DetachaTip III-Multi Use Laparoscopic Instruments With Luer Port Instructions for Use

ENGLISH/INSTRUCTIONS FOR USE STERILE

DetachaTip® III Multi-Use Laparoscopic Instrument with Luer Port READ AND BECOME FAMILIAR WITH ALL INSTRUCTIONS, WARNINGS, AND PRECAUTIONS PRIOR TO USING THIS PRODUCT. Description DetachaTip® III Multi-Use Laparoscopic Instruments are provided sterile in a variety of shaft configurations; scissors, graspers, dissectors. The outer shaft of these instruments is manufactured with a non-conductive material to allow for the use of these instruments during monopolar electrosurgical usage. These instruments comply with IEC 60601-1. Both a Multi-Use DetachaTip III Handle and a DetachaTip III Shaft with Luer Lock Port are required for use.

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Inspect the Luer Port Cap after each sterilization to ensure the cap fits tightly over the Luer Port. If the Luer port cap does not fit tightly, replace the Luer port cap. Ensure the Luer Port Cap is securely in place prior to and during use. 9. After use, this product may be a potential biohazard. Clean and re-sterilize as detailed in this IFU or dispose in accordance with accepted hospital or facility medical practice and following applicable local, state and federal laws and regulations. 10. This product is designed for non-continuous operation, with a duty cycle of 10 seconds ON, and 30 seconds OFF. Device Identification 8

Indications: The DetachaTip III Multi-Use instruments are intended for use in a variety of laparoscopic procedures to transect, dissect, grasp, and coagulate tissue. Contraindications: • These instruments are not intended for contraceptive coagulation of the fallopian tubes, but may be used to achieve hemostasis following transection of the fallopian tubes. • These instruments are not indicated for use by any person other than surgeons trained in laparoscopic procedures.

WARNINGS: 1.

Do not use the DetachaTip III Shaft for the purposes of suction/irrigation or any other purpose for which it is not intended to be used. Injury to patient and/or user may result. Actuation of electrosurgical unit simultaneously with suction irrigation mode may increase the capacitive coupling through the shaft area of the insulated instrument and cause arcing at the distal end of the instrument. 2. Laparoscopic procedures should be performed only by physicians with adequate training and knowledge of these procedures. In addition, medical literature should be consulted regarding techniques, hazards, contraindications, and complications prior to the performance of these procedures. 3. When electrosurgical instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of the procedure and ensure that electrical insulation is not compromised. 4. Use only with electrosurgical units that comply with IEC 60601-1 Standards. Do not exceed the maximum electrical capacity of the device. Maximum Rated Voltage is 2000 Vp. 5. Keep the voltage power as low as possible to achieve the desired end effect. Refer to use instructions provided by the electrosurgical generator manufacturer to ensure that all safety precautions are followed. Ensure the electrosurgical cord is fully mated with the device prior to electrosurgical use. 6. Using a metal cannula in conjunction with a plastic site stability device creates a potential hazard when using electrosurgical instruments. 7. Inspect the connecting insulation at the distal end of the shaft which intersects with the jaws for any broken, cracked, or torn surfaces or parts. If any of these conditions appear, do not use the instrument. 8. After prolonged electrosurgical use, residual heat in the instrument tip can cause tissue damage. 9. Care must be exercised during electrosurgery to avoid use in areas of explosive gas concentrations. 10. The risk associated with surgical smoke toxicity may be mitigated by the use of an appropriate smoke evacuation system. Follow hospital procedures for venting of the pneumoperitoneum. 11. Do not activate the electrosurgical function of the device until the tip of the instrument is touching the target tissue. 12. It is strongly recommended that the surgeon use high quality surgical gloves that have good insulation properties, thereby minimizing the risk of puncture and burn. 13. The functional tip and shaft of the device are the applied parts.

Precautions: 1. 2. 3. 4.

These devices are provided sterile for multiple use. Instruments are to be resterilized using steam sterilization (See Instrument Care, Cleaning & Sterilization Instructions). Federal (USA) law restricts this device to sale by or on the order of a physician. This instrument should be used with IEC 60601-1 approved recognized monopolar electrosurgical generators with the capability of being activated with a foot switch. Before using the instrument, make sure the Luer Lock Cap is securely in place to prevent pneumoperitoneum leakage.

Handling of Insulated Instruments DetachaTip III Instruments are precision surgical laparoscopic instruments. To ensure lasting quality of the instruments, please follow the handling instructions described below: 1. Always support the instrument by firmly grasping the handle, or proximal end of the instrument. Never handle the instrument by the distal end alone. Never place heavy items on top of the instruments. 2. Avoid overstressing mechanisms of instruments by properly gripping and maneuvering during surgery. If excessive force is applied, the mechanism can be easily overstressed resulting in damage or breakage. 3. The DetachaTip III instruments are designed for use with the DetachaTip III Instrument Tray (3-4329) and DetachaTip III Plus Instrument Tray (3-4343). Directions for Use 1. Inspect the package and product for damage. Do not use if packaging is breached or product is damaged. This instrument is delivered sterile. No modification of this device is allowed. The blue foam must be removed and discarded per hospital protocol. 2. This device is designed for introduction and use through a port of appropriate size. 3. The jaw tips must be closed prior to insertion into or removal from the cannula. 4. The jaw tips open and close to cut, dissect and/or grasp tissue by actuating the ring handles. 5. The device is equipped with a standard 4mm male plug connector. To operate the monopolar electrosurgical feature, follow instructions provided by the electrosurgical generator manufacturer. 6. Shaft must be assembled to handle prior to use, refer to Assembly Instructions. 7. The device shaft is equipped with a standard Luer Lock Connector located on the rotation knob of the shaft. The Luer Lock facilitates cleaning the interior of the instrument shaft, using either the manual or the automated cleaning methods (See Instrument Care Cleaning and Sterilization Instructions).

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Distal End Scissors/ Grasper/Dissector Shaft Lot Code Non-Conductive Composite Shaft Luer Port Cap Rotation Knob Proximal End Inserts Into Handle Shaft Release Button

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REF 3-XXXX

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8. 9. 10. 11. 12. 13. 14. 15.

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5 4 mm Standard 15 Monopolar Post Thumb Bump for Palming Ratchet Lever Thumb Ring Scallop for Palming Pinky Finger Bump Handle Lot Code Index Finger Bump

REF 3-1010 XXXXXXX

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Assembly Instructions 1. Use with DetachaTip III Handle (REF 3-1010) 1.1. Connecting the Shaft to the Handle Using sterile techniques, hold the shaft and front finger ring of the handle as shown in Illustration 1. Ensure that the thumb-ring has free movement, and the ratchet is in the “OFF” position before inserting the instrument shaft. Firmly insert the shaft into the handle. The thumb-ring will swing down as the shaft locks in place. Rotate the shaft 360° in the handle to make sure it locks in Illustration 1. Allow thumb ring free range of place. Check function of handle and working motion during insertion and removal tip to confirm proper assembly. 1.2. The universal handle is designed to be held around the inside of both handle finger holes, the front finger ring and the thumb-ring. They are intended to maximize surgeon comfort and flexibility. Palming the instrument is also designed into the handle features using the thumb-bump, or the thumb-scallop. DetachaTip III Handle allows for use with or without the locking ratchet. Ratchet OFF allows for use of any shaft without ratchet function. With the exception of the scissors, ratchet ON allows for ratcheting function regardless of the ratchet lever position. Slight downward movement of the ratchet lever (in the ON position) towards the front ring handle, releases the ratchet momentarily. Upon release of the ratchet lever, ratchet automatically returns to the ON position. NOTE: The ratchet will only function with a Grasper/Dissector shaft. 1.3. Detaching the Shaft from the Handle Make sure the ratchet lever is in the “OFF” position. Push downward on the blue shaft lock release button while holding the top of the handle, as shown in Illustration 2. While holding the button down, pull the shaft and handle apart. The thumb-ring will swing up as the shaft detaches from the handle.

Illustration 2. Allow thumb ring free range of motion during insertion and removal

DetachaTip III Laparoscopic instrument functionality has been validated after thirty (30) steam sterilization cycles at 134°C/273°F with 18 minute hold time. The useful life span of a surgical instrument is largely dependent on the care and handling of the instrument. For optimal product life, protect the DetachaTip III instruments from contact with other instruments during decontamination and re-sterilization. Allow instruments to cool and dry prior to handling. USE OF CHLORINATED CLEANING OR DISINFECTING AGENTS IS CONTRAINDICATED AND MAY CAUSE DEGRADATION OF INSTRUMENT MATERIAL AND MAY CONTRIBUTE TO INSTRUMENT BREAKAGE.

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P/N 14152 REV F 12/2021