Arthrex
4K Laparoscope, 0°, 10 mm × 330 mm NIR
Endoscopic Imaging System Endoscopes Instruction for Use and Processing Instructions
4 Pages
![English Symbols glossary can be found at www.arthrex.com/symbolsglossary. A. REFERENCES These instructions were developed using the guidance given in the following standards: • ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities • ISO 17664: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices • ISO 17665-1: Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices • AAMI TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices • AAMI ST77: Containment devices for reusable medical device sterilization • AAMI TIR 34: Water for the reprocessing of medical devices • Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff B. DEVICE DESCRIPTION This SynergyID™ endoscopic imaging system 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. There is one green band and etching NIR on the main body to help identify the NIR endoscopes. C. INDICATIONS Indications for CE Accepting Countries: The SynergyID endoscopic imaging system is indicated for use to provide real time endoscopic visible and nearinfrared fluorescence imaging. Indications for United States and Non-CE Accepting Countries: The Arthrex SynergyID endoscopic imaging system is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery. The Arthrex SynergyID endoscopic imaging system is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex SynergyID endoscopic imaging system is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. 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: • Laparoscope: laparoscopic procedures • Fluorescence imaging NIR endoscope: endoscopic visible and nearinfrared fluorescence imaging procedures For the benefit and safety of patients, physicians must select a method which they consider suitable, based on their experience. E. WARNINGS 1. Caution: Federal law restricts this device to sale by or on the order of a physician. 2. This device is intended to be used by a trained medical professional. 3. Follow your institutions policy for safe disposal of all needles and other sharps or medical waste. 4. Biohazard waste, such as explanted devices, needles and contaminated surgical equipment, should be safely disposed of in accordance with hospital policy. 5. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred. F. SAFETY INFORMATION The endoscope may only be used by trained medical professionals, in medical facilities. • After receipt of the device(s), inspect the endoscope for completeness and damage. • Read, observe and store these instructions and any other applicable instructions. • Use endoscopes only as intended. CAUTION: For storage, transport and processing, ensure that the endoscope is not subjected to mechanical strain, particularly to prevent damage to the sensitive lens system. 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! • Carry out a visual inspection and function check prior to each use. • Only use endoscopes which are in perfect condition. G. INSPECTION, HANDLING AND MAINTENANCE 1. Arthrex endoscopes are precision medical instruments and must be used and handled with care. 2. Inspect the endoscope for damage prior to use and at all stages of handling thereafter. 3. If damage is detected, do not use the endoscope prior to consulting the manufacturer for guidance. 4. Do not subject the endoscope to impact. Put the endoscope down carefully. 5. Hold the endoscope only by the ocular funnel/main part and not by the sheath. 6. Do not bend the sheath or use as a prying tool. 7. After insertion of the endoscope into the body, do not apply additional flexion to the body. 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. H. DESCRIPTION I. CONSTRUCTION ENDOSCOPE – SEE FIGURE 1 II. MARKINGS ON THE MAIN PART • CE mark with identification number of the notified body where applicable: Endoscopes conform to the requirements of the guideline 93/42/EEC. • For autoclavable endoscopes: Etching of autoclavable • For endoscopes: Specification of the direction of view • For NIR endoscopes: One green band and etching NIR on the main part III. AVAILABLE DESIGNS AND SIZES The endoscopes are available in the following designs and sizes: • Straight endoscopes • Angled endoscopes • Sheath diameter 5.5–10 mm IV. COMBINABLE PRODUCTS The NIR endoscopes can be combined with common camera systems, illumination fibers and instruments from Arthrex. They are also combinable with the SynergyID endoscopic imaging system with visible and near-infrared fluorescence capabilities. I. PREPARATION FOR USE I. VISUAL INSPECTION AND FUNCTION CHECK WARNING: Risk of injury due to faulty endoscopes! • Carry out visual inspection and function check, prior to initial use and after each subsequent use. • Only use endoscopes which are in perfect condition. CAUTION: Clean/disinfect and sterilize the endoscope 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. • Inspect the entire endoscope, particularly the sheath figure 1 [2] 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 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. 1. Apply polishing paste to a clean cotton swab. 2. For large end surfaces: press cotton swab lightly on the end surface to be cleaned and rub it over the glass. 3. For small end surfaces: press cotton swab lightly on the end surface to be cleaned and turn it. Figure 2 – Cleaning 4. Clean all optical end surfaces with warm water and neutral-pH detergent to remove polishing paste residue. 5. Rinse optical end surfaces under running water. 6. Dry optical end surfaces with a soft cloth. 7. Carry out visual inspection. If the deposits were not removed: send endoscope in for repair 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). J. 1. 2. 3. ASSEMBLY Connection for ACMI type illumination fiber Adapter for Wolf type illumination fiber Adapter for Storz / Olympus type illumination fiber Figure 3 – Assembly • If required, mount the appropriate adapter figure 3 [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). K. DISASSEMBLY 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 3 [2, 3], if used. L. 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 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 repaired by Arthrex only. • Clean, disinfect and sterilize the endoscope thoroughly, prior to returning it for repair. • Ideally, send in the endoscope in its original packaging. If this is not possible, securely package it for transport. • Arthrex is not liable for damage resulting from improper shipping. M. ACCESSORIES/SPARE PARTS Please contact your Arthrex representative for additional polishing paste and light post adapters. N. VALIDATION The recommended cleaning, disinfection, and sterilization methods in this DFU have been validated in compliance with federal and international guidance/ standards. In accordance with ISO 17665, the “overkill” approach was used for sterilization validation, and demonstrates a sterility assurance level (SAL) of 10-6. Cleaning, disinfecting, and sterilizing equipment and materials vary in performance characteristics. Therefore, it is the responsibility of the facility/ end user to perform the appropriate validation testing for any use beyond recommended performance characteristics. In accordance with EN ISO 17664 and AAMI TIR30, limit values and a means for monitoring chemical residues following cleaning have been established for the product. In assessing the level of cleaning residuals following the cleaning processes, a clinically relevant method was utilized for testing the safety of residuals as part of the validation protocol. Deionized (critical) water was utilized as the terminal rinse water quality to ensure that residuals will not interfere with subsequent processing steps. Repeated processing has minimal effect on these devices. End of life is normally determined by wear and damage due to the intended use. The user assumes liability and is responsible for the use of a damaged and dirty device. O. CLEANING AND DISINFECTION Devices must be adequately cleaned and sterilized prior to use or re-use. All devices are to be cleaned, disinfected, and sterilized prior to each application; this is required as well for the first use after delivery of the unsterile devices. Effective cleaning is an indispensable requirement for effective sterilization of the devices. If possible, the Machine procedure (Washer-Disinfector) should be used for cleaning and disinfection. The Manual Cleaning procedure should only be used if an automated procedure is not available; in this case, the significantly lower efficiency and reproducibility of the manual procedure should be considered. The Preliminary Cleaning steps are to be performed in both cases. Manual cleaning may require onsite validation by the healthcare facility and appropriate procedures should be in place to avoid human factor variability. I. POINT- OF-USE PREPARATION, CONTAINMENT AND TRANSPORTATION It is recommended that endoscopes are reprocessed within a maximum of 2 hours of use. At point of use, soiled instruments must be removed from trays and moistened to prevent debris from drying before transportation to the reprocessing area for cleaning procedures. Soaking in enzyme solutions facilitates cleaning, especially in devices with complex features and hard-to-reach areas (lumens, etc.). These enzyme solutions as well as enzymatic foam sprays break down protein matter and prevent blood and protein-based materials from drying on devices. Manufacturer’s instructions for preparation and use of these solutions should be explicitly followed. Devices should be contained and transported in a closed, puncture-proof device to ensure safety. Do not clean soiled instruments while in cases or trays. Instrument cases and trays are considered reusable devices. Trays should be inspected for visible soil and must be cleaned prior to use. II. DETERGENT SELECTION Consider the following points during selection of the cleaning detergent: 1. Suitability of the cleaning agent (no foam development). CAUTION: Do not clean endoscopes with sonication, whether in an ultrasonic bath or an automated washer/disinfector with ultrasonic power. 2. Compatibility of the cleaning agent with the instruments. Arthrex recommends the use of neutral pH or enzymatic cleaning agents. Alkaline agents may be used to clean devices in countries where required by law or local ordinance, or where prion diseases such as transmissible spongiform encephalopathy (TSE) or Creutzfeldt - Jakob disease (CJD) are a concern (applies only outside of the US). Arthrex does not recommend the use of a specific brand of cleaning agent. Enzol® and neodisher® MediClean forte were utilized during the validation of these instructions. Caution: Low acid or alkaline solutions are not recommended, as they corrode metal parts and anodized aluminum and compromise polymer plastics. If non-neutral pH cleaning chemistries are utilized, care should be taken to ensure appropriate rinsing, as validated by the end-user facility, and neutralization steps are taken so as to not negatively impact the fit, finish, or function of the device. Pay attention to the instructions of the detergent manufacturer with respect to neutralization and post-rinsing. Follow the instructions of the detergent manufacturer regarding use concentration and temperature for either manual or automated cleaning. Please use only freshly prepared solutions as well as only purified/highly purified water at least for final rinse, and a soft, low-linting cloth and/or filtered medical grade air for drying, respectively. III. PRELIMINARY CLEANING 1. Ensure existing adapters are disassembled from the endoscope (see K. DISASSEMBLY). 2. Remove excess soil from devices, especially in areas such as joints and crevices, by cleaning the surfaces with a non-shedding disposable wipe for a minimum of 30 seconds. 3. Rinse the devices at least 1 minute under running utility water (temperature < 35 °C/95 °F). Special attention should be given to lumens, joint, crevices, and other hard-to-reach areas. 4. Immerse the devices in cleaning solution inside an appropriate bath. While immersed in solution, flush the devices a minimum of 5 times using an appropriate syringe. After flushing and while still immersed in solution, brush the devices for 1 minute using a soft-bristled brush. Special attention should be given to lumens, joints, crevices, and other hard-to-reach areas. Lumens should be brushed with appropriate diameter and length bristle sizes for the particular lumen. 5. CAUTION: Do not scratch contaminants off with hard objects, as this may cause damage to the optical end surfaces. 6. Remove the devices from the cleaning solution and rinse at least 1 minute with utility water. Thoroughly and aggressively rinse lumens, joints, crevices, and other hard-to-reach areas. 7. After the completion of preliminary cleaning, the end user has the option to perform either Manual Cleaning and Disinfection or Machine (Automated) Cleaning and Thermal Disinfection (preferred). IV. MACHINE (AUTOMATED) CLEANING AND THERMAL DISINFECTION Considerations for the selection of the washer-disinfector: • Capable of providing an approved program for thermal disinfection (appropriate exposure time and temperature according to A0 concept) • Final rinse completed with purified (critical, e.g. RO or DI) water and utilizes only filtered air for drying Cleaning Procedure: 1. After preliminary cleaning is complete, load the devices in the washer-disinfector such that all design features of the device are accessible to cleaning and such that design features that might retain liquid can drain (for example, hinges should be open and cannulations/holes positioned to drain). 2. If using alkaline cleaning agents, a neutralization step should be utilized as appropriate. 3. Run an automated wash cycle with fundamentally approved efficiency of the washer-disinfector (for example, CE marking according to EN ISO 15883 or FDA approval/clearance/registration). The following minimum recommended wash cycle parameters were utilized by Arthrex during the validation of these instructions. RECOMMENDED WASHING CYCLE PARAMETERS Phase Recirculation Time Temperature Detergent Pre-Wash 3 Minutes Cold Water N/A Cleaning Wash 10 Minutes Follow detergent manufacturer’s recommendation Enzymatic or alkaline detergent Neutralization Rinse (optional) 2 Minutes Follow detergent manufacturer’s recommendation Neutralizing agent (as needed) Rinse 3 Minutes Cold Water N/A Thermal Disinfection Rinse 5 Minutes 90°C (194°F) N/A Drying Minimum 6 Minutes or until visibly dry Minimum 100°C (212°F) N/A 4. Remove the devices from the washer-disinfector following the completion of the program and check devices for visible soil. Repeat cleaning if soil is visible and re-inspect. 5. Ensure devices are thoroughly dry and carry out visual inspection, function check, and preparation for use (see sections G. and I.). Proceed to the Sterilization section. V. MANUAL CLEANING AND DISINFECTION Following preliminary cleaning, the instructions for Manual Cleaning and Disinfection may be followed as an alternative cleaning method to Machine (Automated) Cleaning and Thermal Disinfection if an automated procedure is not available. 1. After preliminary cleaning is complete, immerse devices in fresh cleaning solution inside appropriate bath. While immersed in solution, brush the devices for 1 minute using a soft-bristled brush. CAUTION: Do not clean endoscopes with sonication. 2. After brushing, allow devices to soak for 10 minutes within the cleaning solution. 3. Remove the devices from the cleaning solution and rinse at least 1 minute with utility water. Thoroughly and aggressively rinse lumens, joints, crevices, and other hard-to-reach areas. 4. Check devices for visible soil. Repeat cleaning if soil is visible and re-inspect. 5. Soak the devices for the given soaking time (provided by the disinfectant manufacturer) in disinfectant solution so that the devices are sufficiently covered. Make sure that there is no contact between the devices. Ensure that the device is in the open position during soaking. 6. Remove the devices from the disinfectant solution and rinse per disinfectant manufacturer’s instructions. Ensure final rinse is performed with purified (critical, e.g. RO or DI) water. 7. Dry devices thoroughly utilizing filtered medical grade air or a soft, clean, and low-linting cloth. Carry out the visual inspection, function check, and preparation for use (see sections G. and I.). R. 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. It is the responsibility of the end-user to ensure devices, once sterilized, are stored in such a way as to maintain the sterility of the device until use. Sterile, packaged devices should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, and temperature/humidity extremes. Sterile device packages should be carefully examined prior to opening to ensure that package integrity has not been compromised. Maintenance of sterile package integrity is generally event related. If a sterile wrap is torn, shows any evidence of tampering, or has been exposed to moisture, the device or set must be cleaned, repackaged, and sterilized. Additional storage requirements: • Avoid direct sunlight. • Ensure that the endoscopes are stored securely. 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. S. INFORMATION 1. In CE Accepting Countries: Procedures carried out using these devices may be used on the general population. 2. In CE Accepting Countries: The clinical benefits associated with the use of these devices outweigh the known clinical risks. 3. In CE Accepting Countries: There are no identified residual risks or uncertainties associated with the clinical use of these devices. Deutsch Eine Erklärung der Symbole finden Sie unter www.arthrex.com/symbolsglossary. A. VERWEISE Diese Anweisungen wurden unter Anwendung der in den folgenden Normen enthaltenen Leitlinien entwickelt: • ANSI/AAMI ST79: „Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities“ • ISO 17664: Aufbereitung von Produkten für die Gesundheitsfürsorge − Vom Hersteller für die Aufbereitung von Medizinprodukten bereitzustellende Informationen • ISO 17665-1: Sterilisation von Produkten für die Gesundheitsfürsorge – Feuchte Hitze – Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte • AAMI TIR30: „A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices“ • AAMI ST77: „Containment devices for reusable medical device sterilization“ • AAMI TIR 34: „Water for the reprocessing of medical devices“ • Wiederaufbereitung von Medizinprodukten in Gesundheitseinrichtungen: Validierungsmethoden und Leitlinien zur Kennzeichnung für Mitarbeiter im Gesundheitswesen und der US-amerikanischen Arzneimittel-Überwachungsbehörde (FDA) B. PRODUKTBESCHREIBUNG Diese Endoskopieoptik für das SynergyID™ Endoskopie-Bildgebungssystem umfasst eine Okularlinse, einen Anschluss für Glasfaserkabel mit Schraubadaptern für Glasfaserkabel anderer Markenhersteller und ein Hüllrohr aus rostfreiem Material, in welchem das Stablinsensystem enthalten ist, sowie einen eingebauten Glasfaser-Leuchtenträger. Auf dem Hauptgehäuse befinden sich ein einzelnes grünes Band und die eingeätzten Buchstaben NRI, um die Identifizierung der NIR-Endoskopieoptiken zu erleichtern. P. STERILIZATION Sterilization is to be performed following cleaning, disinfection, and sterile packaging prior to use. I. STERILE PACKAGING Singly: Single devices should be packed as to ensure that the pack is large enough to contain the device without stressing the seals. Packaging should be completed utilizing a pouch or wrap which conforms to the recommended specifications for steam sterilization as outlined below. If a wrap is utilized, it should be completed following AAMI double-wrap or equivalent guidelines with an appropriate wrap (cleared by the FDA or the local governing body). Sets: Where appropriate, cleaned, disinfected and inspected devices should be placed into trays/cases as provided or in general-purpose sterilization trays. The total weight of trays/cases should not exceed 11.4kg/25 lbs. (other local limits below 11.4kg/25 lbs. may apply). Trays/cases should be double wrapped following AAMI or equivalent guidelines with an appropriate wrap (cleared by the FDA or the local governing body). Sets may also be placed into an approved reusable rigid sterilization container. Aesculap SterilContainer™ and Genesis® rigid containers with perforated bottoms and lids are approved for use with Arthrex, Inc. sets. Areas, or bracketed positions, designated for specific devices shall contain only devices intended for those areas. Devices should not be stacked or placed in close contact. Only Arthrex devices should be included in the trays or cases. These validated instructions are not applicable to trays or cases that include devices not intended to be used with Arthrex trays or cases. II. STEAM STERILIZATION Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the table below. Sterilizers vary in design and performance characteristics. Cycle parameters and the load configuration should always be verified against the sterilizer manufacturer’s instructions. Exposure Temperature Exposure Time Minimum Drying Time1 Minimum Cooling Time2 US Prevacuum Cycle3 132°C (270°F) 4 Minutes 30 Minutes 30 Minutes UK Prevacuum Cycle3 134°C (273°F) 3 Minutes 30 Minutes 30 Minutes Gravity-Displacement3 (single devices) 132°C (270°F) 15 Minutes 30 Minutes 30 Minutes Gravity-Displacement3 (sets) 132°C (270°F) 30 Minutes 30 Minutes 30 Minutes Q. PACKAGING AND LABELING 1. Arthrex devices should be accepted only if the factory packaging and labeling arrive intact. 2. Contact Customer Service if the package has been opened or altered. Endoskopieoptiken für SynergyID Endoskopie-Bildgebungssystem Anweisungen für die Verwendung und Aufbereitung Sistema de imágenes endoscópicas SynergyID Instrucciones de uso y de manipulación DFU-0327-4 Rev. 0 08/2021 Page 1 of 4 2797 IMPORTANT PRODUCT INFORMATION WICHTIGE PRODUKTINFORMATION INSTRUCCIONES IMPORTANTES PARA EL USO NOTICE D’UTILISATION IMPORTANTE IMPORTANTI INFORMAZIONI PER L’USO EC REP Figure 1: 1 Drying times vary according to load size and should be increased for larger loads. 2 Cooling times vary according to the sterilizer used, device design, temperature and humidity of ambient environment, and type of packaging used. Cooling process should comply with ANSI/AAMI ST79. 3 For markets outside of the US, the cycle parameters listed for exposure time and temperature can be considered as minimum values. III. HYDROGEN PEROXIDE STERILIZATION Arthrex endoscopes can be sterilized by the following Hydrogen Peroxide methods: STERRAD® systems: o STERRAD 100S, short cycle o STERRAD NX, standard cycle o STERRAD 100NX, standard cycle Observe specifications of the manufacturer (ASP, Advanced Sterilization Products) regarding the corresponding method. Steris systems: o V-Pro® 1 Low Temperature Sterilization System o V- Pro® 1 Plus Low Temperature Sterilization System, Non Lumen Cycle o V- Pro® maX Low Temperature Sterilization System, Non Lumen Cycle Observe specifications of the manufacturer (Steris) regarding the corresponding method. IV. 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 (TSE) 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. Refer to ANSI/AAMI ST79 for further information. Instructions for Use and Processing Instructions Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108-1945 • USA Toll free: 1-(800) 934-4404 www.arthrex.com https://www.arthrex.com/dfu-list RECOMMENDED STEAM STERILIZATION PARAMETERS Cycle Type SynergyID™ Endoscopic Imaging System Endoscopes 1. Distal end 2. Sheath 3. Main part 4. Ocular funnel 5. Proximal end 6. Irradiation surface of the illumination fibers 7. Connection for illumination fibers 8. Adapter for illumination fiber, type Wolf, pre-assembled 9. Adapter for illumination fiber, type Storz / Olympus (see assembly instructions) 10. Green ring ~~~~~~~~~~~~~~~~~~~~~~~~ 1. Distales Ende 2. Schaft 3. Hauptteil 4. Okulartrichter 5. Proximales Ende 6. Strahlfläche der Lichtfasern 7. Verbindung für die Lichtfasern 8. Adapter für die Lichtfaser Wolf, vormontiert 9. Adapter für die Lichtfaser Storz / Olympus (siehe Montageanweisungen) 10. Grüne Ring ~~~~~~~~~~~~~~~~~~~~~~~~ 1. Extremo distal 2. Camisa 3. Pieza principal 4. Embudo ocular 5. Extremo proximal 6. Superficie de irradiación de las fibras de iluminación 7. Conexión para las fibras de iluminación 8. Adaptador para la fibra de iluminación tipo Wolf, premontado 9. Adaptador para fibra de iluminación tipo Storz / Olympus (consultar instrucciones de montaje) 10. Anillos verde ~~~~~~~~~~~~~~~~~~~~~~~~ 1. Extrémité distale 2. Gaine 3. Partie principale 4. Entonnoir oculaire 5. Extrémité proximale 6. Surface d’irradiation des fibres d’éclairage 7. Connexion pour fibres d’éclairages 8. Adaptateur pour fibre d’éclairage, type Wolf, préassemblé 9. Adaptateur pour fibre d’éclairage, type Storz/Olympus (consulter les instructions d’assemblage) 10. Bagues verte ~~~~~~~~~~~~~~~~~~~~~~~~ 1. Estremità distale 2. Guaina 3. Corpo principale 4. Imbuto oculare 5. Estremità prossimale 6. Superficie di irradiazione delle fibre luminose 7. Connessione per fibre luminose 8. Adattatore per fibra luminosa, tipo Wolf, preassemblata 9. Adattatore per fibra luminosa, tipo Storz/Olympus (vedere istruzioni di assemblaggio) 10. Ghiere verd 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. Dies ist keine Garantieurkunde. Sämtliche Informationen bezüglich Gewährleistung und Garantie, z.B. Haftungs- und sonstige Ausschlüsse, Geschäftsbedingungen und zugehörige Bestimmungen, finden Sie im Abschnitt „Arthrex U.S. Product Warranty“ (US-Produktgarantie von Arthrex) auf der Website von Arthrex, Inc. unter www.arthrex.com, auf deren Regelungen hierin Bezug genommen wird. Este documento no es una garantía. Para obtener toda la información sobre la garantía, incluidos los descargos de responsabilidad, exclusiones, términos, condiciones y disposiciones relacionadas, consulte la sección “Arthrex U.S. Product Warranty” (Garantía de los productos Arthrex para los Estados Unidos) del sitio web de Arthrex, Inc., www.arthrex.com, cuyas disposiciones se incorporan a este documento por referencia. Ce document n’est pas un document de garantie. Pour les informations relatives à la garantie, y compris les avis de non-responsabilité, les exclusions, les conditions et les dispositions correspondantes, se reporter à la rubrique « Garantie des produits Arthrex aux États-Unis » du site Web d’Arthrex, Inc., à l’adresse www.arthrex.com, dont les dispositions sont ajoutées ici pour référence. Questo non è un documento di garanzia. Per tutte le informazioni sulla garanzia, compresi clausole esonerative, esclusioni, termini, condizioni e clausole correlate, consultare la sezione “Arthrex U.S. Product Warranty” del sito web di Arthrex, Inc., all’indirizzo www.arthrex.com le cui clausole sono qui incorporate a titolo di riferimento.](https://public.bioclinicalservices.com.au/library/representations/proxy/eyJfcmFpbHMiOnsiZGF0YSI6MTU0OTU0LCJwdXIiOiJibG9iX2lkIn19--85288ee44b5cb81577384a47309fc03c5e03f442/eyJfcmFpbHMiOnsiZGF0YSI6eyJyZXNpemUiOiIzMjB4In0sInB1ciI6InZhcmlhdGlvbiJ9fQ==--4214356078d1f110e449cda512a9432562da3e70/Arthrex%20-%20DFU-0327-4%20-%20Endoscopic%20Imaging%20System%20Endoscopes%20Instruction%20for%20Use%20and%20Processing%20Instructions%20-%202021-08%20-%20Rev%200.pdf.png)
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English Symbols glossary can be found at www.arthrex.com/symbolsglossary. A. REFERENCES These instructions were developed using the guidance given in the following standards: • ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities • ISO 17664: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices • ISO 17665-1: Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices • AAMI TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices • AAMI ST77: Containment devices for reusable medical device sterilization • AAMI TIR 34: Water for the reprocessing of medical devices • Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff B. DEVICE DESCRIPTION This SynergyID™ endoscopic imaging system 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. There is one green band and etching NIR on the main body to help identify the NIR endoscopes. C. INDICATIONS Indications for CE Accepting Countries: The SynergyID endoscopic imaging system is indicated for use to provide real time endoscopic visible and nearinfrared fluorescence imaging. Indications for United States and Non-CE Accepting Countries: The Arthrex SynergyID endoscopic imaging system is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery. The Arthrex SynergyID endoscopic imaging system is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex SynergyID endoscopic imaging system is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. 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: • Laparoscope: laparoscopic procedures • Fluorescence imaging NIR endoscope: endoscopic visible and nearinfrared fluorescence imaging procedures For the benefit and safety of patients, physicians must select a method which they consider suitable, based on their experience. E. WARNINGS 1. Caution: Federal law restricts this device to sale by or on the order of a physician. 2. This device is intended to be used by a trained medical professional. 3. Follow your institutions policy for safe disposal of all needles and other sharps or medical waste. 4. Biohazard waste, such as explanted devices, needles and contaminated surgical equipment, should be safely disposed of in accordance with hospital policy. 5. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred. F. SAFETY INFORMATION The endoscope may only be used by trained medical professionals, in medical facilities. • After receipt of the device(s), inspect the endoscope for completeness and damage. • Read, observe and store these instructions and any other applicable instructions. • Use endoscopes only as intended. CAUTION: For storage, transport and processing, ensure that the endoscope is not subjected to mechanical strain, particularly to prevent damage to the sensitive lens system. 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! • Carry out a visual inspection and function check prior to each use. • Only use endoscopes which are in perfect condition. G. INSPECTION, HANDLING AND MAINTENANCE 1. Arthrex endoscopes are precision medical instruments and must be used and handled with care. 2. Inspect the endoscope for damage prior to use and at all stages of handling thereafter. 3. If damage is detected, do not use the endoscope prior to consulting the manufacturer for guidance. 4. Do not subject the endoscope to impact. Put the endoscope down carefully. 5. Hold the endoscope only by the ocular funnel/main part and not by the sheath. 6. Do not bend the sheath or use as a prying tool. 7. After insertion of the endoscope into the body, do not apply additional flexion to the body. 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. H. DESCRIPTION I. CONSTRUCTION ENDOSCOPE – SEE FIGURE 1 II. MARKINGS ON THE MAIN PART • CE mark with identification number of the notified body where applicable: Endoscopes conform to the requirements of the guideline 93/42/EEC. • For autoclavable endoscopes: Etching of autoclavable • For endoscopes: Specification of the direction of view • For NIR endoscopes: One green band and etching NIR on the main part III. AVAILABLE DESIGNS AND SIZES The endoscopes are available in the following designs and sizes: • Straight endoscopes
• Angled endoscopes • Sheath diameter 5.5–10 mm IV. COMBINABLE PRODUCTS The NIR endoscopes can be combined with common camera systems, illumination fibers and instruments from Arthrex. They are also combinable with the SynergyID endoscopic imaging system with visible and near-infrared fluorescence capabilities. I. PREPARATION FOR USE I. VISUAL INSPECTION AND FUNCTION CHECK WARNING: Risk of injury due to faulty endoscopes! • Carry out visual inspection and function check, prior to initial use and after each subsequent use. • Only use endoscopes which are in perfect condition. CAUTION: Clean/disinfect and sterilize the endoscope 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. • Inspect the entire endoscope, particularly the sheath figure 1 [2] 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 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. 1. Apply polishing paste to a clean cotton swab. 2. For large end surfaces: press cotton swab lightly on the end surface to be cleaned and rub it over the glass. 3. For small end surfaces: press cotton swab lightly on the end surface to be cleaned and turn it.
Figure 2 – Cleaning 4. Clean all optical end surfaces with warm water and neutral-pH detergent to remove polishing paste residue. 5. Rinse optical end surfaces under running water. 6. Dry optical end surfaces with a soft cloth. 7. Carry out visual inspection. If the deposits were not removed: send endoscope in for repair 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). J. 1. 2. 3.
ASSEMBLY Connection for ACMI type illumination fiber Adapter for Wolf type illumination fiber Adapter for Storz / Olympus type illumination fiber
Figure 3 – Assembly • If required, mount the appropriate adapter figure 3 [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). K. DISASSEMBLY 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 3 [2, 3], if used. L. 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 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 repaired by Arthrex only. • Clean, disinfect and sterilize the endoscope thoroughly, prior to returning it for repair. • Ideally, send in the endoscope in its original packaging. If this is not possible, securely package it for transport. • Arthrex is not liable for damage resulting from improper shipping. M. ACCESSORIES/SPARE PARTS Please contact your Arthrex representative for additional polishing paste and light post adapters. N. VALIDATION The recommended cleaning, disinfection, and sterilization methods in this DFU have been validated in compliance with federal and international guidance/ standards. In accordance with ISO 17665, the “overkill” approach was used for sterilization validation, and demonstrates a sterility assurance level (SAL) of 10-6. Cleaning, disinfecting, and sterilizing equipment and materials vary in performance characteristics. Therefore, it is the responsibility of the facility/ end user to perform the appropriate validation testing for any use beyond recommended performance characteristics. In accordance with EN ISO 17664 and AAMI TIR30, limit values and a means for monitoring chemical residues following cleaning have been established for the product. In assessing the level of cleaning residuals following the cleaning processes, a clinically relevant method was utilized for testing the safety of residuals as part of the validation protocol. Deionized (critical) water was utilized as the terminal rinse water quality to ensure that residuals will not interfere with subsequent processing steps.
Repeated processing has minimal effect on these devices. End of life is normally determined by wear and damage due to the intended use. The user assumes liability and is responsible for the use of a damaged and dirty device. O. CLEANING AND DISINFECTION Devices must be adequately cleaned and sterilized prior to use or re-use. All devices are to be cleaned, disinfected, and sterilized prior to each application; this is required as well for the first use after delivery of the unsterile devices. Effective cleaning is an indispensable requirement for effective sterilization of the devices. If possible, the Machine procedure (Washer-Disinfector) should be used for cleaning and disinfection. The Manual Cleaning procedure should only be used if an automated procedure is not available; in this case, the significantly lower efficiency and reproducibility of the manual procedure should be considered. The Preliminary Cleaning steps are to be performed in both cases. Manual cleaning may require onsite validation by the healthcare facility and appropriate procedures should be in place to avoid human factor variability. I. POINT- OF-USE PREPARATION, CONTAINMENT AND TRANSPORTATION It is recommended that endoscopes are reprocessed within a maximum of 2 hours of use. At point of use, soiled instruments must be removed from trays and moistened to prevent debris from drying before transportation to the reprocessing area for cleaning procedures. Soaking in enzyme solutions facilitates cleaning, especially in devices with complex features and hard-to-reach areas (lumens, etc.). These enzyme solutions as well as enzymatic foam sprays break down protein matter and prevent blood and protein-based materials from drying on devices. Manufacturer’s instructions for preparation and use of these solutions should be explicitly followed. Devices should be contained and transported in a closed, puncture-proof device to ensure safety. Do not clean soiled instruments while in cases or trays. Instrument cases and trays are considered reusable devices. Trays should be inspected for visible soil and must be cleaned prior to use. II. DETERGENT SELECTION Consider the following points during selection of the cleaning detergent: 1. Suitability of the cleaning agent (no foam development). CAUTION: Do not clean endoscopes with sonication, whether in an ultrasonic bath or an automated washer/disinfector with ultrasonic power. 2. Compatibility of the cleaning agent with the instruments. Arthrex recommends the use of neutral pH or enzymatic cleaning agents. Alkaline agents may be used to clean devices in countries where required by law or local ordinance, or where prion diseases such as transmissible spongiform encephalopathy (TSE) or Creutzfeldt - Jakob disease (CJD) are a concern (applies only outside of the US). Arthrex does not recommend the use of a specific brand of cleaning agent. Enzol® and neodisher® MediClean forte were utilized during the validation of these instructions. Caution: Low acid or alkaline solutions are not recommended, as they corrode metal parts and anodized aluminum and compromise polymer plastics. If non-neutral pH cleaning chemistries are utilized, care should be taken to ensure appropriate rinsing, as validated by the end-user facility, and neutralization steps are taken so as to not negatively impact the fit, finish, or function of the device. Pay attention to the instructions of the detergent manufacturer with respect to neutralization and post-rinsing. Follow the instructions of the detergent manufacturer regarding use concentration and temperature for either manual or automated cleaning. Please use only freshly prepared solutions as well as only purified/highly purified water at least for final rinse, and a soft, low-linting cloth and/or filtered medical grade air for drying, respectively. III. PRELIMINARY CLEANING 1. Ensure existing adapters are disassembled from the endoscope (see K. DISASSEMBLY). 2. Remove excess soil from devices, especially in areas such as joints and crevices, by cleaning the surfaces with a non-shedding disposable wipe for a minimum of 30 seconds. 3. Rinse the devices at least 1 minute under running utility water (temperature < 35 °C/95 °F). Special attention should be given to lumens, joint, crevices, and other hard-to-reach areas. 4. Immerse the devices in cleaning solution inside an appropriate bath. While immersed in solution, flush the devices a minimum of 5 times using an appropriate syringe. After flushing and while still immersed in solution, brush the devices for 1 minute using a soft-bristled brush. Special attention should be given to lumens, joints, crevices, and other hard-to-reach areas. Lumens should be brushed with appropriate diameter and length bristle sizes for the particular lumen. 5. CAUTION: Do not scratch contaminants off with hard objects, as this may cause damage to the optical end surfaces. 6. Remove the devices from the cleaning solution and rinse at least 1 minute with utility water. Thoroughly and aggressively rinse lumens, joints, crevices, and other hard-to-reach areas. 7. After the completion of preliminary cleaning, the end user has the option to perform either Manual Cleaning and Disinfection or Machine (Automated) Cleaning and Thermal Disinfection (preferred). IV. MACHINE (AUTOMATED) CLEANING AND THERMAL DISINFECTION Considerations for the selection of the washer-disinfector: • Capable of providing an approved program for thermal disinfection (appropriate exposure time and temperature according to A0 concept) • Final rinse completed with purified (critical, e.g. RO or DI) water and utilizes only filtered air for drying Cleaning Procedure: 1. After preliminary cleaning is complete, load the devices in the washer-disinfector such that all design features of the device are accessible to cleaning and such that design features that might retain liquid can drain (for example, hinges should be open and cannulations/holes positioned to drain). 2. If using alkaline cleaning agents, a neutralization step should be utilized as appropriate. 3. Run an automated wash cycle with fundamentally approved efficiency of the washer-disinfector (for example, CE marking according to EN ISO 15883 or FDA approval/clearance/registration). The following minimum recommended wash cycle parameters were utilized by Arthrex during the validation of these instructions.
RECOMMENDED WASHING CYCLE PARAMETERS Phase
Recirculation Time
Temperature
Detergent
Pre-Wash
3 Minutes
Cold Water
N/A
Cleaning Wash
10 Minutes
Follow detergent manufacturer’s recommendation
Enzymatic or alkaline detergent
Neutralization Rinse (optional)
2 Minutes
Follow detergent manufacturer’s recommendation
Neutralizing agent (as needed)
Rinse
3 Minutes
Cold Water
N/A
Thermal Disinfection Rinse
5 Minutes
90°C (194°F)
N/A
Drying
Minimum 6 Minutes or until visibly dry
Minimum 100°C (212°F)
N/A
4. Remove the devices from the washer-disinfector following the completion of the program and check devices for visible soil. Repeat cleaning if soil is visible and re-inspect. 5. Ensure devices are thoroughly dry and carry out visual inspection, function check, and preparation for use (see sections G. and I.). Proceed to the Sterilization section. V. MANUAL CLEANING AND DISINFECTION Following preliminary cleaning, the instructions for Manual Cleaning and Disinfection may be followed as an alternative cleaning method to Machine (Automated) Cleaning and Thermal Disinfection if an automated procedure is not available. 1. After preliminary cleaning is complete, immerse devices in fresh cleaning solution inside appropriate bath. While immersed in solution, brush the devices for 1 minute using a soft-bristled brush. CAUTION: Do not clean endoscopes with sonication. 2. After brushing, allow devices to soak for 10 minutes within the cleaning solution. 3. Remove the devices from the cleaning solution and rinse at least 1 minute with utility water. Thoroughly and aggressively rinse lumens, joints, crevices, and other hard-to-reach areas. 4. Check devices for visible soil. Repeat cleaning if soil is visible and re-inspect. 5. Soak the devices for the given soaking time (provided by the disinfectant manufacturer) in disinfectant solution so that the devices are sufficiently covered. Make sure that there is no contact between the devices. Ensure that the device is in the open position during soaking. 6. Remove the devices from the disinfectant solution and rinse per disinfectant manufacturer’s instructions. Ensure final rinse is performed with purified (critical, e.g. RO or DI) water. 7. Dry devices thoroughly utilizing filtered medical grade air or a soft, clean, and low-linting cloth. Carry out the visual inspection, function check, and preparation for use (see sections G. and I.).
R. 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. It is the responsibility of the end-user to ensure devices, once sterilized, are stored in such a way as to maintain the sterility of the device until use. Sterile, packaged devices should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, and temperature/humidity extremes. Sterile device packages should be carefully examined prior to opening to ensure that package integrity has not been compromised. Maintenance of sterile package integrity is generally event related. If a sterile wrap is torn, shows any evidence of tampering, or has been exposed to moisture, the device or set must be cleaned, repackaged, and sterilized. Additional storage requirements: • Avoid direct sunlight. • Ensure that the endoscopes are stored securely. 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. S. INFORMATION 1. In CE Accepting Countries: Procedures carried out using these devices may be used on the general population. 2. In CE Accepting Countries: The clinical benefits associated with the use of these devices outweigh the known clinical risks. 3. In CE Accepting Countries: There are no identified residual risks or uncertainties associated with the clinical use of these devices.
Deutsch Eine Erklärung der Symbole finden Sie unter www.arthrex.com/symbolsglossary. A. VERWEISE Diese Anweisungen wurden unter Anwendung der in den folgenden Normen enthaltenen Leitlinien entwickelt: • ANSI/AAMI ST79: „Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities“ • ISO 17664: Aufbereitung von Produkten für die Gesundheitsfürsorge − Vom Hersteller für die Aufbereitung von Medizinprodukten bereitzustellende Informationen • ISO 17665-1: Sterilisation von Produkten für die Gesundheitsfürsorge – Feuchte Hitze – Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte • AAMI TIR30: „A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices“ • AAMI ST77: „Containment devices for reusable medical device sterilization“ • AAMI TIR 34: „Water for the reprocessing of medical devices“ • Wiederaufbereitung von Medizinprodukten in Gesundheitseinrichtungen: Validierungsmethoden und Leitlinien zur Kennzeichnung für Mitarbeiter im Gesundheitswesen und der US-amerikanischen Arzneimittel-Überwachungsbehörde (FDA) B. PRODUKTBESCHREIBUNG Diese Endoskopieoptik für das SynergyID™ Endoskopie-Bildgebungssystem umfasst eine Okularlinse, einen Anschluss für Glasfaserkabel mit Schraubadaptern für Glasfaserkabel anderer Markenhersteller und ein Hüllrohr aus rostfreiem Material, in welchem das Stablinsensystem enthalten ist, sowie einen eingebauten Glasfaser-Leuchtenträger. Auf dem Hauptgehäuse befinden sich ein einzelnes grünes Band und die eingeätzten Buchstaben NRI, um die Identifizierung der NIR-Endoskopieoptiken zu erleichtern.
P. STERILIZATION Sterilization is to be performed following cleaning, disinfection, and sterile packaging prior to use. I. STERILE PACKAGING Singly: Single devices should be packed as to ensure that the pack is large enough to contain the device without stressing the seals. Packaging should be completed utilizing a pouch or wrap which conforms to the recommended specifications for steam sterilization as outlined below. If a wrap is utilized, it should be completed following AAMI double-wrap or equivalent guidelines with an appropriate wrap (cleared by the FDA or the local governing body). Sets: Where appropriate, cleaned, disinfected and inspected devices should be placed into trays/cases as provided or in general-purpose sterilization trays. The total weight of trays/cases should not exceed 11.4kg/25 lbs. (other local limits below 11.4kg/25 lbs. may apply). Trays/cases should be double wrapped following AAMI or equivalent guidelines with an appropriate wrap (cleared by the FDA or the local governing body). Sets may also be placed into an approved reusable rigid sterilization container. Aesculap SterilContainer™ and Genesis® rigid containers with perforated bottoms and lids are approved for use with Arthrex, Inc. sets. Areas, or bracketed positions, designated for specific devices shall contain only devices intended for those areas. Devices should not be stacked or placed in close contact. Only Arthrex devices should be included in the trays or cases. These validated instructions are not applicable to trays or cases that include devices not intended to be used with Arthrex trays or cases. II. STEAM STERILIZATION Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the table below. Sterilizers vary in design and performance characteristics. Cycle parameters and the load configuration should always be verified against the sterilizer manufacturer’s instructions.
Exposure Temperature
Exposure Time
Minimum Drying Time1
Minimum Cooling Time2
US Prevacuum Cycle3
132°C (270°F)
4 Minutes
30 Minutes
30 Minutes
UK Prevacuum Cycle3
134°C (273°F)
3 Minutes
30 Minutes
30 Minutes
Gravity-Displacement3 (single devices)
132°C (270°F)
15 Minutes
30 Minutes
30 Minutes
Gravity-Displacement3 (sets)
132°C (270°F)
30 Minutes
30 Minutes
30 Minutes
Q. PACKAGING AND LABELING 1. Arthrex devices should be accepted only if the factory packaging and labeling arrive intact. 2. Contact Customer Service if the package has been opened or altered.
Endoskopieoptiken für SynergyID Endoskopie-Bildgebungssystem Anweisungen für die Verwendung und Aufbereitung Sistema de imágenes endoscópicas SynergyID Instrucciones de uso y de manipulación
DFU-0327-4 Rev. 0 08/2021 Page 1 of 4
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IMPORTANT PRODUCT INFORMATION WICHTIGE PRODUKTINFORMATION INSTRUCCIONES IMPORTANTES PARA EL USO NOTICE D’UTILISATION IMPORTANTE IMPORTANTI INFORMAZIONI PER L’USO
EC REP Figure 1:
1 Drying times vary according to load size and should be increased for larger loads. 2 Cooling times vary according to the sterilizer used, device design, temperature and humidity of ambient environment, and type of packaging used. Cooling process should comply with ANSI/AAMI ST79. 3 For markets outside of the US, the cycle parameters listed for exposure time and temperature can be considered as minimum values. III. HYDROGEN PEROXIDE STERILIZATION Arthrex endoscopes can be sterilized by the following Hydrogen Peroxide methods: STERRAD® systems: o STERRAD 100S, short cycle o STERRAD NX, standard cycle o STERRAD 100NX, standard cycle Observe specifications of the manufacturer (ASP, Advanced Sterilization Products) regarding the corresponding method. Steris systems: o V-Pro® 1 Low Temperature Sterilization System o V- Pro® 1 Plus Low Temperature Sterilization System, Non Lumen Cycle o V- Pro® maX Low Temperature Sterilization System, Non Lumen Cycle Observe specifications of the manufacturer (Steris) regarding the corresponding method. IV. 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 (TSE) 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. Refer to ANSI/AAMI ST79 for further information.
Instructions for Use and Processing Instructions
Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108-1945 • USA Toll free: 1-(800) 934-4404 www.arthrex.com https://www.arthrex.com/dfu-list
RECOMMENDED STEAM STERILIZATION PARAMETERS
Cycle Type
SynergyID™ Endoscopic Imaging System Endoscopes
1. Distal end
2. Sheath 3. Main part 4. Ocular funnel 5. Proximal end 6. Irradiation surface of the illumination fibers 7. Connection for illumination fibers 8. Adapter for illumination fiber, type Wolf, pre-assembled 9. Adapter for illumination fiber, type Storz / Olympus (see assembly instructions) 10. Green ring ~~~~~~~~~~~~~~~~~~~~~~~~ 1. Distales Ende 2. Schaft 3. Hauptteil 4. Okulartrichter 5. Proximales Ende 6. Strahlfläche der Lichtfasern 7. Verbindung für die Lichtfasern 8. Adapter für die Lichtfaser Wolf, vormontiert 9. Adapter für die Lichtfaser Storz / Olympus (siehe Montageanweisungen) 10. Grüne Ring ~~~~~~~~~~~~~~~~~~~~~~~~ 1. Extremo distal 2. Camisa 3. Pieza principal 4. Embudo ocular 5. Extremo proximal 6. Superficie de irradiación de las fibras de iluminación 7. Conexión para las fibras de iluminación 8. Adaptador para la fibra de iluminación tipo Wolf, premontado 9. Adaptador para fibra de iluminación tipo Storz / Olympus (consultar instrucciones de montaje) 10. Anillos verde ~~~~~~~~~~~~~~~~~~~~~~~~
1. Extrémité distale 2. Gaine 3. Partie principale 4. Entonnoir oculaire 5. Extrémité proximale 6. Surface d’irradiation des fibres d’éclairage 7. Connexion pour fibres d’éclairages 8. Adaptateur pour fibre d’éclairage, type Wolf, préassemblé 9. Adaptateur pour fibre d’éclairage, type Storz/Olympus (consulter les instructions d’assemblage) 10. Bagues verte ~~~~~~~~~~~~~~~~~~~~~~~~ 1. Estremità distale 2. Guaina 3. Corpo principale 4. Imbuto oculare 5. Estremità prossimale 6. Superficie di irradiazione delle fibre luminose 7. Connessione per fibre luminose 8. Adattatore per fibra luminosa, tipo Wolf, preassemblata 9. Adattatore per fibra luminosa, tipo Storz/Olympus (vedere istruzioni di assemblaggio) 10. Ghiere verd
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. Dies ist keine Garantieurkunde. Sämtliche Informationen bezüglich Gewährleistung und Garantie, z.B. Haftungs- und sonstige Ausschlüsse, Geschäftsbedingungen und zugehörige Bestimmungen, finden Sie im Abschnitt „Arthrex U.S. Product Warranty“ (US-Produktgarantie von Arthrex) auf der Website von Arthrex, Inc. unter www.arthrex.com, auf deren Regelungen hierin Bezug genommen wird. Este documento no es una garantía. Para obtener toda la información sobre la garantía, incluidos los descargos de responsabilidad, exclusiones, términos, condiciones y disposiciones relacionadas, consulte la sección “Arthrex U.S. Product Warranty” (Garantía de los productos Arthrex para los Estados Unidos) del sitio web de Arthrex, Inc., www.arthrex.com, cuyas disposiciones se incorporan a este documento por referencia. Ce document n’est pas un document de garantie. Pour les informations relatives à la garantie, y compris les avis de non-responsabilité, les exclusions, les conditions et les dispositions correspondantes, se reporter à la rubrique « Garantie des produits Arthrex aux États-Unis » du site Web d’Arthrex, Inc., à l’adresse www.arthrex.com, dont les dispositions sont ajoutées ici pour référence. Questo non è un documento di garanzia. Per tutte le informazioni sulla garanzia, compresi clausole esonerative, esclusioni, termini, condizioni e clausole correlate, consultare la sezione “Arthrex U.S. Product Warranty” del sito web di Arthrex, Inc., all’indirizzo www.arthrex.com le cui clausole sono qui incorporate a titolo di riferimento.