Ossur PROPRIO FOOT User manual

Instructions for use / Patient EN

.................................................................
Safety Precautions..................................................
Introduction............................................................
Technical Specifications.........................................
Basic Operation......................................................
Functions................................................................
Maintentance.........................................................
Warranty..................................................................
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5
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12
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4
C D
2x
2x
Hold
Hold 3x
3x
Hold
Hold
E
1x
1x
1x
1x - 1x- 1x
Press
2x
Press
G
1x
3x
1x - 3x
Hold
5x
Press
F
5x
H
1x
1x
Hold
Press
A B
7x
Function
Power NO/OFF
Set heel height 2x
5x
7x
Set relax mode
Sound NO/OFF
Hold Press
Move to neutral/relax
Manual motor movement
Set heel height 2x
Function Press
Power ON/OFF
Hold
Sound ON/OFF
4x
6x
7x
Move to neutral/relax
Manual motor movement
Set heel height 2x
Function Press
Power ON/OFF
Hold
Sound ON/OFF
4x
6x
7x
Move to neutral/relax
Manual motor movement
Set heel height 2x
Function Press
Power ON/OFF
Hold
Sound ON/OFF
4x
6x
7x
Move to neutral/relax
Manual motor movement
Set heel height 2x
Function Press
Power ON/OFF
Hold
Sound ON/OFF
4x
6x
7x
Move to neutral/relax
Manual motor movement
Set heel height 2x
Function Press
Power ON/OFF
Hold
Sound ON/OFF
4x
6x
7x
Move to neutral/relax
Manual motor movement
Set heel height 2x
Function Press
Power ON/OFF
Hold
Sound ON/OFF
4x
6x
7x
Move to neutral/relax
Manual motor movement
Set heel height 2x
Function Press
Power ON/OFF
Hold
Sound ON/OFF
4x
6x
7x
2x BEEP Approx 120 min left
3x BEEP Approx 60 min left
4x BEEP Approx 30 min left
5x BEEP Foot will return to neutral prepare
for immediate power loss
IndicatesWarning

5
SAFETY PRECAUTIONS
• Whenthebatterychargeislow,PROPRIOFOOT®will return to the last preset heel height position.
A warning signal will occur (Figure B).
• WhenmakingadjustmentstoPROPRIOFOOT®ensure the user is seated or in a stable standing position.
• Theusershouldstopwalkingimmediatelyifalarmsignalsarefeltorheard.Proceedtowalkwithcaution.
• DonotusePROPRIOFOOT®while the battery is charging. Be sure to disconnect it from the charger prior to
putting on the prosthesis.
• Whenthepowerisotheanklepositionmightchangeresultinginmisalignment.
• ImproperhandlingoradjustmentofPROPRIOFOOT®may cause malfunction that may subject the user to
the risk of falling.
• High-impactactivityandsports,excessiveloading,andheavy-dutyuseshouldbeavoided.
• Avoidimpacttothebattery.
• Ensurethatthebatterycabledoesnotinterferewiththeactuatormotion.Interferencebetweenthebattery
cable and the actuator can cause damage and interruption of function.
* Do not use power supplies other than those provided with the device.
* Ensure that the Flex-Foot sock, shoe or any external load does not interfere with the actuator motion,
since this can cause restriction of the ankle motion.
• Lithium-ionbatteriescontainhazardousmetalsandshouldneverbedisposedofinresidentialorcommercial
garbage. They should never be incinerated because they may explode.
• Fieldserviceshouldbeperformedattherecommendedintervals(see chapter Service). This will prevent
malfunction or failure. Not following the instructions invalidates the warranty.
• Avoidspillageorimmersioninwater(oranyotheruids),useinhighlyelectricaland/ormagnetic
(i.e. electrical transformers, high-power radio/TV transmitters) and dirty environments.
• Avoidexposuretoextremeheatand/orcold(see chapter Technical Specifications).
• Avoidexposuretointensedust,smokeormechanicalvibrations.
• Donotuseiftheproductenclosureorcoversarebroken.
• Donottamperwiththekeypad.
• DisablePROPRIOFOOT®when driving a vehicle (see chapter Power OFF).
• Steepinclinesordeclines(above20°)maytriggerthestairresponseresultinginunexpectedfootalignment.
• PROPRIOFOOT®detects walking on uneven or level ground, walking on inclines and declines, climbing
stairs and riding a bike. Non-identified movements may cause unexpected ankle alignments.
• Notsuitableforuseinthepresenceofammableanestheticmixturewithairoxygenornitrousoxide.
• Protectthefootandbatterypackagainstwaterorrain,andensurethatnowaterentersthebatterycharge
plug.
• Batteryperformancemaybeaectedbyveryloworveryhightemperaturesthatmaycauseinconsistencyin
battery warnings.

EN - Caution: Össur products and components are designed and tested to ISO 10328. Compatibility and compli-
ance with this standard is achieved only when Össur products and components are used with other recommend-
ed Össur or authorized components. If un-usual movement or product wear is detected in a structural part of a
prosthesis at any time, the patient should be instructed to immediately discontinue use of the device and consult
his/her clinical specialist. This product has been designed and tested based on single patient usage. This device
should NOT be used by multiple patients. If any problems occur with the use of this product, immediately con-
tact your medical professional.

6
Level-Ground Calibration
Auditory feedback signal "BEEP"
Vibration feedback signal.
Keypad: Lower button
CALIBRATION
Keypad: Upper button
INTRODUCTION
PROPRIO FOOT®from Össur is a Bionic foot and ankle system that is designed to facilitate walking on level
ground and a variety of surfaces less stressful during activities of daily living.
FUNCTIONS
PROPRIO FOOT®adapts ankle position during swing phase as the user ascends or descends ramps and stairs
making ambulation on these alternative surfaces easier, less stressful and more secure for the user.
PROPRIO FOOT®isalsodesignedtodorsi-exduringswingphaseoflevel-groundwalkingtoimprovetoe
clearance for less stressful and more secure walking. When seated, PROPRIO FOOT®willplantarexforamore
natural appearance of the artificial leg. PROPRIO FOOT®isadjustabletoavarietyofheelheightstotdierent
types of shoes (i.e. tennis shoes, boots, and formal shoes).
PROPRIO FOOT®hastheabilitytoplantar-exwhenkneelingandalsowhenlyingdown.
INDICATIONS FOR USE
PROPRIO FOOT®is to be used exclusively for transtibial amputees engaging in low to moderate impact
activities. It is not suitable for sport and high-impact activities like sprinting, jumping, free climbing, competitive
athletic sports, etc. Suitable environmental conditions are described in the technical specifications.
PROPRIO FOOT®is suitable for continuous use.
ABBREVIATIONS

7
TECHNICAL SPECIFICATIONS
SAFETY STANDARDS AND CLASSIFICATION
PROPRIO FOOT®is tested and certified compliant with the IEC/EN60601-1, standard of electrical safety of
medical devices and IEC/EN60601-1-2, electromagnetic compatibility for medical electrical devices and
ISO 10328. The company fulfills the requirements of ISO13485, MDD 93/42/EEC, and the PROPRIO FOOT®
carries the CE mark accordingly. It is in compliance with UL60601-1, CAN/CSA C22.2 No.601.1 - M90, US and
Canadian Standards for medicaltechnical and electrical products.
The device has type B applied parts.
AUTHORIZED REPRESENTATIVE
ÖSSUR HF.
Grjothals 5
110 Reykjavik
Iceland
[phone]
PHYSICAL PROPERTIES
Weight limit: 125kg (275lbs)
•Frameconstruction: Aluminum
•Netweight:  1220g(2.7lbs),(size26,cat.6)
BATTERY
Rechargeable lithium-ion battery (1800 mAh)
Output Voltage: 14,8 V
Charging time 3-4 hours at 90% discharge.
!Consult the accompanying documents.
CE label with Notified Body indentification number
Must be disposed of or recycled properly
Connection for DC power supply
Connection for battery extension cable to PROPRIO FOOT®
Manufacturer
Date of manufacture
Consult Instructions for use
Meets IEC type B leakage current requirements
SYMBOLS
DC in
DC out

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Fully charged battery is sucient for 24-48 hours of use, dependent on activity.
POWER SUPPLY
An external power supply for medical use (Class 1)
Input voltage: 100-240 VAC
Input current: 600 mA
Input frequency: 50-60 Hz
Output current: 1.0 A
Input connector: IEC 320 AC
Output connector: Female 2,1x5,5x9,5
Output voltage: 24VDC
ENVIRONMENTAL
Operating temperature: -10°C to 40°C (14ºF to 104ºF)
Operating humidity: 0% -90%
Shipping and storage humidity: 0%-90%
Shipping and storage temperature: -40ºC to 70ºC (-40ºF to 158ºF
BASIC OPERATION
POWER ON (Figure C)
• ToturnonthePROPRIOFOOT,holdandpress (both buttons) for at least one second.
* The system confirms with two beeps and vibrations.
* LED will blinks green and yellow
NOTE: The keypad will be disabled after 60 sec from use. To enable the keypad, hold and press at least
one second. When the PROPRIO FOOT®is activated for the first time, the default manufacturer settings will be
enabled. Your prosthetist may alter the settings to adjust the response.
POWER OFF (Figure D )
• Toenablethekeypad,holdandpress for at least one second.
• TopowerOFFholdandpress (both buttons) for at least one second.
NOTE: Pay attention to the button audible feedback.
* The system confirms with three beeps and three vibrations.
 *TheLEDsturno.
NOTE: The keypad will be disabled after 60 sec from use. To enable the keypad, press the upper and lower
buttons at the same time.
HEEL HEIGHT ADJUSTMENT (Figure E+F)
The PROPRIO FOOT®can be adjusted for variable heel height. The heel height adjustment ensures correct
alignment of the prosthesis which is essential for proper Terrain Logic™ function.
Heelheightadjustmentontheoor
• Wearsuitablefootwearandensurefreeanklemotion.
• WithpowerONandtheprosthesisstandingonalevelsurface,initiateheelheightadjustmentbyholding
down the upper button and pressing the lower button twice .
NOTE: Pay attention to the audible feedback.
* The system confirms with a beep and vibration.
• Heelheightadjustmentwillstart.

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* The system beeps and vibrates a second time.
• Theactuatorwillmovetheprosthesisintoaverticalposition.
* The system confirms with a beep and vibration.
* The LED blinks green and yellow.
• Heelheightadjustmentiscomplete.
NOTE: If the heel height exceeds 50 mm (2“) a signal will be heard and the unit will not adjust to the heel height.
Change shoes for lower heel height and repeat the adjustment. Ensure free ankle motion.
Heel height adjustment when wearing the prosthesis.
If shoes are changed then the heel height may be adjusted while the user is wearing the prosthesis.
Advise the user to follow the instructions:
• Takeaseatandensuretheprosthesisispositionedat(heelandforefootarea)ontheground.
• EnsurepowerisONandthekeypadisenabled(Figure C).
• Toinitiateheelheightadjustment,holddowntheupperbutton and press the lower button twice.
* The system confirms with a beep and vibration
• Heelheightadjustmentwillstart.
* The system beeps and vibrates a second time.
• Immediately lift the prosthesis from the ground to allow for ankle adaptation!
• Theactuatorwillmovetheprosthesisintoaverticalposition.
* The system confirms with a beep and vibration.
* The LED blinks green and yellow.
• Heelheightadjustmentiscomplete.
FUNCTIONS
LEVEL GROUND WALKING
• PROPRIOFOOT®is enabled.
• Duringlevel-groundwalkingatmoderatespeedPROPRIOFOOT®will raise the toe to provide more ground
clearance.
• Thisisaresultoftheanklemotion.
• Thiswillreducetheriskofstumblingandimprovethegaitsymmetry.
• Whentheunitisturnedon,thismotionwillbeactiveduringeachstep.
• Youmayfeelenhancedshockabsorptionastheheelstrikestheground.Thisisaresultoftheanklemotion.
NOTE:Circumductionoranyabnormalmovementtothesidemayhindertheinitiationofdorsiexioninswing.
ASCENDING STAIRS
• Duringstairascent,PROPRIOFOOT®will raise the toe of the prosthetic foot.
* This will facilitate stair ambulation and improve gait symmetry.

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• Leadingwiththeprostheticsideupstairsandleadingwiththeprostheticsidewhengoingdownwillprovide
stair adaptation after the second prosthetic step on the stairs.
• Whennishingthestairascentandsteppingontolevelground,itwilltakeonestrideforPROPRIOFOOT®
to adapt to the level ground position. You may also shift weight from sound limb to prosthetic limb to have
the foot return to neutral.
• Ifyoufeelunduesocketpressurewiththestairresponsepleaseconsultyourprosthetist,whomayalterthe
stair response to decrease this socket pressure.
DESCENDING STAIRS
• Duringstairdescent,PROPRIOFOOT®will raise the toe of the prosthetic foot.
* This will facilitate stair ambulation and improve gait symmetry.
• Whendescendingstairs,itisimportanttounderstandthatthetoeoftheprostheticfootwillberaised.Be
prepared to PLACE THE ENTIRE FOOT ON THE STEP. This makes the descent much more stable when
compared to using non-microprocessor controlled foot systems.
• Leadingwiththeprostheticsideupstairsandleadingwiththeprostheticsidewhengoingdownwillprovide
stair adaptation after the second prosthetic step on the stairs.
• ThedorsiexedpositionallowsyoutopositionPROPRIOFOOT®completely into the step. There is no need
to place the foot on the edge of the stair case.
• Whenreachingthebottomofthesteps,itwilltakeonestrideforPROPRIOFOOT®to adapt to the neutral
level ground. You may also shift weight from sound limb to prosthetic limb to have the foot return to neutral.
• Ifyoufeelunduesocketpressurewiththestairresponse,pleaseconsultyourprosthetist,whomayalterthe
stair response.
INCLINES
• Oninclines,PROPRIOFOOT®gradually raises the toe of the prosthetic foot to the degree of the slope.
• Duringtheswingphase,PROPRIOFOOT®will raise the toe to provide additional ground clearance,
* This will facilitate ramp ambulation, by reducing socket pressure and strain on ligaments, and lowers the
risk of stumbling.
• Itisnotnecessarytoleadwithaparticularlimbwhenascendingslopes.
DECLINES
• Ondeclines,PROPRIOFOOT®lowers the toe of the prosthetic foot.
* This helps to increase safety and gives better support during roll over of the prosthetic side.
RELAX MODE/CHAIR EXIT MODE FIGURE G
RELAXMODEallowstheankletomoveintofullplantarexionthatwillprovideimprovedbodysymmetrytothe
natural limb when sitting.
RELAX MODE is OFF by default.
• ToenableRELAXMODEholddown and press five times.
* The system confirms with two beeps and vibrations.
• TodisableRELAXMODEandenableChairExitModeONLY,holddown and press five times.
* The system confirms with three beeps and vibrations.
• TodisableRELAXMODEanddisableCHAIREXITMODEholddown and press five times.
* The system confirms with a single beep and vibration.

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• InitiateRELAXMODEinasittingpositionbyextendingthekneeforatleast2seconds.
* This provides a more natural ankle position when sitting with the lower leg extended.
Following the Relax Mode the PROPRIO FOOT®will move into CHAIR EXIT MODE.
To initate this use one of the following methods:
1) Tap the heel of the foot.
2) Flex the knee and place the foot beneath the chair. Lift the foot to allow the adjustment to take place.
Theanklewillmovetodorsiexionthatwillenabletheusertobringthelegfurtherback,providingmore
controlled transition from sitting to standing. The ankle will move back to neutral after the first step.
Tapping on the heel will move PROPRIO FOOT®to the next mode, i.e. tapping the heel when in RELAX MODE
will move PROPRIO FOOT®direct into CHAIR EXIT MODE. A second tap on the heel will move PROPRIO
FOOT®further to neutral ready for walking.
If you feel uncomfortable with the RELAX MODE/CHAIR EXIT MODE please consult your prosthetist, who may
alter the response to your comfort.
SOUND ON/OFF (Figure H)
To enable or disable the auditory feedback hold down the lower button and press down the upper button
seven times.
* The system confirms with a beep and vibration when enabled.
• Thereisnoconrmationwhentheaudiblefeedbackisdisabled.
DRIVING (Figure D)
Caution should be taken with respect to use of PROPRIO FOOT®inside of a motor vehicle. Inadvertent
movement of the ankle may interfere with automobile control functions of brake and/or accelerator. It is best to
follow the recommendations below regarding use of the foot in a motor vehicle.
• Whenpreparingtodrive,turnthefooto(see chapter Power OFF).
OTHER ACTIVITIES
• Whenclimbingladders,adaptationwilloccurasifyouareusingthedevicewhileascendingastair.Itis
generally best to lead with the prosthesis. This method allows for a more stable starting position and faster
adaptation to the ladder.
• WhenkneelingPROPRIOFOOT®will enter RELAX MODE. The knee and shin will be allowed to rest in a less
stressfulpositionwithlessexcessivekneeexion.
ERROR CONDITION:
If for any reason, PROPRIO FOOT®indicates an error
– it is confirmed by a beep and vibration
– the LED will blink red; the system returns to neutral position and acts like a standard prosthesis without
ankle motion. To activate the system again proceed as indicated in chapter Maintenance.
CHARGING AND POWER
• Onlyusethepowersource,suppliedforthePROPRIOFOOT®.
• ConnectthepowersupplycabletoDC.
• Connectthepowersourcetothebatterypack.Allow3-4hourstoensureafullcharge.
Battery Charge – The LED lights indicate the charge state of PROPRIO FOOT®.

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• Pressthecontrolbuttontocheckthecharginglevel.Whenthebatteryisfullycharged,allLEDlightswillturn
green.
Guidelines Regarding Lithium-ion Battery:
• Avoidfrequentfulldischarges.Rechargingapartiallychargedlithium-ionbatterydoesnotcauseharm.
Recharging daily is the most ecient routine.
POWER SUPPLY:
Only use the charger supplied.
ATTENTION: Do not charge when prosthesis is being worn!
NOTE: The yellow LED light on the PROPRIO FOOT®will blink when charging. The green will be steady.
• Donotstoretheprosthesis/batteryinhotplacesorclosetoheat-emittingdeviceslikeradiators.
WARNING SIGNALS FOR POWER LOSS: (Figure B)
Vibratory and/or auditory warning systems are provided by PROPRIO FOOT®to indicate to the user that power
loss is forthcoming. The warning signals are provided in a series of intermittent pulses. Ensure that the user
recognizes the warnings.
CAUTION: When the PROPRIO FOOT®battery charge is low and the warning pulses for power loss are
delivered, the foot will return to the latest preset heel height position.
Thefootshouldnotbeusedwhenthepoweriso.
MAINTENANCE
SERVICE
PROPRIO FOOT®is designed and manufactured to provide long and troublefree service intervals.
It is warranted against defective materials and workmanship for a period of 24 months. To ensure proper
function, it is recommended that PROPRIO FOOT®is inspected every six months by a qualified professional.
Check for signs of unusual wear.
CLEANING
Follow these instructions:
• RemovePROPRIOFOOT®from the cosmetic cover
• Wipethefootwithasoftclothmoistenedwithasmallamountofisopropanolalcohol.
• Removedebrisordustwithouttheuseofcompressedair.
NOTE: Do not dip the whole foot or pour solvent over the foot. The bearings and seals will be damaged.
Do NOT use compressed air to clean the foot. Air will force pollutants into the bearings which may cause
malfunctions and early deterioration.
WARRANTY
Össur provides a warranty of 24 months on PROPRIO FOOT®.
See Terms of Warranty for details.

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