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Bioness NESS L300, User Manual

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NESS L300

®

User’s Guide

Summary of Contents for NESS L300

Page 1: ...NESS L300 User s Guide...

Page 2: ...r 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 p...

Page 3: ...Not Be Disposed of with Other Household Waste Refer to Instruction Manual Booklet Re Order Number Lot Number Serial Number Complies with United States and Canadian Product Safety Standards Single Pat...

Page 4: ...Affect Use 9 Radio Frequency RF Communication 9 Travel 10 Chapter 4 L300 System Kit 11 Contents 11 Chapter 5 Device Description 15 Functional Stimulation FS Cuff 15 L300 RF Stim Unit 15 Electrodes and...

Page 5: ...5 Gait Mode 35 Training Mode 36 Standby Mode 36 Adjusting Stimulation Intensity 36 Adjusting the Volume of Audio Alerts 37 Turning On Audio Feedback During Stimulation 37 Chapter 8 Maintenance and Cle...

Page 6: ...ing 51 Chapter 9 Electronic Registration of Replacement 0ARTS 53 Registering a New Control Unit 53 Registering a New RF Stim Unit 55 Registering a New Intelli Sense Gait Sensor 57 Chapter 10 Troublesh...

Page 7: ...VII User s Guide T h i s p a g e i n t e n t i o n a l l y l e f t b l a n k...

Page 8: ...design features to improve walking and quality of life The L300 System consists of a Functional Stimulation FS Cuff available in regular and small sizes with a Radio Frequency RF Stim Unit an Intelli...

Page 9: ...about the L300 System The components of the L300 System How to set up operate and maintain your L300 System Troubleshooting information Your clinician has prescribed the L300 System to treat your foo...

Page 10: ...cted The L300 FS Cuff should not be used on a leg where a regional disorder such as a fracture or dislocation could be adversely affected by motion from the stimulation The L300 FS Cuff should not be...

Page 11: ...tation an allergic reaction or hypersensitivity to the electrical stimulation or the electrical conductive medium Irritation may be avoided by having your clinician change the stimulation parameters t...

Page 12: ...ll electronic components from contact with water such as from sinks bathtubs shower stalls rain snow etc Do not leave the L300 System stored where temperatures may exceed the acceptable environmental...

Page 13: ...been reported with the use of powered muscle stimulators Skin Care Guidelines In the absence of proper skin care extended use of electrical stimulation may cause skin irritation or a skin reaction to...

Page 14: ...Ventilate the skin by removing the L300 FS Cuff for at least 15 minutes every three to four hours If skin irritation or a skin reaction occurs stop using your L300 System immediately and contact your...

Page 15: ...8 User s Guide T h i s p a g e i n t e n t i o n a l l y l e f t b l a n k...

Page 16: ...ich can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna...

Page 17: ...radio transmitting devices be turned off during flight Electromagnetic Emissions The L300 System needs special precautions regarding electromagnetic compatibility EMC and needs to be installed and pu...

Page 18: ...tim Unit Intelli Sense Gait Sensor Control Unit System Charger Set Small L300 FS Cuff Strap XXS Gait Sensor Pads Shoe Spacers Gait Sensor Replacement Battery Small Electrode Bases Cloth Electrode Mesh...

Page 19: ...Gait Sensor Control Unit System Charger Set Regular L300 FS Cuff Strap S Regular L300 FS Cuff Strap L Gait Sensor Pads Shoe Spacers Gait Sensor Replacement Battery Cloth Electrode Mesh Bag Control Un...

Page 20: ...er 4 L300 System Kit Control Unit System Charger Set Intelli Sense Gait Sensor Regular FS Cuff Strap S M L Small FS Cuff Strap XXS XS Regular L300 FS Cuff and RF Stim Unit Small L300 FS Cuff and RF St...

Page 21: ...it Wrist Strap Control Unit Neck Strap Gait Sensor Replacement Battery Small Electrode Bases only in the Small L300 System Kit Cloth Electrode Mesh Bag Control Unit Belt Pouch Shoe Spacers Phillips Sc...

Page 22: ...or accurate placement on the leg and a strap that can be fastened with one hand Figure 5 1 L300 FS Cuff Features RF Stim Unit The RF Stim Unit snaps into the cradle of the L300 FS Cuff See Figure 5 1...

Page 23: ...ay Description Definition Status Light Flashes Green System is On Flashes Yellow Low Battery Alternately Flashes Yellow and Green Battery Charging Solid Green Battery Fully Charged Flashes Red Radio C...

Page 24: ...er With a Small L300 System the following electrodes and electrode bases can be used See Figure 5 2 Small L300 Quick Fit Electrode Size A or B as fitted by your clinician Small L300 Cloth Electrodes S...

Page 25: ...d Bases for the Regular L300 FS Cuff Your clinician will fit you with the appropriate electrode option and attach them to your L300 FS Cuff Afterward you will need to replace the electrodes every two...

Page 26: ...Sensor can be transferred to a different shoe or additional sensors can be purchased for different shoes You do not need to detach the Intelli Sense Gait Sensor between uses Figure 5 4 Intelli Sense G...

Page 27: ...eable AAA battery Figure 5 5 Control Unit Operating Buttons Indicators and Digital Display Operating Modes The Control Unit has four operating modes standby gait training and clinician Note Only clini...

Page 28: ...nt or retard disuse atrophy of the lower leg muscles maintain or improve range of motion of the ankle joint and improve local blood circulation Training mode also can be used to check if the L300 FS C...

Page 29: ...ator Lights The Control Unit digital display and indicator lights indicate stimulation intensity level operating mode battery charge status electronic registration status and error messages See Figure...

Page 30: ...Communication Failure Between the Control Unit and RF Stim Unit Gait Sensor and RF Stim Unit Indicators Alternately Flash Red and E Flashes Gait Sensor Hibernation or Radio Communication Failure betwe...

Page 31: ...24 User s Guide T h i s p a g e i n t e n t i o n a l l y l e f t b l a n k...

Page 32: ...es your power outlet Four blades are provided for use in the US the European Union Australia and the United Kingdom See Figure 6 1 Figure 6 1 System Charger Interchangeable Blades 2 Slide the selected...

Page 33: ...green Note The charging process should last approximately three hours Note If the Control Unit battery is completely discharged the letter b will flash for a few seconds in the Control Unit digital d...

Page 34: ...ter Rinse well 2 If necessary trim excess body hair from the area using scissors Do not use a razor A razor can irritate the skin Attaching the Electrodes Caution Use only the L300 electrodes supplied...

Page 35: ...ry three to four hours of use When wetting the L300 Quick Fit Electrode always remove it from the L300 FS Cuff L300 Cloth Electrodes To attach the L300 Cloth Electrodes 1 Make sure the Control Unit is...

Page 36: ...e Remove and re wet the L300 Cloth Electrodes every time you remove the L300 FS Cuff from your leg for more than one hour and after every three to four hours of use When wetting the electrodes always...

Page 37: ...8 Recommended Knee Angle for Positioning the L300 FS Cuff 2 Make sure the electrodes are securely attached Then grasp the front of the L300 FS Cuff by the cradle and tilt the bottom of the FS Cuff up...

Page 38: ...abilize the cuff on the leg Figure 6 10 Fastening the L300 FS Cuff Strap 5 Make sure the L300 FS Cuff is correctly positioned See Figure 6 11 If it is not take off the L300 FS Cuff and reposition it A...

Page 39: ...le of your shoe If your shoe does not have a detachable insole place the sensor on top of the insole Then place a generic soft thin one layer versus two insole over it Generic insoles can be purchased...

Page 40: ...over the clamp on the transmitter with the shoe spacer if desired See Figure 6 14 The teeth of the clamp may scuff the shoe if not covered Figure 6 14 Covering the Clamp with a Shoe Spacer Shoe Spacer...

Page 41: ...ferent shoe make sure to place a Gait Sensor pad in the other shoe first 1 Turn off the L300 System 2 Remove the Intelli Sense Gait Sensor from the shoe 3 Follow the steps outlined in this chapter for...

Page 42: ...alert The L300 System will deliver a warning default stimulation to lift the foot for six seconds before shutting down Turning the L300 System On Off To turn on the L300 System press the on off button...

Page 43: ...ity level will be 5 This level is set by your clinician Normally you will not need to adjust stimulation intensity other than when walking on different surfaces or in different shoes To adjust stimula...

Page 44: ...e lowest setting When the system is turned off the active volume level is saved If the active volume level is mute the default volume level is automatically restored Turning On Audio Feedback During S...

Page 45: ...38 User s Guide T h i s p a g e i n t e n t i o n a l l y l e f t b l a n k...

Page 46: ...6 Check each component for wear or damage Replace any components that appear old worn or damaged Contact the Bioness Client Relations Department at 800 211 9136 Option 3 in the United States or your l...

Page 47: ...t Sensor battery Lithium coin cell CR2430 1 Use the Phillips screwdriver supplied in the system kit to unscrew the two screws from the battery cover See Figure 8 1 Figure 8 1 Replacing the Intelli Sen...

Page 48: ...ly the label after the battery is replaced Figure 8 2 Replacing the Control Unit Battery 2 Remove the battery cover 3 Note the orientation of the old battery and remove the old battery 4 Insert the ne...

Page 49: ...emove excess water from the L300 Quick Fit Electrode with a cloth 5 Align the orange and blue snaps on the L300 Quick Fit Electrode with the orange and blue plug holes on the L300 FS Cuff 6 Press firm...

Page 50: ...43 Chapter 8 Maintenance and Cleaning Figure 8 3 Replacing the L300 Quick Fit Electrode 2 3 4 5 6 Orange and Blue Plug Holes...

Page 51: ...substance 4 Wet the new L300 Cloth Electrodes with water until they are saturated 5 With a soft cloth gently wipe or blot excess water off the back side with the snap of the L300 Cloth Electrodes 6 At...

Page 52: ...ed to replace the hydrogel electrodes at least every two weeks Caution Use only L300 Hydrogel Electrodes supplied by Bioness Caution Do not use your NESS L300 System without electrodes To replace the...

Page 53: ...electrode and discard them 6 Attach the grid side of the electrodes to the electrode bases and then press firmly 7 Remove the covers from the electrodes Note Save the covers Always reapply the covers...

Page 54: ...rst fitting Your clinician will need to fit the electrode bases and adjust your stimulation settings To replace the electrode bases 1 If your clinician installed wire concealers over the electrode bas...

Page 55: ...rode bases where the previous bases were attached See Figure 8 8 6 Connect the electrode base snaps to the plug holes See Figure 8 8 7 Recover the wires and snaps with the wire concealers if desired F...

Page 56: ...RF Stim Unit away from the cradle See Figure 8 9 If the fit is too tight open the flexible cover over the charging port for a better grasp 3 Remove the bottom of the RF Stim Unit from the cradle Figu...

Page 57: ...t Do not use a washing machine 4 Rinse the L300 FS Cuff thoroughly under running water 5 Immerse the L300 FS Cuff for an additional 15 minutes in clean lukewarm water 6 Rinse the L300 FS Cuff again un...

Page 58: ...ystem Kit carrying case may be cleaned and low level disinfected using 70 isopropyl alcohol IPA per the following instructions 1 Wipe the entire surface of the System Kit carrying case with a cloth or...

Page 59: ...52 User s Guide T h i s p a g e i n t e n t i o n a l l y l e f t b l a n k...

Page 60: ...d the new replacement component must be electronically registered to the existing components Note Components can only be successfully registered once Additional attempts will elicit an error indicatio...

Page 61: ...ontrol Unit may take up to four minutes 4 When registration is complete the letter C will appear in the digital display and the Control Unit indicator will turn green for a few seconds See Figure 9 2...

Page 62: ...f cradle 3 Put the old L300 RF Stim Unit in an envelope for shipment to Bioness Then place it at least 30 feet 9 meters from the components you are registering 4 Locate the System ID Number on the L30...

Page 63: ...everal seconds to complete 4 When registration is complete the letter C will appear in the Control Unit digital display and the RF Stim Unit indicator will turn green for a few seconds The Control Uni...

Page 64: ...gital display will show two alternating green arches while registration is in process 4 Within 15 seconds of initiating the registration procedure repeatedly press and release the pressure sensor 5 Wh...

Page 65: ...58 User s Guide Figure 9 5 Intelli Sense Gait Sensor Blank Label for the System ID Number Blank Label...

Page 66: ...the components connected to the system charger set If I charge the L300 System every day will I harm the batteries No Daily charging will not affect the lifespan or functionality of the batteries Dai...

Page 67: ...Unit should flash green Communication should be restored I hear a beep the RF Stim Unit indicator on the Control Unit flashes red and the stimulation intensity level flashes in the Control Unit digita...

Page 68: ...ff the L300 FS Cuff Replace any worn or damaged electrodes or electrode bases How will I know when the Intelli Sense Gait Sensor battery charge level is low A Gait Sensor battery will last for approxi...

Page 69: ...proper placement of the pressure sensor reposition the pressure sensor slightly forward in your shoe or loosen your shoelace Check the Intelli Sense Gait Sensor wires for wear or fraying and check the...

Page 70: ...ess Clinician mode is started by pressing the minus and on off buttons on the Control Unit Registration is started with the Control Unit off and then by pressing the minus and mode buttons on the Cont...

Page 71: ...64 User s Guide T h i s p a g e i n t e n t i o n a l l y l e f t b l a n k...

Page 72: ...ntrol Unit RF Stim Unit and Intelli Sense Gait Sensor Numerical display designates relative stimulation intensity Illuminated buttons designate system operating mode Beeps for audio alerts Carrying Op...

Page 73: ...mm 0 6 in Weight 50 grams 1 6 oz Environmental Ranges Transport and storage temperature 20 C to 60 C 4 F to 140 F Operating conditions temperature 5 C to 40 C 41 F to 104 F Charging temperature 5 C t...

Page 74: ...20 45 Hz 5 Hz resolution Gait Parameters Ramp Up 0 2 seconds 0 1 second resolution Ramp Down 0 2 seconds 0 1 second resolution Extend Delay 0 100 of stance time 10 resolution Max Duration of Stimulat...

Page 75: ...ly powered continuous operation with type BF applied part s Battery Type Lithium coin cell CR2430 280 mAh Dimensions of the Transmitter Length 80 mm 3 2 in Width 50 mm 2 0 in Height 10 mm 0 4 in Weigh...

Page 76: ...rovided by Bioness Inc Regular Hydrogel Electrode Bases Two relocatable polymer electrode bases for individual fitting Regular Cloth Electrodes Two 45 mm 1 77 in diameter surface area 15 8 cm2 non wov...

Page 77: ...woven polymer fabric 80 viscose 20 polypropylene conductive layer stainless steel Male snap connector Low Density Polyethylene LDPE 10 Ethylene Vinyl acetate EVA Small L300 Quick Fit Electrode A Non w...

Page 78: ...g Frequency Band 2401 2482 MHz Type of Modulation FSK Type of Modulating Signal Binary data message Data Rate Frequency of Modulating Signal 250 Kbps Effective Radiated Power 10 dBm Receivers Operatin...

Page 79: ...domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage...

Page 80: ...el Compliance Level Electromagnetic Environment Guidance Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip...

Page 81: ...ration distance d 1 2 P Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz E1 10 V m in 26 MHz to 1 GHz E1 3 V m in 1 GHz to 2 5 GHz Recommended separation distance d 0 4 P 80 800 MHz range d 0 7 P 800...

Page 82: ...bile RF Communications Equipment and the NESS L300 System The NESS L300 System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or th...

Page 83: ...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 tr...

Page 84: ...one Ra Anana 43654 Israel European Authorized Representative NESS Europe B V Stationsweg 41 3331 LR Zwijndrecht The Netherlands Telephone 31 78 625 6088 Email international nl bioness com Website www...

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