Carbon Footplate Rigid - Instructions for Use

Product Description

A carbon footplate designed to limit the range of motion (ROM) in the metatarsophalangeal joints (MTP-joints). It effectively distributes pressure in the forefoot and facilitates the natural roll-over motion of the foot during walking.

Intended Use

This footplate is intended to protect the MTP-joints and the forefoot by limiting their range of motion (ROM). It aids in distributing pressure across the forefoot and facilitates a smoother roll-over. The Carbon Footplate Rigid can also be used after immobilization treatments, such as with a POST-OP shoe or walker, to gradually increase movement. Additionally, it can help improve balance following a toe amputation. It is essential that the footplate is always covered by an insole. This product is designed for single-patient, multiple-use applications.

Indications

• Hallux Rigidus
• Hallux Limitus
• Stress fractures
• Other injuries or arthritis conditions in the forefoot/midfoot
• Forefoot trauma
• Toe sprain
• Toe amputation

Contraindications

• Open ulcers on the foot
• Non-stable fractures
• Weight exceeding 300 lbs / 135 kg

Adjustments

This product should only be altered or adjusted by a qualified medical professional.

Warnings

• Extra precaution is required if the patient has neuropathy, diabetes, or other conditions that may lead to ulcers.
• Ensure the carbon footplate is covered by a proper and functional foot orthotic that effectively manages pressure distribution on the plantar surface.
• Verify that the selected shoe has sufficient inner volume to prevent the occurrence of pressure sores.

Material Handling & Specifications

Material Specifications

Carbon fiber in an epoxy matrix. Fiber reinforced thermoset composite.

Handling during Grinding/Cutting

• Protect the eyes.
• Use dust protection over the nose and mouth.
• Ensure the edges of the footplate are carefully smoothed and all loose fiber particles are removed.
• Do not overheat the composite material (maximum temperature: 100°C / 212°F) when grinding.

User Instructions

• The condition of the foot should be checked daily.
• In case of skin irritation or discoloration, discontinue use immediately and contact the fitter or prescriber.
• If your ability to monitor the foot daily is reduced, ask for assistance.
• Do not bend the carbon footplate excessively, for example, by squatting.

Washing Instructions

Wash with soap and water.

Disposal

Dispose of in accordance with local legislation.

Reporting Incidents

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority in the location where the user and/or patient is established.

Fitting the Carbon Footplate

Follow these steps to fit the carbon footplate:

1. Step 1: Preparation

   Remove the insole from the patient's shoe. Select a carbon footplate that is closest to the patient's shoe size.

2. Step 2: Templating and Shaping

   Use the original shoe insole as a template. Trace this template onto the carbon footplate. The traced outline should be a few millimeters larger than the carbon footplate itself. Grind the carbon footplate using a belt sander or a Dremel tool, carefully smoothing and shaping the edges.

3. Step 3: Placement

   Place the adjusted carbon footplate into the shoe.

4. Step 4: Finalizing the Fit

   Place the original shoe insole back on top of the carbon footplate.

Product Dimensions

Contact Information

Manufacturer: Camp Scandinavia AB

Address: Karbingatan 38, 254 67 Helsingborg, Sweden

Phone: +46 42 25 27 01

Email: info@camp.se

Website: camp.se

Regional Contacts:

• Denmark: Phone: +45 43 96 66 99, Email: info@camp.dk, Website: camp.dk
• Finland: Phone: +358 9 350 76 30, Email: info@camp.fi, Website: camp.fi
• Norway: Phone: +47 23 23 31 20, Email: info@camp.no, Website: camp.no
• UK/Ireland: Email: info@allarduk.co.uk, Website: allarduk.co.uk
• USA: Phone: 888-678 6548, Email: info@allardusa.com, Website: allardusa.com
• International: Phone: +46 42-25 27 01, Email: info@allardint.com, Website: allardint.com