Bioness NESS L300 Plus User's Guide

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VIIIUser's Guide

90User's GuideCharging the BatteriesWhen a NESS L300 Plus System component has a low battery, the L300 Plus Control Unit will beep and the compon

91Chapter 9 - Maintenance and CleaningTo charge the batteries in the L300 Plus Control Unit, L300 RF Stim Unit, and Thigh RF Stim Unit:1. Select an a

92User's Guide2. Open the flexible covers over the charging ports. See Figure 9-3.Figure 9-3: Charging setup.W CableFlexible CoverChargerFlexible

93Chapter 9 - Maintenance and Cleaning7. Allow the charging process to continue until: • A horizontal GREEN line appears in the L300 Plus Control U

94User's GuideNote: If the L300 Plus Control Unit battery is completely discharged, a “b” (for boot) will flash for a few seconds in the L300 Plus

95Chapter 9 - Maintenance and CleaningBattery ReplacementThe battery in the Intelli-Sense Gait Sensor is not rechargeable. It may need to be replaced

96User's Guide2. Slide the cover out.3. Note the “+” orientation of the old battery.CAUTION: Use only a battery supplied by Bioness.Remove the

97Chapter 9 - Maintenance and CleaningThe battery in the L300 Plus Control Unit is a rechargeable AAA NiMH battery. It should be replaced approximatel

98User's Guide4. Insert the new rechargeable battery in the proper "+/-" orientation. 5. Slide the cover into place.CAUTION: Use only

99Chapter 9 - Maintenance and CleaningThe RF Stim Units have a rechargeable battery that can only be replaced by a Bioness authorized representative.

1Chapter 1 - Introduction1IntroductionCentral nervous system (CNS) injuries and diseases often cause a gait disorder called foot drop. People who have

100User's GuideBasesReplace the L300 electrode bases if they appear worn or damaged.To replace the L300 electrode bases:1. Mark the position of

101Chapter 9 - Maintenance and CleaningFigure 9-8: Removing the used L300 electrode bases.Figure 9-9. Attaching the new L300 electrode bases.3. Remov

102User's GuideFigure 9-10: Snapping the L300 electrode bases to the L300 FS Cuff plug holes.Figure 9-11: Wire concealers covering the L300 elect

103Chapter 9 - Maintenance and CleaningL300 FS Cuff StrapTo replace the L300 FS Cuff strap:1. Remove the used L300 FS Cuff strap from the L300 FS Cuf

104User's GuideThigh Silicone PanelsTo replace the Thigh silicone panels:1. Unsnap and remove the Thigh cloth electrodes.2. Gently detach the lo

105Chapter 9 - Maintenance and Cleaning3. Slide the band on the bottom silicone panel over the Thigh RF Stim Unit. See Figure 9-14.Figure 9-14: Slidi

106User's Guide5. Gently slide the new silicone panels around the electrode snaps.6. Slide the band on the bottom silicone panel over the Thigh

107Chapter 9 - Maintenance and CleaningRemoving the L300 and Thigh RF Stim UnitsThe L300 and Thigh RF Stim Units should only be removed for maintenanc

108User's GuideCleaning the L300 Plus ComponentsAll L300 Plus components may be cleaned by carefully wiping them with a damp cloth. The electrica

109Chapter 9 - Maintenance and CleaningDisinfecting the L300 Plus ComponentsAll NESS L300 Plus System Kit components excluding the L300 FS Cuff and th

2User's Guide

110User's Guide

111Chapter 10 - Electronic Registration 10Electronic RegistrationThe NESS L300 Plus System components must be electronically registered to each other

112User's GuideSetup:1. Place the components you are registering close together on a table but not touching. See Figure 10-1.Figure 10-1: Regist

113Chapter 10 - Electronic RegistrationTo register a replacement L300 Plus Control Unit or RF Stim Unit:1. Turn off the L300 Plus System.2. Simultan

114User's Guide6. Locate the System ID Number for the NESS L300 Plus System (for example, A334). The System ID Number can be found on the back la

115Chapter 10 - Electronic RegistrationTo register a replacement/additional Intelli-Sense Gait Sensor:Note: Read steps 1–4 before starting.1. Turn of

116User's GuideBlank Label7. Locate the System ID Number for the NESS L300 Plus System (for example, A334). The System ID Number can be found on

117Chapter 11 - Troubleshooting11TroubleshootingIf you have any questions or concerns, please call the Bioness Client Relations Department at (800) 21

118User's Guide Stimulation works in training mode but not in gait mode. When I turn on gait mode I hear a beep. The Intelli-Sense Gait Sensor in

119Chapter 11 - Troubleshooting I hear a beep and an RF Stim Unit indicator (L300 or Thigh) on the L300 Plus Control Unit FLASHES RED. • If you feel s

3Chapter 2 - Device Description and Safety Information2Device Description and Safety InformationDevice DescriptionThe NESS L300 Plus System consists o

120User's Guide •Make sure the L300 and Thigh RF Stim Units are properly snapped into the cradles on the L300 and Thigh FS Cuffs. Press firmly nea

121Chapter 11 - Troubleshooting One of the component indicators is SOLID RED and the L300 Plus Control Unit beeps. •The respective component is malfun

122User's GuideStimulation is inconsistent when I am walking, but the NESS L300 Plus System is not indicating any errors. •Stop walking and shift

123Chapter 11 - TroubleshootingI tried the registration procedure and saw a immediately, but I never saw the alternating arches in the digital displ

124User's Guide

125Chapter 12 - Technical Specifications12Technical SpecificationsL300 Plus Control Unit SpecificationsClassification Internally powered, continuous ope

126User's GuideL300 RF Stim Unit SpecificationsClassificationInternally powered, continuous operation with type BF applied partsOperating Voltage3.

127Chapter 12 - Technical SpecificationsSymmetric AsymmetricPositive Pulse Duration (µsec) 100 200 300 100 200 300Negative Pulse Duration (µsec)100 2

128User's GuideThigh RF Stim Unit SpecificationsClassificationInternally powered, continuous operation with type BF applied partsOperating Voltage3

129Chapter 12 - Technical SpecificationsSymmetric AsymmetricPositive Pulse Duration (µsec) 100 200 300 100 200 300Negative Pulse Duration (µsec)100 2

4User's GuideIndications for UseThe NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals wi

130User's GuideL300 FS Cuff SpecificationsMaterial Fabric-PolymerFits Limb Circumference29–51 cm (11–20 in.)Dimensions• Height: 160 mm (6.3 in.)•

131Chapter 12 - Technical SpecificationsIntelli-Sense Gait Sensor SpecificationsClassificationInternally powered, continuous operation with type BF appl

132User's GuideCharger SpecificationsUse medical Class II safety approved power supply provided/approved by Bioness with the following ratings:Inp

133Chapter 12 - Technical SpecificationsL300 Electrode and L300 Electrode Base SpecificationsHydrogelElectrodesTwo 45-mm (1.77-in.) diameter hydrogel e

134User's Guide

135Chapter 13 - Appendix - EMI Tables13Appendix - EMI TablesSystem CharacteristicsTransmittersOperating Frequency Band 2401–2482 MHzType of Modulation

136User's GuideGuidance and Manufacturer’s Declaration—Electromagnetic EmissionsThe NESS L300 Plus System is intended for use in the electromagne

137Chapter 13 - Appendix - EMI TablesGuidance and Manufacturer’s Declaration—Electromagnetic Immunity for All Equipment and SystemsThe NESS L300 Plus

138User's GuideImmunity Test IEC 60601 Test LevelCompliance Level Electromagnetic Environment—GuidanceVoltage dips, short interruptions and volta

139Chapter 13 - Appendix - EMI TablesGuidance and Manufacturer’s Declaration—Electromagnetic ImmunityThe NESS L300 Plus System is intended for use in

5Chapter 2 - Device Description and Safety InformationWarnings • The long-term effects of chronic electrical stimulation are unknown. • The L300 and T

140User's GuideNOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electr

141Chapter 13 - Appendix - EMI TablesRecommended Separation Distances Between Portable and Mobile RF Communications Equipment and the NESS L300 Plus S

142User's GuideNOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electr

6User's Guide •Obtain physician clearance prior to use if you have an alteration in normal arterial or venous flow in the region of the L300 and/o

7Chapter 2 - Device Description and Safety Information • Do not use the NESS L300 Plus System without electrodes. • Use only electrodes supplied by Bi

8User's Guide • Do not attempt to repair your NESS L300 Plus System. Changes or modifications to the NESS L300 Plus System components not expressl

9Chapter 2 - Device Description and Safety InformationAdverse ReactionsIn the unlikely event that any of the following occurs, stop using your NESS L3

User’s Guide

10User's Guide • Replace the electrodes at least every two weeks, even if they appear to be in good condition. • Store the L300 hydrogel electrod

11Chapter 3 - Environmental Conditions that Affect Use3Environmental Conditions that Affect UseRadio Frequency (RF) Communication InformationSeveral c

12User's GuideConformity CertificationThe NESS L300 Plus System complies with Part 15 of the FCC rules. Operation is subject to the following two

13Chapter 3 - Environmental Conditions that Affect UseElectromagnetic EmissionsThe NESS L300 Plus System needs special precautions regarding electroma

14User's Guide •The use of the accessory, transducer, or cable with equipment and systems other than those specified may result in increased emiss

15Chapter 4 - NESS L300 Plus System Kits4NESS L300 Plus System KitsNESS L300 Plus System KitSystem Components • L300 Plus Control Unit • L300 FS Cuff

16User's Guide • Replacement Battery, Gait Sensor • Gait Sensor Pads • Shoe Spacers • Thigh Elongation Bar Locks • Thigh Electrode Marking Rings

17Chapter 4 - NESS L300 Plus System Kits Control Unit Wrist StrapControl Unit Belt PouchControl Unit Neck StrapSystem Charger SetReplacement Battery,

18User's GuideNESS L300 Plus System Upgrade KitThe NESS L300 Plus System Upgrade Kit is for individuals who have a NESS L300 Foot Drop System. Sy

19Chapter 5 - NESS L300 Plus System5NESS L300 Plus SystemL300 Functional Stimulation (FS) Cuff The L300 FS Cuff fits on the affected leg below the knee

IUser’s GuideRx Only

20User's GuideLocatorThe locator fits under the kneecap of the affected leg. The locator is used to accurately place the L300 FS Cuff on the leg,

21Chapter 5 - NESS L300 Plus SystemL300 RF Stim UnitThe L300 RF Stim Unit generates the electrical stimulation used to dorsiflex the foot. It responds

22User's GuideThe L300 RF Stim Unit emits visual and/or audio alerts when: • Stimulation is on. • RF communication with the L300 RF Stim Unit fai

23Chapter 5 - NESS L300 Plus SystemThigh FS Cuff The Thigh FS Cuff is a lightweight, low-profile orthosis designed to assist with knee flexion or extens

24User's GuidePanelsThe Thigh FS Cuff features two panels. The top panel fits higher on the thigh. The bottom panel fits lower on the thigh. The bo

25Chapter 5 - NESS L300 Plus SystemFigure 5-4: Snapping the small Thigh cloth electrode to the bottom panel.CAUTION: Do not wear the Thigh FS Cuff wit

26User's GuideThigh RF Stim UnitThe Thigh RF Stim Unit generates the electrical stimulation used to flex or extend the knee. It responds to wirele

27Chapter 5 - NESS L300 Plus SystemThighRF Stim UnitDisplay Description DefinitionStatus LightFLASHES GREEN System is OnFLASHES YELLOW Low BatteryALTER

28User's GuideIntelli-Sense Gait SensorThe Intelli-Sense Gait Sensor features a pressure sensor and a transmitter. See Figure 5-6. Figure 5-6: In

29Chapter 5 - NESS L300 Plus SystemClampGait Sensor PadFigure 5-7: Intelli-Sense Gait Sensor in a left shoe.The transmitter: • Is worn clamped to the

IIUser's GuideUser’s Guide Copyright© 2011, Bioness IncAll Rights ReservedNo part of this publication may be reproduced, transmitted, transcribed

30User's GuideL300 Plus Control UnitThe L300 Plus Control Unit is used to: • Turn on/off the NESS L300 Plus System. • Test the position of the FS

31Chapter 5 - NESS L300 Plus SystemThe L300 Plus Control Unit communicates wirelessly with the L300 and Thigh RF Stim Units. It is powered by a single

32User's GuideOperating ModesThe L300 Plus System has three operating modes: standby, gait, and training. Standby ModeIn standby mode, the NESS L

33Chapter 5 - NESS L300 Plus SystemIntelli-Sense Gait Sensor Indicator Digital DisplayL300 RF Stim Unit Indicator/Selection Arrow L300 Plus Control Un

34User's GuideDisplay Description DefinitionOn/Off Button FLASHES GREEN System is On Mode Button FLASHES YELLOW SLOWLYStimulation is OffMode Butto

35Chapter 5 - NESS L300 Plus SystemDisplay Description DefinitionThigh RF Stim Unit Indicator FLASHES REDFaulty Electrode Contact in Thigh FS CuffL300

36User's GuideDisplay Description DefinitionThigh RF Stim Unit Indicator and RF Communication Indicator ALTERNATELY FLASH REDRF Communication Fail

37Chapter 5 - NESS L300 Plus SystemDisplay Description DefinitionThigh RF Stim Unit Indicator FLASHES YELLOWThigh RF Stim Unit Low BatteryL300 RF Stim

38User's GuideDisplay Description DefinitionROTATING GREEN Circle L300 Plus Control Unit ChargingHorizontal GREEN LineL300 Plus Control Unit Fully

39Chapter 6 - L300 Plus Accessories6L300 Plus AccessoriesL300 Electrodes and BasesThe L300 electrodes deliver the electrical stimulation used to dorsi

IIIContentsList of Symbols ... VIIChapter 1: Introducti

40User's GuideLarge Cloth ElectrodeThe L300 FS Cuff uses one large cloth electrode. The large cloth electrode snaps to the L300 FS Cuff plug hole

41Chapter 6 - L300 Plus Accessories3. Wet the entire large cloth electrode with water. See Figure 6-3.Figure 6-3: Wetting the large cloth electrode.F

42User's Guide5. Align the orange and blue snaps on the large cloth electrode with the orange and blue plug holes on the L300 FS Cuff. See Figur

43Chapter 6 - L300 Plus AccessoriesL300 Hydrogel Electrodes and BasesThe L300 FS Cuff uses two L300 hydrogel electrodes and two L300 hydrogel electrod

44User's GuideFigure 6-8: Removing the used L300 hydrogel electrodes.To replace the L300 hydrogel electrodes:1. Turn off the L300 Plus System an

45Chapter 6 - L300 Plus Accessories4. Separate the new L300 hydrogel electrodes along the perforation. See Figure 6-9.Figure 6-9: Separating the new

46User's GuideFigure 6-11: Adhering the L300 hydrogel electrodes to the bases.Figure 6-12: Removing the covers from the L300 hydrogel electrodes.

47Chapter 6 - L300 Plus AccessoriesL300 Cloth Electrodes and BasesThe L300 cloth electrodes are for people who opt to use them instead of the L300 hyd

48User's GuideTo rewet/replace the L300 cloth electrodes:1. Turn off the L300 Plus System and remove the L300 FS Cuff.2. Gently pull the L300 c

49Chapter 6 - L300 Plus Accessories4. Wet the L300 cloth electrodes with water until they are saturated. See Figure 6-15.Figure 6-15: Wetting the L30

IVUser's GuideStrap ... 20L300 Electrode

50User's GuideFigure 6-17: Snapping the L300 cloth electrodes to the cloth electrode bases.6. Snap the L300 cloth electrodes to the L300 cloth e

51Chapter 6 - L300 Plus AccessoriesCAUTION: The electrodes are for single patient use.CAUTION: Wet the cloth electrodes before use, and remove and rew

52User's GuideMarking RingMarkingThe small Thigh cloth electrode has a marking around one of the snaps. Align the marking with the electrode mark

53Chapter 6 - L300 Plus AccessoriesTo rewet/replace the Thigh cloth electrodes:1. Turn off the L300 Plus System and remove the Thigh FS Cuff.2. Gent

54User's GuideFigure 6-22: Blotting the snap side of the Thigh cloth electrodes.4. Gently squeeze the Thigh cloth electrodes together.5. Blot e

55Chapter 6 - L300 Plus AccessoriesThigh Electrode Marking RingThe Thigh electrode marking ring marks the orientation of the small Thigh cloth electro

56User's GuideFigure 6-26: Cloth electrode mesh bag.Cloth Electrode Mesh BagThe cloth electrode mesh bag is for storing the L300 and Thigh cloth

57Chapter 6 - L300 Plus AccessoriesThigh Elongation Bar LockThe Thigh elongation bar lock prevents the elongation bar from sliding. See Figure 6-27. F

58User's GuideControl Unit Wrist Strap, Neck Strap, and Belt PouchThe L300 Plus control unit wrist strap, neck strap, and belt pouch are for carr

59Chapter 6 - L300 Plus AccessoriesSystem Charger SetThe system charger set is for charging the L300 RF Stim Unit, Thigh RF Stim Unit, and L300 Plus C

VControl Unit Wrist Strap, Neck Strap, and Belt Pouch ... 58System Charger Set ...

60User's GuideReplacement Battery, Gait SensorThe Intelli-Sense Gait Sensor battery may need to be replaced approximately every six months. See F

61Chapter 6 - L300 Plus AccessoriesFigure 6-31: Placement of the gait sensor pad in the heel of a shoe.Gait Sensor PadsThe gait sensor pad stabilizes

62User's GuideShoe SpacersThe shoe spacer is placed on the inner clamp of the Intelli-Sense Gait Sensor. See Figure 6-32.Figure 6-32: Attaching t

63Chapter 7 - Setting Up the NESS L300 Plus System7Setting Up the NESS L300 Plus SystemPreparing the SkinBefore you put on the L300 and Thigh FS Cuffs

64User's GuidePutting on the L300 FS CuffTo put on the L300 FS Cuff:1. Remove and wet the L300 cloth electrode(s), if appropriate.2. Remove the

65Chapter 7 - Setting Up the NESS L300 Plus System4. Grasp the front of the L300 FS Cuff by the cradle. Then tilt the bottom of the L300 FS Cuff up.5

66User's GuideFigure 7-3: Fastening the L300 FS Cuff strap.Locator Below the KneecapThumb on the Cradle and Fingers on the Strap Handle6. While

67Chapter 7 - Setting Up the NESS L300 Plus SystemFigure 7-4: The L300 FS Cuff correctly positioned on the right leg.Locator Below the KneecapStrap Ha

68User's GuideTesting the Position of the L300 FS CuffTo test the position of the L300 FS Cuff:1. Place the L300 Plus Control Unit in standby mo

69Chapter 7 - Setting Up the NESS L300 Plus SystemPutting on the Thigh FS CuffTo put on the Thigh FS Cuff:1. Remove and wet the Thigh cloth electrode

VIUser's GuideAdjustment Guidelines ... 82Thigh FS Cuff...

70User's GuideFigure 7-6: Thigh FS Cuff correctly positioned on the quadriceps.4. Center the elongation bar on the midline of the thigh. See Fig

71Chapter 7 - Setting Up the NESS L300 Plus SystemTesting the Position of the Thigh FS CuffTo test the position of the Thigh FS Cuff:1. Place the L30

72User's GuidePlacing the Intelli-Sense Gait Sensor in the ShoeThe Intelli-Sense Gait Sensor is used when walking in gait mode. Make sure it is p

73Chapter 7 - Setting Up the NESS L300 Plus SystemNote: If your shoe does not have a detachable insole, place the pressure sensor on top of the insole

74User's GuideTo position the transmitter:1. Cover the inner clamp of the Intelli-Sense Gait Sensor with the shoe spacer. See Figure 7-9. Figure

75Chapter 7 - Setting Up the NESS L300 Plus SystemFigure 7-10: Clamping the transmitter to the inner rim of the shoe.Pressure SensorTransmitterClamp A

76User's GuideTransferring the Intelli-Sense Gait Sensor to Another ShoeTo transfer the Intelli-Sense Gait Sensor to another shoe:1. Turn off th

77Chapter 8 - Operating the NESS L300 Plus System8Operating the NESS L300 Plus SystemThe NESS L300 Plus System is designed to operate as a complete sy

78User's GuideTesting the Position of the FS CuffsThe stimulation test button is used to test the position of the FS Cuffs. Only one FS Cuff can

79Chapter 8 - Operating the NESS L300 Plus SystemSelecting an Operating ModeSelecting Gait ModeTo select gait mode:1. Turn on the L300 Plus System.2.

VIIList of SymbolsCaution or WarningDouble Insulated (Equivalent to Class II of IEC 536)Type BF Applied Part(s)Non-Ionizing RadiationDate of Manufactu

80User's GuideReturning to Standby ModeTo return to standby mode from gait or training mode: • Press the flashing mode button briefly. The L300 P

81Chapter 8 - Operating the NESS L300 Plus SystemAdjusting Stimulation IntensityWhen the L300 Plus Control Unit is turned on, the stimulation intensit

82User's Guide2. Press the plus or minus intensity adjustment button on the L300 Plus Control Unit to change the intensity level.The L300 Pl

83Chapter 8 - Operating the NESS L300 Plus SystemThigh FS CuffTo adjust stimulation intensity for the Thigh FS Cuff:1. Press the Thigh RF Stim Unit s

84User's GuideTurning on Audio Feedback During StimulationThe mute button is used to turn on audio feedback when stimulation is on. Audio feedbac

85Chapter 8 - Operating the NESS L300 Plus SystemThigh FS CuffTo turn on audio feedback during stimulation:1. Place the L300 Plus Control Unit in sta

86User's GuideMuting/Un-Muting the L300 Plus Control UnitTo mute/un-mute the L300 Plus Control Unit: • Press the mute button briefly.Note: When th

87Chapter 8 - Operating the NESS L300 Plus SystemTurning Off Audio/Visual AlertsThe NESS L300 Plus System is designed to be worn as a complete system

88User's Guide

89Chapter 9 - Maintenance and Cleaning9Maintenance and CleaningDaily MaintenanceWhen the NESS L300 Plus System is not in use:1. If appropriate, reapp