Novartis

A/W, DFU, BIPOLAR COAG REUSABLE

Reusable Bipolar Coagulation Accessories Directions for Use

3 Pages

REV L M  REVISION HISTORY CN CN044786ECN CN050221ECN  DATE 07/17/13 1/16/14  DO TH NOArtwork for IS T Reusable Bipolar P Coagulation Accessories PAGERINT DIRECTION FOR USE  DFU SIZE 4...  X 6...  Inches  BY E...  STEDMAN  DATE 10/30/97  CHECKER RE  DATE 11/5/97  APPROVED R... OSSBACK  DATE 11/5/97  FORMAT REVISION 11/10/2010  THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION WHICH SHALL NOT BE REPRODUCED OR TRANSFERRED TO OTHER DOCUMENTS OR DISCLOSED TO OTHERS OR USED FOR MANUFACTURING OR ANY OTHER PURPOSE WITHOUT PRIOR WRITTEN PERMISSION OF ALCON  DESCRIPTION A/W,DFU,BIPOLAR COAG REUSABLE  DRAWING NUMBER 328-1002-401  REV M  SCALE: 1:1 SHEET i OF i   DIRECTIONS FOR USE  Reusable Bipolar Coagulation Accessories  Refer to the Driving Console Operator’s Manual (and Addendums)  For Bipolar Coagulation Accessories Compatibility  CAUTION: The Bipolar Coagulation Accessory Directions-for-Use are not intended to substitute for the necessity of reading and  understanding the driving console Operator’s Manual... he Operator’s Manual, which is provided with the console, includes  in-depth material intended to familiarize the Operating Room Staff with the controls and functions of the console... CAUTION: U...  federal law restricts this device to sale by or on the order of a physician... WARNINGS  1... f the Bipolar Coagulation Accessory is received in a defective condition, do not use and notify Alcon immediately:  By Phone: (In USA) (800) 445-2389 or (713) 668-9100  By Mail: Alcon  Ask for Consumer Affairs  Attention: Consumer Affairs  (International) contact local Alcon representative  9965 Buffalo Speedway  Houston, TX 77054-1309... SA  Each package is identified by a Lot Number which provides traceability and should be given to the Consumer Affairs  Department when discussing the Bipolar Coagulation Accessory... 2... lcon assumes no responsibility for complications that may arise as a result of the improper reuse or improper usage of the  Bipolar Coagulation Accessories... 3... hese accessories used in conjunction with an Alcon® ophthalmic surgical console constitute a complete surgical system... Use of accessories other than those of Alcon may affect system performance and create potential hazards... 4... erify that all connections are thoroughly dry prior to use... o not activate coagulation while holding forceps with an un-  gloved hand or while forceps are in contact with a metallic surface... ailure to do so may result in electrical shock... 5... onnect cables and instruments to the surgical console only while the coagulator mode is off (standby)... ailure to do so  may result in injury or electrical shock to the patient or operating room personnel... 6... ables should always be positioned in such a way that contact with the patient is prevented... 7... ipolar accessories should be checked before each use for tip damage (i...  misalignment, burrs, bending or discoloration) or  insulation damage (i...  cracks, nicks, lacerations or abrasions); electrode cables should particularly be checked for possible  damage to the insulation... amaged instruments or cables should be discarded and replaced... sing forceps or cables which  are damaged can be hazardous to both the patient and operating room personnel... 8... hese bipolar coagulation accessories are limited to extraocular uses only... 9... lammable agents or solvents should be allowed to fully evaporate before the application of high-frequency energy... 10... o reduce the risk of accidental burns, caution should always be taken when operating high-frequency surgical equipment... 11... o not use the coagulation devices on patients with pacemakers... f electrosurgery is used on patients with implanted  cardiac pacemakers or pacemaker electrodes, be aware that irreparable damage to the pacemaker and its function may  occur and lead to ventricular fibrillation... 12... f in the medical opinion of the physician a patient with a prion related disease undergoes a high risk procedure, the  instrument should be destroyed or be processed according to local requirements... DESCRIPTION: Each package contains one non-sterile reusable bipolar coagulation forceps or cable... DIRECTIONS FOR USE:  Setup:  1... ithin the sterile field, the Scrub Nurse should attach the sterile forceps or brush to the sterile bipolar cable ensuring that  instrument pins are fully in the cable receptacle... 2... he Scrub Nurse passes the other end of the cable to the Circulator and ensures that the instrument and sufficient cable  remain in the sterile field... 3... fter verifying that the coagulator mode is off (standby), the Circulator inserts the bipolar cable safety plugs into the  surgical console bipolar coagulation (“COAG”) connectors... CLEANING AND STERILIZATION: Alcon recommends a maximum of twenty (20) uses of reusable bipolar coagulation  accessories... Note:	The following cleaning and sterilization instructions provide a method for effectively cleaning and sterilizing the  Reusable Bipolar Coagulation Accessories per EN ISO 17664¹... ue to the potential for Toxic Anterior Segment  Syndrome (TASS), Alcon does not recommend the use of enzymatic cleaners, detergents or disinfectant solutions... f,  however, local jurisdictions mandate their use relative to ophthalmic instruments, the materials of construction of the  Reusable Bipolar Coagulation Accessories are compatible with both, up to a pH of 11...  when the enzymatic chemicals,  detergents or disinfectant solutions are completely rinsed/neutralized immediately after cleaning/processing per the  surgical facility’s standard procedure... 1... horoughly clean bipolar coagulation accessories before initial use and IMMEDIATELY after each subsequent use... o not  store or allow the accessories to dry after use until thoroughly cleaned... 2... leaning Procedure: Manual  Perform the following steps to thoroughly clean the accessories:  Step One: Unplug the bipolar cable from the console and disconnect the instrument from the cable... Step Two: Discard single use cables, brushes or forceps according to surgical facility guidelines... Step Three: Wipe off any residue with a soft, clean, lint free non-abrasive cloth and rinse the forceps and/or cable with  room temperature sterile deionized water to remove any remaining debris... f necessary, hand wash the forceps and/or  cable using a soft bristled brush... he use of abrasive cleaners or solvents is not recommended... Step Four: Thoroughly flush all surfaces with room temperature sterile deionized water until no visible debris remains... Step Five: Dry the forceps and/or cables with a soft, clean, lint free nonabrasive cloth... Step Six: Visually inspect to ensure the bipolar coagulation accessories are clean and dry... epeat the process as needed... Step Seven: Place the cleaned bipolar coagulation accessories in an autoclavable tray to prevent damage to forceps  (especially tips) and cables during storage and autoclaving or wrap to prevent damage in preparation for autoclaving... Loosely coil (10 - 15 cm diameter) the reusable bipolar cables... o prevent damaging the cable insulation or inner wire,  avoid kinking, sharply bending or placing heavy objects on the cables... 3... leaning Procedure: Automatic  In the event use of an automated process is required, perform all of the following steps to process the Bipolar Coagulation  Accessories... Note: a) Due to the potential for the accumulation of particulate and bioburden residues in the washer water reservoirs, it is  the surgical facility’s responsibility to properly maintain the equipment and their associated filters to ensure the introduction  of contaminant free solutions to the Bipolar Coagulation Accessories... - 1 -
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