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BionX BiOM T2 Ankle Instructions For Use Manual

Manual is about: Personal Bionics Device

Summary of BiOM T2 Ankle

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    Instructions for use biom ® t2 ankle.

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    2.

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    Introducti on 7 indications for use 8 safety precautions 9 product overview 11 powering on/off 14 setup 15 alignment 15 attach foot module 17 remove foot module 18 hardstop cover 19 tuning 20 connect to the ankle 20 troubleshoot connection 21 tune the ankle 22 troubleshoot tuning 28 battery and char...

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    5 customer service • e-mail: service@bionxmed.Com • phone: +1 855.889.2466 the biom t2 (ankle) is designed and tested to iso 10328. Compatibility and compliance with this standard is achieved only when the ankle is used with other components tested to iso 10328 that conform to the european directive...

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    7 the ankle is a personal bionics device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. The ankle employs a bionic muscle-tendon unit that normalizes self-selected walking speed and metabolism while walking on level-ground across a walki...

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    8 indications for use the ankle is intended to replace a missing foot and ankle. The ankle is to be used exclusively for fittings of lower extremity amputations as prescribed by a physician. The ankle does not work for everyone and individual results may vary. The most common complications are compl...

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    9 a trained healthcare professional must provide each user with training for appropriate use of the ankle. Carefully review all instructions for proper use of the ankle and follow safety precautions, as failure to do so can lead to the risk of fall, injury to the user and/ or the malfunction of the ...

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    10 everyday considerations • make user aware of the low level audible sounds that the ankle makes during power delivery. • it is recommended that the ankle is used with the supplied foot cover. • prior to donning, inspect the visible parts of the ankle and battery for wires that are frayed, pinched,...

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    11 safety standards and classifications the ankle is internally powered with classification ip24. The ankle is tested and compliant with the iec/en60601-1, standard of electrical safety for medical devices and iec/en60601-1-2, electromagnetic compatibility for medical electrical devices and iso 1032...

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    12 ankle specifications weight of the ankle with battery, foot module and foot cover: 5.1 lbs (2.3 kg) minimum clearance: 8 5/8” plantarflexion range of motion: 24° degrees dorsiflexion range of motion: 0°-10° foot module flexion battery specifications battery type: rechargable lithium-ion battery b...

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    13 indicators visual • the power light indicator is a light on the front of the ankle that blinks green when the ankle is on. • when the ankle is off, the light is off. Tactile • when battery power is low the ankle will vibrate once for 3 seconds. • when battery power is very low the ankle will vibr...

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    14 powering on/off press the power switch on the battery holster to the on position to activate the ankle. The power light indicator, on the front of the ankle should be illuminated. With the hardstop cover near but not in contact with the ankle housing, listen for a single, high pitched beep to con...

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    15 alignment initial alignment - transtibial 1. Establish neutral position • ensure ankle housing is in contact with the hardstop cover. • if the heel height of the shoe is greater than 3/8” (9.5mm), extend the pylon to achieve a neutral position. 2. Adjust battery holster to avoid interference with...

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    16 setup initial alignment - transfemoral 1. For transfemoral applications, please reference the knee manufacturer’s recommended alignment. 2. Follow relevant instructions from initial alignment - transtibial. When using the ankle in combination with a prosthetic knee at maximum flexion, ensure ther...

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    17 attach foot module (if necessary) before installing the foot module, determine if a foot shim is necessary by turning the ankle over and looking at the bottom of the foot structure. If “no shim” is printed proceed to step 2 “install foot module”. If there is no inscription on the foot structure f...

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    18 remove foot module (if necessary) 1. Remove foot cover • pull the heel on the foot cover out and down to release. Remove it from the interior ridge at the base of the foot cover and remove it from the foot module. • remove the spectra sock from the foot module. 2. Remove screws • remove and disca...

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    19 hardstop cover (if necessary) the hardstop cover prevents socks or pants from inadvertently being caught in the hardstop. This ensures that the ankle function is not compromised. Attaching the hardstop cover 1. Snap the hook of the hardstop cover over the top edge of the encoder cap. 2. With the ...

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    20 connect to the ankle 1. Start the personal bionics tuning application by selecting the blue-colored biom icon on the desktop screen. 2. Reset the password at your preference. To continue without changing the password, enter the default password ‘1234’ and select ‘go’. 3. Select the ankle from the...

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    21 troubleshoot connection if the personal bionics tuning application cannot communicate with the ankle: 1. Make sure the ankle is powered on. 2. Make sure bluetooth is enabled on the personal bionics tuning application. 3. Make sure ankle is paired with the personal bionics tuning device, see pairi...

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    22 tune the ankle basic tuning settings parameter description default resistance at heelstrike use to adjust resistance of plantarflexion at heel strike. 0% self-selected power use to adjust power at self-selected speed, before fine-tuning power for fast and slow speed. Adjusts both power bars toget...

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    23 step 1 - setup the ankle enter the patient’s weight by selecting the value on the screen and typing in the weight. To lower the keyboard, select the down/back button on the bottom of the screen. To transfer a step count from a previous ankle to this one, select ‘change cumulative mybiom step coun...

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    24 4. Select ‘slow power’ to fine-tune the powered push off at ‘slow power’. 5. To adjust powered push off on stairs and ramps, select ‘fast power’ and adjust as needed. In stair ascent, instruct the user to lead with their non-affected side on the first step. When stepping onto the ankle, the user ...

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    25 attention message - “motor is overheating!” this message will appear if the motor is overheating. Please follow the instructions and lower the power settings if this message appears when the patient is walking on level ground. If not addressed, the battery may drain unusually fast. Attention mess...

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    26 step 3 - battery alert setting 1. Select an alert type or disable low battery alert. 2. Select the alert strength. 3. Select “preview ‘low battery’ alert” to demonstrate the battery warning to the user. Step 4 - save settings select ‘save biom settings to tablet’ to save the settings to the ankle...

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    27 generate an ankle tuning record 1. Touch the arrow to the left of the net work graph to open a drawer that contains: • a record button (• rec) • a button for more information about the net work graph (?) • a button to clear the dots on the graph (x) • bluetooth connection strength • battery charg...

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    28 6. Complete the information for the tuning record by selecting the relevant field line and either selecting from a list of options or typing the information. 7. A pdf file named h2_xxxxxxxx_yyyymmdd hhmmss_tuning (where xxxxxxxxx is the ankle serial number, yyyymmdd is the year, month and day and...

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    29 to maximize the function of the ankle, it is important to walk with gait characteristics of normal human locomotion. Do not use compensatory motions, especially on stair ascent and descent. A full length step will allow the user to obtain maximum performance from the ankle. The table below lists ...

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    30 tuning issue solution/adjustment not enough power during stair ascent • increase fast power and/or increase virtual dorsi/plantarflexion setting (+30% to +50%). Have user walk on a flat surface and increase cadence range until power is normalized on net work graph. User feels unstable during hill...

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    31 battery specifications: battery type: rechargeable lithium-ion battery battery capacity: 30 w-hr which results in 1500-2000 strides per battery depending on user activity and weight. Battery output voltage: 22.2 vdc (nominal) charging time: 45 minutes after normal usage depletion operating temper...

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    32 charger specifications: charger input: 13-30 vdc, 5a max ac power adapter input: 100-240 vac, 50/60hz output: charging current of 2.0 amperes charging temperature: 14°f (-10°c) to 113°f (45°c) charging humidity:20-90% relative humidity, non-condensing. Shipping & storage temperature: -22°f (-30°c...

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    33 charge the battery 1. Connect the power supply’s cord to the charger unit. Connect the power cord directly to an outlet. 2. Remove the battery from the ankle by first turning the ankle off and then pressing the battery release button and lift the battery out. 3. Align the battery connector with t...

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    34 battery management the ankle is powered by a state-of-the-art lithium-ion battery. The batteries have been tested to last 1 million steps and still maintain 80% of their original capacity. Users typically get 3 to 6 hours of battery life a day depending on their usage. To ensure the battery provi...

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    35 this power ‘lock out’ happens automatically if the battery operating limits are exceeded. In this state, the battery will not charge or discharge. Causes for the ‘lock out’ include: • too high of a temperature (110˚f while charging, 150°f while walking). • too low of a temperature (40°f while cha...

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    36 • warning: do not use any other power supply and cord with the charger other than the one supplied with the charger. • warning: do not block the cooling vents on the charger, as this can result in overheating and risk of charger malfunction. • warning: do not expose the battery to prolonged perio...

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    37 troubleshoot battery and charger issue solution battery does not fit properly inside the charger • with the charger unplugged, remove any debris in the charger holster, or the connector. • examine connectors in the charger holster and on the battery for damage. Charger rattles when shaken, indica...

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    38 issue solution battery does not charge • ensure battery connector is firmly placed in the charger. • verify blue led is illuminated. Follow troubleshooting for no blue led illuminated on charger. • be sure to use the correct battery in the charger. Only batteries with a gray battery release butto...

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    39 service to ensure proper function, it is recommended that the ankle is inspected every six months to check for signs of unusual wear. Refer to the image on page 12 of this manual and visually inspect: • the hardstop cover in the front of the ankle and the internal guard at the back of the ankle j...

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    40 transport • always use the packaging supplied with the ankle for transporting the ankle, when not attached to the socket. • when traveling via air with batteries not in use, individually package and transport them in carry-on luggage. The batteries should not be put in checked luggage. Before tra...

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    41 warranty bionx medical technologies, inc. (“company”) provides the following warranty only to the initial purchaser (“purchaser”) of each new device (as defined below). 1. What does this limited warranty cover? This limited warranty covers any material defects in the following new devices purchas...

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    42 5. Warranty disclaimers. To the maximum extent permitted by law, the company expressly disclaims any implied warranty of merchantability and any implied warranty of fitness for a particular purpose. The device is for walking and everyday use only. Do not use the device for sports or high impact a...

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    43 emc precautions - ankle guidance and manufacturer’s declaration – electromagnetic emissions the ankle is intended for use in the electromagnetic environment specified below. The customer or the user of the ankle should assure that it is used in such an environment. Emissions test compliance elect...

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    44 guidance and manufacturer’s declaration – electromagnetic immunity the ankle is intended for use in the electromagnetic environment specified below. The customer or the user of the ankle should assure that it is used in such an environment. Immunity test iec 60601 test level compliance level elec...

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    45 guidance and manufacturer’s declaration – electromagnetic immunity the ankle is intended for use in the electromagnetic environment specified below. The customer or the user of the ankle should assure that it is used in such an environment. Immunity test iec 60601 test level compliance level elec...

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    46 recommended separation distances between portable and mobile rf communications equipment and the ankle the ankle is intended for use in an electromagnetic environment in which radiated rf disturbances are controlled. The customer or the user of the ankle can help prevent electromagnetic interfere...

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    47 guidance and manufacturer’s declaration – electromagnetic emissions the battery charger is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the battery charger should assure that it is used in such an environment. Emissions test compliance electro...

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    48 guidance and manufacturer’s declaration – electromagnetic immunity the battery charger is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the battery charger should assure that it is used in such an environment. Immunity test iec 60601 test level...

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    49 guidance and manufacturer’s declaration – electromagnetic immunity the battery charger is intended for use in the electromagnetic environment specified below. The customer or the user of the battery charger should assure that it is used in such an environment. Immunity test iec 60601 test level c...

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    50 recommended separation distances between portable and mobile rf communications equipment and the battery charger the battery charger is intended for use in an electromagnetic environment in which radiated rf distur- bances are controlled. The customer or the user of the battery charger can help p...

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    This product, and the use thereof, may be covered by one or more of the following us patents: 5,650,704 and 7,313,463 with additional patents pending. Bionx and biom are trademarks of bionx medical technologies, inc. All other brands may be trademarks of their respective holders. © 2016 bionx medica...