Bioness Ness H200 Manuel utilisateur
User’s Guide
H200®Wireless, Bioness, the Bioness Logo®and LiveOn®are trademarks of Bioness Inc.
in the United States or other countries. | www.bioness.com
612-00964-001 Rev. A
03/2018
Rx Only (US Only)
©2018 Bioness Inc.
Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: 800.211.9136 or 661.362.4850
Email: [email protected]
Website: www.bioness.com
Bioness Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, The Netherlands
Telephone: +31.78.625.6088
Email: [email protected]
Website: www.bioness.com
H200 Wireless User’s Guide Copyright
© 2018, 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
H200®Wireless, Bioness, the Bioness Logo®and LiveOn®are trademarks of Bioness Inc. in the
United States or other countries. | www.bioness.comom
Rx Only (US Only)
Bioness Patents
This product is covered by one or more US and international patents. Additional patents pending. For
more information on patents visit Bioness web site at: https://www.bioness.com/Patents.php
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 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 Inc
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: 800.211.9136 or 661.362.4850
Email: [email protected]
Website: www.bioness.com
Bioness Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, The Netherlands
Telephone: +31.78.625.6088
Email: [email protected]
Website: www.bioness.com
Conformity Certification
List of Symbols
Caution
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
Refer to Instruction Manual/ Booklet
Re-Order Number
Lot Number
Serial Number
Complies with United States and Canadian Product Safety Standards
Single Patient Use
Storage Temperature
Complies with the European Union Medical Device Directive
European Authorized Representative
Humidity Limitation
Atmospheric Pressure Limitation
IP27 Degree of Ingress Protection (for Orthosis)
IP22 Degree of Ingress Protection (for Control Unit)
Keep Dry
ii
iii
Table of Contents
List of Symbols .................................................................................................. ii
Chapter 1: Introduction......................................................................... 1
Device Description............................................................................................. 1
Chapter 2: Safety Information .............................................................. 3
Indications for Use............................................................................................. 3
Contraindications............................................................................................... 3
Warnings ........................................................................................................... 4
Adverse Reactions ............................................................................................ 6
Precautions........................................................................................................ 6
Chapter 3: Environmental Conditions that Affect Use....................... 11
Radio Frequency (RF) Communication ............................................................. 11
Travel and Airport Security ................................................................................ 12
Electromagnetic Compatibility ........................................................................... 13
Warnings and Cautions ............................................................................... 13
Chapter 4: H200 Wireless System Kit.................................................. 15
Contents ............................................................................................................ 15
Chapter 5: H200 Wireless Orthosis...................................................... 19
Flexor Support................................................................................................... 20
Extensor Wing ................................................................................................... 22
Wing Release Handle.................................................................................. 22
Wing Arm ..................................................................................................... 23
Fitting Panels .................................................................................................... 24
Spiral End of the Orthosis.................................................................................. 25
Thenar ......................................................................................................... 25
Wrist Bridge ................................................................................................. 26
Trigger Button .............................................................................................. 27
iv User's Guide
Wrist Strap Attachment Ring........................................................................ 27
Wrist Strap Attachment Bar ......................................................................... 27
Status Light ....................................................................................................... 28
Stimulation Light ............................................................................................... 28
Audio Alerts ....................................................................................................... 29
Rechargeable Battery and Charging Port.......................................................... 29
Chapter 6: H200 Wireless Control Unit................................................ 31
Operating Buttons.............................................................................................. 31
Indicators and Digital Display ............................................................................ 33
Audio Alerts ....................................................................................................... 35
Charging Port .................................................................................................... 36
Chapter 7: H200 Wireless Stimulation Programs ............................... 45
Chapter 8: Setup Instructions .............................................................. 47
Charging the H200 Wireless System................................................................. 47
Checking the System Components ................................................................... 50
Preparing Your Skin........................................................................................... 50
Wetting/Attaching the Cloth Electrodes............................................................. 51
Putting on the Orthosis...................................................................................... 53
Chapter 9: Operating the H200 Wireless System ............................... 59
RF Communication Features............................................................................. 59
Turning On the System...................................................................................... 59
Turning Off the System...................................................................................... 59
Testing Stimulation in the Orthosis .................................................................... 59
Selecting a Stimulation Program ....................................................................... 61
Changing Stimulation Programs........................................................................ 61
Starting Stimulation ........................................................................................... 61
Pausing/Resuming Stimulation.......................................................................... 62
v
Using a Neuroprosthesis Program .................................................................... 62
Open Hand .................................................................................................. 62
Grasp and Release...................................................................................... 63
Key Grip....................................................................................................... 63
Stopping Stimulation.......................................................................................... 64
Adjusting Stimulation Intensity........................................................................... 64
Muting/Un-Muting the System Audio Alerts ....................................................... 65
Chapter 10: Removing the Orthosis .................................................... 67
Chapter 11: Maintenance and Cleaning............................................... 69
Daily Maintenance and Storage ........................................................................ 69
Charging............................................................................................................ 69
Battery Replacement: H200 Wireless Control Unit............................................ 69
Battery Replacement: H200 Wireless Orthosis ................................................. 71
Cleaning ............................................................................................................ 71
Disinfecting........................................................................................................ 72
Chapter 12: Electronic Registration of Replacement Parts............... 75
Chapter 13: Troubleshooting................................................................ 79
RF Communication Failure................................................................................ 79
Frequently Asked Questions.............................................................................. 79
Quick Reference Troubleshooting ..................................................................... 84
Chapter 14: Technical Specifications.................................................. 87
Chapter 15: Appendix - EMI Tables...................................................... 95
vi User's Guide
Chapter 1
1Chapter 1 - Introduction
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 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 H200 Wireless System delivers electrical stimulation to the nerves of
the muscles that control the hand. The H200 Wireless System may help to improve
hand function and assist with tasks of daily living.
This H200 Wireless User's Guide describes:
• Important safety information about the H200 Wireless System.
• The components of the H200 Wireless System.
• How to set up, operate, and maintain your H200 Wireless System.
• Troubleshooting information.
Be sure to review this guide with your clinician before using your H200 Wireless
System. If you have questions contact the Bioness Client Relations Department at
800.211.9136, Option 3 (in the United States) or your local distributor (outside of
the United States). You can also visit the Bioness website at www.bioness.com.
Device Description
The H200 Wireless System consists of an H200 Wireless Orthosis and a H200
Wireless Control Unit. See Figure 1-1.
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