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Instructions for Use

BiOM

T2 Ankle

Содержание BiOM T2 Ankle

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

Страница 2: ...2...

Страница 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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Страница 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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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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Страница 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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