Bioness Ness H200 User manual

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: [phone] or 661.362.4850
Email: [email protected]
Website: www.bioness.com
Bioness Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, The Netherlands
Telephone: [phone]
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: [phone] or 661.362.4850
Email: [email protected]
Website: www.bioness.com
Bioness Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, The Netherlands
Telephone: [phone]
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.

2User's Guide
Figure 1-1: H200 Wireless Orthosis and Control Unit
H200 Wireless Orthosis
The 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
The Control Unit communicates wirelessly with the 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.
Caution: Do not put on or operate the H200 Wireless System before being
properly fitted by a trained clinician.
H200 Wireless Orthosis H200 Wireless
Control Unit

Chapter 2
3Chapter 2 - Safety Information
Safety Information
Indications for Use
The 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.
Contraindications
• Do not use the H200 Wireless System where a cancerous lesion is present or
suspected.
• Do not use the H200 Wireless System if you have a cardiac pacemaker,
implanted defibrillator, or implanted metallic device in the forearm or hand
intended for the H200 Wireless use. Use of the H200 Wireless System in
conjunction with any of the above may cause electric shock, burns, electrical
interference, or death.
• Do not use the 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.

4User's Guide
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.
• Do not wear the H200 Wireless Orthosis over swollen, infected, or inflamed
areas. Do not wear the Orthosis over skin eruptions, such as phlebitis,
thrombophlebitis, and varicose veins.
• Apply stimulation to normal, intact, clean, healthy skin only.
• Turn off the H200 Wireless System before driving or operating machinery.
• Turn off stimulation before performing any activity in which involuntary muscle
contractions may injure you.
• Do not use the H200 Wireless System while sleeping.
• Only trained clinicians should fit and program the 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.
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.

5Chapter 2 - Safety Information
• Swelling of the hand, wrist, or forearm.
• Any other unanticipated reaction.
Skin irritations and burns beneath the stimulating electrodes have been reported
with the use of powered muscle stimulators.
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 H200 Wireless System. The 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.
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 (bradycardia).
• Use caution if you have suspected or diagnosed epilepsy.
• Talk to your doctor before using the 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).
• Arteriovenous 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.
• The safety of using the H200 Wireless System during pregnancy has not
been established.
• Keep the H200 Wireless System out of the reach of children.

6User's Guide
• 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 Orthosis. Stop using the H200 Wireless
System until any inflammation is gone.
• Always check the skin for redness or a rash when putting on and taking off
the H200 Wireless Orthosis.
• 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 H200 Wireless System until any irritation is
completely gone.
• Turn off the H200 Wireless System before putting on or taking off the
Orthosis. Do not turn on the H200 Wireless System until the Orthosis
is on the arm and the wing is closed.
• Turn off the H200 Wireless System when at a refueling place. Do not use the
H200 Wireless System near flammable fuel, fumes, or chemicals.
• Turn off the H200 Wireless System before removing or replacing the cloth
electrodes.
• Remove the H200 Wireless Orthosis before wetting the cloth electrodes.
• The H200 Wireless Orthosis is 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.

7Chapter 2 - Safety Information
• Do not use the H200 Wireless System without the cloth electrodes.
• Be sure the H200 Wireless cloth electrodes are wet and securely attached to
the electrode bases before use.
• Wet the H200 Wireless cloth electrodes before use and after every three to
four hours of use.
• Replace the H200 Wireless cloth electrodes at least every two weeks, even if
they appear to be in good condition.
• Always store the H200 Wireless cloth electrodes where they can air dry.
• When putting on the H200 Wireless Orthosis, make sure the cloth electrodes
uniformly contact the skin.
• Ventilate the skin by removing the H200 Wireless Orthosis for at least 15
minutes every 3 to 4 hours.
• Store the H200 Wireless Orthosis where it can air dry.
• Do not store the 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.
If skin irritation or a skin reaction occurs, stop using your H200 Wireless System
immediately and contact your clinician or dermatologist. Also contact the Bioness
Client Relations Department: 800.211.9136, Option 3 (in the United States) or your
local distributor (outside the United States). Resume use only when the skin is
completely healed. Then follow a skin conditioning protocol, per the recommendation
of your health-care specialist.

8User's Guide

Chapter 3
9Chapter 3 - Environmental Conditions that Affect Use
Environmental Conditions
that Affect Use
Radio Frequency (RF) Communication
Several components of the 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 Federal Communications
Commission (FCC) rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates,
uses, and can radiate RF energy. If not installed and used according to the instructions,
it may cause harmful interference with radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment
does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, try one or more of the following
corrective measures:
• Reorient or move the receiving antenna.
• Increase the separation distance between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
• Consult the dealer or technician for assistance.
The antenna for each transmitter must not be near to or operating in conjunction
with any other antenna or transmitter.
Portable and mobile RF communications equipment can affect the H200 Wireless
System.

10 User's Guide
Conformity Certification
The H200 Wireless System complies with Part 15 of the FCC regulations. 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.
Note: FCC regulations provide that changes or modifications not expressly approved
by Bioness Inc. could void authority to operate.
Travel and Airport Security
The H200 Wireless System charger is compatible with Australian, U.K., European
Union, and U.S. voltages: 100-240 VAC, 50/60 Hz.
Turn off your 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 H200 Wireless System will likely set off the security alarm. Be prepared
to remove the H200 Wireless System so that security can scan it, or ask for the
system to be scanned if you do not want to remove it. You may want to carry a
copy of your H200 Wireless System prescription. A prescription can be useful when
passing through customs as well.
To request a copy of your prescription, call the Bioness Client Relations Department:
Telephone: [phone], Option 3; or your local distributor. A Bioness representative
can fax or mail you a copy.
Note: The H200 Wireless System contains radio transmitters. The Federal Aviation
Administration rules require that all radio-transmitting devices be turned off during
flight.

11Chapter 3 - Environmental Conditions that Affect Use
Electromagnetic Compatibility
The 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 H200 Wireless System
should be configured and used in accordance with the instructions provided in this
guide.
The H200 Wireless System was tested and certified to use the following:
• DC power supply as provided by Bioness Inc., manufactured by FRIWO, Part
No. FW7555M/05.
• Y cable (2-way splitter) as provided by Bioness Inc., Model No. L3G-5C00.
Manufactured by Tamuz Electronics Ltd.
The plug-in AC/DC adapters for the H200 Wireless Control Unit and Orthosis are
the only means for disconnecting the devices from the AC power.
Warnings and Cautions
• Use caution when treating patients with implanted intrathecal/intravascular
drug delivery systems. During initial trials with the H200 Wireless System,
clinicians should carefully monitor patients on intraspinal/intravascular
therapy for any new neurological or other medical signs or symptoms. Those
clinicians should be advised to inform patients of the signs and symptoms of
drug underdose or overdose. Clinicians and patients also should be advised
to follow programming guidelines and precautions provided in the relevant
drug delivery system product manuals.
• 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.