PROPRIO FOOT Technical Manual

Technical Manual
PROPRIO FOOT®
3
Safety precautions5
Introduction7
Technical specifications7
Setup8
Basic operation11
Calibration13
Functions14
Advanced operation15
Maintenance16
Training tips17
Warranty17
Electromagnetic compatibility precautions17
Category selection chart20
a
b
c
d
f
1/2
1/2
1/2
1/2
e
1/3
1/3
1/3
1/2
1/2
3
g
h
j
i
k
Keypad
Battery
Control
button
l
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
n
Stair mode
Sequence
m
Function
Hold
Press
BEEP
2 beeps = on
3 beeps = off
Power on/off
Set heel height
2×
1× start
1× move
1× complete
Move to neutral/relax
4×
1× relax
Manual motor
movement
6×
n/a
Hold
Press
Sound
Stair Mode 4°
2× beep
Stair Mode 6°
3× beep
3×
Stair Mode off
1× beep
Default manufacturer setting: Stair Mode 4º
o
Relax Mode
Hold
Press
Relax Mode off
Sound
1× beep
Relax Mode on
2× beep
5×
Sound on/off
7×
1× on
Chair Exit Mode only
calibration on/off
9×
1× on/off
Default manufacturer setting: Relax Mode off
3× beep
4
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.
5
ABBREVIATIONS
Keypad:Upper button
Keypad: Lower button
Vibration feedback signal.
Auditory feedback signal "BEEP"
CALIBRATION
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
DC in
DC out
Connection for DC power supply
Connection for battery extension cable to PROPRIO FOOT
Manufacturer
Date of manufacture
INDICATOR
Battery Charge Level
6
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 Reykjavik
Iceland
+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.
7
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
pressure
700 - 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")
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.
8
• 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.
M
ake 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.
9
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.
10
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
2×
• 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.
2×
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)
Hold
®
Hold
Hold
POWER OFF
• To enable the keypad, hold
least one second.
• To power OFF hold and press
at least one second.
3×
(both buttons) for at
(both buttons) for
note:Pay attention to the button audible feedback.
The system confirms with three beeps and three
vibrations. The LEDs turn off.
3×
Hold
note: T
he keypad will be disabled after 60 seconds from use.
To enable the keypad hold both buttons at least for
one second.
Hold
11
HEEL HEIGHT ADJUSTMENT
1×/1×/1×
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.
1×
1×
1×
Hold
Press
2×
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
»» The system confirms with a beep and vibration.
and press the lower button
twice.
• 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.
12
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.
1×
• 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
»» The system confirms with a beep and a vibration.
»» The LED blinks green and yellow.
nine times.
1×
• 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.
9×
Press
Hold
note: M
ake 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: T
he 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.
13
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.
1× – 3×
1× – 3×
3×
Press
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.
Hold
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
»» The system confirms with a single beep and vibration.
• To enable a stair response of 4°, hold down
and press
»» The system confirms with two beeps and vibrations.
three times.
three times.
14
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.
1× – 3×
1× – 3×
• To disable RELAX MODE and disable CHAIR EXIT
MODE hold down
and press
five times.
»» The system confirms with a single beep and vibration.
5×
Press
• 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.
Hold
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 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.
NEUTRAL – MAX. PLANTAR FLEXION
1×
• 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.
1×
Hold
Press
4×
15
MANUAL ANKLE OPERATION
1×
• 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.
1×
Hold
Press
6×
SOUND ON/OFF
1×
• 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.
1×
7×
Press
Hold
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.
16
TRAINING TIPS
Start the training after the proprio foot® is aligned and calibrated.
Ensure full function with all connections secured.
Charging:
Heel height
adjustment:
Curbs:
Note:
Sitting:
Chair Exit Mode:
Level ground:
Ramps:
Train the user on how to charge the unit.
Encourage the user to switch shoes or try out barefoot walking using the heel height adjustment.
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.
Walking across high curbs may initiate the stair response!
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).
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.
Ask the user to walk at slow and fast speed. Observe the dorsiflexion in swing.
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:
Half step:
Power loss:
Motor stuck:
Very slow walking speed won’t trigger toe lift.
Sharp turns, zigzagging or stepping up high curbs may cause dorsiflexion.
Results in plantarflexion.
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 it
needs 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.
17
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
Harmonics Emissions
IEC 61000-3-2
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.
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.
Electromagnetic Environment –
Guidance
Immunity Test
IEC 60601 Test Level
Compliance Level
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/burst
IEC 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, Short
interruptions and
voltage variations on
power supply
lines 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 field
IEC 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.
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 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 MHz
d=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.
19
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
m
W
150 kHz to 80 MHz
d=1,2√P
80 MHz to 800 MHz
d=1,2√P
800 MHz to 2,5 GHz
d=2,3√P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
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
NOTE 2
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
CATEGORY SELECTION CHART
Please refer to the selection charts below to determine the appropriate stiffness required according to Össur
recommendations.
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
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
20
ISO 10328 - “P” - “m”kg *)
*)
Body mass limit not to be exceeded!
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.
For specific conditions and limitations of use see
manufacturer’s written instructions on intended use!
Category Össur high activity
Category
Weight (Kg)
1
52
P3
ISO 10328 -
Lable text
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.
21
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.
Össur Americas
27051 Towne Centre Drive
Foothill Ranch, CA 92610, USA
Tel: +1 (949) 382 3883
Tel: +1 800 233 6263
Fax: +1 800 831 3160
[email protected]
Össur Canada
2150 – 6900 Graybar Road
Richmond, BC
V6W OA5 , Canada
Tel: +1 604 241 8152
Fax: +1 866 441 3880
Össur Europe BV
De Schakel 70
5651 GH Eindhoven
The Netherlands
Tel: +800 3539 3668
Tel: +31 499 462840
Fax: +31 499 462841
[email protected]
Össur Deutschland GmbH
Augustinusstrasse 11A
50226 Frechen
Deutschland
Tel: +49 (0) 2234 6039 102
Fax. +49 (0) 2234 6039 101
[email protected]
Össur Nordic
P.O. Box 67
751 03 Uppsala, Sweden
Tel: +46 1818 2200
Fax: +46 1818 2218
[email protected]
Össur Europe BV – Italy
Via Baroaldi, 29
40054 Budrio, Italy
Tel: +39 05169 20852
Fax: +39 05169 22977
[email protected]
Össur Iberia S.L.U
Calle Caléndula, 93 Miniparc III
Edificio E, Despacho M18
28109 El Soto de la Moraleja,
Alcobendas
Madrid – España
Tel: 00 800 3539 3668
Fax: 00 800 3539 3299
[email protected]
[email protected]
Össur APAC
2F, W16 B
No. 1801 Hongmei Road
200233, Shanghai, China
Tel: +86 21 6127 1707
Fax: +86 21 6127 1799
[email protected]
Össur UK Ltd
Unit No 1
S:Park
Hamilton Road
Stockport SK1 2AE, UK
Tel: +44 (0) 8450 065 065
Fax: +44 (0)161 475 6321
[email protected]
Össur Australia
26 Ross Street,
North Parramatta
NSW 2151 Australia
Tel: +61 2 88382800
Fax: +61 2 96305310
[email protected]
Össur Head Office
Grjótháls 5
110 Reykjavík, Iceland
Tel: +354 515 1300
Fax: +354 515 1366
[email protected]
WWW.OSSUR.COM
©Copyright Össur 2016
TM 0056 EN / 1020_002
Rev. 6