Single-Piece Laparoscopic and Rack Instructions for Use

2 Pages

Warning: Risk of injury: The electrosurgical cord must cover the Monopolar Post. - (see Figure 2)  Instructions For Use Single-Piece Laparoscopic Devices and Laparoscopic Rack  Figure 2  Slide-Lock (SL, SLR)  Warning: Risk of injury: DO NOT EXCEED maximum output voltage of 2000 Volts Peak at a Crest Factor of less than 1.6 DO NOT EXCEED maximum output voltage of 2100 Volts Peak at a Crest Factor of less than 2.8 DO NOT EXCEED maximum output voltage of 3000 Volts Peak at a Crest Factor of less than 5.5 Warning: Risk of injury: The non-conductive Luer Port Cap must securely cover the Luer Port during use. Warning: Risk of infection: Devices ship from manufacturer non-sterile. Clean and sterilize per these IFU (instructions for use) prior to use. Warning: Risk of injury: Neither the product nor the product container contains Natural Rubber Latex. Test cuts with scissors of materials containing Natural Rubber Latex may contaminate the device and result in an allergic reaction. Warning: Risk of infection: Do no reuse devices suspected to have been contaminated with transmissible spongiform encephalopathy (TSE) agents (prions). Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Caution: Incorrect application of medical devices poses a risk of injury. Users of medical instruments must have an appropriate medical qualification and be acquainted with the application. Caution: Laparoscopic surgery may result in gas embolism due to insufflation of gas into the abdomen. Caution: Sharp edges or pinch points may damage personal protective equipment such as surgical gloves.  1. 2. 3. 4.  Movable Handle Fixed Handle Handle Screw Luer Port Cap  5. Shaft Insulation 6. Rotation Assembly or Port Collar* 7. Slide Ratchet *Non-Rotatable instruments only  Monopolar (M, MR)  Caution: Due to the carcinogenic and infectious potential of electrosurgical by-products (such as tissue smoke plume and aerosols), protective eyewear, filtration masks, and effective smoke evacuation equipment should be used in both open and laparoscopic procedures. Caution: Do not re-sharpen Scissors. Caution: Keep the active electrodes clean. Build-up of eschar may reduce the instrument’s effectiveness. Do not activate the instrument while cleaning. Caution: Use instruments only in conditions that assure adequate visualization to minimize risk of misapplied electrosurgical energy. Caution: Output power selected should be as low as possible for the intended purpose. Caution: A singular instrument must be the sole conductor of energy to tissue. Do not conduct energy by touching an instrument to a second instrument contacting tissue. Caution: Wear of insert clevis may be an indication of impending mechanical failure, which may result in component coming loose during use. Caution: Proper care and maintenance of hand held laparoscopic instruments is essential for safe and effective operation. Prior to each use, instruments should be thoroughly examined for end of life indicators such as broken or worn parts which may inhibit the function. Specifically, instruments used for electro surgery must be checked for nicks, cracks, or damaged insulation. Careful inspection upon receipt and frequent inspection during use for functional integrity is recommended as a safeguard against possible injury to patient or operator. Instruments should be used with extreme care when inserting or removing from the cannula. Lateral pressure on the device during removal can damage the working tip, the shaft of the device, and/or insulation. Be sure the tips are closed and the device is pulled straight out until completely clear of cannula to avoid catching valve assemblies or dislodging the cannula. Caution: The non-conductive Luer Port Cap must be installed securely on the flush port during use to minimize insufflation leakage from the patient. The Luer Port Cap must NOT cover the flush port during cleaning and sterilization. Caution: Use of instrument for a task other than that for which it is intended may result in a damaged or broken device. For example:  Use of a delicate dissector as a grasper.  Use of a scissors to cut staples  Use of a 5mm grasper or dissector instead of a 10mm claw extractor forceps to remove excised tissue through cannula. Caution: Incorrect placement of trocars can adversely affect instrument effectiveness, patient safety, and operator comfort. Caution: Electrosurgical cords must comply with IEC 60601-2-2:2009. Always reference and follow the IFU (instructions for use) for Electrosurgical Cords. Caution: Electrosurgical Generators must comply with IEC 60601-2-2:2009. Always reference and follow the IFU (instructions for use) for the ESU (electrosurgical generator) 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. Use Single-Piece Laparoscopic Devices until the following end of life indicators are detected: End of life indicators include:  Cracked, broken, bent, missing, loose, or damaged components.  Damaged, missing, or modified shaft insulation, especially at the distal end of the tube assembly.  Intermittent electrical performance  Impaired mechanical function  1. 2. 3. 4.  Fixed Handle Movable Handle Handle Screw Monopolar Post  5. Luer Port Cap 6. Shaft Insulation 7. Rotation Assembly or Port Collar* *Non-Rotatable instruments only  Standard (S, SR) Ratchet (R, RR) Autoclosure (AC, ACR)  1. 2. 3. 4.  Fixed Handle Movable Handle Handle Screw Luer Port Cap  5. Shaft Insulation 6. Rotation Assembly or Port Collar* 7. Ratchet** *Non-Rotatable instruments only **Ratcheting Handles only  Graspers & Forceps (Various)  Warranty: 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. Single-Piece Laparoscopic Devices: One year warranty for defects in materials and workmanship. Return of Product: Regardless of age, if any Endoplus device needs service, return it to Endoplus. Contact Endoplus for a Return Goods Authorization (RGA) number. Prior to returning any device to Endoplus, it must be cleaned and sterilized per these IFU Instructions for Use. A Produce Safety Form must be attached to the outside of the box. Contact Information: Endoplus Customer Service: orders@endoplususa.com 847-325-5660, 800-236-5972 www. endoplususa.com Manufactured by: Endoplus, 750 Tower Rd, Suite A, Mundelein, IL 60060  4  1. Clevis 2. Shaft Insulation 3. Linkage Mechanism 4. Jaws (Various)  1  F-7.15.1 Rev H
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