User Manual GET RELIEF GET ACTIVE GET SLEEP
TABLE OF CONTENTS Chapter 1: Overview..................................................................... 3 Introduction.................................................................................... 3 What You Should Have Received................................................... 4 Device Components....................................................................... 6 Chapter 2: Quick Start Instructions............................................ 7 Chapter 3: SENSUS Device Basics.................
TABLE OF CONTENTS CONT. Chapter 9: Maintenance, Safety, and Service.......................... 24 Maintenance................................................................................. 24 Cleaning....................................................................................... 24 Device Storage............................................................................. 24 Disposal........................................................................................ 24 Limited Warranty.........
Chapter 1: Overview Introduction The SENSUS™ Pain Management System 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, just below the knee. Your doctor may prescribe one or two SENSUS devices. If you have been prescribed two devices, they can be used at the same time (one on each leg). SENSUS provides pain relief by comfortably stimulating your sensory nerves, which d ecreases the perception of pain.
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 * Two are provided if your doctor p rescribed two devices. You may also have received 1 or more electrode packages (Figure 2). If any of the items a ppear damaged, contact your supplier.
Figure 1. Carrying Case A B C D E User Manual Get Relief Get Active Get Sleep Figure 2.
Device Components The device has the following components: 1 Push button 2 Indicator light 3 Adjustable Velcro® strap 4 Two electrode connector snaps 5 USB port 1 3 3 2 5 4 6 SENSUS™ Pain Management User Manual
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. Step 1: Check Battery Briefly press and release the button. Indicator Light Flash charged recharge Step 2: Attach Electrode Snap in a new electrode.
Step 5: 60 Minute Therapy Session Press and hold button for a few seconds, release the button when the indicator light starts blinking green. Stimulation should feel strong but comfortable. To decrease: Briefly press the button. Each press will decrease the intensity. To increase: Press and hold the button. The intensity will increase while the button is held down. To stop therapy, tap center compartment twice while keeping leg still.
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). Charging Battery A fully charged battery should provide Figure 3. 20-40 hours of use. To charge the battery: 1.
A blinking red light indicates that 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 a single therapy session. To confirm that it has enough charge, disconnect the USB cable from the device and briefly press and release the button. If the indicator light flashes green, there is enough charge. If the indicator light flashes red, reconnect the USB cable and continue charging.
Figure 6. 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). Two electrodes are included in each pouch. You should reseal the pouch if it contains an electrode. To attach an electrode, snap the e lectrode into the two connectors as shown in Figure 7. ONLY USE SENSUS E LECTRODES MANUFACTURED BY NEUROMETRIX, INC. Figure 7.
Figure 8. Figure 9. 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 3 days if a new electrode is not available). Device Placement Place the device on your upper calf about Figure 10. 1-2 inches below the knee (Figure 10). Be sure the electrode is only c overing healthy skin that is not irritated and does not have cuts or other wounds.
Figure 11. pads are only partially on the skin, then the stimulation may feel uncomfortable. 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: 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.
device is seated in a chair, lying in bed or on a sofa with your leg crossed over for easy access (Figure 12). You should not c onfigure within an hour of a therapy session. It is best to configure using a new electrode. If you have difficulty with configuration, call NeuroMetrix customer service at (888) 786-7287. Configuration Process STEP 1 Snap electrode to device. STEP 2 Remove electrode liner and place the device on your upper calf 1-2 inches below knee. The exact position is not critical.
To maximize pain relief, it is important that the stimulation feels strong. However, it should also feel c omfortable. The intensity that you will require is estimated based on your configuration. However, b ecause of differences among people, this estimated intensity may be too low, and it will feel weak or too high and may feel uncomfortable. In either case, you should adjust the intensity as described on page 16.
Please be patient because it is important for pain relief that the intensity feels strong but comfortable. However, if the intensity is uncomfortable or painful, you should decrease it as described in the next section. Once your therapy session has begun, you may cover the device with your c lothing. You should be careful not to dislodge the device and electrode when covering with clothing. It is best not to wear tight fitting clothing that makes it difficult for you to access the device.
Ending Therapy Session A therapy session automatically stops after 60 minutes. If the device is in continuous mode, a new therapy session will automatically start 60 minutes following the end of prior session (see page 18 for explanation of continuous mode). Figure 14. You can end a therapy session early by tapping the center compartment with your hand twice, while keeping your leg still, as shown in Figure 14.
Setting Continuous Mode A device in continuous mode will restart therapy an hour after your last session has completed. This may be convenient if you choose to wear it during sleep or if you need extended pain relief during the day. When you receive your device, continuous mode is off. You may toggle the continuous mode from off to on 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.
Chapter 6: Using SENSUS During Sleep Chronic pain often gets worse during the day, reaching its peak at night. 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.
Run the electrode under a gentle water stream for 10 seconds as shown in Figure 15. Let air dry for 1 minute before using. Electrode Removal Figure 16. You should be careful not to damage the electrode when you remove it from your upper calf area. To remove the electrode, first unsnap the device so that you have easy access to the electrode. 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).
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. There are some simple things you can do to prevent skin irritation and allow it to heal if it does occur.
Cleaning and Shaving the Skin When cleaning the skin, never use harsh soaps or alcohol as they strip away your natural protective barrier and can make the skin more susceptible to irritation. 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. In general, shaving is not required when using SENSUS.
More severe skin reactions such as hives, welts, or blisters are rare. If your skin itches, please resist the urge to scratch as this will increase irritation. Wait at least 1 day before placing device over the same area. Protect Your Skin and Let it Heal if Irritation Develops If you experience skin irritation or generally have sensitive skin, you may consider applying a skin protectant before placing the device and electrode on your leg. Skin protectants are available as wipes, swabs, or sprays.
Chapter 9: Maintenance, Safety, and Service Maintenance Contact your supplier if the device requires service. Cleaning Use a damp cloth moistened with mild soap and water to clean the exterior of the device. Do not use any other cleaning solutions since they may damage the case. Never immerse the device in water or other liquids. Device Storage When device is not in use, place it in the carrying case and store it in a dry location. Disposal Used electrodes should be disposed in normal trash receptacles.
This warranty does not cover damage due to external causes, including accident, abuse, misuse, p roblems 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.
ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT REGARDLESS OF THE LEGAL T HEORY UPON WHICH SUCH CLAIM IS BASED AND EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY THEREOF.
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 27
APPENDIX B: Troubleshooting Configuration: I 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. I t may take 20-30 seconds to first feel the tingling stimulation sensation.
When I start a therapy session the light immediately blinks red. Generally, a flashing red light indicates that the contact between the electrode and the skin is inadequate. This may occur because the device is not securely placed on the leg or because the electrode is dry or damaged. Wait a few minutes and then restart the therapy session. If this happens again then wait 15 minutes and restart the therapy session. If the problem recurs, then remove the device and inspect the electrode.
APPENDIX B: Troubleshooting CONT. What should I do if stimulation stings or feels uncomfortable? Turn off the device. Remove the device and inspect the electrode. If the gel is dry, then hydrate the electrode as described in Chapter 7. 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 despite taking these steps then the electrode should be changed. I am not getting pain relief.
Skin Care: My skin is irritated (redness or rash) or itchy after I remove the device. Skin irritation may occur. The skin should be ventilated after wearing for several 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 NeuroMetrix customer service at (888) 786-7287.
APPENDIX C: Frequently Asked Questions What should the stimulation feel like? 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 b etween sessions. When do I need to configure my device? You must configure the device before first use.
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 SENSUS while sleeping? You may use it to help you fall asleep and to keep pain under control while sleeping. You may want to set the device for continuous mode in order to obtain overnight pain relief (see page 18). Can I use my device while showering or bathing? No. Are there side effects? No.
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: • At mid-calf as shown in Figure 17. • 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. 34 SENSUS™ Pain Management User Manual Figure 18.
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 (±10%) 100 V Maximum Output Current (<1KΩ load) (±10%) 100 mA Pulse Duration (±4%) 200 - 400 µsec Pulse Frequency (±4%) 60-100 Hz, randomly varying Pulse Pattern Continuous Maximum Phase Charge 20 µC Maximum Current Density 0.
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.
Power continued Patient Leakage Current, DC < 10 µA Patient Leakage Current, Enclosure < 100 µA Physical Dimensions 176 mm x 63 mm x 18 mm Weight 82 g Environmental Operating Temperature Range 10° C to 40° C Atmospheric Pressure Range 50 kPa to 106 kPa Relative Humidity Range 30% to 75% Transport and Storage Temperature Range -40° C to 50° C Atmospheric Pressure Range 50 kPa to 106 kPa Relative Humidity Range 10% to 90% Guidance Documents & Standards FDA Draft Guidance for Industry and
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.
• 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. • Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or e lectrical conductive medium (gel).
APPENDIX F: Prescribing Information CONT. • 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 s uppliers meet the IEC 60950 standard. If in doubt, consult with your local information technology support. Adverse Reactions • Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin e ruptions (e.g., phlebitis, thrombophlebitis, varicose veins). • Do not apply stimulation over, or in proximity to, cancerous lesions. • 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. • Do not apply stimulation when in the bath or shower.
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 MN 42 Abbreviation for model number SENSUS™ Pain Management User Manual
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 – guidance Emissions test Compliance RF emissions; CISPR 11 Group 1 ENSUS uses RF energy only S for its internal function. Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
62 Fourth Avenue Waltham, MA 02451 (888) 786-7287 www.SENSUSRx.com SENSUS version 1.6 ©2014 NeuroMetrix, Inc. All Rights Reserved. PN2203652 Rev.
