Calamine Instructions For Use (IFU)

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View CoFlex® TLC Calamine

Description
These instructions are for CoFlex TLC Calamine and CoFlex TLC Calamine Lite.
• CoFlex TLC Calamine is standard compression (30-40 mmHg)
• CoFlex TLC Calamine Lite is lite compression (20-30 mmHg).
• CoFlex TLC Calamine and CoFlex TLC Calamine Lite are a two-step non-latex compression system. Layer 1 is a foam roll, with calamine that provides comfort and is intended for use over an appropriate primary wound dressing. Layer 2 is a short stretch 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 and CoFlex TLC Calamine Lite are designed to treat venous leg ulcers, chronic venous insufficiency, and other edema-related conditions.
• CoFlex TLC Calamine (standard compression) can be used by patients with an Ankle Brachial Index (ABI) greater than or equal to 0.8.
• CoFlex TLC Calamine Lite (lite compression) can be used by patients with an ABI greater than or equal to 0.5.

Contraindications
• CoFlex TLC Calamine (standard compression): cannot be used by patients with an ABI lessthan0.8.
• CoFlex TLC Calamine Lite (lite compression): cannot be used by patients with an ABI less than 0.5.

Precautions & Warnings

• For compression use only. Incorrect application could lead to severe clinical complications such as tissue damage. To be used under the supervision of a healthcare professional.
• Single use item. If reused, intended restorative compression cannot be assured and increases potential for infection.
• To be used up to 7 days. If used longer than 7 days, intended restorative compression cannot be assured and increases potential for infection.
• Layer 1 of this product contains aloe and calamine.

• CoFlex TLC Calamine and CoFlex TLC Calamine Lite are not made with natural rubber latex.
• CoFlex TLC Calamine and CoFlex TLC Calamine Lite Layer 1 is not a primary wound dressing. Follow appropriate wound care treatment for the wound condition before applying.

• CoFlex TLC Calamine and CoFlex TLC Calamine Lite Layer 2 may initially be applied with less tension allowing the patient to adjust to or tolerate the long stretch compression system.
• Wrapping too tightly may impair circulation. Monitor the area of application frequently for signs of pain, numbness, tingling, discoloration, or swelling. If these symptoms occur, remove the product and contact your healthcare professional.

• CoFlex TLC Calamine and CoFlex TLC Calamine Lite should be changed if it becomes loose fitting, or when it no longer conforms to the shape of the bandaged area. The patient should contact their healthcare professional to determine if it should be replaced.
• CoFlex TLC Calamine and CoFlex TLC Calamine Lite should be kept dry. Avoid showering, bathing, or swimming unless appropriate waterproof protection is used. If the bandage becomes wet, contact your healthcare professional to determine if it should be replaced.

• 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.

Initial assessment and first-time use:

• Clinical consultation and a comprehensive physical assessment should be carried out by a healthcare professional prior to first use.
• The Ankle Brachial Index (ABI) should be measured prior to first application.

Subsequent uses and ongoing assessment / monitoring:

• Patients and caregivers should be trained and cleared by a healthcare professional prior to independent application.
• Continuous and frequent clinical and physical assessment is required. Follow the instructions given by your doctor / healthcare professional for ongoing assessments and monitoring.
• The use of this product is strictly reliant on the patient’s Ankle Brachial Index (ABI) as per the indications for use.

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

1. Begin wrapping Layer 1 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).  
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 Calamine and CoFlex TLC Calamine Lite may be removed by unwrapping or with blunt tip bandage scissors.

If using blunt tip bandage scissors:
• Insert the blunt tip between the wrap and your skin before cutting.
• Cut slowly, using small cuts rather than one long cut.
• Keep the scissors angled away from your skin to help reduce the risk of injury.
• If needed, continue cutting until the wrap can be gently unwrapped and removed.
• Take extra care over bony areas such as the ankle, shin, top of the foot, and behind the knee where the skin is more vulnerable.
• Never force the scissors if you cannot easily slide the blunt tip beneath the wrap.
• DO NOT use sharp household scissors or knives.

• DO NOT pull or tear the wrap off if it is stuck to a dressing or your skin.
• CoFlex TLC Calamine and CoFlex TLC Calamine Lite may be disposed as normal hospital household waste or according to facility protocol.

Storage
• Store CoFlex TLC Calamine and CoFlex TLC Calamine Lite in their 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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