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GYN SURGICAL SOLUTIONS
Guide to Cleaning and Reprocessing
The Olive HD System for hysteroscopy Cleaning Instructions CAUTION: Wear protective gloves, clothing and a face mask for the cleaning of contaminated instruments. 1. Upon completion of the procedure, disassemble the components according to the component IFU. NOTE: Disconnecting the coupler is a sterilization requirement only.
2. Inflow/outflow and instrument port valves on the sheath should be in the open position. See figure 1. 3. Completely immerse components in a neutral pH enzymatic cleaning solution (i.e., Enzol® or equivalent) diluted to proper concentration per the manufacturer’s instructions. 4. While components are immersed: a) Remove any residual blood, protein material and contaminants from the components with soft-bristled brushes, sponges, soft cloths or cotton-tip applicator. See figure 2. b) CLEAN SHEATH CHANNELS: Flush the sheath channels/ports with cleaning solution. Clean the inside of the channels/ports with a soft-bristled cleaning brush.
Closed Valve
Figure 1.
Figure 2.
NOTE: Cleaning brushes should be cleaned and high-level disinfected or steam-sterilized after each use.
c) Triple rinse each component with distilled water. Flush out the sheath channels/ports using a syringe. See figure 3.
Figure 3.
5. Wipe dry using a soft, sterile lint-free cloth. See figure 4. NOTE: It is important to remove all cleaning solution before reprocessing.
6. After cleaning, inspect the instruments for cleanliness and/or damage.
This is not a replacement for the cleaning and reprocessing instructions contained within the IFU.
Figure 4.
Opened Valve
Reprocessing Instructions The following chart outlines the validated reprocessing methods for each component. Product
Sterilization
Refer to reprocessing sections for detailed instructions.
Steam (wrapped)
Scope
High-level Disinfection CIDEX® OPA (0.55% orthophthalaldehyde)
✓
Resert® XL HLD (2.0% hydrogen peroxide concentration solution)
*
*
Sheath (diagnostic)
✓
*
*
Sheath (operative)
✓
*
*
Luer lock connector
✓
*
*
Light cord
✓
✓
✓
✓
✓
*
*
Camera head 5 Fr. hand instruments
✓
Coupler
✓
✓ = Approved method * High-level disinfection is recommended only for semi-critical instruments that come into contact with intact mucous membranes. High-level disinfection is NOT recommended for critical instruments to be used for hysteroscopy. WARNING: Do not use immediate-use steam (FLASH) sterilization for any equipment. WARNING: Do not steam-sterilize the camera head. CAUTION: Any deviations from the recommended parameters for reprocessing should be validated by the user.
Steam Sterilization Guidelines (Use one of the two methods listed below for sterilization.) WARNING: Before sterilization, the instruments must be thoroughly cleaned and all visible organic material, blood and cleaning solution completely removed. CAUTION: During sterilization, components should not come into direct contact with metal. 1. Place the components in a sterilization tray. 2. Wrap with two layers of FDA-cleared polypropylene wrap or equivalent material. 3. The components are validated for the following steam sterilization methods: Pre-vacuum Steam Sterilization Temperature: 270°F - 272°F (132°C - 133°C) Exposure Time: 4 minutes Dry Time: 20 minutes Gravity Steam Sterilization (Gravity Autoclave) Temperature: 250°F - 252°F (121°C - 122°C) Exposure Time: 30 minutes 4. Components should be positioned in the sterilizer so that there is adequate circulation and penetration of steam, air removal and condensate drainage. A loosely loaded sterilizer allows the best penetration of sterilant. 5. At the completion of the steam sterilization cycle, all instruments should remain untouched until adequately cooled. This is not a replacement for the cleaning and reprocessing instructions contained within the IFU.
GYN SURGICAL SOLUTIONS
Manual High-level Disinfection Guidelines The Olive camera head and light cord are validated for manual chemical disinfection. Please refer to the chart for validated methods. CAUTION: Before disinfection, the instruments must be thoroughly cleaned, rinsed and dried, if applicable. CAUTION: To avoid damage, do not immerse the device in disinfectant solution for longer than one hour. 1. Prepare the disinfecting solution for use in accordance with the solution manufacturer’s label: CIDEX® OPA No activation is necessary. Use CIDEX (Activated Dialdehyde) Solution Test Strips to verify that the solution is above the minimum effective concentration (MEC). Test the solution prior to each use. Record the date that the solution was poured out of the original container. Resert XL HLD No activation is necessary. Use Verify® Chemical Monitoring Strip for Resert XL HLD Solution to confirm hydrogen peroxide concentration before each use. Record the date that the solution was poured out of the original container. 2. Completely immerse the components in the disinfection solution: CIDEX OPA minimum of 12 minutes at 68°F (20°C) Resert XL HLD (2% hydrogen peroxide concentration solution) minimum of 8 minutes at 68°F (20°C). NOTE: Fill the instrument and irrigation channels with disinfectant solution; a large luer tip syringe is useful for drawing disinfectant solution into the instrument channel. After disinfection has been completed, remove the components from the disinfectant solution and rinse by completely immersing in a large volume of sterile water. Keep the components in the water for a minimum of 1 minute. Repeat this procedure for a total of 3 immersion rinses. Discard the water after each rinse, as it will be contaminated with the disinfectant. Use fresh sterile water for each immersion rinse. NOTE: Please refer to the disinfectant manufacturer’s Instructions for Use for more detailed information regarding the use of the disinfectant solution, including proper rinsing techniques.
3. Dry the instruments with a sterile, lint-free cloth.
This is not a replacement for the cleaning and reprocessing instructions contained within the IFU.
Fog Prevention: 1. Dry coupler and camera head with dry, lint-free cloth.
2. With a new dry, lint-free cloth, dry threads on coupler and camera head.
3. Repeat step two with another dry, lint-free cloth.
4. Air-dry for one minute.
5. Tightly attach coupler to camera head.
This is not a replacement for the cleaning and reprocessing instructions contained within the IFU.
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