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Description #

These instructions are for both CoFlex TLC LS and CoFlex TLC LS Lite. CoFlex TLC LS (Standard & Lite) is a two-step non-latex compression system. Layer 1 is a foam roll, with odor and itch control properties, that provides comfort and absorbs drainage. Layer 2 is a long stretch compression bandage that provides the proper levels of sustained working pressures to promote venous return. This system is designed to bond together and provide continuous restorative compression for up to one week. A nylon stocking is included for ease of use and patient comfort.

Indications for Use #

CoFlex TLC LS (Standard & Lite) is designed to treat venous leg ulcers and other related conditions. CoFlex TLC LS (Standard) can be used for patients with an ABI greater than or equal to 0.8. CoFlex TLC LS (Lite) can be used for patients with an ABI greater than or equal to 0.5.

Contraindications #

CoFlex TLC LS (Standard): ABI less than 0.8. CoFlex TLC LS (Lite): ABI less than 0.5.

Precautions & Warnings #

• Should be used under the care of a licensed healthcare professional.
• Measure the Ankle Brachial Index prior to application.
• CoFlex TLC LS (Standard & Lite) Layer 1 is not a primary wound dressing. Follow appropriate protocol for the wound condition before applying.
• CoFlex TLC LS (Standard & Lite) Layer 2 may initially be applied with less tension allowing the patient to adjust to or tolerate the short stretch compression system.
• At the discretion of a healthcare professional, patients or their care providers can be trained to apply the bandage.
• Instruct patient to contact physician or nurse if they experience pain, numbness, tingling, discoloration or if swelling occurs.
• Product is not made with natural rubber latex.
• Single use item. If reused, intended restorative compression cannot be assured and increases potential for infection.
• Layer 1 of this product contains aloe.
• If redness or irritation occurs, discontinue use.
• Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

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Directions for Use #

Position the foot at a 90° angle.
Layer 1 – Foam Layer:

1. Begin wrapping Layer 1 (with colored side against the skin) on the top of the foot, at the base of the fifth digit in a spiral technique (figure 1).
2. Continue spiral wrapping across the top of the foot then proceed to wrap 1 figure of 8 around the back of the heel/ankle. The plantar surface of the heel may be partially
   exposed (figure 2).
3. Continue spiral wrapping up the leg. Apply with a 50% overlap using just enough tension to conform to the shape of the leg, ending just below the knee (figure 3).
4. Cut or hand-tear excess material and tape to keep the bandage in place (figure 4).

Layer 2 – Compression Layer:

1. Begin wrapping Layer 2 on the top of the foot, at the base of the fifth digit in a spiral technique (figure 5).
2. Hold the bandage with thumb and stretch until the ovals become circles. Begin spiral wrapping across the top of the foot, then proceed to wrap two figure of 8’s around the back of the heel/ankle, completely covering the heel and foot. Continue to maintain even tension by stretching the visual indicators from ovals to circles (figure 6). For 2” size, indicators are not included – stretch to the appropriate level.                                                                                                         
3. Continue to spiral wrap up the leg, covering Layer 1 with 50% overlap while maintaining even tension (figure 7).
4. Cut or hand-tear excess material (figure 8).
5. Gently press over entire application to ensure a strong bond & reduce slippage (figure 9).
6. Apply the nylon stocking over the system for ease of movement and patient comfort in footwear, under clothes and on bed sheets (figure 10).

Removal/Disposal
• CoFlex TLC LS (Standard & Lite) may be removed by unwrapping or with bandage scissors.
• Dispose of product per your facilities protocol.

Storage
For best results, store CoFlex TLC LS (Standard & Lite) in its original packaging at room temperature until use. Avoid excessive heat and humidity. Refer to the label on each box for expiration date.

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