Neuro/Spine Bi-Polar Forceps

Artwork No: 36-5093B

DCN No: 43528

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Business Unit: V. Mueller

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Label: DIRECTION INSERT

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Description: Bi-Polar instruments 1.0 2.0 2.1 2.2 2.3 3.0

s DESIGNATED INSPECTION DIMENSION OR CHARACTERISTIC PHYSICAL REQUIREMENTS: Dimensions: 8.5”W x 11”H Material: WHITE STOCK Color of Ink: BLACK SUPPLIER IDENTIFICATION REQUIREMENTS: Identify each carton or bundle in a shipment with CareFusion stock number, CareFusion P.O. number, manufacturer’s name, and quantity.

4.0 COPY REQUIREMENTS: 4.1 Printed content must match artwork exactly. s See artwork below. 4.2 Units must be free of dirt and smeared ink s which is easily visible at a distance of 12 - 189. 4.3 Clean sharp edges, free of shreds, wrinkles, and loose particles. 4.4 Printing must be legible. s 5.0 SPECIAL REQUIREMENTS:

V.Mueller® Neuro/Spine Bi-Polar Forceps Devices Bipolar forceps are reusable simple hinged surgical instruments supplied by CareFusion, V.Mueller, for use in general surgical procedures and designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy, activated by a foot switch. Cautions & Warnings Any variation between what is suggested here and your facility’s policies and procedures or those indicated by your sterilizer manufacturer should be brought to the attention of the appropriate responsible persons for direction before using, cleaning, and sterilizing your instruments. Federal Law (USA) restricts this device to sale by or on the order of a physician only. Failure to observe these Cautions and Warnings may result in injury, malfunction or other unanticipated occurrences or events for the operator, staff and/or the patient. Incorrect handling and care as well as misuse can lead to premature wear of surgical instruments. Prior to use, all instruments should be inspected to insure proper function and condition. Do not use instruments if they do not perform satisfactorily in an operational test. Please read all information contained in this insert. Incorrect handling and care as well as misuse can lead to premature wear of surgical instruments. Special safety precautions should be observed when using electrosurgical instruments. Electrosurgical instruments can pose a significant shock, burn or explosion hazard if used improperly, incorrectly or carelessly. Electrosurgical instruments should be used only by individuals who are trained and licensed to use such devices. Examples of such training and experience include: Training through qualified residency program, surgical skills workshops, training programs offered by equipment manufacturers or preceptorship/surgical assistant training. Adverse events reported while using bipolar electrosurgical devices include: • Inadvertent activation with resultant tissue damage at the wrong site and/or equipment damage. • Fires involving surgical drapes and other combustible materials. • Alternate current pathways resulting in burns where the patient or physician or assistant is in contact with exposed metal. • Explosions caused by electrosurgical sparking in a flammable gas environment (i.e. explosive anesthetic gases or combustible liquids). • Organ perforation. Sudden massive hemorrhage. Avoid touching or grounding electrosurgical instruments to non-insulated instruments, scopes, trocar sleeves, etc. All persons using such devices should be knowledgeable in the use and handling of laparoscopic instruments, coagulation equipment, their accessories and other related equipment. Written Standard Operating Procedures for the cleaning, sterilization, storage, inspection and maintenance of the instruments, accessories and equipment are recommended.

Initial use of new instruments Every instrument must be cleaned and sterilized before it is used for the first time. The instrument was developed for sterilization by autoclave and has shown good results using this method. Preparation for Cleaning • Disassembly of the instrument not required. Remove the connector cord (cable) from the instrument, clean and sterilize separately. Cleaning and Maintenance Every surgical instrument should be disinfected and thoroughly cleaned after each use. Proper cleaning, inspection and maintenance will help ensure correct function of the surgical instrument. Clean, inspect and test each instrument carefully. A good cleaning and maintenance procedure will extend the useful life of the instrument. Special attention must be paid to slots, stops, ends, hollow tubes and other highly inaccessible areas. Check insulation, cables and connectors for cuts, voids, cracks, tears, abrasions, etc. Do not use damaged instruments. Cleaning and rinsing must take place immediately after each use for best effect. Failure to clean promptly may result in adherent particles or dried secretions that may resist cleaning and complicate or resist future sterilization. Instruments must be completely cleaned and rinsed of all foreign matter. Use warm water and a commercially available instrument pre-soak or cleaning agent. Enzymatic cleaners must be used to remove protein deposits. Follow the enzymatic cleaner’s instructions; rinse thoroughly. Your V. Mueller sales representative can provide a full line of cleaning solutions and other instrument care products. • Do not use corrosive cleaning agents (i.e. bleach). Cleaning solutions and rinses at or near a neutral pH (7.0) are best. • Do not use abrasive cleaners. • Only a soft bristle brush should be used. • Can be disinfected in the washing machine up to 203°F (95°C). • Rinse thoroughly with distilled water. • Prepare for storage and/or sterilization. After cleaning and rinsing, dry instruments completely and carefully with compressed air (including inside channels and highly inaccessible areas). Note: After cleaning and before sterilization, lubricate the instrument before autoclaving with InstraLube™, or a steam permeable instrument lubricant, especially blades, ends, stops, snaps and all movable parts. Inspection and functional check It is very important to carefully examine each surgical instrument for breaks, cracks or malfunctions before use. It is especially essential to check areas such as blades, points, ends, stops and snaps as well as all movable parts. Do not use damaged instruments. Never attempt to make repairs yourself. Service and repairs should be referred to trained qualified persons only. Refer questions about repair to your V. Muller sales representative.

Do not use electrosurgical instruments on patients with pacemakers. Electrosurgical generators used with these devices are designed to cause destruction of tissue and are inherently dangerous if operated improperly. Follow all safety precautions and instructions supplied by the manufacturer of the electrosurgical generator. The electrode tip must always be in full view before activating power. Apply power only when electrode tip is in full contact with the tissue selected for coagulation. Electrode tip must not come in contact with other metal instruments during use. Limitations on reprocessing Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and damage due to use. Instructions Point of use Connect and disconnect instruments, cords, adapters, and accessories only while the generator is off (standby). Verify that all electrical currents have ceased prior to the cleaning of these instruments. Failure to do so could result in injury, malfunction or other unanticipated occurrences or events for the operator, staff and/or the patient. Containment and Transportation • It is recommended that instruments are reprocessed as soon as is reasonably practical following use.

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At the lowest power setting, test the forceps by pressing the generator’s activating switch. If the generator fails to activate, check the forceps connection with the cable, and the cable with the generator. If activation is still not achieved, check the switching mechanism (foot switch or hand stitch). Storage and sterilization Instruments must be stored in a clean, dry, moisture free area. The instruments should be stored individually in their shipping carton or in a protective tray with partitions. Protect tips with cloth, gauze or tubing if stored in drawers. Bi-Polar instruments are reusable and meet AAMI standards for sterilization. Sterilization Sterilization of instruments may be accomplished by Autoclave. Follow the sterilizer manufacturer’s instructions for operation and loading of steam autoclaves. Other time and temperature may be used provided the user has successfully validated those cycles. There must be direct steam exposure to all surfaces of the instruments being sterilized including the internal surface and tube channels. Allow instrument to air cool to room temperature before use. • Do Not sterilize instruments at temperatures over 137°C (280°F). Parameters for Steam (Autoclave) Sterilization Temperature Exposure 132°C(270°F) 15 Minutes

Drying 45 minutes

Storage All surgical instruments must be handled with the greatest care when being transported, cleaned, treated, sterilized and stored.This is especially true for blades, fine points and other sensitive areas. Surgical instruments corrode and their functions are impaired if they come into contact with aggressive materials. The instruments must not be exposed to acids or other aggressive cleaning agents. Guarantee We guarantee every surgical instrument bearing the V. Mueller brand name to be free of functional defects in workmanship and materials when used normally for its intended surgical purpose. Any V. Mueller instrument proving to be so defective will be replaced or repaired at no charge.

CareFusion 75 North Fairway Drive Vernon Hills, IL 60061 USA

Instra-Lube is a trademark of CareFusion, V.Mueller Products and services or one of its subsidiaries.

36-5093B

Proofed by: ____________________________ Date: _____________ Dimensions checked: ______________ Copy checked: _____________

36-5093B S. Sebastian 12-08-14 12-29-14