BionX BiOM T2 Ankle Instructions For Use Manual Download Page 1

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Instructions for Use

BiOM

T2 Ankle

Summary of Contents for BiOM T2 Ankle

Page 1: ...Instructions for Use BiOM T2 Ankle...

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Page 3: ...MODULE 18 HARDSTOP COVER 19 TUNING 20 CONNECT TO THE ANKLE 20 TROUBLESHOOT CONNECTION 21 TUNE THE ANKLE 22 TROUBLESHOOT TUNING 28 BATTERY AND CHARGER 31 CHARGE THE BATTERY 33 BATTERY MANAGEMENT 34 BAT...

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Page 5: ...d healthcare professional on the order of a physician The fitting of the Ankle and its accessories to a user must be performed only by trained healthcare professionals who are authorized by BionX Medi...

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Page 7: ...se that emulates the activation of the dorsiflexors In late stance the muscle tendon applies powered plantarflexion that emulates the activation of the calf muscle and Achilles tendon propelling the u...

Page 8: ...oral and the other transtibial FUNCTIONAL LEVEL K3 ability or potential for ambulation with variable cadence K4 ability or potential for prosthetic ambulation that exceeds basic ambulation skills exhi...

Page 9: ...to use a handrail when negotiating ramps or stairs Improper handling or adjustment of the Ankle may cause knee instability which can increase the risk of falls The Ankle is for walking and everyday u...

Page 10: ...is and a dynamic response foot During the initial tuning of the Ankle dynamic alignment of the Ankle must be established with the power OFF which functions the same as when power is lost ENVIRONMENTAL...

Page 11: ...ical electrical devices and ISO 10328 The Ankle carries the CE mark accordingly AUTHORIZED REPRESENTATIVE SYSTEM COMPONENTS AND ACCESSORIES DESCRIPTION Black Edition Ankle 11 03B Silver Edition Ankle...

Page 12: ...amperes ENVIRONMENTAL SPECIFICATIONS FOR ANKLE AND BATTERY OPERATING 32 F 0 C to 113 F 45 C 20 90 relative humidity non condensing SHIPPING STORAGE A fully charged Battery and Ankle can withstand sto...

Page 13: ...t 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 vibrate twice for 3 seconds each Ankle Housing Battery Hinge Battery...

Page 14: ...t with the Ankle Housing listen for a single high pitched beep to confirm ankle calibration If a series of low beeps is heard have the user plantarflex the foot until the single high pitched beep conf...

Page 15: ...E Attach socket to the Integrated Male Pyramid on the Ankle Do not exceed 5 of external rotation of the ankle assembly Reference line should bisect the socket and fall at the junction of the posterior...

Page 16: ...ct by establishing a level pelvis 2 Verify that the foot is flat on the floor 3 Establish that the pylon is vertical in both the sagittal and the coronal planes DYNAMIC ALIGNMENT 1 Keep the Ankle turn...

Page 17: ...tructure 2 INSTALL FOOT MODULE Install the Foot Module by aligning the two holes with the bosses located on the bottom side of the foot structure Ensure the toe end faces forward Secure the Foot Modul...

Page 18: ...screws and accompanying washers that attach the Foot Module to the foot structure 3 REMOVE FOOT MODULE Remove the Foot Module and the foot shim if present from the Ankle 4 CLEAN FOOT STRUCTURE Clean t...

Page 19: ...his 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 hook still in place pull the p...

Page 20: ...he 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 list with the serial numbe...

Page 21: ...Device see PAIRING THE ANKLE WITH PERSONAL BIONICS TUNING APP 4 If still unable to connect unpair and re pair the Ankle with the Personal Bionics Tuning Device see PAIRING ANKLE WITH THE PERSONAL BION...

Page 22: ...ard between self selected and fast walking speeds 44 Slow Power Timing Affects the timing of the powered push off at slow walking speed Increase if powered push off is more up than forward between slo...

Page 23: ...mal tuning the dots will plot near the dashed lines and form a parallel slope 1 With the power parameters set at 0 adjust the Resistance at Heelstrike while at self selected speed This will control th...

Page 24: ...ned to the lowest acceptable level for the user NOTE FOR BILATERAL USERS Tune power on the non dominant side before the dominant side Ensure the patient feels stable while standing All users must be t...

Page 25: ...echanical components can fail By adding motor protection the patient may feel a slight reduction in powered push off THE NET WORK GRAPH The graph shows the BiOM Net Work normalized by the patient weig...

Page 26: ...that the Low Battery Alert will occur once with approximately 400 steps remaining and twice with 150 steps remaining Vibration Strength and Alert Type will be the same for both Low and Very Low Batte...

Page 27: ...he recording 3 Have the user walk on level ground at 3 speeds Slow Self Selected and Fast Power for a minimum of 20 steps each 4 Select stop recording same button as the record button 5 Respond to the...

Page 28: ...s when powered ON Have user unload foot place light pressure on heel power ankle ON and listen for the high pitched beep for calibration confirmation Before adjusting the tuning parameters verify the...

Page 29: ...Virtual Dorsi Plantarflexion setting in Advanced Tools Inconsistent powered push off at slow speed Decrease Slow Power Timing in the Advanced Tools on the Tuning Application Inconsistent power across...

Page 30: ...uch powered push off at slow speed Decrease Slow Power in Step 2 Powered push off felt too late at slow fast speed Decrease Slow Fast Power Timing in Advanced Tools Power pushes wearer up rather than...

Page 31: ...DICATOR A blinking green light visible through the Battery Connector right after removing it from the Charger or Ankle The duration of illumination indicates the level of charge Solid light means full...

Page 32: ...to 113 F 45 C CHARGING HUMIDITY 20 90 relative humidity non condensing SHIPPING STORAGE TEMPERATURE 22 F 30 C to 140 F 60 C SHIPPING STORAGE HUMIDITY 20 90 relative humidity non condensing Do not atte...

Page 33: ...2 Wipe the Charger and Battery clean with isopropyl alcohol 3 After cleaning let the Battery and Charger dry thoroughly before using If there is a red fast blinking light indicator on the charger remo...

Page 34: ...ontrolled dry location out of direct sunlight Avoid leaving the Batteries in a car where temperature extremes can permanently damage the Batteries EXTENDING SHELF LIFE The most common problem people e...

Page 35: ...attery to lock out permanently because charging or discharging could present a safety hazard If a Battery goes into permanent lock mode it is time to replace the Battery ANKLE WILL NOT POWER ON Unplug...

Page 36: ...arger itself or the connectors on the Charger as this will result in a risk of malfunction Always examine the Charger and its connector prior to use and clear away any foreign objects before inserting...

Page 37: ...nking red light on Charger Remove Battery unplug Charger replug Charger and insert Battery If fast blinking red light persists contact Customer Service Red light blinking 3 times on 5 sec interval on...

Page 38: ...arger Be sure to use the correct Battery in the Charger Only batteries with a gray Battery Release Button are compatible with the dual bay Charger Try the alternate bay of the dual bay Charger Contact...

Page 39: ...move the Foot Cover and clean any debris on the inside Use a soft cloth to clean any dirt or debris from the Foot Module and the heel wedge area DO NOT use solvents stronger than isopropyl alcohol DO...

Page 40: ...put in checked luggage Before traveling please check the latest FAA regulations and any airline carrier regulations For damaged or defective Batteries please contact Customer Service for appropriate...

Page 41: ...rranty begins on the date the Device was originally shipped from the Company Warranty Period With respect to any Device Replacement Device which is shipped by the Company in replacement of a returned...

Page 42: ...pany specifically disclaims any express or implied warranty of fitness for use outside of the instructions for use 6 CAP AND OTHER LIMITS ON LIABILITY To the maximum extent permitted by law in no even...

Page 43: ...onment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 2 The Ankle emits electromagnetic energy in order to perform its intended function Nearby electronic e...

Page 44: ...4 2 kV for power supply lines 1kV for input output lines Not applicable Not applicable The Ankle is battery powered Surge IEC 61000 4 5 1 kV line to line 2 kV line to earth Not applicable Not applica...

Page 45: ...gths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment m...

Page 46: ...a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum out...

Page 47: ...Group 1 The Battery Charger uses RF energy only for its internal func tion Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissi...

Page 48: ...kV line to earth 1 kV line to line 2 kV line to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interrupts and voltage variations on power...

Page 49: ...ters as determined by an electromagnetic site surveya should be less than the compli ance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following s...

Page 50: ...er of Transmitter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1...

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Page 52: ...ditional patents pending BionX and BiOM are trademarks of BionX Medical Technologies Inc All other brands may be trademarks of their respective holders 2016 BionX Medical Technologies Inc All rights r...

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BionX BiOM T2 Ankle, Instructions For Use Manual

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