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Symbols Used on Labeling Auf der Verpackung verwendete Symbole Symboles utilisés sur l’etiquetage Simboli usati sull’etichetta Símbolos utilizados en las etiquetas Símbolos utilizados na embalagem  English A. DEVICE DESCRIPTION This endoscope consists of an eyepiece lens, a connection for fiber optic light cables with screw-on adapters for other makes of fiber optic light cables and a jacket tube made of a non-corrosive material that encloses the rod lens system, and a built in fiber optic light carrier. Endoscopic Medical Instruments are sheaths, bridges, cannulas, compatible trocars and/or obturators, which are available in various styles and sizes.  All symbols shown may not apply to this device. Please refer to the package labeling for utilized symbols. Möglicherweise treffen nicht alle abgebildeten Symbole auf dieses Produkt zu. Die Packungskennzeichnung gibt Aufschluss über die verwendeten Symbole. Tous les symboles illustrés ici ne s’appliquent pas nécessairement au dispositif. Se reporter à l’étiquette sur l’emballage pour l’interprétation des symboles. I simboli mostrati possono non essere pertinenti per questo dispositivo. Consultare le etichette della confezione per i simboli utilizzati. No todos los símbolos son aplicables a este dispositivo en particular. La etiqueta del paquete contiene los símbolos que se emplean. Nem todos os símbolos apresentados serão aplicáveis a este dispositivo. Consulte os símbolos utilizados no rótulo da embalagem. Consulte os símbolos utilizados no rótulo da embalagem. Catalog Number Bestellnummer Référence catalogue Numero di catalogo Número de catálogo Número de catálogo  REF  Electronic Waste Elektronischer Abfall Déchet électronique Rifiuti elettronici Desperdicio electrónico Resíduos electrónicos  Contains phthalates Enthält Phthalate Contient des phthalates Contiene ftalati Contiene ftalatos Contém ftalatos  PHT DEHP  7°C 45°F  32°C 90°F  SN  NON STERILE  Manufacturer Hersteller Fabricant Produttore Fabricante Fabricante  LOT  Serial Number Seriennummer Numéro de série Numero di serie Número de serie Número de série  2  Non sterile Nicht steril Non stérile Non sterile No estéril Não estéril  Authorized Representative in the European Community Bevollmächtigter in der Europäischen Gemeinschaft Mandataire dans la Communauté européenne Mandatario nella Comunità Europea Representante autorizado en la Comunidad Europea Representante autorizado na União Europeia  EC REP  STERILE EO  STERILE R  Do not reuse Nicht wiederverwenden! Ne pas réutiliser Monouso No reutilizar Não reutilizar  Manufacture Date Herstellungsdatum Date de fabrication Data di produzione Fecha de fabricación Data de fabrico See instructions for use Bitte Gebrauchsanweisung beachten Lire attentivement la notice d’utilisation Leggere attentamente il foglio illustrativo Ver instrucciones de uso Consultar instruções de utilização  Storage Temperature Range Lagertemperatur La Portée de Température d’emmagasinage Gamma Di Temperature Di Immagazzinaggio Temperaturas de Almacenamiento Intervalo de temperatura de conservação  Use by - year & month Verwendbar bis Jahr und Monat À utiliser avant le (mois/année) Da usarsi entro anno e mese Caduca - año y mes Utilizar por – ano e mês  Lot number Chargenbezeichnung No. de lot Numero di lotto Número de lote Número de lote  QTY  Quantity Quantität Quantité Quantità Cantidad Quantidade  Not to be used if package is damaged Nicht verwenden, wenn die Verpackung beschädigt ist Ne pas utiliser si l’emballage est endommagé Non usare se la confezione è danneggiata No utilizar si el paquete ha sufrido algún desperfecto Não deve ser utilizado se a embalagem estiver danificada  Sterile unless the package is damaged or open. Method of sterilization - EO Steril, solange die Verpackung ungeöffnet und unbeschädigt ist. Sterilisationsmethode - EO Produit stérile si l’emballage n’a pas été ouvert ou endommagé. Méthode de stérilisation - EO Il prodotto è sterile se la confezione non è aperta o danneggiata. Metodo di sterilizzazione - EO Esteril mientras el envase no sea abierto o dañado. Método de esterilización - EO Estéril a não ser que a embalagem esteja danificada ou aberta. Método de esterilização - EO  Sterile unless the package is damaged or open. Method of sterilization - gamma radiation Steril, solange die Verpackung ungeöffnet und unbeschädigt ist. Sterilisationsmethode - Bestrahlung Produit stérile si l’emballage n’a pas été ouvert ou endommagé. Méthode de stérilisation - irradiation Il prodotto è sterile se la confezione non è aperta o danneggiata. Metodo di sterilizzazione - Raggi Gamma Esteril mientras el envase no sea abierto o dañado. Método de esterilización - irradiación Estéril a não ser que a embalagem esteja danificada ou aberta. Método de esterilização – radiação gama  The product meets the essential requirements of Medical Device Directive 93/42 EEC. Das Produkt entspricht den grundlegenden Anforderungen der Richtlinie des Rates über Medizinprodukte 93/42/EWG. Ce produit est conforme aux exigences de la directive sur les dispositifs médicaux CEE 93/42. Il prodotto è conforme ai requisiti essenziali della Direttiva CEE 93/42 sui Dispositivi Medici. Este producto cumple con las normas básicas de la Directiva de productos médicos, 93/42 CEE. O produto cumpre os requisitos essenciais da Directiva de Dispositivos Médicos 93/42 EEC.  Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. ACHTUNG: Gemäß der gesetzlichen Bestimmungen (USA) darf dieses Produkt nur durch einen Arzt oder auf Grund einer ärztlichen Verordnung verkauft werden. Mise en garde : la loi fédérale des états-unis limite la vente de ce dispositif par un médecin ou sur l’ordonnance d’un médecin. Attenzione: le leggi federali (USA) autorizzano la vendita di questo dispositivo esclusivamente da parte di un medico o dietro sua prescrizione. Precaución: la ley federal (estados unidos) restringe la venta de este aparato a médicos, o bajo las órdenes de éstos. Atenção: A legislação federal (EUA) restringe a venda deste dispositivo a médicos ou mediante receita médica.  B. INDICATIONS The Arthrex Arthroscope and accessories is a tubular endoscopic device with accessory devices which attach to the Arthroscope and is intended to examine and/or perform surgery on the interior of a joint. Arthroscopic minimal invasive procedures are performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal-mandibular joint, ankle, elbow and feet (plantar fascia release). The Arthrex Laparoscopy Set is intended for use in general laparoscopic surgery. Laparoscopic surgery is a means of performing diagnostic and therapeutic surgical procedures intra-abdominally using equipment that minimizes surgical invasiveness. Rather than creating large incisions to gain access to surgical sites, surgeons view inside the body and operate by using instruments inserted through small skin punctures (inserted through the laparoscope or through another small incision). This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder and liver. The Arthrex Sinuscope is intended to provide the physician with a means for endoscopic diagnostic and therapeutic sinus surgical procedures. The Arthrex Sinuscope will include Sheaths – to establish portals for visualization and surgical access and the Suction/Irrigation Handle – to remove debris and body fluids from the surgical site and to provide irrigation of the site with a sterile solution. The Sinuscope and accessories are indicated for use in, but not limited to such procedures as examination of sinus passages and cavities, removal of abnormal growths such as polyps and facio-plastic surgery. C. ABOUT THIS DOCUMENT This document describes the correct handling, functioning and recommended reprocessing of the rigid endoscope and endoscopic medical instruments, as well as the recommended processing methods. This document may not be used to carry out endoscopic examinations or surgeries, nor may it be used for training purposes. The current version of this document can be found on the internet at www. arthrex.com. This document may also be obtained from Arthrex. Users of these endoscopes and endoscopic medical instruments are encouraged to contact their representatives if, in their professional judgment, they require more comprehensive information on their use and care. D. INTENDED USE Arthrex rigid medical endoscopes are used to visualize body cavities. Each endoscope was developed for diagnostic and surgical procedures in one of the following fields of application: • Arthroscope: arthroscopic procedures • Laparoscope: laparoscopic procedures • Endoscope: endoscopic procedures The intended use of the Arthrex endoscopic medical instruments are: • Arthroscopy sheaths for endoscopic diagnosis and treatment in arthroscopic interventions • Trocars – sharp - for use with compatible arthroscopy sheaths • Obturators – blunt and conical blunt - for use with compatible arthroscopy sheaths For the benefit and safety of patients, physicians must select a method which they consider suitable, based on their experience. E. SAFETY INFORMATION The endoscope and endoscopic medical instruments may only be used by trained medical professionals, in medical facilities. • After receipt of the device(s), inspect the endoscope or endoscopic medical instruments for completeness and damage. • Read, observe and store these instructions and any other applicable instructions. • Use endoscopes and endoscopic medical instruments only as intended. CAUTION: For storage, transport and processing, ensure that the endoscope and endoscopic medical instruments are not subjected to mechanical strain, particularly to prevent damage to the sensitive lens system. CAUTION: C-Mount Endoscopes may only be used with camera systems with electrical insulation that are classified as Type BF or CF. Usage with other systems may harm the patient. WARNING: Risk of injury, contamination or infection to the patient or medical professionals! The endoscopes and endoscopic medical instruments are delivered unsterile as reusable products. The state-of-the-art and national laws require the observance of validated processes. In general, users are responsible for the validation of their cleaning and sterilization processes. • Ensure that the processing, material and personnel are suitable for achieving the results necessary. • Observe any and all valid local operator regulations for all manual cleaning and drying processes. • Clean/disinfect and sterilize the endoscope and endoscopic medical instruments prior to initial use, as well as after each subsequent use. • Bring the endoscope and endoscopic medical instruments to the decontamination area as soon as possible after use. • Prepare the endoscope and endoscopic medical instruments for processing immediately after use, to prevent surface drying of contaminants. Observe valid protective measures to prevent contaminating the environment. WARNING: Risk of burns! The optical fibers emit high-energy light at the distal end of the endoscope. This can cause the temperature of the body tissue to rise to 41°C (106 °F). • Avoid direct contact of the distal end with body tissue or flammable materials, as it can cause burns and fires. • Reduce the light intensity of the light source when working near body tissue or flammable materials. WARNING: Risk of injury due to faulty endoscopes and endoscopic medical instruments! • Carry out a visual inspection and function check, prior to each use. • Only use endoscopes and endoscopic medical instruments which are in perfect condition. During storage, transport and processing, ensure that the endoscopes and endoscopic medical instruments are not subjected to mechanical strain. WARNING: C-Mount Endoscopes contain permanent magnets that may impact the functionality of nearby active implants and electrical devices. F. INSPECTION, HANDLING AND MAINTENANCE • Arthrex endoscopes and endoscopic medical instruments are precision medical instruments and must be used and handled with care. • Inspect the endoscope and endoscopic medical instruments for damage prior to use and at all stages of handling thereafter. • If damage is detected, do not use the endoscope and endoscopic medical instruments prior to consulting the manufacturer for guidance. • Do not subject the endoscope and endoscopic medical instruments to impact. Put the endoscope and endoscopic medical instruments down carefully. • Hold the endoscope only by the ocular funnel/main part and not by the sheath. • Do not bend the sheath or use as a prying tool. • After insertion of the endoscope into the body, do not apply additional flexion to the joint. A piece of a broken endoscope can become lodged in soft tissue and/or disappear from the endoscopic view of the surgical field, and can be left in the patient. • Transport endoscopes and endoscopic medical instruments individually and store them safely by using a screen basket or container. G. DESCRIPTION I. Construction Endoscope (see Figure 1) II. Markings on the Main Part • CE mark with identification number of the notified body where applicable: Endoscope and endoscopic medical instruments conform to the requirements of the guideline 93/42/EWG. • For autoclavable endoscopes: Etching of autoclavable. • For endoscopes: Specification of the direction of view III. Available Designs and Sizes The endoscopes are available in the following designs and sizes: • Straight endoscopes • Angled endoscopes • Sheath diameter 1.9–11 mm  DFU-0073r6 The endoscopic medical instruments are available in the following designs and sizes: • Arthroscopy sheaths and corresponding Trocars (sharp), Obturators (blunt and conical) for arthroscopes with a diameter of 1.9 mm – 6 mm. IV. Combinable Products You can combine the endoscopes with common camera systems, illumination fibers and instruments from Arthrex. CAUTION: The Arthrex C-Mount endoscopes are designed for direct coupling to the Arthrex C-Mount camera head. The C-Mount endoscopes are not necessarily compatible to camera heads from other manufacturers. H. PREPARATION FOR USE I. Visual inspection and function check WARNING: Risk of injury due to faulty endoscopes and endoscopic medical instruments! • Carry out visual inspection and function check, prior to initial use and after each subsequent use. • Only use endoscopes and endoscopic medical instruments which are in perfect condition. CAUTION: Clean/disinfect and sterilize the endoscope and endoscopic medical instruments prior to initial use, as well as after each subsequent use. If not cleaned properly, contaminants on the irradiation surfaces of the illumination fibers figure 1 [6] can burn-in during use, which impacts image quality. • Ensure that the proximal end of the endoscope figure 1 [5] is dry, to prevent the endoscope from fogging up during the examination/procedure. • Ensure that no parts are missing or loose. • Ensure that there are no residual cleaning agents or disinfectants on the endoscope and endoscopic medical instruments. • Inspect the entire endoscope, particularly the sheath figure 1 [2], as well as endoscopic medical instruments for contaminants and damage of any type, such as dents, scratches, cracks, bending and sharp edges. • Inspect the distal end figure 1 [1], proximal end figure 1 [5] and irradiation surface of the illumination fibers figure 1 [6] for any contaminants and scratches. Make contaminants and scratches visible using light reflexes by holding the endoscope with the connection for the illumination fiber against the light and inspect whether the illumination fibers illuminate evenly at the distal end figure 1 [1]. • Check image quality: The image should not be blurry, clouded or dark. If necessary, remove deposits on the optical end surface using polishing paste provided (see “Removing deposits from optical surfaces” see P. 4. Removing deposits from optical end surfaces). • For endoscopes with a locking device: Inspect between the sheath figure 1 [2] and the main part figure 1 [3] for contaminants and damage, to ensure a fixed and secure connection. • For endoscopic medical instruments with a locking device, inspect the locking device for contaminants and damage, to ensure a fixed and secure connection. • For C-Mount endoscopes: Ensure that the O-Ring at the C-Mount threads is in place and not damaged. Missing or damaged O-Rings need to be replaced. • For endoscopic medical instruments with a stopcock, inspect all components of the stopcock for function and damage. II. Provisioning • If required, mount the adapter for illumination fiber (see J. Assembly). • Mount illumination fiber (see manufacturer’s specifications). • If required, adapt the camera (see manufacturer’s specifications). • For C-Mount Endoscopes: Screw the endoscope into the C-Mount camera head and tighten it by hand I. PROCESSING The recommended method and the processing instructions, as well their provision at the usage site are described in the reprocessing section of this document. • Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and damage due to use. J. ASSEMBLY I. Endoscopes • If required, mount the appropriate adapter figure 2 [2, 3] for the illumination fiber. • Ensure that the irradiation surface of the illumination fiber figure 1 [6] is clean. • Mount illumination fiber (see manufacturer’s specifications). • If required, adjust the camera settings (see manufacturer’s specifications). II. Endoscopic Medical Instruments In order to ensure sterility, only use grease which is suitable for medical instruments for the stopcock. • Lubricate stopcock. • Mount stopcock and fix with stopcock nut. • Remove excess grease. K. DISASSEMBLY I. Endoscopes CAUTION: Do not remove the ocular funnel figure 1 [4] or the endoscope will be damaged. WARNING: Risk of burns! Prior to removing the illumination fiber, allow sufficient time for it to cool. The ends can get extremely hot and may cause severe burns. • Remove the illumination fiber. • Unscrew existing adapters figure 2 [2, 3], if used. II. Endoscopic Medical Instruments • Loosen stopcock nut. • Disassemble stopcock. L. STORAGE Non-sterile metal devices should be stored in a clean, dry environment. The shelf life of non-sterile devices is not limited; the devices are manufactured from non-degradable material, which does not raise any question of device stability when stored under recommended conditions. As long as the endoscopes and endoscopic medical instruments are stored unsterile in the original packaging, the following storage conditions apply: • Temperature: –10 to +40 °C (14 – 104 °F) • Humidity: 10–90 % Additional storage requirements: • Avoid direct sunlight. • Store endoscopes and endoscopic medical instruments either in the original packaging or in a screen tray/container. • Ensure that the endoscope and endoscopic medical instruments are stored securely. • Apply the respective valid national provisions when storing in a sterile condition. Storage between processing: • Verify that the endoscope is disassembled from the illumination fiber and the camera. • Ensure all adapters, if used, are disassembled from the endoscope. M. DISPOSAL Observe country-specific regulations and laws for the disposal of medical products. N. SERVICE AND MAINTENANCE Arthrex does not supply original parts to independent workshops or other endoscope manufacturers. Thus only Arthrex is in a position to carry out repairs using original parts. The original technical specifications and the operational safety of the endoscope and endoscopic medical instrument can only be guaranteed by using original parts. The warranty for Arthrex products shall become void if repairs are carried out by an unauthorized workshop. In this case Arthrex is also no longer responsible for the technical specifications or safety of the product. • Have the endoscope and endoscopic medical instrument repaired by Arthrex only. For service, send the defective endoscope or endoscopic medical instrument to the address of the sales partner. • Clean, disinfect and sterilize the endoscope or endoscopic medical instrument thoroughly, prior to returning it for repair. • Ideally, send in the endoscope or endoscopic medical instrument in its original packaging. If this is not possible, securely package it for transport. • Arthrex is not liable for damage resulting from improper shipping O. ACCESSORIES/SPARE PARTS Accessories  Contact  Polishing paste, stopcock lubricant, stopcock replacement parts, spare o-rings, and light post adapters  Contact your Arthrex Representative  P. REPROCESSING I. Containment & Transportation It is recommended that endoscopes and endoscopic medical instruments are reprocessed as soon as is reasonably practical following use. Instrument cases and trays are considered reusable devices. Trays should be inspected for visible soil and must be cleaned prior to use. They can be cleaned manually or in an automatic washer using a detergent. Always store endoscopes and endoscopic medical instruments securely and transport it to processing in a closed container to prevent damage to the endoscopes and endoscopic medical instruments and contamination of the environment. II. Cleaning and Disinfection A. Manual cleaning / Pre-cleaning and chemical disinfection CAUTION: Do not use fixating cleaning agents or hot water (>40 °C, 104 °F) as it may cause fixation of the contaminants and prevent successful cleaning. CAUTION: Do not scratch contaminants off with hard objects, as this may cause damage to the optical end surfaces. CAUTION: Do not clean endoscopes in an ultrasonic bath. CAUTION: Non-compliance with the manufacturer’s specifications may result in damage to the endoscopes and endoscopic medical instruments. 1) Endoscopes: • Existing adapters are dismounted from Endoscope (see K. Disassembly). • Remove coarse contamination from the endoscope. With a soft brush, clean the endoscope and endoscopic medical instruments under cold tap water until all visible contamination has been removed. • Disinfect endoscope. In doing so, observe the specifications of the disinfectant manufacturer regarding temperature, concentration and application time. • Rinse endoscope with running water. • Dry endoscope with a soft cloth. • Carry out visual inspection, function check and servicing (see H. I. Visual inspection and function check). The endoscopes have material compatibility with the Steris™ System1 process. • Disinfect endoscope. In doing so, observe the specifications of the disinfectant manufacturer regarding temperature, concentration and application time. • Rinse endoscope with running water. • Dry endoscope with a soft cloth. • Carry out visual inspection, function check and servicing. (see H. I. Visual inspection and function check) 2) Endoscopic medical instruments • For endoscopic medical instruments with stopcock: All parts of the stopcock are dismounted. • Remove coarse contamination from the instrument. With a soft brush, clean the instrument under cold tap water until all visible contamination has been removed. • The endoscopic medical instruments from Arthrex can be cleaned in an ultrasonic-bath. • Put the instrument in an ultrasonic device and have the instrument cleaned for at least 20 minutes according to the instructions of the manufacturer of the ultrasonic device. • After cleaning with the ultrasonic device, rinse the instrument thoroughly with water. • Inspect the instrument for visible contaminants. Repeat cleaning if any contaminants are visible and check again. • Disinfect instrument. In doing so, observe the specifications of the disinfectant manufacturer regarding temperature, concentration and application time. • Rinse instrument with running water. • Dry instrument with a soft cloth. • Carry out visual inspection, function check and servicing. (see F. I. Visual inspection and function check) III. Machine cleaning and thermal disinfection The rigid endoscopes and endoscopic medical instruments from Arthrex are suitable for prevalent machine methods of cleaning and thermal disinfection. In doing so, use gentle cycles for rigid endoscopes and suitable cleaning agents and disinfectants. The instructions of the machine, cleaning agent and disinfectant manufacturers must be observed. The cleaning and disinfectant result must be confirmed by the machine, cleaning agent and disinfectant manufacturers in cooperation with the user. Start cleaning process: • Pre-rinse with cold water for 1 minute • Drain • Pre-rinse with cold water for 3 minutes • Drain • Clean with 0.5 % alkaline cleaning agent for 5 minutes at 55 °C (131 °F) or with 0.5 % enzymatic cleaning agent at 45 °C (113 °F) • Drain • Neutralize for three minutes with warm tap water (<40 °C, 104 °F) and neutralizer • Drain • Intermediate rinse for 2 minutes with warm tap water (<40 °C, 104 °F) • Drain Perform the machine thermal disinfection using the national requirements for A0 value (see ISO 15883).Ensure that the exteriors of the endoscope are dry. If necessary, dry with a soft cloth. Carry out visual inspection, function check and servicing (see H. I. Visual inspection and function check). IV. Removing deposits from optical end surfaces of endoscopes If deposits are detected when checking the image quality, they can be removed with the provided polishing paste as follows: Only clean with polishing paste, if the image which you see through the endoscope is cloudy and blurry. • Apply polishing paste to a clean cotton swab. • For large end surfaces: press cotton swab lightly on the end surface to be cleaned and rub it over the glass. • For small end surfaces: press cotton swab lightly on the end surface to be cleaned and turn it. See Figure 3 • Clean all optical end surfaces with warm water and mild detergent to remove polishing paste residue. • Rinse optical end surfaces under running water. • Dry optical end surfaces with a soft cloth. • Clean/disinfect and sterilize endoscope if necessary. • Carry out visual inspection. If the deposits were not removed: send endoscope in for repair Q. STERILIZATION Prior to each sterilization, rigid endoscopes and endoscopic medical instruments must be cleaned and disinfected according to the methods in these cleaning instructions. Sterilize endoscopes and endoscopic medical instruments in suitable packaging to prevent subsequent contamination. I. Steam sterilization (autoclaving) CAUTION: Only endoscopes which are marked with the writing autoclavable are intended for autoclaving. The permissible processing methods are explained in these instructions. CAUTION: Comply with specified process parameters. The parameters stipulated have been validated to ensure the sterility of the endoscopes and the endoscopic medical instruments. Deviating from process parameters could damage the endoscope or the endoscopic medical instrument. In this case, the guarantee and warranty shall become void. Autoclavable endoscopes and endoscopic medical instruments can be sterilized with the French cycle (134 °C [273 °F], 18 minutes, 3.1 bar (absolute)) without restrictions regarding material compatibility. In general, users are responsible for the validation of their processes. When selecting the processing method, observe the valid national hygienic regulations and local provisions for hospital hygiene. • Existing adapters are dismounted (see – K. DISASSEMBLY). • For endoscopic medical instruments with stopcock: All parts of the stopcock are dismounted. • Sterilize endoscopes and endoscopic medical instruments with one of the following methods: 			 – Fractionated pre-vacuum method. 			 – Gravitation method. • When the sterilization process has ended, allow the endoscopes and endoscopic medical instruments to gradually cool to room temperature.  II. Fractionated Pre-vacuum Method The following process has been validated: Temperature Time Configuration Drying  132–137 °C (270–278 °F) at least 3 minutes double wrapped at least 10 minutes  III. Hydrogen Peroxide Sterilization Arthrex endoscopes and endoscopic medical instruments can be sterilized by the followingHydrogen Peroxide methods: STERRAD systems: • STERRAD 100S, Short Cycle • STERRAD NX, Short Cycle • STERRAD 100NX, Standard Cycle Observe specifications of the manufacturer (ASP, Advanced Sterilization Products) regarding the corresponding method. Steris systems: • V-Pro® 1 Low Temperature Sterilization System • V- Pro® 1 Plus Low Temperature Sterilization System, Non Lumen Cycle • V- Pro® 1 maX Low Temperature Sterilization System, Non Lumen Cycle Observe specifications of the manufacturer Steris regarding the corresponding method. R. SPECIAL PRECAUTION:TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY AGENTS It is outside the scope of this document to describe in detail the precautions that should be taken for Transmissible Spongiform Encephalopathy Agents. The agents for transmission of Creutzfeldt-Jakob disease (CJD) are believed to be resistant to normal processes of disinfection and sterilization and therefore the normal processing methods of decontamination and sterilization as described above may not be appropriate where CJD transmission is a risk. In general, the tissues that come into contact with orthopedic surgical instruments are those of low TSE infectivity. However, particular precautions should be taken when handling instruments that have been used on known, suspected, or at-risk patients.  Autoclavable Rigid Medical Endoscopes and Endoscopic Medical Instruments Autoklavierbare starre medizinische Endoskope und endoskopische Zusatzinstrumente Endoscopios Médicos Rígidos e Instrumentos Médicos Endoscópicos Autoclavables  DFU-0073 Revision 6 Page 1 of 4  0086  0086 0086  IMPORTANT PRODUCT INFORMATION WICHTIGE PRODUKTINFORMATION NOTICE D’UTILISATION IMPORTANTE IMPORTANTI INFORMAZIONI PER L’USO INSTRUCCIONES IMPORTANTES PARA EL USO INFORMAÇÕES IMPORTANTES ACERCA DO PRODUTO  Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108-1945 • USA Toll free: 1-(800) 934-4404 www.arthrex.com  EC REP  Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany Tel: +49 89 909005-0 www.arthrex.de  This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions and related provisions, refer to the “Arthrex U.S. Product Warranty” section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by reference. comp dfu-0073-1 r0
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