Cleaning and disinfecting (reprocessing) Begin reprocessing at the point of use to facilitate subsequent cleaning steps to avoid the drying of soiled material and to reduce the risk of infection. It is important to follow the steps below:
Step 1: Clean the Exo Iris device, Duo cap, and cables using one of the indicated products for cleaning. Follow with one of the two disinfection methods (Step 2 or Step 3).
Step 2: If the Exo Iris device has come into contact with only unbroken skin, perform a low-level disinfection using one of the indicated products for low-level disinfection; otherwise, proceed to Step 3.
or
Step 3: If the Exo Iris device has come into contact with blood, broken skin, or bodily fluids, perform a high-level disinfection with one of the indicated products for high-level disinfection. Cleaning the Exo Iris device, back cap, and cables.
Step 1: Cleaning the Exo Iris device, Duo Cable
Cleaning should remove all visible gel, soil, bodily fluids, and particulate matter on all surfaces of the device, Duo cap, and cable. Follow the approved cleaning product manufacturing guidelines for directions of use, contact time, and precautions.
Products for cleaning
TO CLEAN THE EXO IRIS DEVICE, DUO CABLE
1. Disconnect the device from the mobile phone.
2. Thoroughly wipe the entire device, Duo cable with one of the indicated cleaning products for a minimum of one minute, paying attention to seams, gaps, gasket material, and recessed areas. Wipe from the clean areas of the device to the soiled areas, which helps reduce cross-contamination.
3. Using a new wipe each time, clean the device until it’s visibly clean.
4. To dry, use a sterile, lint-free cloth.
5. Visually inspect the device in a well-lit area to ensure all surfaces are clean. If the device is not clean, repeat the cleaning steps above.
6. Dispose of the cleaning material in accordance with all applicable regulations.
7. Proceed with low-level or high-level disinfection
Disinfecting Exo Iris device
There are two levels of disinfecting:
• Low-level disinfecting - Use this level when the device comes into contact with only unbroken skin (noncritical use).
• High-level disinfecting - Use this level when the device comes into contact with blood, broken skin, or bodily fluids (semi-critical use).
Step 2: Low-level disinfecting
Follow the approved disinfecting product manufacturing guidelines for directions of use, contact time, and precautions.
Products for low-level disinfection
TO DISINFECT EXO IRIS DEVICE AT A LOW LEVEL
1. After thoroughly cleaning the device, wipe it with one of the indicated low-level disinfection products to saturate a sterile, lint-free cloth.
2. Make sure the treated surfaces remain wet for a minimum of two minutes. Pay attention to seams and gaps. Use additional fresh wipes as needed to ensure continuous two minutes of contact time.
3. To dry the device, use a sterile, lint-free cloth.
4. Visually inspect the device in a well-lit area to ensure all surfaces are clean. If the device is not clean, repeat the disinfecting steps above.
5. Dampen a sterile, lint-free wipe with 70% IPA, and wipe the entire device surface for a minimum of one minute. Using new wipes saturated with 70% IPA, repeat wiping the device five times for a total each time of one minute.
6. Dispose of the disinfectant in accordance with all applicable regulations.
7. Examine the device for damage, such as cracks or splitting where fluid can enter.
8. If there is damage, discontinue using the device.
Step 3: High-level disinfecting
Follow the approved high-level disinfecting product manufacturing guidelines for directions of use, contact time, and precautions.
TO DISINFECT EXO IRIS DEVICE AT A HIGH LEVEL
1. Clean the device with one of the indicated high-level disinfecting products to remove any gel, debris, or bodily fluids.
2. Prepare one of the indicated disinfecting products in a container or bowl.
3. Immerse the device up to the line, ensuring the connector and Duo cap remain out of the fluid. Do not immerse the device any higher than this line.
4. Soak the device in the solution for 12 minutes at 20°C-22°C, and ensure no air bubbles to be trapped.
5. Rinse the device three separate times using the following procedure:
- Rinse the device in clean, running water according to the disinfectant manufacturer’s instructions (for at least one minute). Ensure that the connector remains out of the fluid.
- Replace the rinse water before beginning the next rinse.
- Rinse two additional times (for a total of three rinses).
6. Dry the device with a sterile, lint-free cloth.
7. Visually inspect the device in a well-lit area to ensure all surfaces are clean. If the device is not clean, repeat the disinfecting steps above.
8. Dispose of the disinfectant according to the manufacturer’s guidelines.
9. Dampen a sterile, lint-free wipe with 70% IPA, and wipe the entire device surface for one minute. Using new wipes saturated with 70% IPA, repeat wiping the device five times for a total each time of one minute.
10. Examine the device for damage, such as cracks or splitting where fluid can enter.
11. If there is damage, discontinue using the device.