0 Electronic Registration The 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.
Setup: 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.
To 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. Registration in Process Registration Complete Registration Error Figure 10-2: Registration digital displays. 4.
6. 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 Label Figure 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.
To 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 GREEN arches while registration is in process. two ALTERNATING 4.
7. 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.
12 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.
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 LEDs “Beeps” for audio alerts Dimensions • • • Length: 74 mm (2.9 in.) Width: 43 mm (1.7 in.) Height: 15 mm (0.6 in.) Weight 50 grams (1.6 oz.
Symmetric Asymmetric Positive Pulse Duration (µsec) 100 200 300 100 200 300 Negative Pulse Duration (µsec) 100 200 300 400 800 1200 Inter-Phase Interval (µsec) 50 Total Pulse Duration (µsec) 250 0 450 650 500 Max Load 5000 ohm (Subject to max voltage limitation) Pulse Repetition Rate 20–45 Hz, 5-Hz resolution 1000 1500 Gait Parameters Ramp Up 0–2 seconds, 0.1-second resolution Ramp Down 0–2 seconds, 0.
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 LEDs “Beeps” for audio alerts Dimensions • • • Length: 74 mm (2.9 in.) Width: 43 mm (1.7 in.) Height: 15 mm (0.6 in.) Weight 50 grams (1.6 oz.
Symmetric Asymmetric Positive Pulse Duration (µsec) 100 200 300 100 200 300 Negative Pulse Duration (µsec) 100 200 300 400 800 1200 Inter-Phase Interval (µsec) Total Pulse Duration (µsec) 50 250 0 450 650 500 Max Load 5000 ohm (Subject to max voltage limitation) Pulse Repetition Rate 20–45 Hz, 5-Hz resolution 1000 1500 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 (%
L300 FS Cuff Specifications Material Fabric-Polymer Fits Limb Circumference 29–51 cm (11–20 in.) Dimensions • • • Weight Approximately 150 grams (4.8 oz.) Height: 160 mm (6.3 in.) Width: 100 mm (3.9 in.) Depth: 125 mm (4.9 in.) Thigh FS Cuff Specifications Material Skeleton–TPU; Panel Assemblies and Buckles–Silicone Fits 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.
Intelli-Sense Gait Sensor Specifications Classification Internally powered, continuous operation with type BF applied part(s) Battery Type Lithium coin cell, CR2430, 280 mAh Dimensions of the Transmitter • • • Weight 35 grams (1.1 oz.) • Environmental Ranges • • • Length: 80 mm (3.2 in.) Width: 50 mm (2.0 in.) Height: 10 mm (0.4 in.
Charger Specifications Use medical Class II safety approved power supply provided/approved by Bioness with the following ratings: Input Voltage 100–240 V AC Current 400 mA Frequency 50–60 Hz Output Voltage 5 V ± 5% Current 2400 mA Note: Do not use the NESS L300 Plus System while charging. Do not wear the L300 or Thigh FS Cuffs while charging. Wireless Link Specifications 132 Frequency Band 2.4 GHz, ISM band Transmission Power Complies with FCC 15.247 (for U.S.
L300 Electrode and L300 Electrode Base Specifications Hydrogel Electrodes Two 45-mm (1.77-in.) diameter hydrogel electrodes Note: Use only electrodes provided by Bioness Inc. Hydrogel Electrode Bases Two relocatable polymer electrode bases Cloth Electrodes Two 45-mm (1.77-in.) diameter non-woven fabric/cloth electrodes Note: Use only electrodes provided by Bioness Inc.
134 User's Guide
13 Appendix - EMI Tables System Characteristics Transmitters Operating 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 Operating Frequency Band 2401–2482 MHz Receiver Bandwidth 812 kHz around a selected frequency Chapter 13 - Appendix - EMI Tables 135
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 it is used in such an environment. 136 Emissions Test Compliance Electromagnetic Environment — Guidance RF emissions CISPR 11 Group 1 The NESS L300 Plus System uses RF energy only for its internal function.
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 in such an environment.
Immunity Test IEC 60601 Test Level 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 <5% UT (>95% dip in UT) for 0.
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 environment.
NOTE 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).
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.
NOTE 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.