in accordance with council directive 2002 96 EC MN Abbreviation for model number SENSUS Pain Management U
14. eparing 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 SENSUS Pain Management User Manual Starting Therapy Session Figure 13 To start a therapy session briefly press the button Figure 13 The indicator light will blink green for the duration of the therapy session The intensity will gradually increase over the first two minutes to the intensity that was determined when you configured your device This intensity will be stronger than what you experienced during configuration You may not feel anything for the first 10 15 seconds however the blinking green light indicates the device is functioning properly Therapy will continue for 60 minutes 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 Once your therapy session has begun you may cover the device with your clothing You should be careful not to dislodge the device and electrode when covering with clothing It is best to wear loose fitting clothing so that you can access the device You may go about your normal activities during a therapy session Do not shower bathe or swim with the device on your leg
15. erapy session If the problem persists then replace the electrode The light is blinking green but I do not feel anything Wait until therapy has run for at least 2 minutes If after 2 minutes you still cannot feel anything the intensity is too low Press and hold the button to increase the intensity until you have a strong but comfortable sensation Alternatively configure the device again What should do if therapy stings or feels uncomfortable Turn off the device by pressing button 4 times Remove the device and inspect the electrode If the gel is dry then hydrate the electrode Chapter 7 If your skin is dry then consider using skin moisturizer see Chapter 8 Place the device and electrode back on your leg making sure that there is complete contact between the electrode and the skin If the discomfort persists then replace the electrode What should do if get cramps under the device You should lower the intensity by briefly pressing the button I am not getting pain relief Make sure you feel a strong but comfortable sensation Either increase the intensity by pressing and holding the button or configure the device again SENSUS Pain Management User Manual Electrode Care The gel sticks to my skin when I remove the electrode If the gel is coming off the electrode then use of a light lotion 30 minutes prior to therapy should help see Chapter 8 The gel is dry and losing its stickiness You shoul
16. in Run the electrode under a gentle water stream for 10 seconds as shown in Figure 15 Let air dry before using SENSUS Pain Management User Manual 17 Electrode Removal Figure 16 You should be careful not to 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 see Figure 16 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 Electrode Storage Electrodes should always be stored with the liner covering the gel pads 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 should be replaced prior to two weeks if stimulation becomes painful despite hydrating the electrode gel pads and positioning the device so that the entire electrode is making smooth contact with the skin Chapter 8 Skin Care SENSUS 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 SENSUS Pain Management User Manual electrode to ensure that skin irritation does n
17. ions every other hour throughout the night to control your pain Will therapy wake me up The device detects that you are sleeping and decreases the intensity to minimize sleep disruption SENSUS Pain Management User Manual Do I need to set up SENSUS differently for sleep use No What if I only want a single 60 minute therapy session Turn automatic therapy restart off Appendix E What should do before going to sleep Make sure the device is securely and comfortably placed around your leg Start the first therapy session by briefly pressing the button Will wearing SENSUS overnight irritate my skin You should air out your skin every morning You should also alternate legs Can use SENSUS every night Yes however you should alternate legs to decrease the risk of skin irritation Will SENSUS reduce or eliminate my need for sleep medications Only your doctor can decide whether changes to your medications are appropriate SENSUS Pain Management User Manual 31 APPENDIX C Frequently Asked Questions CONT Does SENSUS treat obstructive sleep apnea No Can I use SENSUS at the same time as a continuous positive airway pressure CPAP machine Yes Will SENSUS help my insomnia There are many causes for insomnia including chronic pain Please discuss with your doctor What should I do if I have concerns about my sleep Poor sleep can impact your health safety and quality of life Plea
18. leaning solutions since they may damage the case Never immerse the device in water or other liquids SENSUS Pain Management User Manual 21 Device Storage When device is not in use place it in the carrying case and store it in a dry location away from direct sunlight Disposal Used electrodes should be disposed in normal trash receptacles Dispose of the device according to national state and local regulations as the device contains a Lithium lon battery Limited Warranty NeuroMetrix Inc manufactures its hardware products in accordance with industry standard practices NeuroMetrix warrants the SENSUS device to be free from defects in materials and workmanship at the time of shipment The warranty term is five years beginning on the date of shipment from the manufacturer as further described in the following text This warranty does not cover damage due to external causes including accident abuse misuse problems with electrical power usage not in accordance with product instructions failure to perform required maintenance and problems caused by use of parts or components not supplied by NeuroMetrix This warranty does not apply to any product repaired or altered by anyone other than NeuroMetrix or an authorized NeuroMetrix representative 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 Neu
19. n care If a problem arises during a therapy session stimulation will stop and the indicator light will blink red for 2 minutes Refer to Appendix B for troubleshooting assistance Air out skin after wearing several hours or overnight device will pulse on and off for 1 minute as a reminder SENSUS Pain Management User Manual Chapter 6 Overnight Therapy You may use SENSUS at bedtime and throughout the night if pain is preventing you from falling asleep or maintaining high quality sleep Before going to sleep make sure the device is placed securely and comfortably around your leg Start a therapy session by briefly pressing the button This 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 The light will blink green at a slower rate during these sleep sessions ES Air out skin after wearing SENSUS overnight ER If you have concerns about the amount or quality of your sleep please discuss with your doctor If you have any questions regarding overnight use of SENSUS call 888 786 7287 Chapter 7 Electrodes The SENSUS Electrodes are designed to Figure 15 operate for 2 weeks can be extended up a to 3 days if a new electrode is not avail able You should hydrate your electrode if the gel pads stop adhering to your sk
20. ncrease 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 e 3M Cavilon No Sting Barrier Film e Smith amp Nephew SKIN PREP e Smith amp Nephew No Sting SKIN PREP e Coloplast Prep Protective Skin Barrier These products are available online SENSUS Pain Management User Manual Check for Skin Irritation Check for signs of irritation including e Skin itches while device is on the skin or after removal e Skin is red where it contacted electrode e 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 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 hours per day for a week to make sure that further irritation does not occur Chapter 9 Maintenance Safety and Service Maintenance Contact your supplier if the device requires service Cleaning Use a damp cloth moistened to clean the exterior of the device Do not use any other c
21. o the AC Adapter Figure 5 The cable should not be plugged into a computer USB port for charging Figure 5 3 The AC Adapter should then be Figure 6 plugged into a standard electrical outlet Figure 6 The indicator light on the device will show steady green during charging and will turn off when the battery is fully charged 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 light blinks red 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 charge for one therapy session To confirm disconnect the USB cable from the device and briefly press the button If the indicator light flashes green battery has enough charge If the indicator light flashes red reconnect the USB cable and continue charging A Do not use your device with the USB cable connected SENSUS Pain Management User Manual Attaching Electrode You will need to attach a new electrode prior to first use of the device and every 2 weeks thereafter can be extended up to 3 days if a new electrode is not available You should reseal the pouch if it contains an electrode To attach an electrode snap the electrode into the two connectors as shown in Figure 7 Only use SENSUS electrodes manufactured by NeuroMetrix Inc Figure 7
22. ot 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 SENSUS T Never use the device on open wounds or rashes or over swollen red infected or inflamed skin Keep Your Skin Moisturized Dry skin can make the electrodes difficult to remove which can potentially damage the electrode gel If you have dry skin or notice that electrode gel comes off the electrodes when removing from the skin you should consider using a light lotion 30 minutes prior to SENSUS use Lotions that are light non greasy fast absorbing and intended for daily use will work best Some examples include e Aveeno Daily Moisturizing Lotion e Lubriderm Daily Moisture Lotion e Gold Bond Skin Therapy Lotion e Curel Daily Moisture Lotion Make sure the lotion has absorbed fully into the skin before placing the electrode and device Prevent Skin Irritation Air Out Skin Air out skin after several hours of use during the day or after overnight use Switch leg on which device is placed when convenient SENSUS Pain Management User Manual Do Not Over Tighten Band The strap should not be so tight that the device and electrode indent the skin 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 i
23. quires charging Blink rate is once per second except when you are sleeping which will be once every 5 seconds SENSUS Pain Management User Manual APPENDIX B Troubleshooting Configuration cannot start the configuration procedure light is not steady green Make sure the device and electrode are properly placed on the leg and the liner has been removed Press and hold the button down for at least 10 seconds until the light turns steady green I am trying to configure but I do not feel anything It may take 20 30 seconds to first feel a sensation Therapy Therapy can only be initiated after the device and electrode are properly placed on the calf Chapter 5 When start therapy all see is a single red blink Recharge device When start therapy the light blinks green a few times and stops Configure device Therapy stopped and the light is blinking red A blinking red light 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 start therapy again If the problem recurs remove the device and inspect the electrode If the gel is dry then hydrate as described in Chapter 7 Place the device back on the leg and SENSUS Pain Management User Manual 25 APPENDIX B Troubleshooting CONT restart the th
24. roMetrix issued Return Material Authorization RMA Number To initiate a return contact your supplier 22 SENSUS Pain Management User Manual All parts removed from repaired products will become the property of NeuroMetrix If NeuroMetrix repairs or replaces a product the original warranty is not extended NEUROMETRIX MAKES NO EXPRESS OR IMPLIED WARRANTIES OR REPRESENTATIONS BEYOND THOSE STATED IN THIS WARRANTY STATEMENT NEUROMETRIX DISCLAIMS ALL OTHER WARRANTIES AND REPRESENTATIONS EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE NEUROMETRIX S OBLIGATIONS FOR ANY FAILURE OF A PRODUCT TO BE AS WARRANTED ARE LIMITED TO AT NEUROMETRIX OPTION REPAIR OR REPLACEMENT OF THE PRODUCTS SET FORTH IN THIS WARRANTY STATEMENT UNDER NO CIRCUMSTANCES WILL NEUROMETRIX BE LIABLE FOR ACTUAL OR CLAIMED DEFECTS IN ANY PRODUCT BEYOND THE REMEDIES SET FORTH IN THIS WARRANTY STATEMENT INNO 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 SENSUS Pain Management User Manual 23 APPENDIX A Indicator Light Indicator Light Status Explanation Solid Green Configuration in progress Single Green Flash Adequate battery charge Single Red Flash Battery re
25. se discuss with your doctor 32 SENSUS Pain Management User Manual APPENDIX D Alternate Placement Sites If your SENSUS device cannot be placed at its usual location just below the knee such as due to a wound or skin irritation then it may be positioned at one of the following alternate sites e At mid calf as shown in Figure 17 e Above the knee on the lower thigh as shown in Figure 18 You should configure the device at the new site before initiating therapy Figure 17 Figure 18 SENSUS Pain Management User Manual 33 APPENDIX E Automatic Restart You may toggle the automatic therapy restart from on to off or vice versa With the device in your hand without an electrode attached press the button for at least 10 seconds and you will then see either a green or red light A green light means the automatic restart is on a red light means the automatic restart is off SENSUS Pain Management User Manual APPENDIX F Technical Specifications Output Waveform Regulated Current or Voltage Net Charge per Pulse Maximum Output Voltage 410 Maximum Output Current lt 1KQ load 10 Pulse Duration 44 Pulse Frequency 4 Pulse Pattern Maximum Phase Charge Maximum Current Density Maximum Average Current Maximum Average Power Density Output Trips No Load Insufficient Charge Over Load Short Circuit Electrode Peeling Biphasic with alternating leading phase symmetrical rect
26. ser Manual APPENDIX I Electromagnetic Compatibility Declaration SENSUS is intended for use in the electromagnetic environment specified below The user should ensure that it is used in such an environment Electromagnetic environment Emissions test Compliance l guidance RF emissions Group 1 SENSUS uses RF energy only CISPR 11 for its internal function Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B SENSUS is suitable for use in CISPR 11 all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Electrostatic 6kV contact Floors should be wood Discharge 8kV air concrete or ceramic tile Immunity ESD IEC 61000 4 2 Radiated RF 3 V m 80 MHz 3 V m compliance level IEC 61000 4 3 to 2 5 GHz SENSUS Pain Management User Manual NEUROMetrix 62 Fourth Avenue Waltham MA 02451 888 786 7287 SENSUS version 2 0 2014 NeuroMetrix Inc www SENSUSRx com All Rights Reserved PN2203652 Rev M
27. tive Humidity Range Transport and Storage Temperature Range Atmospheric Pressure Range Relative Humidity Range Patient disconnected when charging lt 10 pA lt 100 pA 176 mm x 63 mm x 15 mm 82 g 10 C to 40 C 50 kPa to 106 kPa 30 to 75 40 C to 50 C 50 kPa to 106 kPa 10 to 90 Guidance Documents amp Standards FDA IEC Draft Guidance for Industry and Staff Class II Special Control Guidance Document Transcutaneous Electrical Nerve Stimulator for Pain Relief April 5 2010 IEC 60601 1 IEC 60601 1 2 IEC 60601 1 6 IEC 62304 SENSUS Pain Management User Manual 37 APPENDIX G Prescribing Information UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR LICENSED MEDICAL PROFESSIONAL Indications The NeuroMetrix SENSUS 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 Contraindications e Do not use this device on patients who have a cardiac pacemaker implanted defibrillator or other implanted metallic or electronic device because this may cause electric shock burns electrical interference or death e The device should not be used on patients whose pain syndromes are undiagnosed Precautions e Transcutaneous electrical nerve stimulation is not effective for pain of central origin including heada
28. ually begins within 15 minutes of 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 You should review this User Manual carefully Chapter 2 shows you how to get started Chapters 3 5 provide detailed instruc tions 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 Appendix C gives answers to frequently asked questions If you have any questions about how to use SENSUS please call NeuroMetrix customer service at 888 786 7287 SENSUS Pain Management User Manual 3 What You Should Have Received Upon receiving your SENSUS Pain Management System you should inspect its contents to make sure all of the following are included and undamaged see Figure 1 A SENSUS Device B Small and Large Replacement Straps C USB Cable D AC Adapter E User Manual You may also have received electrode packages Figure 2 If any of the items appear damaged contact your supplier 4 SENSUS Pain Management User Manual Figure 1 Carrying Case SENSUS User Manual EUROMetrix Figure 2 SENSUS Pain Management User Manual 5 Device Components The device has the following components ad Push button EH Indicator light eo Adjust
29. uner 24 APPENDIX B Troubleshooting a narvnnnnnvnnnnnnvnnnnnnnnnnnnnnnnnennuner 25 APPENDIX C Frequently Asked Questions nnrnnnnnnnnnnnnvnnnnnnenn 28 APPENDIX D Alternate Placement Sites nurnnnnnnnnnvnnnnnevnnuvenn 33 APPENDIX E Automatic Restart an nnnnnnnnnnnnnnnnnnvnnnvnnnvnnnvnnnens 34 APPENDIX F Technical Specifications anenannannnnnnnnennnvnnennnnnn 35 APPENDIX G Prescribing Information an vnnnnnnnnnnnnnnevnnennnenn 38 APPENDIX H Symbols aneennanvennnnnennnnnnnnnnnnvennnnnennnnnvennnnnennnnnnen 42 APPENDIX I Electromagnetic Compatibility Declaration 43 2 SENSUS Pain Management User Manual Chapter 1 Overview Introduction The SENSUS Pain Management System is an innovative wearable medical 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 SENSUS provides pain relief by comfortably stimulating the nerves that carry normal non painful sensations to your brain Electrical stimulation of these nerves is believed to change the levels of certain natural chemicals in your nervous system that decrease your pain Pain relief is initiated by simply pressing a button on the device Each therapy session is 60 minutes After your first session therapy will automatically restart every other hour Pain relief us
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