Bioness Neuromodulation A Bioness L3P-T-RFS-V20 L300 Plus Thigh RF Stimulation Unit User Manual part 2
Bioness Neuromodulation ltd. A Bioness Inc Company L300 Plus Thigh RF Stimulation Unit part 2
Contents
user manual part 2
15
Chapter 4 - NESS L300 Plus System Kits
4
NESS L300 Plus System Kits
NESS L300 Plus System Kit
System Components
•L300 Plus Control Unit
•L300 FS Cuff and RF Stim Unit
•Thigh FS Cuff and RF Stim Unit
•Intelli-Sense Gait Sensor
Accessories
•System Charger Set
•Control Unit Neck Strap
•Control Unit Wrist Strap
•Control Unit Belt Pouch
L300 Plus Control Unit
L300 FS Cuff and
RF Stim Unit
Thigh FS Cuff and
RF Stim Unit Intelli-Sense Gait Sensor
16 User's Guide
•Replacement Battery, Gait Sensor
•Gait Sensor Pads
•Shoe Spacers
•Thigh Elongation Bar Locks
•Thigh Electrode Marking Rings
•Large Cloth Electrode*
•L300 Hydrogel Electrodes and Bases*
•L300 Cloth Electrodes and Bases*
•Thigh Cloth Electrodes
•Cloth Electrode Mesh Bag
•Carrying Case
•L300 Plus User’s Guide
•User’s Reference Card
*One L300 electrode type included, as determined by your clinician.
L300 Hydrogel
Electrode
L300 Cloth
Electrode
L300 Hydrogel
Electrode Base
L300 Cloth
Electrode Base
L300 Large Cloth Electrode
18 User's Guide
NESS L300 Plus System Upgrade Kit
The NESS L300 Plus System Upgrade Kit is for individuals who have a NESS
L300 Foot Drop System.
System Components
•L300 Plus Control Unit
•Thigh FS Cuff and RF Stim Unit
Accessories
•System Charger Set
•Thigh Elongation Bar Locks
•Thigh Electrode Marking Rings
•Thigh Cloth Electrodes
•Carrying Case
•Control Unit Neck Strap
•Control Unit Wrist Strap
•Control Unit Belt Pouch
•Cloth Electrode Mesh Bag
•L300 Plus User’s Guide
•User's Reference Card
IMPORTANT! Bring your NESS L300 Foot Drop System to your L300 Plus
fitting session.
19
Chapter 5 - NESS L300 Plus System
5
NESS L300 Plus System
L300 Functional Stimulation (FS) Cuff
The L300 FS Cuff fits on the affected leg below the knee. See Figure 5-1. The
L300 FS Cuff is designed to facilitate dorsiflexion of the foot. It is lightweight,
easy to put on with one hand, and can be worn under loose clothing.
The L300 FS Cuff features a radio frequency (RF) stimulation unit that
communicates wirelessly with the L300 Plus Control Unit and Intelli-Sense
Gait Sensor.
Figure 5-1: L300 FS Cuff.
Locator
Strap
Handle
Cradle L300 RF
Stim Unit
Strap
20 User's Guide
Locator
The locator fits under the kneecap of the affected leg. The locator is used
to accurately place the L300 FS Cuff on the leg, and to ensure repeatable
electrode contact.
Cradle
The cradle holds the L300 RF Stim Unit. The L300 RF Stim Unit snaps in
and out of the cradle.
Note: The L300 RF Stim Unit should only be removed for maintenance and
when cleaning the L300 FS Cuff.
Strap
The L300 FS Cuff strap is adjustable and has a flexible handle, which fits
over the cradle to fasten.
L300 Electrodes and Electrode Bases
The following electrodes may be used with the L300 FS Cuff:
•Large Cloth Electrode, L300 systems.
•L300 Hydrogel Electrodes and Hydrogel Electrode Bases.
•L300 Cloth Electrodes and Cloth Electrode Bases.
The electrodes attach to the inside of the L300 FS Cuff. Your clinician will
determine the type of electrodes most appropriate for you and then fit the
electrodes to your L300 FS Cuff.
CAUTION: Do not wear the L300 FS Cuff without electrodes.
21
Chapter 5 - NESS L300 Plus System
L300 RF Stim Unit
The L300 RF Stim Unit generates the electrical stimulation used to dorsiflex
the foot. It responds to wireless signals from the L300 Plus Control Unit and
the Intelli-Sense Gait Sensor to turn stimulation on/off.
The L300 RF Stim Unit includes a status light, a stimulation light, and a
rechargeable battery. The battery charging port is located at the top of the
L300 RF Stim Unit, under the flexible cover. See Figure 5-2.
Figure 5-2: L300 RF Stim Unit.
Charging
Port under
Flexible
Cover
Cradle
Status Light
Stimulation Light
L300 RF
Stim Unit
22 User's Guide
The L300 RF Stim Unit emits visual and/or audio alerts when:
•Stimulation is on.
•RF communication with the L300 RF Stim Unit fails.
•The L300 RF Stim Unit battery charge level is low.
•The L300 RF Stim Unit battery is charging.
•The L300 RF Stim Unit malfunctions. See Table 5-1.
L300
RF Stim Unit Display 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 RF Communication Failure
SOLID RED Malfunction
Stimulation
Light FLASHES YELLOW
SLOWLY Stimulation is Off
FLASHES YELLOW
RAPIDLY Stimulation is On
Table 5-1: L300 RF Stim Unit displays.
23
Chapter 5 - NESS L300 Plus System
Thigh FS Cuff
The Thigh FS Cuff is a lightweight, low-profile orthosis designed to assist
with knee flexion or extension. See Figure 5-3. The Thigh FS Cuff fits above
the affected knee, centered on the back or front of the thigh.
The Thigh FS Cuff features an RF stimulation unit that communicates wirelessly
with the L300 Plus Control Unit and Intelli-Sense Gait Sensor.
Figure 5-3: Thigh FS Cuff.
Cradle
Locator
Elongation
Bar Thigh RF Stim
Unit
Top Panel
Bottom Panel
24 User's Guide
Panels
The Thigh FS Cuff features two panels. The top panel fits higher on the thigh.
The bottom panel fits lower on the thigh. The bottom panel has a cradle for
the Thigh RF Stim Unit.
Elongation Bar
The elongation bar connects the top and bottom Thigh FS Cuff panels. Your
clinician will adjust the elongation bar and lock it.
Locator
The Thigh FS Cuff locator should rest on the center of the thigh, three finger
widths from the knee of the affected leg. The locator is used to accurately
place the Thigh FS Cuff on the leg, and to ensure repeatable electrode contact.
Cradle
The cradle holds the Thigh RF Stim Unit. The Thigh RF Stim Unit snaps in
and out of the cradle.
Note: The Thigh RF Stim Unit should only be removed for maintenance and
when cleaning the Thigh FS Cuff.
25
Chapter 5 - NESS L300 Plus System
Figure 5-4: Snapping the small Thigh cloth electrode to the bottom panel.
CAUTION: Do not wear the Thigh FS Cuff without the cloth
electrodes.
Thigh Cloth Electrodes
The Thigh FS Cuff uses two cloth electrodes to provide electrical stimulation.
The large Thigh cloth electrode snaps to the Thigh FS Cuff top panel. The
small Thigh cloth electrode snaps to the Thigh FS Cuff bottom panel. See
Figure 5-4.
26 User's Guide
Thigh RF Stim Unit
The Thigh RF Stim Unit generates the electrical stimulation used to flex or
extend the knee. It responds to wireless signals from the L300 Plus Control
Unit and the Intelli-Sense Gait Sensor to turn stimulation on/off.
The Thigh RF Stim Unit includes a status light, a stimulation light, and a
rechargeable battery. See Figure 5-5. The battery charging port is located
at the top of the Thigh RF Stim Unit, under the flexible cover.
Figure 5-5: Thigh RF Stim Unit.
Charging Port Under
Flexible Cover
Thigh RF Stim Unit
Stimulation Light
Status Light
27
Chapter 5 - NESS L300 Plus System
Thigh
RF Stim Unit Display 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 RF Communication
Failure
SOLID RED Malfunction
Stimulation
Light
FLASHES YELLOW
SLOWLY Stimulation is Off
FLASHES YELLOW
RAPIDLY Stimulation is On
Table 5-2: Thigh RF Stim Unit displays.
The Thigh RF Stim Unit emits visual and/or audio alerts when:
•Stimulation is on.
•RF communication with the Thigh RF Stim Unit fails.
•The Thigh RF Stim Unit battery charge level is low.
•The Thigh RF Stim Unit battery is charging.
•The Thigh RF Stim Unit malfunctions. See Table 5-2.
30 User's Guide
L300 Plus Control Unit
The L300 Plus Control Unit is used to:
•Turn on/off the NESS L300 Plus System.
•Test the position of the FS Cuffs.
•Select an operating mode (gait, training, or standby).
•Fine-tune stimulation intensity.
•Mute/un-mute system audio alerts.
•Turn off visual alerts.
•Turn on/off audio feedback during stimulation.
•Monitor system status. See Figure 5-8 and Table 5-3.
Figure 5-8: L300 Plus Control Unit operating buttons and digital display.
Mute Button
L300 RF Stim
Unit Selection
Button
Stimulation
Test Button
On/Off Button
Loop Hole for Wrist and Neck Straps
Mode Button
Intensity
Adjustment
(Plus/Minus)
Buttons
Digital
Display
Thigh RF Stim
Unit Selection
Button
31
Chapter 5 - NESS L300 Plus System
The L300 Plus Control Unit communicates wirelessly with the L300 and Thigh
RF Stim Units. It is powered by a single rechargeable AAA NiMH battery, and
is small enough to wear on a neck strap or in a belt pouch.
L300 Plus
Control Unit
Operating
Button Description Function
On/Off Turns On/Off the System
Mode Selects Standby, Gait, or
Training Mode
Intensity
Adjustment
(Plus/Minus)
Increases Stimulation
Intensity
Decreases Stimulation
Intensity
RF Stim Unit
Selection
Top: Selects the Thigh RF Stim
Unit.
Bottom: Selects the L300 RF
Stim Unit
Mute
Mutes/Un-Mutes the Control
Unit Audio Alerts; Turns Off the
Visual and Audio Indicators in
the Selected RF Stim Unit;
Turns On/Off Audio Feedback
During Stimulation
Stimulation
Test
Tests Stimulation for the
Selected RF Stim Unit
Table 5-3: L300 Plus Control Unit operating buttons.
32 User's Guide
Operating Modes
The L300 Plus System has three operating modes: standby, gait, and training.
Standby Mode
In standby mode, the NESS L300 Plus System is on and waiting for commands.
Stimulation is off.
Gait Mode
Gait mode is used when walking. In gait mode, the Intelli-Sense Gait Sensor
signals the L300 and Thigh RF Stim Units when the heel leaves the ground
and when the heel contacts the ground. Stimulation in the L300 and Thigh
RF Stim Units respond as programmed by the clinician.
Training Mode
Training mode is used to train the muscles when not walking (for example,
sitting or lying down). Training mode works independently of the Intelli-Sense
Gait Sensor. Stimulation is delivered in cycles pre-set by the clinician.
Training mode is designed to:
•Facilitate muscle re-education.
•Prevent or retard disuse atrophy of the lower leg and thigh muscles.
•Maintain or improve range of motion of the ankle and knee joints.
•Improve local blood circulation.