Bionic Leg Orthosis User Manual - AlterG · • The Bionic Leg will always provide the user with...

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]

mailto:[email protected]

http://www.tibion.com/

AlterG Bionic Leg User Manual

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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



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



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.



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.



• 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



• 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



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.



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


• 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


• 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


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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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%.


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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.


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7.3. Fitting Issues TABLE 17: FITTING ISSUES


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)


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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.


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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.


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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]

mailto:[email protected]

http://www.tibion.com/

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