college park Trustep Foot Instruction Manual

College Park Trustep Foot

Product Information
Package Contents

• (1) Trustep Foot
• (1) Foot Shell

Tools Recommended

• (1) #2 Phillips Screwdriver
• (1) Torque Wrench
• (1) CPI Sock
• (1) Sealing Boot (upon request)
• (1) 4 mm and 6 mm Hex Keys
• (1) Foot Horn
• (1) TruLube Lubricant
• (1) Pin Guide
• (1) Preloader Tool

Key Components (Figure 1)

Product Description
This prosthetic foot device is constructed with an endo or exo ankle bone option, heel bone, forefoot bone, bumpers, bushings, axial pins, preload insert, and fasteners. The ankle, heel, and forefoot bones are assembled with the axial pins and screws. The the forefoot is secured with the preload insert and screw.

Intended Use
The Trustep is a prosthetic foot designed to replace one or more functions of the biological human foot.

• Indications
• Lower limb amputations
• Contraindications
• None known

Protective Cover on Dome
Remove the protective cover on the dome after alignment is completed and before the patient leaves the clinic.

Technical Specifications

25cm foot with shell

Firmness Categories

Product Usage Instructions
Step 1: Protective Cover Remove the protective cover on the dome after alignment is completed and before the patient leaves the clinic.

Step 2: Firmness Category Selection
Refer to the Firmness Categories table to determine the correct firmness category based on the user’s weight and size. The firmness category is important for device function.

Step 3: Component Selection
Refer to the Gait Match Chart to determine the recommended components based on the firmness category. Adjustments can be made for gait matches as needed.

Step 4: Endoskeletal Mounting (Optional)
If using an endoskeletal mounting, use only high-quality proximal endoskeletal components (30 mm). Attach the 30 mm endo components to the Exo Pyramid Tool and temporarily mount the socket.

Package Contents

1. 1. Trustep Foot
2. (1) Foot Shell
3. (1) #2 Phillips Screwdriver
4. (1) Torque Wrench
5. (1) CPI Sock

Tools Recommended

1. (1) Sealing Boot (upon request)
2. (1) 4 mm and 6 mm Hex Keys (1) Foot Horn
3. (1) TruLube Lubricant
4. (1) Pin Guide
5. (1) Preloader Tool

This diagram is to help familiarize you with the unique parts of the Trustee. These parts are referenced in the instructions and used when speaking with a technical service representative

Key Components (Figure 1)

• Ankle Bone
• Heel Bone
• Forefoot Bone
• Rear Bumper
•  Midstance Pad
• Front Bumper
• Ankle Bushings (2)
• Lower Bushings (2)
• Axial Pins (2)
• Axial Pin Screws (2)
• Torque 4 N·m (36 in·lbs)
• Preload Insert
• Torque 2 N-m (18 in-lb)
• Insert Screw
• CPI Sock (not shown)
• Foot Shell (not shown)

Optional EXO Mount

• Exo Pyramid Tool
• (additional purchase)
• Exo Block Kit (additional purchase)
• Exo Ankle Bone P. Exo Mounting Bolt
• (included w/exo block kit)
• Torque 61 N·m (45 ft·lbs)

PRODUCT DESCRIPTION

This prosthetic foot device is constructed with an endo or exo ankle bone option, heel bone, forefoot bone, bumpers, bushings, axial pins, preload insert, and fasteners. The ankle, heel, and forefoot bones are assembled with axial pins and screws. The forefoot is secured with the preload insert and screw.

INTENDED USE
The Trustep is a prosthetic foot designed to replace one or more functions of the biological human foot.

INDICATIONS

Lower limb amputation

CONTRAINDICATIONS
None known

PROTECTIVE COVER ON DOME
Remove the protective cover on the dome after alignment is completed and before the patient leaves the clinic.

TECHNICAL SPECIFICATIONS

523 g

26-30 cm| 275 lbs / 125 kg| 2.6 in / 6.5 cm

FOOT SIZE WEIGHT LIMIT BUILD HEIGHT FOOT WEIGHT

• 21-25 cm 200 lbs / 100 kg 2.4 in / 6.2 cm 523 g
• 26-30 cm 275 lbs / 125 kg 2.6 in / 6.5 cm
• 25cm foot with shell

GAIT MATCHING® GUIDELINES
The gait match determines the firmness of the foot based on the user’s specifications (foot size, patient weight, and impact level).

FIRMNESS CATEGORIES
Refer to the chart below to determine the correct firmness category.
Note: Incorrect category selection may result in poor device function. Contact College Park Technical Service if you have questions about category selection.

WEIGHT LBS| 0-74| 75- 100| 101- 120| 121- 140| 141- 160| 161- 180| 181- 200| 201- 220| 221- 250| 251- 275| 276- 300| 301- 330| 331- 352
---|---|---|---|---|---|---|---|---|---|---|---|---|---
WEIGHT KG| 0-33| 34-45| 46-54| 55-63| 64-72| 73-81| 82-91| 92-100| 101-113| 114-125| 126-136| 137-150| 151-160
SIZE CM| 22- 31| EXO ONLY
LOW IMPACT| 1| 2| 3| 4| 4| 5| 6| 6| 7| 7| 8| 8| 9
MODERATE IMPACT| 1| 2| 3| 4| 5| 6| 6| 7| 7| 7| 8| 9| 9
HIGH IMPACT| 2| 3| 4| 5| 6| 6| 7| 7| 8| 8| 8| 9| 9

GAIT MATCH CHART
Components may be changed as needed. Determine the user’s firmness category, then refer to the chart below for the recommended components. For gait match adjustments, see the section: Dynamic Adjustments.

COMPONENT

| FIRMNESS CATEGORY
---|---
1| 2| 3| 4| 5| 6| 7| 8| 9
FRONT BUMPER| 1| 2| 3| 4| 5| 6| 7| 8| 8
ANKLE BUSHINGS| S| S| S| S| M| M| M| F| F
MIDSTANCE PAD| M| M| M| M| M| M| M| F| F
REAR BUMPER| XS| XS| S| S| M| H| 1X| 2X| 3X
LOWER BUSHINGS| ONE FIRMNESS| ONE FIRMNESS| ONE FIRMNESS| ONE FIRMNESS| ONE FIRMNESS| ONE FIRMNESS| ONE FIRMNESS| ONE FIRMNESS| ONE FIRMNESS

ENDOSKELETAL MOUNTING
Use only high-quality proximal endoskeletal components (30 mm).

EXOSKELETAL MOUNTING

1. Remove Exo Ankle Bone, then attach to College Park Exo Block with anti-rotation pin(s) oriented. Apply Loctite® 242 to the mounting bolt. Torque to 61 N·m (45 ft·lbs). To skip alignment and lamination, go to Step 9.
2. If using the alignable Exo option, attach Exo Pyramid Tool to Exo Block with four 6 mm screws. Torque to 15 N·m (11 ft·lbs).
3. Attach 30 mm endo components to the Exo Pyramid Tool and temporarily mount the socket.
4. Re-attach the ankle bone to the foot, donning CPI Sock and foot shell, then perform a dynamic alignment.
5. Remove the foot from Exo Block.
6. Mount aligned prosthesis in transfer jig. Lock socket and Exo Block in position.
7. Remove endo components and Exo Pyramid Tool.
8. Use the desired method to span Exo Block to the socket and remove it from the jig. Shape and laminate to desired finish. Do not remove foam from the top of the Exo Block
9. Re-attach the ankle bone to the heel bone. Re-assemble the foot, and don CPI Sock and foot shell.

ANKLE REMOVAL (ACCESS TO REAR BUMPER, ANKLE
BUSHINGS AND MIDSTANCE PAD)

1. Use the Foot Horn to don/doff the foot shell. Remove the CPI Sock and replace it as needed.
2. Use 6 mm and 4 mm hex keys to remove the axial pin screw.
3. Attach the pin guide to the axial pin. Push and rotate clockwise.
4. Unscrew the axial pin from the pin guide and remove it from the ankle bone.
5. Remove the ankle bone to access the rear bumpers, ankle bushings, and the midstance pad.
6. For re-assembly, lubricate the axial pin, inside and outside of the ankle bushings, ankle bushing pocket, and the contact surface of the midstance pad, then reverse steps 1-4. Torque the axial pin screw to 4 N·m (36 in·lbs).
7. DO NOT lubricate the front and rear bumpers.

FOREFOOT REMOVAL (ACCESS TO FRONT BUMPER AND LOWER BUSHINGS)
To remove the Preload Insert, position the Preloader Tool on the foot to remove the load off of the insert. Tighten the handle down on the forefoot then swing the cam lever to either side.

1. For detailed instructions refer to the Preloader Tool Instruction Sheet.
2. Remove the front bumper and axial pin as instructed (above) for the Ankle Bone.
3. Remove the forefoot bone to access the lower bushings.
4. For re-assembly, lubricate the axial pin, inside and outside of the lower bushings, then reverse steps 1-4.
5. Torque the axial pin screw to 4 N·m (36 in·lbs)

STATIC ALIGNMENT (Figure 2)
For optimal function, balance the patient’s weight evenly between the heel and toe.

• The Trustee was designed with a 1/2” (13 mm) heel rise.
• The load line divides the foot at 1/3 heel lever and 2/3 toe lever.

DYNAMIC ADJUSTMENTS

Front Bumper down one step softer or use MIN Insert
FIRMER HEEL RESPONSE| Dorsiflex the Trustep or move load line anterior| Rear Bumper up one step firmer
SOFTER HEEL RESPONSE| Plantarflex the Trustep or move load line posterior| Rear Bumper down one step softer
INCREASE/DECREASE ROTATION, INVERSION OR EVERSION| ****

—

| ****

Change Ankle Bushings

WARNING

• Do not expose this product to pH extremes or corrosive materials (water, salt water or other liquids).
• Failure to follow these technical instructions or use of this product outside the scope of its Limited Warranty may result in injury to the patient or damage to the product.
• Disassembly, modification, or removal from the foot shell or any further disassembly or modification of components will void the warranty.

RESIDUAL RISK STATEMENT NOTICE OF RESIDUAL RISK
During the fitting process, ensure that the CPI sock does not become pinched between the foot and endoskeletal componentry.

WARRANTY INSPECTION / MAINTENANCE INFORMATION
College Park recommends that you schedule your patients for check-ups according to the warranty Inspection schedule below. High patient weight and/or impact level may require more frequent inspections. Soft component wear depends on the patient’s weight, impact level, and environment. We recommend you inspect the following applicable parts for excessive wear and fatigue at each warranty inspection and replace them as needed.

• Soft components (disassemble, inspect & re-lubricate)
• Composites and Adapters
• CPI Sock
• Foot Shell

WARRANTY INSPECTION SCHEDULE FOR TRUSTEE: SIX MONTHS, THEN ANNUALLY.
TECHNICAL ASSISTANCE / EMERGENCY SERVICE 24-7-365
College Park’s regular office hours are Monday through Friday, 8:30 am – 5:30 pm (EST). After hours, an emergency Technical Service number is available to contact a College Park representative.

LIABILITY
The manufacturer is not liable for damage caused by component combinations that were not authorized by the manufacturer

CAUTION
College Park 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 standards are achieved only when College Park products are used with other recommended College Park components. This product has been designed and tested based on single-patient usage. This device should NOT be used by multiple patients.

CAUTION
If any problems occur with the use of this product, immediately contact your medical professional. The prosthetist and/or patient should report any serious incident* that has occurred in relation to the device to College Park Industries, Inc. and the competent authority of the Member State in which the prosthetist and/or patient is established. ‘Serious incident’ is defined as any incident that directly or indirectly led, may have led, or might lead to any of the following; (a) the death of a patient, user, or other people, (b) the temporary or permanent serious deterioration of a patient’s, user’s, or other person’s state of health, (c) a serious public health threat.

COLLEGE PARK INDUSTRIES, INC
27955 College Park Dr. Warren, MI 48088 USA

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