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6

Adverse Reactions

In the unlikely event of any of the following occurrences, stop using your NESS
L300 immediately and consult your personal physician.

•

Signs of significant skin irritation or pressure sores on the limb in areas
of contact with the orthosis.

•

A significant increase in muscle spasticity.

•

A feeling of heart-related stress during stimulation.

•

Swelling of the leg, knee, ankle, or foot.

•

Any other unanticipated reaction.

Radio Communication Information

This device 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.

Parts of the NESS L300 communicate via radio communication and have been tested and found
to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, 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, the user is
encouraged to try to correct the interference by one or more of the following measures:

•

Reorient or relocate the receiving antenna.

•

Increase the separation between the equipment and receiver.
Consult the dealer or an experienced radio/TV technician for help.

Changes or modifications to this equipment not expressly approved by the NESS Ltd.

could void the user’s authority to operate the equipment.

The antenna for each transmitter must not be co-located or operating in

conjunction with any other antenna or transmitter.

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Содержание L300

Страница 1: ...NESS L300 User Guide i NESS L300 User Guide ...

Страница 2: ... 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 L300 care should be taken to dispose of those parts in the correct manner where applicable parts should be recycled When the lifecycle of the NESS L300 TM has been completed the product should be discarded according to the laws and regula...

Страница 3: ...co il Website www NESSLTD com U S Distributor Bioness Inc 25134 Rye Canyon Loop Suite 300 Santa Clarita California 91355 Tel 800 211 9136 Fax 661 702 6707 Email info bionessinc com Website www bionessinc com European Distributor NESS Europe Zadelmakerstraat 53 2984 CC Ridderkerk The Netherlands Tel 31 180 481600 Fax 31 180 463752 Email ness ness nl Website www ness nl ...

Страница 4: ... L300 7 THE ORTHOSIS 8 Indicator lights on the orthosis electronic module 9 THE FOOT SENSOR 9 THE CONTROL UNIT 11 Control Unit Buttons and Display 12 Operating the Control Unit 13 Control Unit Display and Audio Indications 16 3 OPERATING MODES 18 STANDBY MODE 18 GAIT MODE 18 TRAINING MODE 18 4 DAILY USE OF YOUR NESS L300 19 ACTIVATING AND USING THE SYSTEM 19 PUTTING ON THE ORTHOSIS 19 Positioning ...

Страница 5: ... REPLACING ELECTRODES 31 CLEANING YOUR NESS L300 32 6 REPLACING AND INSTALLING SYSTEM COMPONENTS 33 REPLACING AND REGISTERING COMPONENTS 33 REMOVING AND INSTALLING THE ORTHOSIS ELECTRONIC MODULE 35 Placing a Foot Sensor in your Shoe 36 7 ACCESSORIES 38 8 TROUBLESHOOTING 39 9 SPECIFICATIONS 44 LIST OF SYMBOLS 50 ...

Страница 6: ...22 Figure 8 Orthosis Fastened in Place 23 Figure 9 Control Unit Charger Socket 28 Figure 10 Charging the Batteries 28 Figure 11 Charging Indicators 28 Figure 12 Foot Sensor and Battery 30 Figure 13 Control Unit and Battery 30 Figure 14 Digital Display while Registering 34 Figure 15 Removing the electronic module from the orthosis 35 Figure 16 Foot Sensor in Place Left Shoe Shown 36 Figure 17 Trans...

Страница 7: ...mduction These patients tend to be less stable suffer the risk of frequent falls and expend more energy when walking The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot During the swing phase of gait the NESS L300 electrically stimulates muscles in the weak leg to provide flexion of the foot thus it may improve the individual s gait The NESS L300 also may facilita...

Страница 8: ...r leg causing the muscles that lift the foot and toes to contract During walking the foot sensor detects when the foot is off the ground and sends a radio signal which initiates the stimulation causing the foot to move in a natural motion according to your walking pattern ...

Страница 9: ...cal stimulation are unknown The orthosis should not be applied over swollen infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc Simultaneous connection of the L300 to the patient and to high frequency surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the electronic module of the orthosis Do not use the ...

Страница 10: ... contraction may disrupt the healing process o Over areas of the skin which lack normal sensation Caution should be used for patients with suspected or diagnosed epilepsy Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium The irritation can usually be reduced by using an alternate conductive medium or alternate electro...

Страница 11: ... weather such as rain or snow or any other source of water Do not leave the NESS L300 stored in a car in hot weather where the temperature may exceed the recommended storage temperature and could cause damage to the device Should any technical problem occur that is not covered in the troubleshooting section of this manual contact your clinician or NESS L300 distributor Do not attempt to repair you...

Страница 12: ...of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particu...

Страница 13: ...ents of the NESS L300 The NESS L300 is supplied with the following components o Control Unit o Orthosis o Orthosis Electronic Module o Foot sensor o Electrodes o Carrying case o User Manual o Charger supplied separately Figure 1 L300 System Components in carrying case ...

Страница 14: ...mmunication circuit is integrated into the orthosis cradle It may be snapped in or out of the orthosis for maintenance or cleaning The entire device is held in place by an adjustable elastic strap which may be fastened easily using one hand Two electrodes are attached to their bases on the inner lining of the orthosis Their position in the orthosis has been Electronic Module Handle Locator Electro...

Страница 15: ...ow and green Battery fully charged Constant Green Status Light Malfunction Constant or flashing red light Stimulation applied Flashes rapid yellow Stimulation Light Stimulation inactive Flashes slow yellow The Foot Sensor The foot sensor Figure 3 detects whether the foot is on the ground or in the air and transmits radio signals to the electronic module in the orthosis according to which the stimu...

Страница 16: ... approximately every six months of use The foot sensor by default should be placed under the paretic weak foot In some cases the foot sensor may be placed under the non paretic foot according to a clinician s judgment Note The foot sensor should be placed only under the foot designated by the clinician Figure 3 Foot Sensor Transmitter Pressure Sensor Clip ...

Страница 17: ...e neck strap supplied in a pocket or belt pouch It is powered by a single rechargeable AAA battery During operation the control unit maintains two way communication with the electronic module in the orthosis If communication is lost the system will cease working Operating Button Description ON OFF Turns the control unit ON and OFF Trigger mode Selects Gait Training or Standby Mode Volume Adjustmen...

Страница 18: ...ure 4 Control unit buttons and display ON OFF Button Trigger Mode Button Intensity Level Buttons Neck Strap Hole Control Unit indicator light Intensity Indicator Foot Sensor Indicator Light Orthosis Indicator Light Volume Adjustment buttons ...

Страница 19: ... the trigger mode button once briefly You should hear a beep and the trigger mode button will begin to blink slowly During stimulation the button blinks rapidly To select the Training Mode after the unit is turned on press the trigger button and hold it for 3 seconds long press until a beep is heard The trigger mode button will begin to blink slowly In addition the intensity indicator displays a t...

Страница 20: ...ou feel that your foot rises too high while walking or that the stimulation is unpleasant the intensity level can be reduced by pressing the button After reducing the intensity take care that your foot doesn t drag or catch on the floor When the intensity level is altered the intensity level appears on the display of the control unit and a corresponding beep is emitted When the system is turned on...

Страница 21: ...n will increase or decrease the volume and you will hear a beep at the volume you have selected Reducing the volume to the minimal setting will mute the control unit When you turn the system off the volume level will be saved unless the volume was set to mute in which case the volume level will be automatically adjusted to the default level ...

Страница 22: ...stimulating Trigger mode button Yellow Rapid System in gait or training mode and stimulating All display lights Red yellow and green Alternating colors one after the other for 1 5 seconds Self test at startup 0 9 Intensity level setting The letter t and intensity digit alternate Training Mode Intensity indicator Segments of the digit rotate in a circular pattern Charging ...

Страница 23: ...he system is first turned on The battery is weak There is an indication such as a malfunction which will be indicated visually on the control unit When the control unit is separated from the system for example when the system is worn and the controller is left on a table ...

Страница 24: ... swing phase of walking and foot rest during the stance phase Training mode Select this mode for muscle training while you are sitting or lying down The purpose of the training mode is to facilitate muscle re education prevent or retard disuse atrophy of the calf muscles maintain or improve range of motion of the ankle joint reduce spasticity and improve local blood circulation In the training mod...

Страница 25: ...1 Remove the protective covers from the electrodes Put on the orthosis Turn on the control unit Select either the gait or training mode Begin walking or let the training mode exercise your leg in place Putting on the orthosis In order to ensure proper foot movement make sure the orthosis is positioned accurately Note Before putting on the orthosis make sure to remove the protective covers from the...

Страница 26: ...end the lower leg as in Figure 5 This causes the outline of the kneecap to be clearly defined It may be helpful to place the foot on a small stool or footrest Figure 5 Positioning the Leg This point under your knee is where the locator see fig 2 of the orthosis fits ...

Страница 27: ...gure 6 Figure 6 Placing the Orthosis on the Leg 2 After the locator is in position slide the orthosis against the leg so that it fits snugly under the kneecap The orthosis will gently grip the leg Make sure it remains in place until you fasten the strap according to one of the methods described below Locator Elastic strap is on the outside of the leg before fastening Handle ...

Страница 28: ...arefully grasp the handle of the elastic belt with the fingers of the opposite hand In Figure the orthosis is on the right leg so the handle is grasped by the left hand Figure 7 Fastening the Strap First Method 2 Placing your thumb on the cradle hold the orthosis in place while you pull the handle toward the cradle and position it around the cradle Attaching Point of Cradle Locator just below the ...

Страница 29: ...e Bad electrode contact indication If for any reason there is no contact between the electrodes and the skin all the indication lights will start flashing red and no stimulation will be applied to resolve this see the troubleshooting section Locator just below the kneecap Handle seated on attaching point of the cradle Electronic Module ...

Страница 30: ...ss the On Off button once to shut the system OFF 2 Unhook the strap handle of the orthosis and remove the orthosis 3 Moisten the electrodes and place protective covers over them 4 Charge the battery fully at the end of your daily use ...

Страница 31: ...prox 4 hours use left Medium speed flash audio indication every 10 minutes Orthosis battery is low Approx 1 hours use left Low Battery in the Orthosis Rapid Flashing and an audio indication every 1 minute Orthosis battery is low Approx 10 minutes use left Starts to flash slowly accompanied by an audio indication Control unit battery is low Approx 4 hours use left Medium speed flash audio indicatio...

Страница 32: ...sh audio indication every 2 hours Foot sensor battery is low Approx 7 days of use left Rapid Flashing and an audio indication every hour Foot sensor battery is low Approx 2 days of use left Low Battery in the Foot sensor Rapid Flashing and an audio indication every 30 seconds Foot sensor battery is low Approx 15 minutes of use left ...

Страница 33: ... the Batteries Control Unit and Orthosis Note Only the Control and Orthosis units batteries are rechargeable 1 Open the cover of the charger socket at the bottom of the control unit as in Figure 9 Figure 9 Control Unit Charger Socket ...

Страница 34: ... the status light on the module should start flashing alternating between yellow and green Figure 10 Charging the Batteries Leave the charger connected until the letter F appears on the control units digital display and the orthosis electronic modules status light turns a constant green indicating a full charge The charging process should last approximately 3 hours Charging Icon Figure 11 Charging...

Страница 35: ...eplacing approximately every 6 months To install a new battery Lithium coin cell CR2430 3 Unscrew the screws from the battery cover Slide the cover out Remove the old battery Insert the new battery The should face up Slide the cover back into place and reinstall the screws Tip If you are unable to replace the battery yourself your clinician or local watchmaker should be able to assist you Screw Co...

Страница 36: ... from the battery cover on the back of the control unit 2 Remove the battery cover Remove the old battery 3 Insert a new battery rechargeable AAA according the and marks in the battery socket 4 Slide the cover back into place and tighten the screw Figure 13 Control Unit and Battery Control Unit Battery Cover and Screw Battery Tip If you are unable to replace the battery yourself your clinician or ...

Страница 37: ...e used only with electrodes supplied by NESS Ltd 1 Make sure the system is off 2 Pull the electrode gently out of its base Take care not to detach the electrode base which is attached to the inside of the orthosis 3 Snap in a new electrode and make sure it s firmly attached to the electrode base 4 Remove the protective cover from the electrode before using the system The cover should be put aside ...

Страница 38: ...ot immerse them in water When the orthosis needs a thorough cleaning 1 Remove the electronic module 2 Immerse in lukewarm water with a small amount of mild detergent 3 Rinse thoroughly and let dry in the shade do not hang 4 Reattach the electronic module after the orthosis is completely dry Do not use a washing machine or drier ...

Страница 39: ...sensor Electronic control unit 1 Make sure the control unit is turned OFF 2 Press the Trigger mode button and button at the same time and hold them for 3 seconds The segments of the stimulation intensity display will light up in 2 alternating circular patterns until the registration is complete See Figure The letter C short for connected will appear if registration was successful and a green light...

Страница 40: ...e registration was unsuccessful If the letter E appears repeat steps 1 3 if the problem persists see the section troubleshooting In the process of registering Registration Complete Registration Unsuccessful Figure 14 Digital Display while Registering ...

Страница 41: ...per edge of the electronic module out of the cradle 2 Pull the electronic module out of the cradle 3 To reinstall the module insert the bottom part into the cradle and push the module gently into the cradle to reinstall Figure 15 Removing the electronic module from the orthosis Note No more than one control and stimulation unit can be registered in your system at any time registering a new unit wi...

Страница 42: ...the adhesive side downward Figure 16 Foot Sensor in Place Left Shoe Shown 3 Press the sensor to fasten it to the shoe 4 Insert the inner sole of the shoe making sure any excess wire is tucked out of the way under the inner sole 5 Attach the transmitter of the foot sensor to the upper edge of the inner side of the shoe The NESS logo on the transmitter should face away from the foot Pressure Sensor ...

Страница 43: ...mitter in Place on a Left Shoe Note Up to four different foot sensors can be used with one L300 system allowing you to use several pairs of shoes without the need to transfer your foot sensor from shoe to shoe NESS Logo faces away from foot ...

Страница 44: ...eck strap The neck strap allows you to hang the control unit around your neck If you find it more convenient you may insert it into your shirt pocket 2 Wrist strap The wrist strap allows you to hang the control unit from your hand or to pull it out of a pocket or pouch easily 3 Belt pouch This small pouch fits on your belt for quick and easy storage of the control unit ...

Страница 45: ...sor also E appears on digital display Radio communication lost All three Component lights on the control unit Red All the component lights flash simultaneously E flashes on the digital display Bad electrode contact with the calf Indicator Color Flash Meaning Flashing Malfunction dangerous to the hardware Red Constant Fault dangerous to the owner or charge malfunction Orthosis Foot sensor or Contro...

Страница 46: ...s for instructions If after charging the battery the Mode display still does not appear contact your NESS L300 distributor A problem which is not covered in this manual occurs Contact your NESS L300 distributor During charging E appears on the screen Try to reconnect the charger cable if this doesn t help contact your NESS L300 distributor Electrodes are frayed peeling damaged or falling off the O...

Страница 47: ...tor I feel stimulation from the orthosis but my foot does not respond in a satisfactory way 1 Make sure that the Orthosis is snug against your calf and that the electrodes are in close contact with the skin 2 Make sure you are in the desired mode If the ankle movement is still unsatisfactory turn OFF the system 3 Remove the Orthosis then replace it on your calf making certain that the Orthosis is ...

Страница 48: ...snapping sound was heard when the electrode was inserted into its base 5 The electrodes may be missing or damaged if this is the case then install new electrodes according to section Replacing Electrodes 6 Put the Orthosis on your calf turn the Control Unit ON again and press the Trigger button If the problem persists then 7 Check that the orthosis electronic module is in place and locked it see t...

Страница 49: ... L300 User Guide 43 Problem Solution Radio communication lost indication appears Make sure that all the components are in radio range of each other the system will not work if all components aren t present ...

Страница 50: ...en charges Shelf life At least 2 weeks between charges Controls On Off illuminated button Trigger mode button for changing system modes Intensity buttons to enable the user fine tune intensity Volume buttons controls buzzer volume Indications 3 Status LED Control Unit Orthosis Electronic Module Indicate battery component status Numerical display designates relative stimulation intensity Illuminate...

Страница 51: ... 3 7 V Operation current 70 mA Battery type Rechargeable Prismatic LiIon Lithium Ion 3 7V 700 mAh Charging time 3 Hours typical using provided power supply Charging cycles At least 350 charging cycles Operation period At least 2 days between charges Battery discharge time when stored At least 1 week between charges Indications Status fault battery charging Stimulation LEDs Buzzer for audible indic...

Страница 52: ...Ω Gait Parameters Pulse repetition rate 1 2 3 4 5 6 7 8 9 10 15 20 25 30 35 40 45 PPS Ramp up 0 4 Sec 0 1 Sec resolution Ramp down 0 4 Sec 0 1 Sec resolution Delay 0 3 Sec 0 1 Sec resolution Max duration 0 10 Sec 0 1 Sec resolution Training Parameters On time 1 8 Sec 1 Sec resolution Off time 2 15 Sec 1 Sec resolution Ramp up 0 4 Sec 1 Sec resolution Ramp down 0 4 Sec 1 Sec resolution Total time 1...

Страница 53: ...85 relative humidity 900hPa to 1060hPa atmospheric pressure Orthosis specifications Orthosis Fabric Polymer orthosis for electrode relocation and single handed attachment Limb size 28 50 cm limb circumference Maintenance Immerse in cold water when needed and let dry in free air NOTE First remove stimulator NOTE DO NOT use drier Dimensions Height 160mm Width 100mm Depth 125mm Weight Approx 160 gram...

Страница 54: ...applied part Operating voltage 3 0 V Operation current 20 µA Battery type Lithium coin cell CR2430 280 mAh Operation period 6 months typical Shelf life 2 years Transducer Force Sensitive Resistor Attachment To the inner side of shoe lining using clip Dimensions of the transmitter Height 80mm Width 50mm Depth 10mm Weight 35 grams Water protection IPX4 Environmental Transport Storage 0 35 Cº Operati...

Страница 55: ...ifications Voltage 5V 5 Current 1300 mA Note Use only power supply provided approved by NESS Wireless link specifications Frequency band 2 4 GHz ISM band Transmission power Complies with regulations FCC 15 247 for US ETSI EN300 440 for Europe ...

Страница 56: ...50 List of Symbols Attention See Instructions for Use Serial Number IPX1 Drip proof IPX4 Splash proof IPX7 Watertight immersible Class II Type BF Applied Part Non Ionizing Radiation ...

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