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User`s Guide

1. susuusse 83 Daily Maintenance and Storage eedem rra Resort peckud rne sten iuRE ora Rd pauio 83 i C Sc H 83 Battery Replacement H200 Wireless Control Unit eesesesssusssuse 84 Battery Replacement H200 Wireless Orthosis esesssssssssusss 85 curo 86 General IIS UC OPIS MR E EET m 86 Control Unit Neck Strap and Wrist Strap cccccsccceecceeeceeeeeeeeeeeeeeeeaeees 86 Orthosis Wrist Sta jom 86 Orthosis Electrode BOSE cciasccccczcectecegtactarecekcnadeesiven dhetecdsteeasbecsctctanataiyacces 86 Pl qi 87 Electronic Components snerist a emen nennen enne 87 WISE INS GMM usi osten tior parre dere rash pube ntu nd de pns usd A unde ERE exERS Fa pue S apcabanten 88 VII NESS A H200 Wireless VIII System Kit Carrying C a8 i eco esee ra a Er eUsS UE UCM e x vE EUR KRVER MR KAEEA MERE 89 Chapter 12 Electronic Registration of Replacement Parts 91 Registration Set p d DT 92 PR IMO secon ROTER DRE EE 94 Chapter 13 Troubleshooting essssssesssseseseseeeeee 97 igkdre tailor Il Uj rtt ay 97 Frequently Asked OUGSIIOFI aiiis onim uere pubprt dr rano Kod Ber pns sape ser La p blu e eeee eee 98 Quick Reference TreubleshioOllig ic o neo in erp
2. Mp hS Bioness 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 Chapter 2 Device Description and Safety Information 7 NESS A H200 Wireless Use the H200 Wireles
3. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e 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 Chapter 3 Environmental Conditions that Affect Use NESS A H200 Wireless 12 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 User s Guide 3n S Bioness 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 lik
4. Chapter 9 Operating the H200 Wireless System 77 NESS A H200 Wireless 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 Ans d 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 78 User s Guide Chapter 1 0 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 Wrist Strap Attachment Bar Figure 10 1 Unfastening the wrist strap Chapter 10 Removing the Orthosis 79 NESS 2 H200 Wireless 3 Pinchthe wing release handle and wing arm together and open the extensor wing See Figure 10 2 Wing Release Handle Figure 10 2 Opening the extensor wing 80 User s Guide 3n S Bioness 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 l
5. Electromagnetic Immunity for AII 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 2 kV for power Mains power any grounded interconnections transient burst supply lines 2 kV for power quality should be IEC 61000 4 4 1 kV for input supply lines that of a typical output lines commercial or hospital environment Surge 1 kV line to line 1 kV line to line Mains power IEC 61000 4 5 2 kV line to earth Class Il without quality should be that of a typical commercial or hospital environment 114 User s Guide 3n S Bioness Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Voltage dips short lt 5 U gt 95 dip lt 5 U gt 95 dip Mains power interruptions and in Ui for 0 5 cycle in U forO 5 cycle quality should be voltage variations that of a typical on power supply 40 U 60 dip in
6. amp 39 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 g two alternating GREEN arches while registration is in process See Figure 12 3 EB A S Registration Registration Registration in Process Complete Error Figure 12 3 Registration digital displays 94 User s Guide A Bioness 5 When registration is complete e a 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 amp 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 I 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 Sy Note If the RF communication indicator Ai on the Control Unit is FLASHING RED registration failed Repeat the registration procedure Chapter 12 Electronic Registration of Replacement
7. 40 U 60 dip in commercial input lines U for 5 cycles U for 5 cycles or hospital IEC 61000 4 11 70 U 30 dip in U for 25 cycles lt 5 U 95 dip in U for 5 sec 70 UT 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec 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 U is the AC mains voltage prior to application of the test level Chapter 15 Appendix EMI Tables NESS A H200 Wireless 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 IEC 60601 Compliance Electromagnetic Environment Test Test Level Level 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 c
8. H200 Wireless Control Unit Figure 11 1 Replacing the H200 Wireless Control Unit battery Note The screw is under a small label Gently peel off the end of the label Reapply the label after the battery is replaced 84 User s Guide 3n S Bioness 2 Remove the battery cover 3 Note the orientation of the old battery 4 Remove the old battery go Insert the new rechargeable battery in the proper orientation m Slide the cover into place N Tighten the screw Fully charge the new battery before use CAUTION Use only a battery supplied by Bioness Inc CAUTION Use of a non rechargeable AAA battery can damage the H200 Wireless Control Unit Remove the old battery and properly dispose of it according to your local environmental regulations ht gt e 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 Chapter 11 Maintenance and Cleaning 85 NESS A H200 Wireless 86 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 waterproo
9. User s Guide mememe P o 25 Bioness Manufactured by Bioness Neuromodulation Ltd A Bioness Inc Company 19 Ha Haroshet Street PO Box 2500 Industrial Zone Ra Anana 43654 Israel Worldwide Corporate Office Bioness Inc 25103 Rye Canyon Loop Valencia CA 91355 USA Telephone 800 211 9136 Email info bioness com Website www bioness com NESS NESS H200 NESS H200 Wireless Bioness the Bioness Logo and LiveOn are trademarks of Bioness Inc www bioness com Rx Only 2011 Bioness Inc 602 00504 001 Rev B Sp e S Bioness NESS c H200 Wireless User s Guide Ny e aS Bioness Rx Only A e NESS H200 Wireless 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 LiveOne 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
10. A Bioness Left Orthosis Display Description Definition NA FLASHES GREEN System On Z9 FLASHES YELLOW Low Battery ALTERNATELY Status Light EUN FLASHES YELLOW Battery Charging and GREEN Battery Fully SOLID GREEN Charged Registration Successful FLASHES RED Faulty Electrode Contact SOLID RED Hardware Software Error Charging Error Stimulation Light SOLID YELLOW Stimulation Paused JE E UU IR FLASHES YELLOW RAPIDLY Stimulation On Table 5 1 H200 Wireless Orthosis displays Chapter 5 H200 Wireless Orthosis 37 NESS A H200 Wireless 38 Audio Alerts The Orthosis will beep when The NESS H200 Wireless System is turned on off e The Orthosis stimulation unit malfunctions e Stimulation is turned on off or paused There is a faulty electrode contact e The battery charge level is low e Acharging error occurs Acharger is connected User s Guide 3n S Bioness 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 Charging Port Figure 5 16 H200 Wireless Orthosis charging port Chapter 5 H200 Wireless Orthosis 39 NESS A H200 Wireless 40 User s Guide Chapter 6 H200 Wireless Control Unit The Control Unit is used to e Turn on off the NESS H200 Wireless System e Test stimulation in the Orthosis
11. H200 Wireless 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 Extensor Wing Wing Release Handle Figure 8 12 Closing the wing 66 User s Guide Sep A hS Bioness 6 Attach the hook on the Orthosis wrist strap to the wrist strap attachment ring See Figure 8 13 Wrist Strap Wrist Strap Hook Attachment Ring Figure 8 13 Attaching the Orthosis wrist strap Chapter 8 Setup Instructions 67 NESS A H200 Wireless 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 Wrist Strap Attachment Bar Cushion Figure 8 14 Attaching the wrist strap 9 Bring the wrist strap down and press to fasten CAUTION Do not pull down on the wrist strap Pulling down on the wrist strap can break the wrist strap attachment bar CAUTION Do not tighten the wrist strap so much that it interferes with blood flow to the hand 68 User s Guide Chapter 9 Operating the NESS H200 Wireless System RF Communication Features The Control Unit and Orthosis must be within RF communication range to communicate wirelessly The communication range is approximately 10 feet If RF communication fails the R
12. e Select a stimulation program e Turn on off and pause stimulation e Adjust the stimulation intensity level e Monitor system status Mute system audio alerts The Control Unit is powered by a single rechargeable NIMH AAA battery N CAUTION Use only a battery supplied by Bioness Inc Chapter 6 H200 Wireless Control Unit 41 NESS 2 H200 Wireless 42 Operating Buttons The Control Unit has eight operating buttons See Table 6 1 Figure 6 1 and Table 6 2 Operating Button Description Function D On Off Button Turns On Off the System Trigger Button Turns On Off and Pauses Stimulation c Intensity Increases Stimulation Intensity Adjustment e Buttons es Decreases Stimulation Intensity Mutes Un Mutes the Control Unit and H200 Wireless Orthosis Audio Alerts Mute Button Program Selection Top Selects Program 1 Buttons Bottom Selects Program 2 63 E Ga Stimulation Test Tests Stimulation in the H200 Wireless Orthosis Button gt Table 6 1 Operating buttons functions User s Guide 3t Bioness On Off Button Mute Button Trigger Button Program 1 Button Program 2 Intensity Button Adjustment Buttons Stimulation Test Button 3 Bioness Figure 6 1 Operating buttons Description Definition On Off Button FLASHES GREEN System On Trigger Button FLASHES YELLOW Stimulation On RAPIDLY m Trigger Bu
13. 9 NESS A H200 Wireless 10 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 User s Guide Chapter 3 Environmental Conditions that Affect Use Radio Frequency RF Communication Several components of the NESS H200 Wireless System communicate via radio communication They have been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 RF Devices of the FCC Federal Communications Commission rules These limits are designed to provide reasonable protection against harmful interference in a residential installation 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 e Reorient or move the receiving antenna e Increase the separation distance between the equipment and receiver
14. Parts 95 NESS A H200 Wireless 96 User s Guide Chapter 1 3 Troubleshooting If you have any questions or concerns please call the Bioness Client Relations Department at 800 211 9136 Option 3 RF Communication Failure AA ZU 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 ACA Radio Communication Failure y C e Make sure the H200 Wireless Orthosis and the Control viv Unit are within 10 feet of each other Control Unit e If the components are within range and working properly FLASHES RED then turn the Control Unit off and back on Reorient the Control Unit e Check for obstructions or sources of interference e Change the H200 Wireless cloth electrodes e Contact the Bioness Client Relations Department Chapter 13 Troubleshooting 97 NESS A H200 Wireless 98 Frequently Asked Questions When charging the NESS H200 Wireless System how will know when the batteries are fully charged e When the Control Unit is fully charged a BH GREEN horizontal line will appear in the Control Unit digital display When the Orthosis is fully charged the 9S9 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 e After the components are fully charged keep them connec
15. 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 58 User s Guide Me 4 Blot excess water from the cloth electrodes See Figure 8 5 es 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 N CAUTION Use only cloth electrodes supplied by Bioness Inc Chapter 8 Setup Instructions e Bioness 59 NESS we H200 Wireless 5 Match each cloth electrode to its corresponding electrode base See Figure 8 6 Electrodes Base 1 Electrode Base 2 Electrode Base 3 Thenar Electrode Base 5 Electrode Base 4 Figure 8 6 Electrode bases 1 5 60 User s Guide A Bioness 6 Snap cloth electrode 3 to the thenar Note The 3 large cloth electrode is for large thenars 7 Forcloth electrodes 1 2 4 and 5 face the white dot on the cloth electrode toward the electrode base Inser
16. 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 Bioness Client Relations Department Telephone 800 211 9136 Option 3 or 661 362 4850 Option 3 Wy wpe Bioness Manufactured by Worldwide Corporate Office Bioness Neuromodulation Ltd Bioness Inc A Bioness Inc Company 25103 Rye Canyon Loop 19 Ha Haroshet Street Valencia CA 91355 USA PO Box 2500 Telephone 800 211 9136 Industrial Zone Email info bioness com Ra Anana 43654 Israel Website www bioness com User s Guide e Bioness Me List of Symbols De pmo 0 Cab ime X This Product Must Not Be Disposed of with Other Household Waste Eum LI Consult Instructions for Use e Re Order Number Lot Number Serial Number tane Complies with United States and Canadian Product Safety Standards Intertek 3106069 Single Patient Use Ip NESS A H200 Wireless IV User s Guide Contents LIST OF S
17. of Modulating Signal Binary data message Data Rate Frequency of Modulating 250 Kbps Signal Effective Radiated Power 10 dBm Receivers Operating Frequency Band 2401 2482 MHz Receiver Bandwidth 812 kHz around a selected frequency User s Guide Chapter 1 5 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 Harmonic emissions ClassA IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The NESS H200 Wireless System CISPR 11 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 Class B The NESS H200 Wireless System is CISPR 11 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 Chapter 15 Appendix EMI Tables 113 NESS A H200 Wireless Equipment and Systems Guidance and Manufacturer s Declaration
18. to max voltage limitation Nominal Load Max Power Load 500 ohm 500 ohm 80 mA 120 V Pulse Repetition Rate 20 45 Hz 5 Hz resolution Ramp Up 0 3 1 seconds Ramp Down Max Duration of Stimulation Program 0 3 1 seconds 4 hours 5 minute resolution User s Guide A Bioness Power Supply Specifications Use medical Class Il 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 5V t 596 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 Chapter 14 Technical Specifications 111 NESS Z H200 Wireless 112 H200 Wireless Cloth Electrode Specifications Non woven cloth Material Note Use only cloth electrodes provided by Bioness Inc Cloth Electrode 1 2 3 Regular 3 Large 4 5 Area mm 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
19. 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 User s Guide e Bioness Me 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 Chapter 9 Operating the H200 Wireless System 75 NESS A H200 Wireless 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
20. your index finger While your fingers and thumb are in this position place the object you want to grip into the gap After several seconds your fingers and thumb will close around the object 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 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 76 User s Guide 3n S Bioness 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
21. 0 01 4 7 in 1 6 in 2 8 in 9 1 in 0 12 m 0 04 m 0 07 m 0 23 m 0 1 15 in 5 2 in 8 7 in 2ft5in 0 38 m 0 13 m 0 22 m 0 73 m 1 3 ft 11 in 15 ft 7 in 2 ft 4 in 7 ft 7 in 1 2 m 0 4 m 0 7 m 2 3 m 10 12 ft 6 in 4 ft 2 in 7 ft 3 in 24 ft 11 in 3 8 m 1 3 m 2 2 m 7 3 m 100 39 ft 4 in 13 ft 1 in 23 ft 75 ft 6 in 12 m 4 m 7 m 23 m User s Guide Mp hS Bioness 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 Chapter 15 Appendix EMI Tables 119 NESS A H200 Wireless 120 User s Guide
22. 20 Chapter 5 H200 Wireless Orthosis sseseessseseeseuussse 21 Orthosis Flexor Support uucssecxcso etc nte ERR RS RR Xe XR YER REA ER XR ERY EATE 23 Onhiosis Extensor VVIHB eicere ise ast eidou paa bebe e ur psi E Rec Ema qM DRE aDEaM dE 25 NESS A H200 Wireless VI Wing Release Handl ett 26 MMIFIG ATI erges E E AE E REEERE 27 Fitting Panels tT 28 Spiral Erid or THES OMMOSIS oos cire ert c eo Ere in ep rr rre eget eerie ripa 30 NECI CINE T M 31 Wrist egere Mec AEA EERETS 32 Tigger m 33 Wrist Strap Attachment Pac ttcatus ackd stc ecbntu t Rotax n ru dun tus acE tuba 34 Wrist Strap Attachment Bar sessssssssssssssssssssesees eene 35 ICUUIIN m 36 Stimulation E Bio m T m 36 P o nTi T 38 Rechargeable Battery and Charging Port cese 39 Chapter 6 H200 Wireless Control Unit sseueueuueuuuse 41 Operating BUttONS t I 42 Indicators and Digital DiS Olay se uode tattoo a 44 PUT ACTA cM CT cc 47 Charging E dol T 48 Chapter 7 H200 Wireless Stimulation Programs 49 Chapter 8 Setup Instructions eeessssssssssseeseeseeesee 51 Charging the NESS H200 Wireless System eseeeeeeeee
23. 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 e 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 User s Guide 3n A hS Bioness 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 incre
24. EEN Arches Stimulation Intensity Level 0 Equals No Stimulation Registration in Process Letter C Registration Complete Letter E Registration Error Letter U Control Unit Unregistered Rotating GREEN Circle Control Unit Charging M e Cp a a Horizontal GREEN Line Control Unit Fully Charged User s Guide A Bioness Left Orthosis Display Description Definition e FLASHES GREEN System On fap FLASHES YELLOW Low Battery ALTERNATELY Status Light EUN FLASHES YELLOW Battery Charging and GREEN Battery Fully SOLID GREEN Charged Registration Successful FLASHES RED Faulty Electrode Contact SOLID RED Hardware Software Error Charging Error Stimulation Light SOLID YELLOW Stimulation Paused 9 80 n J U FLASHES YELLOW RAPIDLY Stimulation On Chapter 13 Troubleshooting 105 NESS A H200 Wireless 106 User s Guide Chapter 14 Technical Specifications H200 Wireless Control Unit Specifications Classification Internally powered continuous operation Operation Modes User and Standby Battery Type Rechargeable AAA NiMH 1 2 V 900 1100 mAh e On Off illuminated button e Trigger illuminated button to turn on and pause stimulation e Intensity buttons to fine tune intensity level EUMD Mute button to mute audio alerts e Program selection buttons 1 2 e Stimulation test but
25. F communication indicator on the H200 Wireless Control Unit will FLASH RED sas wu Turning On the System Press the G 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 e 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 93 on off button once Chapter 9 Operating the H200 Wireless System 69 NESS A H200 Wireless 70 Testing Stimulation in the Orthosis The amp 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 Press and hold the amp 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 Release the amp stimulation test button to turn off stimulation Repeat to test stimulation of the flexor muscles 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 y
26. H200 Wireless Orthosis 29 3n hS Bioness 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 Attachment Bar Trigger Button Wrist Strap Attachment Ring Figure 5 10 Spiral end of the Orthosis Chapter 5 H200 Wireless Orthosis 30 3n S Bioness 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 Snap for Thenar Cloth Electrode Figure 5 11 The thenar inset and placement of the thenar CAUTION Do not operate the NESS H200 Wireless System without a thenar cloth electrode in place Chapter 5 H200 Wireless Orthosis 31 NESS A H200 Wireless Wrist Bridge The wrist bridge wraps around the back of your wrist See Figure 5 12 The wrist bridge e Stabilizes the Orthosis on your hand e 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 Or
27. YMBOLS P Il Chapter T Introduction esseen aeii 1 Chapter 2 Device Description and Safety Information 3 DEVICE DESCIPTION scsi E 3 Iridicatioris Tor Se iones decido mere cna v oa uad uad 4 Contraindications sssssssssssse eme 5 Cups c M re 5 Adverse Reactions uiii eere a Fea utut t eto Eau 6 P recautiOmnsa serre etas ease erae matre xu s qua e dr ule eR dc t m e 7 Chapter 3 Environmental Conditions that Affect Use 11 Radio Frequency RE Comida lE bosse onc nadese tu uiDataE ao SE Dati aps motas 11 Travel and Airport Security CT 13 Electromagnetic CornpatiDilily corr tret rate saninin innin Esa 14 Warnings and COUUDEPIS secs sacsusdasuratexenumsnugecksncnenduauecsasnantmetieeaghaaneadipateiatesues 14 Chapter 4 H200 Wireless System Kit eee teeter 17 eic 17 H200 Wireless Orthosis ssssssssssssssssseeeeeeeeeeee en 19 H200 Wireless Control Unit 00 ccc eceecceee cee eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 19 System Charger Sefiros pkn a EER EEEE 19 Orthosis Wrist Strap se trt gu Feux e aetas 19 Control Unit Neck Strap Wrist Strap and Belt Pouch 19 H200 Wireless Cloth Electrodes ssssssssseeeee 19 Cloth Electrode MS B iii oc detec ctecickcewakendiieiactonn MER iaa
28. 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 User s Guide 3n S Bioness 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 12 2 Spray the entire surface of the System Kit carrying case with CaviCide Use a clean towel to remove any surface contaminants Soil etc will impede the disinfectant s effectiveness if not removed Spray the entire surface of the System Kit carrying case again with CaviCide Keep spraying the entire carrying case surface as needed to keep it wet for 10
29. alculated from the equation applicable to the frequency of the transmitter Conducted 3 Vrms 3 Vrms Recommended separation RF 150 kHz to 150 kHz to distance IEC 61000 80 MHz 80 MHz d 1 2 P 4 6 Radiated RF 3 V m E 3 V m Recommended separation IEC 61000 80 MHz to in 80 MHz to distance 4 3 2 5 GHz 2 5 GHz d 0 44P 80 800 MHz range E 10 V m d 0 74P 800 1000 MHz range in 26 MHz to d 2 3JP 1000 2500 MHz range 1 GHz User s Guide 3n S Bioness 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 should be less than the compliance level in each frequency range NOTE 5 Interference may occur in the vicinity of equipment marked with the following symbol Ke 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 fix
30. and replace the cloth electrodes Make sure the extensor wing is closed properly Chapter 13 Troubleshooting 99 NESS A H200 Wireless How will 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 know when the Control Unit battery charge level is low e 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 Contro Unit is SOLID RED and the Control Unit beeped e Ifthe Control Unit is connected to the system charger and stimulation is not affected a charging error has occurred e Reconnect the charger e Change the battery e Ifthe problem persists contact the Bioness Client Relations Department at 800 211 9136 Option 3 e Ifthe 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 e Ifthe problem persists stop using the system and contact the Bioness Client Relations Department Option 3 100 User s Guide 3n VS Bioness My hand is not moving satisfactorily and the NESS H200 Wireless System is not indicating any errors e The Orthosis may not be positioned correctly Turn off the Control Unit Make sure the clot
31. ased 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 Chapter 3 Environmental Conditions that Affect Use 15 NESS A H200 Wireless 16 User s Guide H200 Wireless System Kit Contents H200 Wireless Orthosis H200 Wireless Control Unit System Charger Set Control Unit Neck Strap Control Unit Wrist Strap Control Unit Belt Pouch Orthosis Wrist Strap H200 Wireless Cloth Electrodes Cloth Electrode Mesh Bag H200 Wireless FPL Panel Large Thenar Wrist Inserts H200 Wireless User s Guide User s Reference Card H200 Wireless Control Unit save System Charger Set H200 Wireless Orthosis Chapter 4 H200 Wireless System Kit 17 NESS A H200 Wireless 3 Regular H200 Wireless Cloth Electrodes 3 Large Control Unit Neck Strap Control Unit Wrist Strap Control U
32. d 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 e Prevention and or retardation of disuse atrophy Increase in local blood circulation e Reduction of muscle spasm e Re education of muscles User s Guide Sep S Bioness Contraindications e Do not use the NESS H200 Wireless System where a cancerous lesion is present or suspected e 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 e Donotuse 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 e 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 e Donot wear the H200 Wireless Orthosis over swollen infected or inflamed areas Do not wear the Orthosis over skin eruptions or varicose veins e Apply stimulation to normal intact clean healthy skin only e Turn off the NESS H200 Wireless System befo
33. ds 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 Chapter 8 Setup Instructions 51 NESS A H200 Wireless 2 Slide the selected blade into the system charger See Figure 8 2 System Charger EM Figure 8 2 Sliding the blade into the system charger i CAUTION Use only the charger included in your H200 Wireless System Kit Use of any other charger could damage the system 52 User s Guide 3n S Bioness 3 Connect the Y cable to the charging ports of the Orthosis and Control Unit The Control Unit charging port is under the flexible cover See Figure 8 3 Charging Port Flexible Cover Y Cable Interchangeable Blade Figure 8 3 Charging setup CAUTION Make sure your hands are dry before connecting the system charger to a power outlet Chapter 8 Setup Instructions 53 NESS A H200 Wireless 4 Plug the system charger into a power outlet m 5 If the Control Unit is charging a C rotating GREEN circle will appear in the Control Unit digital display See Table 8 1 Control Unit Display Description Definition Rotating GREEN Circle in Digital Display Battery Charging Digital Display Bat
34. ed 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 Chapter 15 Appendix EMI Tables 117 NESS A H200 Wireless 118 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 Separation Distance According to Frequency of Transmitter Maximum Output 150 kHz to 80 MHz to 800 MHz to 1000 MHz to Power of 80 MHz 800 MHz 1000 MHz 2 5 GHz Transmitter Outside ISM d 0 4JP d 0 74P d 2 3vP W Bands d 1 2 P
35. ed 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 Extensor Wing Arm Figure 5 7 Orthosis wing arm Chapter 5 H200 Wireless Orthosis 27 NESS A H200 Wireless 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 Extensor Wing Extensor Fitting Panel Figure 5 8 Reattaching the extensor fitting panel 28 User s Guide A Bioness 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 Fitting Panel Figure 5 9 Reattaching the flexor fitting panel If you have questions contact the Bioness Client Relations Department at 800 211 9136 Option 3 Chapter 5
36. ee the Maintenance and Cleaning chapter of this guide e 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 N 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 User s Guide 3n S Bioness 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 Cleanthe 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 N CAUTION Do not wear the Orthosis over broken skin Chapter 8 Setup Instructions 57 NESS A H200 Wireless
37. ely 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 Chapter 3 Environmental Conditions that Affect Use 13 NESS A H200 Wireless 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 e DC power supply as provided by Bioness Inc manufactured by FRIWO Part No FW7555M 05 e Y cable 2 way splitter as provided by
38. ess 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 Chapter 2 Device Description and Safety Information
39. f 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 User s Guide Me 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 Chapter 11 Maintenance and Cleaning e Bioness 87 NESS A H200 Wireless 88 The Orthosis except for the wrist insert may be cleaned and low level disinfected using wipes or cloths saturated with 70 isopropyl
40. h 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 Astimulation 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 Chapter 13 Troubleshooting 101 NESS A H200 Wireless 102 The Control Unit does not light up when turned on e The Control Unit needs to be charged e Ifthe problem persists contact the Bioness Client Relations Department Option 3 received a replacement Control Unit When 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 e Areplacement component needs to be electronically registered to the existing component for the NESS H200 Wireless System to communicate wirelessly e For instructions on how to register a replacement component see Electronic Registration of Replacement Parts tried the electronic registration procedure but never saw the alternating arches in the digital display T
41. he replacement component is not working e Turn off the Control Unit Press the minus button and the G9 trigger button on the Control Unit and then press the trigger button on the Orthosis to start the registration process User s Guide 3n S Bioness After fully charged the NESS H200 Wireless System 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 need to repeat the charging process e The components are fully charged You do not need to repeat the charging process Quick Reference Troubleshooting Control TN E Unit Description Definition Control Unit Status Indicator Low Battery H200 Wireless FLASHES YELLOW Control Unit Control Unit Charging Error e Control Unit Status Indicator is Electronic Registration Error SOLID RED Control Unit Hardware Software Error Program 1 Indicator is GREEN Program 1 Selected 2 Program 2 Indicator is GREEN Program 2 Selected wy RF Communication Indicator me g lt a P rus ABS FLASHES RED RF Communication Error Chapter 13 Troubleshooting 103 NESS Z H200 Wireless 104 Control TU Unit Description Definition On Off Button FLASHES GREEN System On Trigger Button FLASHES YELLOW Stimulation On RAPIDLY Trigger Button is SOLID YELLOW Stimulation Paused EF Displays 0 9 Alternating GR
42. ift 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 Chapter 10 Removing the Orthosis 81 NESS A H200 Wireless 82 User s Guide Chapter 11 Maintenance and Cleaning Daily Maintenance and Storage 1 Store the H200 Wireless cloth electrodes in the cloth electrode mesh bag or where they can air dry Check the system components for signs of wear and damage Replace any components that appear old worn or damaged Contact the Bioness Client Relations Department at 800 211 9136 Option 3 for assistance Store the Orthosis where it can air dry 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 Chapter 11 Maintenance and Cleaning 83 NESS A H200 Wireless Battery Replacement H200 Wireless Control Unit The battery in the H200 Wireless Control Unit is a rechargeable AAA NiMH battery It should be replaced approximately every two years To replace the Control Unit battery AAA NiMH 1 2 V 1 Using a Phillips screwdriver remove the screw from the battery cover on the back of the H200 Wireless Control Unit See Figure 11 1 Battery Cover Screw Battery
43. igned 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 Electrode Base 5 Electrode Base 4 Figure 5 3 Orthosis flexor support Chapter 5 H200 Wireless Orthosis 23 NESS 2 H200 Wireless 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 FPL Panel Electrode Base 5 Figure 5 4 Orthosis flexor support with an FPL panel 24 User s Guide At Bioness Orthosis Extensor Wing The extensor wing delivers electrical stimulation to the nerves of the muscles that extend your hand The extensor wing features e Two electrode bases 1 and 2 See Figure 5 5 Awing release handle Awing arm Extensor Wing Wing Arm Electrode Wing Release Base 1 Handle Electrode Base 2 Figure 5 5 Orthosis extensor wing Chapter 5 H200 Wireless Orthosis 25 NESS A H200 Wireless 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 Extensor Wing Arm Wing Wing Release Handle Figure 5 6 Orthosis wing release handle 26 User s Guide e Bioness Me Wing Arm The wing arm is us
44. ll Medium Large Side Left and Right e Total of 6 configurations Environmental Ranges Transport and storage temperature 25 C to 70 C 13 F to 158 F e Operating conditions temperature 5 C to 40 C 41 F to 104 F e Operating conditions relative humidity 15 to 93 e Charging temperature 5 C to 40 C 41 F to 104 F IP classification IP27 108 User s Guide Me H200 Wireless Orthosis Specifications Small Medium Large Length 270 mm Length 270 mm Length 300 mm 10 63 in 10 63 in 11 81 in Dimensions Width 110 mm Width 110 mm Width 130 mm closed 4 33 in 4 33 in 5 11 in Depth 90 mm Depth 90 mm Depth 130 mm 3 54 in 3 54 in 5 11 in 300 grams 300 grams 300 grams Estimated TIME Gig Eg oz 10 58 oz 10 58 oz Chapter 14 Technical Specifications e Bioness 109 NESS Z H200 Wireless 110 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 120V Symmetric Positive Pulse Duration usec 100 200 300 Negative Pulse Duration usec 100 200 300 Inter Phase Interval usec 50 Max Total Pulse Duration 250 450 650 usec Load Range 0 5000 ohm Subject
45. minutes 70 IPA Ts Wipe the entire surface of the System Kit carrying case with a cloth or wipe saturated with 7096 IPA Use a new cloth or wipe saturated with 7096 IPA to remove any surface contaminants Soil etc will impede the disinfectant s effectiveness if not removed Wipe the entire surface of the System Kit carrying case again with a new cloth or wipe saturated with 7096 IPA Use additional new cloths or wipes saturated with 7096 IPA as needed to keep the entire surface of the carrying case wet for 10 minutes Chapter 11 Maintenance and Cleaning 89 NESS A H200 Wireless 90 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 7096 IPA is available at your local drugstore or pharmacy User s Guide Chapter 12 Electronic Registration of Replacement Parts The NESS H200 Wireless System Control Unit and Orthosis must be electronically registered to each other to communicate wirelessly The components in your System Kit are electronically registered When you purchase a replacement H200 Wireless Control Unit or Orthosis the replacement component must be electronically registered to
46. nit Belt Pouch Large Thenar Wrist Insert Orthosis Wrist Strap ECCO s x Se SISOS H200 Wireless FPL Panel Cloth Electrode Mesh Bag 18 User s Guide 3n VS Bioness 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 Chapter 4 H200 Wireless System Kit 19 NESS A H200 Wireless 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 withou
47. our 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 User s Guide 3t Bioness Selecting a Stimulation Program To select Program 1 Turn on the system Program 1 is selected automatically When Program 1 is selected the Program 1 indicator will be GREEN To select Program 2 1 Turn on the system 2 Press the Program 2 button See Figure 9 1 When Program 2 is selected the Program 2 indicator will be GREEN On Off Button Mute Button Trigger Button Program 1 Button Program 2 Intensity Buton Adjustment Buttons Stimulation Test Button J Bioness Figure 9 1 Operating buttons Chapter 9 Operating the H200 Wireless System 71 NESS A H200 Wireless 72 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 e 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
48. our 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 Chapter 1 Introduction NESS A H200 Wireless 2 User s Guide Chapter 2 Device Description and Safety Information Device Description The NESS H200 Wireless System consists of an Orthosis and a wireless handheld Control Unit See Figure 2 1 H200 Wireless Control Unit H200 Wireless Orthosis Figure 2 1 H200 Wireless Orthosis and Control Unit H200 Wireless Orthosis delivers electrical stimulation to the nerves of the muscles that control hand opening and closing and movement of the thumb The Orthosis also stabilizes the wrist Chapter 2 Device Description and Safety Information NESS A H200 Wireless 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 e Improvement of han
49. petto peter Rn Roe RE be ocke E pnrk urna 103 Chapter 14 Technical Specifications ssueueueueuuuuus 107 Chapter 15 Appendix EMI Tables 0 ccccccceeeeeeeeeeeteneeeeees 113 User s Guide Chapter 1 Introduction Stroke and other disorders of the central nervous system CNS may cause long term disability For many people long term disability may impair muscle control increase muscle spasm reduce muscle strength and reduce functional abilities When the upper limb is involved complications may include contractures tightening of muscle edema swelling pain syndromes of the hand and shoulder and limb neglect 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 e Important safety information about the NESS H200 Wireless System e The components of the NESS H200 Wireless System e How to set up operate and maintain the NESS H200 Wireless System e Troubleshooting information Be sure to review this guide with your clinician before using your H200 Wireless System If you have questions consult y
50. r Signal Input Output Port Figure 6 3 Control Unit charging port CAUTION The signal input output port on the Control Unit is only to be used by the clinician during setup 48 User s Guide Chapter 7 H200 Wireless Stimulation Programs The NESS H200 Wireless System supports Functional Training Neuroprosthesis and Motor Neuromodulation programs designed to open and close the hand Functional Training programs are designed to exercise your hand They consist of repetitive opening and or closing motions with a relaxation pause between each motion Neuroprosthesis programs are designed to assist with the performance of a specific functional task such as opening a door or holding a cup 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 e Your clinician will select the stimulation programs that best fit your therapeutic needs e Assign programs to the program buttons on your Control Unit for you to use at home e Customize the programs based on your specific impairment Chapter 7 H200 Wireless Stimulation Programs 49 NESS A H200 Wireless 50 User s Guide Chapter 8 Setup Instructions Charging the NESS H200 Wireless System It is important to charge your H200 Wireless System daily and for at least four hours before a fitting programming session Bioness recommen
51. re driving or operating machinery e Turn off stimulation before performing any activity in which involuntary muscle contractions may injure you e Do not use the NESS H200 Wireless System while sleeping e Only an authorized clinician should fit and program the NESS H200 Wireless System Chapter 2 Device Description and Safety Information 5 NESS A H200 Wireless 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 Asignificant increase in muscle spasticity e Afeeling of heart related stress during stimulation e 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 User s Guide
52. rol Unit digital display shows Stimulation intensity level 0 9 Electronic registration status e Battery charging status See Table 6 4 Display Description Definition Bo 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 M Ge up QR p Ey H200 Wireless Control Unit Fully Charged Table 6 4 H200 Wireless Control Unit digital displays User s Guide 3n As Bioness Audio Alerts The H200 Wireless Control Unit beeps to indicate e Electronic registration was initiated successful or unsuccessful e The NESS H200 Wireless System was turned on off e A program has ended and stimulation has stopped e An Control Unit hardware software error occurred e The Control Unit battery charge level is low e The audio alerts were muted un muted e Acharger was connected e RF communication failed e A button was pressed Chapter 6 H200 Wireless Control Unit 47 NESS A H200 Wireless 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 programme
53. s Orthosis with caution e If you have a tendency to bleed heavily following acute trauma or fracture e Following recent surgical procedures when muscle contraction may disrupt the healing process e Over areas of the skin that lack normal sensation e 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 e Always check the skin for redness or a rash when putting on and taking off the H200 Wireless Orthosis e 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 e 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 e 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 e Turn off the NESS H200 Wireless System before removing or replacing the cloth electrodes e Remove the H200 Wireless Orthosis before wetting the cloth electrodes 8 User s Guide Sep VS Bioness The H200 Wirel
54. ses 51 Checking the System Components s ease eoe barn porro rites D had suwene snena 56 Preparing M eidcm TU 57 Wetting Attaching the Cloth Electrodes seeeeeecesseeessess 58 Putting Oni the OMmmOsis e 63 Chapter 9 Operating the NESS H200 Wireless System 69 RF espace timi t 69 Turr rg Ori the Syste Mesiran iasan anA 69 User s Guide Turturig OI the SY SUC Ise esee arna a nu UU an par o san UrE Er Nasan 69 Testing Stimulation in the CIRBIOSIS ssscebkRdpntas ga cia metta dundexu mauu ctnac vicus dS E me nucis 70 Selecting a Stimulation Program sea noie erue RR ia 71 Changing Stimulation Programs sooo eoa Ga darme tus SE rpas o bebo ne ak E Bet Ep aaa i 72 T ming On Stimulators ctcsteibuthn indita aita b dps rao nd aub st dA nd ersetunetuund 72 Pausing Resuming SUPIuUldtigri coo e iere tr eE as ER aaa 73 Using a Neuroprosthesis Program usce ueteri rtr paese spesa Pax bona tires n Ua E tunes 74 Open Hand sirsie R 74 Grasp and Re leaSGn dinoana aa aE R ERRE EEIE ENE 75 aac 76 Stopping StimulatiQni sisnsssesessese teen erri ath Ret c e E e EXER XY ER C oe S A d v rd TT Adjusting Stimulation Interielly erbe pex anaana 77 Muting Un Muting the System Audio Alerts eseeeeeeseesss 78 Chapter 10 Removing the Orthosis 2 0 0 0 eee teeta 79 Chapter 11 Maintenance and Cleaning
55. stimulation will turn off and the Orthosis stimulation light will FLASH YELLOW SLOWLY The Control Unit trigger button will continue to FLASH YELLOW User s Guide 3n S Bioness 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 e 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 N Control Unit is not operable or accessible and the Orthosis trigger button is disabled Chapter 9 Operating the H200 Wireless System 73 NESS A H200 Wireless 74 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
56. t the cloth electrodes CAUTION The H200 Wireless cloth electrodes must be replaced every two weeks or sooner if they become damaged CAUTION The H200 Wireless cloth electrodes are for single patient use CAUTION The H200 Wireless cloth electrodes must be wet before use and wet again after every four hours of use gt gt gt amp 20 User s Guide Chapter 5 H200 Wireless Orthosis The Orthosis generates the electrical stimulation used to open and close your hand and move your thumb The Orthosis has an integrated radio frequency stimulation unit and five stimulating electrodes that have been predetermined by your clinician and configured with fitting panels See Figure 5 1 The Orthosis responds to wireless signals from the Control Unit to turn stimulation on and off and to adjust the stimulation intensity level 3 Electrode Electrode 4 5 Electrode Figure 5 1 Orthosis stimulating electrodes Chapter 5 H200 Wireless Orthosis 21 NESS 2 H200 Wireless The H200 Wireless Orthosis features See Figure 5 2 e A flexor support e An extensor wing e Aspiral end Astatus light e Astimulation light Audio alerts e Arechargeable battery and charging port Extensor Wing Stimulation Light Status Light Charging Port N Flexor Support Spiral End Figure 5 2 Orthosis features 22 User s Guide A Bioness Orthosis Flexor Support The flexor support is des
57. t 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 Chapter 8 Setup Instructions 61 NESS A H200 Wireless 8 Check that each cloth electrode is securely attached to its corresponding electrode base See Figure 8 8 Figure 8 8 Cloth electrodes in place on the Orthosis N CAUTION Do not wear the Orthosis without the cloth electrodes 62 User s Guide 3n S Bioness 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 jl Figure 8 9 Positioning the thenar Chapter 8 Setup Instructions 63 NESS A H200 Wireless 2 Position the Orthosis wrist bridge comfortably on the back of your wrist See Figure 8 10 Wrist Bridge Figure 8 10 Positioning the wrist bridge WARNING Do not turn on stimulation until your Orthosis is completely set up and correctly attached to your arm 64 User s Guide A Bioness 3 Place your forearm in the Orthosis flexor support See Figure 8 11 Flexor Support Figure 8 11 Positioning the flexor support Chapter 8 Setup Instructions 65 NESS A
58. ted to the system charger until ready to use If charge the NESS H200 Wireless System every day will harm the batteries e No Daily charging will not affect the lifespan or functionality of the batteries Daily charging is recommended While charging the Control Unit the e status light on the Control Unit turns RED e Acharging 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 User s Guide 3n S Bioness When I turn on the H200 Wireless Control Unit it beeps and the RF communication indicator FLASHES RED 54 The status light and stimulation light on the Orthosis are not lit e RFcommunication 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 hear a beep and the a status light on the Orthosis FLASHES RED e 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
59. tery Fully Charged amp g Horizontal GREEN Line in Status Light is SOLID RED Charging Error Table 8 1 H200 Wireless Control Unit charging displays 54 User s Guide 3n S Bioness 6 If the Orthosis is charging the status light on the Orthosis will ALTERNATELY FLASH YELLOW and GREEN See Table 8 2 Orthosis Display Description Definition Status Light ALTERNATELY NES FLASHES YELLOW and Battery Charging GREEN 209 Status Light is SOLID GREEN Battery Fully Charged Table 8 2 H200 Wireless Orthosis charging displays left Orthosis The charging process is complete when e Ahorizontal GREEN line B 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 Chapter 8 Setup Instructions 55 NESS A H200 Wireless 56 Checking the System Components Before using your H200 Wireless System e Visually inspect the Orthosis and Control Unit for signs of damage e 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 e Open the Orthosis and check the electrode bases to see if they are clean If necessary clean the electrode bases S
60. 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 N certain any other H200 Wireless System component is at least 30 feet from the components to be registered Chapter 12 Electronic Registration of Replacement Parts 91 NESS A H200 Wireless Registration Setup 1 Verify that all H200 Wireless System components are turned off 2 Place the components to be registered close together on a table but not touching See Figure 12 1 H200 Wireless Control Unit H200 Wireless Orthosis Figure 12 1 Place the components to be registered close together 3 If necessary connect the components to the system charger set and plug the system charger into a power outlet 92 User s Guide 3t Bioness 4 Locate the System ID Number for example A334 on the existing system component The System ID Number is on the back of the H200 Wireless Control Unit and under the extensor wing of the H200 Wireless Orthosis See Figure 12 2 System ID Number System ID Number Figure 12 2 Location of the System ID Numbers Chapter 12 Electronic Registration of Replacement Parts 93 NESS 2 H200 Wireless 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
61. thosis positioned against your wrist Wrist Bridge Figure 5 12 The H200 Wireless Orthosis wrist bridge 32 User s Guide 3n VS Bioness 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 Trigger Button Figure 5 13 The H200 Wireless Orthosis trigger button Chapter 5 H200 Wireless Orthosis 33 NESS A H200 Wireless Wrist Strap Attachment Ring The wrist strap attachment ring is for hooking the Orthosis wrist strap to the Orthosis See Figure 5 14 Orthosis Wrist Strap Hook Wrist Strap Attachment Figure 5 14 Hooking the Orthosis wrist strap to the attachment ring 34 User s Guide 3n S Bioness Wrist Strap Attachment Bar The wrist strap attachment bar is for securing the Orthosis wrist strap around the wrist See Figure 5 15 Wrist Strap Orthosis Wrist Attachment Bar Figure 5 15 Securing the Orthosis wrist strap Chapter 5 H200 Wireless Orthosis 35 NESS A H200 Wireless 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 36 User s Guide
62. ton e Four status icons H200 Wireless Control Unit RF Communication Status Selected Program 1 2 Indications e Digital display designates relative stimulation intensity Illuminated buttons designate system on off and stimulation on off or paused e Beeps for audio alerts Carrying Options In pocket neck strap wrist strap or belt pouch Length 73 mm 2 9 in Width 46 mm 1 8 in Height 18 mm 0 7 in Dimensions Weight 45 grams 1 5 oz e Transport and storage temperature 25 C to 70 C 13 F to 158 F Environmental e Operating conditions temperature 5 C to 40 C 41 F to Ranges 104 F e Operating conditions relative humidity 15 to 93 e Charging temperature 5 C to 40 C 41 F to 104 F Chapter 14 Technical Specifications 107 NESS A H200 Wireless H200 Wireless Orthosis Specifications Classification Internally powered continuous operation with type BF applied parts Operating Voltage 3 7 V Proprietary rechargeable Li lon Lithium lon 3 7 V 280 350 T Battery Type mAh e H200 Wireless Orthosis status fault battery charging and Indications Stimulation LEDs e Beeps for audio alerts Main body cover Rilsan BZM 30 OTL Wing cover TEREZ ABS 5010 Material e Wrist insert Flexible foam two components urethane non integral skin Purtec GMBH Thenar Dow Corning Silicone Rubber NPC 40 Configurations Size Sma
63. tton is SOLID YELLOW Stimulation Paused Table 6 2 Operating buttons visual displays Chapter 6 H200 Wireless Control Unit 43 NESS A H200 Wireless Indicators and Digital Display The Control Unit front panel features AA Control Unit status indicator 7 An RF communication indicator al e Program 1 and Program 2 selection indicators e A digital display See Figure 6 2 Control Unit Status RF Communication Indicator Indicator Program 1 Indicator Program 2 Indicator Digital Display Figure 6 2 H200 Wireless Control Unit digital display and indicators 44 User s Guide e Bioness Me The Control Unit indicators show e Control Unit status e Stimulation program selected e Control Unit low battery e RF communication status See Table 6 3 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 sal Program 2 Indicator is GREEN Program 2 Selected JIN C UP RF Communication Indicator FLASHES RED RF Communication Error Table 6 3 H200 Wireless Control Unit indicator lights Chapter 6 H200 Wireless Control Unit NESS 2 H200 Wireless 46 The Cont

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