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Legend 1 Ocular 2 Focussing ring 3 Working channel for flexible instruments 4 Bending protection 5 Deflectable, distal end 6 Lever for control of distal end 7 Fixation thread for pressure compensation cap 8 ACM / British Standard light guide connection 9 Wolf / HSW light guide connection 10 Aesculap / Storz light guide connection 11 pressure compensation cap 12 Cap for leak test 13 Manometer Symbols on product and packaging Warning: General danger signal. Indicates a hazard. If not avoided, the hazard can result in death or serious injury. Warning: refer to accompanying documents. Caution: Indicates a potential hazard. If not avoided, this hazard may result in minor personal injury or product/property damage. Manufacturer Purpose The flexible controllable endoscope 65-001-43 is used for visualization of body cavities in the area of ear-nose-throat (ENT). Safe handling and preparation Risk of injury due to defect product! 1. Only use faultless product. The product and accessory may only be used by persons who have the needed training, knowledge and experience. Read, observe and store instructions for use. Only use the product for its intended use, see chapter purpose. Thoroughly clean the new product after removing the transport packaging and before first sterilization (manually or mechanically). Store the new or unused product at a dry, clean and protected place. Visually check product before each use regarding: cleanness, function and damages, e. g. loose, bent, cracked, used up or broken parts. Do not use damaged or defect products. Immediately remove damaged products. Replace damaged parts immediately by original spare parts. Operation Danger of injury and/or malfunction! Do functional check before each use. Risk of burns to patient and user, caused by high-intensity light! The light guide end at the instrument side can reach temperatures, which can cause burns. Make certain the distal end of the endoscope or optical cable connection does not touch human tissue or any Page 2 of 9
flammable or heat-sensitive materials while the light source is active. Do not put the endoscope on the patient. Do not touch the distal end of the endoscope and the optical cable connection. Adjust the light source to the minimum required power for optimal illumination of the endoscopic image. Only use light sources of a power rating of up to 180 W. Operation of product The product is equipped with an ocular 1 corresponding to DIN norm. The image can be viewed directly looking into the ocular or on the monitor, using a camera. The focussing ring 2 at the ocular is used to focus the image. The connection for the light guide is suitable for the most popular adapter systems 7. The deflection of the distal end 4 is effected by moving up and down the lever 5 at the main body. The product is delivered with an additional pressure compensation cap 8 and a leak tester 9, 10. The use of those components is explained in chapter Validated reprocessing. Functional and visual inspection Check product regarding damages before each use to exclude endangering of the patient. Carefully carry out the inspection of the product. Due to their small outer diameter they have an increased risk to break. The change over main body/flexible part is particularly at risk. This area is protected by a special bending protection 3. Check the complete coating tube regarding outer damages. Breaks or holes have to be repaired by the manufacturer. Haze of the distal objective glass 11, proximal ocular glass 12 and entrance surface at the light guide connection 7 can usually be cleaned with a pad moistened with alcohol. If those hazes cannot be removed the product has to be sent to the manufacturer to be inspected. The image quality can be checked by focussing an object within the given depth of field. The object has to be clearly visible. Black points show breaks. A bigger quantity of those points means a deterioration of the image quality. In this case a repair by the manufacturer is necessary. Hold the probe with the light guide against a light source and check the distal end. Uniform bright spots signalize an intact illumination 13. Damages and interferences of function due to use of unsuitable or wrong accessory! Other accessory than indicated in the instructions for use may only be used if the characteristics and safety requirements for the intended application will not be influenced. Damages at the deflection due to wrong handling! Only operate the deflection with lever 5. If a resistance can be felt when operating the deflection, do not try to forcibly reach a higher deflection. When pulling out the product of the body the distal end may not be deflected. Damages due to wrong use of the pressure compensation cap! During cleaning, disinfection and wet chemical cold sterilization the pressure compensation cap 8 may not be screwed onto the connection 6. During gas sterilization the pressure compensation cap 8 must be screwed onto the connection 6. Always clean product immediately after use. The distal end is not electrically insulated against the main body. Only use product with light sources which have a spare lamp. If the product is used with electromedical devices, the BF regulations have to be kept. Disassembly Screw off adapter 9, 10. Remove sealing cap compensation cap from Luer Lock connection. Assembly Page 3 of 9
Screw on adapter 9, 10. Attach sealing cap to Luer Lock connection. Validated processing procedure Note Adhere to national statutory regulations, international standards and guidelines, and local, clinical hygiene instructions for sterile processing. Note Successful processing of this medical product can only be ensured if processing is peformed through a validated processing procedure. The user/processor is responsible for the validation. General hints To avoid unnecessary, excessive contamination of the complete instrument tray during operations, take care that contaminated instruments are collected separately and not put back into the instrument tray. Encrusted or fixated residues from surgery can make the cleaning process more difficult or ineffective, and can cause corrosion of stainless steel. Therefore the time interval between application and cleaning should not exceed 6 h, no potentially fixating pre-cleaning temperatures > 45 C be applied, and no fixating disinfectants (active ingredient: aldehyde, alcohol) be used. Excessive doses of neutralizers or basic detergents can cause chemical degradation and/or fading and obliteration of laser inscriptions on stainless steel surfaces, regarding visual reading and machinereadability of the inscriptions. Residues containing chlorine or chlorides e. g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfecting and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of the stainless steel products. To remove such residues, the products must be rinsed sufficiently with fully desalinated water and dried thoroughly. Only use process chemicals that have been tested and approved (e.g. VAH/DGHM or FDA approval or CE mark) and which are compatible with the product s materials according to the chemical manufacturers recommendations. All process parameters specified by the chemical s manufacturer, such as temperatures, concentrations and exposure times, must be strictly observed. Failure to do so can result in the following problems: Optical deterioration, e.g. fading or discoloration of titanium or aluminum surfaces. For aluminum, ph>8 in the application/process solution can already cause visible surface changes. Material damage, e.g. corrosion, cracks, fracturing, premature aging or swelling. Do not use process chemicals that would cause stress cracking or brittleness of plastics. Clean the product immediately after use. Crude pollution can be removed manually with a soft cloth or a soft brush. Following the further common steps of the processing. For further detailed advice on hygienically safe and material-/value-preserving reprocessing, see www.a-k-i.org Use appropriate cleaning/disinfecting agents if the product is put away in wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. The bending radius of the flexible endoscope part may not be smaller than 8 cm. Avoid excessive pressure onto the product. Clean used cleaning brushes after each use in ultrasonic bath and disinfect it afterwards. At the end of the day, store the used brushes after cleaning and disinfection dry and protected against contamination. Do not use the product in case of breakage or kinking of the wire. Page 4 of 9
Preparations at the place of application Disassemble the product immediately after use, as described in these instructions for use, see Disassembling. Remove the sealing cap from Luer Lock connector. Rinse surfaces that cannot be visually inspected, e.g. on products with hidden crevices or lumens or products with complex geometries, preferably with distilled water, using e.g. a disposable syringe. Remove visible surgical residues as completely as possible, using a lint-free wet wipe. Put the dry product into a closed disposal container and have it transferred to cleaning and disinfection within 6 h. Preparation before cleaning Disassemble the product prior to cleaning, see Disassembling. Carry out leak test. Damages due to reprocessing of untight product/leak test! To avoid damages, carry out leak test before each cleaning and disinfection. Screw pressure compensation cap for leak test 12 onto thread 7 of the product. Increase pressure by operating the balloon pump until the pressure reaches 140-180 mmhg. After reaching this value, observe display of the manometer. A sudden significant decrease in pressuresignalizesleakage. In this case the product has to be repaired before using it again. To do so, send it dry and in a tight case with the marking not disinfected to the manufacturer. If the pressure will not decrease the product has no untight areas and can be reprocessed according to the cleaning and disinfection schedule. Cleaning/Disinfection Damages to the product due to inappropriate cleaning/disinfection agents and/or excessive high temperatures! Use cleaning and disinfection agents according to the manufacturer s instructions. The cleaning an disinfecting agents must - be approved for flexible endoscopes - not attack softeners (e.g. silicone) Observe specifications regarding concentration, temperature, exposure time and use-by-date. Do not exceed the maximum allowable cleaning temperature of 30 C. Damage to the optical system caused by loosening of connections during ultrasound cleaning! Do not clean the product in ultrasonic bath. Damages at the endoscope due to mechanical cleaning! Do not clean the product mechanically. Manual cleaning/disinfection Clean product with flexible joints in open position, respectively move joints. Inspect visible surfaces for residual contamination after manual cleaning/disinfection. Repeat the cleaning process if necessary. Do not insert the product in cleaning/disinfectant agent over night. Damages at the product due to wrong handling! Only reprocess product if it is tight (see leak test). During reprocessing, the product must be in a stretched position, respectively the bending radius must not be smaller than 8 cm. Avoid excessive pressure or tension on the flexible probe. Do not insert the product in cleaning/disinfectant agent over night. Page 5 of 9
Manual cleaning with immersion disinfection Stage Step T ( C/ F) t (min) Conc. [%] Water quality Chemical I Cleaning 34-45/95-113 15 1.0 D-W B. Braun Cleaner N II Intermediate RT (cold) 3 x 1 n.a. D-W n.a. rinse III Disinfection 20-25/68-77 15 1,5 D-W B. Braun HelipurHplusN IV Final rinse RT (cold) 3 x 2 n.a. FD-W sterile n.a. V Drying RT n.a. n.a. n.a. n.a. D-W: FD-W: RT: Drinking water Fully desalinated water (demineralized, low microbiological contamination: max. 10 microorganisms/ml, low endotoxin: max. 0.25 endotoxin units/ml) Room temperature Stage I Fully immerse the product in the cleaning solution. Make certain that all accessible surfaces are moistened and all lumens, channels and complex geometries are filled with cleaning agent, free of bubbles. Clean the product immersed in the cleaning solution, using a soft, lint free disposable tissue from outside. Brush through all surfaces that are not accessible to visual inspection, e.g. in products with hidden crevices, lumens (e. g. working channel) or complex geometries with the enclosed brush for at least 1 min or until no more residues can be removed. Observe that the brush will be pulled through the working channel. To do so, insert the wire end at the proximal end of the working channel (Luer Lock) and carefully push it forward until the wire can be catched at the distal end. Then pull the brush slowly through the working channel to remove residues from the inner surfaces of the channel. Mobilize non-rigid components, e.g. set screws, joints, slides, etc. 3 times in each direction to the positive stop. After cleaning, thoroughly rinse through these components (at least five times) with the cleaning disinfectant, using a disposable syringe (20 ml). The working channels must be cleaned by mechanical cleaning (at least 1 minute) with the enclosed brush and by rinsing thoroughly (at least 5 times) with the cleaning solution, using a disposable syringe (20 ml). Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. Stage II Completely rinse through the product (all accessible surfaces) 3 times for at least 1 minute and use fresh water for every rinse. Mobilize non-rigid components, e.g. set screws, joints, slides, etc. 3 times in each direction to the positive stop. Thoroughly rinse lumens and channels during each rinse at least 5 times, using a disposable syringe (20 ml). Allow water to drip off for a sufficient length of time. Stage III Fully immerse the product in the disinfecting solution. Make certain that all accessible surfaces are moistened and all lumens, channels and complex geometries are filled with disinfecting solution, free of bubbles. Rinse the lumens at the beginning of the residence time at least 5 times, using a disposable syringe (20 ml) and a suitable rinsing adapter. Mobilize non-rigid components, e.g. set screws, joints, etc. during cleaning 3 times in each direction to the positive stop. Page 6 of 9
Stage IV Rinse/rinse through the product completely (all accessible surfaces) 3 times for at least 2 minutes and use fresh water for every rinse. Rinse lumens and channels during every rinse with help of a disposable syringe (20 ml) at least 5 times. Mobilize non-rigid components, e.g. set screws, joints, etc. during cleaning 3 times in each direction to the positive stop. Allow water to drip off for a sufficient length of time. Stage V Thoroughly dry the product with a soft, lint free disposable cloth. Thoroughly blow-dry lumens and channels with air, e.g. of a disposable syringe (50 ml). Do not use compressed air! Inspection, maintenance and checks Cool down product to room temperature. After each complete cleaning, disinfection and drying cycle, check that the product is: dry, clean, operational, and free of damage (e. g. broken insulation or corroded, loose, bent, broken, cracked, worn or fractured components). Dry the product if it is wet or moist. Repeat cleaning and disinfecting of products that still show impurities or contamination. Check the product for proper functioning. Immediately sort out damaged or inoperative products and have them sent to the Service, see Technical Service. Assemble the separable product, see Assembling. Check compatibility with associated products. Packaging Appropriately protect products with fine working tips. Sort the product into its appropriate storage device or put it on a suitable tray. Package trays appropriately for the sterilization process (e. g. in sterile containers). The bending radius of the flexible part may not be smaller than 8 cm. Ensue that the packaging provides sufficient protection against recontamination of the product during storage (DIN EN ISO 11607). Sterilization Note The product must be disas sembled before sterilization. Damages at the product due to wrong sterilization method! Do not sterilize the product in steam and hot air. Do not flash sterilize the product. Do wet chemical cold sterilization only as alternative method if possibilities for different sterilization methods are not given. Damages at the product due to sterilization without pressure compensation cap! For gas sterilization, always screw on the pressure compensation cap onto the light guide connection. Make certain that all external and internal surfaces will be exposed to the sterilizing agent (e. g. by opening and closing the valves and faucets). The bending radius of the flexible part may not be smaller than 8 cm. The sterilization of the product is preferably done by Ethylenoxide sterilization agents according to Sterivit process. Validated sterilization method: ETO - Disassemble product. - Screw on pressure equilibration cap 11 onto the optical waveguide connection 7. - Sterilization according to Sterivit method: Page 7 of 9
Gas compound: Sterilization temperature: Chamber pressure: Sterilization time: Degassing time: 6% Ethylene oxide, 94% CO2 55 C±2 C / 131 F±5 F 1.7 bar (170 kpa) 120 minutes minimum 12 hours Storing Store sterile products in a germ-proof packaging under dust protection in a dry, dark and temperature-controlled room. Store the product hanging. If this should not be possible, store product in elongated position. The bending radius of the flexible part may not be smaller than 8 cm. The transport packaging may not be used for storing, due to the risk of recontamination. Maintenance The product is maintenance-free. If the product may get damaged, send it, in the original packaging to avoid transport damages, to the below mentioned service address. Repairs may only be done by persons, which have been authorized to do so by the manufacturer. Only by observing this, guarantee claims will persist. The manufacturer is only responsible for impact to security, reliability and product performance, if the product is used in accordance with the instructions for use. Technical service Risk of injury and/or malfunction! Do not modify the product. For service and repairs, please contact the below mentioned service address. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. For the protection of your staff, as well as the staff, thoroughly clean and sterilize the product (and, if applicable, accessories) before shipment. If this should, due to pressing reasons, not be possible, process the product as good as possible and mark it accordingly. The repair center can refuse the repair of polluted or decontaminated products due to safety reasons. Service address AS Medizintechnik GmbH Sattlerstrasse 15 78532 Tuttlingen / Germany Technical data Diameter distal end: 4.3 mm Diameter working channel: 1.4 mm Diameter flexible part: 400 mm Max. deflection, up/down: 140 /140 Field of view: 85 Direction of view: 0 Depth of field: 3 mm - Page 8 of 9
Disposal Always observe national regulations when disposing of or recycling the product or its components! AS MEDIZINTECHNIK GMBH DOES NOT ACCEPT RESPONSIBILITY IF THIS CUSTOMER INFORMATION HAS BEEN VIOLATED PROVABLY. Page 9 of 9