Trulife SKF100 Kinetic Foot/Ankle and Pylon System for K2 Level User Guide
- June 5, 2024
- Trulife
Table of Contents
SKF100, SKF103, SKF200, SKF203
SKF-KIT, SKF-REFURB-KIT-01
KINETIC
Installation and User Guide
17772-001 REV R 2021-05-21
INTRODUCTION
The Kinetic system is a complete foot, ankle, and pylon system suitable for K2
level end users up to 350 lbs. The Kinetic features a full-length flexible
keel, integrated multi-axis ankle, proximal adapter, and a 16″ pylon.
These products are designed to provide variable ankle stiffness, excellent ML
compliance, and plantar flexion in an aesthetically appealing Trulife
Lightfoot cosmesis. The Kinetic system is available in sizes 22 to 30 cm with
two color options and five bumper durometer selections.
The Kinetic has a female proximal adapter and male pylon while the Kinetic
Light has a male proximal adapter and female pylon.
| Product Code | Description | Patient Weight Limit |
|---|
SKF100
SKF103| Kinetic Light, Light Foot
Kinetic Light, Dark Foot| 160 kg / 350 lb
160 kg / 350 lb
SKF200
SKF203| Kinetic, Light Foot
Kinetic, Dark Foot| 160 kg / 350 lb
160 kg / 350 lb
INDICATIONS
The Kinetic and Kinetic Light are designed for lower extremity, K2 amputees that weigh (carried load included) according to the selection chart below.
Selection
To optimize the selection, follow the three steps below to determine the
appropriate category.
- Locate the column associated with the amputee’s foot length.
- Locate the row corresponding to the amputee’s weight.
- The area where the column and row intersect lists the appropriate category.
If the amputee has a long BK or carries heavy loads, choose the next
category higher.
Choosing a lower strength category than what is suggested based on the
above procedure and patient data will void the warranty and put your patient
at risk. If your patient’s weight exceeds the limits of the chart please call
Trulife Customer Service.
Patient
Weight| Foot Length (cm)
---|---
22| 23| 24| 25| 26| 27| 28| 29| 30
137-160 kg
301-350 lb| –| –| –| –| 5| 5| 5| 5| 5
101-136 kg
21-300 lb| –| –| 4| 4| 4| 4| 4| 4| 4
81- 100 kg
177-220 lb| –| 2| 3| 3| 3| 3| 3| 3| –
≤80 kg
≤176 lb| 1| 1| 2| 2| 2| 2| 2| –| –
INSTALLATION AND USE
Recommended installation and use procedures must be followed for maximum safety and service life.
Failure to follow the installation and use procedures may lead to
structural failure of the components subjecting the user to a risk of serious
personal injury.
Never modify the keel or structural ankle components.
Kinetic Installation:
- Place the male bonded pylon into the foot pyramid receiver and tighten the four set screws to maintain the appropriate alignment.
- To maintain set screw tightness, remove the set screws individually and apply Loctite 242® removable thread locking compound to the threads of each set screw and replace them.
- Using a 4 mm hex head driver and torque wrench, tighten the set screws to 15 Nm (11 ft-lbs or 133 in-lbs).
The Kinetic female adapter uses GEOMET® coated set screws rather than the industry standard nickel-plated or black oxide steel screws, which tend to rust in increased humidity. You may notice that the coated screws, which have the same torque requirements, have a different “feel” when tightening.
- Use set screws supplied by Trulife. The use of unapproved fasteners will void the warranty and can lead to failure.
- Do not contaminate set screws with any type of paint, glue, or cement.
- Torque settings should be checked periodically. A loosely fastened bolt or set screw could lead to failure.
Kinetic Light Foot Installation:
- Connect proximal connecting components (pylon, clamp adapter, etc.) to the male proximal male pyramid feature of the foot as per typical modular component procedures.
- Refer to the IFUs of the attached component for proper torque values and assembly procedures (typical set screw torque values for titanium and stainless steel 30mm female adapters are 15 Nm / 11 ft-lbs).
Alignment
The recommendations in this guide provide reliable starting points for static
bench alignment.
- To establish anterior/ posterior placement of the foot, ensure the pyramid receiver is 13mm (1/2”) posterior to the mid-line of the socket (Illustration 1).
- To establish medial/lateral placement of the foot, position the pyramid center 6mm (1⁄4″) medial to the midline of the socket.
Maintenance
Replacement of the bumper is recommended once a year (less often for low
activity amputees) to maintain optimum performance of the Kinetic and Kinetic
Light. Refer to the selection chart located on page 1 of this install guide
for the recommended replacement bumper.
Kinetic and Kinetic Light Maintenance Kits:
Product Code
SKF-KIT*
SKF-REFURB-KIT-01
SKF-BMP-1
SKF-BMP-2
SKF-BMP-3
SKF-BMP-4
SKF-BMP-5| Description
Kinetic Maintenance Tool Kit
Kinetic Refurb Kit
Kinetic Soft Bumper
Kinetic Medium Bumper
Kinetic Firm Bumper
Kinetic X-Firm Bumper
Kinetic XX-Firm Bumper| For use with:
All Kinetic Foot Models
All Kinetic Foot Models
All Kinetic Foot Models
All Kinetic Foot Models
All Kinetic Foot Models
All Kinetic Foot Models
All Kinetic Foot Models
---|---|---
*** This kit is absolutely necessary for re-assembly of the Kinetic foot family. Without this tool, the axis shaft may not seat properly in the assembly leading to product failure.
BUMPER CHANGING AND REFURBISHING INSTRUCTIONS
Required Tools and Supplies:
SKF-KIT (Figure 1)
SKF-REFURB-KIT-01 (Kinetic Refurb Kit).
Additional Tools (Figure 2):
a. 4 mm hex key (quantity of 2)
b. Torque wrench with 4 mm hex driver
c. Mallet
d. Scrap piece of wood or plastic
e. Arbor press or bar clamp (not pictured)
NOTE: The functional mechanisms of the Kinetic and Kinetic Light are the same, except that the Kinetic uses a female upper bracket component and the Kinetic Light uses a male upper bracket component.
Disassembly:
- Remove the two cosmetic plugs on either side of the foot.
- Using the two 4 mm hex wrenches, remove the button head screw and step washer from one side of the foot (Figure 3).
- Lightly tap the mallet on the head of the hex key to lightly tap out the shaft (Figure 4).
- Remove the internal components from the foot.
Assembly:
-
Coat the cylindrical part of the dorsi stop with white lithium grease, then insert it up through the distal pad and the bumper (Figure 5A, 5B).
-
Insert the bumper assembly into the foot cavity, then coat the spherical Delrin washers with white lithium grease and place them along the sides of the bumper (Figure 6). Orient the spherical surfaces of the washers so they are facing inward towards the bumper.
-
Use a hex wrench to loosely align the bumper and components. (Figure 7).
-
Insert the hex shaft driver into the head of the shaft and thread the bullet onto the axis (Figure 8A, 8B).
Note: If the foot is undergoing a refurbish procedure, the bushing will need to be pressed into the distal end of the upper bracket prior to the upper bracket being inserted into the foot cavity. -
Place the upper bracket down onto the assembly through the cavity in the foot (Figure 9A, 9B)
-
Use the 4 mm hex wrench to generally align the holes of the assembly.
-
Compress the assembly with an arbor press or bar clamp until the holes appear to be aligned. Use a scrap piece of wood or plastic to prevent scratching the surface of the upper bracket (Figure 10).
-
Lightly lubricate the bullet and axis with a coat of white lithium grease. With the assembly compressed, push the axis assembly through the ankle joint (Figure 11A, 11B), until the bullet begins to protrude from the opposite side. A light tap with a mallet might be necessary while maintaining a compressive force on the assembly.
|
---|--- -
Place the tip of the protruding bullet into the shaft guide (Figure 12), and use your arbor press or bar clamp to drive the axis all the way until it is seated through the far side of the internal stirrup (Figure 13A, 13B).
| |
---|---|--- -
Remove the bullet from the axis.
**The bullet should back out easily. If it doesn’t, then the shaft was not pressed completely through the assembly. Repeat step 9 if necessary.** -
Install the M6 button head screw and washer into the axis. Use Loctite 242 on the threads (Figure 14). Ensure that the recess feature of the washer is oriented inward, towards the foot.
-
Use a 4 mm hex wrench to hold the shaft and use a torque wrench to tighten the button head cap screw to 8 Nm (6 ft-lb).
-
Insert the cosmetic plugs back into the foot.
STORAGE AND USE
There are no identified restrictions on the temperature of storage and use.
DISPOSAL
There are no hazardous materials in the device. Comply with local and national
laws and regulations.
LEGAL INFORMATION
The use of this class 1 medical device is subject to the respective national
laws of the country of use and may vary accordingly.
The user of this device should report any serious incident to Trulife and the
competent authority of the country of use.
Trulife
26284 Twelve Trees Lane NW
Poulsbo, WA 98370
USA
Phone (+1) 360 697 5656
Email [email protected]|
MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany
Phone (+49) 511 6262 8630
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LIMITED WARRANTY
Trulife warrants that the PRODUCT will be free from defects in material and
workmanship from the date of installation for the warranty period stated on
the PRODUCT warranty card.
This warranty will not apply if the PRODUCT has been damaged by misuse, abuse,
neglect, improper care, failure to follow instructions, abnormal wear, and
tear, or in the event that the PRODUCT has been modified/repaired by persons
unauthorized by Trulife.
If a defect in material or workmanship is found during the warranty period,
Trulife will, at Trulife’s option, either repair or replace the product. If it
is not possible to repair or replace the product, Trulife will be limited to
refunding the purchase price.
Trulife will not be liable under any legal theory for any direct, indirect,
special, incidental, or consequential damages arising from the use of or
inability to use this product.
The application guidelines for this Trulife product are for the use of and by
a certified, qualified practitioner only. Patients are not to attempt to apply
or adjust the item unless expressly instructed to do so by the practitioner
responsible for the prescription and/or initial fitting of the device. All
patient questions should be referred to the practitioner and not to the
manufacturer. The manufacturer warrants only that the enclosed product has
been inspected for quality and can be effective for certain indications, but
final decisions and ongoing monitoring must be made by the medical
professional(s) prescribing and/or fitting the device to determine its
effectiveness for an individual patient. Patient compliance is an integral
part of the entire protocol and must be adhered to in order to avoid potential
problems and maximize the effectiveness of the prescribed product.
As a condition of the sale of any Trulife product, this product is restricted
to a “Single Patient Use Only” by the originally fitted patient in order to
protect the care provider and the patient against potentially adverse
consequences of infectious disease transmission, material instability in
adapting to the configuration of the original user and/or decrease in
effectivity. Any express or implied warranties are voided if the product is
reused or fitted to another patient. Additionally, a license or right to use
under any relevant patents pertaining to the product is terminated with the
cessation of use by the original patient. As with all Trulife products, this
product must be prescribed and applied by a qualified practitioner to
determine whether it meets the needs of the particular patient and
accomplishes the desired results.
Trulife www.trulife.com