Fillauer Wave Comfort User manual

Wave
Comfort
Product Manual

3
Contents
Intended Use...................................................4
Warnings and Precautions .......................................5
Alignment (Specications & PreparationsBefore Use)................6
Consumable Components: Foot Shell and Spectra®Sock .............8
Compatibility ...................................................9
Disposal/ Waste Handling .......................................9
Warranty .....................................................10
User Instructions ..............................................10
Serious Incidents ..............................................11
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Intended Use
The Wave Comfort 3 (WC3) prosthetic foot is intended for use in lower
extremity prostheses. The foot uses three carbon composite elements
(Figure 1) that conform to terrain while storing and releasing energy
during gait. The two upper carbon springs in the WC3 combine to
provide a high rate of energy return while the separation between those
springs reduces stiness in all three planes. The wave spring foot plate
creates a soft heel for shock absorption, quick foot at, and a resulting
early stance stability at the knee. Patients will experience signicantly
improved range of motion when walking up and down slopes compared
to similar devices as well as greater compliance on uneven terrain.
Wave Spring
Top Spring
Main Spring
Figure 1
Indications
• Low to moderate activity transtibial or transfemoral amputees as
dened by functional K3 activity levels
• Unilateral or bilateral patients
• Patients that would benet from moderate energy return
• Patients that would benet from knee stabilization from heel strike to
foot at
• Patients weighing up to 330 lbs. (150 kg)
Contraindications
• Clearance below 4 in. (10 cm)
• Patients weighing over 330 lbs. (150 kg)
• Patients wanting to run or jog regularly on the device
The device is intended for single patient use only.
Performance Characteristics
• Patient weight: Up to 330 lbs. (150 kg)
• Foot weight: 13.2 oz. (374 g)
• Build height: 4 in. (10 cm)
• Functional level: K3
• Durable; meets ISO-22675 standard

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• Primary Materials: Carbon composite, stainless steel, titanium, and
aluminum
• Waterproof: The foot unit is waterproof to 1 meter. See additional
information below.
Storage and Handling
It is recommended that prosthetic feet be stored in a cool, clean, dry
environment away from harsh chemicals (chlorine, acids, acetone, etc.).
Warnings and Precautions
CAUTION: The Wave Comfort 3 is designed to be
maintenance free and should not be disassembled. The
pyramid dome on the foot is permanently attached to the
pylon (main and top) spring and should not be removed.
CAUTION: For patient safety and device compatibility, only
Fillauer or equal, ISO 10328 compliant, pyramid receivers
should be used with this foot.
CAUTION: Abnormal or improper environmental conditions
will lead to malfunctioning and damage of the prosthesis
and is not covered under the warranty of the device. This
prosthetic/orthotic component must not be subjected
to dust/debris, liquids other than fresh water, abrasives,
vibration, activities which would damage the biological limb,
or prolonged, extreme temperatures (< -5 °C or > 50 °C). Do
not allow debris or liquids to remain in the prosthesis and
its components during use. Rinse the foot with fresh water
and dry immediately after exposure.
CAUTION: The foot unit is waterproof to 1 meter. However,
if the foot is submerged, the foot and foot shell should
be rinsed with fresh water and dried immediately to
remove salt, chlorine, or debris. The foot shell and sock will
experience signicant deterioration if not allowed to fully
dry before return to normal use and are not covered under
warranty for this failure.

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NOTICE: The foot should be inspected by the clinician every
six months for signs of abnormal wear and to assure that
the attachment/alignment screws are secure.
NOTICE: The foot stiness is based on weight and activity
level. Please provide accurate patient information so that
the appropriate foot may be selected.
NOTICE: Attachment, alignment, and delivery of the foot
must be performed by or under the direct supervision of
a qualied prosthetist. Any adjustment or modications
should be done by the clinician and not by the user.
NOTICE: If any serious incidents occur in relation to the
usage of the device, contact your Fillauer Representative
and the appropriate authority in your country.
Alignment (Specications &
PreparationsBefore Use)
Proximal attachment
Attachment of the foot may be achieved via the proximal pyramid to any
ISO 10328 compliant, Fillauer or equal, standard adult pyramid receiver.
Torque all set screws to the setting specied by the manufacturer of
the pyramid receiver. For Fillauer components, this is 15N·m. Proper
thread locker must be used for nal delivery per the component
manufacturer’s specications.
Static and Bench Alignment
Standard bench alignment techniques may be used for the Wave
Comfort 3 (Figure 2). Before aligning, the initial heel height should be
established. The Wave Comfort 3 is designed for a ⅜ inch or 1 cm heel
height. The initial heel height can be established with a simple spacer
under the heel. The top of the pyramid should be parallel with the
work surface before proceeding with alignment. A backward leaning
pylon indicates that the heel height is too low and will make late-stance
rollover dicult.

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5°
Figure 2
The socket should be set with the proper amount of inset found in the
evaluation. A plum line from the bisection of the socket at the proximal
brim in the frontal and sagittal plane should bisect the ankle pyramid.
The foot may be slightly inset, 1–12 mm, depending on the limb length.
Short limb lengths are set with very little inset of 2–3 mm and longer
limb lengths may tolerate a greater varus thrust of 10–12 mm. The
longitudinal axis of the foot will be outset approximately 5° by aligning
the medial border of the foot with the line of progression.
Transfemoral Bench Alignment
Alignment at the transfemoral level should be consistent with the
instructions provided by the manufacturer of the prosthetic knee in use.
Dynamic Alignment
The Wave Comfort 3 is exible and conforms well to the ground. This
characteristic may make the foot appear to be properly aligned after the
static alignment. However, small adjustments in the alignment however
will smooth the transition from heel to toe, optimize gait and eciency.
Patient feedback during this process is essential. In the dynamic
alignment of the foot, the socket exion angle and heel stiness are
altered to achieve optimal alignment and patient gait.
• Check for smoothness of gait and ground contact during stance
phase.
• If the heel is too soft, there may be delayed heel rollover from heel
strike to midstance. Dorsiexing the foot may resolve this issue or use
a rmer heel bumper as described below.
• If the heel is too rm, heel rollover may be too rapid from heel strike
to mid stance. Also, patient may complain of anterior distal pressure.

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Plantarexing the foot may resolve this issue or use a softer heel
bumper as described below.
• If the anterior keel rollover progresses too quickly from midstance
to toe loading, the patient may say that they are “walking up a hill.”
Plantarex the foot to provide more anterior support.
• If the anterior keel rollover hesitates from midstance to toe loading,
the patient may say that they are “walking down a hill.” Dorsiex the
foot to increase the rate of rollover.
Changing the toe stiness
The toe stiness is pre-determined by the load category of the anterior
spring members. This stiness can be dynamically adjusted by changing
the amount of plantar/dorsi-exion of the foot. This adjustment
increases or decreases the amount of anterior support during gait.
If a smooth stance phase of gait cannot be achieved, contact Fillauer for
additional assistance.
Consumable Components:
Foot Shell and Spectra®Sock
The WC3 uses a unique cosmetic foot shell that is exible and durable
(sold separately). Use care in the installation and removal of the foot
shell to maintain its appearance and durability. Always use the shell with
an internal Spectra sock (included). Never use a sharp-edged tool such
as a screwdriver to install or remove the foot shell.
Figure 3
Heel Lock
Installation
• Slide the provided Spectra sock onto the foot from toe to heel, pulling
excess material to the ankle so that it does not bunch under the heel
or toe of the foot.

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• Insert the forefoot into the foot shell as far as possible. Set the heel
on a supportive surface with the toe up and push the shell onto the
foot until the toe is in position.
• Rotate the foot side to side to allow the foot shell to slide onto the
heel.
• Push the foot shell up onto the heel or, if necessary, insert a shoehorn
into the foot shell and allow the heel to slide down a shoehorn
into the heel lock. The heel must lock (Figure 3) in place for proper
function and safety.
• The foot shell should be inspected daily by the user and replaced by
the clinician when tears or breaks are evident in the surface of the
shell.
• The Spectra sock should be inspected and replaced if needed every
3–6 months by the prosthetist. The plantar surface of the foot
should be inspected at this time and if there is excessive wear of the
protective soling, it should be replaced.
Removal
• Place the foot on the bench so that the heel is hanging over the edge
of the bench.
• Apply downward force to the top portion of the foot shell at the heel.
The heel plate should pop out of the heel lock, allowing removal of
the foot shell by hand.
• If the foot shell is too tight, a smooth-edged shoehorn may be used to
disengage the heel lock.
Compatibility
Fillauer feet are appropriate for use with Fillauer or equal, ISO 10328
compliant, endoskeletal components. A Fillauer foot shell should be
used with this device, the t of other manufacturers’ shells cannot be
guaranteed.
Disposal/ Waste Handling
The product must be disposed of in accordance with applicable local
laws and regulations. If the product has been exposed to bacteria or
other infectious agents, it must be disposed of in accordance with

10
applicable laws and regulations for the handling of contaminated
material.
All metal components may be removed and recycled at the appropriate
recycling facility.
Warranty
• 36 months from date of patient tting
• Foot Shell (sold separately) — 6 months from date of patient tting.
User Instructions
The providing health care professional must review the following
information directly with the user.
Care and Maintenance
WARNING: If the foot performance changes or it begins to
make noise, the patient should immediately contact his or
her practitioner. These things may be as sign of a failure
of the foot or other part of the prosthesis that could
result in a fall or other serious injury.
CAUTION: Attachment, alignment, and delivery of the foot
must be performed by or under the direct supervision of
a qualied prosthetist. Any adjustment or modications
should be done by the clinician and not by the user.
CAUTION: The foot should be inspected by the clinician
every six months for signs of abnormal wear and to assure
that the attachment/alignment screws are secure.
CAUTION: The foot is waterproof to 1 meter. However, if
the foot is submerged, the foot and foot shell should be
rinsed with fresh water and dried immediately to remove
salt, chlorine, or debris.
CAUTION: The foot shell is designed to provide realistic
appearance and maximum performance of the Wave

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Comfort 3. The life of the foot shell will depend on level of
activity and degree to which it is protected from wear and
damage with socks and shoes. Socks and shoes should be
worn at all times and should be allowed to dry fully after
exposure to water to prevent damage to the shell.
CAUTION: Patients should inspect the shell daily for signs
of cracks or holes and for the presence of sand or other
debris. If the foot shell shows signs of failure, it should be
replaced as soon as possible to prevent damage to the
carbon ber and soling materials. If debris is present, the
foot and shell should be rinsed and allowed to fully dry.
CAUTION: The foot shell may also be cleaned with a soft
cloth and a soap and water solution or with rubbing alcohol
(70%). Do not use acetone. It will damage the foot shell.
Serious Incidents
In the unlikely event of a failure resulting in a fall and/or injury, seek
immediate medical help and contact your prosthetist at the earliest
possible convenience.

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Chattanooga, TN 37406
423.624.0946
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Salt Lake City, UT 84107
801.281.9964
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192 68 Sollentuna, Sweden
[phone]
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M054/11-18-11/10-04-21/Rev.1