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Bioness NESS L300 Plus Clinician Manual - Contraindications

Other manuals for NESS L300 Plus: User Manual
Manual is about: Bioness Foot Drop System Clinician's guide

Summary of NESS L300 Plus

  • Page 1

    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 nes...

  • Page 2: Clinician’S Guide

    Clinician’s guide.

  • Page 3: Clinician’S Guide

    I clinician’s guide rx only.

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    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 pri...

  • Page 5: Table of Contents

    Iii table of contents list of symbols ........................................................................................................................................... Ix chapter 1: introduction ..................................................................................................

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    Iv clinician’s guide thigh cloth electrodes .........................................................................................................................29 locator ...............................................................................................................................

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    V sd (secure digital) slot .......................................................................................................................44 battery ..................................................................................................................................................

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    Vi clinician’s guide advanced gait settings .................................................................................................................67 maximum duration of stimulation ...........................................................................................67 programming th...

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    Vii placing the hydrogel electrodes and bases on the leg ...............................................................96 connecting the fitting cable .........................................................................................................98 adjusting the position of the electrodes...

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    Viii clinician’s guide thigh cuff buckles ...................................................................................................................................128 thigh clinic straps ..........................................................................................................

  • Page 11: List of Symbols

    Ix caution complies with united states and canadian product safety standards complies with the european union medical device directive double insulated (equivalent to class ii of iec 536) type bf applied part(s) non-ionizing radiation date of manufacture manufacturer this product must not be dispose...

  • Page 12

    X clinician’s guide.

  • Page 13: Introduction

    1 1 chapter 1: introduction introduction central nervous system (cns) injuries and/or diseases often cause a gait disorder called foot drop. People who have foot drop are unable to raise their foot while walking. They often drag their foot, resulting in instability and increased effort during gait. ...

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    2 clinician’s guide.

  • Page 15: Device Description

    2 3 chapter 2: device description and safety information device description and safety information device description the ness l300 plus system consists of four main components: • l300 functional stimulation (fs) cuff with l300 radio frequency (rf) stim unit— delivers electrical pulses over the comm...

  • Page 16: Contraindications

    4 clinician’s guide contraindications • patients with a demand-type cardiac pacemaker, defibrillator, or any electrical or metallic implant should not use the ness l300 plus system. • the ness l300 plus system should not be used on a leg where a cancerous lesion is present or suspected. • the ness l...

  • Page 17

    5 chapter 2: device description and safety information • specific physician clearance should be obtained before using the ness l300 plus system on patients who have an alteration of normal arterial or venous flow in the region of the l300 and/or thigh fs cuffs because of local insufficiency, occlusi...

  • Page 18: Adverse Reactions

    6 clinician’s guide • protect all electronic components from contact with water, such as from sinks, bathtubs, shower stalls, rain, snow, etc. • do not leave the ness l300 plus system stored where temperatures may exceed the acceptable environmental range: -25°c to +55°c (-13°f to +131°f). Temperatu...

  • Page 19: Skin Care Guidelines

    7 chapter 2: device description and safety information skin care guidelines in the absence of proper skin care, extended use of electrical stimulation may cause skin irritation or a skin reaction to the ness l300 plus system electrodes or the l300 and/or thigh fs cuffs. To promote healthy skin with ...

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    8 clinician’s guide.

  • Page 21

    3 9 chapter 3: environmental conditions that affect use environmental conditions that affect use radio frequency (rf) communication information several components of the ness l300 plus system communicate via radio communication and have been tested and found to comply with the limits for a class b d...

  • Page 22: Travel And Airport Security

    10 clinician’s guide travel and airport security the ness l300 plus system charger is compatible with australian, u.K., european union, and u.S. Voltages: 110/220 v, 50/60 hz. Patients should turn off the ness l300 plus system before going through airport security. They should wear loose clothing so...

  • Page 23: Electromagnetic Emissions

    11 chapter 3: environmental conditions that affect use electromagnetic emissions the ness l300 plus system needs special precautions regarding electromagnetic compatibility (emc) and needs to be installed and put into service according to the emc information provided in this manual. See appendix. Th...

  • Page 24

    12 clinician’s guide.

  • Page 25: The Ness L300 Plus System

    4 13 chapter 4: the ness l300 plus system the ness l300 plus system the ness l300 plus system incorporates the ness l300 foot drop system with a thigh fs cuff for stimulation of the quadriceps or hamstrings. The ness l300 plus system is designed for individuals with foot drop who require added knee ...

  • Page 26: L300 Fs Cuff

    14 clinician’s guide figure 4-2: l300 fs cuff, right configuration. L300 fs cuff the l300 fs cuff is a lightweight, low-profile neuroprosthesis that straps onto the leg directly under the patella. See figure 4-2. The l300 fs cuff can easily be worn under clothing and is available in right and left c...

  • Page 27

    15 chapter 4: the ness l300 plus system figure 4-3: l300 fs cuff. The l300 fs cuff features: • an l300 rf stim unit. See figure 4-3. • a cradle for the l300 rf stim unit. • a locator. • an adjustable strap. • a liner. • three electrode options: • large cloth electrode, l300 systems. • l300 hydrogel ...

  • Page 28

    16 clinician’s guide l300 rf stim unit the l300 rf stim unit generates the electrical stimulation used to dorsiflex the foot. It snaps into the cradle of the l300 fs cuff and responds to wireless signals from the l300 plus control unit and the intelli-sense gait sensor to turn stimulation on/off. Th...

  • Page 29

    17 chapter 4: the ness l300 plus system the l300 rf stim unit emits visual and audio alerts when: • stimulation is on. • rf communication fails. • the battery charge level is low. • the battery is charging. • the l300 rf stim unit malfunctions. See table 4-1. L300 rf stim unit display description de...

  • Page 30

    18 clinician’s guide cradle the cradle for the l300 rf stim unit is located on the medial side of the l300 fs cuff. The l300 rf stim unit easily snaps in and out of the cradle. See figure 4-5. Cradle figure 4-5: rf stim unit cradle. Locator the l300 fs cuff locator is used to accurately place the l3...

  • Page 31

    19 chapter 4: the ness l300 plus system figure 4-7: l300 fs cuff strap. Figure 4-8: l300 fs cuff liner. Strap the l300 fs cuff strap holds the l300 fs cuff on the lower leg. The strap wraps around the leg and fastens around the l300 rf stim unit cradle the l300 fs cuff strap is available in three si...

  • Page 32

    20 clinician’s guide electrode options the l300 electrodes deliver the stimulation generated by the l300 rf stim unit to dorsiflex the foot. The following electrodes may be used with the l300 fs cuff: • large cloth electrode, l300 systems. See figure 4-9. • l300 hydrogel electrodes and hydrogel elec...

  • Page 33

    21 chapter 4: the ness l300 plus system l300 hydrogel electrodes and bases the l300 fs cuff uses two hydrogel electrodes and two hydrogel electrode bases. The l300 hydrogel electrode bases snap to the plug holes of the l300 fs cuff. See figure 4-11. Figure 4-11: snapping the l300 hydrogel electrode ...

  • Page 34

    22 clinician’s guide figure 4-13: snapping the l300 cloth electrodes to the l300 cloth electrode bases. L300 cloth electrodes and bases the l300 fs cuff uses two cloth electrodes and two cloth electrode bases. The l300 cloth electrode bases snap to the plug holes of the l300 fs cuff. The l300 cloth ...

  • Page 35: Thigh Fs Cuff

    23 chapter 4: the ness l300 plus system thigh fs cuff the thigh fs cuff is a lightweight neuroprosthesis that straps onto the hamstrings or quadriceps to assist with knee flexion or extension. See figures 4-14. The thigh fs cuff can easily be worn under a loose pant leg and is available in left and ...

  • Page 36

    24 clinician’s guide the thigh fs cuff features: • a proximal and distal panel. See figure 4-15. • an adjustable elongation bar. • a thigh rf stim unit. • a cradle for the thigh rf stim unit. • a locator. • adjustable straps. • two thigh cloth electrodes. Figure 4-15: thigh fs cuff. Cradle locator e...

  • Page 37

    25 chapter 4: the ness l300 plus system proximal and distal panels the thigh fs cuff proximal and distal panels have a removable silicone panel and two snaps for attaching the thigh cloth electrodes. See figure 4-16. Elongation bar the thigh elongation bar is used to adjust the distance between the ...

  • Page 38

    26 clinician’s guide thigh rf stim unit the thigh rf stim unit generates the electrical stimulation used to flex or extend the knee. It snaps into the cradle of the thigh fs cuff, and responds to wireless signals from the l300 plus control unit and intelli-sense gait sensor to turn stimulation on an...

  • Page 39

    27 chapter 4: the ness l300 plus system the thigh rf stim unit emits visual and/or audio alerts when: • stimulation is on. • rf communication fails. • the battery charge level is low. • the battery is charging • the thigh rf stim unit malfunctions. See table 4-2. Thigh rf stim unit display descripti...

  • Page 40

    28 clinician’s guide thigh clinic straps the thigh clinic straps are removable, replaceable, and adjustable. See figure 4-20. The smooth side of the strap faces the patient's skin. Cradle the cradle for the thigh rf stim unit is located on the thigh fs cuff distal panel. The thigh rf stim unit easil...

  • Page 41

    29 chapter 4: the ness l300 plus system locator the thigh fs cuff locator is used to accurately position the thigh fs cuff on the leg, to ensure repeatable electrode positioning. When the thigh fs cuff is correctly positioned, the locator is in line with the center of the patella (quadriceps) or the...

  • Page 42: Intelli-Sense Gait Sensor

    30 clinician’s guide intelli-sense gait sensor the intelli-sense gait sensor detects heel events when the l300 plus system is used for walking. The intelli-sense gait sensor wirelessly signals the l300 rf stim unit and the thigh rf stim unit to synchronize movement of the foot and knee according to ...

  • Page 43: L300 Plus Control Unit

    31 chapter 4: the ness l300 plus system figure 4-24: l300 plus control unit. L300 plus control unit the l300 plus control unit is used to: • turn on/off the ness l300 plus system. • test the position of the l300 and thigh fs cuffs. • select an operating mode (gait, training, standby, or clinician). ...

  • Page 44

    32 clinician’s guide table 4-3: l300 plus control unit operating buttons. L300 plus control unit operating button description function on/off turns on/off the system mode selects standby, gait, or training mode intensity adjustment increases stimulation intensity decreases stimulation intensity rf s...

  • Page 45

    33 chapter 4: the ness l300 plus system thigh fs cuff 1. Place the l300 plus control unit in standby mode. 2. Press the thigh rf stim unit selection button. 3. Press and hold the stimulation test button. The thigh rf stim unit will stimulate until the stimulation test button is released. Selecting a...

  • Page 46

    34 clinician’s guide standby mode in standby mode, the ness l300 plus system is on and waiting for commands. Stimulation is off. To return to standby mode from gait or training mode: 1. Press the flashing yellow mode button briefly. The l300 plus control unit will beep, and the mode button will stop...

  • Page 47

    35 chapter 4: the ness l300 plus system adjusting stimulation intensity l300 fs cuff 1. Press the l300 rf stim unit selection button. 2. Then press the plus or minus button to change the intensity level. The l300 plus control unit will beep with each change in level. The new level will show in the d...

  • Page 48

    36 clinician’s guide to mute the alerts for the l300 rf stim unit: 1. Place the l300 plus control unit in standby mode. 2. Press and release the l300 rf stim unit selection button. 3. Press and hold the mute button for three seconds. To mute the alerts for the thigh rf stim unit: 1. Place the l300 p...

  • Page 49

    37 chapter 4: the ness l300 plus system digital display l300 plus control unit indicator thigh rf stim unit indicator and selection arrow rf communication indicator intelli-sense gait sensor indicator l300 rf stim unit indicator and selection arrow figure 4-25: l300 plus control unit digital display...

  • Page 50

    38 clinician’s guide table 4-4: l300 plus control unit operational displays. Table 4-5: l300 plus control unit charging displays. Display description definition on/off button flashes green system is on mode button flashes yellow slowly stimulation is off mode button flashes yellow rapidly stimulatio...

  • Page 51

    39 chapter 4: the ness l300 plus system table 4-6: l300 plus control unit error displays. Table 4-7: l300 plus control unit electronic registration displays. Display description definition thigh rf stim unit indicator flashes red faulty electrode contact in thigh fs cuff l300 rf stim unit indicator ...

  • Page 52

    40 clinician’s guide table 4-8: l300 plus control unit rf communication error displays. Table 4-9: l300 plus control unit low battery displays. Display description definition thigh rf stim unit indicator flashes yellow thigh rf stim unit low battery l300 rf stim unit indicator flashes yellow l300 rf...

  • Page 53: Software

    5 41 chapter 4: clinician's components and accessories clinician’s components and accessories hp ipaq clinician’s programmer hp ipaq clinician’s programmer charger hp ipaq configuration cradle with stylus l300 plus clinician’s pack w/ software • l300 plus intelli-gait software* • thigh clinic strap ...

  • Page 54

    42 clinician’s guide personal panel l300 fs cuff strap personal strap cover fitting cable l300 hydrogel electrode l300 hydrogel electrode base tester, l300 systems thigh elongation bar locks shoe spacer clinical scissors shoe horn tape measure phillips screwdriver marking pen bolster personal panel ...

  • Page 55: Pda Components and Setup

    6 43 chapter 6: pda components and setup pda components and setup the descriptions in this section are for the l300 hp ipaq clinician's programming components. The ness l300 plus system is also compatible with the l300 dell clinician's programming components. Hp ipaq clinician’s programmer the hp ip...

  • Page 56

    Clinician’s guide 44 on/off button the on/off button is used to turn on/off the clinician’s programmer. Reset button the reset button is used to soft reset the clinician’s programmer. Charge indicator light the charge indicator light is amber when the clinician’s programmer is charging and green whe...

  • Page 57

    45 chapter 6: pda components and setup hp ipaq configuration cradle with stylus the hp ipaq configuration cradle with stylus is used to connect the hp ipaq clinician’s programmer to the l300 plus control unit and to the hp ipaq clinician’s programmer charger. While the clinician’s programmer is conn...

  • Page 58: Programming Setup

    Clinician’s guide 46 programming setup orient the clinician’s programmer in the configuration cradle with the touchscreen facing up and the connector port facing left. See figure 6-3. 1. Plug the communication connector cable with charger adapter into the connector port. Figure 6-3: clinician's prog...

  • Page 59

    47 chapter 6: pda components and setup to connect the l300 plus control unit: 1. Turn off the l300 plus control unit, or place it in standby mode. 2. Plug the communication connector cable into the connector port of the l300 plus control unit. The white arrow should be facing up. See figure 6-4. 3. ...

  • Page 60

    48 clinician’s guide.

  • Page 61

    7 49 chapter 7: ness l300 plus intelli-gait software information icon display description definition solid green l300 plus control unit connected. Solid gray l300 plus control unit disconnected. Flashing yellow low battery in one or more of the components. Flashing red error: rf communication failur...

  • Page 62

    50 clinician’s guide advanced settings and audio feedback icons the advanced settings icon opens the advanced settings screen. The audio feedback icon turns on/off audio feedback during stimulation. See figure 7-2. Figure 7-2: advanced settings and audio feedback icons. Audio feedback icon advanced ...

  • Page 63

    51 chapter 7: ness l300 plus intelli-gait software table 7-2: menu functions. Menu function exit exit or log off the l300 plus intelli-gait software. Patients open the patient list window to open, add, modify, or remove a patient record. Settings open the setup window to select a system configuratio...

  • Page 64

    52 clinician’s guide note: the settings menu has four tabs: setup, stim, gait, and training. See figure 7-5. Figure 7-5: settings menu, tabs. Figure 7-6: tools menu, tabs. Tabs tabs note: the tools menu has four tabs: info, users, backup, and restore. Only administrators have access to the users, ba...

  • Page 65

    53 chapter 7: ness l300 plus intelli-gait software button function start/stop starts/stops stimulation in both the l300 rf stim unit and the thigh rf stim unit. Test tests stimulation in the selected rf stim unit. Session from the history menu, opens the patient's session history. Gait from the hist...

  • Page 66

    54 clinician’s guide l300 and thigh tabs press the l300 tab to program settings for the l300 fs cuff. See figure 7-8. L300 tab figure 7-8: l300 tab. Top: l300 only configuration. Bottom: l300 and thigh configuration. L300 tab.

  • Page 67

    55 chapter 7: ness l300 plus intelli-gait software figure 7-9: thigh tab. Thigh tab press the thigh tab to program settings for the thigh fs cuff. See figure 7-9. Figure 7-10: scroll bars. Scroll bars stimulation intensity scroll bar scroll bars press the arrows on a scroll bar to move through the s...

  • Page 68

    56 clinician’s guide keyboard use the on-screen keyboard to enter characters in a field that requires alphanumeric input. The keyboard appears collapsed at the bottom right of most screens. To enlarge or reduce the keyboard, touch the keyboard with the stylus. To enter data, select each character us...

  • Page 69

    57 chapter 7: ness l300 plus intelli-gait software programming the ness l300 plus system logging in 1. Turn on the clinician’s programmer and launch the ness l300 plus intelli-gait software. 2. From the login screen, enter a user name and password, and then press login. See figure 7-12. Figure 7-12:...

  • Page 70

    58 clinician’s guide connecting the l300 plus control unit. When an l300 plus control unit is connected to the clinician’s programmer, one of the following start-up message screens may appear. New patient detected message appears when an l300 plus control unit with patient data on it is connected to...

  • Page 71

    59 chapter 7: ness l300 plus intelli-gait software figure 7-15: unassigned control unit message. Control unit unassigned message appears when a new, unassigned l300 plus control unit (one with no patient data on it) is connected to the clinician’s programmer. See figure 7-15. Do one of the following...

  • Page 72

    60 clinician’s guide thigh rf stim unit not detected message appears when the clinician's programmer does not detect the thigh rf stim unit. This may occur, for example, when a patient forgets to bring the thigh fs cuff to a follow- up session, or the patient and clinician choose to discontinue use ...

  • Page 73

    61 chapter 7: ness l300 plus intelli-gait software figure 7-18: new patient window. 2. For new patients, enter the patient’s first and last name (alpha characters only) in the new patient window, and assign a patient id (1–14 characters). All fields must be completed. Then press ok. See figure 7-18....

  • Page 74

    62 clinician’s guide selecting a system configuration the l300 plus system supports three system configurations: • l300 only. • l300 and thigh hamstrings. • l300 and thigh quadriceps. To select a system configuration: 1. Press the setup tab. 2. Select l300 only, l300 and thigh hamstrings, or l300 an...

  • Page 75

    63 chapter 7: ness l300 plus intelli-gait software programming the l300 stim settings 1. Press the stim tab and the l300 tab. See figure 7-20. Figure 7-20: l300 tab, stim settings window (l300 only configuration). Advanced settings icon intensity bar 5-ma increase 1-ma increase 5-ma decrease 1-ma de...

  • Page 76

    64 clinician’s guide advanced stim settings 1. Press the advanced settings icon to open the advanced stim settings window. 2. From the advanced stim settings window, check the box next to increased charge. See figure 7-21. 3. Press the back icon to return to the stim settings window. Note: if asymme...

  • Page 77

    65 chapter 7: ness l300 plus intelli-gait software table 7-4: l300 stim and gait parameters. L300 stim parameter definition intensity strength of stimulation: 0 ma to 80 ma, in 1-ma steps and 5-ma steps waveform type of stimulation: symmetric or asymmetric phase duration length of time of the pulse:...

  • Page 78

    66 clinician’s guide gait settings the intelli-sense gait sensor must be in the patient’s shoe to program and test the gait settings. To program gait settings: 1. Press the gait tab and the l300 tab. See figure 7-22. Figure 7-22: l300 tab, gait settings window. Audio feedback icon intensity bar 5-ma...

  • Page 79

    67 chapter 7: ness l300 plus intelli-gait software advanced gait settings 1. Press the advanced settingsicon to open the l300 advanced gait settings window. 2. Set the maximum duration of stimulation. See figure 7-23. 3. Press the back icon to return to the gait settings window. Maximum duration of ...

  • Page 80

    68 clinician’s guide programming the thigh stim settings 1. Press the stim tab and the thigh tab to open the thigh stim settings window. See figure 7-24. Figure 7-24: stim settings window, thigh hamstrings. Intensity bar 5-ma increase 1-ma increase 5-ma decrease 1-ma decrease 2. Adjust intensity, wa...

  • Page 81

    69 chapter 7: ness l300 plus intelli-gait software gait settings, thighhamstrings the intelli-sense gait sensor must be in the patient’s shoe to program and test the gait settings. To program gait settings for the thigh hamstrings: 1. Press the gait tab and the thigh tab to openthe gait settings win...

  • Page 82

    70 clinician’s guide stim parameter definition intensity strength of stimulation: 0 ma to 100 ma, in 1-ma steps and 5-ma steps waveform type of stimulation: symmetric or asymmetric phase duration length of time of the pulse: 100, 200, or 300 μsec pulse rate frequency of stimulation: 20 hz to 45 hz, ...

  • Page 83

    71 chapter 7: ness l300 plus intelli-gait software 3. Adjust swing ramp up, swing ramp down, stance ramp up, and stance ramp down. 4. Press start to turn on stimulation in both fs cuffs. Stimulation will respond to input from the intelli-sense gait sensor. Note: the l300 plus intelli-gait software w...

  • Page 84

    72 clinician’s guide maximum duration of stimulation to avoid excessive fatigue of the muscles that activate dorsiflexion, the ness l300 plus system is designed to automatically stop stimulation after a set number of seconds (the maximum duration of stimulation). This safety feature is useful when a...

  • Page 85

    73 chapter 7: ness l300 plus intelli-gait software gait settings, thigh quadriceps the intelli-sense gait sensor must be in the patient’s shoe to program and test the gait settings. To program gait settings for the thigh quadriceps: 1. Press the gait tab and the thigh tab to openthe gait settings wi...

  • Page 86

    74 clinician’s guide advanced gait settings, thigh quadriceps 1. Press the advanced settingsicon to open the advanced gait settings window. 2. Set the maximum duration of stimulation. See figure 7-28. 3. Adjust stance ramp up and stance ramp down. 4. Press start to turn on stimulation in both the l3...

  • Page 87

    75 chapter 7: ness l300 plus intelli-gait software programming training settings 1. Press the training tab to open the training settings window. See figure 7-29. Figure 7-29: training settings window. Intensity bar 1-ma increase 5-ma increase 5-ma decrease 1-ma decrease 2. Choose a training configur...

  • Page 88

    76 clinician’s guide training parameter definition on time the amount of time that stimulation is applied. Off time the amount of rest time between stimulations. Ramp up the time, in seconds, that it takes for the stimulation to increase from zero to the maximum level set. • a gradual buildup of the...

  • Page 89

    77 chapter 7: ness l300 plus intelli-gait software viewing a patient's history session history a patient session begins when an l300 plus control unit is connected to the clinician’s programmer and the patient’s record is opened. A patient session ends when session data are saved and the l300 plus c...

  • Page 90

    78 clinician’s guide figure 7-31: session details window. 3. Select a session from the sessions list and press open. 4. The session details window will open, showing the parameters saved for that session. See figure 7-31. 5. From the view drop-down list, select “all” to view all the session details,...

  • Page 91

    79 chapter 7: ness l300 plus intelli-gait software gait log the gait log is a record of the patient’s ness l300 plus system usage history. The gait log can be filtered by date and time frame, and displayed as a table or graph. To view a patient’s gait log: 1. Open the patient’s record and press hist...

  • Page 92

    80 clinician’s guide figure 7-33: gait log, # of steps graph. 3. From the drop-down list at the bottom right of the screen, select tabular view, # of steps graph, or gait duration graph. • tabular view displays: » date. » number of steps recorded for a given date. » cumulative number of steps record...

  • Page 93

    81 chapter 7: ness l300 plus intelli-gait software training log the training log is a record of the patient’s ness l300 plus system training history. The training log can be filtered by date and resolution, and displayed as a table or graph. To view a patient’s training log: 1. Open the patient’s re...

  • Page 94

    82 clinician’s guide figure 7-35: training log, graph view. 3. From the drop-down list at the bottom right of the screen, select tabular view or graph view. • tabular view displays: » the session date. » session duration (time in training mode). » total (cumulative) time in training mode. » average ...

  • Page 95

    83 chapter 7: ness l300 plus intelli-gait software figure 7-36: modify patient window. Managing patient records modifying a patient name 1. Select a patient from the patient list, and then press modify. 2. The modify patient window will open. See figure 7-36. 3. Modify the name and press ok. Note: p...

  • Page 96

    84 clinician’s guide removing a patient record 1. Select a patient from the patient list. 2. Press remove. 3. The remove patient confirmation window will open. See figure 7-37. 4. Press yes. Figure 7-37: remove patient confirmation window..

  • Page 97

    85 chapter 7: ness l300 plus intelli-gait software viewing the system information 1. Connect an l300 plus control unit to the clinician's programmer. 2. Press the tools menu and the info tab. See figure 7-38. Note: if an l300 plus control unit is not connected, no system information will be displaye...

  • Page 98

    86 clinician’s guide managing users from the tools menu, administrators can add or remove users, change user passwords, and back up and restore the database. Adding a user 1. Press the users tab to view the user administration window. See figure 7-39. Figure 7-39: user administration window. Figure ...

  • Page 99

    87 chapter 7: ness l300 plus intelli-gait software figure 7-41: remove user confirmation window. Figure 7-42: change user’s password window. Removing a user 1. From the user administration window, select a user. 2. Press remove user. 3. A confirmation message will appear. See figure 7-41. Press yes....

  • Page 100

    88 clinician’s guide backing up and restoring the database automatic backup the l300 intelli-gait software will automatically back up the database whenever the application is exited. If a storage card is not in the sd slot, upon exiting the application a warning will appear. Note: users should exit ...

  • Page 101

    89 chapter 7: ness l300 plus intelli-gait software restore administrators can restore the database when the clinician’s programmer is replaced or the database is corrupted. Do not enter new patient information before restoring the database. To restore the database: 1. If a new storage card is in the...

  • Page 102

    90 clinician’s guide.

  • Page 103: Skin Preparation

    91 chapter 8: fitting the ness l300 plus system 8 fitting the ness l300 plus system before fitting, check all components and accessories for signs of wear or damage. If any component is damaged, contact the bioness client relations department at (800) 211- 9136, option 3. If the electrodes are old, ...

  • Page 104

    92 clinician’s guide 2. Remove the existing strap from the l300 fs cuff, if required. 3. Orient the selected l300 fs cuff strap with the hook and loop fasteners facing away from the l300 fs cuff. 4. Insert the selected strap through the strap leads and buckles on the l300 fs cuff. See figure 8-1. St...

  • Page 105

    93 chapter 8: fitting the ness l300 plus system attaching the personal panel the personal panel is used as an hygienic liner for the l300 fs cuff. It is also used to preserve the placement of the l300 electrode bases and/or l300 electrode(s) when an l300 fs cuff is used by multiple patients. The per...

  • Page 106

    94 clinician’s guide 3. Remove excess water from the large cloth electrode. See figure 8-5. Figure 8-5: blotting the large cloth electrode. 4. Align the orange and blue snaps on the large cloth electrode with the orange and blue plug holes on the l300 fs cuff. See figure 8-6. Figure 8-6: aligning th...

  • Page 107

    95 chapter 8: fitting the ness l300 plus system 5. Press firmly to snap the large cloth electrode to the l300 fs cuff. See figure 8-7. 6. Gently remove and rewet the large cloth electrode after every three to four hours of use. See figure 8-8. Figure 8-7: snapping the large cloth electrode. Figure 8...

  • Page 108

    96 clinician’s guide attaching the l300 hydrogel electrodes and bases the l300 hydrogel electrodes are an alternative to the large cloth electrode. The l300 fs cuff uses two l300 hydrogel electrodes and two l300 hydrogel electrode bases. The electrode bases snap to the l300 fs cuff plug holes. The e...

  • Page 109

    97 chapter 8: fitting the ness l300 plus system figure 8-11: splitting the two-piece covers. 3. Attach the grid side of the electrodes to the electrode bases and then press firmly. 4. Remove the larger covers (with the bioness logo) from the electrodes and save them. (always cover the hydrogel elect...

  • Page 110

    98 clinician’s guide connecting the fitting cable the fitting cable is used to connect the l300 hydrogel electrode base snaps to the l300 fs cuff plug holes, for aid in determining optimal placement of the l300 hydrogel electrodes on the leg. To connect the fitting cable: 1. Make sure the l300 rf st...

  • Page 111

    99 chapter 8: fitting the ness l300 plus system adjusting the position of the electrodes: patient seated 1. Connect the patient’s l300 plus control unit to the clinician’s programmer. 2. Log into the l300 plus intelli-gait software and open the patient’s record. 3. Press the stim tab and the l300 ta...

  • Page 112

    100 clinician’s guide figure 8-14: positioning the l300 fs cuff locator below the patella. Transferring the electrodes to the l300 fs cuff 1. Stop stimulation. 2. Using a marking pen, make four small, evenly spaced marks on the patient’s leg around the electrode bases for reference. 3. Disconnect th...

  • Page 113

    101 chapter 8: fitting the ness l300 plus system 9. Press firmly on the l300 electrode bases to secure them to the l300 fs cuff. Plug the l300 electrode base snaps into the l300 fs cuff plug holes. Donning the l300 fs cuff turn off stimulation before donning the l300 fs cuff. To don the l300 fs cuff...

  • Page 114

    102 clinician’s guide 3. Have the patient grasp the handle of the l300 fs cuff strap. With the thumb on the l300 rf stim unit cradle, have the patient fasten the l300 fs cuff strap handle around the cradle. See figure 8-18. 4. Make sure the l300 fs cuff fits comfortably, with the locator below the p...

  • Page 115

    103 chapter 8: fitting the ness l300 plus system retesting electrode placement: patient sitting and standing 1. Press the stim tab and the l300 tab. 2. Press test to turn on stimulation in the l300 only. 3. Press stop to turn off stimulation. 4. If patient response is not accurate or is inconsistent...

  • Page 116

    104 clinician’s guide l300 cloth electrode bases 1. Turn off the l300 plus system. 2. Using the marking pen, mark the position of the l300 hydrogel electrode bases on the l300 fs cuff liner. See figure 8-21. Figure 8-21: marking the position of the l300 hydrogel electrode bases on the l300 fs cuff l...

  • Page 117

    105 chapter 8: fitting the ness l300 plus system 4. Remove the l300 hydrogel electrode bases from the l300 fs cuff liner. See figure 8-23. Figure 8-23: removing the l300 hydrogel electrode bases. Figure 8-24. Attaching the l300 cloth electrode bases. 5. Attach the l300 cloth electrode bases to the l...

  • Page 118

    106 clinician’s guide 6. Snap the l300 cloth electrode bases to the plug holes of the l300 fs cuff. See figure 8-25. Note: the l300 cloth electrode base is 2 mm smaller in diameter than the l300 hydrogel electrode base. L300 cloth electrodes 1. Make sure the l300 plus system is turned off. 2. Wet th...

  • Page 119

    107 chapter 8: fitting the ness l300 plus system figure 8-28: snapping the l300 cloth electrodes to the l300 cloth electrode bases. Figure 8-27: blotting the snap side of the l300 cloth electrodes. 3. With a soft cloth, gently wipe or blot excess water from the snap side of the l300 cloth electrodes...

  • Page 120

    108 clinician’s guide figure 8-29: l300 fs cuff without (left) and with (right) wire concealers. Wire concealer snap wire electrode base attaching the wire concealers the wire concealers may be used to cover the wires and snaps of the l300 electrode bases on the l300 fs cuff. See figure 8-29. Press ...

  • Page 121: Thigh Fs Cuff

    109 chapter 8: fitting the ness l300 plus system 3. Refer to table 8-2 to select the thigh fs cuff size. Thigh fs cuff the thigh fs cuff is available in two sizes: regular and large. Measuring for thigh fs cuff size 1. Have the patient sit at the edge of a chair. 2. Using the tape measure, determine...

  • Page 122

    110 clinician’s guide adjusting the elongation bar the thigh elongation bar is used to adjust the distance between the thigh fs cuff proximal and distal panels, to accommodate different leg sizes. The elongation bar has six adjustment holes. The default elongation bar position is the #3 adjustment h...

  • Page 123

    111 chapter 8: fitting the ness l300 plus system attaching the thigh cloth electrodes the thigh fs cuff uses two cloth electrodes. The proximal thigh electrode snaps to the thigh fs cuff proximal panel and the distal thigh electrode snaps to the thigh fs cuff distal panel. The distal thigh electrode...

  • Page 124

    112 clinician’s guide figure 4-35: electrode positioning on the quadriceps: centered (left) and off-centered (right) position. Figure 4-36: electrode positioning on the hamstrings: centered (left) and off-centered (right) position. Note: • wet the thigh cloth electrodes before use. After every three...

  • Page 125

    113 chapter 8: fitting the ness l300 plus system to attach the thigh cloth electrodes: 1. Wet the thigh cloth electrodes with water until saturated. See figure 8-37. Figure 8-37: wetting the thigh cloth electrodes. Figure 8-38: blotting the thigh cloth electrodes. 2. Press the electrodes together an...

  • Page 126

    114 clinician’s guide figure 8-39: snapping the proximal thigh cloth electrode. Figure 8-40: snapping the distal cloth electrode. 3. Snap the proximal thigh cloth electrode to the proximal panel. See figure 8-39. 4. Snap the distal thigh cloth electrode to the distal panel. See figure 8-40..

  • Page 127

    115 chapter 8: fitting the ness l300 plus system donning the thigh fs cuff turn off stimulation before donning the thigh fs cuff. To don the thigh fs cuff: 1. Center the thigh elongation bar on the thigh. 2. Position the thigh fs cuff locator approximately three finger widths proximal from the patel...

  • Page 128

    116 clinician’s guide checking the position of the thigh cloth electrodes: patient seated stimulation can be tested in the thigh fs cuff only by way of the stimulation setting screen. Stimulation cannot be tested in the thigh fs cuff alone by way of the gait setting screen. To check the position of ...

  • Page 129: Programming Gait Settings

    117 chapter 8: fitting the ness l300 plus system checking the position of the thigh cloth electrodes: patient standing after proper extension or flexion is achieved with the patient seated, if possible, retest with the patient standing, the knee at an adjustable angle, and the foot in the air. If ne...

  • Page 130

    118 clinician’s guide 4. Attach a shoe spacer to the inner clamp of the intelli-sense gait sensor. The shoe spacer stabilizes the intelli-sense gait sensor in the shoe. It also protects the rim of the shoe from the clamp on the intelli-sense gait sensor. The shoe spacer fits between the inner clamp ...

  • Page 131

    119 chapter 8: fitting the ness l300 plus system programming training settings training settings should be adjusted with the patient seated. Doffing the ness l300 plus system 1. If the l300 fs cuff is for clinic use, remove the patient's personal strap cover and personal panel, with the l300 electro...

  • Page 132

    120 clinician’s guide figure 8-47: thigh electrode marking ring on the thigh distal panel snap. Figure 8-48: attaching the thigh electrode marking ring. Marking ring caution: store the thigh cloth electrodes where they can air dry. Attaching the thigh electrode marking ring 1. Check the orientation ...

  • Page 133

    9 121 chapter 9: patient training and follow-up patient training and follow-up clinicians and patients should know the limitations, warnings, and precautions associated with the ness l300 plus system. Clinicians should review the safety information with patients, and train patients on system set-up,...

  • Page 134

    122 clinician’s guide a suggested follow-up agenda would include: • check out the system for wear and function. • programming adjustments: stimulation, gait, and training parameters. • gait training, including advanced training as appropriate (for example, stair negotiation). • review of training to...

  • Page 135: Maintenance and Cleaning

    10 123 chapter 9: maintenance and cleaning maintenance and cleaning registering an l300 plus system upgrade kit the components in a ness l300 plus system upgrade kit must be electronically registered to the existing l300 components for the l300 plus system to operate. The clinician will need to elec...

  • Page 136

    124 clinician’s guide registration the registration procedure must be performed twice: once for the l300 plus control unit and once for the thigh rf stim unit. Note: the existing intelli-sense gait sensor does not need to be registered. Only a new intelli-sense gait sensor needs to be registered. To...

  • Page 137

    125 chapter 10: maintenance and cleaning to register the thigh rf stim unit: 1. Simultaneously press and hold for three seconds the mode and minus buttons on the l300 plus control unit. The l300 plus control unit will beep when registration begins. 2. The l300 plus control unit digital display will ...

  • Page 138: Charging

    126 clinician’s guide caution: only use electrodes supplied by bioness inc. Charging charge the hp ipaq clinician's programmer and the ness l300 plus system daily. Pda battery storage during extended periods of nonuse, remove the battery from the hp ipaq clinician’s programmer. Refer to the pda manu...

  • Page 139: Electrode Bases

    127 chapter 10: maintenance and cleaning electrode bases the l300 electrode bases are reusable. When a patient discontinues use of the ness l300 plus system, remove the l300 electrode bases from the personal panel or the l300 fs cuff, and remove the l300 electrodes from the l300 electrode bases. Cle...

  • Page 140: Thigh Cuff Buckles

    128 clinician’s guide *if using l300 hydrogel electrodes and bases: 1. Place the old l300 fs cuff on the leg. 2. Use a marking pen to mark the position of the l300 fs cuff locator on the leg. (mark a few small dots.) 3. Remove the l300 fs cuff from the leg. (the leg should show impressions where the...

  • Page 141: Thigh Clinic Straps

    129 chapter 10: maintenance and cleaning thigh clinic straps the thigh clinic strap set includes two straps and one handle. The thigh clinic straps slide in and out of the thigh fs cuff distal and proximal panels. To replace the thigh clinic straps: 1. Note the orientation of the buckle and handle o...

  • Page 142: Thigh Elongation Bar Lock

    130 clinician’s guide thigh elongation bar lock the thigh elongation bar lock is used to lock the position of the elongation bar on home-use systems. To adjust the elongation bar, the thigh elongation bar lock must be removed. Note: only clinicians should remove the thigh elongation bar lock. To rem...

  • Page 143: Cleaning

    131 chapter 10: maintenance and cleaning cleaning all l300 plus components may be cleaned by carefully wiping them with a damp cloth. The electrical components are not waterproof. Do not immerse them in water. If necessary, clean the l300 electrode bases with a damp cloth. Do not use a chemical- bas...

  • Page 144

    132 clinician’s guide.

  • Page 145: Troubleshooting

    11 133 chapter 11: troubleshooting troubleshooting using the tester the tester is used to troubleshoot if there is a disconnection in one of the fs cuffs or a faulty rf stim unit. The tester provides audio feedback when connected to the ness l300 plus system and stimulation is applied. Testing the l...

  • Page 146

    134 clinician’s guide testing the l300 fs cuff in gait mode 1. Connect the tester to the l300 fs cuff. 2. Press the l300 plus control unit on/off button to turn on the system. 3. Press the mode button briefly to enter gait mode. The l300 plus control unit will beep and the mode button will flash yel...

  • Page 147

    135 chapter 11: troubleshooting figure 11-2: removing the l300 rf stim unit. Figure 11-3: tester connected to the l300 rf stim unit. Step 2: test the l300 rf stim unit: 1. Remove the l300 rf stim unit from the cradle. See figure 11-2. 2. Connect the tester to the electrical sockets on the back of th...

  • Page 148

    136 clinician’s guide testing the thigh fs cuff in training mode 1. Connect the tester to the proximal snap on the thigh fs cuff proximal panel and to the proximal snap on the thigh fs cuff distal panel. See figure 11-4. Figure 11-4: tester connected to the thigh fs cuff. 2. Press the l300 plus cont...

  • Page 149

    137 chapter 11: troubleshooting advanced testing if stimulation is not delivered to the patient’s leg, a “faulty electrode contact” error may appear. Recheck that the thigh rf stim unit is fully snapped into the cradle of the thigh fs cuff. Then follow the steps below: step 1: test the thigh fs cuff...

  • Page 150

    138 clinician’s guide 2. Connect the tester to the electrical sockets on the back of the thigh rf stim unit. See figure 11-6. The connectors on the tester and the electrical sockets on the thigh rf stim unit are color coded. Figure 11-6: tester connected to the thigh rf stim unit. 3. Apply stimulati...

  • Page 151: Frequently Asked Questions

    139 chapter 11: troubleshooting frequently asked questions if you have any questions or concerns, please contact the bioness client relations department at (800) 211-9136, option 3. Our clinic owns multiple ness l300 plus systems. How can we identify which components belong to which system? • each n...

  • Page 152

    140 clinician’s guide i connected the l300 plus control unit to the configuration cradle. A message appeared on the clinician’s programmer. The message says that a new patient was found and asks if i would like to add the patient record to the database. • select yes, if you want to add that patient ...

  • Page 153

    141 chapter 11: troubleshooting if i charge the l300 plus system every day, will i harm the batteries? • no. Daily charging will not affect the lifespan or functionality of the batteries. Daily charging is recommended. While charging the l300 plus control unit and rf stim units, "e" appears in the d...

  • Page 154

    142 clinician’s guide when i turn on the l300 plus control unit, it beeps. One of the rf stim unit indicators and the rf communication indicator on the l300 plus control unit is flashing red. The rf stim unit indicators are not lit. • the rf stim unit battery is likely discharged, preventing the l30...

  • Page 155

    143 chapter 11: troubleshooting an electrode or base is frayed, peeling, damaged, or falling off the fs cuff. • replace any worn or damaged electrodes or electrode bases. A component indicator is solid red and the l300 plus control unit is beeping. • the component is malfunctioning. Turn off the l30...

  • Page 156

    144 clinician’s guide i tried the registration procedure and saw a immediately, but i never saw the alternating green arches in the digital display. The replacement component is not working. • clinician mode may have been started instead of the registration process. Clinician mode is started by pres...

  • Page 157

    145 chapter 11: troubleshooting l300 plus control unit solution will not turn on. • charge the l300 plus control unit. • change the battery, and charge the l300 plus control unit. • replace the l300 plus control unit. Component malfunction. Replace the l300 plus control unit. L300 and thigh rf stim ...

  • Page 158

    146 clinician’s guide the l300 plus control unit is displaying a faulty electrode connection. • ensure good contact of the electrodes to the skin (and l300 electrode bases). • ensure that the fs cuff connections are intact. An electrode is damaged or peeling off. Replace the electrode. An l300 elect...

  • Page 159: Technical Specifications

    12 147 chapter 12: technical specifications technical specifications l300 plus control unit specifications classification internally powered, continuous operation operation modes gait, training, clinician, and standby battery type rechargeable aaa nimh 1.2 v, 900–1100 mah controls • on/off illuminat...

  • Page 160

    148 clinician’s guide l300 rf stim unit specifications classification internally powered, continuous operation with type bf applied parts operating voltage 3.7 v battery type proprietary rechargeable li-ion (lithium ion) 3.7 v, 750 mah indications • status (fault, battery, charging) and stimulation ...

  • Page 161

    149 chapter 12: technical specifications gait parameters ramp up 0–2 seconds, 0.1-second resolution ramp down 0–2 seconds, 0.1-second resolution extended (%) 0–100% of stance time, 10% resolution max duration 2–10 seconds, 1-second resolution training parameters on time 4–20 seconds, 1-second resolu...

  • Page 162

    150 clinician’s guide thigh rf stim unit specifications classification internally powered, continuous operation with type bf applied parts operating voltage 3.7 v battery type proprietary rechargeable li-ion (lithium ion) 3.7 v, 750 mah indications • status (fault, battery, charging) and stimulation...

  • Page 163

    151 chapter 12: technical specifications gait parameters swing control delay (%) 0–100% of phase* time, 5% resolution swing control end (%) 0–100% of phase* time, 5% resolution stance control delay (%) 0–100% of phase* time, 5% resolution stance control end (%) 0–100% of phase* time, 5% resolution r...

  • Page 164

    152 clinician’s guide thigh cloth electrode specifications material non-woven cloth note: use only electrodes provided by bioness inc. Dimensions proximal: oval, 130 x 75 mm ( distal: oval, 120 x 63 mm intelli-sense gait sensor specifications classification internally powered, continuous operation w...

  • Page 165: Appendix - Emi Tables

    13 153 chapter 13: appendix - emi tables appendix - emi tables guidance and manufacturer’s declaration—electromagnetic emissions the ness l300 plus system is intended for use in the electromagnetic environment specified below. The customer or the user of the ness l300 plus system should assure that ...

  • Page 166

    154 clinician’s guide guidance and manufacturer’s declaration— electromagnetic immunity for all equipment and systems the ness l300 plus system is intended for use in the electromagnetic environment specified below. The customer or the user of the ness l300 plus system should assure that it is used ...

  • Page 167

    155 chapter 13: appendix - emi tables guidance and manufacturer’s declaration—electromagnetic immunity the ness l300 plus system is intended for use in the electromagnetic environment specified below. The customer or the user of the ness l300 plus system should assure that it is used in such an envi...

  • Page 168

    156 clinician’s guide recommended separation distances between portable and mobile rf communications equipment and the ness l300 plus system the ness l300 plus system is intended for use in an electromagnetic environment in which radiated rf disturbances are controlled. The customer or the user of t...