ENDO SMARTCAP Adapter Instructions Rev E 2019

ENDO SMARTCAP™ Adapter

ENDO SMARTCAP™ Adapter for OLYMPUS® UCR® CO2 Insufflators #100555 For connecting an OLYMPUS® UCR® CO2 Intra-luminal Insufflation Unit to ENDOGATOR™ Hybrid Tubing or ENDO SMARTCAP™ CO2 Source Tubing

Intended Use: The ENDO SMARTCAP™ Adapter connects to the gas outlet port on the front of the OLYMPUS® UCR® CO2 Intra-Luminal Insufflation Unit. The ENDO SMARTCAP Adapter provides a connection for the ENDO SMARTCAP™ CO2 Source Tubing or the ENDOGATOR™ Hybrid Irrigation Tubing.

Warnings and Precautions: Guidelines for Preventing Cross Contamination:

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ALWAYS prime the air/water channel prior to inserting the GI endoscope into the patient. NEVER attach or reattach the ENDOGATOR Hybrid Tubing or ENDO SMARTCAP CO2 Source Tubing to a GI endoscope that is/was inside a patient and has not been reprocessed. NEVER turn off the CO2 supply while the ENDOGATOR Hybrid Tubing or ENDO SMARTCAP CO2 Source Tubing is attached to the GI endoscope. If any of the above prevention guidelines were not followed, or there is any reason to believe that the ENDOGATOR Hybrid Tubing system or ENDO SMARTCAP CO2 Source Tubing was contaminated, immediately discard the entire tubing, accessories and water bottle. Replace with new tubing and an unopened sterile water bottle. • ALWAYS inspect the GI endoscope’s o-rings and gaskets (air/water button, GI endoscope connection, etc.) for damage. Damaged components can result in less than optimal performance of the ENDOGATOR Hybrid Tubing or ENDO SMARTCAP CO2 Source Tubing. Contact customer service for assistance. Federal (USA) law restricts the sale of this device by or on order of a physician.

ONLY

WARNING: To prevent cross contamination, always prime the air/water channel prior to inserting the GI endoscope into the patient.

Instructions for Use: 1. 2. 3. 4. 5.

Open the peel pack and remove the ENDO SMARTCAP Adapter. Place the ENDO SMARTCAP Adapter on the “gas outlet port” on the front of the OLYMPUS UCR Endoscopic CO2 Regulation Unit. Turn the ENDO SMARTCAP Adapter clockwise until it is held securely in place. Use the luer connector of the ENDOGATOR Hybrid Tubing or the ENDO SMARTCAP CO2 Source Tubing to connect to the ENDO SMARTCAP Adapter. Turn luer until firmly connected. For directions related to the ENDO SMARTCAP™ Irrigation Tubing, the ENDO SMARTCAP CO2 Source Tubing or the ENDOGATOR Hybrid Tubing, please see the product specific instructions for use.

Cleaning, Disinfecting or Sterilizing the ENDO SMARTCAP Adapter: Guidelines for Reprocessing Adapter:

• •

Always follow national and local guidelines and your hospital’s infection control department to determine appropriate high level disinfection or sterilization procedures. The ENDO SMARTCAP Adapter does not require cleaning, disinfection or sterilization. If your internal and/ or local guidelines require these steps, the instructions are listed below.

Cleaning Steps: 1. 2. 3. 4. 5. 6. 7. 8. 9.

Immerse the adapter in the basin with detergent solution. Using a clean, lint-free cloth, clean the outer surface in detergent solution. Attach the 30 cm3 (30 ml) syringe to the adapter and flush thoroughly with detergent solution to clean the inside. Soak the adapter for the amount of time and at the temperature recommended by the detergent manufacturer. Remove the adapter from the detergent solution and place it in clean water. Using a clean, lint-free cloth, clean the outer surface of the adapter under the surface of the clean water. Remove the adapter from the clean water. Attach the 30cm3 (30 ml) syringe to the adapter and flush with air to remove the detergent solution from the inside. Wipe and dry the outer surface with a clean, lint-free cloth.

English

IFU-64 / Rev E