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The procedures for proper handling and care of KARL STORZ Bipolar Instruments are described in this manual. KARL STORZ Bipolar Instruments are delicate surgical instruments and should be handled with care.
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Illustrated Description Single Tube Bipolar Forceps...
Contents Illustrated Description.......4 General Information for the Safe Use of Bipolar Instruments ......7 Inspection ..........12 Handling of Bipolar Instruments.....13 Cleaning and Sterilization Instructions ...14 Bipolar Forceps, Take-apart Bipolar Instruments.........20 Bipolar Electrodes/Coagulation Probes ..........28 Bipolar Suction Coagulators....29 Cleaning Accessories Available from KSEA ..........30 Shipping ..........30...
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General Information for the Safe Use of Bipolar Instruments User Qualifications These instruments may only be used by licensed physicians and qualified medical personnel who have been trained in their use. Warnings and Precautions Please read this manual carefully. It is very important that the user be thoroughly familiar with the operation of the instrument prior to use on a patient.
General Information for the Safe Use of Bipolar Instruments (Continued) Description of Device KARL STORZ bipolar instruments and Take- apart bipolar instruments include, but are not limited to, forceps, coagulating electrodes and suction coagulators. All KARL STORZ bipolar instruments conform to the following...
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Careful monitoring of gas volume and patient pressure should be performed throughout electrosurgical procedures in order to minimize any such risk. KARL STORZ recommends that gas insufflation NOT be used during operative hysteroscopic proce- dures.
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General Information for the Safe Use of Bipolar Instruments (Continued) WARNING: Gas emboli, the entrapment of air in the systemic circulation, have been reported in association with hysteroscopic surgery and the occurrence of cardiovascular collapse and death. Priming media inflow lines and purging them of air may reduce the incidence of gas emboli.
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WARNING: DO NOT use laser fibers when using electrosurgical instruments. WARNING: Avoid long activation of the electrosurgical generator to reduce the pos- sibility of RF leakage current. WARNING: Use surgical gloves specifically designated by their manufacturer for electro surgical procedures. The use of other gloves may result in electrosurgical shocks or burns to the surgeon.
Inspection of Bipolar Instruments Inspection Inspection of KARL STORZ Bipolar Instru- ments for signs of damage should be perfor- med before and after every surgical proce- dure. All instruments should be examined for full function prior to use. All moving parts, such as jaws, valves, handles, etc., should...
Technical Support Staff directly at KSEA (1-800-421-0837). Handling Handling of Bipolar Instruments KARL STORZ Bipolar Instruments are delicate endoscopic instruments. To ensure the long lasting quality of the instruments, please follow the handling instructions described below. Please refer to operation and handling instructions for each type of bipolar instrument at the end of this manual.
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Bipolar Instruments WARNING: Sterilization is recom- mended for “critical” instruments to be used for Hysteroscopy, Neuroend- oscopy, Arthroscopy, or Laparoscopy. WARNING: KARL STORZ bipolar instruments provided NON- STERILE and should be thoroughly cleaned and/or sterilized according to validated infection control proce- dures prior to use and subsequent reuse.
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(e.g. Enzol) diluted to proper concentration per manufacturer's instruc- tions. Fill all lumens with cleaning solution. KARL STORZ does not recommend the use of detergents alone, as they contain high concentrations of surfactants which may leave a film on the instruments.
Cleaning and Sterilization Instructions (Continued) 3. Manual cleaning recommended. Remove any residual blood, protein material and contaminants from the instruments with brushes, sponges, soft cloths or a cotton cloth applicator. KARL STORZ recommends ultrasonic clean in to remove tissue debris from the difficult to clean areas of the instruments, such as jaws, hinges and lumens.
Ethylene Oxide (EtO) Gas validated by the user. Sterilization 1. Place the instruments in a sterilization tray. 2. Wrap with two layers of FDA-cleared poly- propylene wrap or equivalent material. 3. KARL STORZ has validated the following Ethylene Oxide (EtO) sterilization parame- ters:...
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2. Wrap with two layers of FDA-cleared poly- propylene wrap or equivalent material. If using a sterilization sealed container refer to the manufacturer’s instructions for use on using the correct disposable filters for the indicated sterilization method. 3. KARL STORZ has validated the following Steam sterilization methods:...
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The drying phase is accomplished by pulling an additional vacuum and allowing the instruments to dry under vacuum for approximately 20 minutes. KARL STORZ has validated sterilization pro- cedures in a pre-vacuum sterilizer using the following conditions: Temperature: 270˚F (132˚C)
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• Use a long cleaning brush to clean the outer tube of the Take-apart bipolar instruments. Cleaning pistols (KARL STORZ part number 27660) are useful for rinsing the inside of lumens, shafts and outer tubes.
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Sterilization WARNING: Take-apart bipolar in - stru ments must be sterilized disas- sembled and reassembled in a sterile field. WARNING: High-level disinfection is NOT recommended for “critical” bipolar instruments to be used for hysteroscopy, laparoscopy, gynecol- ogy or neuroendoscopy procedures.
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Bipolar Forceps, Take-apart Bipolar Instruments (Continued) Disassembly of Take-apart Single Tube Bipolar Instruments...
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1. Gently hold the forceps by the jaws A with one hand and the handle E or I with the other hand. 2. Press the release button F , on the black block, and then pull the insert B out of the outer tube C .
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Bipolar Forceps, Take-apart Bipolar Instruments (Continued) Assembly of the Take-apart Single-Tube Bipolar Instruments 1. Insert the rubber nipple G into the han- dle. 2. Thread the outer tube C back onto the handle and tighten the knurled screw D 3. Insert the insert B into the outer tube C, with the jaws facing upward.
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Disassembly of Take-apart™ Double Tube Bipolar Forceps...
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Bipolar Forceps, Take-apart Bipolar Instruments (Continued) Disassembly: Double Tube Bipolar Forceps 1. Hold the Take-apart™ forceps by the jaws of the working insert and by the connecting piece A behind the handle. 2. Press the release button B on the con- necting piece A and simultaneously pull out working insert towards the front.
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Assembly: Double Tube Bipolar Forceps " 1. Put sealing cap I onto handle. Hold handle in ‘OPEN’ position. 2. Attach outer sheath F to the handle and tighten the thumbscrew G in counter- clockwise fashion. Slide inner sheath H into outer sheath. 3.
Bipolar Electrodes/ Coagulation Probes Indication • To coagulate tissue via a high frequency electrical current waveform during general, endoscopic and laparoscopic surgical procedures. Inspection • The shaft of the instruments should be straight. • The insulation should be intact. There should be no dents, scratches, burn marks, cracking or splitting of the insulation.
Bipolar Suction Coagulators Indication • To coagulate tissue and evacuate smoke from the surgical site during laparo- scopic and endoscopic electrosurgical procedures. Inspection • The shaft of the instruments should be straight. • The insulation should be intact. There should be no dents, scratches, burn marks, cracking or splitting of the insulation.
27660 Shipping THOROUGHLY INSPECT SHIPMENT IMMEDIATELY UPON ARRIVAL. Although KARL STORZ products are care- fully packed to minimize in-transit damage, all shipments should be carefully examined upon receipt and if a product is damaged, Customer must document the nature and extent of the damage and immediately con- tact KSEA.
(2) the telephone number and the person to contact; (3) the applicable P.O. number; (4) the KARL STORZ catalog number and, if applicable, the serial number for each prod- uct; and, (5) the reason for the return. KSEA reserves...
The following products may not be returned for credit or exchanged: (1) products held longer than 90 days from invoice date; (2) sterile packaged products where the package is opened and/or damaged; (3) discontinued products; (4) instruments that are etched or engraved by Customer;...
All repairs carry a 90 day warranty. Exchange products carry the applicable KARL STORZ product warranty. If the damaged product is not returned within thirty (30) days of receipt of the replacement product, Customer will be invoiced for the full list price of the replacement.
To ensure proper use, handling and care of KARL STORZ products, Customer should consult the prod- uct specific literature, instruction manual, and/or labeling included with the product or otherwise available.
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LIABILITY WILL BE LIMITED TO THE GREATEST EXTENT PERMITTED BY LAW IN THE SUBJECT JURISDICTION. DISTRIBUTED AND SERVICED BY: KARL STORZ Endoscopy-America, Inc. 2151 East Grand Avenue El Segundo, California 90245-5017 Telephone 424 218 8100 Toll Free 800 421 0837...
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KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Telefon: +49 (0) 7461 708-0 Telefax: +49 (0) 7461 708-105 Email: info@karlstorz.com Web: www.karlstorz.com KARL STORZ Endoscopy-America, Inc. 2151 East Grand Avenue El Segundo, CA 90245...
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