Össur PROPRIO FOOT Technical Manual

Brand: Össur

Model: PROPRIO FOOT

Type: Technical Manual

PROPRIO FOOT®

TechnicalManual

Safety precautions 5

Introduction 7

Technical specications 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

1/3 1/3 1/3

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

1/2

Keypad Battery

Control

button

Warning Indicates

×  approx.  min left

×  approx.  min left

×  approx.  min left

×  Foot will return to neutral

Function Hold Press BEEP

Power /

  = 

  = 

Set heel height ×

× 

× 

× 

Move to neutral/relax × × 

Manual motor

movement × /

Sound / × × 

 / × × /

Default manufacturer setting: Stair Mode º

Stair mode

Sequence Hold Press Sound

Stair Mode °

×

× 

Stair Mode ° × 

Stair Mode  × 

Default manufacturer setting: Relax Mode 

Relax Mode Hold Press Sound

Relax Mode 

×

× 

Relax Mode  × 

Chair Exit Mode only × 

SAFETY PRECAUTIONS

• When the battery charge is low,  ® will return to the last preset heel height position. A warning

signal will occur (see “Charging and power”).

• When making adjustments to  ® 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.

•   use  ® while the battery is charging. Be sure to disconnect it from the charger prior to

putting on the prosthesis.

• Improper handling or adjustment of  ® 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.

•  impact to the battery.

•  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.

»  use power supplies other than those provided with the device.

» 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.

•  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.

•  exposure to extreme heat and/or cold (see “Technical specifications”).

•  exposure to intense dust, smoke or mechanical vibrations.

•   use if the product enclosure or covers are broken.

•   tamper with the keypad.

• Disable  ® when driving a vehicle (see “Power off”).

• Steep inclines or declines (above °) may trigger the stair response resulting in unexpected foot alignment.

•  ® 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.

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

INTRODUCTION

FUNCTIONS

•  ® is designed to dorsiflex during swing phase to improve ground clearance, thus enhancing

gait symmetry and reducing the likelihood of catching the toe.

•  ® 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.

•  ® provides the user with the ability to automatically adjust the ankle position to a range of

heel heights, conveniently allowing a choice of shoes.

•  ® will plantarflex for a more natural appearance in sitting.

• The  ® assists in standing up from a seated position through an adaptation of its ankle

position.

• The  ® has the ability to plantarflex when kneeling and also when lying down.

INDICATIONS FOR USE

•  ® 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”).  ® is suitable for

continuous use. The  ® may only be fitted by a qualified and trained prosthetist.

TECHNICAL SPECIFICATIONS

SAFETY STANDARDS AND CLASSIFICATION

 ® is tested and certified compliant with the IEC/EN-, standard of electrical safety of

medical devices and IEC/EN--, electromagnetic compatibility for medical electrical devices and ISO

. The company fulfills the requirements of ISO, MDD //EEC, and  ® carries the

CE mark accordingly. It is in compliance with UL-, CAN/CSA C. No.. - M, US and Canadian

Standards for medical-technical and electrical products.

The device has type B applied parts.

AUTHORIZED REPRESENTATIVE

 .

Grjótháls .

 Reykjavik

Iceland

+  

PHYSICAL PROPERTIES

Weight limit kg (lbs)

Frame construction Aluminum

Net weight g (.lbs), (size , cat. )

BATTERY

Rechargeable lithium-ion battery ( mAh)

Output Voltage . V

Charge time - hours at % discharge.

Operating autonomy Fully charged battery is sufficient for - hours of use, dependent on activity.

SYSTEM DIAGRAM (Figure B)

SETUP

PROCEDURAL OVERVIEW

. Check battery level, charge if required.

. Attach the battery to the diagnostic socket. (See chapter “Diagnostic socket: battery assembly”).

. Power ON (see chapter “Power on”).

. Adjust the Heel Height to the preferred shoe (see chapter “Heel Height Adjustment”).

. Perform bench alignment (see chapter “Bench alignment”).

. Perform dynamic alignment (see chapter “Dynamic alignment and use of heel wedges”).

. Check whether user recognizes vibratory and auditory feedback.

. Perform Calibration (see chapter “Calibration”).

:   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 - VAC

Input current  mA

Input frequency - Hz

Output current . A

Input connector IEC  AC

Output connector -Female .x.x. mm

Output voltage VDC

Operating temperature °C to °C (ºF to ºF)

ENVIRONMENTAL

Operating temperature -°C to °C (ºF to ºF)

Operating humidity % - %RH

Operating Atmospheric pressure  -  hPa

Shipping and storage humidity % - %RH

Shipping and storage temperature -ºC to ºC (-ºF to ºF)

Shipping and storage Atmospheric

pressure  -  hPa

SYSTEM COMPONENTS

PRXXYYZ Kit PROPRIO FOOT

PRX Batterie provisoire

PRX Kit d’entretien PROPRIO FOOT

CLEARANCE AND DIMENSIONS (Figure A)

Clearance  mm–. mm ("–½")

Sizes  - 

Heel hights – mm (")

• 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 /

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 °, ° & ° 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  ® 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.

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 

® 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.

:   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  ®.

• Connect the power supply cable to the power supply (PRX).

»Green LED turns on continuously.

»Yellow LED will flash while charging.

• Connect the power source to the battery pack. Allow – hours to ensure a full charge.

Battery charge

• The LED lights indicate the charge state of  ®.

• 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.

: The yellow LED light on  ® will blink when charging. The green will be steady.

Power supply

   ® fully discharged or fully charged.

The recommended for storage charge level is at %. Only use the charger supplied.

:   charge when the prosthesis is being worn!

  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  ® 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.

When the  ® battery charge is low and the warning pulses for power loss are delivered, the

foot will return to the latest preset heel height position.

          .

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  , hold both buttons

at least one second.

»The system confirms with two beeps and vibrations.

»The LED blinks green and yellow

: The keypad will be disabled after  seconds from use.

To enable the keypad hold both buttons at least for

one second.

When  ® is activated for the first time, the

default manufacturer settings will be enabled.

In the default manufacturer settings, the stair response is

set to  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.

: Pay attention to the button audible feedback.

The system confirms with three beeps and three

vibrations. The LEDs turn off.

: The keypad will be disabled after  seconds from use.

To enable the keypad hold both buttons at least for

one second.

Hold

2×

Hold

3×

HEEL HEIGHT ADJUSTMENT

The  ® 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.

: 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.

: If the heel height exceeds  mm (") 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.

•  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.

Press

×

Hold

1×

1×/1×/1×

CALIBRATION

Calibration must be performed during the initial fitting to calibrate the  ® to the user’s individual

gait. During calibration,  ® 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  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  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.

: 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.

: The user may take gentle turns during the calibration walk. If the calibration is not completed after

approximately  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  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

×

Press

1×

FUNCTIONS

INCLINES/DECLINES

• During ramp ascent,  ® 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.  ®

continuously adapts on every step.

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

• During the swing phase,  ® 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,  ® lowers the toe of the prosthetic foot.

»This helps to increase safety and gives better support during roll over of the prosthetic side.

: Steep inclines or declines (above °) may trigger stair response resulting in unexpected

ankle adaptation.

STAIRS

• During stair ascent,  ® will raise the toe.

This will facilitate stair ambulation and improve gait

symmetry.

• When leading with the prosthetic side, 

® will adapt to this position after the second

prosthetic step on the stairs.

: Pay attention to transitions from and to

stairs.

When  ® is activated for the first time, the

default manufacturer settings will be enabled. In the

default manufacturer settings, the stair response is

preset to ° dorsiflexion.

To change the stair response, press the following

sequence: (Figure N)

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

»The system confirms with two beeps and vibrations.

Hold

×

Press

1× – 3×

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  seconds.

»This provides a more natural ankle position when sitting

with the lower leg extended.

Following the Relax Mode the  ® will move

into CHAIR EXIT MODE.

To initiate this use one of the following methods:

. Tap the heel of the foot.

. 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 more

controlled transition from sitting to standing. The ankle will move back to neutral after the first step.

Tapping on the heel will move  ® to the next mode, i.e. tapping the heel when in RELAX MODE

will move  ® direct into CHAIR EXIT MODE. A second tap on the heel will move 

® 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

×

Press

1× – 3×

Press

×

Hold

1×

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

 ® is designed and manufactured to provide long and trouble free service intervals.

To ensure proper function, it is recommended that  ® is inspected every six months by a

qualified professional. Check for signs of unusual wear.

CLEANING

Follow these instructions:

• Remove  ® 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.

:   dip the whole foot or pour solvent over the foot. The bearings and seals will be damaged.

  use compressed air to clean the foot. Air will force pollutants into the bearings which may cause

malfunctions and early deterioration.

Press

×

Hold

1×

Press

×

Hold

1×

TRAINING TIPS

Start the training after the  ® 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 ° 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  ® needs special precautions regarding electromagnetic compatibility (EMC). Specifically it

needs to be installed and put into service according to the EMC information provided as follows:

• The  ® should not be used adjacent to or stacked with other equipment. In case adjacent or

stacked use is necessary, the  ® should be observed to verify normal operation in the configuration

in which it will be used.

• The  ® may be susceptible to electromagnetic interference from portable and mobile RF

communications devices such as mobile (cellular) telephones.

• The  ® may be interfered with by other equipment, even if that other equipment complies with

  requirements.

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  Group  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  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 --

Class B

Voltage Fluctuations/

Flicker Emissions

vIEC --

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  Test Level Compliance Level

Electromagnetic Environment –

Guidance

Electrostatic Discharge

(ESD)

IEC --

± kV contact

± kV air

± kV contact

± kV air

Floors should be wood, concrete,

or ceramic tile. If floors are

covered with synthetic material,

the relative humidity should be at

least %.

Electrical fast

transient/burst

IEC --

± kV for power supply lines

± kV for input/output lines

± kV for power supply lines

± kV for input/output lines

Mains power quality should be

that of a typical commercial or

hospital environment.

Surge IEC -- ± kV line(s) to line(s)

± kV line(s) to earth

± kV line(s) to line(s)

± kV line(s) to earth

Mains power quality should be

that of a typical commercial or

hospital environment.

Voltage dips, Short

interruptions and

voltage variations on

power supply

lines IEC --

< % UT (> % dip in UT) for

. cycle.

 % UT ( % dip in UT) for 

cycles.

 % UT ( % dip in UT) for

 cycles.

< % UT (>% dip in UT) for

 s.

< % UT (> % dip in UT)

for . cycle.

 % UT ( % dip in UT) for

 cycles.

 % UT ( % dip in UT) for

 cycles.

< % UT (>% dip in UT) for

 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

(/ Hz)

magnetic field

IEC --

 A/m  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.

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  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

--

 Vrms,  kHz to

 MHz

 Vrms d=.√P

Radiated RF IEC

--

 V/m,  MHz to

. GHz

 V/m d=.√P  MHz to  MHz

d=.√P  MHz to . 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  At  MHz and  MHz, the higher frequency range applies.

Note  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  kHz to  MHz, field strengths should be less than  V/m.

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  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 power

of transmitter

Separation distance according to frequency of transmitter

 kHz to  MHz

d=,√P

 MHz to  MHz

d=,√P

 MHz to , GHz

d=,√P

, , , ,

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

1 1,2 1,2 2,3

 , , ,

   

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  At  MHz and  MHz, the separation distance for the higher frequency range applies.

NOTE  These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects and people.

USER INFORMATION KG - - - - - - - -

USER INFORMATION LBS - - - - - - - -

Low Impact Level        

Moderate Impact Level        

Page is loading ...

Össur PROPRIO FOOT Technical Manual

Össur PROPRIO FOOT Technical Manual

Össur PROPRIO FOOT Technical Manual

Related papers

Other documents