The patient should be encouraged to receive prompt medical attention for any infection that may occur, either at the surgery site or elsewhere in the body. In order to make an informed decision, the patient should clearly understand all applicable warnings, precautions, possible intraoperative and postoperative complications and possible adverse effects associated with the surgical procedure and implantation of the device. NiTiNOL-based DynaNail products approved for use with new ICD-10-PCS code. Home DJO DJO DynaNail Helix Fixation System Instruction Manual. CleaningThe DynaNail Deployment Frame and each Ancillary Surgical instrument must be cleaned in accordance with appropriate healthcare facility procedures prior to sterilization. Avoid contacting the implant with other tools or materials that could notch, scratch or otherwise damage the implant surface. FDA-cleared medical grade steam sterilization compatible wrap that has been validated to allow sterilant penetration and to subsequently maintain sterility. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. Tibiotalocalcaneal Arthrodesis with. Printed in the USA.Pat. The patient should be provided with detailed written instructions regarding postoperative care, and the use and limitations of the device. NOTE: Synonyms for batch code are lot number and batch number.. : http://www.medshape.com/patents.htmlMK-10062 Rev. Return ConditionsIn the event the device must be returned for any reason, return the product in the original packaging. Never attempt to reuse the devices, even though they may appear undamaged. The End Cap is manufactured from titanium alloy (Ti 6Al-4V ELI). Resterilization may result in loss of proper mechanical function of the device and could result in patient injury. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. Your email address will not be published. Indicates a medical device that has been sterilized using irradiation. Demonstrates physiologic or anatomic anomalies. The health care facility is responsible for maintaining water quality that is compliant with AAMI TIR34. The DynaNail Deployment Frame and the Ancillary Surgical Instruments are provided NON-STERILE. The DynaNail Helix Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Extreme care must be taken when following the technique for removal of the device. The Fusion Nail, End Cap, and Screws are supplied sterile for single use only. Prolonged exposure to saline may result in corrosion of stainless steel instruments. 1 (5): 1-8. In Sets: Load DJO Surgical Instruments into the appropriate instrument trays. The adequacy of any healthcare facility sterilization procedure must be suitably tested. According to ANSI/AAMI standard ST79:2010. the accepted standard for the degree of cleanliness is visibly clean. on DYNANAIL TTC Fusion System Instructions. Single: A standard packaging material may be used. When evaluating patients for implantation using the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer, always consider the patients weight, occupation, activity level and the presence of any degenerative disease. Achieves 6 mm of post-operative compression PLUS 6 mm of intra-operative manual compression Provides automatic dynamization upon weightbearing Cannulated portions should be cleaned with a soft-bristled nylon brush, pipe cleaner, or appropriately sized guidewire. Soak the instruments in Ultra Clean System Low Foam Detergent (pH neutral) for a minimum of one (1) minute. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. According to the Association for the Study of Internal Fixation principles . 3. Intraoperative fluoroscopy (C-Arm) should be available and utilized as required to confirm correct positioning of implantable DynaNail Mini Fusion System components. Innovative implant technologies that cover a wide range of solutions. The latest addition to DJO's robust suite of foot and ankle products and an expansion of the DynaNail Mini line, the system leverages MedShape's proven active, adaptive healing technology 1 . The DynaNail Hybrid shares universal instrumentation with the DynaNail Mini to provide surgeons with intraoperative ease and flexibility. Limited Liability:The DynaNail TTC Fusion Nail, DynaNail End Cap, and the DynaNail Screws are guaranteed for materials, function, and workmanship for single patient use. The physician should always have a full inventory of sterile Fusion Nails and Screw sizes on hand at the time of surgery to ensure availability of the optimum size for the patient. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. Misuse, mishandling and/or improper operation. Serious postoperative complications may occur from use of the implant in a patient who: This device contains NiTiNOL, an alloy of nickel and titanium. 6. Resterilization may result in loss of proper mechanical function of the device and could result in patient injury.Carefully inspect product packaging and all device components for damage or defects prior to use. The DynaNail TTC Fusion System is designed for use in tibiotalocalcaneal (TTC) fusion, or hindfoot fusion, procedures to address degenerative conditions, correct joint deformities and revise failed total ankle replacements or arthrodesis non-unions. Read More About This Manual & Download PDF: step2bed mini Assembly Instructions www.step2health.com www.facebook.com/step2bed 1. The physician should always have a full inventory of sterile DynaNail TTC Fusion Nails and DynaNail Screw sizes on hand at the time of surgery to ensure the availability of the optimum size for the patient. The Fusion Nail , Continue reading MEDSHAPE DynaNail Mini Fusion System Instruction Manual, MEDSHAPE DynaNail Mini Fusion System Instruction Manual, on MEDSHAPE DynaNail Mini Fusion System Instruction Manual, MEDSHAPE DynaNail Mini Fusion System Instruction Manual, Hitachi CPAW3005 LCD Projector Users Manual, LG P1400RTM 14 KG Washing Machine Owners Manual, BOFIDAR Touch Screen Bluetooth Smartwatch Operational Guide, KICKER CXA360.4 4-Channel 490-Watts Class A-B Full-Range Car Audio Amplifier Owners Manual, PreSonus Studio 68c USB Audio Interface USER GUIDE, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. Contact DJO customer service for replacements. The DynaNail Helix Fixation System components manufactured by DJO must not be used in conjunction with screws, wire bands, or other metallic devices manufactured by any other manufacturer, as component parts may not be compatible. MedShape, Inc.1575 Northside Drive, NW,Suite 440Atlanta, Georgia 30318USAT: 877-343-7016F: 877-343-7017www.medshape.com, DynaNail Mini is a registered trademark of MedShape, Inc. DynaNail Mini Hybrid is a trademark of MedShape, Inc.2019 MedShape, Inc. All rights reserved. Visually inspect all instruments to ensure that all blood, saline, and traces of tissue are removed and instruments are visibly clean.. Designed for use in subtalar fusion procedures, the DynaNail Hybrid contains an Superelastic Internal NiTiNOL Element that maintains active, dynamic compression in response to bone settling or resorption. Always follow the sterilizer manufacturers recommendations. Washer-decontaminators may also be used in addition to manual cleaning. Moist heat/steam is the only method that has been validated for reprocessing by DJO. Failure to immobilize the site during healing may result in bending and/or breakage of the device and/or failed fusion. A member of the DynaNail Mini family, The DynaNail Hybrid Fusion System features a unique dual design that combines the compressive power and stability of a nail with the easy insertion and anatomical friendliness of a screw. Each patient should understand that the implant is manufactured from titanium alloys which may cause possible reactions and complications, including those listed herein. Comment * document.getElementById("comment").setAttribute("id","aca1f0c90a5e9c87e2f6c09ac786d880");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. Background Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation. Modified devices may not perform as intended and could result in patient injury. on MEDSHAPE DynaNail Mini Fusion System Instruction Manual, MEDSHAPE DynaNail Mini Fusion System Instruction Manual, 14. The DynaNail Mini Fusion System has not been evaluated for safety and compatibility in the MR environment. In order to make an informed decision, the patient should clearly understand all applicable warnings precautions, possible intraoperative and postoperative complications and possible adverse effects associated with the surgical procedure and implantation of the device. Do not modify the implant. SterilizationRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. FDA-cleared medical-grade steam sterilization compatible wrap that has been validated to allow sterilant penetration and subsequently maintains sterility. Knowledge of appropriate surgical techniques, instrumentation, proper selection and placement of implants and postoperative patient care and management are essential to a successful outcome. Comment * document.getElementById("comment").setAttribute("id","aa0031aceadd6ff5ff5e8761e89208bc");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. the dynanail mini fusion system in extended lengths was designed for use in midfoot reconstruction procedures and features patented and proven superelastic internal nitinol compressive element technology now miniaturized to accommodate smaller bone anatomy 2,3unlike traditional beaming devices that lose compression within 1 mm of bone THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED, AND/OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS, AND/OR SUITABILITY FOR A PARTICULAR PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON MEDSHAPES PART. We and our partners use cookies to Store and/or access information on a device.We and our partners use data for Personalised ads and content, ad and content measurement, audience insights and product development.An example of data being processed may be a unique identifier stored in a cookie. Serious postoperative complications may occur from use of the implant in a patient who: This device contains NiTiNOL, an alloy of nickel and titanium. Repairs or modifications performed other than by DJO or a DJO authorized repair facility. Use of the implant or system components for these purposes may result in patient injury. The DynaNail Deployment Frame and the Ancillary Surgical Instruments are designed to be cleaned and steam sterilized following the instructions below. Return Conditions:In the event the device must be returned for any reason, return the product in the original packaging. Rigid sterilization container that complies with ANSI/AAMI ST46. Patients with an insufficient plantar pad. It is critical that the appropriate process parameters be validated for each healthcare facilitys sterilization equipment and product/load configuration by persons who have training and expertise in sterilization processes to substantiate the process and its reliability and reproducibility. NOTE: Indicates the manufacturers batch code so that the batch or lot can be identified. Gravity displacement sterilization is not recommended due to extended cycle times. Drug and/or alcohol and/or smoke addiction and/or abuse. Indicates a medical device that should not be used if the package has been damaged or opened. MedShape's DynaNail Mini is designed for subtalar arthrodesis and other large bone foot and ankle fusions. It is the responsibility of the user to ensure that the sterilization process is actually performed using qualified equipment, materials, and personnel such that the recommended parameters are achieved. Place all parts on a flat working surface. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture. 4 kontraindikasi. Patients with severe peripheral vascular disease. :http://www.medshape.com/patents.htmlMK-10161 Rev. Because of the much narrower range of the Y-axis it is possible to find the P1dB point quite accurately from this graph. It is critical that the appropriate process parameters be validated for each healthcare facilitys sterilization equipment and product/load configuration by persons who have training and expertise in sterilization processes to substantiate the process and its reliability and reproducibility.Any recommendations provided herein are provided as general guidelines only. The surgeon must make the final decision regarding implant removal. Demonstrated psychological instability, inappropriate motivation, or attitude. Postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident. In the case of very small dimension cannulations, a wire can be used to ensure that foreign material has been removed from the cannulation. Note: If you have questions concerning the disassembly of the instruments, contact the DJO Customer Service or your local DJO sales representative. Inspect all components preoperatively to ensure that the device components and instruments are appropriate for use. Please review the instructions of the sterilizer, manufacturer, or healthcare facility procedures prior to sterilization. Check final position of Implant using fluoroscopy, close wounds, and end procedure. The appearance of bubbles confirms the presence of protein and the instrument should be re- cleaned. Potential adverse effects resulting from the use of the DynaNail Mini Fusion System include, but are not limited to, the following: Adverse effects may necessitate reoperation, revision or removal surgery and/or amputation of the limb. Indicates the need for the user to consult the instructions for use. Ideally, all components should be cleaned within 30 minutes and after no more than 4 hours of use to minimize the potential for saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on the instrument prior to cleaning. Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. Do not use device if it appears defective, damage or otherwise compromised. The patient should be encouraged to report to his/her surgeon any unusual changes to the operated extremity. Additional MedShape Cleaning Instructions. If evidence suggests loosening of the implant (particularly pain and/or progressive changes in the radiographs), an intensified schedule of check-ups is advised and new warnings and instructions to the patient may be necessary to further restrict activities.The patient should be encouraged to receive prompt medical attention for any infection that may occur, either at the surgery site or elsewhere in the body. DynaNail Mini was introduced in 2019 with 60-100 mm lengths for use in subtalar fusion procedures. Keep instruments moist after use to prevent soil from drying on them. The safety of DynaNail Helix Fixation System in the MR environment is unknown. central supply wrap (CSR), paper/plastic pouches, rigid containers, etc.) About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Sensitivity, allergies, or other reaction to the device material. Post-traumatic or primary arthrosis involving both ankle and subtalar joints. Each patient should understand that the implant is manufactured from titanium alloys which may cause possible reactions and complications, including those listed herein. AAMI/AORN steam sterilization cycles with cycle times longer than those listed are also acceptable. Follow the manufacturers instructions for mixing, preparing, and using such detergents. A thorough manual or combination manual/automated cleaning process is required. and sterilized prior to surgical use. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiological examination) is established. Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. The DynaNail Mini Fusion System components manufactured by MedShape must not be used in conjunction with screws, wire bands, or other metallic devices manufactured by any other manufacturer, as component parts may not be compatible. Demonstrates physiologic or anatomic anomalies. Here gain compression , normalized to small signal gain , is plotted against input power. The Ancillary Surgical Instruments should not be reused if visible deterioration such as corrosion or damage resulting from use or handling is evident. DMP 711 Zone Expander Module . The patient should be advised that noncompliance with postoperative instructions could lead to loosening, bending, or breakage of the implant, requiring revision surgery to remove the device. Damage to the implants surface finish may result in loss of proper mechanical function of the device. Correct selection of the DynaNail Mini Fusion System and device components is extremely important. The appearance of bubbles confirms. In Sets: Load MedShape Surgical Instruments into the appropriateinstrument trays. Prior to surgery. Ft. White Top Load Washer User Guide, Fujifilm Finepix A900 9MP Digital Camera Owners Guide, LG HU80KA Smart CineBeam DLP Projector Owners Manual, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. Deployment Frame and Ancillary Surgical Instruments should be carried out by proficient personnel following appropriate healthcare facility procedures. The carbon-fiber PEEK frame also features a robust, universal one-arm design allows for reliable drilling and screw placement. The healthcare facility isresponsible for maintaining water quality that is compliant with AAMI TIR34. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. The patient should not have unrealistic expectations regarding the results that the surgery and implant may provide. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. Inspect all components preoperatively to ensure that the device components and instruments are appropriate for use. Patients with foreign body sensitivity is suspected, or documented metal allergy or intolerance. pipe cleaner, or appropriately sized guidewire. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. [emailprotected], Your email address will not be published. Loss of fixation in bone attributable to nonunion, osteoporosis, and/or markedly unstable comminuted fractures. AAMI/AORN steam sterilization cycles with cycle times longer than those listed are also acceptable. Please review the instructions of the sterilizer, manufacturer, or healthcare facility procedures prior to sterilization. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. These specialized instruments are required to correctly perform the DynaNail Helix implantation procedure and to remove the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer if required, following implantation. The Ancillary Surgical Instruments should be fully disassembled into component parts prior to cleaning. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Do not stack the DynaNail Instrument Caddies during sterilization. Manual cleaning should be done while the instrument is immersed. Careful preoperative planning must be conducted based on radiographic findings.Never attempt a surgical procedure with defective, damaged or otherwise compromised instruments or implants. The Ancillary Surgical Instruments must be placed in the designated location within the DynaNail Helix Instrument Tray. 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