Bioness Neuromodulation A Bioness H200W-RFSO RF wireless orthosis User Manual
Bioness Neuromodulation ltd. A Bioness Inc Company RF wireless orthosis
user manual
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
602-00504-001 Rev. B
Rx Only
©2011 Bioness Inc.
I
User’s Guide
Rx Only
II User's Guide
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.
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
Manufactured by
Bioness Neuromodulation Ltd.
A Bioness Inc Company
19 Ha’Haroshet Street
PO Box 2500
Industrial Zone
Ra’Anana 43654, Israel
Bioness Client Relations Department: Telephone: (800) 211-9136, Option 3; or (661) 362-4850, Option 3.
III
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
IV User's Guide
V
Contents
List of Symbols .................................................................................................. III
Chapter 1: Introduction ......................................................................... 1
Chapter 2: Device Description and Safety Information ..................... 3
Device Description ............................................................................................. 3
Indications for Use ............................................................................................. 4
Contraindications ............................................................................................... 5
Warnings ........................................................................................................... 5
Adverse Reactions ............................................................................................ 6
Precautions ........................................................................................................ 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
VI User's Guide
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
VII
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
VIII User's Guide
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
1
Chapter 1 - Introduction
1
Chapter
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.
2User's Guide
3
Chapter 2 - Device Description and Safety Information
2
Chapter
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.
Figure 2-1: H200 Wireless Orthosis and Control Unit.
H200 Wireless
Orthosis
H200 Wireless
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.
4User's Guide
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.
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.
5
Chapter 2 - Device Description and Safety Information
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.
•
Do not wear the H200 Wireless Orthosis over swollen, infected, or inflamed
areas. Do not wear the Orthosis over skin eruptions or varicose veins.
• Apply stimulation to normal, intact, clean, healthy skin only.
• Turn off the NESS 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 NESS H200 Wireless System while sleeping.
• Only an authorized clinician should fit and program the NESS H200
Wireless System.
6User's Guide
• 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.
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.
• Skin irritations and burns beneath the stimulating electrodes have been
reported with the use of powered muscle stimulators.
7
Chapter 2 - Device Description and Safety 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.
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.
• Use caution if you have suspected or diagnosed epilepsy.
• 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.
• The safety of using the NESS H200 Wireless System during pregnancy
has not been established.
• Keep the NESS H200 Wireless System out of the reach of children.
8User'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 H200 Wireless Orthosis. Stop
using the NESS 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 NESS H200 Wireless System
until any irritation is completely gone.
• 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.
• 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.
• Turn off the NESS H200 Wireless System before removing or replacing
the cloth electrodes.
•
Remove the H200 Wireless Orthosis before wetting the cloth electrodes.
9
Chapter 2 - Device Description and Safety Information
•
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.
•
Do not use the NESS 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 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.
10 User's Guide
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.
11
Chapter 3 - Environmental Conditions that Affect Use
3
Chapter
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. This equipment generates, uses, and can radiate RF energy.
If not installed and used in accordance with the instructions, it may cause
harmful interference to 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 an experienced radio/TV technician for assistance.
The antenna for each transmitter must not be near to or operating in conjunction
with any other antenna or transmitter.
12 User's Guide
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.
Note: Changes or modifications to this equipment not expressly approved
by Bioness Inc could void the user’s authority to operate the equipment.
13
Chapter 3 - Environmental Conditions that Affect Use
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. Be prepared to remove the NESS 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: (800) 211-9136, Option 3; or (661) 362-4850, Option
3. A Bioness representative can fax or mail you a copy.
Note: The NESS H200 Wireless System contains radio transmitters. The
Federal Aviation Administration rules require that all radio-transmitting devices
be turned off during flight.
14 User's Guide
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.
The NESS 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 NESS H200 Wireless
System, clinicians should monitor carefully 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.
15
Chapter 3 - Environmental Conditions that Affect Use
•
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.
•
The use of accessories, transducers, and cables other than those specified,
with the exception of transducers and cables sold by the manufacturer
of the NESS H200 Wireless System as replacement parts for internal
components, may result in increased emissions or decreased immunity
of the NESS H200 Wireless System.
•
The use of the accessory, transducer, or cable with equipment and systems
other than those specified may result in increased emissions or decreased
immunity of the NESS H200 Wireless System.
•
The NESS H200 Wireless System may be interfered with by other equipment,
even if that other equipment complies with CISPR (International Special
Committee on Radio Interference, International Electrotechnical Commission)
emission requirements.
• Do not use the NESS H200 Wireless System within three feet of short
wave or microwave therapy equipment. Such equipment may produce
instability in the stimulation output by the H200 Wireless Orthosis.
16 User's Guide
17
Chapter 4 - H200 Wireless System Kit
4
Chapter
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 Orthosis
H200 Wireless Control Unit
System Charger Set
18 User's Guide
Control Unit Wrist Strap Control Unit Belt Pouch
Control Unit Neck Strap
Orthosis Wrist Strap
Cloth Electrode
Mesh Bag
H200 Wireless Cloth Electrodes
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19
Chapter 4 - H200 Wireless System Kit
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. The
wrist strap hooks onto the Orthosis and wraps under the wrist.
Control Unit Neck Strap, Wrist Strap, and Belt Pouch
The Control Unit neck strap, wrist strap, and belt pouch are for carrying the
Control Unit. The neck strap and wrist strap loop through the hole at the top
of the Control Unit. The belt pouch has a clamp for attaching to a belt.
H200 Wireless Cloth Electrodes
The cloth electrodes deliver the stimulation generated by the Orthosis. The
cloth electrodes attach to the electrode bases on the Orthosis.
20 User's Guide
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 wet
before use and wet again after every four hours of use.
CAUTION: The H200 Wireless cloth electrodes are for single
patient use.
CAUTION: The H200 Wireless cloth electrodes must be replaced
every two weeks or sooner if they become damaged.
21
Chapter 5 - H200 Wireless Orthosis
5
Chapter
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.
Figure 5-1: Orthosis stimulating electrodes.
(OHFWURGH (OHFWURGH
(OHFWURGH
(OHFWURGH
(OHFWURGH
22 User's Guide
Figure 5-2: Orthosis features.
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.
([WHQVRU:LQJ
6SLUDO(QG
6WDWXV
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6WLPXODWLRQ
/LJKW
)OH[RU6XSSRUW
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3RUW 7KHQDU
23
Chapter 5 - H200 Wireless Orthosis
Figure 5-3: Orthosis flexor support.
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)OH[RU
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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.
24 User's Guide
Figure 5-4: Orthosis flexor support with an FPL panel.
)3/3DQHO
(OHFWURGH%DVH
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.
25
Chapter 5 - H200 Wireless Orthosis
Figure 5-5: Orthosis extensor wing.
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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.
26 User's Guide
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.
Figure 5-6: Orthosis wing release handle.
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27
Chapter 5 - H200 Wireless Orthosis
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.
Figure 5-7: Orthosis wing arm.
:LQJ$UP
([WHQVRU
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28 User's Guide
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.
([WHQVRU
)LWWLQJ3DQHO
([WHQVRU:LQJ
Figure 5-8: Reattaching the extensor fitting panel.
29
Chapter 5 - H200 Wireless Orthosis
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.
)OH[RU6XSSRUW
([WHQVRU
:LQJ
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3DQHO
Figure 5-9: Reattaching the flexor fitting panel.
If you have questions, contact the Bioness Client Relations Department at
(800) 211-9136, Option 3.
30
Chapter 5 - H200 Wireless Orthosis
Figure 5-10: Spiral end of the Orthosis.
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.
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31
Chapter 5 - H200 Wireless 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.
Figure 5-11: The thenar (inset) and placement of the thenar.
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CAUTION: Do not operate the NESS H200 Wireless System
without a thenar cloth electrode in place.
32 User's Guide
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.
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Figure 5-12: The H200 Wireless Orthosis wrist bridge.
33
Chapter 5 - H200 Wireless Orthosis
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.
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Figure 5-13: The H200 Wireless Orthosis trigger button.
34 User's Guide
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Figure 5-14: Hooking the Orthosis wrist strap to the attachment ring.
Wrist Strap Attachment Ring
The wrist strap attachment ring is for hooking the Orthosis wrist strap to the
Orthosis. See Figure 5-14.
35
Chapter 5 - H200 Wireless Orthosis
Figure 5-15: Securing the Orthosis wrist strap.
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Wrist Strap Attachment Bar
The wrist strap attachment bar is for securing the Orthosis wrist strap around
the wrist. See Figure 5-15.
36 User's Guide
Status Light
The status light communicates system status and error messages. See
Table 5-1.
Stimulation Light
The stimulation light communicates whether stimulation is on, off, or
paused. See Table 5-1.
Note: The illustrations in Table 5-1 are for a left H200 Wireless Orthosis.
37
Chapter 5 - H200 Wireless Orthosis
Left Orthosis Display Description Definition
Status Light
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
Stimulation
Light SOLID YELLOW Stimulation Paused
FLASHES YELLOW
RAPIDLY Stimulation On
Table 5-1: H200 Wireless Orthosis displays.
38 User's Guide
Audio Alerts
The Orthosis will beep when:
• 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.
39
Chapter 5 - H200 Wireless Orthosis
Figure 5-16: H200 Wireless Orthosis charging port.
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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.
40 User's Guide
41
Chapter 6 - H200 Wireless Control Unit
6
Chapter
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.
42 User's Guide
Operating Buttons
The Control Unit has eight operating buttons. See Table 6-1, Figure 6-1, and
Table 6-2.
Operating
Button Description Function
On/Off Button Turns On/Off the System
Trigger Button Turns On/Off and Pauses Stimulation
Intensity
Adjustment
Buttons
Increases Stimulation Intensity
Decreases Stimulation Intensity
Mute Button Mutes/Un-Mutes the Control Unit and H200
Wireless Orthosis Audio Alerts
Program Selection
Buttons
Top: Selects Program 1
Bottom: Selects Program 2
Stimulation Test
Button Tests Stimulation in the H200 Wireless Orthosis
Table 6-1: Operating buttons: functions.
43
Chapter 6 - H200 Wireless Control Unit
Figure 6-1: Operating buttons.
Table 6-2: Operating buttons: visual displays.
Mute Button
Program 2
Button
Stimulation
Test Button
On/Off Button
Trigger Button
Intensity
Adjustment
Buttons
Program 1
Button
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
44 User's Guide
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.
Figure 6-2: H200 Wireless Control Unit digital display and indicators.
Digital Display
Program 2 Indicator
Control Unit Status
Indicator
Program 1 Indicator
RF Communication
Indicator
45
Chapter 6 - H200 Wireless Control Unit
Indicator Description Definition
Control Unit Status Indicator
FLASHES YELLOW
Low Battery, H200 Wireless
Control Unit
Control Unit Status Indicator is
SOLID RED
Control Unit Charging Error;
Electronic Registration Error;
Control Unit Hardware/Software
Error
Program 1 Indicator is GREEN Program 1 Selected
Program 2 Indicator is GREEN Program 2 Selected
RF Communication Indicator
FLASHES RED RF Communication Error
Table 6-3: H200 Wireless Control Unit indicator lights.
The Control Unit indicators show:
• Control Unit status.
• Stimulation program selected.
• Control Unit low battery.
• RF communication status. See Table 6-3.
46 User's Guide
Display Description Definition
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" H200 Wireless Control Unit Unregistered
Rotating GREEN Circle H200 Wireless Control Unit Charging
Horizontal GREEN Line H200 Wireless Control Unit Fully Charged
Table 6-4: H200 Wireless Control Unit digital displays.
The Control Unit digital display shows:
• Stimulation intensity level: 0–9.
• Electronic registration status.
• Battery charging status. See Table 6-4.
47
Chapter 6 - H200 Wireless Control Unit
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.
48 User's Guide
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.
Figure 6-3: Control Unit charging port.
Signal Input/
Output Port
Charging
Port
CAUTION: The signal input/output port on the Control Unit is
only to be used by the clinician during setup.
49
Chapter 7 - H200 Wireless Stimulation Programs
7
Chapter
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.
Motor Neuromodulation programs deliver rapid bursts of stimulation to the flexor
and extensor muscles, the flexor muscles only, or the extensor muscles only.
During your clinical/therapy sessions:
•
Your clinician will select the stimulation programs that best fit your therapeutic
needs.
• Assign programs to the program buttons on your Control Unit for you to
use at home.
• Customize the programs based on your specific impairment.
50 User's Guide
51
Chapter 8 - Setup Instructions
8
Chapter
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.
Figure 8-1: System charger interchangeable blades.
52 User's Guide
2. Slide the selected blade into the system charger. See Figure 8-2.
Figure 8-2: Sliding the blade into the system charger.
System
Charger
Blade
CAUTION: Use only the charger included in your H200 Wireless
System Kit. Use of any other charger could damage the system.
53
Chapter 8 - Setup Instructions
Figure 8-3: Charging setup.
Flexible
Cover
Charging Port
Charging Port
System
Charger
Y Cable
Interchangeable
Blade
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.
CAUTION: Make sure your hands are dry before connecting
the system charger to a power outlet.
54 User's Guide
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.
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.
55
Chapter 8 - Setup Instructions
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.
6. If the Orthosis is charging, the status light on the Orthosis will
ALTERNATELY FLASH YELLOW and GREEN. See Table 8-2.
The charging process is complete when:
• A horizontal GREEN line appears in the Control Unit digital
display.
• The status light on the Orthosis is solid GREEN.
The charging process should last approximately four hours. The Control Unit
can take up to six hours to charge.
Note: Keep the Control Unit and Orthosis connected to the system charger
until ready for use.
56 User's Guide
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.
• Make sure your Orthosis and Control Unit are charged.
Do not use your H200 Wireless System if a component appears to be damaged.
If you have any questions about your H200 Wireless System, contact the
Bioness Client Relations Department at (800) 211-9136, Option 3.
CAUTION: Extreme temperatures may damage your system.
Store your H200 Wireless System where it will not be exposed
to extreme temperatures or humidity. See the environmental
ranges in the Technical Specifications chapter of this guide
for safe storage conditions.
57
Chapter 8 - Setup Instructions
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. If
any lotions are on the skin, clean the skin with soap and water. Rinse well.
3.
If necessary, trim excess body hair from the area using an electric shaver
or scissors. Do not use a razor. A razor can irritate the skin.
CAUTION: Do not wear the Orthosis over broken skin.
58 User's Guide
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.
59
Chapter 8 - Setup Instructions
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.
60 User's Guide
5. Match each cloth electrode to its corresponding electrode base. See
Figure 8-6.
Figure 8-6: Electrode bases #1–#5.
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61
Chapter 8 - Setup Instructions
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.
62 User's Guide
Figure 8-8: Cloth electrodes in place on the Orthosis.
8. Check that each cloth electrode is securely attached to its corresponding
electrode base. See Figure 8-8.
CAUTION: Do not wear the Orthosis without the cloth electrodes.
63
Chapter 8 - Setup Instructions
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.
64 User's Guide
2. Position the Orthosis wrist bridge comfortably on the back of your wrist.
See Figure 8-10.
Figure 8-10: Positioning the wrist bridge.
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WARNING: Do not turn on stimulation until your Orthosis is
completely set up and correctly attached to your arm.
65
Chapter 8 - Setup Instructions
Figure 8-11: Positioning the flexor support.
3. Place your forearm in the Orthosis flexor support. See Figure 8-11.
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66 User's Guide
Figure 8-12: Closing the wing.
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.
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67
Chapter 8 - Setup Instructions
6. Attach the hook on the Orthosis wrist strap to the wrist strap attachment
ring. See Figure 8-13.
Figure 8-13: Attaching the Orthosis wrist strap.
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68 User's Guide
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.
Figure 8-14: Attaching the wrist strap.
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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.
CAUTION: Do not tighten the wrist strap so much that it interferes
with blood flow to the hand.
69
Chapter 9 - Operating the H200 Wireless System
9
Chapter
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. All display indicators on the Control Unit and the Orthosis
will light up for a few seconds while the system performs a self-test.
When the system is on:
• The on/off button on the Control Unit will FLASH GREEN.
• The status light on the Orthosis will FLASH GREEN.
Turning Off the System
Press the on/off button once.
70 User's Guide
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 trigger button should
not be lit.
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.) When stimulation is on, the trigger button will FLASH
YELLOW RAPIDLY.
3. Release the stimulation test button to turn off stimulation.
4. Repeat to test stimulation of the flexor muscles.
5. If the Orthosis is not positioned correctly:
• Turn off the system.
• Open the Orthosis wing and remove the Orthosis. Do not slide
the Orthosis on your arm.
• Recheck the cloth electrodes to make sure they are positioned
correctly and wet.
• Put the Orthosis back on.
• Close the Orthosis extensor wing until no clicking can be
heard.
• Retest stimulation.
71
Chapter 9 - Operating the H200 Wireless System
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.
Figure 9-1: Operating buttons.
Mute Button
Program 2
Button
Stimulation
Test Button
On/Off Button
Trigger Button
Intensity
Adjustment
Buttons
Program 1
Button
72 User's Guide
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 trigger button will FLASH YELLOW.
• The Orthosis stimulation light will FLASH YELLOW
RAPIDLY.
3. Your hand will start moving per the program selected.
Note: Some of the programs contain rest periods. A rest period will last for
at least one minute. During a rest period, stimulation will turn off and the
Orthosis stimulation light will FLASH YELLOW SLOWLY. The Control Unit
trigger button will continue to FLASH YELLOW.
73
Chapter 9 - Operating the H200 Wireless System
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. When the program is paused:
• The Control Unit trigger button will be SOLID YELLOW.
• The Orthosis stimulation light will be SOLID YELLOW.
Note: Neuroprosthesis programs cannot be paused. Pressing the trigger
button when stimulation is on starts the second phase of a Neuroprosthesis
program.
CAUTION: Remove the Orthosis to stop stimulation when the
Control Unit is not operable or accessible and the Orthosis
trigger button is disabled.
74 User's Guide
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. Your hand will remain open until you press the Control Unit trigger button
or Orthosis trigger button a second time, turning off stimulation.
Note: Do not use the Open Hand program for more than 30 seconds at a
time. Your muscles may begin to fatigue.
75
Chapter 9 - Operating the H200 Wireless System
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. Stimulation will then stop. Your hand will relax.
Note: If stimulation turns off abruptly, the object will release from your grasp.
76 User's Guide
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. 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. Stimulation will then stop. Your hand will relax.
Stopping Stimulation
Press the trigger button on the Control Unit or the trigger button on the
Orthosis. Stimulation will turn off.
Note: In a Neuroprosthesis program press the on/off button to stop
stimulation immediately.
77
Chapter 9 - Operating the H200 Wireless System
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. The new level will show
in the digital display.
Note: An intensity level of “0” equals no stimulation.
Note: When the system is turned on the next time, the stimulation intensity
level set by your clinician ("5") will be restored.
78 User's Guide
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.
Types of Audio Alerts Muting
Allowed
Faulty electrode contact Yes
Changes in software state Yes
Power supply detected Yes
Charging error No
Software/Hardware Error No
Battery depletion threshold reached No
Orthosis electronic registration successful/unsuccessful No
Table 9-1: Types of audio alerts.
79
Chapter 10 - Removing the Orthosis
10
Chapter
Removing the Orthosis
To remove the Orthosis:
1. Press the Control Unit on/off button to turn off the H200 Wireless
system.
2. Carefully unfasten the wrist strap and slide it away from the wrist strap
attachment bar. See Figure 10-1.
Figure 10-1: Unfastening the wrist strap.
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80 User's Guide
3.
Pinch the wing release handle and wing arm together and open the extensor
wing. See Figure 10-2.
Figure 10-2: Opening the extensor wing.
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81
Chapter 10 - Removing the Orthosis
4.
With the extensor wing open (See Figure 10-3), remove the flexor support
from under your forearm.
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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82 User's Guide
83
Chapter 11 - Maintenance and Cleaning
11
Chapter
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.
Charging
The Control Unit and Orthosis batteries should be charged daily. Charging
instructions can be found in the Setup Instructions chapter of this guide.
84 User's Guide
H200
Wireless
Control Unit
Battery
Battery Cover
Screw
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.
Note: The screw is under a small label. Gently peel off the end of the label.
Reapply the label after the battery is replaced.
Figure 11-1: Replacing the H200 Wireless Control Unit battery.
85
Chapter 11 - Maintenance and Cleaning
Remove the old battery, and properly dispose of it according to
your local environmental regulations.
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.
Battery Replacement: H200 Wireless Orthosis
The Orthosis has a rechargeable battery that can only be replaced by a Bioness
authorized representative. If the battery needs to be replaced, contact the
Bioness Client Relations Department, at (800) 211-9136, Option 3.
CAUTION: Use only a battery supplied by Bioness Inc.
CAUTION: Use of a non-rechargeable AAA battery can damage
the H200 Wireless Control Unit.
86 User's Guide
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.
Orthosis Wrist Strap
Hand wash the Orthosis wrist strap in mild soap and cold water. The Orthosis
wrist strap has a metal piece that may rust if machine washed.
Orthosis Electrode Bases
The Orthosis electrode bases may be wiped with a clean, damp cloth.
87
Chapter 11 - Maintenance and Cleaning
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. As needed, use additional saturated disinfectant wipes or cloths to keep
the components surface wet for 3 minutes.
Note: Be sure to follow the Bioness instructions for the specified contact time
to ensure an effective bacteria kill.
88 User's Guide
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. As needed, use additional saturated disinfectant wipes or cloths to keep
the components surface wet for 3 minutes.
Note: Be sure to follow the Bioness instructions for the specified contact time
to ensure an effective bacteria kill.
Wrist Insert
The wrist insert cannot be disinfected. The wrist insert can only be cleaned
with soap and water. Do not use 70% IPA on the wrist insert. If infection is a
concern contact your clinician or the Bioness Client Relations Department
at (800) 211-9136, Option 3, for assistance.
89
Chapter 11 - Maintenance and Cleaning
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.
4. Keep spraying the entire carrying case surface as needed to keep it wet
for 10 minutes.
70% IPA:
1. Wipe the entire surface of the System Kit carrying case with a cloth or
wipe saturated with 70% IPA.
2. Use a new cloth or wipe saturated with 70% IPA to remove any surface
contaminants. Soil, etc., will impede the disinfectant's effectiveness, if
not removed.
3. Wipe the entire surface of the System Kit carrying case again with a new
cloth or wipe saturated with 70% IPA.
4. Use additional new cloths or wipes saturated with 70% IPA as needed to
keep the entire surface of the carrying case wet for 10 minutes.
90 User's Guide
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.
91
Chapter 12 - Electronic Registration of Replacement Parts
12
Chapter
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.
This section describes the steps to electronically register a replacement H200
Wireless Control Unit or Orthosis.
IMPORTANT: When registering a replacement component, make
certain any other H200 Wireless System component is at least 30
feet from the components to be registered.
92 User's Guide
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.
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.
H200 Wireless
Orthosis
H200 Wireless
Control Unit
93
Chapter 12 - Electronic Registration of Replacement Parts
System ID Number
System ID Number
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.
Figure 12-2: Location of the System ID Numbers.
94 User's Guide
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.
Registration
Error
Registration
Complete
Registration
in Process
Figure 12-3: Registration digital displays.
95
Chapter 12 - Electronic Registration of Replacement Parts
5. When registration is complete:
• (“C” for complete) will appear in the digital display.
• The Control Unit status light and the Orthosis status
light will turn GREEN for a few seconds.
• The Control Unit will beep.
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.
Turn the Control Unit off and repeat the registration process.
Note: Components can only be successfully registered once. Additional
attempts will generate an error indication.
6. After registration is complete, turn on your H200 Wireless System. If the
Control Unit is registered to the Orthosis, the Orthosis will turn on.
Note: If the RF communication indicator on the Control Unit is FLASHING
RED, registration failed. Repeat the registration procedure.
96 User's Guide
97
Chapter 13 - Troubleshooting
13
Chapter
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 Problems/Solutions
Control Unit
FLASHES RED
Radio Communication Failure
• Make sure the H200 Wireless Orthosis and the Control
Unit are within 10 feet of each other.
• If the components are within range and working properly,
then turn the Control Unit off and back on.
Reorient the Control Unit.
• Check for obstructions or sources of interference.
• Change the H200 Wireless cloth electrodes.
• Contact the Bioness Client Relations Department.
98 User's Guide
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 GREEN horizontal line will
appear in the Control Unit digital display.
•
When the Orthosis is fully charged, the status light on the Orthosis
will be SOLID GREEN.
• Charging takes approximately four hours, but the Control Unit can take
as long as six hours to charge.
• After the components are fully charged, keep them connected to the
system charger until ready to use.
If I charge the NESS H200 Wireless System every day, will I harm the
batteries?
•
No. Daily charging will not affect the lifespan or functionality of the batteries.
Daily charging is recommended.
While charging the Control Unit, the status light on the Control Unit
turns RED.
• A charging error has occurred. Reconnect the system charger Y cable.
If the problem persists, contact the Bioness Client Relations Department
at (800) 211-9136, Option 3.
99
Chapter 13 - Troubleshooting
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.
I hear a beep and the status light on the Orthosis FLASHES RED.
• A faulty electrode contact error has occurred. One or more of the cloth
electrodes is not in contact with the skin.
• Turn off the Control Unit and remove the Orthosis.
• Thoroughly cleanse the skin, removing any oils.
• Remove and examine the cloth electrodes. If the cloth
electrodes are old or damaged, then replace them.
• Clean the electrode bases, if necessary.
• Wet and replace the cloth electrodes.
• Make sure the extensor wing is closed properly.
100 User's Guide
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.
• If the Control Unit is connected to the system charger and stimulation is
not affected, a charging error has occurred.
• Reconnect the charger.
• Change the battery.
• If the problem persists, contact the Bioness Client Relations
Department at (800) 211-9136, Option 3.
•
If the Control Unit is not connected to the system charger and the system
does not operate, a Control Unit hardware or software malfunction has
occurred.
• Turn off the Control Unit and turn it back on.
• If the problem persists, stop using the system and contact the
Bioness Client Relations Department, Option 3.
101
Chapter 13 - Troubleshooting
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 stimulation test
button.
My skin is irritated where the cloth electrodes touch.
• Stop using the NESS H200 Wireless System immediately.
• Contact your clinician or dermatologist, and the Bioness Client
Relations Department, Option 3.
• Resume use only when your skin is completely healed.
• Ask your clinician or dermatologist for a skin conditioning
protocol.
102 User's Guide
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.
• A replacement component needs to be electronically registered to the
existing component for the NESS H200 Wireless System to communicate
wirelessly.
• For instructions on how to register a replacement component,
see "Electronic Registration of Replacement Parts."
I tried the electronic registration procedure, but I never saw the alternating
arches in the digital display. The replacement component is not working.
• Turn off the Control Unit.
•
Press the minus button and the trigger button on the Control Unit,
and then press the trigger button on the Orthosis, to start the registration
process.
103
Chapter 13 - Troubleshooting
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.
Quick Reference Troubleshooting
Control
Unit Description Definition
Control Unit Status Indicator
FLASHES YELLOW
Low Battery, H200 Wireless
Control Unit
Control Unit Status Indicator is
SOLID RED
Control Unit Charging Error;
Electronic Registration Error;
Control Unit Hardware/Software
Error
Program 1 Indicator is GREEN Program 1 Selected
Program 2 Indicator is GREEN Program 2 Selected
RF Communication Indicator
FLASHES RED RF Communication Error
104 User's Guide
Control
Unit 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
105
Chapter 13 - Troubleshooting
Left Orthosis Display Description Definition
Status Light
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
Stimulation
Light SOLID YELLOW Stimulation Paused
FLASHES YELLOW
RAPIDLY Stimulation On
106 User's Guide
107
Chapter 14 - Technical Specifications
14
Chapter
Technical Specifications
H200 Wireless Control Unit Specifications
Classification Internally powered, continuous operation
Operation Modes User and Standby
Battery Type Rechargeable AAA NiMH 1.2 V, 900–1100 mAh
Controls
• On/Off illuminated button
• Trigger illuminated button to turn on and pause stimulation
• Intensity +/- buttons to fine-tune intensity level
• Mute button to mute audio alerts
• Program selection buttons (1, 2)
• Stimulation test button
Indications
• Four status icons: H200 Wireless Control Unit, RF
Communication Status, Selected Program (1, 2)
• Digital display designates relative stimulation intensity
• Illuminated buttons designate system on/off and stimulation
on/off or paused.
• “Beeps” for audio alerts
Carrying Options In pocket, neck strap, wrist strap, or belt pouch
Dimensions Length: 73 mm (2.9 in.); Width: 46 mm (1.8 in.);
Height: 18 mm (0.7 in.)
Weight 45 grams (1.5 oz.)
Environmental
Ranges
• Transport and storage temperature: -25°C to +70°C (-13°F to
+158°F)
• Operating conditions temperature: 5°C to 40°C (41°F to
104°F)
• Operating conditions relative humidity: 15% to 93%
• Charging temperature: 5°C to 40°C (41°F to 104°F)
108 User's Guide
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) 3.7 V, 280–350
mAh
Indications
• H200 Wireless Orthosis status (fault, battery, charging) and
Stimulation LEDs
• “Beeps” for audio alerts
Material
• Main body cover: Rilsan BZM 30 OTL
• Wing cover: TEREZ ABS 5010
• Wrist insert: Flexible foam, two components urethane non-
integral skin, Purtec GMBH
• Thenar: Dow Corning Silicone Rubber NPC 40
Configurations
• Size: Small/Medium/Large
• Side: Left and Right
• Total of 6 configurations
Environmental
Ranges
• Transport and storage temperature: -25°C to +70°C (-13°F
to +158°F)
• Operating conditions temperature: 5°C to 40°C (41°F to
104°F)
• Operating conditions relative humidity: 15% to 93%
• Charging temperature: 5°C to 40°C (41°F to 104°F)
• IP classification: IP27
109
Chapter 14 - Technical Specifications
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.)
110 User's Guide
H200 Wireless Orthosis Pulse Parameters
Pulse Balanced Biphasic
Waveform Symmetric
Intensity (Peak) 0–80 mA, 1-mA resolution (positive phase)
Maximum Current Intensity
(rms)
• Electrodes #1, #2, #3, #5: 13.1 mA rms
• Electrode #4: 18.6 mA rms
Max Voltage 120 V
Symmetric
Positive Pulse Duration (μsec) 100 200 300
Negative Pulse Duration (μsec) 100 200 300
Inter-Phase Interval (μsec) 50
Max Total Pulse Duration
(μsec)
250 450 650
Load Range 0–5000 ohm (Subject to max voltage limitation)
Nominal Load 500 ohm
Max Power Load 500 ohm (80 mA, 120 V)
Pulse Repetition Rate 20–45 Hz, 5-Hz resolution
Ramp Up 0–3.1 seconds
Ramp Down 0–3.1 seconds
Max. Duration of Stimulation
Program
4 hours, 5-minute resolution
111
Chapter 14 - Technical Specifications
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.
112 User's Guide
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.
Transmitters
Operating Frequency Band 2401–2482 MHz
Type of Modulation FSK
Type of Modulating Signal Binary data message
Data Rate [=Frequency of Modulating
Signal]
250 Kbps
Effective Radiated Power <10 dBm
Receivers
Operating Frequency Band 2401–2482 MHz
Receiver Bandwidth 812 kHz around a selected frequency
113
Chapter 15 - Appendix - EMI Tables
15
Chapter
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. Therefore, its RF emissions
are very low and are not likely to cause
any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B The NESS H200 Wireless System is
suitable for use in all establishments,
including domestic establishments and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
114 User's Guide
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
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be
wood, concrete,
or ceramic tile. If
floors are covered
with synthetic
material, the
relative humidity
should be at least
30%.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power
supply lines
1 kV for input/
output lines
2 kV for power
supply lines
Mains power
quality should be
that of a typical
commercial
or hospital
environment.
Surge
IEC 61000-4-5
1 kV line to line
2 kV line to earth
1 kV line to line
(Class II without
any grounded
interconnections)
Mains power
quality should be
that of a typical
commercial
or hospital
environment.
115
Chapter 15 - Appendix - EMI Tables
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
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip
in UT) for 5 sec
<5% UT (>95% dip
in UT) for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip
in UT) for 25 cycles
<5% UT (>95% dip
in UT) for 5 sec
Mains power
quality should be
that of a typical
commercial
or hospital
environment. If
the user of the
NESS H200
Wireless System
requires continued
operation during
power mains
interruptions, it
is recommended
that the equipment
be powered from
an uninterruptible
power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE: UT is the AC mains voltage prior to application of the test level.
116 User's Guide
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.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment—
Guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of the NESS H200 Wireless
System, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Conducted
RF
IEC 61000-
4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to
80 MHz
Recommended separation
distance:
d = 1.2√P
Radiated RF
IEC 61000-
4-3
3 V/m
80 MHz to
2.5 GHz
[E1] = 3 V/m
in 80 MHz to
2.5 GHz
[E1] = 10 V/m
in 26 MHz to
1 GHz
Recommended separation
distance:
d = 0.4√P, 80–800 MHz range
d = 0.7√P, 800–1000 MHz range
d = 2.3√P, 1000–2500 MHz range
117
Chapter 15 - Appendix - EMI Tables
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).
NOTE 4: Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,a should be less than the compliance level in each
frequency range.b
NOTE 5: Interference may occur in the vicinity of equipment marked with the following
symbol:
a Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in
the location in which the NESS H200 Wireless System is used exceeds the applicable
RF compliance level above, the NESS H200 Wireless System should be observed to
verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the NESS H200 Wireless
System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.
118 User's Guide
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. The customer or the user of the NESS H200
Wireless System can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and
the NESS H200 Wireless System as recommended below, according to the maximum
output power of the communications equipment.
Rated
Maximum
Output
Power of
Transmitter
(W)
Separation Distance According to Frequency of Transmitter
150 kHz to
80 MHz
Outside ISM
Bands
d = 1.2√P
80 MHz to
800 MHz
d = 0.4√P
800 MHz to
1000 MHz
d = 0.7√P
1000 MHz to
2.5 GHz
d = 2.3√P
0.01 4.7 in.
(0.12 m)
1.6 in.
(0.04 m)
2.8 in.
(0.07 m)
9.1 in.
(0.23 m)
0.1 15 in.
(0.38 m)
5.2 in.
(0.13 m)
8.7 in.
(0.22 m)
2 ft 5 in.
(0.73 m)
1 3 ft 11 in.
(1.2 m)
15 ft 7 in.
(0.4 m)
2 ft 4 in.
(0.7 m)
7 ft 7 in.
(2.3 m)
10 12 ft 6 in.
(3.8 m)
4 ft 2 in.
(1.3 m)
7 ft 3 in.
(2.2 m)
24 ft 11 in.
(7.3 m)
100 39 ft 4 in.
(12 m)
13 ft 1 in.
(4 m)
23 ft
(7 m)
75 ft 6 in.
(23 m)
119
Chapter 15 - Appendix - EMI Tables
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.
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable
to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note: All calculations were made according to tables 204 and 206 of IEC 60601-1-2
for equipment that is not life-supporting using factors of 3.5 in 0.15–800 MHz and 7 in
800–2500 MHz. There are no requirements for ISM bands in these tables.
120 User's Guide