B&B TEBBETTS Monopolar Forceps Instructions for Use

5 Pages

HH-896_Black-Black-BipolarForceps-2016_vC.doc Rev. C 28.09.2016/MA  TEBBETTS MONOPOLAR FORCEPS Instructions for Use Handhabungshinweise Instructions de service Istruzioni per l’uso Instrucciones de uso Gebruiksaanwijzing  Manufactured for: Black & Black Surgical, Inc. 5238 Royal Woods Pkwy Suite 170 Tucker, GA 30084. USA Tel: 877-252-2517 (in USA) 770-414-4880(outside USA) Fax: 770-414-4879  Black & Black Surgical B65240 – B65245  Guenter Bissinger Medizintechnik GmbH Hans-Theisen-Str.1 79331 Teningen, Germany  0297  ENGLISH Monopolar Forceps Caution Please read all information contained in this insert. Incorrect handling and care as well as misuse can lead to premature wear of surgical instruments. Indications for Use The Monopolar Forceps are designed to grasp, dissect and coagulate selected tissue. They must be connected to the monopolar output of an electrosurgical generator and must only be used with parameters for monopolar coagulation. Do not exceed a maximum output of 2000 Vp of your generator. Attention: Instruments for electrosurgery should be used only by persons who have been specially trained in the use of such instruments. Contraindications Adverse events reported while using 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 have been reported. 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 anestetic gases). Organ perforation. Sudden massive hemorrhage. Use and safety instructions - All instruments have to be completely cleaned, disinfected and sterilised before initial use and any other use. - It is very important to check each surgical instrument for visible damage and wear, such as cracks, breaks or insulation defects before each use. In particular, areas such as blades, tips, notches, locking and blocking devices as well as all mobile parts, insulations and ceramic elements have to be checked carefully. - Never use damaged instruments. - If the BLUE layer is visible under the black layer, the coating is damaged and the forceps should NOT be used until inspected by BLACK & BLACK (Note: You will see the blue insulation at the tips, this is OKAY).  - Never use the instruments in the presence of flammable or explosive substances. - The instrument may not be laid down on the patient. - Coagulation should only be performed if the contact surfaces are visible. Do not touch any other metallic instruments during coagulation. Cautions & Warnings US Federal Law restricts this device to sale by or on the order of a physician only. 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. Avoid touching or grounding electrosurgical instruments to noninsulated 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. Test all instruments, accessories and equipment prior to each use. Do not use in presence of flammable liquids or anaesthetics. 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. Failure to observe these cautions and contraindications may result in injury, malfunction or other unanticipated occurrences or events for the operator, staff and/or the patient. Reprocessing Due to the product design, the raw materials used and the intended purpose it is not possible to determine a precise limit with regard to the maximum possible number of reprocessing cycles. The serviceable life of the instruments is determined by their function as well as by a careful handling. Instruments for electrosurgery are by nature subject to increased wear depending on the type and time of use.  Cleaning detergents must be suitable for silicone materials.  3.  Preparation and transport Remove coarse dirt from the instruments immediately after each use. Do not use fixation agents or hot water (>40°C) as this may result in the fixation of residues and could reduce the cleaning success. Storage and transport of the instruments to the reprocessing location must be ensured in a sealed container to avoid any damage to the instruments and any contamination of the environment.  4.  Machine reprocessing Cleaning Place the instruments in a basket on the insert module or on the inserts of the MIS module and start the cleaning process. 1. Prerinse for 1 min. with cold water 2. Discharging 3. Prerinse for 3 min. with cold water 4. Discharging 5. Wash for 5 min. at 55°C with a 0.5% alkaline or at 45°C with an enzymatic cleaning agent. 6. Discharging 7. Neutralise for 3 min. with warm tap water (>40°C) and a neutralising agent. 8. Discharging 9. Rinse for 2 min. with warm tap water (>40°C). 10. Discharging Disinfection Machine operated thermal disinfection has to be carried out in consideration of the national requirements with regard to the A0 value (see ISO 15883). Drying Dry the outside of the instruments by carrying out a drying cycle of the cleaning/disinfection machine. If necessary, manual drying may additionally be carried out using a lint free cloth. Dry cavities of the instruments by blowing with sterile compressed air. Manual reprocessing Cleaning Prepare a cleaning bath according to the manufacturer's instructions. 1. Rinse products with cold tap water (<40°C) until all visible accumulations of dirt have been removed. Remove stuck dirt by using a soft brush. 2. Place products in the prepared cleaning bath so that they are completely submersed. Observe residence time according to the manufacturer's instructions.  Clean the instrument in the bath manually using a soft brush. All surfaces have to be brushed several times. Rinse the products thoroughly with running tap water to remove the cleaning agents without residue.  Disinfection Prepare a disinfectant bath according to the instructions of the disinfectant manufacturer. Place the instruments in the disinfectant bath and observe the specified residence time. Rinse the products thoroughly with fully demineralised water to remove the disinfectant without residue. Drying Manual drying is carried out using a lintfree cloth and, in particular, for drying cavities and channels, sterile compressed air. Functional test and packaging Perform visual inspection for cleanliness; if required, perform an assembly and functional test according to the operating instructions. If necessary, repeat the reprocessing process until the instrument is optically clean. Packaging has to comply with ISO 11607 and EN 868 standards for packaging for sterilised instruments. Sterilisation Sterilisation of the products with fractional pre-vacuum procedure (in accordance with ISO 13060 / ISO 17665) in consideration of the respective national requirements. - 3 pre-vacuum phases, pressure at least 60 mbar - Heating up to a sterilisation temperature of min. 132°C and max. 137°C - Shortest exposure time: 3 min. - Drying time: at least 10 min. Storage Sterilised instruments have to be stored in a dry, clean and dust-free area at moderate temperatures from 5°C to 40°C.  Information on the validation of the reconditioning The following testing instructions, materials and equipment have been used for validation: Cleaning agents (for machine use): Neodisher FA by Dr. Weigert (alkaline) Endozime by Ruhof (enzymatic) Cleaning agents (manual cleaning): Enzol Enzym, detergent by Johnson&Johnson Neutralising agent: Neodisher Z by Dr. Weigert Cleaning and disinfection device: Miele G 7736 CD Miele insert module E 327-06 Miele MIS module E 450 For details, see report. SMP GmbH # 01707011901-2 (machine cleaning) Northview Laboratories #P8H066 (manual cleaning, sterilisation) Nelson Labs # 200432706-02 (sterilisation) MDS GmbH Testbericht 084183-10 (Sterilisation) If the chemicals and machines described above are not available, the user has to validate the used process accordingly.  Handling During transport, cleaning, care, sterilisation and storage, all surgical instruments should be handled with maximum care. This applies particularly to blades, fine tips and other sensitive areas. Warranty Guenter Bissinger Medizintechnik GmbH exclusively supplies tested and faultless products to the customers. All products are designed and manufactured to comply with maximum quality requirements. We refuse any liability for products which, compared to the original product, have been modified, misused or handled or used in an inexpert way. Explanation of symbols LOT Number  Repairs Never attempt to perform repairs yourself. Service and repair work may only be performed by persons qualified and trained accordingly. For any question on these matters, please contact either the manufacturer or your medico-technical department. Attention: Defect products must pass the complete reprocessing process before being returned for repair.  Reference Number Attention! Refer to Instructions for Use  Manufacturer  DEUTSCH Monopolare Pinzetten Achtung Bitte lesen Sie aufmerksam alle Informationen in diesem Faltblatt. Unsachgemäße Handhabung und Pflege, sowie zweckentfremdeter Gebrauch können zu vorzeitigem Verschleiß der chirurgischen Instrumente führen. Gebrauchshinweise Die monopolaren Pinzetten dienen dem Fassen, Präparieren und Koagulieren von Gewebe. Sie müssen an den monopolaren Ausgang eines Elektrochirurgie-Generators angeschlossen werden und dürfen nur mit den entsprechenden Parametern für monopolare Koagulation genutzt werden. Die maximale Ausgangsspannung des Generators darf 2000 Vp nicht überschreiten. Achtung: Instrumente für die Elektrochirurgie dürfen nur von Personen eingesetzt werden, die speziell dafür ausgebildet oder eingewiesen sind. Kontraindikationen Vorfälle, die im Zusammenhang mit dem Einsatz elektrochirurgischer Instrumente berichtet wurden: Unbeabsichtigte Aktivierung mit resultierender Gewebeschädigung an der falschen Stelle und/oder Beschädigung der Ausrüstung. Feuer in Verbindung mit Abdecktüchern und anderen entzündlichen Materialien. Alternierende Strompfade, die zu Verbrennungen führen an Stellen, an denen der Patient oder Anwender mit unisolierten Bauteilen in Berührung kommt. Explosionen, verursacht durch Funkenbildung in der Umgebung von entzündlichen Gasen (z.B. explosive Anästhesiegase). Perforation von Organen. Plötzliche schwere Blutungen. Anwendungs- und Sicherheitshinweise - Alle Instrumente müssen vor der ersten Ingebrauchnahme und vor jeder weiteren Anwendung komplett gereinigt, desinfiziert, sterilisiert und auf Funktionsfähigkeit geprüft werden. - Es ist sehr wichtig, jedes chirurgische Instrument vor jedem Gebrauch auf sichtbare Beschädigungen und Verschleiß, z.B. Risse, Brüche oder Defekte an der Isolation zu untersuchen. Vor allem Bereiche wie Schneiden, Spitzen, Schlüsse, Sperren und Rasten, sowie alle
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