Sensus Pain Management System User Manual
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Sensus Pain Management System User Manual

Pain management
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Summary of Contents for Sensus Pain Management System

  • Page 1 User Manual GET RELIEF GET ACTIVE GET SLEEP...

  • Page 3: Table Of Contents

    Attaching Electrode ..............11 Device Placement ................ 12 Chapter 4: Configuring SENSUS ..........13 Chapter 5: Pain Therapy with SENSUS ........14 Preparing for Therapy Session ............ 15 Starting Therapy Session ............15 Adjusting Intensity During Therapy Session ........ 16 Ending Therapy Session ..............
  • Page 4 APPENDIX C: Frequently Asked Questions .......32-33 APPENDIX D: Alternate Sites ........... 34 APPENDIX E: Technical Specifications ......35-37 APPENDIX F: Prescribing Information ........38-41 APPENDIX G: Symbols .............. 42 APPENDIX H: Electromagnetic Compatibility Declaration ..43 SENSUS Pain Management User Manual ™...

  • Page 5: Chapter 1: Overview

    You may start a therapy session anytime you need pain relief. It is important that you use SENSUS correctly in order to gain the most benefit. You should review this User Manual carefully.

  • Page 6: What You Should Have Received

    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). SENSUS Device* Small and Large Replacement Straps* USB Cable*...
  • Page 7 Figure 1. Carrying Case User Manual Get Relief Get Active Get Sleep Figure 2. SENSUS Pain Management User Manual ™...

  • Page 8: Device Components

    Device Components The device has the following components: Push button Indicator light Adjustable Velcro strap ® Two electrode connector snaps USB port SENSUS Pain Management User Manual ™...

  • Page 9: Chapter 2: Quick Start Instructions

    Chapter 2: Quick Start Instructions The following instructions will help you start using SENSUS quickly. For detailed instructions, please review Chapters 3-8. These instructions are also available in video format. Please visit www.SENSUSRx.com and click on the Resources for Users tab.
  • Page 10 The intensity will increase while the button is held down. To stop therapy, tap center compartment twice while keeping leg still. Ventilate skin after wearing SENSUS for several hours and after overnight use. Watch for skin irritation. Helpful Tips • Entire electrode should contact skin • Every few hours and before sleep, make sure strap is snug...

  • Page 11: Chapter 3: Sensus Device Basics

    Chapter 3: SENSUS Device Basics Checking Battery With the device in your hand, briefly press and release 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).
  • Page 12 If the indicator light flashes green, there is enough charge. If the indicator light flashes red, reconnect the USB cable and continue charging. You should never use your SENSUS device with the USB cable connected. Figure 4.

  • Page 13: Attaching Electrode

    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.

  • Page 14: Device Placement

    If there is buckling of the electrode, loosen the strap, smooth the electrode and re-secure the strap. It is important that each of the four electrode pads are in contact with your skin. If the SENSUS Pain Management User Manual ™...

  • Page 15: Chapter 4: Configuring Sensus

    Chapter 4: Configuring SENSUS Before you begin using your device for the first time you will need to configure it for the right intensity level for you. You should also re-configure your device if you feel that the intensity is no longer providing pain relief.

  • Page 16: Chapter 5: Pain Therapy With Sensus

    You may configure both devices on one leg, or one device on each leg. Chapter 5: Pain Therapy with SENSUS During a therapy session, the device will comfortably stimulate the sensory nerves in your leg to provide pain relief. Each therapy session lasts 60 minutes.

  • Page 17: Preparing For Therapy Session

    Stimulation will continue for a total of 60 minutes. The intensity may feel strong at first but that sensation will typically fade to a comfortable level after a couple of minutes. SENSUS Pain Management User Manual ™...

  • Page 18: Adjusting Intensity During Therapy Session

    Release the button when the intensity reaches a strong but comfortable intensity. You may adjust the intensity at any time during a therapy session. Maximum pain relief will be obtained at the highest intensity level that is also comfortable. SENSUS Pain Management User Manual ™...

  • Page 19: Ending Therapy Session

    Refer to Chapter 8 for skin care. If a problem arises during a therapy session, stimulation will stop and the indicator light will blink red for 10 minutes. Refer to Appendix B for troubleshooting assistance. SENSUS Pain Management User Manual ™...

  • Page 20: Setting Continuous Mode

    • Battery is low • Even if you are in continuous mode, you can always start a therapy session at any time. It is recommended that you wait at least 30 minutes following the prior session. SENSUS Pain Management User Manual ™...

  • Page 21: Chapter 6: Using Sensus During Sleep

    As a result, many people with chronic pain have difficulty falling asleep or maintaining high quality sleep throughout the night. You may use SENSUS to provide overnight pain relief to help you sleep better. You may wear your SENSUS device at bedtime when you are going to sleep and throughout the night.
  • Page 22 The electrode should be replaced prior to two weeks if stimulation becomes consistently painful despite hydrating the electrode and positioning the device so that the entire electrode is making smooth contact with the skin. SENSUS Pain Management User Manual ™...

  • Page 23: Chapter 8: Skin Care

    Chapter 8: Skin Care SENSUS works by electrically stimulating your sensory nerves through your skin. Many 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, it can make the stimulation uncomfortable.
  • Page 24 It is not necessary for you to clean your skin immediately before or after using SENSUS. The most important step you can take after using SENSUS is to ventilate the skin that was under the device and electrode.
  • Page 25 If skin irritation develops then you should not place the device over the irritated area until it completely heals. You may place the device on the other leg or use alternate locations as shown in Appendix D. SENSUS Pain Management User Manual ™...

  • Page 26: Chapter 9: Maintenance, Safety, And Service

    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.
  • Page 27 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 SENSUS Pain Management User Manual ™...
  • Page 28 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 ™...

  • Page 29: Appendix A: Indicator Light

    APPENDIX A: Indicator Light Indicator Light Status Explanation Blinking Green Stimulating Steady Green Configuring or battery charging Blinking Red Error Single Green Flash Adequate battery charge Single Red Flash Battery requires charging SENSUS Pain Management User Manual ™...

  • Page 30: Appendix B: Troubleshooting

    When I start therapy nothing happens (i.e., light is off). Recharge device. When I start therapy all I see is a single red blink. Recharge device. When I start therapy the light blinks green a few times and stops. Configure device. SENSUS Pain Management User Manual ™...
  • Page 31 Chapter 7. Place the device back on the leg making sure that the entire electrode is in contact with the skin. Wait a few minutes and restart the therapy session. SENSUS Pain Management User Manual ™...
  • Page 32 If the gel is coming off the electrode then use of a light lotion 10 minutes prior to therapy should help (see Chapter 8 in User Manual). The gel is dry and losing its stickiness. You should hydrate the electrodes as described in Chapter 7. SENSUS Pain Management User Manual ™...
  • Page 33 Legs should be alternated. Chapter 8 provides information on skin care. If you need assistance, call NeuroMetrix customer service at (888) 786-7287. SENSUS Pain Management User Manual ™...

  • Page 34: Appendix C: Frequently Asked Questions

    The stimulation should feel like a buzzing or light pressure sensation. You may reduce the intensity if it feels uncomfortable. How often can I use SENSUS? You may start a therapy session whenever you need pain relief. However, it is best to wait 30 minutes between sessions.
  • Page 35 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...

  • Page 36: Appendix D: Alternate Sites

    APPENDIX D: Alternate 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: •...

  • Page 37: Appendix E: Technical Specifications

    APPENDIX E: SENSUS Technical Specifications Output Waveform Biphasic with alternating leading phase, symmetrical, rectangular Regulated Current or Voltage Current Net Charge per Pulse 0±1 µC into 500Ω load Maximum Output Voltage 100 V (±10%) Maximum Output Current 100 mA (<1KΩ load) (±10%) Pulse Duration (±4%)
  • Page 38 APPENDIX E: SENSUS Technical Specifications CONT. Therapy Session Timer 60 minutes Start Stimulation Press button down for more than 2 seconds Halt Stimulation Tap center compartment twice with hand Intensity Increase/Decrease 0.5 - 2 mA/sec above sensation threshold Habituation Compensation...
  • Page 39 Guidance Documents & Standards 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 ™...

  • Page 40: Appendix F: 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 stimulator for the symptomatic relief and management of chronic intractable pain. Contraindications •...
  • Page 41 • Keep this device out of the reach of children. • Use this device only with the leads, electrodes, and accessories recommended by the manufacturer. • Use this device only under the continued supervision of a licensed medical professional. SENSUS Pain Management User Manual ™...

  • Page 42: Appendix F: Prescribing Information

    • 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 ™...
  • Page 43 • Consult with the patient’s 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. SENSUS Pain Management User Manual ™...

  • Page 44: Appendix G: Symbols

    APPENDIX G: 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 SENSUS Pain Management User Manual ™...

  • Page 45: Appendix H: Electromagnetic Compatibility Declaration

    APPENDIX H: 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 – guidance RF emissions; Group 1 SENSUS uses RF energy only CISPR 11 for its internal function.
  • Page 48 62 Fourth Avenue Waltham, MA 02451 SENSUS version 1.6 (888) 786-7287 ©2014 NeuroMetrix, Inc. www.SENSUSRx.com All Rights Reserved. PN2203652 Rev. L...

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