PROPRIO FOOT®

Technical Manual

3

Safety precautions 5

Introduction 7

Technical specifications 7

Setup 8

Basic operation 11

Calibration 13

Functions 14

Advanced operation 15

Maintenance 16

Training tips 17

Warranty 17

Electromagnetic compatibility precautions 17

Category selection chart 20

3

1/3 1/3 1/3

1/2 1/2 1/2 1/2

1/21/2

a b

c

d

e

f

3 4

Keypad Battery

Control button

Warning Indicates

2× beep approx. 120 min left

3× beep approx. 60 min left

4× beep approx. 30 min left

5× beep Foot will return to neutral

Function Hold Press BEEP

Power on/off

2 beeps = on3 beeps = off

Set heel height 2×1× start1× move1× complete

Move to neutral/relax 4× 1× relax

Manual motor movement 6× n/a

Sound on/off 7× 1× on

calibration on/off 9× 1× on/off

Default manufacturer setting: Stair Mode 4º

Stair mode Sequence Hold Press Sound

Stair Mode 4°

3×

2× beep

Stair Mode 6° 3× beep

Stair Mode off 1× beep

Default manufacturer setting: Relax Mode off

Relax Mode Hold Press Sound

Relax Mode off

5×

1× beep

Relax Mode on 2× beep

Chair Exit Mode only 3× beep

g h i

j k

l

m

n

o

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 (see “Charging and power”).

• 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.

• 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 connection cable does not interfere with the actuator motion. Interference between the battery connection wires and the actuator can cause damage to the wires 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.

• Perform field servicing at the recommended intervals, according to the instructions (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 fluids), 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 “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 “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 flammable 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 affected by very low or very high temperatures that may cause inconsistency in battery warnings.

6

ABBREVIATIONS

Keypad:Upper button

Keypad: Lower button

Vibration feedback signal.

Auditory feedback signal "BEEP"

Level-Ground Calibration

SYMBOLS

Consult the accompanying documents.

Consult Instructions for use

Meets IEC type B leakage current requirements

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

INDICATOR

Battery Charge Level

calibRaTion

DC in

DC out

76

INTRODUCTION

FUNCTIONS

• proprio foot® is designed to dorsiflex during swing phase to improve ground clearance, thus enhancing gait symmetry and reducing the likelihood of catching the toe.

• proprio foot® adapts the ankle position as the user walks on inclines, declines and stairs providing a more natural gait, enhancing the user’s ability to under take these activities.

• proprio foot® provides the user with the ability to automatically adjust the ankle position to a range of heel heights, conveniently allowing a choice of shoes.

• proprio foot® will plantarflex for a more natural appearance in sitting.• The proprio foot® assists in standing up from a seated position through an adaptation of its ankle

position.• The proprio foot® has the ability to plantarflex 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. Suitable environmental conditions are described in the technical specifications (see “Technical specifications”). proprio foot® is suitable for continuous use. The proprio foot® may only be fitted by a qualified and trained prosthetist.

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 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 medical-technical and electrical products.The device has type B applied parts.

AUTHORIZED REPRESENTATIVE

össur hf.Grjótháls 5.110 ReykjavikIceland+354 515 1300

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

Charge time 3-4 hours at 90% discharge.

Operating autonomy Fully charged battery is sufficient for 24-48 hours of use, dependent on activity.

8

SYSTEM DIAGRAM (Figure B)

SETUP

PROCEDURAL OVERVIEW

1. Check battery level, charge if required.2. Attach the battery to the diagnostic socket. (See chapter “Diagnostic socket: battery assembly”).3. Power ON (see chapter “Power on”).4. Adjust the Heel Height to the preferred shoe (see chapter “Heel Height Adjustment”).5. Perform bench alignment (see chapter “Bench alignment”).6. Perform dynamic alignment (see chapter “Dynamic alignment and use of heel wedges”).7. Check whether user recognizes vibratory and auditory feedback.8. Perform Calibration (see chapter “Calibration”).

note: do not fit boots or shoes that cover the ankle area! The ankle must be able to move freely over the full range of ankle motion. To ensure proper function do not restrict the motion of the ankle.

DIAGNOSTIC SOCKET: BATTERY ASSEMBLY

The battery pack is designed to fit to the rear aspect of the socket with the thicker portion of the battery in the most proximal position possible. Avoid flexion limitations to the knee.Check the position using the dummy. The position of the battery assembly may vary on individual sockets. Care must be taken to ensure that the battery connection cable does not interfere with the actuator motion.

PoWeR SUPPlY

An external power supply for medical use (Class II)

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 mm

Output voltage 24VDC

Operating temperature 10°C to 40°C (50ºF to 104ºF)

enViRonmenTal

Operating temperature -10°C to 40°C (14ºF to 104ºF)

Operating humidity 0% - 90%RH

Operating Atmospheric pressure 700 - 1060 hPa

Shipping and storage humidity 0% - 90%RH

Shipping and storage temperature -40ºC to 70ºC (-40ºF to 158ºF)

Shipping and storage Atmospheric

pressure700 - 1060 hPa

SYSTem comPonenTS

PRX0XYYZ Kit PROPRIO FOOT

PRX00431 Batterie provisoire

PRX60137 Kit d’entretien PROPRIO FOOT

cleaRance and dimenSionS (figure a)

Clearance 180 mm–190.5 mm (7"–7½")

Sizes 22 - 30

Heel hights 0–50 mm (2")

98

• Roughen the rear aspect of the socket and then clean the surface.• Attach Velcro to the socket and the corresponding surface on the battery. (Figure C)• Press down the battery pack for secure attachment.• Reinforce the attachment of the battery module by wrapping the battery to the socket with electrical tape

or similar.

Make sure the connection cable lies flat against the surface of the prosthesis because a loose cable can get caught. Observe the cable position during walking and make changes to the assembly if necessary.

DEFINITIVE SOCKET: BATTERY ASSEMBLY

• Mark the best suitable position of the battery pack identified during diagnostic socket fitting (see chapter “Diagnostic socket: battery assembly”).

• Recommendation: Position the battery pack as proximal as possible on the rear aspect of the socket.• Check the position using the dummy (Figure D).• Follow the common lamination guidelines and position the lamination dummy as marked, with the curved

side facing towards the socket before applying the final layer.• Proceed with lamination as usual.• After the lamination has cured expose and remove the dummy (Figure E).• Apply double-sided tape on the imprinted area and attach the battery pack by pressing both surfaces

together.• Wrap any excess length of the battery connection cable around the pylon or socket connector. Make sure

that the connection cable does not interfere with actuator motion. Observe the cable position during walking and make changes if necessary to the assembly.

BENCH ALIGNMENT (Figure F)

Overview

• Fit the foot with the selected cover and shoe.• Power ON (see chapter “Power ON”).• Adjust the Heel Height to the preferred shoe (see chapter “Heel Height Adjustment”).• Proceed with alignment and corrections above the foot level.• Establish the correct height of the prosthesis using the appropriate components.• Ensure that the alignment is correct in the sagittal and coronal planes. In the sagittal plane, the alignment

reference line should bisect the center of the socket at MPT and pass through the posterior middle 1/3 mark on the foot module.

DYNAMIC ALIGNMENT AND USE OF HEEL WEDGES

Optimum functional benefits will only be achieved when the rollover function is optimized. The heel wedge can influence the heel- to-toe function. Start changing the heel resistance to improve foot response adding a heel wedge. The 2°, 4° & 6° wedges can be interchanged to customize the stiffness of the heel and achieve the desired functional characteristics. A combination of wedges may be used. Have the user walk on even ground and assess proper heel-to-toe function.

Temporary Wedge Placement (Figure G)

• Cut the wedge to the width of the foot module.• Roughen the upper and lower surface of the wedge with abrasive paper.• Place the wedge in the angle of the heel and foot module.• Secure the wedge in position with tape wrapped around the foot module.

Permanently fix wedges when proprio foot® is used for more than a couple of days. Temporarily fitted wedges will move out of position and cause functional issues. Failure to do so can void the warranty.

10

Permanent Wedge Placement (Figure H)

• Apply adhesive to the upper side of the wedge only.• Locate it in the foot/heel junction and position it before the adhesive sets.• For split toe feet first install the heel wedge, then remove a thin slice in the middle by cutting with a sharp

knife through the split in the carbon foot module.• Complete the dynamic alignment by performing calibration. (See chapter “Calibration”)

HEEL DIVIDER

The heel divider should be placed in the posterior portion of the split heel. To secure its position, a drop of instant adhesive can be used on one side.

Flex-foot sock FCX63007 (Figure I)

To protect the cover a Flex-Foot sock is fitted over the foot module before applying the cover. The sock should fit loosely in the heel area. To hold the Flex-Foot® sock in place attach the self adhesive velcro tabs to the sides and front of the ankle. Press the Flex-Foot® sock firmly onto the tabs to hold in place. It is important that the Flex-Foot® sock doesn’t slip down as this will cause interference with the proprio

foot® function and performance.

FOOT COVER REMOVAL (Figure J)

To remove the foot cover, grasp and pull on the Flex-Foot Sock. Hold down the cosmetic cover with a hand on the rear aspect of the cosmetic cover. The heel module will snap out of the heel clip. Continue to pull and remove the foot completely.

note: do not use a Flex-Foot® shoe horn or any other lever to remove the foot cover as this may cause damage to the ankle unit.

CHARGING AND POWER (Figure K)

• Only use the power supply, supplied for proprio foot®.

• Connect the power supply cable to the power supply (PRX60015). » Green LED turns on continuously. » Yellow LED will flash while charging.

• 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®.• 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 does not cause harm.• Recharging daily is the most efficient routine.

note: The yellow LED light on proprio foot® will blink when charging. The green will be steady.

Power supply

never store proprio foot® fully discharged or fully charged. The recommended for storage charge level is at 40%. Only use the charger supplied.attention: do not charge when the prosthesis is being worn!

do not leave the prosthesis/battery in hot places or close to heat emitting devices like radiators.

Warning signals for power loss

Vibratory and/or auditory warning systems are provided by the proprio foot® to indicate to the user that power loss is forthcoming. The warning signals are provided in a series of intermittent pulses. The sequence of pulses is described in (Figure L). Ensure that the user recognizes the warnings.

1110

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 off.

FINISHING

• When covering the foot, take care not to restrict the motion of the system.• It is recommended not to use any foam covering except the foot cover supplied.

BASIC OPERATION

POWER ON

• To turn on the proprio foot, hold both buttons at least one second.

» The system confirms with two beeps and vibrations. » The LED blinks green and yellow

note: The keypad will be disabled after 60 seconds from use. To enable the keypad hold both buttons at least for one second.

When proprio foot® is activated for the first time, the default manufacturer settings will be enabled.In the default manufacturer settings, the stair response is set to 4 degrees dorsiflexion, sound is ON and the RELAX MODE is OFF. (Figure I-O)

POWER OFF

• To enable the keypad, hold (both buttons) 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 off.

note: The keypad will be disabled after 60 seconds from use. To enable the keypad hold both buttons at least for one second.

Hold

hold

hold

2×

2×

hold

hold3×

3×

12

HEEL HEIGHT ADJUSTMENT

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 bench

• 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. » 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 flat (heel and forefoot area)on the ground.

• Ensure the power is ON.

• 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. » Then LED blinks green and yellow.

• Heel height adjustment is complete.

Press2×

hold1×1×1×

1×/1×/1×

1312

CALIBRATION

Calibration must be performed during the initial fitting to calibrate the proprio foot® to the user’s individual gait. During calibration, proprio foot® recognizes the user’s specific gait parameters, allowing for accurate and consistent terrain detection. For calibration the user must walk on level ground for at least 15 consecutive strides without interruption.

• Have the user stand still.

• Make sure the keypad is active. » The LED blinks green and yellow (The keypad will lock automatically after 60 sec. of use).

• Make sure the user has access to a path on level ground long enough to complete at least 15 strides without interruption.

• To enable Calibration, hold down and press nine times. » The system confirms with a beep and a vibration. » The LED blinks green and yellow.

• Have the user walk on level ground at a self-selected walking speed until completion of calibration is confirmed by a beep and vibration.

» The LED blinks green. » The system is now properly calibrated to the user and enabled for normal adaptive functions.

note: Make sure the surface is completely flat. It is recommended that calibration is performed on an indoor surface. No sharp turns should be taken during calibration.

note: The user may take gentle turns during the calibration walk. If the calibration is not completed after approximately 15 strides, see below.

TROUBLESHOOTING

• Ensure the correct alignment.• Ensure there are no extreme gait deviations, such as significant circumduction or rotation, as this may

prevent the completion of calibration.• Ensure consistent walking speed.• Avoid walking in a circle or sharp curves.• If calibration is not confirmed after 15 strides, you must perform calibration again.• If the alignment is changed you must perform the calibration again.• If for any reason the LED turns red the procedure must be repeated.

To cancel the calibration, hold down and press nine times.

hold

9×Press1×

1×

14

FUNCTIONS

INCLINES/DECLINES

• During ramp ascent, proprio foot® gradually raises the toe of the prosthetic foot. Adaptation begins on the second step and makes small changes until it reaches the gradient of the ramp. proprio foot® continuously adapts on every step.

» Dorsiflexion of the foot during ramp ascent reduces socket pressure and strain on the ligaments.

• During the swing phase, proprio foot® will raise the toe to provide additional ground clearance.

• It is not necessary to lead with a particular limb when ascending ramps.

• During ramp descent, 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.

note: Steep inclines or declines (above 20°) may trigger stair response resulting in unexpected ankle adaptation.

STAIRS

• During stair ascent, proprio foot® will raise the toe. This will facilitate stair ambulation and improve gait symmetry.

• When leading with the prosthetic side, proprio foot® will adapt to this position after the second prosthetic step on the stairs.

note: Pay attention to transitions from and to stairs.

When proprio foot® is activated for the first time, the default manufacturer settings will be enabled. In the default manufacturer settings, the stair response is preset to 4° dorsiflexion.

To change the stair response, press the following sequence: (Figure N)

• To change stair response from 4° to 6°, hold down and press three times.

» The system confirms with three beeps and vibrations.

• To disable the stair response, hold down and press three times. » The system confirms with a single beep and vibration.

• To enable a stair response of 4°, hold down and press three times. » The system confirms with two beeps and vibrations.

hold

3×Press

1× – 3×

1× – 3×

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ADVANCED OPERATION

RELAX MODE/CHAIR EXIT MODE (Figure O)

RELAX MODE allows the ankle to move into full plantarflexion 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.

• 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 initiate 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 dorsiflexion that will enable the user to bring the leg further back, providing morecontrolled 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.

NEUTRAL – MAX. PLANTAR FLEXION

• To run the ankle into max. plantarflexion, hold down the upper button and press the lower button four times.

» The system confirms with a beep and vibration when moving to maximum plantar flexion.

» Repeat the procedure to return to normal function.

hold

5×Press

1× – 3×

1× – 3×

Press4×

hold1×

1×

16

MANUAL ANKLE OPERATION

• To enable step by step manual ankle operation, hold down the upper button and press the lower button

six times. » The system confirms with a beep and vibration. » Use the upper and lower button to move the foot.

• If during use, ankle motion is repeatedly restricted for any reason, the foot enters an error state and the manual ankle operation is enabled automatically.

» An alarm will sound and the LED blinks red and yellow, green LED being steady on. Motor retries three times before manual ankle operation is enabled.

SOUND ON/OFF

• To enable or disable auditory feedback hold down the lower button and press the upper button seven times.

» The system confirms with a beep and vibration when enabled.

» There is no confirmation when sound is disabled.

MAINTENANCE

SERVICE

proprio foot® is designed and manufactured to provide long and trouble free service intervals.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.

Press6×

hold1×

1×

Press7×

hold

1×

1×

1716

TRAINING TIPS

Start the training after the proprio foot® is aligned and calibrated. Ensure full function with all connections secured.

Charging: Train the user on how to charge the unit.

Heel height adjustment:

Encourage the user to switch shoes or try out barefoot walking using the heel height adjustment.

Curbs: Ask the user to take a long step onto and down a curb. This will limit the ankle adaptation. This will prevent false ankle adaptation.

Note: Walking across high curbs may initiate the stair response!

Sitting: Ask the user to sit down and position the shank at over 20° relative to the ground (stretch legs). To allow for the Relax Mode the prosthesis has to be slightly unloaded PROPRIO FOOT will move into a plantar flexed position (toe down).

Chair Exit Mode: Ask the user while in a seated position to move the prosthesis under or close to the chair. PROPRIO FOOT will dorsiflex (toe up) to facilitate standing up.

Level ground: Ask the user to walk at slow and fast speed. Observe the dorsiflexion in swing.

Ramps: Ask the user to walk up and down on a shallow and steep ramp. Observe the ankle adaptation and ask whether the user can sense it.

Stairs: Ask the user to walk up and down on stairs. Advise to lead with the prosthetic side upstairs and to lead with the prosthetic side when going down. This will provide stair adaptation after the first step on stairs.

Note: Instruct the user to be careful walking downstairs for the first time, since they will not be used to the dorsiflexed ankle position. Encourage the user to switch shoes or try out barefoot walking using the heel height adjustment.

Toe lift: Very slow walking speed won’t trigger toe lift.

Half step: Sharp turns, zigzagging or stepping up high curbs may cause dorsiflexion.

Power loss: Results in plantarflexion.

Motor stuck: Light tapping on the toe or heel can free it up.

WARRANTY

See Terms of Warranty for details.

ELECTROMAGNETIC COMPATIBILITY PRECAUTIONS

The proprio foot® needs special precautions regarding electromagnetic compatibility (EMC). Specifically itneeds to be installed and put into service according to the EMC information provided as follows:

• The proprio foot® should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the proprio foot® should be observed to verify normal operation in the configuration in which it will be used.

• The proprio foot® may be susceptible to electromagnetic interference from portable and mobile RF communications devices such as mobile (cellular) telephones.

• The proprio foot® may be interfered with by other equipment, even if that other equipment complies with cispr emission requirements.

18

guidance and manufacturer’s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The customer or user of device should assure that it is used in such an environment.

emissions Test compliance electromagnetic environment – guidance

RF Emissions CISPR 11 Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions are low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11 Class B The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.Harmonics Emissions

IEC 61000-3-2Class B

Voltage Fluctuations/Flicker Emissions vIEC 61000-3-3

Complies

guidance and manufacturer’s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The customer or user of device should assure that it is used in such an environment.

immunity Test iec 60601 Test level compliance levelelectromagnetic environment – guidance

Electrostatic Discharge (ESD)IEC 61000-4-2

±6 kV contact±8 kV air

±6 kV contact±8 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burstIEC 61000-4-4

±2 kV for power supply lines±1 kV for input/output lines

±2 kV for power supply lines±1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5 ±1 kV line(s) to line(s)±2 kV line(s) to earth

±1 kV line(s) to line(s)±2 kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, Shortinterruptions and voltage variations on power supplylines IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0.5 cycle.40 % UT (60 % dip in UT) for 5 cycles.70 % UT (30 % dip in UT) for 25 cycles.<5 % UT (>95% dip in UT) for 5 s.

<5 % UT (>95 % dip in UT) for 0.5 cycle.40 % UT (60 % dip in UT) for 5 cycles.70 % UT (30 % dip in UT) for 25 cycles.<5 % UT (>95% dip in UT) for 5 s.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz)magnetic fieldIEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

1918

guidance and manufacturer’s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The customer or user of the device should assure that it is used in such an environment.

immunity Test iec 60601 Test level compliance level electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separatvion distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

Conducted RF IEC 61000-4-6

3 Vrms, 150 kHz to 80 MHz

3 Vrms d=1.2√P

Radiated RF IEC 61000-4-3

3 V/m, 80 MHz to 2.5 GHz

3 V/m d=1.2√P 80 MHz to 800 MHzd=2.3√P 800 MHz to 2.5 GHz

where “P” is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey*, should be less than the compliance level in each frequency range**.

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2 These guidelines may not apply in situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

* Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.

** Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

20

CATEGORY SELECTION CHART

Please refer to the selection charts below to determine the appropriate stiffness required according to Össur recommendations.

LIABILITY

The manufacturer recommends using the device only under the specified conditions and for the intended purposes. The device must be maintained according to the instructions for use. The manufacturer is not liable for damage caused by component combinations that were not authorized by the manufacturer.

COMPLIANCE

This component has been tested according to ISO 10328 standard to two million load cycles. Depending on the amputee’s activity this corresponds to a duration of use of two to three years. We recommend carrying out regular yearly safety checks

Recommended separation distances between portable and mobile Rf communications equipment and the device.

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output powerof transmitter

W

Separation distance according to frequency of transmitter

m

150 kHz to 80 MHzd=1,2√P

80 MHz to 800 MHzd=1,2√P

800 MHz to 2,5 GHzd=2,3√P

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters rated at 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 output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

USeR infoRmaTion kg 45-52 53-59 60-68 69-77 78-88 89-100 101-116 117-125

USeR infoRmaTion lbS 99-115 116-130 131-150 151-170 171-194 195-221 222-256 257-275

Low Impact Level 1 1 2 3 4 5 6 7

Moderate Impact Level 1 2 3 4 5 6 7 8

2120

In the standard mentioned, test levels (P) are assigned to a certain maximal body masses (m in kg). In some cases, which are marked with, no test level is assigned to the product related maximal body mass. In these cases, the test loads have been adapted adequately on the basis of the specified load level.

category Össur high activity

category Weight (kg) lable text

1 52 P3 ISO 10328 - P3 52 kg

2 59 P3 ISO 10328 - P3 59 kg

3 68 P4 ISO 10328 - P4 68 kg

4 77 P4 ISO 10328 - P4 77 kg

5 88 P4 ISO 10328 - P5 88 kg

6 100 P5 ISO 10328 - P5 100 kg

7 116 P5 ISO 10328 - P6 116 kg

8 130 P6 ISO 10328 - P6 130 kg

• This manual is intended for use by a certified prosthetist.

ISO 10328 - “P” - “m”kg *)

*) Body mass limit not to be exceeded!

For speci�c conditions and limitations of use see manufacturer’s written instructions on intended use!

en – caution: Össur products and components are designed and tested according to the applicable official standards or an in-house defined standard when no official standard applies. Compatibility and compliance with these standard is achieved only when Össur products are used with other recommended Össur components. If un-usual movement or product wear is detected in a structural part of a device 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 contact your medical professional.

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