Bioness Ness H200 User manual

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: [phone]
Email: [e-mail]
Website: www.bioness.com
602-00503-001 Rev. C
NESS®, NESS H200®, NESS H200® Wireless, Bioness, the Bioness Logo®, and LiveOn® are trademarks of Bioness Inc. | www.bioness.com
Rx Only
©2011 Bioness Inc.

Clinician’s Guide

Clinician’s Guide
Rx Only

II Clinician's Guide
Clinician’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 and its affiliates do 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. When the life cycle of the NESS H200 Wireless System has been completed, the product
should be discarded according to the laws and regulations of the local authority. 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: [phone]
Email: [email protected]
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: [phone], Option 3; or [phone], Option 3.

III
List of Symbols
Caution or Warning
Type BF Applied Part(s)
Complies with the European Union Medical Device Directive
Double Insulated (Equivalent to Class II of IEC 536)
Non-Ionizing Radiation
This Product Must Not be Disposed of with Other Household Waste
Complies with United States and Canadian Product Safety Standards
European Authorized Representative
Manufacturer
Consult Instructions for Use
Re-Order Number
Lot Number
Serial Number
Single Patient Use
Date of Manufacture
Lt Fits Left Orthosis
Rt Fits Right Orthosis

IV Clinician's Guide
Rt
Fits Large Orthosis
Lt
Fits Small and Medium Orthoses
Lt
Thick Wrist Insert
Rt
Large Thenar
Lt
FPL Panel

V
Table of 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 ..........................................................................................................................................4
Warnings ......................................................................................................................................................4
Adverse Reactions .......................................................................................................................................5
Precautions ...................................................................................................................................................5
Chapter 3: Environmental Conditions that Affect Use .......................................................... 9
Radio Frequency (RF) Communication ........................................................................................................9
Travel and Airport Security .........................................................................................................................10
Electromagnetic Compatibility ....................................................................................................................10
Warnings and Cautions ........................................................................................................................ 11
Chapter 4: The NESS H200 Wireless System ...................................................................... 13
H200 Wireless Orthosis ..............................................................................................................................13
Stimulating Electrodes ......................................................................................................................... 14
Orthosis Flexor Support .......................................................................................................................15
Orthosis Extensor Wing ....................................................................................................................... 15
Spiral End of the Orthosis ....................................................................................................................16
Indicator Lights .....................................................................................................................................17
Audio Alerts ..........................................................................................................................................18
Rechargeable Battery and Charging Port ............................................................................................19
H200 Wireless Control Unit ........................................................................................................................ 20
Operating Buttons ................................................................................................................................20
On/Off Lights ........................................................................................................................................22
Operating Modes .................................................................................................................................22
Standby Mode .........................................................................................................................22
User Mode...............................................................................................................................22
Clinical Mode...........................................................................................................................22
Indicators and Digital Display ...............................................................................................................23
Audio Alerts ..........................................................................................................................................26
Rechargeable Battery and Charging Port ............................................................................................27

VI Clinician's Guide
H200 Wireless Clinical Programs ...............................................................................................................28
Functional Training Programs ..............................................................................................................28
Program A—Grasp and Release ............................................................................................28
Program B—Open Hand .........................................................................................................28
Program C—Grasp .................................................................................................................28
Neuroprosthesis Programs ..................................................................................................................29
Program D—Open Hand .........................................................................................................29
Program E—Grasp and Release ............................................................................................29
Program F—Key Grip..............................................................................................................29
Motor Neuromodulation Program .........................................................................................................29
Program G—Extensors and Flexors, Extensors Only, Flexors Only .......................................29
Personal Preset Programs ...................................................................................................................30
Personal Custom Programming ...........................................................................................................30
Operating the NESS H200 Wireless System ..............................................................................................31
Turning the System On/Off ..................................................................................................................31
Testing Stimulation in the H200 Wireless Orthosis ..............................................................................31
Selecting a User Program ....................................................................................................................31
Entering Clinical Mode .........................................................................................................................31
Selecting a Clinical Program ................................................................................................................31
Turning On Stimulation ........................................................................................................................32
Pausing Stimulation ............................................................................................................................. 32
Turning Off Stimulation ........................................................................................................................32
Adjusting Stimulation Intensity .............................................................................................................32
Muting/Un-Muting the System Audio Alerts ..........................................................................................32
Entering and Exiting Deep Sleep Mode ...............................................................................................32
Chapter 5: NESS H200 Wireless Clinician’s Kit .................................................................. 33
H200 Wireless Clinician’s Kit (small/medium) ............................................................................................33
H200 Wireless Clinician’s Kit (large) ..........................................................................................................34
H200 Wireless Clinician’s Upgrade Kit (small/medium) .............................................................................34
H200 Wireless Clinician’s Upgrade Kit (large) ............................................................................................35
PDA Components .......................................................................................................................................37
HP iPAQ Clinician’s Programmer with NESS H200 Wireless Software ...............................................37
On/Off Button ..........................................................................................................................38
Charge Indicator Light .............................................................................................................38

VII
SD (Secure Digital) Slot ..........................................................................................................38
Connector Port ........................................................................................................................38
HP iPAQ Configuration Cradle with Stylus ........................................................................................... 38
HP iPAQ Clinician’s Programmer Charger ...........................................................................................38
Accessories ................................................................................................................................................39
Thenar ..................................................................................................................................................39
Thenar Screws .....................................................................................................................................39
Wrist Insert ...........................................................................................................................................40
Wrist Insert Screws ..............................................................................................................................40
Wrist Insert Covers ...............................................................................................................................40
H200 Wireless FPL Panel ....................................................................................................................41
H200 Wireless FPL Panel Screws .......................................................................................................41
Fitting Panels ....................................................................................................................................... 42
Extensor Fitting Panels ...........................................................................................................42
Flexor Fitting Panels ...............................................................................................................43
Electrode Base Set .............................................................................................................................. 44
Electrode Base Screw and Washer Set ...............................................................................................44
H200 Wireless Cloth Electrodes ..........................................................................................................44
Chapter 6: Fitting the H200 Wireless Orthosis ................................................................... 45
Measuring for Orthosis Size ....................................................................................................................... 45
Fitting the Thenar .......................................................................................................................................46
Fitting the Wrist Insert .................................................................................................................................48
Fitting the Wrist Strap and FPL Panel ........................................................................................................51
Attaching the Wrist Strap ..................................................................................................................... 53
Attaching the FPL Panel ......................................................................................................................55
Determining the Optimal Electrode Configuration ...................................................................................... 57
Extensor Fitting Panels ........................................................................................................................57
Flexor Fitting Panels ............................................................................................................................ 59
Wetting/Attaching the H200 Wireless Cloth Electrodes ..............................................................................61
Chapter 7: PDA Setup ......................................................................................................... 63
Connecting the Clinician’s Programmer to the Cradle ................................................................................63
Charging the Clinician’s Programmer .........................................................................................................63
Connecting the H200 Wireless Control Unit ...............................................................................................64
Chapter 8: NESS H200 Wireless Software .......................................................................... 65

VIII Clinician's Guide
Navigation Tools .........................................................................................................................................65
Information Icon ................................................................................................................................... 65
Menus ..................................................................................................................................................66
Tabs .....................................................................................................................................................67
Buttons .................................................................................................................................................68
Keyboard ..............................................................................................................................................69
Drop-Down Lists ..................................................................................................................................69
Scroll Bars ............................................................................................................................................70
Stimulation Intensity Bar ...................................................................................................................... 70
Program Countdown Clock ..................................................................................................................71
Program Active Phase Color Display ...................................................................................................71
Programming the NESS H200 Wireless System ........................................................................................72
Logging In ............................................................................................................................................72
Start-Up Messages .............................................................................................................................. 73
New Patient Detected .............................................................................................................73
Control Unit Unassigned .........................................................................................................74
H200 Wireless Control Unit Not Registered ............................................................................74
Data Inconsistency ..................................................................................................................75
Opening/Creating a Patient Record .....................................................................................................76
Configuring Stimulation Parameters ....................................................................................................77
Configuring Clinical Programs A–G .....................................................................................................78
Program A—Grasp & Release ................................................................................................79
Program B—Open Hand ......................................................................................................... 80
Program C—Grasp .................................................................................................................81
Program D—Grasp & Release ................................................................................................82
Program E—Open Hand ......................................................................................................... 83
Program F—Key Grip..............................................................................................................84
Program G—Motor Neuromodulation .....................................................................................85
Ext. and Flex. (Extensors and Flexors) ......................................................................85
Extensors ...................................................................................................................86
Flexors .......................................................................................................................87
Configuring a Personal Custom Program ............................................................................................88
Assigning User Program Buttons 1 and 2 ............................................................................................90

IX
Viewing a Patient’s Session Log ................................................................................................................92
Viewing a Patient's Use Log .......................................................................................................................94
Viewing the System Information .................................................................................................................95
Managing Patient Records .........................................................................................................................96
Modifying a Patient Name ....................................................................................................................96
Removing a Patient Record .................................................................................................................96
Managing Users .........................................................................................................................................97
Adding a User ...................................................................................................................................... 97
Removing a User ................................................................................................................................. 98
Changing a User’s Password ...............................................................................................................98
Backing Up and Restoring the Database ...................................................................................................99
Automatic Backup ................................................................................................................................99
Manual Backup .................................................................................................................................... 99
Restore ..............................................................................................................................................100
Chapter 9: Patient Training and Follow-Up ....................................................................... 101
Patient Training .........................................................................................................................................101
Donning/Doffing the H200 Wireless Orthosis ....................................................................................102
Operating the NESS H200 Wireless System .....................................................................................103
Maintaining and Cleaning the NESS H200 Wireless System ............................................................103
Troubleshooting .................................................................................................................................103
Practicing with the NESS H200 Wireless System ..............................................................................103
Patient Follow-Up and Clinical Support ...................................................................................................104
Suggested Follow-up Agenda ............................................................................................................104
Chapter 10: Maintenance and Cleaning ............................................................................ 105
Charging ...................................................................................................................................................105
Batteries ...................................................................................................................................................105
HP iPAQ Clinician’s Programmer .......................................................................................................105
H200 Wireless Orthosis .....................................................................................................................105
H200 Wireless Control Unit ................................................................................................................105
H200 Wireless Cloth Electrodes ...............................................................................................................106
Electrode Bases .......................................................................................................................................106
Electronic Registration ..............................................................................................................................106
Maintenance Summary .............................................................................................................................107

XClinician's Guide
Cleaning the H200 Wireless Components ................................................................................................108
Disinfecting the H200 Wireless Components ........................................................................................... 108
Electronic Components ......................................................................................................................108
Wrist Insert .........................................................................................................................................109
Chapter 11: Troubleshooting ............................................................................................111
Frequently Asked Questions ..................................................................................................................... 112
Chapter 12: Technical Specifications ............................................................................... 115
Chapter 13: Appendix - EMI Tables ................................................................................... 119

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, edema, pain syndromes of the hand and shoulder,
and limb-neglect due to learned non-use.
The NESS H200 Wireless Hand Rehabilitation System delivers electrical stimulation to the
nerves of the flexor and extensor muscles that control the hand, to improve hand function and
treat upper limb impairments resulting from injury to the central nervous system. The NESS
H200 Wireless System is easy to operate independently, and promotes clinical efficacy and
patient compliance.
This NESS H200 Wireless Clinician’s Guide describes:
• The NESS H200 Wireless System.
• The NESS H200 Wireless Software.
• How to fit the NESS H200 Wireless System.
• How to program the NESS H200 Wireless System.
This guide also includes important safety instructions. Be sure to review the safety instructions
with patients before they use the NESS H200 Wireless System.
If you have any questions, please call the Bioness Client Relations Department at
[phone], Option 3, or visit the Bioness website: www.bioness.com.

2Clinician'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 a radio-frequency controlled 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—stabilizes the wrist at a functional angle and transmits electrical
stimulation through five surface electrodes to provide optimal wrist and hand movements.
H200 Wireless Control Unit—used to start and stop stimulation, adjust stimulation intensity,
and select stimulation programs. The clinician customizes stimulation programs for each
patient using specialized H200 Wireless Software installed on the H200 Wireless Clinician's
Programmer.
These components communicate wirelessly to stimulate the nerves of the flexor and extensor
muscles that control the hand, to improve hand function and treat upper limb impairments
resulting from injury to the central nervous system.

4Clinician's Guide
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.
Contraindications
• Do not use the NESS H200 Wireless System on an arm where a cancerous lesion is
present or suspected.
• Do not use the NESS H200 Wireless System on patients who 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 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.
• The H200 Wireless Orthosis should not be worn over swollen, infected, or inflamed areas
or skin eruptions such as phlebitis, thrombophlebitis, and varicose veins.
• Stimulation should only be applied to normal, intact, clean, healthy skin.
• Advise patients to turn off the NESS H200 Wireless System before driving, operating
machinery, or performing any activity in which involuntary muscle contractions may put
them at undue risk of injury.
• Advise patients not to use the NESS H200 Wireless System while sleeping.

5
Chapter 2 - Device Description and Safety Information
• The NESS H200 Wireless System should only be configured by an authorized clinician.
• Only trained clinicians should determine electrode placement and stimulation settings.
• The H200 Wireless Clinician’s Programmer should only contain the Windows Mobile for
Pocket PC operating system and Bioness Inc proprietary software. Third-party software
packages are not supported and may interfere with proper operation of the NESS H200
Wireless System, thus voiding the warranty.
• 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, advise patients to stop using the
NESS H200 Wireless System immediately and to consult their physician:
• 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.
Precautions
• The long-term effects of chronic electrical stimulation are unknown.
• Use caution with patients who have suspected or diagnosed heart problems. Consult
with the patient’s physician before using the NESS H200 Wireless System. The NESS
H200 Wireless System may cause lethal rhythm disturbances to the heart in susceptible
individuals.
• Any noxious stimulation can trigger autonomic dysreflexia in patients with spinal cord
injury at the T6 level and above (acute hypertension and bradycardia).

6Clinician's Guide
• Use caution with patients who have suspected or diagnosed epilepsy.
• Obtain specific physician clearance before using the NESS H200 Wireless System on
patients who have an alteration of normal arterial or venous flow in the region of the H200
Wireless Orthosis because of local insufficiency, occlusion, arteriovenous fistula for the
purpose of hemodialysis, or a primary disorder of the vasculature.
• Obtain specific physician clearance before using the NESS H200 Wireless System when
patients have a structural deformity in the area to be stimulated.
• The safe use of the NESS H200 Wireless System during pregnancy has not been
established.
• Keep the NESS H200 Wireless System out of the reach of children. Advise patients to
use the H200 Wireless Orthosis with caution:
• If the patient has a tendency to hemorrhage 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.
• Inflammation in the region of the H200 Wireless Orthosis may be aggravated by motion,
muscle activity, or pressure from the Orthosis. Advise patients to stop using the NESS
H200 Wireless System until any inflammation is gone.
• Always check the skin for redness or a rash when donning and doffing the H200 Wireless
Orthosis.
• After doffing 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. Use of the NESS H200
Wireless System should be temporarily halted until any irritation is resolved completely.
• Turn off the NESS H200 Wireless System before donning or doffing the H200 Wireless
Orthosis. Do not turn on the NESS H200 Wireless System until the Orthosis is securely
in place on the arm and the extensor wing is closed.
• Advise patients to turn off the NESS H200 Wireless System when at a refueling place.
They should not use the NESS H200 Wireless System near flammable fuel, fumes, or
chemicals.
• Turn off the NESS H200 Wireless System before attaching the electrode bases to the
Orthosis.
• Turn off the NESS H200 Wireless System before removing or replacing the cloth
electrodes.
• Remove the H200 Wireless Orthosis before wetting the cloth electrodes.

7
Chapter 2 - Device Description and Safety Information
• The H200 Wireless Control Unit and Orthosis are splash proof. However, protect all
electronic components from contact with water, such as from sinks, bathtubs, shower
stalls, rain, snow, etc. Keep the H200 Wireless Control Unit and Orthosis away from the
water used to wet the cloth electrodes.
• 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 NESS H200 Wireless cloth electrodes are 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 donning 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.
• After doffing the H200 Wireless Orthosis, allow the Orthosis to air dry.
• Do not leave the NESS H200 Wireless System stored 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, advise patients to stop using the NESS H200 Wireless
System immediately, and to contact their clinician or dermatologist and the Bioness Client
Relations Department: [phone], Option 3. They should resume use only when the
skin is completely healed, and then follow a skin conditioning protocol per the recommendation
of their health-care specialist.

8Clinician's Guide