Bionic Leg Orthosis User Manual - AlterG · AlterG Bionic Leg User Manual 116569 Rev B Page 4 of 53...
Transcript of Bionic Leg Orthosis User Manual - AlterG · AlterG Bionic Leg User Manual 116569 Rev B Page 4 of 53...
Bionic Leg Orthosis
User Manual
P/N: 116569 Rev B
Oct 2018
ECO-TBD
European Authorized
Representative
Obelis s.a.
Bd. Général Wahis 53
B-1030 Brussels, Belgium
Phone: 32.2.732.59.54
Fax: 32.2.732.60.03
E-mail: [email protected]
AlterG, Inc.
48438 Milmont Dr.
Fremont, CA 94538
www.alterg.com
Office: 1-510-270-5900
Support: US: +1.510.270.5369
UK: +44 (0)7733 179187
Fax: 1-510-225-9399
E-mail: [email protected]
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Table of Contents
1. PURPOSE ............................................................................................................ 4
1.2. INDICATIONS FOR USE .................................................................................... 4 1.3. CONTRAINDICATIONS TO USE ........................................................................... 4
2. SAFETY INSTRUCTIONS ................................................................................ 5
2.1. WARNINGS AND CAUTIONS .............................................................................. 5 2.2. DEVICE LABELING AND ICON DESCRIPTION ................................................. 9 2.3. AUDIO NOTIFICATIONS .................................................................................... 14
3. PRODUCT DESCRIPTION AND FUNCTION ....................................... 15
3.1. PRODUCT DESCRIPTION ................................................................................ 15 3.2. PRODUCT OVERVIEW ....................................................................................... 16 3.3. USER INTERFACE ............................................................................................. 17 3.4. SHOE INSERT ................................................................................................... 18 3.5. DEVICE ORTHOSIS ......................................................................................... 18 3.6. OPERATING MODE........................................................................................... 21 3.7. CONFIGURABLE OPERATING PARAMETERS ................................................ 23
4. INSTRUCTIONS FOR USE ........................................................................ 25
4.1. DONNING INSTRUCTIONS .............................................................................. 25 4.2. REMOVAL INSTRUCTIONS ............................................................................. 31 4.3. SET-UP INSTRUCTIONS ................................................................................. 32 4.4. CLINICAL APPLICATION ................................................................................ 34 4.5. ADDITIONAL INTERFACE FEATURES ........................................................... 36
5. REMOVABLE BATTERY AND BATTERY CHARGER ...................... 38
5.1. BATTERY TYPE ............................................................................................... 38 5.2. BATTERY CAPACITY ........................................................................................ 38 5.3. SPECIFICATIONS, ENVIRONMENTAL AND SAFETY .................................... 38 5.4. CHANGING THE BATTERY .............................................................................. 39 5.5. BATTERY CHARGER ....................................................................................... 40 5.6. CHARGING THE BATTERY ................................................................................ 40 5.7. BATTERY LABELING ...................................................................................... 40
6. ENVIRONMENTAL AND SAFETY CONDITIONS ............................. 43
6.1. OPERATING CONDITIONS................................................................................. 43 6.2. STORAGE AND TRANSPORTATION ................................................................... 43
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6.3. SAFETY SPECIFICATIONS ................................................................................. 43 6.4. CARE AND MAINTENANCE ............................................................................... 43
7. TROUBLESHOOTING .................................................................................... 45
7.1. ERROR CODES ................................................................................................ 45 7.2. OPERATIONAL ISSUES ...................................................................................... 46 7.3. FITTING ISSUES ................................................................................................ 50
8. WARRANTY AND SERVICE ........................................................................ 51
8.1. WARRANTY ...................................................................................................... 51 8.2. CUSTOMER SERVICE ........................................................................................ 52
9. CONTACT ......................................................................................................... 53
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1. Purpose
1.2. Indications for Use The AlterG Bionic Leg Orthosis is designed to provide temporary active external
support and stability assistance for individuals who have impaired lower extremity
function.
The Bionic Leg is a prescriptive Device. It cannot be ordered except by Medical
professionals.
1.3. Contraindications to Use The AlterG Bionic Leg should not be used with individuals with unhealed bone
fractures or at risk of fracture as a consequence of osteoporosis or bone cancer.
Individuals with the following on the intended limb should also not use the Bionic
Leg: open wounds, fragile skin, deep vein thrombosis (DVT), unstable
cardiovascular conditions, incontinence, or those who are on contact precautions for
infection.
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2. Safety Instructions
2.1. Warnings and Cautions IMPORTANT: For your safety, basic precautions should always be followed when
using this device. Read all instructions, especially safety warnings, before using the
device. Save this guide for future use.
SAFETY WARNING
THESE SAFETY PROCEDURES MUST BE FOLLOWED TO AVOID
INJURY
• Use this product only for its intended use and only as described in this
manual.
• Always visually inspect the device (including foot insert, cable, and
connector) for damage before use.
• If there are any signs of damage to the device or accessories, do not use.
• Use the AlterG Bionic Leg only within the range of motion and level of
assistance that is safe for the user’s condition.
• Do not use the Bionic Leg if the user has fragile skin, open lesions, or
blisters in the vicinity of where the device will be placed.
• Footwear must be worn when using the AlterG Bionic Leg. Failure to do
so may affect device performance and/or cause injury to the patient.
• Avoid over-tightening any part of the device around the user’s lower
extremity. This may reduce blood circulation to the limb and potentially
cause swelling, paresthesia (tingling or numbness), tissue death, or other
symptoms.
• Discontinue use of the device if the user experiences irritation, swelling,
pain, or other similar symptoms in the lower extremity wearing the Bionic
Leg.
• Discontinue use of the device if the user has sustained an injury that may
affect their ability to use this product safely.
• Do not use (or discontinue use of) the device if the user experiences any
unusual cardiovascular responses or feels dizzy, lightheaded or nauseated.
• Keep fingers away from all moving components of the AlterG Bionic Leg
orthosis.
• Remove obstructions from the path of the user’s motion.
• The device is not to be turned off while supporting end-user ambulation.
• The device battery is not to be removed while supporting end-user
ambulation.
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• Always use caution and have assistance when the user is training on
stairs. Users should always use a railing or assistive device (cane, walker,
etc.) when using the Bionic Leg on stairs.
• Always follow basic safety precautions when using electrical products to
avoid electric shock, burns, or fire.
• Do not use the Battery Charger or the Power Supply if either appears
damaged or is not working properly.
• The Removable Battery (P/N: 19-00015-00) contains a Lithium Ion power
cell. The Battery must be disposed of (or recycled) in accordance with local
regulations. Do not dispose of the Battery in the trash or fire.
• When using the Battery Charger, attach only the Power Supply that is
provided.
• During charging the Battery Charger may become warm. Place the
Charger in a cool spot, away from external heat sources (such as direct
sunlight, or other electronic devices).
• Keep the Battery Charger’s power cord away from heated surfaces.
• Do not immerse the Battery or Charger in water. Do not expose the
Charger or Power Supply to water or liquids.
• Do not open the Charger or Power Supply case; no user serviceable parts
are inside.
• Always remove the Battery when device is shipped via air or ground
transport.
• Never attempt to open, disassemble, modify, or repair any component of
the AlterG Bionic Leg, including accessories. Contact AlterG Customer
Service for all service related concerns.
• If the AlterG Bionic Leg has a serious malfunction, remove the Battery or
use the Main ON/OFF switch to disconnect power from the device.
Contact AlterG Customer Service immediately.
• If the AlterG Bionic Leg becomes too warm, turn off the device using the
Main ON/OFF switch. Remove device from the user. Contact AlterG
Customer Service immediately.
• If user’s safety is threatened by fire, natural disaster, or other emergency,
DO NOT turn off the device. Use the AlterG Bionic Leg to help escape the
emergency situation calmly. Activation of the ON/OFF switch or Standby
button may result in limited range of motion, posing an additional obstacle
to an evacuation.
ATTENTION
PLEASE FOLLOW THESE INSTRUCTIONS TO AVOID
DAMAGING THE DEVICE
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• Exercise caution and use good clinical judgment when using the Bionic Leg.
• If the Shoe Insert is not fitted properly (e.g. Footpad is wrinkled or folded
under the foot), the device may be unable to gather correct information from
the sensors and therefore may not perform as expected.
• Always store the Shoe Inserts in a place where they can remain flat. While the
Footpad is designed to flex under the user’s foot, avoid bending or folding the
Footpad in order to prevent damaging the embedded sensors.
• It is recommended, but not required, that the Anklet be positioned to cover the
Footpad Cable Connector to provide a barrier and protect the connector from
inadvertent damage during use.
• Handle this product with care. Avoid dropping or hitting the device against
hard surfaces.
• Store the device in its protective case in a clean, dry location.
• Avoid storage locations subject to excessive temperatures or humidity (see
section 6.2).
• Follow the instructions in this manual to clean the device.
• Do not saturate or submerge the AlterG Bionic Leg or its accessories in fluid of
any kind.
• The Bionic Leg generates, uses, and can radiate radio frequency energy and, if
not used in accordance with the manufacturer’s instructions, may cause
harmful interference to other devices in the vicinity. The device has been tested
to – and complies with -- the emission limits of the standard EN60601-1-2.
NOTE
PLEASE FOLLOW THESE RECOMMENDATIONS TO ACHIEVE
THE BEST RESULTS
• The Bionic Leg should be placed over the user’s clothes or suitable protective
barrier. Do not allow the device to directly contact the user’s skin.
• Users should wear appropriate, comfortable and supportive shoes while using
the Bionic Leg. Low profile athletic shoes or walking shoes are best.
• Be sure to firmly tighten the quick release handle after adjustment to maintain
proper alignment of device.
• A comfortable level of tightness –—as tight as possible without constriction –
—should be achieved using the cable reels. If the device is too loose it may
impact the ability of the device to efficiently transfer assistance to the user.
• Continuous activity with the device will cause the cable system to naturally
loosen over time. The cable reels should be frequently checked to maintain a
“comfortable level of tightness”.
• The “Pause” soft key or Home button can be depressed while in
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Active Mode to stop the device and allow for a parameter to be adjusted by
then depressing the “Settings” soft key. To return to the Active Mode press
the Home button and then “Start” soft key.
• The Bionic Leg will always provide the user with free motion when there is no
weight on the foot. If the user wishes to disengage the device, the user should
be assisted to take the weight off the foot by lifting it off the ground.
• The battery charge icon on the Bionic Leg may not be a precise indication of
the remaining charge. Whenever possible, use a fully charged battery for each
therapy session.
At the end of the useful life of the Bionic Leg, please refer to our website for
instructions on proper disposal or return of the product.
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2.2. Device Labeling and Icon Description
TABLE 1: USER MANUAL ICONS
Name Icon Description
SAFETY
WARNING
Warns the user of a potential safety hazard; follow
these instructions to avoid injury or bodily harm.
ATTENTION
Cautions the user of a potential hazard to the product;
follow these instructions to prevent product damage
and maintain proper function.
NOTE
Advises the user of important information regarding
the use of the product for the best results.
TABLE 2: DEVICE LABELS
Name Icon Type/Description
Main Power
(ON)
Switch prevents or interrupts the main power to
the device.
To turn the device on, you must slide the switch
to the ON position.
(OFF)
To disable the power to the device, slide the
switch to the OFF position.
During transport of the device, slide the switch
to the OFF position so that the device cannot be
inadvertently powered on.
Select Keys N/A Oval soft buttons that will select the function
listed on the display screen next to the button.
Home
Large round button that returns the display to
the Home menu screen and stops the device if
pressed while device is operating. If the button
is held and released for greater than 2 seconds
the display will rotate 180°.
Standby/ON
Small round button that turns the device ON or
places it in Standby/ OFF mode. To turn the
device ON, press button once. The device will
automatically start up. Press button and hold for
1-2 seconds to turn the device to Standby/OFF
mode. The device will automatically go from
ON to Standby mode if there has been no
movement or button activity for 30 minutes.
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Name Label Image
Company Name
Product Name Bionic Leg
Product Patent
Information www.alterg.com/patents
Manufacture
Operating
Instructions – Refer
to User Manual
Warning and
Precautions – Refer
to User Manual
Minimum/Maximum
Operating
Temperature
Keep Dry
Electrical and
Electronic Recycling
Required
Non-sterile Device
Product Name
Product
Certification
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TABLE 3: Icon Descriptions
Icon Meaning Description Previous Text
Patient
Weight
Patient Weight lbs. or kg.
Change to/from lbs/kg in
third Information screen.
Patient Wt.
Assist %
Assistance delivered as a
percent of entered body
weight. Turns orange
near limits of assistance
Assistance
Resistance
(1/2/3)
Resistance for stair
descent or stand-to-sit.
Higher numbers give
slower descent.
Resistance
Low/Medium/High
Threshold
Start threshold as
percentage of body
weight on foot sensor in
order for device to
activate
Threshold (%)
Assist
Cutoff
Limit in degrees from
vertical when device will
cease to give assistance.
Increase this to prevent
hyperextension.
Ext. Limit (degree)
Settings
Go to settings screen to
examine/modify the five
settings above. Defaults
restored at power on or
foot sensor change.
Settings
Information
Go to information screens
for AlterG contact
information, serial
numbers, device usage,
and change of weight
units.
Left/right scroll
arrows
Help
Go to help screens for
sequence of images
showing steps of device
donning and setup.
N/A
Start
Start active assistance.
Device activates with
weight on foot sensor
above threshold with
knee angle change.
Auto
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Pause
Stop active assistance and
return to the home
(paused) screen The
home button performs the
same function.
(Press home button)
Done
Finish update of settings.
The home button
performs the same
function.
(Press Auto or Home)
Next Screen Advance to the next
settings or help screen. N/A
Previous
Screen
Go to the preceding help
screen. N/A
Device
Usage or
Session
Steps
Shows a number with the
number of repetitions or
steps. Session reps
shown while paused or
active.
Device Usage: Steps
Auto Mode:
Reps/Steps
Device
Usage
Hours
Total device hours while
in active mode. Shown on
information screen along
with total repetitions.
Device Usage: Hours
Home,
Pause,
Invert
screen
Return to home (paused)
screen. If button is held
down for several seconds,
the screen flips around.
If settings have never
been examined or
changed since defaults
were restored, the home
button goes to the
initialize screen.
(Home button)
Full Battery Battery fully charged Full Battery
Partial
Battery
Battery partially charged;
the battery has
approximately 50%
charge remaining
Partial Battery
Empty
Battery
Battery empty; the
battery should be
removed and recharged
Empty Battery
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2.2.1.1. Quick Start Label
The “Quick Start Instructions” label provides quick instructions on programing and
putting the Bionic Leg on.
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2.3. Audio Notifications The Bionic Leg provides audio notifications to the user when attention may be
required on the device or when an action has completed. The different conditions
are described below:
TABLE 4: AUDIO NOTIFICATIONS
Name Description
Power On Complete initialization is indicated by a series of two
beeps
Error Single beep or series of beeps (every 5 seconds) that
persists until it is cleared on the display
Warning Notice Single beep that will clear itself
Low Battery
(< 30 % charge) Series of beeps (every 10 seconds)
Very Low Battery
(< 20% charge) Series of beeps (every 4 seconds)
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3. Product Description and Function
3.1. Product Description The AlterG Bionic Leg is a non-invasive, dynamic, wearable lower extremity orthosis that is
battery-powered and portable. It acts to supplement existing muscle strength, provide sensory
inputs (i.e. auditory and sensory feedback) and mobility assistance for users with impaired
lower-extremity function during rehabilitation. The range of motion and amount of assistance
delivered by the Bionic Leg is customizable through the device settings. These parameters
are determined by the clinician.
The Bionic Leg is fitted and worn in a manner similar to an
orthopedic knee brace. The device couples two main
assemblies: a drive system and an exoskeleton.
An actuator in the internal mechanism of the Bionic Leg’s
drive system provides assistance and resistance felt by the user
during knee movement, as well as the sounds that provide
feedback. The exoskeleton is a dynamic orthosis, specifically
designed to provide support in response to weight shifts and
knee movement, as well as external support to the lower
extremity.
The Bionic Leg uses sensors, microprocessor technology and
customized software to automatically detect a user’s actions,
such as walking or climbing stairs, and allows the device to respond as needed. There are
sensors in the Shoe Insert that detect when weight is on and shifting through the foot, sending
a signal to the microprocessor. When the device detects motion at the knee hinge, the system
will then determine the required amount of assistance and activate the Bionic Leg. The user
will feel a support when extending the knee and a resistance when flexing the knee while
weight bearing. The amount of assistive/resistive support (called “Assistance” and
“Resistance” ) offered by the device will be determined by the clinician depending on the
user’s needs. In addition to the support perceived by the user, audible sounds will be heard
from the Bionic Leg as it moves forward and backward. The sounds are distinguishable and
can be used as feedback mechanisms for identifying proper movement sequences; that is,
performing knee swing into extension versus flexion and moving with a smooth, desirable
rate.
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3.2. Product Overview
3.2.1. Basic Components
3.2.1.1. Bionic Leg Orthosis
• Rigid exoskeleton lower limb
orthosis
• Drive system and housing
• Battery (removable)
• Textiles (thigh, knee, calf)
• Cable and reel system
• Finger shield
• User interface
3.2.1.2. Shoe Insert
• Foot sensor (sizes: XS, S, M, L)
• Medial and lateral stays
• Footpad Cable Connector
• Anklet
3.2.1.4. Portable Case
3.2.1.5. Removable Battery System
• Battery
• Battery Charger
3.2.2. Accessories
• Additional Rechargeable
Batteries
• Additional Shoe Inserts
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3.3. User Interface
3.3.1. Components
a. Main ON/OFF power switch
b. Input selection buttons
c. Display screen
d. Home button
e. Standby button
3.3.2. Display Screen
The information displayed on the display screen
changes based on what is selected, and what
stage of set up or review you are in.
3.3.2.1. Orientation of the Display Screen
Upon initial power-up from factory default settings, the
information on the display screen is oriented so that the setting
can be easily read. The display may be rotated 180 degrees by
pressing and holding the Home button on the user interface for
approximately 2 seconds. Upon releasing the button, the
displayed information will be rotated 180 degrees. The
information will remain in this orientation until the Home
button is pressed again for 2 seconds. When the device is
restored to defaults or main power disconnected, the orientation
will revert to the default setting.
a
b
c
d
e
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3.4. Shoe Insert The Shoe Insert consists of the Sensors, Footpad, Footpad Cable Connector, and
medial and lateral ankle pads. Each Footpad is dedicated to either the right or left
foot and comes in four different sizes (S, M, L, XL).
Embedded in the Footpad are force sensors that are located in the heel and forefoot
areas.
3.5. Device Orthosis The Bionic Leg orthosis consists of a dynamic exoskeleton, drive system, textiles,
adjustment cables with tightening reels, a finger shield and a cable to the Shoe
Insert. The orthosis extends from the thigh to the ankle of the user’s lower
extremity. Textiles are wrapped around the user’s thigh, knee and lower leg. These
textiles are then secured around the leg with the cable and reel fitting system. This
mechanism provides circumferential tactile snugness around the user’s lower
extremity. Lastly, the distal portion of the exoskeleton connects and stabilizes the
orthosis, near the ankle.
3.5.1. Exoskeleton
This is the rigid portion of the orthosis, which adds
strength and stability to the device.
3.5.2. Drive System
The drive system is the powerhouse of the device. It is
located under the plastic housing and comprises the
mechanisms that allow the Bionic Leg to provide
mobility assistance and audible feedback to the user.
Connector
Footpad
Sensors
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3.5.3. Textiles
The device has three distinct sections of cloth textiles, located
at the thigh, knee and lower leg. These textiles secure the
orthosis to the user’s lower extremity by wrapping around the
limb and being attached by Velcro. They are to be put on from
bottom to top (lower leg, knee, upper leg) according to the
Quick Start Guide
3.5.4. Cable and Reel System
The cable and reel system fine-tunes the
circumferential snugness of the textiles around the
user’s limb. The rotation of the reels adjusts the
tightness of the textiles.
SAFETY WARNING
Users should not open the drive system housing; access to this area
is restricted to AlterG Customer Service.
3.5.5. Finger Shield
SAFETY WARNING
AlterG Bionic Leg to be operated only with housing and finger
shields in place.
Keep all fingers and appendages away from moving components of
the AlterG Bionic Leg exoskeleton.
A finger shield is provided for safety; however, always keep fingers and appendages
away from the knee hinge joint and all other moving components of the orthosis
when the device is in use.
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For Illustration Only—
keep fingers away from the locations shown.
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3.6. Operating Mode Active Mode uses information from the sensors in the device to automatically
detect the user’s actions (walking, sit to stand, climbing stairs, etc.) and deliver
assistance or resistance as needed. The device will provide assistance when the
user puts sufficient weight on their foot to initiate movement; the device will then
adjust its action based on the user’s further movements.
The device can be customized to accommodate a user’s specific needs through
parameter settings described under Section 3.7.
Table 5 below, Clinical Activities, summarizes what to expect from the device
during the functional activity listed. This is not an all-inclusive list of mobility
training tasks that may be performed with the device.
TABLE 5: CLINICAL ACTIVITIES
Activity What to Expect
Sit to Stand
Once the user places sufficient weight on to the Footpad Sensors the
device will enter the “Ready” state. As the user begins to stand from a
seated position, knee angle sensors will detect the intention and the
device will respond by providing assistance with extension. The user
will feel assistance when rising.
Stand to Sit
Once the user places sufficient weight onto the Footpad Sensors the
device will enter the “Ready” state. As the user begins to transfer
from standing to sitting, the knee angle sensors will detect the
movement and the device will respond by providing assistance to
flexion. The user will feel the device “brake,” which will slow down
the user’s movement onto the seat.
Walking
Stance Phase: Once the user plants their foot on the ground and
shifts sufficient weight on to leg, the user will feel assistance to reach
full extension. The device helps the user maintain a stable extended
knee position of the involved limb in stance.
Swing Phase: At toe-off the device allows the leg to swing freely
during knee flexion. During flexion, the user may hear the motors run
in preparation for the next step, but the device does not provide active
flexion assistance. As the user swings the device leg forward, they
will experience free motion in the knee.
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Ascending
Stairs
Stepping up with the device (weak) leg: The user lifts their foot up
on the step in front of them, and shifts their weight up and forward.
The user will experience assistance with knee extension from the
device, as needed.
Stepping up with the non-device (strong) leg: The user lifts the
strong leg up on the step in front of them; the device will provide
passive assistance with maintaining knee extension and stability of
the device (weak) leg.
The user will then alternate stepping to the same or next level step.
Descending
Stairs
Stepping down using the device (weak) leg: The device leg is
securely positioned in full extension on the step. The user lifts,
swings, and lowers the non-device foot down to the step below.
During this movement, the device knee will begin to bend and the
device will resist the flexion. This action allows the patient to control
knee flexion movement and gently lower the non-device foot down
on to the step.
Stepping down with the non-device (strong) leg: Once the non-
device leg is securely placed and extended on the lower step, the user
can lift, swing, and lower the device leg to the same or next-level
step. During this movement, the non-device knee will be in control of
the descent and the device knee will be free to bend and straighten as
the user moves it down to the next step. Once the device foot is
securely placed on the step and weight is shifted over, the device may
provide extension assistance if the knee is not fully extended based on
the parameter settings. Thus, the user will experience assistance to
extension of device knee.
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3.7. Configurable Operating Parameters The Bionic Leg utilizes a set of configurable parameters, allowing customizable
performance of the device to meet the needs of individual users. These parameters
are accessible through the User Interface and are summarized in Table 6A below.
There are five parameters that can be set by the clinician: Weight ,
Threshold , Assistance , Resistance and Assist Cutoff .
TABLE 6A: CONFIGURABLE OPERATING PARAMETERS
Parameter Symbol Description Range Default
User Weight User body weight
110 to 300
lbs (50 to
135kgs)
110 lbs (50 kgs)
Threshold
Percentage of single-
limb body weight that
must be on the foot
before assistance will
be provided.
5 to 95% 30%
Assistance
Factor
Amount of assistance
(in % single-limb body
weight) provided for
knee extension.
10 to 90%* 45%
Resistance
Factor
Amount of resistance
provided during knee
flexion activities (stair
descent, sitting).
Low-Med-
High Med
Assist Cutoff
Degrees from full
extension to which the
device will provide
assistance.
0º to 120º 6º
* Assistance is a non-linear value and diminishes with heavier patients. During set-up this
is noted when the Assistance value turns orange and patients may require additional
assistance from the therapist to complete a task or prevent a possible fall.
SAFETY WARNING
The Bionic Leg provides limited assistance for heavier patients. When the
combination of Patient Weight and requested assistance exceeds
this limit, the displayed Assistance Percentage value turns orange. When you
see an orange value, the actual assistance delivered to the patient is less than
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the percentage shown and extra caution should be taken to assure that the
patient is always properly supported.
Threshold is the percentage of overall body weight that is necessary through the
user’s foot to activate the device in a “ready” state before it will provide assistance.
Typically, in normal stance half of body weight (50%) is distributed in each leg. By
setting the Threshold with a lower value, the device activates with less weight
through the foot (i.e., it is more sensitive to small weight shifts.) By setting this
value higher, the device requires more weight to be shifted to the foot by the user
before it assists the user. The higher the percentage, the more difficult it may
become for the user to use the device properly. This setting can be adjusted at any
time and may need to be modified during different mobility activities depending on
the needs of the user.
Assistance factor is an approximate percentage measurement that refers to the
amount of support the device provides to the user to help with extension of the
lower extremity. This parameter has the most impact during standing up or going up
stairs. Typically a higher value will provide more assistance for users who need
more to accomplish a task.
Resistance factor refers to the support provided during descent (flexion moment)
that a user will experience during such tasks as sitting down or descending stairs.
The High setting can be used to perform eccentric strength training or when poor
control is present with knee flexion. The Low setting can allow the user to train in a
normalized knee flexion movement pattern.
Assist Cutoff sets the range of motion through which the device is active. . The
actual value set is the minimum angle of extension by the device. For example, if
the limit is set to 10° (which is equivalent to -10° extension), any extension of the
knee beyond 10° (e.g., 5°) would not be assisted by the device. The device does not
provide a hard stop to this angle.
All parameters are returned to the default values whenever the unit is powered on or
when the foot sensor is disconnected.
Disconnecting the foot sensor while paused also unlocks the device to allow it to be
fully flexed. Disconnecting the foot sensor before powering down allows the
device to be easily stored in the case.
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4. Instructions for Use
4.1. Donning Instructions
4.1.1. User Guidelines
TABLE 7:USER SIZE GENERAL GUIDELINES
Measurement Measurement Details Recommended Range
Weight N/A 110 – 300 lbs
(50kg – 135 kg)
Height N/A 5’0” to 6’0”
(152 cm to 183 cm)
4.1.2. Positioning
Ideally, the user should be positioned in a comfortable
seated position with the target knee in a flexed position.
4.1.3. Fitting and Applying the Shoe Insert
It is recommended that the user always wear comfortable,
supportive shoes with wide footing while using the Bionic
Leg. Boots and high-top shoes will interfere with the
attachment of the exoskeleton to the shoe insert stay and
therefore cannot be worn with the device.
Each Shoe Insert can be used on the right or left foot
interchangeably, by flipping it over, and comes in four
sizes. See Table 8 for a conversion chart for shoe insert
sizing.
TABLE 8: SHOE INSERT SIZING
Shoe Insert Size Women’s Shoe Size Men’s Shoe Size
XS US Size: 4 to 6½
EU Size: 35 to 37 N/A
S US Size: 7 to 9
EU Size: 38 to 40 cm
US Size: 6 to 8
EU Size: 39 to 41 cm
M US Size: 9½ to 11
EU Size: 41 to 42 cm
US Size: 8½ to 10½
EU Size: 42 to 43 cm
L US Size12
EU Size: 43 cm
US Size:11 to 16
EU Size: 44 to 49 cm
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Once proper size has been identified, slip the Shoe Insert into the patient’s shoe.
Make sure that the Footpad is sitting flush with the shoe insole. If the user has a
custom orthotic that is interfering with the proper placement of the Shoe Insert, it
may be removed during training if the patient can adequately maintain proper foot
position in stance.
Similarly, when using an ankle-foot orthosis (AFO), the Shoe Insert should be
placed in the shoe first, followed by the foot wearing the AFO. The outer portion
of the Velcro stays must be exposed for attachment to the lower stays of the
orthosis.
After the Shoe Insert is in position, the user’s foot can
be placed into the shoe.
Adjust the of the ankle wings so they are aligned with
the malleoli. Visually verify alignment. Additional
padding may be placed around a lean leg/ankle for
comfort.
The outer portion of the Velcro stays must be exposed
for attachment to the lower stays of the orthosis. The
user’s clothing must be positioned on the inside of the
anklet.
SAFETY WARNING
Footwear must be worn when using the AlterG Bionic Leg. Failure
to do so may affect device performance and/or cause injury to the
patient.
ATTENTION
• If the Footpad is not fitted properly (e.g., Footpad is wrinkled or folded under
the foot or too long), the device may be unable to gather correct information
from the sensors and therefore, may not perform as expected.
• Always store the Footpad in a place where it can remain flat. While the
Footpad is designed to flex under the user’s foot, avoid bending or folding the
Footpad in order to prevent damaging the embedded sensors.
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NOTE
• Users should wear appropriate, comfortable and supportive shoes while using
the Bionic Leg, e.g., low profile athletic shoes or walking shoes.
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4.1.4. Device Preparation
The most efficient manner to fit the Bionic Leg is to start with making adjustments
to the exoskeleton in order to prepare the device prior to fitting it to the user.
• Open all three textile segments from the device by
separating the Velcro patches and opening the
textile straps.
• Open all cable reel knobs. Pulling out the knob and
verifying that a red marker is visible on the “neck”
of the knob. Additionally, a snap sound should be
heard when pulling out or pushing in the knob.
Check to make sure that the cables can be pulled
smoothly through the mechanisms and that none of
the cables/patches have been twisted.
4.1.5. Textile Fitting
• Have the user sit near the edge of the seat to allow
access to the entire thigh.
• Place the housing portion of the device on the
user’s thigh, as proximal to the groin as possible,
and align the orthosis hinges around the knee
axis.
• Insert the Footpad Cable located on the distal end
of the orthosis into the mating connector attached
to the Shoe Insert.
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• Snugly wrap the Lower Leg Textile around the
calf and attach the corresponding Velcro sections
to one another. Verify that the lower leg portion
of the device is aligned properly and attached to
the Velcro on the Foot Insert ankle wings. Verify
that the user’s ankle can be dorsiflexed without
interference from the textiles.
• Wrap the Knee Textile around the back of the
knee, as snug as possible, and attach Velcro.
• Next, snugly wrap the Upper Leg Textile around
the thigh and attach the corresponding Velcro
sections to one another.
• While wrapping the textiles, make sure that the knee maintains its position in
the orthosis and remains centered.
• Confirm that the device housing is placed centrally on the user’s leg. Adjust the
device if necessary.
Knee is centered and anterior in brace
Clearance and coverage at ankle
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4.1.6. Cable and Reel System Fitting
A snug fit of the textiles is necessary for effective support from the Bionic Leg to
the user’s leg. For optimum performance, it is important to tension the cable
systems securely; excessive tightening (constriction) should be avoided.
• Verify that the Bionic Leg did not rotate on the thigh during the above process;
if rotated, realign the device. Once properly aligned, tighten the device first at
the lower leg followed by the thigh region.
• Secure the textiles around the calf by pushing IN (a snap should be heard) on
the lowest reel knob, and turning clockwise. This will apply tension to the
cable system and secure the textiles around the lower leg. Tighten the cable
system until it is as tight as comfortably possible.
• Next secure the textiles around the thigh by pushing IN on the upper-most and
middle reel knobs
• Verify the user’s comfort level. Excessive constriction should be avoided.
SAFETY WARNING
Do not use the device if the user has fragile skin, open wounds, sores or
blisters in the vicinity of where the device will be placed.
Avoid over-tightening any part of the device around the leg. This may
reduce blood circulation to the limb and potentially cause swelling,
paresthesia (tingling or numbing), blood clots, or other symptoms.
For users with impaired sensation of the lower extremity, caution should
be taken during the tightening process. This is accomplished by
inserting fingers between the textile and user’s limb to assess cable
tension and potential for discomfort.
Avoid direct skin contact with the cables. Cable guides, in addition to
guidance Velcro patches on the posterior of the textile, should be
adjusted to prevent cable-skin contact.
Verify that the cable reel knobs do not rub against the opposite thigh.
Usage should be discontinued if irritation occurs on the opposite leg.
Placing a neoprene sleeve or wrapping on the opposite thigh with elastic
wrap may mitigate the rubbing effect.
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NOTE
• The Bionic Leg is to be placed over the user’s clothes or suitable protective
barrier. Do not allow the device to come into direct contact with the user’s
skin.
• A comfortable level of tightness, as secure as possible without over
constriction, should be achieved using the cable reels. If the device is too loose
it may impact the ability of the device to efficiently transfer assistance force.
• Continuous activity with the Bionic Leg will cause the cable system to loosen.
Thus, the cable reels should be intermittently tightened during extended use.
4.2. Removal Instructions To remove the Bionic Leg, have the user sit with the device still in Active Mode.
Press the Home Button to change the device state to Standby (Home screen will
appear) before fully removing the device. The device does not need to be powered
off before removal.
To remove the Bionic Leg:
• Disconnect the Footpad Cable Connector at the ankle.
• Release all four cable reels by pulling OUT on the knobs (a snapping sound
should be heard). The textiles will loosen around the leg.
• Release all Velcro attachments. Separate lower leg orthosis and ankle
wings.
• Lift device off the leg and place it in a safe location.
• Remove the user’s shoe and remove the Shoe Insert.
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4.3. Set-Up Instructions Note: At least ten walking steps must be the performed for the device to
calibrate to the user’s movements.
Once the device has been fitted to the user, it is ready to be configured. Turn the
device on as instructed above. The device will initialize and the Home menu screen
will appear. The function of the four select buttons will activate the action labeled
in the corresponding corner of the display screen. The functions will change
according to the commands shown on the screen.
• From the Home screen press Settings using the
lower left soft key. The “Settings” menu allows the
clinician to set the five parameters for the user.
• NOTE: If no other parameters need to be set, press
the “Home” button at any time to return to the Home
menu screen.
Weight
• When the Settings menu is selected, Weight
will display automatically with the current weight
setting.
• To modify, use the +10 and -10 increment buttons
(or +5 and -5 if set to kilograms) to enter the user’s
weight.
• When finished entering the Weight value, press
the top right soft key .
•
Threshold
• Use the +5 and -5 increment soft keys to enter the
desired value.
• When finished entering the Threshold value, press
the top right soft key .
Assistance
• Use the +5 and -5 increment soft keys to enter the
desired value.
• When finished entering the Assistance value,
press the top right soft key . If the assistance limit
is reached, then the value will turn orange.
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Resistance
• Use the + and - soft keys to select the desired value.
• When finished entering the Resistance setting,
press the top right soft key .
Assist Cutoff
• Use the +2 and -2 increment soft keys to enter the
desired value.
• When finished entering the Assist Cutoff , press
the top right soft key to examine all settings.
Then press or the home button to return to
the Home screen.
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4.4. Clinical Application
4.4.1. Operating Mode: Active Assistance Mode
To verify the settings of the device, perform the following:
• Select the Settings soft key. Review each
parameter by using the top arrows to scroll through
parameters. To return to the main screen, press the
Home button
• To adjust a parameter during a session, press the Pause
soft key or Home button to exit Active
Mode. Press the Settings soft key to begin
modifying the settings. To return to the active state,
press the Home button and Start soft key .
• To exit Active Mode, press the Pause soft key or
Home button
• To activate the device from the Home screen, select
Start . The device will then immediately enter
Active Mode, and the screen will display the
cumulative number of Reps/Steps taken with the
device. This value is reset to zero each time Active
mode is entered.
• The Reps/Steps counter records the movements
performed by a user while wearing the Bionic Leg
when Active Mode is activated.
• A “Step” is when the user shifts approximately 10-
15% of their body weight on to the device’s Footpad.
This value is independent of the entered Threshold
value.
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• A “Rep” occurs when the sensors detect 10 to 15% of
the entered body weight and the knee angle of the
exoskeleton moves past 45 degrees for a combined
extension and flexion of the knee joint. Thus, when a
user moves from sitting to standing to sitting from a
standard height chair, the device Reps/Steps counter
will increase by one.
• Pressing the Home button at this point will stop the
device and return the display to the Home screen.
At the beginning of each session, place the device in Active Mode and direct the
user to stand and sit in order to become familiar with the device. Instruct the user to
walk with the device.
SAFETY WARNING
Read and understand the User’s Manual for the Bionic Leg before using this
device.
Use the Bionic Leg only within the range of motion and level of assistance that
is safe for the user’s condition.
Always use caution and remain in close proximity to the user when training
and when used on stairs. Instruct users to use a railing or supportive aid when
using the Bionic Leg on stairs.
Discontinue use of the Bionic Leg if the user experiences irritation, swelling,
blistering, pain, or similar symptoms from wearing the Bionic Leg.
Discontinue use of the device if the user has sustained an injury that affects
their ability to use this product safely.
Use the main power switch to turn off the device if you suspect the device could
be overheating. Use the Standby power button to stop the device if it is
operating in a way that inflicts pain or may cause harm. Remove the Bionic
Leg immediately and contact AlterG Customer Service.
ATTENTION
Exercise caution and use good clinical judgment when using the Bionic
Leg.
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NOTE
• Users should not perform high-impact activities such as running or jumping
activities while wearing the Bionic Leg.
• Closely monitor the user when walking on non-level surfaces, over obstacles,
gravel, sand, or rocks while wearing the Bionic Leg.
• The Settings soft key can be depressed while in Active Mode to stop the
device and allow for the settings to be adjusted. To return to Active Mode press
the Home button and then the Start soft key .
4.5. Additional Interface Features In the top menu there are several screens that provide additional information.
Information screens include the AlterG customer service phone number, the device
identifier, serial number and the software firmware version. Additionally,
interactive screens include Service Mode and Expert Menu. Use the top soft keys
above the directional arrows to scroll through each screen. These screens are
described below.
4.5.1. Customer Service Information
The information on these screens should be provided to AlterG Customer Service if
issues arise with the device.
4.5.2. Restore Default Settings
The entire set of default settings will be restored at any time the device is powered
back on or when the foot sensor is disconnected
The default settings follow the “Mod” description on the Quick Start Guide,
including the following parameters:
Weight: 110 lbs.
Assistance: 45%
Resistance: 2 (Med)
Threshold: 25%
Assist Cutoff: 6°
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4.5.3 Select Weight Units
This screen sets the device to display either Pounds or Kilograms. To select the unit
press the soft key under either KG (kilograms) or LB (pounds.)
4.5.4 Device Usage
This screen displays the cumulative number of Usage Hours and Reps/Steps taken
with the device. The Usage Hours feature records the time the device is in Active
Mode. These values can only be cleared by AlterG Customer Support.
4.5.5 Expert and Calibration Menus
These screens are for AlterG Customer Service use only. They are used for device
maintenance and are password protected. Users should not attempt to access or
change any settings via these screens.
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5. Removable Battery and Battery Charger
5.1. Battery Type The AlterG Bionic Leg uses a removable, rechargeable
Lithium Ion battery as its power source. Only AlterG
Lithium Ion Batteries (P/N: 19-00015-00) should be used
with Bionic Leg. Batteries can only be charged in the
AlterG Battery Charger.
5.2. Battery Capacity The amount of time that the Bionic Leg will operate with a fully charged battery
will vary depending on the activities performed and the size and weight of the user.
The battery will drain faster when used during high intensity and high repetition
activities (i.e., higher functioning users walking quickly on a treadmill). Users
should pay attention to the battery status icon on the Display Screen to know
battery levels and when to replace the battery. It is recommended that a fully
charged battery be used with each new session.
5.3. Specifications, Environmental and Safety
TABLE 9: SPECIFICATION AND OPERATIONAL ENVIRONMENTS
Specification Value
Rated Nominal Voltage 11.1V
Battery Capacity (typical) 1,500 mAh
Environmental Factor Range
Operating Temperature -22° to 40°C (-4°to 104°F)
Storage Temperature < 35°C (95°F) – do not store in direct sunlight
5.3.1. Battery Disposal
Check your local ordinances regarding disposal of Lithium Ion batteries before
disposal. Alternatively, the battery may be returned to AlterG for recycling.
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5.4. Changing the Battery To change the battery, do the following:
• Locate battery latch on housing of device.
• Gently lift the latch to remove the current battery. As the latch moves the
battery will slide upward.
• Grasp the battery and slowly remove it from the housing.
• Insert the new battery with the connector facing inward. Align the battery with
the receiving hooks on the latch.
• Once aligned, gently push the latch down to secure the battery. If latch does not
easily close, verify that the battery is positioned properly on hooks of latch.
The latch will close only if the battery is properly positioned.
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5.5. Battery Charger Use only approved AlterG Battery Chargers (115014) when charging your batteries.
The Cord and Power Supply connect to the back of the Battery Charger.
TABLE 10: CHARGER POWER SUPPLY VOLTAGE
Specification Value
Rated Power Supply Output DC Voltage and
Current
24.0 VDC; 3.75A
Rated Power Supply Input AC Voltage and
Frequency
100-240 VAC; 47-63Hz
Individual Charging Receptacle
DC Voltage and Current
12.4-12.6 VDC; 1.5 A [max]
5.6. Charging the Battery A green LED will illuminate when a battery is placed in a battery receptacle. If the
battery is not fully charged, the green LED will continually flash green until it’s
fully charged. It may take up to 45 min to fully charge a battery. Batteries can be
left in charger for storage. The Battery Charger LED Symbols outlined in Table 11
show the possible status of each receptacle.
5.7. Battery Labeling
TABLE 11: BATTERY CHARGER LED SYMBOLS
Specification Value State Description
Fully Charged
Solid Battery is fully charged.
Charging
Flashing Battery is charging
When the charging light continues to flash after several hours, it indicates that the
battery is near the end of its service life. Batteries that cannot be fully charged may
not provide full-length therapy sessions and should be replaced. Contact AlterG
service to obtain a replacement.
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TABLE 12: BATTERY AND CHARGER LABELING
Label Location
Applied to Battery
Applied to Battery
Charger
SAFETY WARNING
Always follow safety precautions when using electrical products in order to
avoid electric shock, burns, or fire.
Do not use the Battery Charger or the Power Supply if either appears
damaged or is not working properly.
The Battery (P/N: 19-00015-00) contains Lithium. The Battery must be
disposed of or recycled in accordance with local regulations. Do not expose the
Battery to fire.
The Battery Charger may only be used with the AlterG Power Supply
(115014).
The Battery Charger may become warm during charging. Always keep the
Battery Charger in a cool area, away from external heat sources and direct
sunlight.
Keep the Battery Charger and Power Supply away from external heat sources.
Do not immerse the Battery, Battery Charger, or Power Supply in water or
expose to liquids.
Always remove the Battery from the Bionic Leg when the device is shipped.
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Do not open the Battery Charger or Power Supply case.
NOTE
• The charge icon on the Bionic Leg is not a precise indicator of the remaining
charge. Whenever possible use a fully charged battery for each therapy session.
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6. Environmental and Safety Conditions
6.1. Operating Conditions The Bionic Leg can be operated under the following conditions:
TABLE 13: OPERATING CONDITIONS
Operating Temperature 10°C to 40°C (50°F to 104°F)
Humidity 30% to 75% RH, non-condensing
6.2. Storage and Transportation The AlterG Bionic Leg must be stored and transported in the following conditions:
TABLE 14: STORAGE/TRANSPORT CONDITIONS
Temperature -20°C to 55°C (-4°F to 131°F)
Humidity 10% to 85% RH, non-condensing
The device should be protected against shock and vibration during transportation.
Contact AlterG for shipping container.
6.3. Safety Specifications The AlterG Bionic Leg is TUV certified by TUV Rheinland for
compliance to the standards:
IEC 60601-1:1988 + A1:1991 + A2:1995; CAN/CSA-C22.2 No.
601.1-M90; and UL 60601-1:2003 R4.06.
6.4. Care and Maintenance
6.4.1 Maintenance
The Bionic Leg is designed so that no periodic adjustment or calibration is required.
However, a routine visual inspection of the device should be conducted monthly to
confirm the textile attachment screws are present and not loose or tearing the
textile. If any of these conditions are present, contact Customer Service (510) 270-
5369.
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6.4.2 Cleaning Instructions
The external surface of the Bionic Leg,
removable battery and Shoe Inserts can be
cleaned with a germicidal disinfectant wipe.
During cleaning no liquid or cleaning cloth
should be placed in the slots near the battery
terminals. None of the components should be
saturated or immersed in liquid. The device
should be cleaned on a regular basis.
SAFETY WARNING
Never shower or expose the Bionic Leg to running water or
submerge in water.
Never attempt to open, dissemble, modify, or repair any component
of the AlterG Bionic Leg, including the accessories. Contact AlterG
Customer Service for all service concerns.
If the device has a malfunction, remove the external battery or use
the main ON/OFF switch to disconnect power from the battery and
contact AlterG Customer Service.
If the device becomes too warm, turn off the device using the main
ON/OFF switch. Remove device from the user and contact AlterG
Customer Service.
ATTENTION
• Handle this product with care. Avoid dropping or hitting the device against
hard surfaces.
• Store the device in its protective case in a clean, dry, cool location.
• Avoid storage locations subject to excessive temperatures or humidity.
• Follow the instructions in this manual to clean the device.
• Do not saturate or submerge the AlterG Bionic Leg and its accessories in
liquid of any kind.
• The Bionic Leg generates, and can radiate radio frequency energy. If not
used in accordance with the manufacturer’s instructions it may cause harmful
interference to other devices in the vicinity. The device has been tested and
complies with the emission standards EN60601-1-2.
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7. Troubleshooting
7.1. Error Codes When device errors occur an Error Code will appear on the display screen. Error
codes will momentarily display but will not interfere with operation. Some errors
will require user interface to clear. Others will be permanent and require user to
contact AlterG Customer Service for repair.
TABLE 15: Errors and Warnings
Icon Meaning Error
Number Description
Low Battery 6x
Low battery warning or error. If
encountered while running, the
device continues to operate until the
battery is very low.
Foot Sensor
Unplugged 400
The foot sensor was unplugged
when the run button was activated.
Foot Sensor
Error 36x
The foot sensor is bad or was
unplugged while in Active Mode.
Force Limit 26x, 38x
Internal force or torque warning.
Too much force was applied to the
device. Usually encountered when
the patient rapidly sits down with all
weight on device. This warning is
displayed for 8 seconds, the device
beeps, then automatically resets
itself. The device continues to be
active the whole time.
!
!
!
!
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Other Errors
7x. 8x,
22x
9x, 13x,
17x, 24x
10x, 14x.
15x, 20x,
27x,
210x, 25x
16x, 23x,
25x
18x, 19x
Mechanical error
Electronics error
Motor error
Initialization or calibration error
Software or factory configuration
error
7.2. Operational Issues
TABLE 16: OPERATIONAL ISSUES
Situation Parameter Relevance Resolution
Device
prematurely
activates (Occurs
primarily in sitting
or on the stairs or
when device is first
placed into Active
Mode.)
Threshold
The Threshold has
been set too low.
The amount of
weight being
applied on the foot
sensor(s) is too
great, causing the
device to extend
before the user is
prepared.
Un-weight foot to remove
pressure. Press Home
button to deactivate
Active Mode. Raise the
Threshold parameter until
issue is resolved.
Device
Calibration
The device may
need to recalibrate
to the new settings.
More repetitions are
needed to interpret
the information
from the sensors in
the Footpad.
Have the user perform 5 -
10 steps (walking) with the
device.
Device appears to
be delayed, slow or
sluggish
Threshold
The Threshold has
been set too high.
The user is not able
to apply the proper
amount of weight to
activate device.
Lower by 5%. If still
unresolved, verify that the
Footpad is operating
properly.
!
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TABLE 16: OPERATIONAL ISSUES
Situation Parameter Relevance Resolution
Assist % or
Resist Level
The Assistance is
set too low and/or
Resistance is set too
high for user’s
ability.
Increase Assistance and/or
decrease Resistance
setting. Note: Some user’s
may not be successful if
setting > 60-70%.
Battery
Power
Level
The battery charge
level is too low. An
audible tone will be
heard when the
battery level drops
significantly.
Replace battery with a
fully charged battery. If
error continues to occur
verify battery is charged
and attempt different
battery. If a charged
battery does not clear the
error, contact AlterG
Customer Service
Device is not
operating as
expected. Either
activating too soon,
too late or
intermittently
during the mobility
task.
Calibration
The device needs to
calibrate to the new
settings.
Have the user take 10
steps. If still unresolved
check foot sensors (see
below).
Foot
Sensor
The Shoe Insert
needs replacement.
The device is not
receiving consistent
and/ or appropriate
information from
sensors.
After session, check
sensors on Footpad.
Connect suspected
Footpad to device and
activate Active Mode.
Gently press each sensor
one at a time. When the
sensors are pressed the
device should activate. If
no or reduced activation
occurs, then the Footpad
has failed and the Shoe
Insert should be replaced.
Threshold
The value is either
set too high or low.
The user is not able
to apply the proper
amount of weight to
activate device at
the proper time.
Adjust the Threshold to
allow for proper activation
to occur.
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TABLE 16: OPERATIONAL ISSUES
Situation Parameter Relevance Resolution
AFO use or
Tone/
Spasticity
Interference may
occur with weight
bearing in foot and
the user is not able
to shift or apply the
proper amount of
weight to activate
the device at proper
time.
Adjust Threshold and user
weight parameters to see if
corrections can be made. If
not, it may be necessary to
remove AFO or modify
intervention to allow for
improved user control.
Device provides
insufficient knee
extension during
use.
Assist
Cutoff
Assist Cutoff angle
is set too high and
the device is not
providing enough
assistance to fully
extend the user’s
knee.
Increase the Assist Cutoff
angle range (e.g. change
from 10 degrees to 5
degrees).
Note: It is possible for the user to override this motion by stopping their movement and
actively bending their knee. The device will stop assisting knee extension and allow knee
flexion.
Device is
intermittently
activating in static
and dynamic
standing and
cannot be
controlled by user.
Assist
Cutoff
Assist Cutoff is set
beyond the user’s
controllable end
range. The user is
shifting weight off
of the foot sensors.
Decrease the Assist Cutoff
(e.g. change limit from 5
degrees to 10 degrees).
Have user shift weight
over foot and attempt to
fully straighten limb until
device is quiet.
Note: This fluttering may be a desired effect to provide audible and tactile input to user in
static and dynamic stance activities.
Device is not
providing
sufficient
assistance to user
during extension
activities.
User’s
Weight
The value has been
set too low.
Insufficient power is
being provided to
assist with knee
extension
Check to make sure that
accurate body weight has
been entered.
Assist %
The Assist
parameter is set too
low. Device is not
providing enough
assistance to the
user.
Increase Assist parameter
by 10% increments up to
90%.
AlterG Bionic Leg User Manual
116569 Rev B Page 49 of 53
TABLE 16: OPERATIONAL ISSUES
Situation Parameter Relevance Resolution
User is being
thrust into
extension
Adjust % or
User
Weight
Setting
Assist % or weight
is set too high.
Check to make sure that
accurate body weight has
been entered. Decrease
Assist by 10% increments.
Assist
Cutoff
Assist Cutoff is set
too high.
Decrease range of Assist
Cutoff (e.g. from 5 to 10
degrees).
Knee won’t flex in
swing phase
Foot sensor
The device remains
engaged in
extension, possibly
due to bend in the
Footpad or bad
sensor
Check to ensure Footpad is
lying flat in shoe with no
bends and/or tears. Try
another pad. If problem is
unresolved contact AlterG
Customer Service.
Power/
Active
Assist
Mode
Possible complete
power failure, error
or inadvertent shut
off of Active Mode.
If device is off power up
using the Standby power
button.
Clear any errors if
appropriate. Attempt to
access Active Mode again.
If unable to correct,
contact Customer Service.
Device does not
turn ON when
Standby power
button is pressed.
Main Power
Switch
Main power switch
may have been
turned to OFF
which disables the
device.
Check main power button,
move switch to icon with
dot within circle position.
Press Standby button,
device should turn ON.
Battery
Power
Battery power may
be too low to turn
on device.
Replace battery with fully
charged battery. If error
continues to occur verify
battery is charged, attempt
different battery and if still
unresolved contact AlterG
Customer Service.
AlterG Bionic Leg User Manual
116569 Rev B Page 50 of 53
7.3. Fitting Issues
TABLE 17: FITTING ISSUES
Situation Parameter Relevance Resolution
Device rotates
on user’s leg
during
operation.
Cable Reel
System
The cables have not
been tightened
adequately to
prevent rotation.
Tighten cables.
Lower leg and
ankle stays
The exoskeleton has
not been aligned
properly with ankle
Stays.
Realign each Stay at ankle.
Be sure to have the Stays
posterior to the ankle.
User complains
of discomfort.
Cable Reel
System
Cables may be too
tight.
Release knobs and re-adjust
cable tightness.
Additionally, one may need
to “smooth” the user’s skin
that could be pinched when
cables are tightened.
Tibial Plate
(lower leg
plate)
The tibial plate
length may be too
long or too short.
Adjust length of plate.
Device slides
down user’s leg
during
operation.
Textiles
The textiles have not
been wrapped
snuggly around
limb. Lower leg
Textile/ Exoskeleton
may not be properly
aligned at ankle (too
short and not
overlapping ankle
stays.)
Rewrap textiles snuggly
around limb. Lengthen
lower leg textile to ensure
adequate overlap of stays at
ankle. Make sure Velcro at
ankle stays is accessible and
sufficiently covered by
lower leg exoskeleton stays.
If absolutely necessary,
apply elastic wrap around
ankle stays to minimize
“bowing” effect.
Orthosis
The thigh portion of
exoskeleton was not
placed high enough
on limb. Poor
alignment at knee
axis.
Keep upward pressure on
hub portion of exoskeleton.
May ask user for assistance.
Check position on thigh;
align parallel to floor to
prevent slippage during
fitting.
Tibial Plate
(lower leg
plate)
The tibial plate has
not been lengthened
fully.
Lengthen plate.
Cable Reel
System
The cables have not
been tightened
adequately to
prevent slipping.
Tighten cables until device
is secure (i.e. cable tension
similar to a guitar string)
AlterG Bionic Leg User Manual
116569 Rev B Page 51 of 53
8. Warranty and Service
8.1. Warranty AlterG warrants that, for a period of one (1) year from the date of initial shipment
to Buyer and under normal and intended use and service, the Products shall be free
from defects in material and workmanship and shall substantially conform to any
specifications therefore agreed to in writing by AlterG or, if no such specifications
exist, the specifications then generally provided by AlterG to the public in its
Product literature. In no event does AlterG warrant that any software included in or
with the Products is error free. Excluded from this limited warranty are expendable
components, parts and supply items, including, without limitation, textiles and shoe
inserts. Buyer’s exclusive remedy and the entire liability of AlterG under this
limited warranty is for AlterG, at its option, to replace or repair the defective
Product or component thereof (in which case AlterG shall pay shipping charges
back to Buyer) or to issue a credit or refund to Buyer for the purchase price of the
Product (without interest). All Products or components replaced by AlterG shall
become the property of AlterG.
AlterG’s obligations under this limited warranty are subject to the satisfaction of all
of the following conditions: (i) AlterG is promptly notified in writing by Buyer of
such warranty claim during the warranty period, (ii) such warranty claim did not
arise as a result of misuse, abuse, accident, use of unauthorized accessories, impact
of faulty electrical power or other external causes, improper storage, transportation
or handling, reasonable wear and tear, or repair or alteration by anyone other than
as authorized by AlterG, (iii) Buyer complies with the return provisions of Section
6 above, and (iv) the serial number on the Product was not removed or altered. Any
replacement Product shall be warranted for the remainder of the original warranty
period or thirty (30) days, whichever is longer. AlterG shall in no event be
responsible for any labor or other costs incurred by Buyer incident to the
replacement of any defective Product. The limited warranty set forth above shall
extend to Buyer only and not to any third party. No person is authorized to make
any warranty or representation on behalf of AlterG concerning the Products other
than the limited warranty set forth above.
DISCLAIMER: OTHER THAN THE LIMITED WARRANTY SET FORTH
ABOVE, TO THE MAXIMUM EXTENT PERMITTED BY LAW, ALTERG
SPECIFICALLY DISCLAIMS ANY AND ALL EXPRESS, IMPLIED OR
STATUTORY WARRANTIES, INCLUDING THE IMPLIED WARRANTIES OF
FITNESS FOR A PARTICULAR PURPOSE, OF MERCHANTABILITY AND
AGAINST INFRINGEMENT.
AlterG Bionic Leg User Manual
116569 Rev B Page 52 of 53
8.2. Customer Service When a device problem occurs that is unresolved in the field and it becomes
necessary to return the device for servicing, follow the procedures below:
• Contact Customer Service at 1-510-270-5369 for technical product support.
• If problem cannot be resolved over the phone, Customer Service will send a
replacement unit or provide instructions for return of the Bionic Leg for
service.
• Do Not return the device without contacting Customer Service first. No devices
will be accepted that do not have a Return Material Authorization (RMA)
number attached.
• AlterG will replace, at no charge, consumable components (i.e. shoe inserts,
rechargeable batteries) with less than 60 days of ownership. If greater than 60
days, replacement items are available for purchase through Customer Service.
• If the Bionic Leg or the case for the Bionic Leg appears damaged upon receipt,
please contact Customer Service.
AlterG Bionic Leg User Manual
116569 Rev B Page 53 of 53
9. Contact
European Authorized Representative
Obelis s.a.
Bd. Général Wahis 53
B-1030 Brussels, Belgium
Phone: 32.2.732.59.54
Fax: 32.2.732.60.03
E-mail: [email protected]
AlterG, Inc.
48438 Milmont Dr.
Fremont, CA 94538
www.alterg.com
Office: 1-510-270-5900
Support: US: +1.510.270.5369
UK: +44 (0)7733 179187
Fax: 1-510-225-9399
E-mail: [email protected]