Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Related Manuals for NeuroMetrix Sensus
Summary of Contents for NeuroMetrix Sensus
- Page 1 User Manual GET RELIEF GET ACTIVE GET SLEEP...
-
Page 3: Table Of Contents
TABLE OF CONTENTS Chapter 1: Pain Relief with SENSUS.......... 3 Introduction ................... 3 What You Should Have Received ..........4 Device Components ..............6 Chapter 2: Getting Started ............7 Chapter 3: Device Basics ............9 Checking Battery ................9 Charging Battery ................ - Page 4 APPENDIX D: Alternate Placement Sites ........ 33 APPENDIX E: Automatic Restart ..........34 APPENDIX F: Technical Specifications ........35 APPENDIX G: Prescribing Information ........38 APPENDIX H: Symbols .............. 42 APPENDIX I: Electromagnetic Compatibility Declaration ..43 SENSUS Pain Management User Manual ®...
-
Page 5: Chapter 1: Pain Relief With Sensus
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 ®... -
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 (not seen in image, port is on side of device) SENSUS Pain Management User Manual ®... -
Page 9: Chapter 2: Getting Started
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. charged recharge Step 2: Attach Electrode Snap in a new electrode. - Page 10 • Every few hours, make sure device fits securely around your leg • Run electrode under water if it stops adhering to skin • Change electrode every 2 weeks If you need assistance, call 1-888-786-7287. SENSUS Pain Management User Manual ®...
-
Page 11: Chapter 3: Device Basics
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 ®... - Page 12 If the indicator light flashes green, battery has enough charge. If the indicator light flashes red, reconnect the USB cable and continue charging. Do not use your device with the USB cable connected. SENSUS Pain Management User Manual ®...
-
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
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. SENSUS Pain Management User Manual ®... -
Page 15: Chapter 4: Configuration
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 ®... -
Page 16: Chapter 5: Pain Therapy
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 ®... -
Page 17: Starting Therapy Session
Intensity: Briefly press the button; each press decreases intensity. Intensity: Hold button down; intensity increases while button down. SENSUS Pain Management User Manual ®... -
Page 18: Ending Therapy Session
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 ®... -
Page 19: Chapter 6: Overnight Therapy
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. -
Page 20: Chapter 8: Skin Care
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... - Page 21 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.
- Page 22 • 3M Cavilon No Sting Barrier Film ™ • Smith & Nephew SKIN-PREP ® • Smith & Nephew No-Sting SKIN-PREP ® • Coloplast Prep Protective Skin Barrier ™ These products are available online. SENSUS Pain Management User Manual ®...
-
Page 23: Chapter 9: Maintenance, Safety, And Service
Use a damp cloth moistened 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. SENSUS Pain Management User Manual ®... -
Page 24: Device Storage
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 25 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...
-
Page 26: Appendix A: Indicator Light
Solid Green Configuration in progress Single Green Flash Adequate battery charge Single Red Flash Battery requires charging *Blink rate is once per second except when you are sleeping which will be once every 5 seconds. SENSUS Pain Management User Manual ®... -
Page 27: Appendix B: Troubleshooting
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 ®... - Page 28 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 ®...
- Page 29 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 ®...
-
Page 30: Appendix C: Frequently Asked Questions
You should feel a vibrating 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 one hour between sessions. - Page 31 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 32 No. The device is configured for one person and should not be shared. Will I 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.
- Page 33 Do I need to set up SENSUS differently for sleep use? What if I only want a single 60 minute therapy session? Turn automatic therapy restart off (Appendix E). What should I do before going to sleep? Make sure the device is securely and comfortably placed around your leg.
- Page 34 APPENDIX C: Frequently Asked Questions CONT. Does SENSUS treat obstructive sleep apnea? 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.
-
Page 35: Appendix D: Alternate Placement Sites
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: • At mid-calf as shown in Figure 17. -
Page 36: Appendix E: Automatic Restart
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 ®... -
Page 37: Appendix F: Technical Specifications
500Ω load Density Output Trips No Load Device not connected to patient Insufficient Charge Delivered charge below target Over Load Delivered charge above target Short Circuit Low impedance Electrode Peeling Electrode dislodging from skin SENSUS Pain Management User Manual ®... - Page 38 33 cm Connector Medical snap (male) Dimensions 0.2 cm x 5.3 cm x 28.3 cm (exterior) Power Source Permanent rechargeable battery Battery Type Rechargeable 3.7V Lithium-Ion battery Charging Source AC line adapter SENSUS Pain Management User Manual ®...
- Page 39 50 kPa to 106 kPa Relative Humidity Range 10% to 90% 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 G: Prescribing Information
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. - Page 41 • U se caution following recent surgical procedures when stimulation may disrupt the patient’s healing process. • U se caution if stimulation is applied over the menstruating or pregnant uterus. • U se caution if stimulation is applied over areas of skin that lack normal sensation. • K eep this device out of the reach of children. • U se this device only with the leads, electrodes, and accessories recommended by the manufacturer. SENSUS Pain Management User Manual ®...
-
Page 42: Adverse Reactions
• D o 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 • C onsult with the patient’s physician before using this device, because it may cause lethal rhythm disturbances to the heart in susceptible individuals. • A pply stimulation only to normal, intact, clean, healthy skin. • N o modification of this device is allowed. SENSUS Pain Management User Manual ®...
-
Page 44: Appendix H: Symbols
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 Abbreviation for model number SENSUS Pain Management User Manual ®... -
Page 45: Appendix I: Electromagnetic Compatibility Declaration
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 – guidance RF emissions; Group 1 SENSUS uses RF energy only CISPR 11 for its internal function. - Page 47 62 Fourth Avenue Waltham, MA 02451 SENSUS version 2.0 (888) 786-7287 ©2014 NeuroMetrix, Inc. www.SENSUSRx.com All Rights Reserved. PN2203652 Rev. M...