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: info@bioness.com 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.
User’s Guide Rx Only I
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.
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 III
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Contents List of Symbols .................................................................................................. III Chapter 1: Introduction ......................................................................... 1 Chapter 2: Device Description and Safety Information ..................... 3 Device Description............................................................................................. Indications for Use ..........................................................................
Wing Release Handle .................................................................................. Wing Arm ..................................................................................................... Fitting Panels .................................................................................................... Spiral End of the Orthosis.................................................................................. Thenar ..................................................................
Turning Off the System ...................................................................................... Testing Stimulation in the Orthosis .................................................................... Selecting a Stimulation Program ....................................................................... Changing Stimulation Programs ........................................................................ Turning On Stimulation ...................................................................
System Kit Carrying Case ........................................................................... 89 Chapter 12: Electronic Registration of Replacement Parts............... 91 Registration Setup ............................................................................................. 92 Registration ....................................................................................................... 94 Chapter 13: Troubleshooting................................................................
Chapter 1 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.
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Chapter 2 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.
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. • Adjust stimulation intensity. • Start, stop, and pause a stimulation program. • Communicate Control Unit battery status, RF communication errors, and Control Unit hardware/software malfunctions.
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 attempt to repair or modify the NESS H200 Wireless System. • If the H200 Wireless Orthosis overheats, turn off stimulation and remove the Orthosis. • 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. • Electrical and wireless medical equipment need special precautions for electromagnetic compatibility and immunity. See Chapter 3 and the Appendix for more information.
Precautions • The long-term effects of chronic electrical stimulation are unknown. • 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. • Talk to your doctor if you have a spinal cord injury at the T6 level or above.
• 8 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. • 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.
• 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. • 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. • Use only H200 Wireless cloth electrodes supplied by Bioness Inc.
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.
Chapter 3 Environmental Conditions that Affect Use Radio Frequency (RF) Communication Several components of the NESS H200 Wireless System communicate via radio communication. They have been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 (RF Devices) of the FCC (Federal Communications Commission) rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Portable and mobile RF communications equipment can affect the NESS H200 Wireless System. Conformity Certification The NESS H200 Wireless System complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference. 2. This device must accept any interference received, including interference that may cause undesired operation. This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment.
Travel and Airport Security The NESS H200 Wireless System charger is compatible with Australian, U.K., European Union, and U.S. voltages: 110/220 V, 50/60 Hz. Turn off your NESS H200 Wireless System before going through airport security. Wear loose clothing so that you can easily show the security person your H200 Wireless System. The NESS H200 Wireless System will likely set off the security alarm.
Electromagnetic Compatibility The NESS H200 Wireless System is medical electrical equipment and was tested for electromagnetic compatibility (EMC) in accordance with International Electrotechnical Committee (IEC) 60601-1-2. The tables in the Appendix provide information regarding the EMC testing and guidance for safe use of the system. The NESS H200 Wireless System should be configured and used in accordance with the instructions provided in this guide.
• 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. • Remove the NESS H200 Wireless System before undergoing any diagnostic or therapeutic medical procedure such as x-ray examination, ultrasound, Magnetic Resonance Imaging (MRI), etc.
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Chapter 4 H200 Wireless System Kit Contents • H200 Wireless Orthosis • H200 Wireless Control Unit • System Charger Set • Control Unit Neck Strap • Control Unit Wrist Strap • Control Unit Belt Pouch • Orthosis Wrist Strap • H200 Wireless Cloth Electrodes • Cloth Electrode Mesh Bag • H200 Wireless FPL Panel • Large Thenar • Wrist Inserts • H200 Wireless User's Guide • User's Reference Card H200 Wireless Control Unit System Charger Set H200 Wireless Orthosis Chapter 4 - H200 Wi
5HJXODU H200 Wireless Cloth Electrodes 18 /DUJH Control Unit Neck Strap Control Unit Wrist Strap Control Unit Belt Pouch /DUJH 7KHQDU :ULVW ,QVHUW Orthosis Wrist Strap + :LUHOHVV )3/ 3DQHO Cloth Electrode Mesh Bag User's Guide
H200 Wireless Orthosis The Orthosis is available in right and left configurations, and in three sizes: small, medium, and large. H200 Wireless Control Unit The Control Unit communicates wirelessly with the Orthosis to control the Orthosis and monitor system status. System Charger Set The system charger set is for charging the Control Unit and Orthosis. Orthosis Wrist Strap The wrist strap helps to position and stabilize the Orthosis on the arm.
Cloth Electrode Mesh Bag The cloth electrode mesh bag is for storing the H200 Wireless cloth electrodes. The mesh bag allows the cloth electrodes to air dry. CAUTION: Do not use the NESS H200 Wireless System without the cloth electrodes. CAUTION: The H200 Wireless cloth electrodes must be replaced every two weeks or sooner if they become damaged. CAUTION: The H200 Wireless cloth electrodes are for single patient use.
Chapter 5 H200 Wireless Orthosis The Orthosis generates the electrical stimulation used to open and close your hand and move your thumb. The Orthosis has an integrated radio frequency stimulation unit and five stimulating electrodes that have been predetermined by your clinician and configured with fitting panels. See Figure 5-1. The Orthosis responds to wireless signals from the Control Unit to turn stimulation on and off, and to adjust the stimulation intensity level.
The H200 Wireless Orthosis features: See Figure 5-2. • A flexor support. • An extensor wing. • A spiral end. • A status light. • A stimulation light. • Audio alerts. • A rechargeable battery and charging port. 6WLPXODWLRQ /LJKW ([WHQVRU :LQJ 6WDWXV /LJKW &KDUJLQJ 3RUW 7KHQDU )OH[RU 6XSSRUW Figure 5-2: Orthosis features.
Orthosis Flexor Support The flexor support is designed to support your forearm while delivering electrical stimulation to the nerves of the muscles that flex your hand. The flexor support includes two electrode bases: #4 and #5. See Figure 5-3. (OHFWURGH %DVH (OHFWURGH %DVH )OH[RU 6XSSRUW Figure 5-3: Orthosis flexor support.
If you have a small wrist, your clinician may have fit an FPL panel to the Orthosis flexor support. The FPL panel fills excess space in the region of the #5 electrode base. See Figure 5-4. )3/ 3DQHO (OHFWURGH %DVH Figure 5-4: Orthosis flexor support with an FPL panel.
Orthosis Extensor Wing The extensor wing delivers electrical stimulation to the nerves of the muscles that extend your hand. The extensor wing features: • Two electrode bases: #1 and #2. See Figure 5-5. • A wing release handle. • A wing arm. ([WHQVRU :LQJ :LQJ $UP (OHFWURGH %DVH :LQJ 5HOHDVH +DQGOH (OHFWURGH %DVH Figure 5-5: Orthosis extensor wing.
Wing Release Handle The wing release handle is used to open the extensor wing. See Figure 5-6. When the wing release handle and wing arm are squeezed together, the extensor wing lifts open. ([WHQVRU :LQJ :LQJ $UP :LQJ 5HOHDVH +DQGOH Figure 5-6: Orthosis wing release handle.
Wing Arm The wing arm is used to close the extensor wing. See Figure 5-7. When the wing arm is pushed down, the extensor wing clicks. The extensor wing is sufficiently closed when no more clicking can be heard. ([WHQVRU :LQJ :LQJ $UP Figure 5-7: Orthosis wing arm.
Fitting Panels If your fitting panels detach from your orthosis, please follow the directions below on how to reattach the fitting panels. Extensor Fitting Panel 1. With the Orthosis wing open, align the extensor fitting panel to the extensor wing. See Figure 5-8. 2. Make sure the lip of the fitting panel rests outside the wing. 3. Grasp the extensor fitting panel and the extensor wing and gently press on the fitting panel until it clicks into place.
Flexor Fitting Panel 1. With the Orthosis wing open, align the flexor fitting panel to the flexor support. See Figure 5-9. 2. Make sure the lip of the fitting panel rests outside the edge of the flexor support. 3. Grasp the edge of the flexor fitting panel and the edge of the flexor support and gently press together until the fitting panel clicks into place. ([WHQVRU :LQJ )LWWLQJ 3DQHO )OH[RU 6XSSRUW Figure 5-9: Reattaching the flexor fitting panel.
Spiral End of the Orthosis The spiral end of the Orthosis supports the hand. It also delivers stimulation to the nerves of the muscles that move the thumb. The spiral end features: See Figure 5-10. • A thenar. • A wrist bridge. • A trigger button. • An Orthosis wrist strap attachment ring. • An Orthosis wrist strap attachment bar. :ULVW 6WUDS $WWDFKPHQW %DU 7ULJJHU %XWWRQ :ULVW 6WUDS $WWDFKPHQW 5LQJ :ULVW %ULGJH 7KHQDU Figure 5-10: Spiral end of the Orthosis.
Thenar The thenar is for controlling thumb movement and is available in regular and large sizes. It has a snap where the thenar cloth electrode is placed. When the Orthosis is positioned correctly, the thenar cloth electrode should rest at the base of your thumb. See Figure 5-11. 6QDS IRU 7KHQDU &ORWK (OHFWURGH Figure 5-11: The thenar (inset) and placement of the thenar. CAUTION: Do not operate the NESS H200 Wireless System without a thenar cloth electrode in place.
Wrist Bridge The wrist bridge wraps around the back of your wrist. See Figure 5-12. The wrist bridge: • Stabilizes the Orthosis on your hand. • Supports your wrist in an extended position. • Helps to keep your wrist extended during finger opening and closing. The wrist bridge has a cushioned wrist insert on the underside to keep the H200 Wireless Orthosis positioned against your wrist. :ULVW %ULGJH Figure 5-12: The H200 Wireless Orthosis wrist bridge.
Trigger Button The trigger button is used to turn on/pause stimulation. See Figure 5-13. The trigger button works like the trigger button on the Control Unit. Note: If the trigger button on your Orthosis is disabled, consult your clinician. 7ULJJHU %XWWRQ Figure 5-13: The H200 Wireless Orthosis trigger button.
Wrist Strap Attachment Ring The wrist strap attachment ring is for hooking the Orthosis wrist strap to the Orthosis. See Figure 5-14. :ULVW 6WUDS $WWDFKPHQW 5LQJ 2UWKRVLV :ULVW 6WUDS +RRN Figure 5-14: Hooking the Orthosis wrist strap to the attachment ring.
Wrist Strap Attachment Bar The wrist strap attachment bar is for securing the Orthosis wrist strap around the wrist. See Figure 5-15. :ULVW 6WUDS $WWDFKPHQW %DU 2UWKRVLV :ULVW 6WUDS Figure 5-15: Securing the Orthosis wrist strap.
Status Light The status light Table 5-1. communicates system status and error messages. See Stimulation Light The stimulation light paused. See Table 5-1. communicates whether stimulation is on, off, or Note: The illustrations in Table 5-1 are for a left H200 Wireless Orthosis.
Left Orthosis Status Light Stimulation Light Display Description Definition FLASHES GREEN System On FLASHES YELLOW Low Battery ALTERNATELY FLASHES YELLOW and GREEN Battery Charging SOLID GREEN Battery Fully Charged; Registration Successful FLASHES RED Faulty Electrode Contact SOLID RED Hardware/Software Error; Charging Error SOLID YELLOW Stimulation Paused FLASHES YELLOW RAPIDLY Stimulation On Table 5-1: H200 Wireless Orthosis displays.
Audio Alerts The Orthosis will beep when: 38 • The NESS H200 Wireless System is turned on/off. • The Orthosis stimulation unit malfunctions. • Stimulation is turned on/off or paused. • There is a faulty electrode contact. • The battery charge level is low. • A charging error occurs. • A charger is connected.
Rechargeable Battery and Charging Port The Orthosis has a rechargeable battery. The charging port is located at the back of the Orthosis. See Figure 5-16. &KDUJLQJ 3RUW Figure 5-16: H200 Wireless Orthosis charging port.
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Chapter 6 H200 Wireless Control Unit The Control Unit is used to: • Turn on/off the NESS H200 Wireless System. • Test stimulation in the Orthosis. • Select a stimulation program. • Turn on/off and pause stimulation. • Adjust the stimulation intensity level. • Monitor system status. • Mute system audio alerts. The Control Unit is powered by a single rechargeable NiMH AAA battery. CAUTION: Use only a battery supplied by Bioness Inc.
Operating Buttons The Control Unit has eight operating buttons. See Table 6-1, Figure 6-1, and Table 6-2.
On/Off Button Mute Button Trigger Button Program 1 Button Program 2 Button Intensity Adjustment Buttons Stimulation Test Button Figure 6-1: Operating buttons. Visual Display Description Definition On/Off Button FLASHES GREEN System On Trigger Button FLASHES YELLOW RAPIDLY Stimulation On Trigger Button is SOLID YELLOW Stimulation Paused Table 6-2: Operating buttons: visual displays.
Indicators and Digital Display The Control Unit front panel features: • A Control Unit status indicator: • An RF communication indicator: • Program 1 and Program 2 selection indicators: • A digital display. See Figure 6-2. Control Unit Status Indicator RF Communication Indicator Program 1 Indicator Program 2 Indicator Digital Display Figure 6-2: H200 Wireless Control Unit digital display and indicators.
The Control Unit indicators show: • Control Unit status. • Stimulation program selected. • Control Unit low battery. • RF communication status. See Table 6-3.
The Control Unit digital display shows: • Stimulation intensity level: 0–9. • Electronic registration status. • Battery charging status. See Table 6-4.
Audio Alerts The H200 Wireless Control Unit beeps to indicate: • Electronic registration was initiated, successful, or unsuccessful. • The NESS H200 Wireless System was turned on/off. • A program has ended and stimulation has stopped. • An Control Unit hardware/software error occurred. • The Control Unit battery charge level is low. • The audio alerts were muted/un-muted. • A charger was connected. • RF communication failed. • A button was pressed.
Charging Port The Control Unit charging port is located at the bottom of the Control Unit, under the flexible cover. See Figure 6-3. Note: Next to the charging port is the signal input/output port for the clinician's programmer. Signal Input/ Output Port Charging Port Figure 6-3: Control Unit charging port. CAUTION: The signal input/output port on the Control Unit is only to be used by the clinician during setup.
Chapter 7 H200 Wireless Stimulation Programs The NESS H200 Wireless System supports Functional Training, Neuroprosthesis, and Motor Neuromodulation programs designed to open and close the hand. Functional Training programs are designed to exercise your hand. They consist of repetitive opening and/or closing motions with a relaxation pause between each motion. Neuroprosthesis programs are designed to assist with the performance of a specific functional task, such as opening a door or holding a cup.
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Chapter 8 Setup Instructions Charging the NESS H200 Wireless System It is important to charge your H200 Wireless System daily and for at least four hours before a fitting/programming session. Bioness recommends charging the Control Unit and the Orthosis at the same time. To charge the NESS H200 Wireless System: 1. Select the interchangeable blade that matches your power outlet. Four blades are provided for use in the US, the European Union, Australia, and the United Kingdom. See Figure 8-1.
2. Slide the selected blade into the system charger. See Figure 8-2. Blade System Charger Figure 8-2: Sliding the blade into the system charger. CAUTION: Use only the charger included in your H200 Wireless System Kit. Use of any other charger could damage the system.
3. Connect the Y cable to the charging ports of the Orthosis and Control Unit. The Control Unit charging port is under the flexible cover. See Figure 8-3. Charging Port Flexible Cover Y Cable Charging Port Interchangeable Blade System Charger Figure 8-3: Charging setup. CAUTION: Make sure your hands are dry before connecting the system charger to a power outlet.
4. Plug the system charger into a power outlet. 5. If the Control Unit is charging, a rotating GREEN circle will appear in the Control Unit digital display. See Table 8-1. Control Unit Display Description Definition Rotating GREEN Circle in Digital Display Battery Charging Horizontal GREEN Line in Digital Display Battery Fully Charged Status Light is SOLID RED Charging Error Table 8-1: H200 Wireless Control Unit charging displays.
6. If the Orthosis is charging, the status light on the Orthosis will ALTERNATELY FLASH YELLOW and GREEN. See Table 8-2. Orthosis Display Description Definition Status Light ALTERNATELY FLASHES YELLOW and GREEN Battery Charging Status Light is SOLID GREEN Battery Fully Charged Table 8-2: H200 Wireless Orthosis charging displays: left Orthosis. The charging process is complete when: • A horizontal GREEN line display.
Checking the System Components Before using your H200 Wireless System: • Visually inspect the Orthosis and Control Unit for signs of damage. • The cloth electrodes must be replaced every two weeks. If the cloth electrodes are old or damaged discard them. Open a new set of cloth electrodes. • Open the Orthosis and check the electrode bases to see if they are clean. If necessary, clean the electrode bases. See the Maintenance and Cleaning chapter of this guide.
Preparing Your Skin Before putting on your Orthosis, always check your skin for signs of irritation. If any irritation is present, do not put on the Orthosis and contact your clinician. Wait for complete healing before using the NESS H200 Wireless System. For optimal stimulation, the skin under the Orthosis should be clean and healthy. To prepare the skin: 1. Remove any jewelry from your hand, wrist, and forearm. 2. Clean the skin where the cloth electrodes will touch with a wet washcloth.
Wetting/Attaching the Cloth Electrodes 1. Make sure the H200 Wireless System is turned off. 2. Place the Control Unit where it cannot be splashed. 3. Wet the cloth electrodes until they are saturated. See Figure 8-4. Figure 8-4: Wetting the cloth electrodes. CAUTION: Before wetting the cloth electrodes, always remove them from the Orthosis.
4. Blot excess water from the cloth electrodes. See Figure 8-5. Figure 8-5: Blotting the cloth electrodes. Note: Remove and rewet the cloth electrodes every time you remove the Orthosis from your arm for more than one hour, and after every three to four hours of use. If the cloth electrodes dry out, your response to the stimulation may change. If you need to adjust stimulation intensity more often than usual, try rewetting the cloth electrodes. CAUTION: Use only cloth electrodes supplied by Bioness Inc.
5. Match each cloth electrode to its corresponding electrode base. See Figure 8-6. (OHFWURGHV %DVH (OHFWURGH %DVH (OHFWURGH %DVH 7KHQDU (OHFWURGH %DVH (OHFWURGH %DVH Figure 8-6: Electrode bases #1–#5.
6. Snap cloth electrode #3 to the thenar. Note: The #3 large cloth electrode is for large thenars. 7. For cloth electrodes #1, 2, 4, and 5, face the white dot on the cloth electrode toward the electrode base. Insert the corners of the cloth electrode into the electrode base. See Figure 8-7. Figure 8-7: Inserting the #5 cloth electrode into the #5 electrode base.
8. Check that each cloth electrode is securely attached to its corresponding electrode base. See Figure 8-8. Figure 8-8: Cloth electrodes in place on the Orthosis. CAUTION: Do not wear the Orthosis without the cloth electrodes.
Putting on the Orthosis Make sure you are sitting upright and centered (not leaning to one side). Your arm should be comfortable and your shoulder relaxed. To put on the Orthosis: 1. Position the Orthosis on a stable surface, and place your hand in the spiral end of the Orthosis. The #3 thenar cloth electrode should rest at the base of your thumb. See Figure 8-9. Figure 8-9: Positioning the thenar.
2. Position the Orthosis wrist bridge comfortably on the back of your wrist. See Figure 8-10. :ULVW %ULGJH Figure 8-10: Positioning the wrist bridge. WARNING: Do not turn on stimulation until your Orthosis is completely set up and correctly attached to your arm.
3. Place your forearm in the Orthosis flexor support. See Figure 8-11. )OH[RU 6XSSRUW Figure 8-11: Positioning the flexor support.
4. Place your hand on top of the wing arm and grasp under the extensor wing with your fingers. 5. Pull the extensor wing out while pushing down on the wing arm. See Figure 8-12. Push down until no more clicking can be heard. ([WHQVRU :LQJ :LQJ $UP :LQJ 5HOHDVH +DQGOH Figure 8-12: Closing the wing.
6. Attach the hook on the Orthosis wrist strap to the wrist strap attachment ring. See Figure 8-13. :ULVW 6WUDS $WWDFKPHQW 5LQJ :ULVW 6WUDS +RRN Figure 8-13: Attaching the Orthosis wrist strap.
7. Bring the wrist strap under the wrist. Make sure the cushion on the wrist strap is touching the wrist. 8. Pull the wrist strap up and through the wrist strap attachment bar. See Figure 8-14. :ULVW 6WUDS $WWDFKPHQW %DU :ULVW 6WUDS &XVKLRQ Figure 8-14: Attaching the wrist strap. 9. Bring the wrist strap down and press to fasten. CAUTION: Do not pull down on the wrist strap. Pulling down on the wrist strap can break the wrist strap attachment bar.
Chapter 9 Operating the NESS H200 Wireless System RF Communication Features The Control Unit and Orthosis must be within RF communication range to communicate wirelessly. The communication range is approximately 10 feet. If RF communication fails, the RF communication indicator on the H200 Wireless Control Unit will FLASH RED . Turning On the System Press the on/off button on the Control Unit once. The system will start in standby mode.
Testing Stimulation in the Orthosis The stimulation test button is for testing whether the Orthosis is positioned correctly on the arm. The button is located on the side of the Control Unit. See Figure 9-1. To test stimulation in the Orthosis: 1. Make sure the system is in standby mode. The not be lit. trigger button should 2. Press and hold the stimulation test button to test stimulation of the extensor muscles. (Stimulation will turn on and stay on until the button is released.
Selecting a Stimulation Program To select Program 1 : Turn on the system. Program 1 is selected automatically. When Program 1 is selected, the Program 1 indicator will be GREEN. To select Program 2 : 1. Turn on the system. 2. Press the Program 2 button. See Figure 9-1. When Program 2 is selected, the Program 2 indicator will be GREEN. On/Off Button Mute Button Trigger Button Program 1 Button Program 2 Button Intensity Adjustment Buttons Stimulation Test Button Figure 9-1: Operating buttons.
Changing Stimulation Programs 1. Press the trigger button to pause stimulation. 2. Press the Program 1 or Program 2 button. Starting Stimulation Press the trigger button on the Control Unit or the trigger button on the Orthosis. Stimulation will turn on. • The Control Unit will beep. • The Control Unit • The Orthosis RAPIDLY. trigger button will FLASH YELLOW. stimulation light will FLASH YELLOW 3. Your hand will start moving per the program selected.
Pausing/Resuming Stimulation Functional Training and Motor Neuromodulation Programs may be programmed to run from 5 minutes to 120 minutes, as determined by your clinician. Personal Custom Programs may be programmed to run from 30 to 240 minutes, as determined by your clinician. Once started, these programs will continue until they are finished. However, they may be paused and resumed at any time. To pause/resume stimulation: Press the trigger button on the Control Unit or the trigger button on the Orthosis.
Using a Neuroprosthesis Program Your clinician may have assigned a Neuroprosthesis Program to the Program 1 or Program 2 button on your Control Unit. Neuroprosthesis programs are used to perform a specific task. There are three types of Neuroprosthesis Programs: Open Hand, Grasp and Release, and Key Grip. Open Hand To use Open Hand: 1. Press the Control Unit trigger button or Orthosis trigger button to start stimulation. Your hand will open. 2.
Grasp and Release To use Grasp and Release: 1. Press the Control Unit trigger button or Orthosis trigger button to start stimulation. Your hand will open. 2. While your hand is open, place it next to the object you want to grasp. 3. After several seconds, your hand will close, allowing you to grasp the object. 4. When you are ready to release the object, press the Control Unit trigger button or the Orthosis trigger button a second time. Your hand will open, allowing you to release the object. 5.
Key Grip To use Key Grip: 1. Press the Control Unit trigger button or Orthosis trigger button to start stimulation. Your fingers will close and your thumb will open. There should be a gap between your thumb and the side of your index finger. 2. While your fingers and thumb are in this position, place the object you want to grip into the gap. 3. After several seconds, your fingers and thumb will close around the object. 4.
Adjusting Stimulation Intensity Each time you turn on your Control Unit, the stimulation intensity level will be “5." If necessary, you can adjust the stimulation intensity level when in standby mode or when stimulation is on. To adjust stimulation intensity: 1. Press the plus button on the Control Unit once to increase stimulation intensity one level. 2. Press the minus button on the Control Unit once to decrease stimulation intensity one level. The Control Unit will beep with each change in level.
Muting/Un-Muting the System Audio Alerts Press the mute button briefly. The mute button is located on the side of the Control Unit. Audio alerts are listed in Table 9-1. Note: When the system is turned on the next time, the default volume setting will be restored.
Chapter 10 Removing the Orthosis To remove the Orthosis: 1. Press the Control Unit system. on/off button to turn off the H200 Wireless 2. Carefully unfasten the wrist strap and slide it away from the wrist strap attachment bar. See Figure 10-1. :ULVW 6WUDS $WWDFKPHQW %DU :ULVW 6WUDS Figure 10-1: Unfastening the wrist strap.
3. Pinch the wing release handle and wing arm together and open the extensor wing. See Figure 10-2. :LQJ $UP :LQJ 5HOHDVH +DQGOH Figure 10-2: Opening the extensor wing.
4. With the extensor wing open (See Figure 10-3), remove the flexor support from under your forearm. )OH[RU 6XSSRUW Figure 10-3: Removing the flexor support. 5. Then lift the flexor support up and over your forearm, and remove the spiral end of the Orthosis from your hand. 6. Remove the H200 Wireless cloth electrodes from the Orthosis. 7. Store the cloth electrodes and Orthosis where they can air dry.
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Chapter 11 Maintenance and Cleaning Daily Maintenance and Storage 1. Store the H200 Wireless cloth electrodes in the cloth electrode mesh bag or where they can air dry. 2. Check the system components for signs of wear and damage. 3. Replace any components that appear old, worn, or damaged. Contact the Bioness Client Relations Department at (800) 211-9136, Option 3, for assistance. 4. Store the Orthosis where it can air dry. 5. Charge the Orthosis and Control Unit until ready to use.
Battery Replacement: H200 Wireless Control Unit The battery in the H200 Wireless Control Unit is a rechargeable AAA NiMH battery. It should be replaced approximately every two years. To replace the Control Unit battery (AAA NiMH 1.2 V): 1. Using a Phillips screwdriver, remove the screw from the battery cover on the back of the H200 Wireless Control Unit. See Figure 11-1. Battery Cover Screw Battery H200 Wireless Control Unit Figure 11-1: Replacing the H200 Wireless Control Unit battery.
2. Remove the battery cover. 3. Note the "+/-" orientation of the old battery. 4. Remove the old battery. 5. Insert the new rechargeable battery in the proper "+/-" orientation. 6. Slide the cover into place. 7. Tighten the screw. 8. Fully charge the new battery before use. CAUTION: Use only a battery supplied by Bioness Inc. CAUTION: Use of a non-rechargeable AAA battery can damage the H200 Wireless Control Unit.
Cleaning General Instructions All H200 Wireless System Kit components may be cleaned as needed or weekly by carefully wiping them with a damp cloth. Use water. Do not use detergents or other cleaning agents, unless otherwise specified below. H200 Wireless electronic components are not waterproof. Do not immerse them in water. Control Unit Neck Strap and Wrist Strap The Control Unit neck strap and Control Unit wrist strap are made of polyester. They may be machine washed on a delicate cycle in cold water.
Disinfecting Electronic Components The Control Unit may be cleaned and low-level disinfected using CaviWipes™ (Metrex, Orange, CA), or wipes or cloths saturated (but not dripping) with 70% isopropyl alcohol (IPA) per the instructions below: 1. Use one saturated disinfectant wipe or cloth to thoroughly wet the component surface. 2. Use a second saturated disinfectant wipe or cloth to remove any surface contaminants. Soil, etc., will impede the disinfectant's effectiveness, if not removed. 3.
The Orthosis (except for the wrist insert) may be cleaned and low-level disinfected using wipes or cloths saturated with 70% isopropyl alcohol (IPA) per the instructions below: 1. Use one saturated disinfectant wipe or cloth to thoroughly wet the component surface. 2. Use a second saturated disinfectant wipe or cloth to remove any surface contaminants. Soil, etc., will impede the disinfectant's effectiveness, if not removed. 3.
System Kit Carrying Case The NESS H200 Wireless System Kit carrying case may be cleaned and low-level disinfected using CaviCide (Metrex, Orange, CA) or 70% isopropyl alcohol (IPA) per the following instructions: CaviCide: 1. Spray the entire surface of the System Kit carrying case with CaviCide. 2. Use a clean towel to remove any surface contaminants. Soil, etc., will impede the disinfectant's effectiveness, if not removed. 3. Spray the entire surface of the System Kit carrying case again with CaviCide.
Note: Be sure to follow the Bioness instructions for the specified contact time to ensure an effective bacteria kill. Note: Do not use other cleaning/disinfecting agents such as a diluted bleach mixture, Lysol or Clorox wipes. Bioness has not tested these products' effectiveness on the H200 Wireless components. Metrex products are sold through authorized dealers worldwide; 70% IPA is available at your local drugstore or pharmacy.
Chapter 12 Electronic Registration of Replacement Parts The NESS H200 Wireless System Control Unit and Orthosis must be electronically registered to each other to communicate wirelessly. The components in your System Kit are electronically registered. When you purchase a replacement H200 Wireless Control Unit or Orthosis, the replacement component must be electronically registered to the existing component.
Registration Setup 1. Verify that all H200 Wireless System components are turned off. 2. Place the components to be registered close together on a table, but not touching. See Figure 12-1. H200 Wireless Control Unit H200 Wireless Orthosis Figure 12-1: Place the components to be registered close together. 3. If necessary, connect the components to the system charger set, and plug the system charger into a power outlet.
4. Locate the System ID Number (for example, A334) on the existing system component. The System ID Number is on the back of the H200 Wireless Control Unit and under the extensor wing of the H200 Wireless Orthosis. See Figure 12-2. System ID Number System ID Number Figure 12-2: Location of the System ID Numbers.
5. Copy the System ID Number onto the blank label on the replacement system component. Registration 1. Simultaneously press and hold for three seconds the trigger button and the minus button on the H200 Wireless Control Unit. 2. Press the trigger button on the wrist bridge of the Orthosis. 3. The Control Unit will beep when registration begins. 4. The Control Unit digital display will show two alternating GREEN arches while registration is in process. See Figure 12-3.
5. When registration is complete: • (“C” for complete) will appear in the digital display. • The Control Unit status light and the Orthosis light will turn GREEN for a few seconds. • The Control Unit will beep. status Note: If (“E” for error) appears in the digital display and the Control Unit status light turns RED, an error has occurred. Turn on the Control Unit. If ("U" for unregistered) appears in the digital display, the system is unregistered.
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Chapter 13 Troubleshooting If you have any questions or concerns, please call the Bioness Client Relations Department at (800) 211-9136, Option 3. RF Communication Failure The Orthosis and Control Unit communicate wirelessly. If RF communication fails, the Control Unit RF Indicator will FLASH RED and emit an audio alert. RF Failure Alert Control Unit FLASHES RED Problems/Solutions Radio Communication Failure • Make sure the H200 Wireless Orthosis and the Control Unit are within 10 feet of each other.
Frequently Asked Questions When charging the NESS H200 Wireless System, how will I know when the batteries are fully charged? • When the Control Unit is fully charged, a appear in the Control Unit digital display. GREEN horizontal line will • When the Orthosis is fully charged, the will be SOLID GREEN. status light on the Orthosis • Charging takes approximately four hours, but the Control Unit can take as long as six hours to charge.
When I turn on the H200 Wireless Control Unit, it beeps and the RF communication indicator FLASHES RED . The status light and stimulation light on the Orthosis are not lit. • RF communication has failed. The Orthosis battery most likely is discharged. • Connect the system charger. (The NESS H200 Wireless System can be charged during operation.) When communication is restored, the RF communication indicator will stop flashing and the status light on the Orthosis will FLASH GREEN.
How will I know when the Orthosis battery charge level is low? • When the Orthosis battery charge level is low, the status light on the Orthosis will FLASH YELLOW and the Orthosis will beep. How will I know when the Control Unit battery charge level is low? • When the Control Unit battery charge level is low, the status light on the Control Unit will FLASH YELLOW and the Control Unit will beep. The status light on the Control Unit is SOLID RED and the Control Unit beeped.
My hand is not moving satisfactorily, and the NESS H200 Wireless System is not indicating any errors. • The Orthosis may not be positioned correctly. • Turn off the Control Unit. • Make sure the cloth electrodes are wet and your hand/arm are clean. • Reposition the Orthosis. • Make sure the thenar is at the base of your thumb. • Make sure the Orthosis wrist strap is snug. • Make sure the extensor wing is completely closed. • Test the position of the Orthosis using the button.
The Control Unit does not light up when turned on. • The Control Unit needs to be charged. • If the problem persists, contact the Bioness Client Relations Department, Option 3. I received a replacement Control Unit. When I turn it on, the RF communication indicator FLASHES RED and a "U" appears in the digital display. The Orthosis status light and stimulation light are not lit.
After I fully charged the NESS H200 Wireless System, I disconnected the system charger and then immediately reconnected it. The charging indications appeared again on the Control Unit and Orthosis. Are the components fully charged or do I need to repeat the charging process? • The components are fully charged. You do not need to repeat the charging process.
Control Unit 104 Description Definition On/Off Button FLASHES GREEN System On Trigger Button FLASHES YELLOW RAPIDLY Stimulation On Trigger Button is SOLID YELLOW Stimulation Paused Displays 0–9 Stimulation Intensity Level; "0" Equals No Stimulation Alternating GREEN Arches Registration in Process Letter "C" Registration Complete Letter "E" Registration Error Letter "U" Control Unit Unregistered Rotating GREEN Circle Control Unit Charging Horizontal GREEN Line Control Unit Fully Charged
Left Orthosis Status Light Stimulation Light Display Description Definition FLASHES GREEN System On FLASHES YELLOW Low Battery ALTERNATELY FLASHES YELLOW and GREEN Battery Charging SOLID GREEN Battery Fully Charged; Registration Successful FLASHES RED Faulty Electrode Contact SOLID RED Hardware/Software Error; Charging Error SOLID YELLOW Stimulation Paused FLASHES YELLOW RAPIDLY Stimulation On Chapter 13 - Troubleshooting 105
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Chapter 14 Technical Specifications H200 Wireless Control Unit Specifications Classification Internally powered, continuous operation Operation Modes User and Standby Battery Type Rechargeable AAA NiMH 1.
H200 Wireless Orthosis Specifications Classification Internally powered, continuous operation with type BF applied parts Operating Voltage 3.7 V Battery Type Proprietary rechargeable Li-Ion (Lithium Ion) 3.
H200 Wireless Orthosis Specifications Small Medium Large Dimensions (closed) Length: 270 mm (10.63 in.) Width: 110 mm (4.33 in.) Depth: 90 mm (3.54 in.) Length: 270 mm (10.63 in.) Width: 110 mm (4.33 in.) Depth: 90 mm (3.54 in.) Length: 300 mm (11.81 in.) Width: 130 mm (5.11 in.) Depth: 130 mm (5.11 in.) Estimated Weight 300 grams (10.58 oz.) 300 grams (10.58 oz.) 300 grams (10.58 oz.
H200 Wireless Orthosis Pulse Parameters Pulse Balanced Biphasic Waveform Symmetric Intensity (Peak) 0–80 mA, 1-mA resolution (positive phase) Maximum Current Intensity (rms) • • Max Voltage 120 V Electrodes #1, #2, #3, #5: 13.1 mA rms Electrode #4: 18.
Power Supply Specifications Use medical Class II safety approved power supply provided/approved by Bioness with the following ratings: Input Voltage 100–240 V AC Current 400 mA Frequency 50–60 Hz Output Voltage 5 V ± 5% Current 2400 mA Note: The H200 Wireless Control Unit and Orthosis can be used while charging if the Control Unit is not connected to the Clinician's Programmer.
H200 Wireless Cloth Electrode Specifications Material Non-woven cloth Note: Use only cloth electrodes provided by Bioness Inc. Cloth Electrode # 1 2 3 Regular 3 Large 4 5 Area (mm2) 1784 1185 791 1284 2038 1185 Area (in.2) 2.8 1.8 1.2 2.0 3.2 1.8 Wireless Technology Description Wireless Link Specifications Frequency Band 2.4 GHz, ISM band Transmission Power Complies with FCC 15.247 (for U.S.) regulations/ETSI EN300-440 (For Europe) regulations.
Chapter 15 Appendix - EMI Tables Guidance and Manufacturer’s Declaration Electromagnetic Emissions The NESS H200 Wireless System is intended for use in the electromagnetic environment specified below. The customer or the user of the NESS H200 Wireless System should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment — Guidance RF emissions CISPR 11 Group 1 The NESS H200 Wireless System uses RF energy only for its internal function.
Guidance and Manufacturer’s Declaration— Electromagnetic Immunity for All Equipment and Systems The NESS H200 Wireless System is intended for use in the electromagnetic environment specified below. The customer or the user of the NESS H200 Wireless System should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment— Guidance Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% UT (>95% dip in UT) for 0.5 cycle <5% UT (>95% dip in UT) for 0.
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The NESS H200 Wireless System is intended for use in the electromagnetic environment specified below. The customer or the user of the NESS H200 Wireless System should assure that it is used in such an environment.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. NOTE 3: P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the NESS H200 Wireless System The NESS H200 Wireless System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
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