CORE Dynamics Cannula Instructions for Use

ENGLISH/INSTRUCTIONS FOR USE CANNULA

READ ALL INFORMATION CAREFULLY BEFORE USING Attention This informational brochure is to assist you in the usage of, and care for, the Core Suction/Irrigation Cannula. This is not an instructional reference to laparoscopic surgery. Device Description Stainless Steel Cannulae devices function to irrigate and aspirate an endoscopic field when attached to a Core Trumpet Hand Control. The Cannulae are available with the following tip designs: Sump with Holes, Poole Suction, Micro Tip, and Stone Extractor with Sheath. These are reusable products, packaged non-sterile and are to be sterilized prior to use. Intended Use Cannulae have applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures for irrigation and aspiration at the surgical site. Instructions for Use Thread the Cannula into the front of the Core Trumpet irrigation and aspiration Hand Control. Securely attach the Cannula to the Hand Control to prevent leaking. Check the pressure of irrigant output prior to use. A pressure of 150-300 mmHg is appropriate although increases may be determined necessary at the discretion of the surgeon. Devices supplied non-sterile must be sterilized prior to initial use to avoid contamination. Prior to subsequent reuse, devices are to be cleaned and sterilized to avoid cross-contamination. Cleaning 1. Remove Sheath from Extractor (Stone Extractor only). 2. Use a mild detergent mixed to manufacturer’s specification for cleaning. NOTE: Luminox® brand detergent was utilized for the cleaning validation study. 3. Thoroughly scrub exteriors of products with a clean, soft brush dampened with detergent. 4. Thoroughly scrub interiors of products (as applicable) with a long cleaning brush or pipe cleaner dampened with detergent. 5. Clean product until able to visually verify soil removal. 6. Rinse product under running water to remove all traces of soap. 7. Rinse with distilled water. 8. Wipe product dry with lint-free towel. 9. Manipulate product to verify all visible surfaces are free of soil. If traces of soil are observed, repeat steps above. Sterilization The devices should be sterilized using an FDA cleared wrap indicated for these sterilization cycles. Prevacuum Sterilization Cycle Configuration Minimum Temperature

Wrapped 132°C

Cycle Time

4 minutes

Minimum Dry Time

10 minutes

Gravity Sterilization Cycle Configuration Minimum Temperature

Wrapped 121°C

Cycle Time

15 minutes

Minimum Dry Time

10 minutes

After cleaning and sterilization, verify presence of o-ring where devices connect to the Hand Controls and also inside of the Stone Extractor Sheath at the proximal end (to user).

Warnings

Procedures for endoscopic surgery should be performed only by qualified and trained physicians familiar with endoscopic surgical technique. A thorough understanding of the principles and techniques involved in laparoscopic laser procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical instruments. When endoscopic instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of the procedure. Do not use device where high pressure irrigant streams/tissue distension is required, e.g. in hysteroscopy and in encapsulated areas. Devices supplied non-sterile must be sterilized prior to initial use to avoid contamination. Prior to subsequent reuse, devices are to be cleaned and sterilized to avoid cross-contamination. Carefully check to ensure irrigation or suction lines connected to the luer on the hand control are linked with the appropriate irrigation or suction sources, respectively. The risk associated with surgical smoke toxicity may be mitigated by the use of an appropriate smoke evacuation system. Follow hospital procedure for venting of the pneumoperitoneum. Do not use for distension of the operating field.

Precautions

Federal law (USA) restricts this device to sale by or on the order of a physician. Core Electrodes and Cannulae are designed for use with Core Trumpet Hand Controls ONLY. Thoroughly inspect device for damage prior to initial use and subsequent reuse. If damage is found, instrument should not be used.

CONMED Corporation 525 French Road Utica, NY 13502-5994 USA Customer Service: 1-866-426-6633 USA FAX: (727) 399-5256 International FAX: +1(727) 397-4540 email: [email protected] www.conmed.com All rights reserved. 14106

Rev F

03/2022