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Description #
These instructions are for both CoFlex TLC Calamine and CoFlex TLC Calamine Lite. CoFlex TLC Calamine (Standard & Lite) is a two-step non-latex compression system. Layer 1 is a foam roll with Calamine that provides comfort and absorbs drainage. Layer 2 is a short stretch, moisture-resistant compression bandage that provides the proper levels of sustained working pressures to promote venous return. This system is designed to work 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 Calamine (Standard & Lite) is designed to treat venous leg ulcers and other related conditions.
CoFlex TLC Calamine (Standard) can be used for patients with an ABI greater than or
equal to 0.8.
CoFlex TLC Calamine (Lite) can be used for patients with an ABI greater than or equal to 0.5.
Contraindications
CoFlex TLC Calamine (Standard): ABI less than 0.8.
CoFlex TLC Calamine (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 Calamine (Standard & Lite) Layer 1 is not a primary wound dressing. Follow appropriate protocol for the wound condition before applying.
- CoFlex TLC Calamine (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:
- Begin wrapping Layer 1 on the top of the foot, at the base of the fifth digit in a spiral
technique (figure 1). - 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). - 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). - Cut or hand-tear excess material and tape to keep the bandage in place (figure 4).
Layer 2 – Compression Layer:
- Begin wrapping Layer 2 on the top of the foot, at the base of the fifth digit in a spiral technique (figure 5).
- 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).
- Continue to spiral wrap up the leg, covering Layer 1 with 50% overlap while maintaining even tension (figure 7).
- Cut or hand-tear excess material (figure 8).
- Gently press over entire application to ensure a strong bond & reduce slippage (figure 9).
- 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.
