PRODUCT MANUAL. patent pending

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1 PRODUCT MANUAL patent pending

2 WAVE COMFORT FOOT SYSTEM The Wave Comfort Foot System brings an exceptional level of comfort to the low and moderate activity user. The unique tri-spring design elements works in concert to provide seamless transition and stable progression from heel-strike to toe-off. The coupled springs react in a compliant manner that promotes a supple feel while maintaining the dynamic response expected in carbon composite feet. The novel wave spring and variable durometer heel bumpers enhance stability at heel strike through shock absorption and plantar-flexion as the wave spring flexes and extends. The smooth action of the heel rocker combined with the stable dynamics of the forefoot insure a Wave of Comfort from heel to toe. 2

3 FEATURES AND BENEFITS Novel tri-spring design Compact comfort Unique Wave Spring Technology Progressive dynamic response Easily adjustable heel stiffness Enhanced plantar flexion Shock absorption Balanced compliance Smooth rollover Low profile (4.0 in.) build height Light weight 13.2 oz. (Size 26 cm) 3

4 INDICATIONS Low to moderate activity level patients BK or AK amputees Unilateral or bilateral patients Patients that would benefit from increased flexibility and smooth roll-over Patients weighing up to 275 lbs. CONTRAINDICATIONS Build height below 4.0 in. High activity users requiring maximum energy return 4

5 SPECIFICATIONS L-CODES Weight rating: 275 lbs. (125 kg) Foot sizes cm Heel height: 10 mm (0.4 in.) Foot weight: 375 g (26 cm) Attachment: Modular pyramid L5981* All Lower extremity Prosthesis, Flex-Walk System or Equal. *Suggested L-Codes are provided as a reference only. It is the responsibility of the practitioner and/or patient care facility submitting this claim to determine and submit the correct coding within all established rules and guidelines. 5

6 WAVE COMFORT FOOT SYSTEM TM - PART NO XX-XXX Foot, three heel bumpers, spectra sock and instruction manual. Foot selection is determined by foot size and patient weight. 22 cm 23 cm 24 cm 25 cm 26 cm 27 cm 28 cm 29 cm 30 cm lbs kg 22-B22 23-B22 24-B22 25-B23 26-B23 N/A N/A N/A N/A lbs kg 22-B22 23-B22 24-B22 25-B23 26-B23 27-B34 28-B34 N/A N/A lbs kg 22-B22 23-B22 24-B22 25-B34 26-B34 27-B34 28-B34 29-C45 30-C lbs kg 22-C33 23-C33 24-C33 25-B34 26-B34 27-C45 28-C45 29-C45 30-C lbs kg 22-C33 23-C33 24-C33 25-C45 26-C45 27-C45 28-C45 29-D56 30-D lbs kg 22-C33 23-C33 24-C33 25-C45 26-C45 27-D56 28-D56 29-D56 30-D lbs kg N/A N/A N/A 25-D56 26-D56 27-D56 28-D56 29-E67 30-E lbs kg N/A N/A N/A 25-D56 26-D56 27-D67 28-D67 29-E67 30-E67 6

7 MCV FOOT SHELL XX XX 13 CC 3 Micro Coated Vinyl Foot Shell Example: = Left, Size 24, Color 13 To order, select the side (left or right) and foot length (24 30 cm) from the chart below. Then, choose the color (CC 03, 09, or 13). 22 cm 23 cm 24 cm 25 cm 26 cm 27 cm 28 cm 29 cm 30 cm Left Right CC 13 CC 09 CC 03 Custom colors are available as a special order with three weeks lead time. Please contact Fillauer Customer Service for more details. 7

8 DAILY CARE AND MAINTENANCE The Wave Comfort is designed to be maintenance free. The foot is water resistant. However, if the foot is submerged in water, the foot and foot shell should be rinsed with fresh water and dried immediately. The Wave Comfort should be inspected every 12 months for signs of abnormal wear and to ensure that the attachment/alignment screws are secure. INSTRUCTIONS TO THE PRACTITIONER The practitioner should discuss indications, contraindications, care, maintenance, and application instructions with the patient and/or caregiver before use. In all cases, choosing the appropriate componentry and designing the prosthesis is the sole responsibility of the practitioner. The practitioner should consider many variables including, but not limited to, the patient s weight, activity level, ambulation characteristics, muscular control, environment and risk of 8 injury due to failure. INSTRUCTIONS TO THE PATIENTS The patient should clean the prosthetic foot and remove any debris inside the footshell on a weekly basis if the cover is left open. If any Noise emanates from the foot, the wearer should contact his or her practitioner to have the foot inspected. As with all prosthetic devices; the foot should be inspected every six months by a certified practitioner.

9 INSTALLATION Deviating from the installation instructions or modifying the foot in any way will void any product warranty and could lead to product failure and injury to the patient Product Description The Wave Comfort foot uses three carbon composite springs that comply, resist and store energy during gait. The Wave Comfort foot s integrated pyramid is designed to be used with a pyramid receiver device such as a standard pylon, a tube clamp or DuraShock torsion/shock absorbing pylon (Figure 1). The pyramid dome for the Wave Comfort foot is permanently attached to the composite spring.warning: Do not remove the pyramid assembly or make any alterations to the structure. Doing so will void the product warranty Alignment Proper alignment is the key to patient comfort and proper gait. Follow Wave Spring Figure 1 Top Spring Main Spring the recommended static and dynamic alignment guidelines for maximum performance. 9

10 2.1 - Static (Bench) Alignment Standard bench alignment techniques are used for initial alignment of the Wave Comfort Foot. The foot is designed with a 1 cm heel height. Place foot in shoe or use a 1 cm heel wedge to accommodate heel height. Align center of the pyramid of the foot 10mm anterior to the sagittal bisection of the proximal brim (Figure 2). Set the desired 5-7⁰ flexion angle in the sagittal plane. Foot should also be set with 0-12mm inset relative to the bisection of the proximal brim. Less inset is required for a shorter limb length. Rotate the foot with approximately 5⁰ of external rotation relative to the line of progression Dynamic Alignment The Wave Comfort foot is flexible and conforms well to the ground. This characteristic may make the foot appear to be properly aligned after the static alignment. Small adjustments in the alignment however will smooth the transition from heel to toe, optimize gait and efficiency. Patient 10 Figure 2 5

11 feedback during this process is essential. In the dynamic alignment of the foot, the socket flexion angle and heel stiffness 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. Dorsiflexing the foot may solve this issue, or use a more firm Heel Wedge as described in section 2.3. If the heel is too firm, heel rollover may be too rapid from heel strike to mid stance. Also, patient may complain of anterior distal pressure. Plantarflexing the foot may solve this issue, or use a softer Heel Wedge as described in section 2.3. If the anterior keel rollover progresses too quickly from midstance to toe loading, patient may say they are walking up a hill. Plantarflex the foot to provide more anterior support. If the anterior keel rollover hesitates from midstance to toe loading, patient may say they are walking down a hill. Dorsiflex the foot to increase the rate of rollover Heel Bumper Use: Removal and Installation The Wave Comfort comes with 3 heel bumpers: Red = Soft Blue = Medium Black = Firm Initial set up uses the Blue bumper on the heel of the Lower Foot Plate so that it creates a bumper between the Lower Foot Plate and the Upper Spring. If the heel feels too firm, the soft bumper is placed in the gap between the Lower Foot Plate and the Upper Spring Wave Comfort. If the heel is too soft with the soft heel bumpers, replace it with the firm heel bumper (Figure 3). If the heel is still too soft check the alignment as well. 11

12 Removal Insert a large flat head screw driver and twist it to open up a large gap as shown (Figure 3). Insert a small screw driver and pry the heel bumper out of the slot to remove (Figure 4). Twist Figure 3 Figure 4 Pry 12

13 Installation Insert a large flat head screw driver and twist it to open up a large gap as shown (Figure 5). Push heel bumper into bracket slot and remove the screw driver to close the gap (Figure 6). Push Figure 5 Figure 6 13

14 2.4 - Changing the toe stiffness The toe stiffness is pre-determined by the load category of the anterior spring members. This stiffness can be dynamically adjusted by changing the amount of plantar/dorsi-flexion of the foot. This adjustment increases or decreases the amount of anterior support during gait. 3.0 Securing the foot after alignment The alignment of the Wave Comfort foot is achieved by tightening and loosening of the 4 set screws in the pyramid receiver, after proper alignment is achieved and the patient is ready to leave the prosthetist s office, all set screws should be properly secured. This is done according to the manufacturer s recommendation but should include the use of a thread locking compound such as Loctite applied to each securing and aligning screws which should then be tightened to the manufacturer s recommended torque specification. The attachment screws should be inspected every twelve months for signs of fatigue or corrosion and should also be re-tightened to the manufacturer s recommended torque specification at that time Foot Shell Installation and Removal The Wave Comfort foot features a unique foot shell that is flexible, durable and cosmetically appealing. Using care in the installation and removal of the foot shell will allow it to maintain its appearance and durability. NOTE: Never use a sharp tool such as a screwdriver to install or remove the foot shell. Installation Pull Spectra sock tightly over foot module so that it does not bunch under the foot. 14

15 2.4 - Changing the toe stiffness The toe stiffness is pre-determined by the load category of the anterior spring members. This stiffness can be dynamically adjusted by changing the amount of plantar/dorsi-flexion of the foot. This adjustment increases or decreases the amount of anterior support during gait. 3.0 Securing the foot after alignment The alignment of the Wave Comfort foot is achieved by tightening and loosening of the 4 set screws in the pyramid receiver, after proper alignment is achieved and the patient is ready to leave the prosthetist s office, all set screws should be properly secured. This is done according to the manufacturer s recommendation but should include the use of a thread locking compound such as Loctite applied to each securing and aligning screws which should then be tightened to the manufacturer s recommended torque specification. The attachment screws should be inspected every twelve months for signs of fatigue or corrosion and should also be re-tightened to the manufacturer s recommended torque specification at that time Foot Shell Installation and Removal The Wave Comfort foot features a unique foot shell that is flexible, durable and cosmetically appealing. Using care in the installation and removal of the foot shell will allow it to maintain its appearance and durability. NOTE: Never use a sharp tool such as a screwdriver to install or remove the foot shell. Installation Pull Spectra sock tightly over foot module so that it does not bunch under the foot. 15

16 Initially insert forefoot into foot shell as far as possible. Rotate the foot side to side to allow the foot shell to slide onto the heel Push foot shell up onto heel, using a shoehorn if necessary, and allow heel to slide under heel lock (Figure 7). Make sure that the Lower Foot Plate fits tightly under heel lock to fully secure foot shell. 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 of foot shell at the heel and the heel of the Lower foot plate should pop out of the lock allowing removal of the foot shell by hand. If foot shell is too tight, a smooth edged shoe horn may be used to push the heel lock down over the heel of the lower foot plate. 16 Heel Lock Figure 7

17 FREQUENTLY ASKED QUESTIONS What can the practitioner do if the heel or toe is too soft or too firm? The three heel bumpers included with each foot and plantar/dorsi flexion of the foot are used to fine tune the performance of the foot. Please see the section on alignment and set up. Should I go up or down a category based on the patient s preference or history with other feet? The Wave Comfort foot selection chart is based on loads that would be generated by an average patient engaged in low to moderate activities. There is a 30 day satisfaction guarantee and if your patient feels the foot is too soft or too stiff after proper alignment (see section ) it may be exchanged for a softer or stiffer foot. Remember, the Wave Comfort foot is designed low to moderate activities. If your patient is more active or lifting heavy loads, please consider our other foot options. How long should the foot shell last? The Wave Comfort foot shell is designed to provide realistic appearance and maximum performance of the Wave Comfort foot. 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. Can the pyramid be removed so that the foot can be bolted directly to the socket or other attachment? No, the pyramid attachment should not be removed or altered in any way. Doing so will void the warranty and could put the patient at risk of injury. What is the weight rating of the Wave Comfort Foot? The Wave Comfort foot is rated for a patient weighing up to 275lbs (125kg). The Wave Comfort foot is tested to the ISO22675 for this 17

18 weight rating. All Wave Comfort feet are selected and designed for a specified patient weight range. It is important to use the properly rated foot in order to ensure safety, durability and maximum performance. The individual components of the Wave Comfort foot- Pyramid, Upper Spring Wave Comfort, Lower Foot Plate and 3rd Wave Comfort spring are combined based on a patient s weight and their foot size. The foot is making noise. How can this be corrected? The causes of other noises should be investigated by removing the foot from the foot shell. If necessary, the foot should be cleaned with compressed air or a soft cloth and inspected for visible damage to the foot or debris in the foot shell. Also, insure that the spectra sock is free of holes, then reinstall in foot shell per instructions in section

19 WARRANTY 36 Months from the date of shipment to the practitioner The Wave Comfort Foot System has been designed and manufactured for specific patient weights. Failure to follow the weight guidelines and/or overload conditions caused by the patient, such as heavy lifting, high impact sports, or abusive activities, that would otherwise damage the natural limb, may void the warranty. SATISFACTION GUARANTEE 30 days from the date of shipment to the practitioner 19

20 3938 South 300 West Salt Lake City, UT Phone: Fax: Worldwide distribution by Fillauer LLC 2710 Amnicola Highway Chattanooga, TN European Representative Centri Kung Hans Väg Sollentuna, Sweden M054/ /

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