Bioness Neuromodulation A Bioness L3P-T-RFS-V10 Thigh RF Stimulation Unit User Manual manual3
Bioness Neuromodulation ltd. A Bioness Inc Company Thigh RF Stimulation Unit manual3
Contents
- 1. manual1
- 2. manual2
- 3. manual3
manual3
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Chapter 8 - Operating the L300 Plus Control Unit
Component Maintenance and Cleaning
Charging the Batteries
When a system component has a low battery, the Control Unit will beep and
the component indicator light will flash YELLOW. See Figure 43.
When an RF Stim Unit battery charge level is low, the RF Stim Unit status
light will also flash YELLOW. See inset in Figure 43.
When the Gait Sensor battery is low, the Control Unit low-battery audio alert
will become more persistent as the battery weakens.
9
Low Battery,
Thigh RF
Stim Unit
Low Battery,
L300 RF Stim
Unit
Low Battery,
Gait Sensor
Low Battery,
Control Unit
Low Battery, RF
Stim Unit
Figure 43: Low battery FLASHING YELLOW indicators.
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To charge the batteries in the Control Unit and RF Stim Units:
1. Open the cover of the charging ports (found at the bottom of the Control
Unit and at the top of the RF Stim Units). See Figure 44.
Figure 44: Charging ports: Control Unit and RF Stim Units.
L300 RF Stim
Unit Charging
Port
Cover
Cover
Control Unit
Charging Port
Cover
Thigh RF Stim Unit
Charging Port
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Chapter 9 - Component Maintenance and Cleaning
2. Connect the system charger set to the Control Unit and both RF Stim
Units. See Figure 45.
Figure 45: Charging setup.
System
Charger
Set
Note: 0.6-cm (1/4-in.) gap is
normal
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3. Plug the system charger set into a wall socket.
4.
Verify that the rotating GREEN circle appears in the Control Unit digital
display, and the status light on the both RF Stim Units is alternately
flashing YELLOW and GREEN.
5. The charging process will continue until a horizontal GREEN line
appears in the Control Unit digital display and the status light on
both RF Stim Units is solid GREEN. See figures 46 and 47. The charging
process should last approximately three hours. The Control Unit and RF
Stim Units can remain connected to the charger after charging is complete.
Note: It is possible to charge the Control Unit and RF Stim Units separately,
but Bioness recommends that they be charged at the same time.
Caution: The batteries must be charged before first use, daily,
and after extended storage.
Caution: Only the Control Unit and RF Stim Unit batteries are
rechargeable.
Caution: Remove the L300 FS Cuff and Thigh FS Cuff before
charging the batteries.
Caution: Do not use the RF Stim Units or the Control Unit
while charging.
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Chapter 8 - Operating the L300 Plus Control Unit
Figure 46: Control Unit charging displays.
Horizontal GREEN Line:
Control Unit
Fully Charged
Rotating GREEN Circle:
Control Unit
Charging
Note: If the Control Unit battery is completely discharged, a “b” (for boot)
will flash for a few seconds in the Control Unit digital display when charging
is started.
Figure 47: RF Stim Unit charging displays.
Status Light Alternately
Flashing GREEN and
YELLOW:
RF Stim Unit
Charging
Status Light
Solid GREEN:
RF Stim Unit
Fully Charged
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Replacing the Batteries
Replacing the RF Stim Unit Batteries
Each RF Stim Unit has a rechargeable battery. The battery should be replaced
approximately every two years by a Bioness certified technician.
Replacing the Gait Sensor Battery
The battery in the Gait Sensor is not rechargeable. It should be replaced
approximately every six months. The Gait Sensor indicator on the Control
Unit will begin to flash YELLOW approximately two weeks before the Gait
Sensor completely loses its charge. The Control Unit will also emit an alarm.
To replace the Gait Sensor battery (Lithium coin cell, CR2430):
1. Unscrew the two screws from the battery cover. See Figure 48. Slide the
cover out.
Figure 48: Replacing the Gait Sensor battery.
Screws Note: If you are
unable to replace the
battery yourself, your
local watchmaker or
battery supply store
should be able to
assist.
Battery
Cover
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Chapter 9 - Component Maintenance and Cleaning
2. Note the “+” orientation of the old battery.
3. Remove the old battery and properly dispose of it according to your local
environmental regulations.
4. Insert the new battery. The “+” should face outward.
5. Slide the cover back into place, and tighten the screws.
6. Press the Gait Sensor pressure sensor to activate the sensor.
Remove the old battery, and properly dispose of it according to
your local environmental regulations.
Replacing the L300 Plus Control Unit Battery
The battery in the Control Unit is a rechargeable AAA battery. It should be
replaced approximately every two years.
To replace the Control Unit battery (AAA NiMH 1.2 V):
1.
Remove the screw from the battery cover on the back of the Control Unit.
See Figure 49. (The screw may be under a small label. If so, gently peel
off one end of the label. Reapply the label after the battery is replaced.)
2. Remove the battery cover.
3. Note the "+/-" orientation of the old battery.
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Figure 49: Replacing the Control Unit battery.
Remove the old battery, and properly dispose of it according to
your local environmental regulations.
4. Insert the new rechargeable battery in the proper "+/-" orientation.
5. Slide the cover into place, and tighten the screw.
6. Fully charge the new battery before first use.
Caution: Use of a non-rechargeable AAA battery can damage
the Control Unit.
Note: If you are unable
to replace the battery,
your local watchmaker
or battery supply store
should be able to assist.
Control Unit
Battery
Battery Cover
Screw
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Chapter 8 - Operating the L300 Plus Control Unit
Replacing the L300 Hydrogel Electrodes
You will need to replace the hydrogel electrodes at least every two weeks.
Caution: Use only NESS L300 electrodes supplied by Bioness.
Caution: Do not use your NESS L300 without electrodes.
To replace the hydrogel electrodes:
1. Turn off the L300 Plus Control Unit.
2.
Gently pull the used L300 hydrogel electrodes from the hydrogel electrode
bases. Be careful not to detach the electrode bases from the L300 FS
Cuff. See Figure 50.
3. If necessary, clean the electrode bases with a damp cloth. Do not use a
chemical-based cleaning substance.
Figure 50: Removing the used L300 hydrogel electrodes.
Electrode Base
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4. Separate the two new hydrogel electrodes along the perforation. See
Figure 51.
Figure 51: Separating the new hydrogel electrodes.
Figure 52: Splitting the L300 hydrogel electrode two-piece covers.
5. Split the two-piece covers on each new electrode and discard them. See
Figure 52.
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Chapter 8 - Operating the L300 Plus Control Unit
Figure 53: Attaching the hydrogel electrodes to the hydrogel electrode bases.
Figure 54: Removing the covers from the hydrogel electrodes.
Note: Save the covers. Always reapply the covers between uses. When
reapplying the covers, make sure the Bioness logo faces up.
Note: If the electrode gel dries, rehydrate it with one to two drops of water.
6. Attach the grid side of the hydrogel electrodes to the hydrogel electrode
bases, and then press firmly. See Figure 53.
7. Remove the covers from the hydrogel electrodes. See Figure 54.
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Replacing the L300 Cloth Electrodes
L300 cloth electrodes and cloth electrode bases are an option for those who
experience a skin sensitivity to the hydrogel electrodes. First fittings will be
done by your clinician. Afterward, you will need to change the cloth electrodes
at least every two weeks and the cloth electrode bases every one to two years.
Caution: Use only NESS L300 cloth electrodes supplied by
Bioness.
Caution: Do not use your NESS L300 without electrodes.
To replace the cloth electrodes:
1. Turn off the Control Unit.
2. Gently pull the used cloth electrodes from the cloth electrode bases. Be
careful not to detach the cloth electrode bases from the L300 FS Cuff.
See Figure 55.
Figure 55: Removing used cloth electrodes.
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Chapter 9 - Component Maintenance and Cleaning
3. If necessary, clean the cloth electrode bases with a damp cloth. Do not
use a chemical-based cleaning substance.
4. Wet the new cloth electrodes with tap water until they are saturated. See
Figure 56.
5. With a soft cloth, gently wipe or blot excess water off the back (side with
the snap) of the cloth electrodes. See Figure 57.
6. Attach the L300 cloth electrodes to the L300 cloth electrode bases. See
Figure 58.
Note: Remove and re-wet the cloth electrodes every time you remove the
L300 FS Cuff from your leg for more than one hour, and after every four hours
of use. When wetting the cloth electrodes, always remove them from the L300
FS Cuff. If the cloth electrodes dry out, your response to the stimulation may
change. If you need to adjust stimulation intensity more often than usual, try
re-wetting the cloth electrodes following the steps listed above.
Figure 56: Wetting the cloth electrodes.
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Figure 57: Blotting the snap side of the cloth electrodes.
Figure 58: Attaching the cloth electrodes to the cloth electrode bases.
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Chapter 9 - Component Maintenance and Cleaning
Replacing the L300 Electrode Bases
If you are switching from L300 hydrogel electrodes to L300 cloth electrodes,
or from L300 cloth electrodes to L300 hydrogel electrodes, you will need to
be seen by a qualified clinician for a first fitting. Your clinician will need to fit
the L300 electrode bases and adjust your stimulation settings. Afterward you
will need to replace the L300 electrode bases after one to two years of use.
Contact Bioness to purchase replacement electrode bases.
To replace the L300 electrode bases:
1. If your clinician installed wire concealers over the electrode base wires,
remove the wire concealers.
2. Mark the position of the used electrode bases on the FS Cuff liner with a
permanent marker. See Figure 59.
Caution: When replacing the L300 FS Cuff, have your clinician
re-fit the electrodes and electrode bases.
Figure 59: Marking the position of the used L300 electrode bases.
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Figure 60: Disconnecting the electrode base snaps.
3.
Disconnect the electrode base snaps from the plug holes. See Figure 60.
4.
Remove the used L300 electrode bases from the L300 FS Cuff. See Figure
61. Attach the new L300 electrode bases where the previous bases were
attached. See Figure 62.
Figure 61: Removing the used L300 electrode bases.
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Chapter 9 - Component Maintenance and Cleaning
Figure 62. Attaching the new L300 electrode bases.
Figure 63: Connecting the electrode base snaps to the plug holes.
5. Connect the electrode base snaps to the plug holes. See Figure 63.
6. Recover the wires and snaps with the wire concealers, if desired.
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Replacing the Thigh FS Cuff Cloth Electrodes
The Thigh FS Cuff uses two cloth electrodes: a larger one for the proximal
panel and a smaller one for the distal panel.
Caution: Use only NESS L300 Plus cloth electrodes supplied
by Bioness.
Caution: Do not use your NESS L300 Plus without electrodes.
To replace the cloth electrodes:
1. Turn off the Control Unit.
2. Gently unsnap the cloth electrodes and remove them from the Thigh FS
Cuff. See Figure 64.
Figure 64: Removing the used Thigh FS Cuff cloth electrodes.
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Chapter 9 - Component Maintenance and Cleaning
3. Wet the new cloth electrodes with tap water until they are saturated. See
Figure 65.
4. With a soft cloth, gently wipe or blot excess water off the back (side with
the snap) of the cloth electrodes. See Figure 66.
5. Attach the Thigh FS Cuff cloth electrodes to the Thigh FS Cuff. See
Figure 67.
Note: Remove and re-wet the cloth electrodes every time you remove the
Thigh FS Cuff from your leg for more than one hour, and after every four hours
of use. When wetting the cloth electrodes, always remove them from the Thigh
FS Cuff. If the cloth electrodes dry out, your response to the stimulation may
change. If you need to adjust stimulation intensity more often than usual, try
re-wetting the cloth electrodes following the steps listed above.
Figure 65: Wetting the Thigh FS Cuff cloth electrodes.
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Figure 66: Blotting the snap side of the cloth electrodes.
Figure 67: Snapping the cloth electrodes to the Thigh FS Cuff.
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Chapter 9 - Component Maintenance and Cleaning
Removing the RF Stim Units
The only time you should remove an RF Stim Unit is to clean the FS Cuff or
replace the RF Stim Unit.
To remove the RF Stim Units:
1. Turn off the Control Unit.
2. Pull the top of the RF Stim Unit away from the cradle. See Figure 68. If
the fit is too tight, open the flexible cover over the RF Stim Unit charging
port for a better grasp.
3. Remove the bottom of the RF Stim Unit from the cradle.
Figure 68: Removing the RF Stim Unit.
Cradle
RF Stim Unit
Inserting the RF Stim Units
To insert the RF Stim Units:
1. Insert the bottom of the RF Stim Unit into the cradle. Then, gently push
the top of the RF Stim Unit into the cradle until it snaps in.
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User’s Guide
Cleaning the System Components
All NESS L300 components may be cleaned by carefully wiping them with a
damp cloth. The electrical components are not waterproof. Do not immerse
them in water. The L300 FS Cuff is the only component that can be immersed
in water to clean. Bioness recommends cleaning the L300 FS Cuff when
replacing the hydrogel electrodes, so that the electrodes do not dry out.
To clean the L300 FS Cuff:
1. Remove the RF Stim Unit.
2. Gently remove the electrodes from the electrode bases. For hydrogel
electrodes, replace the electrode covers. Do not remove the electrode
bases.
3.
Immerse the FS Cuff for 30 minutes in lukewarm water and mild detergent.
Do not use a washing machine.
4. Rinse the FS Cuff thoroughly under running water.
5.
Immerse the FS Cuff for an additional 15 minutes in clean, lukewarm water.
6. Rinse the FS Cuff again under running water.
7. Gently blot excess moisture from the FS Cuff with a towel. Do not wring
the FS Cuff. Lay the FS Cuff flat in the shade to dry. (Do not hang dry.)
Drying time will vary from 4 to 12 hours depending on climate and humidity.
For faster drying, place the FS Cuff in front of a circulating cold-air fan.
Do not use a hot-air dryer or other heat source to dry.
8. When the FS Cuff is completely dry, insert the RF Stim Unit and attach
the electrodes.
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Chapter 10 - Electronically Registering New Components
10
Electronically Registering New Components
When a NESS L300 Plus Control Unit, an RF Stim Unit, or a Gait Sensor is
replaced, the new component must be electronically registered to the other
NESS L300 Plus components for the system to communicate wirelessly.
NOTE: Components can only be successfully registered once. Additional
attempts will elicit an error indication.
Registering a New L300 Plus Control Unit
Setup
1.
Connect the new L300 Plus Control Unit and RF Stim Units to the system
charger set during registration.
2. Place the FS Cuffs with RF Stim Units attached, the Gait Sensor, and the
new L300 Plus Control Unit close together on a table but not touching.
3.
Turn off the old Control Unit and put it in an envelope for shipping to Bioness.
Then, place it at least 30 feet from the NESS L300 Plus components you
are registering.
4. Make sure all other NESS L300 Plus System components are at least 30
feet from the NESS L300 Plus components you are registering.
Registration
1. Turn off the new Control Unit.
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User’s Guide
2. Simultaneously press and hold for three seconds the mode and
minus buttons. See Figure 69. The Control Unit will beep when registration
begins.
3. The Control Unit digital display will show two alternating GREEN
arches while registration is in process. See Figure 70. Registration of a
new Control Unit may take up to four minutes.
4. When registration is complete, (“C” for complete) will appear in the
digital display and the Control Unit indicator will turn GREEN for a few
seconds. See Figure 70. The Control Unit will beep.
5. If (“E” for error) appears in the digital display, an error has occurred.
Repeat the procedure. ( "E" may also indicate that the registration
procedure was successful on a prior attempt and not noticed.)
New
Unregistered
Control Unit
Press and hold the
mode and minus
buttons for three
seconds.
Figure 69: Registering a new Control Unit.
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Chapter 10 - Electronically Registering New Components
6. After registration is complete, turn on your NESS L300 Plus System. If
the new Control Unit is registered, the RF Stim Units will turn on. If you
see an RF failure indication between the Control Unit and RF Stim Units,
wait 20 minutes for the RF Stim Units to enter energy-saving mode, and
then repeat the registration procedure.
7. Once the Control Unit is registered, locate the System ID Number on the
NESS L300 Plus carrying case (for example, A334). Write the number
on the blank label on the back of the Control Unit. See Figure 71. This
ID number identifies which NESS L300 Plus System the new Control
Unit is registered to.
Registration
Error
Registration
Complete
Registration
in Process
Blank Label
Figure 71: Label on the L300 Plus Control Unit for the System ID Number.
Figure 70: Registration digital displays.
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User’s Guide
Registering a New RF Stim Unit
Set-Up
1. Turn off the L300 Plus Control Unit.
2. Remove the old RF Stim Unit from the cradle of the FS Cuff.
Caution: Do not turn on the Control Unit if the RF Stim Unit
is not in the cradle.
3. Put the old RF Stim Unit in an envelope for shipment to Bioness. Place
it at least 30 feet from the components you are registering.
4. Locate the System ID Number on the NESS L300 Plus carrying case (for
example, A334). Write the number on the blank label on the back of the
new RF Stim Unit. See Figure 72. This number identifies which NESS
L300 Plus System the new RF Stim Unit will register to.
5. Attach the new RF Stim Unit to the FS Cuff.
6.
Connect the Control Unit and the new RF Stim Unit to the system charger
set during registration.
Figure 72: Label on the RF Stim Unit for the System ID Number.
Blank Label
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Chapter 10 - Electronically Registering New Components
1. Place the FS Cuff with the attached new RF Stim Unit, the other FS Cuff
with attached RF Stim Unit, the Control Unit, and the Gait Sensor close
to each other on a table but not touching.
2. Make sure all other NESS L300 Plus System components are at least 30
feet from the NESS L300 Plus components you are registering.
Registration
1. Make sure the Control Unit has been off for 20 minutes, and that the RF
Stim Units are in energy-saving mode.
2. Simultaneously press and hold for three seconds the mode and
minus buttons on the Control Unit. The Control Unit will beep when
registration begins. See Figure 73.
Figure 73: Registering a new RF Stim Unit.
Press and hold the
mode and minus
buttons for three
seconds.
New
Unregistered
RF Stim Unit
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NESS L300 Plus
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3. The Control Unit digital display will show two alternating GREEN
arches while registration is in process. Registration should take several
seconds to complete.
4. When registration is complete, (“C” for complete) will appear in the
digital display and the RF Stim Unit indicator will turn GREEN for a few
seconds. The Control Unit will beep.
5. If (“E” for error) appears in the digital display, an error has occurred.
Repeat the procedure. ( "E" also can mean that the registration procedure
was successful on a prior attempt and not noticed.)
After registration is complete, turn on the Control Unit. If the new RF Stim Unit
is registered, the RF Stim Unit will turn on. If you see an RF failure indication,
wait 20 minutes for the RF Stim Unit to enter energy-saving mode, and then
repeat the procedure.
Registering a New Gait Sensor
Setup
1. Connect the Control Unit and RF Stim Units to the system charger set
during registration.
2.
Place the new Gait Sensor, FS Cuffs with RF Stim Units, and Control Unit
close together on a table but not touching. See Figure 74.
3. Make sure all other NESS L300 Plus System components (including the
used Gait Sensor in your shoe) are at least 30 feet from the components
you are registering.
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Chapter 10 - Electronically Registering New Components
Registration (Important: Read Steps 1–4 Before Starting)
1. Turn off the Control Unit.
2. Simultaneously press and hold for three seconds the mode and
minus buttons on the Control Unit. The Control Unit will beep when
registration begins.
3. The 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 Gait Sensor indicator will turn GREEN for a few seconds, and
the Control Unit will beep. If registration fails, wait 20 seconds for the RF
Stim Units to enter energy-saving mode, and then repeat the procedure.
Figure 74: Registering a new Gait Sensor.
Press and hold the
mode and minus
buttons for three
seconds.
New
Unregistered
Gait Sensor
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Blank Label
Figure 75: Label on the Gait Sensor for the System ID Number.
6. After registration is complete, turn on the system and select gait mode.
Press and release the pressure sensor. If the new Gait Sensor is registered,
the mode button will flash YELLOW rapidly for four seconds.
7. Locate the System ID Number on the NESS L300 Plus carrying case (for
example, A334). Write the number on the small label on the back of the
new Gait Sensor. See Figure 75. This number identifies which system
the sensor is registered to.
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Chapter 11 - Troubleshooting
11
Troubleshooting
If you have any questions or concerns, please contact the NESS L300 Plus
Technical and Clinical Support Department at (800) 211-9136, Option 3.
When charging the L300 Plus System, how will I know when the batteries
are fully charged?
•When the L300 Plus Control Unit is fully charged, a GREEN
horizontal line will appear in the Control Unit digital display.
•When the RF Stim Units are fully charged, the status light
on the RF Stim Units will be solid GREEN.
•
Charging takes approximately three hours. Once the components
are fully charged, you may keep the components connected to
the system charger set.
If I charge the L300 Plus System every day, will I harm the batteries?
•No. Daily charging will not affect the lifespan or functionality of
the batteries. Daily charging is recommended.
While charging, "E" appears in the digital display.
•An error occurred while charging. Reconnect the system
charger set. If the problem persists, contact Bioness.
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Stimulation works in training mode but not in gait mode. When
I turn on gait mode I hear a beep, the RF Stim Units and Gait Sensor
indicators on the Control Unit alternately flash RED, and “E” flashes
in the digital display.
•The Gait Sensor and RF Stim Unit are not communicating. The
Gait Sensor is probably asleep. Apply pressure to the Gait Sensor
pressure sensor. If this does not resolve the problem, the battery
may be depleted or the Gait Sensor may be faulty. If no wire issues
are apparent, replace the Gait Sensor battery and try again.
When I turn on the Control Unit, it beeps, the Control Unit and
RF Stim Unit indicators alternately flash RED, and “E” flashes in the
digital display. The RF Stim Unit indicators are not lit.
•
The RF Stim Unit battery is likely discharged, preventing the Control
Unit and RF Stim Unit from communicating. Turn off the Control
Unit, and charge the Control Unit and RF Stim Unit fully. Then,
disconnect the charger and turn on the Control Unit. The Control
Unit On/Off button and the status light on the RF
Stim Unit should flash GREEN. Communication should be restored.
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Chapter 11 - Troubleshooting
I hear a beep, the RF Stim Unit indicator on the Control Unit
flashes RED, and the stimulation intensity level flashes in the Control
Unit digital display.
If you feel stimulation but the intensity level seems weaker than usual and
ankle movement is unsatisfactory, electrode contact may be compromised.
•Turn off the Control Unit and remove the FS Cuff.
•Thoroughly cleanse the skin, removing dead cells and oils.
•If you are using hydrogel electrodes, remove and replace the
worn electrodes. Press firmly on the new electrodes until they
are securely attached to the bases. Then, remove the covers.
•
If you have cloth electrodes, remove the cloth electrodes and wet
them with water until saturated. Blot the snap side of the electrodes
before re-adhering them to the electrode bases.
•Replace hydrogel and cloth electrodes every two weeks.
If you do not feel stimulation:
•Turn off the Control Unit and remove the FS Cuff.
•
For hydrogel electrodes, confirm that the covers have been removed.
•For cloth electrodes, remove and wet the cloth electrodes, if they
are dry.
•Make sure the RF Stim Unit is properly snapped into the cradle
on the FS Cuff. Press firmly near the upper edges of the RF Stim
Unit until it is flush with the cradle.
•Make sure the electrode bases are snapped into the plug holes
of the FS Cuff.
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The electrodes or electrode bases are frayed, peeling, damaged, or
falling off the FS Cuff.
•Replace any worn or damaged electrodes or electrode bases.
How will I know when the Gait Sensor battery charge level is low?
•A Gait Sensor battery will last for approximately six months, and
then it will need to be replaced. When the Gait Sensor battery
charge level is low, the Gait Sensor indicator on the Control Unit
will flash YELLOW and the Control Unit will emit an audio alert. The
audio alert will become more persistent as the battery weakens.
One of the component indicators is solid RED, an "E" appears
in the digital display, and the Control Unit beeps.
•
The respective component is malfunctioning. Turn off the Control
Unit and turn it back on. If the problem persists, then stop using
the NESS L300 and contact Bioness.
One of the component indicators is flashing YELLOW.
•The respective component battery charge level is low. Charge or
replace the battery.
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Chapter 11 - Troubleshooting
My ankle is not moving (or my foot does not lift satisfactorily), and the
system is not indicating any errors.
•Turn off the Control Unit and reposition the FS Cuff. Make sure
the strap is snug and the FS Cuff is secure.
Stimulation is inconsistent when I am walking, but the system is not
indicating any errors.
•
Stop walking and shift your weight from side to side. If the problem
persists, check for proper placement of the pressure sensor,
reposition the pressure sensor slightly forward in your shoe, or
loosen your shoelace if it is tight. Also, check the Gait Sensor
wires for wear or fraying, and check the transmitter and pressure
sensor for damage.
My skin is irritated or has a skin reaction where the electrodes or FS
Cuff adheres.
•
Stop using the NESS L300 immediately and contact your clinician,
dermatologist, or Bioness Clinical Specialist. Resume use only when
the skin is completely healed. Ask your clinician or dermatologist
for a skin conditioning protocol.
I received a replacement component and was told I need to “register”
it. Why is registration important and how do I register a component?
•A replacement Control Unit, RF Stim Unit, or Gait Sensor needs
to be electronically registered to the other components in the
system to communicate wirelessly. To register a component, see
Chapter 9.
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I tried the registration procedure and saw a “C” immediately, but I
never saw the alternating arches in the digital display. The replacement
component is not working.
•
Clinician mode (for use by clinicians only) may have been started
instead of the registration process. Clinician mode is started by
pressing the minus and on/off buttons on the Control
Unit. Registration is started with the Control Unit off, and then by
pressing the minus and mode buttons on the Control
Unit. Turn off the Control Unit, and press the minus and
mode buttons to restart the registration process.
The Control Unit (or RF Stim Unit) does not light up when turned on.
•
The battery needs to be charged. Charge the battery. If the problem
persists, contact Bioness.
After I fully charged the Control Unit and RF Stim Unit, I disconnected
and then immediately reconnected the system charger set. The
charging icons displayed again. Are the components still fully
charged or do I need to repeat the charging process?
•If you just charged your system and the fully charged icons
were displayed, your system is still fully charged. You do not
have to repeat the charging process.
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Component Technical Specifications
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 for changing operating modes
Intensity +/- buttons to fine-tune intensity level
Volume buttons to adjust volume of audio alerts
Indications
Three status LEDs: Control Unit, RF Stim Unit, and Intelli-
Sense Gait Sensor
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: -20°C to +60°C (-4°F
to +140°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: 900 hPa to 1060 hPa
12
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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, 700 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: -20°C to +60°C (-4°F to
+140°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: 900 hPa to 1060 hPa
Pulse Parameters
Pulse Balanced Biphasic
Waveform Symmetric or Asymmetric
Intensity 0–80 mA, 1-mA resolution (positive phase)
Max Voltage 120 V
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Chapter 11 - Troubleshooting
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 (Delay) 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
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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.)
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: -20°C to +60°C (-4°
F
to
+140°F)
Operating conditions temperature: 5°C to 40°C (41
°
F to
104°F)
Relative humidity: 25% to 85%
Atmospheric pressure: 900 hPa to 1060 hPa
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Chapter 11 - Troubleshooting
Power Supply Specifications
Use medical Class II safety approved power supply provided/approved
by Bioness with the following ratings:
Input
Voltage 100–240 V AC
Current 200 mA
Frequency 50–60 Hz
Output
Voltage 5 V ± 5%
Current 1300 mA
Note: Do not use the Control Unit or RF Stim Unit while charging.
Wireless Link Specifications
Frequency Band 2.4 GHz, ISM band
Transmission
Power
Complies with FCC 15.247 (for U.S.) / ETSI EN 300-440
(for Europe) regulations
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Hydrogel Electrode and Electrode Base Specifications
Electrodes Two, 45-mm (1.77-in.) diameter hydrogel electrodes
Note: Use only electrodes provided by Bioness Inc
Electrode Bases Two relocatable polymer electrode bases for individual
fitting