Bioness Neuromodulation A Bioness L3P-T-RFS-V20 L300 Plus Thigh RF Stimulation Unit User Manual part 6

Bioness Neuromodulation ltd. A Bioness Inc Company L300 Plus Thigh RF Stimulation Unit part 6

user manual part 6

111Chapter 10 - Electronic Registration 10Electronic RegistrationThe NESS L300 Plus System components must be electronically registered to each other to communicate wirelessly. The components in your L300 Plus System Kit are registered.If you have an L300 Plus System Upgrade Kit, bring your upgrade kit and your L300 Foot Drop System to your first fitting session. Your clinician will register your NESS L300 Plus System at your first fitting session.This section describes the steps to register a replacement L300 Plus Control Unit, Thigh RF Stim Unit, L300 RF Stim Unit, or Intelli-Sense Gait Sensor. If you have any questions, please call the Bioness Client Relations Department, Option 3.Note: Components can only be successfully registered once. Additional attempts will generate an error indication.
112 User's GuideSetup:1. Place the components you are registering close together on a table but not touching. See Figure 10-1.Figure 10-1: Registration setup.2. Make certain no other L300 Plus components are within 30 feet of the components you are registering. 3. Connect the components to the system charger set.
113Chapter 10 - Electronic RegistrationTo register a replacement L300 Plus Control Unit or RF Stim Unit:1. Turn off the L300 Plus System.2. Simultaneously press and hold for three seconds the mode and minus buttons. The L300 Plus Control Unit will beep when registration begins.3. The L300 Plus Control Unit digital display will show two alternating GREEN arches while registration is in process. See Figure 10-2. RegistrationErrorRegistration CompleteRegistrationin ProcessFigure 10-2: Registration digital displays.4. When registration is complete, (“C” for complete) will appear in the digital display and the L300 Plus Control Unit indicator will turn GREEN for a few seconds. See Figure 10-2. The L300 Plus Control Unit will beep.Note: If (“E” for error) appears in the digital display, an error has occurred. Repeat steps 2 though 4. 5. After registration is complete, turn on your NESS L300 Plus System. If the replacement component is registered, the L300 and Thigh RF Stim Units will turn on. If you see an RF communication failure indication, then repeat the registration procedure.
114 User'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 label of the existing NESS L300 Plus System components. 7. Write the System ID Number on the blank label on the back of the replacement L300 Plus component. See Figure 10-3. Blank LabelFigure 10-3: L300 Plus Control Unit (left) and RF Stim Unit (right).CAUTION: Do not turn on the L300 Plus Control Unit if the L300 and Thigh RF Stim Units are not in their cradles.
115Chapter 10 - Electronic RegistrationTo register a replacement/additional Intelli-Sense Gait Sensor:Note: Read steps 1–4 before starting.1. Turn off the L300 Plus System.2. 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.3. The L300 Plus Control Unit digital 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. When registration is complete, (“C” for complete) will appear in the digital display, the Intelli-Sense Gait Sensor indicator will turn GREEN for a few seconds, and the L300 Plus Control Unit will beep. If registration fails, then repeat the procedure.Note: If (“E” for error) appears in the digital display, an error has occurred. Repeat the registration procedure. ( "E" also can mean that the registration procedure was successful on a prior attempt and not noticed.)6. After registration is complete, turn on the NESS L300 Plus System and select gait mode. Press and release the Intelli-Sense Gait Sensor pressure sensor. If the new Intelli-Sense Gait Sensor is registered, the mode button will FLASH YELLOW rapidly for four seconds.
116 User'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 the back label of the existing NESS L300 Plus System components. The System ID Number identifies which NESS L300 Plus System the replacement/additional Intelli-Sense Gait Sensor is registered to. The System ID Number on each component of a NESS L300 Plus System must match.8. Write the number on the small label on the back of the new Intelli-Sense Gait Sensor. See Figure 10-4.Figure 10-4: Intelli-Sense Gait Sensor.
125Chapter 12 - Technical Specifications12Technical SpecificationsL300 Plus Control Unit SpecificationsClassification Internally powered, continuous operationOperation Modes Gait, Training, Clinician, and StandbyBattery Type Rechargeable AAA NiMH 1.2 V, 900–1100 mAhControls• On/Off illuminated button• Mode illuminated button to change operating modes• Intensity +/- buttons to fine-tune intensity level• Mute button to mute audio and visual alerts• RF Stim Unit selection buttons• Stimulation test buttonIndications• Seven status LEDs: L300 Plus Control Unit, L300 RF Stim Unit, Thigh RF Stim Unit, Intelli-Sense Gait Sensor, L300 RF Stim Unit and Thigh RF Stim Unit Arrow Indicators, and RF Communication• Numerical display designates relative stimulation intensity• Illuminated buttons designate system operating mode• “Beeps” for audio alertsCarrying Options In pocket, neck strap, wrist strap, or belt pouch Dimensions Length: 73 mm (2.9 in.); Width: 46 mm (1.8 in.); Height: 18 mm (0.7 in.)Weight 45 grams (1.5 oz.)Environmental Ranges• Transport and storage temperature: -25°C to +55°C (-13°F to +131°F)• Operating conditions temperature: 5°C to 40°C (41°F to 104°F) • Charging temperature: 5°C to 40°C (41°F to 104°F)• Relative humidity: 25% to 85% • Atmospheric pressure: 700 hPa to 1060 hPa
126 User's GuideL300 RF Stim Unit SpecificationsClassification Internally powered, continuous operation with type BF applied partsOperating Voltage 3.7 VBattery Type Proprietary rechargeable Li-Ion (Lithium Ion) 3.7 V, 750 mAhIndications • Status (fault, battery, charging) and Stimulation LEDs• “Beeps” for audio alertsDimensions• Length: 74 mm (2.9 in.)• Width: 43 mm (1.7 in.)• Height: 15 mm (0.6 in.)Weight 50 grams (1.6 oz.)Environmental Ranges• Transport and storage temperature: -25°C to +55°C (-13°F to +131°F)• Operating conditions temperature: 5°C to 40°C (41°F to 104°F) • Charging temperature: 5°C to 40°C (41°F to 104°F) • Relative humidity: 25% to 85% • Atmospheric pressure: 700 hPa to 1060 hPaPulse ParametersPulse Balanced BiphasicWaveform Symmetric or AsymmetricIntensity (Peak) 0–80 mA, 1-mA resolution (positive phase)Maximum Intensity (rms) 13.2 mA (rms)Max Voltage 120 V
127Chapter 12 - Technical SpecificationsSymmetric AsymmetricPositive Pulse Duration (µsec) 100 200 300 100 200 300Negative Pulse Duration (µsec) 100 200 300 400 800 1200Inter-Phase Interval (µsec) 50 0Total Pulse Duration (µsec) 250 450 650 500 1000 1500Max Load 5000 ohm (Subject to max voltage limitation)Pulse Repetition Rate 20–45 Hz, 5-Hz resolution Gait ParametersRamp Up 0–2 seconds, 0.1-second resolutionRamp Down 0–2 seconds, 0.1-second resolutionExtend (%) 0–100% of stance time, 10% resolutionMax. Duration of Stimulation 2–10 seconds, 1-second resolutionTraining ParametersOn Time 4–20 seconds, 1-second resolutionOff Time 4–60 seconds, 1-second resolutionRamp Up 0–2 seconds, 1-second resolutionRamp Down 0–2 seconds, 1-second resolutionTotal Time 1–60 minutes
128 User's GuideThigh RF Stim Unit SpecificationsClassification Internally powered, continuous operation with type BF applied partsOperating Voltage 3.7 VBattery Type Proprietary rechargeable Li-Ion (Lithium Ion) 3.7 V, 750 mAhIndications • Status (fault, battery, charging) and Stimulation LEDs• “Beeps” for audio alertsDimensions• Length: 74 mm (2.9 in.)• Width: 43 mm (1.7 in.)• Height: 15 mm (0.6 in.)Weight 50 grams (1.6 oz.)Environmental Ranges• Transport and storage temperature: -25°C to +55°C (-13°F to +131°F)• Operating conditions temperature: 5°C to 40°C (41°F to 104°F) • Charging temperature: 5°C to 40°C (41°F to 104°F) • Relative humidity: 25% to 85% • Atmospheric pressure: 700 hPa to 1060 hPaPulse ParametersPulse Balanced BiphasicWaveform Symmetric or AsymmetricIntensity (Peak) 0–100 mA, 1-mA resolution (positive phase)Maximum Intensity (rms) 16.5 mA (rms)Max Voltage 120 V
129Chapter 12 - Technical SpecificationsSymmetric AsymmetricPositive Pulse Duration (µsec) 100 200 300 100 200 300Negative Pulse Duration (µsec) 100 200 300 400 800 1200Inter-Phase Interval (µsec) 50 0Total Pulse Duration (µsec) 250 450 650 500 1000 1500Max Load 5000 ohm (Subject to max voltage limitation)Pulse Repetition Rate 20–45 Hz, 5-Hz resolution Gait ParametersSwing Control Delay (%) 0–100% of phase* time, 5% resolutionSwing Control End (%) 0–100% of phase* time, 5% resolutionStance Control Delay (%) 0–100% of phase* time, 5% resolutionStance Control End (%) 0–100% of phase* time, 5% resolutionRamp Up 0–2 seconds, 0.1-second resolutionRamp Down 0–2 seconds, 0.1-second resolutionExtend (%) 0–100% of stance time, 10% resolutionMax. Duration of Stimulation 2–10 seconds, 1-second resolution* Stimulation burst can start either on swing or stance phase.
130 User's GuideL300 FS Cuff SpecificationsMaterial Fabric-PolymerFits Limb Circumference 29–51 cm (11–20 in.)Dimensions• Height: 160 mm (6.3 in.)• Width: 100 mm (3.9 in.)• Depth: 125 mm (4.9 in.)Weight Approximately 150 grams (4.8 oz.)Thigh FS Cuff SpecificationsMaterial Skeleton–TPU; Panel Assemblies and Buckles–SiliconeFits Limb Circumference• Upper thigh circumference: 53 cm–85 cm (20.9 in.–33.5 in.) • Knee circumference: 33 cm–50 cm (13 in.–19.7 in.)• Thigh length: 24 cm–35 cm (9.4 in.–13.8 in.)Dimensions• Length: 17 cm–26 cm (6.7 in. – 10.24 in.)• Circumference (minimal):• Proximal panel: 42 cm (16.5 in.)• Distal panel, regular: 45 cm (17.7 in.)• Distal panel, large: 51 cm (20.1 in.Weight Approximately 420 grams (14.8 oz.)
131Chapter 12 - Technical SpecificationsIntelli-Sense Gait Sensor SpecificationsClassification Internally powered, continuous operation with type BF applied part(s)Battery Type Lithium coin cell, CR2430, 280 mAhDimensions of the Transmitter• Length: 80 mm (3.2 in.)• Width: 50 mm (2.0 in.)• Height: 10 mm (0.4 in.)Weight 35 grams (1.1 oz.)Environmental Ranges• Transport and storage temperature: -25°C to +55°C (-13°F to +131°F)• Operating conditions temperature: 5°C to 40°C (41°F to 104°F) • Relative humidity: 25% to 85% • Atmospheric pressure: 700 hPa to 1060 hPa
132 User's GuideCharger SpecificationsUse medical Class II safety approved power supply provided/approved by Bioness with the following ratings:InputVoltage 100–240 V ACCurrent 400 mAFrequency 50–60 HzOutputVoltage 5 V ± 5%Current 2400 mANote: Do not use the NESS L300 Plus System while charging. Do not wear the L300 or Thigh FS Cuffs while charging.Wireless Link SpecificationsFrequency Band 2.4 GHz, ISM bandTransmission Power Complies with FCC 15.247 (for U.S.) regulations
133Chapter 12 - Technical SpecificationsL300 Electrode and L300 Electrode Base SpecificationsHydrogelElectrodesTwo 45-mm (1.77-in.) diameter hydrogel electrodesNote: Use only electrodes provided by Bioness Inc.HydrogelElectrode Bases Two relocatable polymer electrode basesCloth ElectrodesTwo 45-mm (1.77-in.) diameter non-woven fabric/cloth electrodesNote: Use only electrodes provided by Bioness Inc.Cloth Electrode Bases Two relocatable polymer electrode basesThigh FS Cuff Cloth Electrode SpecificationsMaterial Non-woven clothNote: Use only electrodes provided by Bioness IncDimensions Proximal: Oval, 130 mm x 75 mm (5.1 in. X 3 in.); Distal: Oval, 120 mm x 63 mm (4.7 in. X 2.5 in.)
134 User's Guide
135Chapter 13 - Appendix - EMI Tables13Appendix - EMI TablesSystem CharacteristicsTransmittersOperating Frequency Band 2401–2482 MHzType of Modulation FSKType of Modulating Signal Binary data messageData Rate [=Frequency of Modulating Signal]250 KbpsEffective Radiated Power <10 dBmReceiversOperating Frequency Band 2401–2482 MHzReceiver Bandwidth 812 kHz around a selected frequency
136 User's GuideGuidance and Manufacturer’s Declaration—Electromagnetic EmissionsThe 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 environment.Emissions Test Compliance Electromagnetic Environment — GuidanceRF emissionsCISPR 11Group 1 The NESS L300 Plus System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF emissionsCISPR 11Class B The NESS L300 Plus System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissions IEC 61000-3-2Class AVoltage fluctuations/flicker emissionsIEC 61000-3-3Complies
137Chapter 13 - Appendix - EMI TablesGuidance and Manufacturer’s Declaration—Electromagnetic Immunity for All Equipment and SystemsThe 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 environment.Immunity Test IEC 60601 Test LevelCompliance Level Electromagnetic Environment—GuidanceElectrostatic discharge (ESD)IEC 61000-4-26 kV contact8 kV air6 kV contact8 kV airFloors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient/burstIEC 61000-4-42 kV for power supply lines1 kV for input/output lines2 kV for power supply linesMains power quality should be that of a typical commercial or hospital environment.SurgeIEC 61000-4-51 kV line to line2 kV line to earth1 kV line to line(Class II without any grounded interconnections)Mains power quality should be that of a typical commercial or hospital environment.
138 User's GuideImmunity Test IEC 60601 Test LevelCompliance Level Electromagnetic Environment—GuidanceVoltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11<5% UT (>95% dip in UT) for 0.5 cycle40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles<5% UT (>95% dip in UT) for 5 sec<5% UT (>95% dip in UT) for 0.5 cycle40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles<5% UT (>95% dip in UT) for 5 secMains power quality should be that of a typical commercial or hospital environment. If the user of the NESS L300 Plus System requires continued operation during power mains interruptions, it is recommended that the equipment be powered from an uninterruptible power supply or a battery.Power frequency (50/60 Hz) magnetic fieldIEC 61000-4-83 A/m 3 A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.NOTE: UT is the AC mains voltage prior to application of the test level.
139Chapter 13 - Appendix - EMI TablesGuidance and Manufacturer’s Declaration—Electromagnetic ImmunityThe 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 environment.Immunity Test IEC 60601 Test LevelCompliance LevelElectromagnetic Environment—GuidancePortable and mobile RF communications equipment should be used no closer to any part of the NESS L300 Plus System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Conducted RFIEC 61000-4-63 Vrms150 kHz to80 MHz3 Vrms150 kHz to80 MHzRecommended separation distance: d = 1.2√PRadiated RFIEC 61000-4-33 V/m80 MHz to2.5 GHz[E1] = 10 V/m in 26 MHz to1 GHz [E1] = 3 V/m in 1 GHz to2.5 GHzRecommended separation distance: d = 0.4√P, 80–800 MHz ranged = 0.7√P, 800–1000 MHz ranged = 2.3√P, 1000–2500 MHz range
140 User's GuideNOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.NOTE 3: P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). NOTE 4: Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.bNOTE 5: Interference may occur in the vicinity of equipment marked with the following symbol: a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the NESS L300 Plus System is used exceeds the applicable RF compliance level above, the NESS L300 Plus System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the NESS L300 Plus System.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
141Chapter 13 - Appendix - EMI TablesRecommended Separation Distances Between Portable and Mobile RF Communications Equipment and the NESS L300 Plus SystemThe 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 the NESS L300 Plus System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the NESS L300 Plus System as recommended below, according to the maximum output power of the communications equipment.Rated Maximum Output Power of Transmitter (W)Separation Distance According to Frequency of Transmitter150 kHz to 80 MHz Outside ISM Bandsd = 1.2√P80 MHz to 800 MHzd = 0.4√P800 MHz to 1000 MHzd = 0.7√P1000 MHz to 2.5 GHzd = 2.3√P0.01 4.7 in. (0.12 m)1.6 in. (0.04 m)2.8 in.(0.07 m)9.1 in.(0.23 m)0.1 15 in. (0.38 m)5.2 in.(0.13 m)8.7 in. (0.22 m)2 ft 5 in. (0.73 m)1 3 ft 11 in. (1.2 m)15 ft 7 in. (0.4 m)2 ft 4 in. (0.7 m)7 ft 7 in. (2.3 m)10 12 ft 6 in. (3.8 m)4 ft 2 in.(1.3 m)7 ft 3 in. (2.2 m)24 ft 11 in.(7.3 m)100 39 ft 4 in. (12 m)13 ft 1 in.(4 m)23 ft (7 m)75 ft 6 in. (23 m)
142 User's GuideNOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects, and people.For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.Note: All calculations were made according to tables 204 and 206 of IEC 60601-1-2 for not life-supporting equipment using factors of 3.5 in 0.15–800 MHz and 7 in 800–2500 MHz. There are no requirements for ISM bands in these tables.

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