Bioness Neuromodulation A Bioness L3P-N-CU-V20 L300 Plus Control Unit User Manual manual part 6

Bioness Neuromodulation ltd. A Bioness Inc Company L300 Plus Control Unit manual part 6

manual part 6

111
Chapter 10 - Electronic Registration
10
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.
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 Guide
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.
113
Chapter 10 - Electronic Registration
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
Error
Registration
Complete
Registration
in Process
Figure 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 Guide
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.
115
Chapter 10 - Electronic Registration
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 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 Guide
Blank Label
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.
Figure 10-4: Intelli-Sense Gait Sensor.
125
Chapter 12 - Technical Specifications
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 1.2 V, 900–1100 mAh
Controls
• 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 button
Indications
• 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 alerts
Carrying 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 Guide
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.)
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
Pulse Parameters
Pulse Balanced Biphasic
Waveform Symmetric or Asymmetric
Intensity (Peak) 0–80 mA, 1-mA resolution (positive phase)
Maximum
Intensity (rms) 13.2 mA (rms)
Max Voltage 120 V
127
Chapter 12 - Technical Specifications
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 0
Total Pulse
Duration (µsec) 250 450 650 500 1000 1500
Max Load 5000 ohm (Subject to max voltage limitation)
Pulse Repetition
Rate 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 (%) 0–100% of stance time, 10% resolution
Max. Duration of
Stimulation 2–10 seconds, 1-second resolution
Training Parameters
On Time 4–20 seconds, 1-second resolution
Off Time 4–60 seconds, 1-second resolution
Ramp Up 0–2 seconds, 1-second resolution
Ramp Down 0–2 seconds, 1-second resolution
Total Time 1–60 minutes
128 User's Guide
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.)
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
Pulse Parameters
Pulse Balanced Biphasic
Waveform Symmetric or Asymmetric
Intensity (Peak) 0–100 mA, 1-mA resolution (positive phase)
Maximum
Intensity (rms) 16.5 mA (rms)
Max Voltage 120 V
129
Chapter 12 - Technical Specifications
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 0
Total Pulse
Duration (µsec) 250 450 650 500 1000 1500
Max Load 5000 ohm (Subject to max voltage limitation)
Pulse Repetition
Rate 20–45 Hz, 5-Hz resolution
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 (%) 0–100% of phase* time, 5% resolution
Stance Control
End (%) 0–100% of phase* time, 5% resolution
Ramp Up 0–2 seconds, 0.1-second resolution
Ramp Down 0–2 seconds, 0.1-second resolution
Extend (%) 0–100% of stance time, 10% resolution
Max. Duration of
Stimulation 2–10 seconds, 1-second resolution
* Stimulation burst can start either on swing or stance phase.
130 User's Guide
L300 FS Cuff Specifications
Material Fabric-Polymer
Fits 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 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.–13.8 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.)
131
Chapter 12 - Technical Specifications
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
• 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 Guide
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
Frequency Band 2.4 GHz, ISM band
Transmission Power Complies with FCC 15.247 (for U.S.) regulations
133
Chapter 12 - Technical Specifications
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.
Cloth Electrode
Bases Two relocatable polymer electrode bases
Thigh FS Cuff Cloth Electrode Specifications
Material Non-woven cloth
Note: Use only electrodes provided by Bioness Inc
Dimensions 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
135
Chapter 13 - Appendix - EMI Tables
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
136 User's Guide
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.
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.
Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class 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 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
137
Chapter 13 - Appendix - EMI Tables
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
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors 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/burst
IEC 61000-4-4
2 kV for power
supply lines
1 kV for input/output
lines
2 kV for power
supply lines
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Surge
IEC 61000-4-5
1 kV line to line
2 kV line to earth
1 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 Guide
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
40% UT (60% dip
in UT) for 5 cycles
70% 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 cycle
40% UT (60% dip
in UT) for 5 cycles
70% UT (30% dip
in UT) for 25 cycles
<5% UT (>95% dip
in UT) for 5 sec
Mains 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 field
IEC 61000-4-8
3 A/m 3 A/m
Power 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.
139
Chapter 13 - Appendix - EMI Tables
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.
Immunity Test IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment—
Guidance
Portable 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 RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to
80 MHz
Recommended separation
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, 800–1000 MHz range
d = 2.3√P, 1000–2500 MHz range
140 User's Guide
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).
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.b
NOTE 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.
141
Chapter 13 - Appendix - EMI Tables
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. 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 Transmitter
150 kHz to 80
MHz Outside
ISM Bands
d = 1.2√P
80 MHz to 800
MHz
d = 0.4√P
800 MHz to
1000 MHz
d = 0.7√P
1000 MHz to
2.5 GHz
d = 2.3√P
0.01 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 Guide
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 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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