Instrument Preparation and Care Instructions Information on cleaning, disinfection and sterilization of medical products. Follow the manufacturer's instructions. 6.1 General Safety Instructions Note Adhere To National Statutory Regulations, National And International Standards And Directives, And Local, Clinical Hygiene Instructions For Sterile. Aesculap Trays - non-CE Mark - English. Healthmark MAG310 enhanced visual inspection product. Page 1. . The Aesculap CRANIOFIX instruments are delivered in unsterile condition and must be cleaned and sterilized prior to use. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver . Aesculap introduced reusable filters in the 1930s, replacing valves and sliding vents. Follow the instructions and warnings issued by the suppliers of any cleaning and equipment used. prior to sterilization. Manual Cleaning / Disinfection Lay instrument in a suitable active disinfectant so that all surfaces, cavities, lumens and openings are covered. DESCRIPTION information related to cleaning of . Aesculap® SterilContainer™ System Instructions for Use. Healthcare product manufacturers are required to produce and provide Instructions for Use (IFU) documents for their reusable surgical instruments, medical devices and equipment and implantable biologics, materials and devices. By clicking Download you are confirming this is the correct document for your purposes. This cleaning and sterilization guide does not replace device-specific instructions for use already included with the device. . The Aesculap® line AdTec® mini with an instrument diameter of 3.5 mm is the logical development and implementation of minimal invasive access. : +49 (0)7461-95 28 80 Helmi Henn c/o Richard Wolf Pforzheimer Str. For cleaning diamond cutters, sonicate in 50 % Helizyme for 30 minutes in an ultrasonic water bath set at 60 °C. CT, Radiation Devices etc.) 20 Pages. not validated for use with the Aesculap sterilization trays. N.B. For information regarding closed Aesculap cases, please refer to appropriate Instructions for Use provided by Aesculap. Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots). Dry the instruments using a clean non-linting cloth. Exposure time 5 minutes, prolong as required. 8. a b 3. and that you agree to our Terms & Conditions. Allow instrument to air dry in basket. Length. Aesculap Surgical Instruments; Scissors; Bandage and Plaster Scissors. SOP-AIC-5001592 Rev. Over time, the small area in and around the hinge can build up a hardened layer of material resulting in corrosion. JG600 Including 2 spray nozzles, Aesculap oil spray, in spray cans (CFC-free), for instrument maintenanceprior to sterilization. We will achieve this through our dedication, our pride, and our personal responsibility. The Aesculap Instrument Repair and Refursbishment Process Previous image 1 Sharpening - Large diameter wheel sharpening provides precise cutting edge curvature of extended "sharp" usage. Remove gross contaminants with a steady stream of lukewarm/cool water (below 110 F/43 C). Cleaning Instruments: Choose a cleaning solution appropriate for surgical instruments and follow manufacturer's instructions for use. Pre-clean clamp jaws and tips with a brush. Rubber gaskets were added shortly thereafter, to ensure a proper seal between the lid and container bottom. Disassemble components to expose all surfaces and clean separately. 7) Dry lumens and conduits with compressed air. Do not use saline or chlorinated solutions. For further product information, please see our . . Make sure that "Sharp" (scissors, knives osteotomes, etc.) Aesculap ElanEC GA-835 Service manual 3.7 MB Download Aesculap GD-307 Service manual 280 KB Download Aesculap GP-125 Service manual . Always rinse sufficiently and intensively with clear and running water after chemical disinfection. ¾ Only use bactericidal, fungicidal and virucidal disinfecting agents. . ¾ Carry out ultrasound cleaning: - as an effective mechanical supplement to manual . After chemical disinfection, always rinse thoroughly with clear, flowing water. c/o Aesculap Am Aesculap-Platz D-78532 Tuttlingen, Germany Tel: +49 (0)7461-95 27 98 . Aesculap Surgical Instruments Instructions for use/Technical description Caiman 5 Sealing & Cutting Instruments Instructions for use/Technical description . • Visually examine each instrument for cleanliness. Remove CO 2cylinder from handle. Jarit® Endoscope & Instrument Holder (JL-00050_Rev C) IFU. Aesculap's rigid container system continues to expand its capabilities to ensure facilities can standardize on one method and brand of containers. Remove shaft from handle Remove the shaft by pulling the instrument shaft out of the handle. Use suitable cleaning utensils. • Using a small, clean hand-held brush, remove soil from all surfaces of instrument while fully immersed in solution. Observe the instructions of the disinfectant manufacturer. Packaging 43 10. • 70% Isopropyl alcohol • Clean cotton-tipped Cleaning swab Jarit® Containers (JL-00105_Rev C) IFU. steel; aluminium; titanium and its alloy etc.) Stryker Spine has validated steam sterilization of complete reusable device trays with Aesculap SterilContainer System. Instruments should never be flash-autoclaved in an instrument case. Appendix 1 provides specific instructions for instruments that requires disassembly prior to cleaning. The Aesculap® System trays are reusable container systems used for the packaging and storage of instruments prior to, during, and after sterilization. With specialized instruments from Aesculap's large, diverse dental portfolio, you can also handle "difficult" cases, apply plastic fillings, fixate jaw fractures and make your everyday work easier. : +49 (0)7461-95 27 98 Gerhard Kirmse c/o Aesculap Am Aesculap-Platz D-78532 Tuttlingen Tel. Complex instruments, e.g. Cleaning-Disinfection- Sterilization of motor systems and handpieces Aesculap motor systems and the handpieces require maintenance and are renowned worldwide for their . (1-800-214-3392). For specific cleaning and sterilization instructions for Zimmer Spine reuseable instruments, refer to the instructions for use (IFU) provided with the product or contact Zimmer Spine Customer Service at 1-800-777-7505 to obtain the appropriate product . Medical Instrument Repair Technician. Jan. 25, 2017. Remove encrusted tissue residues or body fluids with a moistened swab. stations, Aesculap manufactured chrome-plated containers for safe transport of sterile instruments. All instruments, instrument trays and sterilization containers must not be exposed to temperatures of 140°C cutting guides or instruments that are introduced in the intramedullary (Im) canal during the procedure as drills and reamers require a manual pre-cleaning according to standard requirements. Jarit® Disposable Bipolar Forceps and Disposable Bipolar Cable (JL-00072) IFU. Disconnect shaft and handle Pull rotation knob back and let movable part of the handle move downwards. Dimensions are approximately 22"lx10.5"Wx9.5"H. Case is in rough but usable condition with wear and some dings and dents. To minimize healthcare-associated infections (HAIs) and adhere to accreditation standards, your Sterile Processing and . Run the processing cycle products.- JG600 Aesculap AG Am Aesculap-Platz 78532 Tuttlingen Germany Phone +49 7461 95-0 Fax +49 7461 95-2600 www.aesculap.de Contact H 2O H 2O * 40 Products. If cartridge is still assembled, press jaws together by pushing lever. 06 Intended for US Only As of June 2020 Page 6 of 83 The System is designed to be processed on a daily basis and provide years of continual use. 8 mm Instruments 1 Weck Hem-o-lok® medium-large polymer clip (Weck product code #544230) is the only compatible clip used with this instrument. Rinse each instrument thoroughly. 2. can aid in locating fragments and/or components of the instrument. Handle Styles Reusable 32 and 45 cm length laparoscopic instruments Operating Instructions Modular Hand Instruments for Laparoscopy TD08_A06x03_Gebrauchsanweisung PLM . Follow the instructions for use of the ABC instruments, the instructions for use of the fixation pins and the O.R. 180.00 mm 145.00 mm 230.00 mm 140.00 mm 160.00 mm 200.00 mm 235.00 mm 115.00 mm 150.00 mm 155.00 mm 205.00 mm . Allow residue of rinse water to remain in Preparation for cleaning Appendix 1 provides specific instructions for instruments that require . Sorting. • Complex instruments, such as air powered instruments, endoscopes or instruments with lumens or channels should be sterilized according to the instrument manufacturer's instructions. caused by aldehyde/ alcohol). Place instrument into a suitable disinfectant with active cleaning properties so that all surfaces, inner cavities, lumens and openings come into contact with the solution. * 21% less force required when closing double action instruments. Jarit® Fan Retractor (JL-00065_Rev D) IFU. Use single-use cannulae whenever possible. Aesculap SterilContainer System Instructions for Use Aesculap®SterilContainer™ System Instructions for Use Steam, Ethylene Oxide and Vapor Hydrogen Peroxide Sterilization Modalities Instructions for Use Intended for US Only As of July 2019 Aesculap® SterilContainer™ System Instructions for Use (IFU) • Optimal Cleaning & Maintenance - Flush ports and expanded push-rod clearance on non-modular instruments, minimum components and solid connections on modular instruments assures easy maintenance. Washing/Decontamination 1. Aesculap GN640 GN202 Olympus ESG-400 A0392 KLS Martin ME 102 80-332-03-04 Berchtold Elektrotom 80 / 80 B . Place instruments in the ultrasonic unit for 10-15 minutes and use a neutral pH ultrasonic solution. prior to sterilization. 4. ¾ Avoid encrustation of residues/proteins (e.g. Category: Healthcare. PRE-CLEANING Keep instruments moist and do not allow blood and/or bodily fluids to dry on the instruments. Synthes Instruments are designed and manufactured to perform safely within the scope of their inteded use. JG600 Aesculap AG Am Aesculap-Platz 78532 Tuttlingen Germany Phone +49 7461 95-0 Fax +49 7461 95-2600 www.aesculap.de Contact H 2O H 2O There may be an increased risk of incision-site hernia with single-incision surgery. General instructions Treatment of brand new instruments Brand new instruments must be cleaned before the first sterilization or use. • Excellent Return on Investment - Completely reusable and fully-autoclavable. Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Remove excess moisture from the instruments using a clean, absorbent, non- shedding wipe. Overview. 11. Rinse each instrument thoroughly. Follow the manufacturer's instructions. The unique surgical instrument design provides 70% more grip than competitive products. tions must always be seen in the context of the general instructions given for all instruments in a particular section. Here are a few tips for Soak instruments, ensure they are fully covered. Do not use saline or chlorinated solutions. Case Medical instrument storage & sterilization products. Effectively processing surgical instruments is itself a tremendous challenge where central sterile/sterile processing department (CS/SPD) professionals must employ a variety of skills (e.g., science, manufacturing . 6.1 Manual cleaning and 2.2 Processing of used medical 3.4 Preparation for cleaning . . 12. For cleaning re-usable instruments, only specifically formulated cleaning agents should be used. For machine cleaning, place instrument in a wire basket suitable for the cleaning process (make sure cleaning solution and rinse water from maschine comes into contact with all parts of instrument). Please note - the lumen and the brush must have the same diameter. Skip to main content Contact: 610-984-9400 Instructions for Use - USA Users Only Integra® Heparin Cannula, Heparin Injector, and Heparin Flushing Needles (JL-00100_Rev A) IFU. All. Then remove and inspect for any residual contamination. File Type: PDF. 9. Start Preamble AGENCY: Food and Drug Administration, HHS. We will achieve this through our dedication, our pride, and our personal responsibility. 5.3 Cleaning/disinfection 7 5.4 Manual cleaning/disinfecting 8 5.5 Mechanical cleaning/disinfecting 9 5.6 Inspection, maintenance and checks 9 . Since the 1960s, Aesculap containers have been 3. Distributed by: Arcamed. Designed with the focus on the end user, the portfolio of SQ.line Surgical Instruments evolved from Aesculap's premium line of products and offers enhanced product features. Complaints. A. Ultrasonic Cleaning For micro and delicate instruments, use manual cleaning (step C). Sept. 21, 2017. Follow cleaning instructions below before sterilization. Any moisture may affect sterilization and devices may remain wet after the drying period. • Dry the instrument with a clean, soft cloth. Follow the instructions . Storage: Storage of the sterilised instruments and compo-nent parts in a dry, clean and dust-free environment at modera-te temperatures of 5 °C to 40 °C. 10.2 materials used wHen Cleaning tHe optiCal surfaCe of tHe endosCope If(Optics should only be cleaned when the image as viewed through the scope is cloudy, and not as part of your routine cleaning procedures.) Process the product in a cleaning/ disinfecting machine. File Name: BBraun - Aesculap - C63402 - Validated Instrument Reprocessing Procedures Guide - 2011-11 - V6.pdf. Kara Nadeau. B. Braun Aesculap Online-Anleitung: Validated Reprocessing Procedure, General Information. Further information in this respect can be found in section "Disinfecting, cleaning, care and sterilization" in the instructions for use of the CRANIOFIX instruments or the CRANIOFIX instrument set. Aesculap instrument oil, for oiling joints, ratchets etc. blades do not touch . instruments According to DIN EN 868-8 and DIN 58953-9 we recommend the follow- Clean intraocular ophthalmic instruments in a designated cleaning area that is separate from the area where general surgical instruments are cleaned. Read more . ACTION: Notice. screenshot of current browser view, browser version, etc. 2 Weck Hem-o-lok® large polymer clip (Weck product code #544240) is the only compatible clip used with this instrument. Ensure that water can flow out of openings. • Only the following lumen devices have been validated for use in the pre-vacuum steam modalities: • ≥ 2.6 8mm in inner diameter and ≤ 45 0mm in length In fact, ultrasonic cleaning is 16 times more efficient than manual cleaning alone. Checks and Care 37 9. 4) Clean any lumens and conduits with soft, round, synthetic brushes. It is the duty of the user to ensure that Disassemble shaft If . It is important to keep the hinged area of scissors and other instruments clean and clear of tissue and other matter. Transport the reusable instruments to the point where cleaning is to be performed as soon as practical. 6) Dry instrument with an absorbent, soft and lint-free cloth. Aesculap SterilContainer System Instructions for Use June 2020 Rev 06.pdf. AESCULAP Surgical Instruments. Type: Regular Full-Time. To order, contact Teleflex Medical (www.teleflex.com) or your local distributor. Instrument Cleaning and Disinfection Getinge 8666, 8668 Washer Disinfector Service manual 6.1 MB Download IC Medical HD-450 Instrument Washer Service manual . Instructions for Use Intended for US Only As of June 2020. eBay requires the following language for all listings in the medical equipment category: The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Follow the instructions provided by the manufacturer of the machine. By sending this form I agree, that information passed by me and additional data related to my current session, e.g. Aesculap®Challenger®Ti-PAesculap Endoscopic Technology 1. Be sure that stainless steel and PRE‐CLEANING Keep instruments moist and do not allow blood and/or bodily fluids to dry on the instruments. • The use of neutral pH detergents is recommended to avoid corrosion, pitting and breakage. 10. Sterilization 45 10.1 Steam Sterilization 45 10.2 Hot Air . breaks during use, a medical imaging device (e.g. For specific cleaning and sterilization instructions for Zimmer Spine reuseable instruments, refer to the instructions for use (IFU) provided with the product or contact Zimmer Spine Customer Service at 1-800-777-7505 to obtain the appropriate product specific IFU. Aesculap, Inc. | 800-282-9000 | www.aesculapusa.com Aesculap, Inc. - a B. Braun company Efficiency That Saves Aesculap SterilContainer™ Systems—the preferred choice for cost savings versus single-use blue wrap Call 610-984-9287 to discuss a customized savings program for your facility, or visit 13.If visible soil remains, repeat cleaning procedure until the device is thoroughly clean. Place instrument in a separate wire basket on top shelf of the automated washer/ decontaminator and allow a full cycle run. Aesculap motor systems and the handpieces require maintenance and are renowned worldwide for their reliability. For specific cleaning and sterilization instructions for Zimmer Spine reuseable instruments, refer to the instructions for use (IFU) provided with the product or contact Zimmer Spine Customer Service at 1-800-777-7505 to obtain the appropriate product . However if a metallic instrument (e.g. Disassemble components to expose all surfaces and clean separately. # of Openings: 1. . Pull push rod out of inner tube. Aesculap Sterile Technology Instructions for use/Technical description . 1. Maintenance & Inspection Visually inspect the instruments following performance of the cleaning instructions prescribed above. The surgical instruments are provided NON-STERILE and must be inspected, cleaned and sterilized before first use and before every reuse. The following instructions are for all NON-POWERED surgical instruments supplied Aesculap Inc., unless stated otherwise with the packaging of the product. : for PO381R only 2. . 6. Remove gross contaminants with a steady stream of lukewarm/cool water (below 110 F/43 C). The full scope of instrument care. instrument cleaning instructions and the manufacturer's . We will achieve this through our dedication, our pride, and our personal responsibility. R euabl Dv icI nt rof U h es int ru cof ad b lg instruments labeled with the CareFusion, V. Mueller®name. 3. The da Vinci Single-Site Instruments and Accessories are only intended to be used for single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and the da Vinci Xi Surgical System (IS4000). Aesculap Surgical Instruments Instructions for use/Technical description Pneumatic clip applier (with detachable titanium clip magazine) Gebrauchsanweisung/Technische . 7. Do not use heated air or radiation sterilization. 3. Final Disinfection 35 8. taken-apart) configuration. Job ID: 2022-20606. Flush or immerse instruments in sterile water immediately at the end of the procedure according to the manufacturer's written IFU. The PrimeLine Pro Lid was recently added to the company's SterilContainer JK and JN Series full, three-quarter and half-size containers. 6.2.1 Machine-Based Cleaning and Thermal Disinfection 27 6.2.2 Machine-Based Cleaning and Chemothermal Disinfection 28 6.2.3 Instrument Groups Requiring Special Treatment 30 6.3 Ultrasonic Cleaning and Disinfecting 32 7. 32 Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Only use ABC instruments provided by Aesculap. . 1. 5101 Decatur Blvd., Suite A. Fax. Instruments should be processed in a cleaner for the full recommended cycle time - usually 5 to 10 minutes. Loading. will be passed to the provider of the portal. Ensure there is no visual contamination of the instruments prior to proceeding with sterilization. When carrying out mechanical cleaning, place instrument in wire baskets suitable for cleaning (to avoid watermarks). While sterile processing follows a logical series of steps — decontamination, cleaning and sterilization — so only safe and effective instruments reach the hands of the surgeon, there are a variety of nuances that can . NuVasive Instrument Cleaning and Decontamination Instructions Page 2 . the cleaning validated instruments from Aesculap. Belangrijk bescherm de desinfeção química, aesculap sterilization instructions for container use. Steam, Ethylene Oxide and Vapor Hydrogen Peroxide Sterilization Modalities. Lubricate the defined places on the instruments with Aesculap Sterilit® Oil (JG598) after each cleaning cycle. Check push rod regarding breakages and bendings. . manual. St. Louis, MO. 2 Alignment - Skilled and experienced craftsmen perfectly align instruments. How Supplied Recommended by Aesculap to clean diamond cutters INSTRUCTIONS FOR USE 1 % (diluted with hand warm water). A method of cleaning that is a necessity is ultrasonic cleaning. Rx Only . Caution: . It consists of Select implant components according to indication, preoperative planning and the bone situation found intraoperatively. Close. This method is the most efficient and effective available today. raspatories or microsurgical instruments. For specific cleaning and sterilization instructions for Zimmer Spine reuseable instruments, refer to the instructions for use (IFU) provided with the product or contact Zimmer Spine Customer Service at 1-800-777-7505 to obtain the appropriate product . General Information . In a properly functioning and calibrated steam sterilizer, effective sterilization may be achieved using the following parameters: Aesculap® SterilContainer™System Instructions for Use (IFU) SOP-AIC-5001592 Rev. Aesculap instrument oil, for oiling joints, ratchets etc. 06. Cleaning/ sterilization: sterilization of the assembled instrument possible. File Size: 807 KB. JG600 Including 2 spray nozzles, Aesculap oil spray, in spray cans (CFC-free), for instrument maintenanceprior to sterilization. Aesculap JK444 Sterilizer Container. Economical price performance ratio: profitable use of financial resources due to modular design. Manual (Required if automatic washer/disinfector method is not used) • All instruments must be cleaned in the completely open and disassembled (i.e. SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and sterilization .

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