Laparoscopic Scissors Insert Instructions for Use

Manual Cleaning Instructions for Scissors Inserts and Laparoscopic Rack:

Instructions For Use

1. Prepare an enzymatic / neutral pH detergent in warm water (15°C - 30°C or 59°F to 86°F) per detergent manufacturer’s IFU (Instructions for Use). 2. Prior to removing Inserts from the Handle Assembly, flush the device with a minimum of 60mL of enzymatic/neutral pH detergent solution through the Luer Port. 3. Completely immerse assembled devices in the enzymatic/neutral pH detergent solution and allow devices to soak for a minimum of 5 minutes. Actuate all movable parts during the initiation of the soak time. 4. Remove Inserts from the Handle Assembly. 5. Ultrasonic clean Inserts/Devices/Laparoscopic Rack in enzymatic/neutral pH detergent solution for a minimum of 10 minutes. 6. Using a hand held soft bristle brush, use a back and forth motion to brush all surfaces of Inserts/Devices/Laparoscopic Rack with particular attention paid to jaws, clevis, linkage mechanism, and crevices.  External Brush Characteristics: Soft nylon (nonmetallic) bristled tooth brush 7. Rinse Inserts/Devices/Laparoscopic Rack by completely immersing in enzymatic/neutral pH detergent solution. 8. If visible soil is detected following the rinse, repeat ultrasonic, brushing, and rinsing steps until visible soil is no longer detected. 9. Rinse the Inserts/Devices/Laparoscopic Rack by completely immersing in warm water for a minimum of 30 seconds to remove any residual detergent or debris. 10. Visually examine each Inserts/Devices/Laparoscopic Rack for cleanliness. 11. If visible soil remains, repeat cleaning procedure.

Laparoscopic Scissors Insert

Modular Monopolar Handle Component Key: 1. Fixed Handle 2. Movable Handle 3. Brush port 4. Handle Screw 5. Monopolar Post 6. Luer Port Cap 7. Shaft Insulation 8. Rotation Assembly

Inspection/Maintenance Instructions for all Inserts AND all Handle Assemblies: Proper care and handling is essential for satisfactory performance of any surgical device. The steps in these Instructions for Use should be taken to ensure long and trouble-free service from all your surgical devices. Inspect devices before each use for end of life indicators. Specifically, instruments used for electrosurgery must be checked for nicks, cracks, gaps, or damage to shaft insulation. Careful inspection upon receipt and frequent inspection during use for end of life indicators and functional integrity is recommended as a safeguard against possible injury to patient or operator. If any conditions appear which would indicate that the device is not safe for use, do not use the device and return the device to Endoplus for investigation.

Scissors Insert Component Key: 1. Scissor Blades 2. Fulcrum Pin 3. Clevis 4. Actuating Rod

Lubricate prior to sterilizing by immersing for a minimum of 30 seconds in instrument milk or a steam permeable/water soluble lubricant. Allow devices to drip dry approximately 3 minutes following lubrication and prior to packaging for sterilization. Follow the lubricant manufacturer's IFU (Instructions for Use). Do not use silicon, mineral oil, or petroleum based lubricants. Sterilization Instructions: Handle Assemblies may be sterilized with the Insert installed. Flush Port Cap must be open during sterilization. Configure devices so that water pooling does not occur. Prevacuum Steam Sterilization Parameters if Sterilized in Instrument Wrap: Minimum Preconditioning Pulses: 3 Minimum Temperature: 132°C (270°F) Minimum Exposure Time: 4 minutes Minimum Dry Time: 20-30 minutes Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply) Storage Instructions if Sterilized in Instrument Wrap: Devices must remain wrapped and be stored in a clean, dry environment to maintain sterility. Follow the Instrument Wrap manufacturer's IFU (Instructions for Use). Prevacuum Steam Sterilization Parameters if Sterilized in a Rigid Container: Minimum Preconditioning Pulses: 3 Minimum Temperature: 132°C (270°F) Minimum Exposure Time: 4 minutes Minimum Dry Time: 0 minutes Sterilization Configuration: Devices in a Laparoscopic Rack which is inside of a Rigid Container Storage Instructions if Sterilized in a Rigid Container: Devices must remain sealed in the rigid container, which has been validated to maintain sterility. Follow the Rigid Container manufacturer's IFU (Instructions for Use) for shelf life. Product Life: Expected life is greatly dependent upon the care, handling, and use of the devices. Product life may be reduced by improper handling, excessive force, or third party modifications. Modular Handle Assemblies: Use until Handle Assembly exhibits end of life indicators. End of life indicators include:  Cracked, broken, bent, missing, loose, or damaged components.  Damaged, missing, or modified shaft insulation, especially the distal end of the Tube Assembly.  Intermittent electrical performance  Impaired mechanical function Product Life: Scissors Inserts: Use until a Scissor Inserts exhibit end of life indicators. End of life indicators include:  Cracked, broken, bent, missing, loose, or damaged components.  Damaged, missing, or modified insulation sheath  Scissors that do not cut or impaired mechanical function  Scissors that have been re-sharpened Warranties: Instruments returned for warranty service which Endoplus determines to be defective in materials or workmanship will either be repaired or replaced by Endoplus without charge. Warranty is void if in Endoplus’ sole determination the device has been used for purposes other than intended, damaged by misuse, damaged by excessive force, or has been altered by a third party. Handle Assemblies: One year warranty for defects in materials and workmanship. Scissor Inserts: 30 day warranty for defects in materials and workmanship does not cover Scissors Inserts which no longer cut after initial use or have been re-sharpened. Return of Product: Regardless of age, if any Endoplus device needs service, return it to Endoplus. 1. Contact Endoplus for a Return Good Authorization (RGA) Number and follow instructions on the website. 2. Prior to returning any device to Endoplus, devices must be cleaned and sterilized per these (IFU) Instructions for Use. 3. A Product Safety Form must be attached to the outside of the box when returning devices. Manufactured By: Endoplus 750 Tower Road, Suite A Mundelein, IL 60060 www.endoplususa.com

4

Intended Use: Hand held Laparoscopic instruments are intended for grasping, cutting, dissecting, retracting, clamping, biopsy, and/or cauterization of tissue. The devices are used in conjunction with a laparoscope during laparoscopic procedures. Instruments should be used only by personnel completely familiar with their operation. Using an instrument improperly for a task which it was not intended may result in a damaged or broken instrument. Contraindications:  Do not activate the electrodes during use if laparoscopic electrosurgical techniques are contraindicated.  DO NOT USE if use if laparoscopic methods have been contraindicated. Supplied Contents: Handle Assemblies and Scissor Inserts are sold separately. Safety Information: Warning: Risk of Injury and Damage to Products:  Failure to read and follow this IFU (Instructions for Use) and the IFU of products used in combination can result in injury or death to patients, users, and third parties as well as damage to the product. Warning: Risk of Injury:  Do not use instruments with damaged or missing insulation. Inspect instruments and cables for damage prior to each use. Insulation failures may result in burns or other injuries to the patient or operator.  There is a risk of injury if active electrodes come into contact with other conductive devices and accessories.  Keep electrical connections dry while in use to prevent unintended conduction of HF current.  Do not activate instrument when not in contact with target tissue, as this may cause injuries due to capacitive coupling.  The surface of the active electrode may remain hot enough to cause burns after the RF current has been deactivated.  Activating the electrosurgical unit simultaneously with suction/irrigation may alter the path of energy. Aspirate fluid from the area before activating the instrument. Conductive fluids (e.g., blood or saline) in direct contact with or in close proximity to an active electrode may alter electrical current which may cause unintended burns to the patient.  Incorrectly assembled and damaged devices can lead to injuries to the patient or operator. Devices and all accessories used in combination must be checked immediately before and after use. Check for missing parts, damaged insulation, loose parts, cracks, broken parts, or bent parts. Verify that devices are fully functional.  The use of excessive force may result in medical devices which malfunction. Regardless of age, any Endoplus devices requiring service should be returned to Endoplus.  If application parts are used outside of the field of vision there is a risk that tissue and accessories could be damaged unintentionally. Always hold the application parts of the active electrode and other instruments which transmit energy in a target-oriented manner and in the field of vision during application.  When not in use, stage devices in a visible area not in contact with the patient to minimize the risk of accidental activation and inadvertent patient contact.  DO NOT USE with hybrid trocar systems, i.e. a combination of metal and plastic. This may result in alternate site burns due to capacitive coupling. Use only all-metal or all plastic trocar systems.  Connect adaptors and accessories to the electrosurgical unit only when the unit is off. Failure to do so may result in electrical shock, burn, or fire hazard.  Prior to increasing the intensity, check the adherence of the neutral electrode and its connections. Apparent low output or failure of the device to function correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact in its connections.

1

F-7.15.3 Rev ORG