Bioness
NESS H 200 User Guide Rev B
User Guide
130 Pages
Preview
Page 1
User’s Guide
Manufactured by Bioness Neuromodulation Ltd. A Bioness Inc Company 19 Ha’Haroshet Street PO Box 2500 Industrial Zone Ra’Anana 43654, Israel Worldwide Corporate Office Bioness Inc 25103 Rye Canyon Loop Valencia, CA 91355 USA Telephone: 800.211.9136 Email: [email protected] Website: www.bioness.com
NESS®, NESS H200®, NESS H200® Wireless, Bioness, the Bioness Logo®, and LiveOn® are trademarks of Bioness Inc. | www.bioness.com
Rx Only ©2011 Bioness Inc. 602-00504-001 Rev. B
User’s Guide
Rx Only
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User’s Guide Copyright © 2011, Bioness Inc All Rights Reserved No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or any computer language, in any form or by any third party, without the prior written permission of Bioness Inc. Trademarks NESS®, NESS H200®, NESS H200® Wireless, Bioness, the Bioness Logo® and LiveOn® are trademarks of Bioness Inc. | www.bioness.com | Rx Only Patents Pending Aspects of this device are covered by several patents and patent applications. Disclaimer Bioness Inc and its affiliates shall not be liable for any injury or damage suffered by any person, either directly or indirectly, as a result of the unauthorized use or repair of Bioness Inc products. Bioness Inc does not accept any responsibility for any damage caused to its products, either directly or indirectly, as a result of use and/or repair by unauthorized personnel. Environmental Policy Service personnel are advised that when changing any part of the NESS H200 Wireless System, care should be taken to dispose of those parts in the correct manner; where applicable, parts should be recycled. For more detailed information regarding these recommended procedures, please contact Bioness Inc. Bioness Inc is committed to continuously seeking and implementing the best possible manufacturing procedures and servicing routines.
Bioness Client Relations Department: Telephone: (800) 211-9136, Option 3; or (661) 362-4850, Option 3.
Manufactured by Bioness Neuromodulation Ltd. A Bioness Inc Company 19 Ha’Haroshet Street PO Box 2500 Industrial Zone Ra’Anana 43654, Israel
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User's Guide
Worldwide Corporate Office Bioness Inc 25103 Rye Canyon Loop Valencia, CA 91355 USA Telephone: 800-211-9136 Email: [email protected] Website: www.bioness.com
List of Symbols Caution or Warning Double Insulated (Equivalent to Class II of IEC 536) Type BF Applied Part(s) Non-Ionizing Radiation Date of Manufacture Manufacturer This Product Must Not Be Disposed of with Other Household Waste Consult Instructions for Use Re-Order Number Lot Number Serial Number
Complies with United States and Canadian Product Safety Standards
Single Patient Use
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User's Guide
Contents List of Symbols... III
Chapter 1: Introduction... 1 Chapter 2: Device Description and Safety Information... 3 Device Description... Indications for Use... Contraindications... Warnings... Adverse Reactions... Precautions...
3 4 5 5 6 7
Chapter 3: Environmental Conditions that Affect Use... 11 Radio Frequency (RF) Communication... 11 Travel and Airport Security... 13 Electromagnetic Compatibility... 14 Warnings and Cautions... 14
Chapter 4: H200 Wireless System Kit... 17 Contents... 17 H200 Wireless Orthosis... 19 H200 Wireless Control Unit... 19 System Charger Set... 19 Orthosis Wrist Strap... 19 Control Unit Neck Strap, Wrist Strap, and Belt Pouch... 19 H200 Wireless Cloth Electrodes... 19 Cloth Electrode Mesh Bag... 20
Chapter 5: H200 Wireless Orthosis... 21 Orthosis Flexor Support... 23 Orthosis Extensor Wing... 25
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Wing Release Handle... 26 Wing Arm... 27 Fitting Panels . ... 28 Spiral End of the Orthosis... 30 Thenar... 31 Wrist Bridge... 32 Trigger Button... 33 Wrist Strap Attachment Ring... 34 Wrist Strap Attachment Bar... 35 Status Light ... 36 Stimulation Light ... 36 Audio Alerts... 38 Rechargeable Battery and Charging Port... 39
Chapter 6: H200 Wireless Control Unit... 41 Operating Buttons... 42 Indicators and Digital Display... 44 Audio Alerts... 47 Charging Port... 48
Chapter 7: H200 Wireless Stimulation Programs... 49 Chapter 8: Setup Instructions... 51 Charging the NESS H200 Wireless System... 51 Checking the System Components... 56 Preparing Your Skin... 57 Wetting/Attaching the Cloth Electrodes... 58 Putting on the Orthosis... 63
Chapter 9: Operating the NESS H200 Wireless System... 69 RF Communication Features... 69 Turning On the System... 69
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Turning Off the System... 69 Testing Stimulation in the Orthosis... 70 Selecting a Stimulation Program... 71 Changing Stimulation Programs... 72 Turning On Stimulation... 72 Pausing/Resuming Stimulation... 73 Using a Neuroprosthesis Program... 74 Open Hand... 74 Grasp and Release... 75 Key Grip... 76 Stopping Stimulation... 77 Adjusting Stimulation Intensity... 77 Muting/Un-Muting the System Audio Alerts... 78
Chapter 10: Removing the Orthosis... 79 Chapter 11: Maintenance and Cleaning... 83 Daily Maintenance and Storage... 83 Charging... 83 Battery Replacement: H200 Wireless Control Unit... 84 Battery Replacement: H200 Wireless Orthosis... 85 Cleaning... 86 General Instructions... 86 Control Unit Neck Strap and Wrist Strap... 86 Orthosis Wrist Strap... 86 Orthosis Electrode Bases... 86 Disinfecting... 87 Electronic Components... 87 Wrist Insert... 88
VII
System Kit Carrying Case... 89
Chapter 12: Electronic Registration of Replacement Parts... 91 Registration Setup... 92 Registration... 94
Chapter 13: Troubleshooting... 97 RF Communication Failure... 97 Frequently Asked Questions... 98 Quick Reference Troubleshooting... 103
Chapter 14: Technical Specifications... 107 Chapter 15: Appendix - EMI Tables... 113
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Chapter
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Introduction Stroke and other disorders of the central nervous system (CNS) may cause long-term disability. For many people, long-term disability may impair muscle control, increase muscle spasm, reduce muscle strength, and reduce functional abilities. When the upper limb is involved, complications may include contractures (tightening of muscle), edema (swelling), pain syndromes of the hand and shoulder, and limb-neglect. The NESS H200 Wireless System is designed to treat the complications associated with upper limb impairment caused by stroke and other disorders of the central nervous system. The NESS H200 Wireless System delivers electrical stimulation to the nerves of the muscles that control the hand. The NESS H200 Wireless System may help to improve hand function and assist with tasks of daily living. This NESS H200 Wireless User's Guide describes: •• •• •• ••
Important safety information about the NESS H200 Wireless System. The components of the NESS H200 Wireless System. How to set up, operate, and maintain the NESS H200 Wireless System. Troubleshooting information.
Be sure to review this guide with your clinician before using your H200 Wireless System. If you have questions, consult your clinician or the Bioness Client Relations Department at (800) 211-9136, Option 3, or visit the Bioness website: www.bioness.com. CAUTION: Do not put on or operate the NESS H200 Wireless System before being properly fitted by a trained clinician. Chapter 1 - Introduction
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Chapter
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Device Description and Safety Information Device Description The NESS H200 Wireless System consists of an Orthosis and a wireless handheld Control Unit. See Figure 2-1.
H200 Wireless Control Unit
H200 Wireless Orthosis
Figure 2-1: H200 Wireless Orthosis and Control Unit.
H200 Wireless Orthosis-delivers electrical stimulation to the nerves of the muscles that control hand opening and closing and movement of the thumb. The Orthosis also stabilizes the wrist.
Chapter 2 - Device Description and Safety Information
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H200 Wireless Control Unit-is lightweight and easy to operate. The handheld Control Unit communicates wirelessly with the H200 Wireless Orthosis to: ••
Select a stimulation program.
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Adjust stimulation intensity.
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Start, stop, and pause a stimulation program.
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Communicate Control Unit battery status, RF communication errors, and Control Unit hardware/software malfunctions.
Indications for Use The NESS H200 Wireless System is an electrical stimulation device indicated for the following uses: ••
Functional Electrical Stimulation (FES). •• Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.
••
NeuroMuscular Electrical Stimulation (NMES). •• Maintenance and/or increase of hand range of motion. •• Prevention and/or retardation of disuse atrophy. •• Increase in local blood circulation. •• Reduction of muscle spasm. •• Re-education of muscles.
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Contraindications ••
Do not use the NESS H200 Wireless System where a cancerous lesion is present or suspected.
••
Do not use the NESS H200 Wireless System if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Use of the NESS H200 Wireless System in conjunction with any of the above may cause electric shock, burns, electrical interference, or death.
••
Do not use the NESS H200 Wireless System on an arm where a regional disorder, such as a fracture or dislocation, would be adversely affected by motion from the stimulation.
Warnings ••
The H200 Wireless Orthosis is to be worn only on the affected forearm and hand of the patient for whom it is fitted. It should not be worn by anyone else or on any other part of the body.
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Do not wear the H200 Wireless Orthosis over swollen, infected, or inflamed areas. Do not wear the Orthosis over skin eruptions or varicose veins.
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Apply stimulation to normal, intact, clean, healthy skin only.
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Turn off the NESS H200 Wireless System before driving or operating machinery.
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Turn off stimulation before performing any activity in which involuntary muscle contractions may injure you.
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Do not use the NESS H200 Wireless System while sleeping.
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Only an authorized clinician should fit and program the NESS H200 Wireless System. Chapter 2 - Device Description and Safety Information
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Do not attempt to repair or modify the NESS H200 Wireless System.
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If the H200 Wireless Orthosis overheats, turn off stimulation and remove the Orthosis.
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If stimulation cannot be turned off using the H200 Wireless Control Unit or the trigger button on the H200 Wireless Orthosis, remove the Orthosis to stop stimulation.
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Electrical and wireless medical equipment need special precautions for electromagnetic compatibility and immunity. See Chapter 3 and the Appendix for more information.
Adverse Reactions ••
In the unlikely event that any of the following occurs, stop using your H200 Wireless System immediately and talk to your doctor or clinician. •• Signs of significant irritation or pressure sores where the H200 Wireless Orthosis contacts the skin. •• A significant increase in muscle spasticity. •• A feeling of heart-related stress during stimulation. •• Swelling of the hand, wrist, or forearm. •• Any other unanticipated reaction.
••
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Skin irritations and burns beneath the stimulating electrodes have been reported with the use of powered muscle stimulators.
User's Guide
Precautions ••
The long-term effects of chronic electrical stimulation are unknown.
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Use caution if you have suspected or diagnosed heart problems. Talk to your doctor before using the NESS H200 Wireless System. The NESS H200 Wireless System may cause lethal rhythm disturbances to the heart in susceptible individuals.
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Talk to your doctor if you have a spinal cord injury at the T6 level or above. Any harmful stimulation can trigger autonomic dysreflexia in patients with spinal cord injury at the T6 level and above. Symptoms of autonomic dysreflexia include acute hypertension and slow heart rate.
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Use caution if you have suspected or diagnosed epilepsy.
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Talk to your doctor before using the NESS H200 Wireless System if you have any one of the following medical conditions in the affected arm: •• Local insufficiency (insufficient blood flow). •• Occlusion (a blood flow blockage). •• Ateriovenous fistula for the purpose of hemodialysis (an abnormal connection between an artery and vein for the purpose of hemodialysis treatment). •• Primary disorder of the vasculature (a disease of the arteries, veins, and lymphatics). •• A bone deformity in the area to be stimulated.
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The safety of using the NESS H200 Wireless System during pregnancy has not been established.
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Keep the NESS H200 Wireless System out of the reach of children.
Chapter 2 - Device Description and Safety Information
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••
Use the H200 Wireless Orthosis with caution: •• If you have a tendency to bleed heavily following acute trauma or fracture. •• Following recent surgical procedures when muscle contraction may disrupt the healing process. •• Over areas of the skin that lack normal sensation.
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Motion, muscle activity, and pressure from the H200 Wireless Orthosis may aggravate any inflammation near the H200 Wireless Orthosis. Stop using the NESS H200 Wireless System until any inflammation is gone.
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Always check the skin for redness or a rash when putting on and taking off the H200 Wireless Orthosis.
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After removing the H200 Wireless Orthosis, it is normal for the areas under the cloth electrodes to be red and indented. The redness should disappear in approximately one hour. Persistent redness, lesions, or blisters are signs of irritation. Stop using the NESS H200 Wireless System until any irritation is completely gone.
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Turn off the NESS H200 Wireless System before putting on or taking off the Orthosis. Do not turn on the NESS H200 Wireless System until the Orthosis is on the arm and the wing is closed.
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Turn off the NESS H200 Wireless System when at a refueling place. Do not use the NESS H200 Wireless System near flammable fuel, fumes, or chemicals.
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Turn off the NESS H200 Wireless System before removing or replacing the cloth electrodes.
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Remove the H200 Wireless Orthosis before wetting the cloth electrodes.
User's Guide
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The H200 Wireless Control Unit and Orthosis are splash proof. Nevertheless, protect all electronic components from contact with water, such as from sinks, bathtubs, shower stalls, rain, and snow.
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Excess body hair where the H200 Wireless cloth electrodes touch may reduce electrode contact with the skin. If necessary, remove excess body hair with an electric shaver or scissors. Do not use a razor. A razor can irritate the skin.
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Use only H200 Wireless cloth electrodes supplied by Bioness Inc.
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Do not use the NESS H200 Wireless System without the cloth electrodes.
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Be sure the H200 Wireless cloth electrodes are wet and securely attached to the electrode bases before use.
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Wet the H200 Wireless cloth electrodes before use and after every three to four hours of use.
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Replace the H200 Wireless cloth electrodes at least every two weeks, even if they appear to be in good condition.
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Always store the H200 Wireless cloth electrodes where they can air dry.
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When putting on the H200 Wireless Orthosis, make sure the cloth electrodes uniformly contact the skin.
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Ventilate the skin by removing the H200 Wireless Orthosis for at least 15 minutes every 3 to 4 hours.
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Store the H200 Wireless Orthosis where it can air dry.
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Do not store the NESS H200 Wireless System where temperatures may exceed the recommended storage temperature range: -25°C (-13°F) to +70°C (+158°F). Temperature extremes can damage the components.
Chapter 2 - Device Description and Safety Information
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If skin irritation or a skin reaction occurs, stop using your H200 Wireless System immediately. Contact your clinician or dermatologist, and the Bioness Client Relations Department: (800) 211-9136, Option 3. Resume use only when the skin is completely healed. Then follow a skin conditioning protocol per the recommendation of your health-care specialist.
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User's Guide