Contact Customer Service or an authorized DJO representative to receive a return authorization number prior to return shipment. Prior to surgery, the surgeon should discuss with the patient all possible risks versus potential benefits of treatment considering the patients preoperative condition and expectations for improvement in his/her condition postoperatively. The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. Rigid sterilization container that complies with ANSI/AAMI ST46. Containment devices can be stacked for storage. Check final position of DynaNail Helix Fixation System implant(s) using fluoroscopy, close wounds, and end procedure. The DynaNail TTC Fusion Nail, DynaNail End Cap, and DynaNail Screws are provided sterile for single use only. Extreme care must be taken when following the technique for the removal of the device. The DynaNail Mini Fusion System is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. Required fields are marked *. 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 DynaNail Hybrid shares universal instrumentation with the DynaNail Mini to provide surgeons with intraoperative ease and flexibility. Patients with an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations or previous infections. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. Loss of anatomic positioning with nonunion or malunion with rotation or angulation. Contact Customer Service or an authorized MedShape representative to receive a return authorization number prior to return shipment. It is the physicians responsibility to determine the correct size of the DynaNail TTC Fusion Nail and DynaNail Screws to be implanted. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. If bubbles were present or instruments were not deemed visibly clean, steps 1-8 of the manual cleaning process should be repeated. The DynaNail TTC Fusion Nail is manufactured from nitinol and titanium alloy (Ti 6Al-4V ELI) and is available in multiple diameters and lengths. Note: If you have questions concerning the disassembly of the instruments, contact the MedShape Customer Service or your local MedShape sales representative. Repeat the process until no visible debris remains. Check final position of Implant using fluoroscopy, close wounds, and end procedure. The use of abrasive compounds or excessively acidic or alkaline solutions may cause damage to the instruments and should be avoided.7. The surgeon must make the final decision regarding implant removal. Achieves 6 mm of post-operative compression PLUS 6 mm of intra-operative manual compression Provides automatic dynamization upon weightbearing If the sterile packaging is found to be damaged or open, do not use the device or attempt to re-sterilize. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. According to ANSI/AAMI standards ST79:2017, the accepted standard for the degree of cleanliness is visibly clean. Single: A standard packaging material may be used. Carefully inspect sterile packaging for damage prior to use. Ce Guide complet adapt aux dbutants et aux utilisateurs expriments vous permettra de matriser la cration d'asset avec un logiciel 2D tapes par tapes. Patients with foreign body sensitivity is suspected, or documented metal allergy or intolerance. Instruments should be cleaned as soon as reasonably practical after use, according to the healthcare facilitys infection control and hazardous waste management procedures. Patients should be cautioned against unassisted activity that requires walking or lifting. the dynanail mini fusion system features djo's patented and proven superelastic internal nitinol compressive element technology miniaturized for use in subtar fusion 2-4unlike traditional screws that lose compression within 1 mm of bone resorption, the dynanail mini is the only internal fixation device for subtalar fusion that maintains active 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. Patients should be cautioned against unassisted activity that requires walking or lifting. Failure to immobilize the site during healing may result in bending and/or breakage of the device and/or failed fusion. Your email address will not be published. The system also features a rigid, radiolucent carbon fiber-filled polyether. The DynaNail Mini Instrument Caddy is designed to hold the DynaNail Mini Deployment Frame and all of the Ancillary Surgical Instruments during sterilization. he patient should be provided with detailed written instructions regarding postoperative care, and the use and limitations of the device.Postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident. When utilizing an automated cleaner, follow equipment manufacturers instructions for use, incorporating a low foaming, pH neutral detergent. Loss of fixation in bone attribute to nonunion, osteoporosis and/or markedly unstable comminuted fractures. Do not use device if it appears defective, damaged or otherwise compromised.The DynaNail Helix Fixation System is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. CLEANINGEach Ancillary Surgical Instrument must be cleaned in accordance with appropriate healthcare facility procedures prior to sterilization. In the absence of a bursa or pain, removal of the implant in elderly or debilitated patients is not recommended. The patient should not have unrealistic expectations regarding the results that the surgery and implant may provide. Bienvenue dans ce guide sur Aseprite et la cration d'asset 2D pour un mini RPG 2D en Pixel Art. Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. DynaNail Mini Fusion System - Subtalar Fusion Surgical Technique Guide. Absent talus (requiring talocalcaneal arthrodesis). Resterilization may result in loss of proper mechanical function of the device and could result in patient injury. Prevaccuum/Pulsating Vacuum/FlashAutoclave, SO 15223-1 Medical Devices Symbols To Be Used with Medical Device Labels, Labeling, and Information To Be Supplied. DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile : Code Information: Model No. The Ancillary Surgical Instruments should be fully disassembled into component parts prior to cleaning. Where material sensitivity is suspected, appropriate tests should be conducted, and sensitivity ruled out prior to implantation. Read More About This Manual & Download PDF: step2bed mini Assembly Instructions www.step2health.com www.facebook.com/step2bed 1. These guidelines are not intended for DJO implants or single-use disposable instruments only for reusable instruments that are supplied non-sterile but are intended to be used in a sterile state. 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 . Manual cleaning should be done while the instrument is immersed. Always handle the DynaNail TTC Fusion Nail carefully. The DynaNail Mini Deployment Frame and the Ancillary Surgical Instruments are provided NON-STERILE. 7 informasi seleksi pasien. Loss of fixation in bone attribute to nonunion, osteoporosis and/or markedly unstable comminuted fractures. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. Avoid contacting the implant with other tools or materials that could notch, scratch, or otherwise damage the implant surface. The health care facility is responsible for maintaining water quality that is compliant with AAMI TIR34. Has immunological responses, sensitization, or hypersensitivity to foreign materials. The DynaNail Mini Fusion System is an innovative nail system designed for use in subtalar fusion and in the fusion of other large bones in the foot and ankle. Just connect the Nail Guide to the Mini Targeting Frame and implant! Damage to the implants surface finish may result in loss of proper mechanical function of the device. Patients with severe peripheral vascular disease. 1 (5): 1-8. Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. Patients who are obese or noncompliant, as well as patients who could be predisposed to delayed union or nonunion, must have auxiliary support. Patients who are obese or noncompliant, as well as patients who could be predisposed to delayed union or nonunion must have auxiliary support. 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. The DynaNail was introduced clinically in 2012. Correct selection of the DynaNail TTC Fusion Nail and device components is extremely important. Use of the implant or system components for these purposes may result in patient injury. 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. The DynaNail TTC Fusion Nail is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. Refer to the Instrument Tray and/or illustration in MedShapes Surgical Technique Guide for the completely disassembled components. on DJO DynaNail Helix Fixation System Instruction Manual, CLEANING AND STERILIZATION PROCEDURES (DEPLOYMENT FRAME AND ANCILLARY SURGICAL INSTRUMENTATION ONLY), DJO PROCARE Pre-Vent Ulnar Nerve Protector Instructions. Patients should be cautioned against unassisted activity that requires walking or lifting.Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. Remove soil from surfaces with a soft-bristled nylon brush and from cannulated parts with a soft-bristled nylon brush. The DynaNailu00ae Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiologicalexamination) is established. 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. Use flowing water and disposable wipes to remove excess soil. Washer-decontaminators may also be used in addition to manual cleaning. If you would like to change your settings or withdraw consent at any time, the link to do so is in our privacy policy accessible from our home page. 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. Do not stack the DynaNail Helix Instrument Trays during sterilization. Containment devices can be stacked for storage. Required fields are marked *. Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. Each patient should understand that the implant is manufactured from titanium alloys which may cause possible reactions and complications, including those listed herein. Careful preoperative planning must be conducted. Carefully inspect sterile packaging for damage prior to use. All instruments should be thoroughly cleaned. Drying times vary according to load size and should be increased for larger loads. Recommended Steam Sterilization ParametersTime and temperature parameters required for sterilization vary according to type of sterilizer and cycle design. Please remove any damaged device or instrument from use and call your MedShape sales representative for a replacement. Call your MedShape sales representative for a replacement. : http://www.medshape.com/patents.htmlMK-10062 Rev. Place your non-custom orders instantly and easily. Other sterilization cycles may also be suitable, but the individuals or hospitals are advised to validate other methods for use with MedShape products. In the case of very small dimension cannulations, a wire can be used to ensure that foreign material has been removed from the cannulation. (DEPLOYMENT FRAME AND ANCILLARY SURGICAL INSTRUMENTATION ONLY). Release the DynaNail Helix Threaded Bone Fastener from the Inserter Body Assembly by unscrewing the Connection Bolt. Manual cleaning should be done while the instrument is immersed. Neuromuscular disease and severe deformity. Any recommendations provided herein are provided as general guidelines only.It is important that adequate cleaning be carried out prior to sterilization. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Rinse instruments following exposure to hydrogen peroxide. Note: If you havequestions concerning the disassembly of the instruments, contact MedShape Customer Service or your local MedShape sales representative. Cannulated portions should be cleaned with a soft-bristled nylon brush, pipe cleaner, or appropriately sized guidewire. Pain, discomfort or abnormal sensations due to presence of the implant. Ensure that cutting / sharp edges are protected. These specialized instruments are required to correctly perform the implantation procedure and to remove the Fusion Nail and Screws if required, following implantation. Distal transverse screw provides additional stability and prevents device migration. FDA-cleared medical-grade steam sterilization compatible wrap that has been validated to allow sterilant penetration and subsequently maintains sterility. Serious postoperative complications may occur from the use of the implant in a patient who: The DynaNail TTC Fusion Nail has not been evaluated for safety and compatibility in the MR environment. Patients with significant tibial malalignment (>10 degrees in either sagittal or coronal plane). SterilizationRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. The DynaNail Mini Deployment Frame and Ancillary Surgical Instruments should not be reused if visible deterioration such as corrosion or damage resulting from use or handling is evident. Longer lengths to accommodate the midfoot anatomy: 110-140 mm Maintains up to 6 mm of post-operative active compression PLUS intra-operative manual compression Required fields are marked *. 02Issued 03/2021. Patients with an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations or previous infections. Rigid sterilization container that complies with ANSI/AAMI ST46. Your email address will not be published. Tibiotalocalcaneal Arthrodesis with Intramedullary Nails - Mechanobiological Background and Evolution of Compressive Technology. Confirm that any moving parts function properly. The DynaNail Mini Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle. The worldwide leading provider of diabetic footwear. Demonstrated psychological instability, inappropriate motivation, or attitude. According to the Association for the Study of Internal Fixation principles, compression across a fusion site promotes bone healing and also provides . Never attempt to reuse. End of life is normally determined by wear and damage due to use. Use in any manner or medical procedure other than those for which it is designed; and any special, indirect, and/or consequential damages of any kind and however caused arising from the sale or use of the product. Do not rely upon automated cleaning using a washer/disinfector alone as this may not be effective for devices and instruments with cannulations, blind holes, mated surfaces, and other complex features. Limited Liability:The DynaNail Mini Fusion System Components are guaranteed for materials, function, and workmanship for a single patient use. Presoak the instruments with an enzymatic solution for a minimum of five (5) minutes. Rinse instruments following exposure to hydrogen peroxide. The surgical procedure will involve subtalar (talocalcaneal) joint preparation through a lateral approach. - Kent. Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and. Do not stack the DynaNail Instrument Caddies during sterilization. The surgeon must make the final decision regarding implant removal. Containment devices can be stacked for storage. Instruments should be cleaned as soon as reasonably practical after use, according to the health care facilitys infection control and hazardous waste management procedures. The DynaNail Screws are manufactured from titanium alloy (Ti 6Al-4V ELI) and are available in a range of lengths. The adequacy of any healthcare facility sterilization procedure must be suitably tested. Printed in USA.Pat. Containment devices can be stacked forstorage. The DynaNail TTC Fusion System should only be used by those physicians who have been trained in the appropriate, specialized procedures. The patient should be encouraged to report to his/her surgeon any unusual changes to the operated extremity. Deployment Frame and Ancillary Surgical Instruments should be carried out by proficient personnel following appropriate healthcare facility procedures. Never attempt to reuse. Post-traumatic and degenerative arthritis. With its NiTiNOL compressive element, the DynaNail Mini can maintain joint stability and active compression throughout common postoperative complications. Tissue reactions including macrophage and foreign body reactions adjacent to implants. For best results, ensure that the components are properly positioned. reverse osmosis or deionized water. Cannulated portions should be cleaned with a soft-bristled nylon brush, pipe cleaner, or appropriately sized guidewire. Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. No reassembly is necessary as the instruments remain in their fully disassembled form during cleaning and sterilization. Intraoperative fluoroscopy (C-Arm) should be available and utilized as required to confirm correct positioning of implantable DynaNail Mini Fusion System components. 1. The DynaNail Mini represents the latest innovation in the DynaNail product line to feature an internal NiTiNOL Compressive Element. 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. Refer to Table A for manual cleaning steps. With the numbered Compression Wheelset to 0, fully stretch the Compressive Element by pulling down on the lever. Place the End Cap into the distal end of the DynaNail Implant and close the incision per surgeon preference. Any recommendations provided herein are provided as general guidelines only. The proposed and predicate devices are comprised of implant grade Titanium alloy and Nickel Titanium Alloy. Limb shortening or loss of anatomic positioning with nonunion or malunion with rotation or angulation. The DynaNail Mini TTC Fusion System is the ONLY fusion approach that offers the compression performance of an external fixator inside an intramedullary nail. Repairs or modifications performed other than by MedShape or a MedShape authorized repair facility.c. 3 indikasi untuk penggunaan. Has immunological responses, sensitization or hypersensitivity to foreign materials. Read this file to learn about the surgical technique guide of this innovative product from MedShape. The DynaNail Mini Fusion Components are provided sterile for single use only. Refer to the Instrument Tray and/or illustration in MedShapes Surgical Technique Guide for the completely disassembled components. Similar to its larger predecessor, the DynaNail TTC Fusion System, it features MedShape's patented internal superelastic NiTiNOL technology that provides strong joint stability due . Primary responsible party for all manufacturing transfer responsibilities for new "Active Adaptive" products at MedShape (Enovis Atlanta Office) including DynaNail, DynaNail Mini and Hybrid, Helix . Do not add other instruments to the DynaNail Helix Instrument Tray that are not part of the standard configuration supplied by DJO. NOTE: Indicates the manufacturers batch code so that the batch or lot can be identified. Repeated reprocessing has minimal effect on the devices. *With the Guide Sleeve placed through the appropriate distal side hole of the Nail Targeting Assembly and abutted to the bone surface, use the Drill Guide and Transverse Screw Drill to drill a pilot hole through the distal screw hole in the DynaNail Mini Implant. Connect corresponding. If the sterile packaging is found to be damaged or open, do not use the device or attempt to resterilize. Misuse, mishandling, and/or improper operation.b. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. The DynaNail Mini Deployment Frame and Ancillary Surgical Instruments must be placed in the designated location within the DynaNail Instrument Caddy. All cleaning should be performed in a manner designed to minimize exposure to bloodborne pathogens. If sensitivity to nickel or titanium is suspected, appropriate testing should be conducted prior to use. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. 6 mri safety information. The DynaNail Helix Ancillary Surgical Instruments are provided NON-STERILE. Follow the manufacturers instructions for mixing, preparing, and using such detergents. It has not been tested for heating or migration in the MR environment. Sensitivity, allergies, or other reactions to the device material. Drying times vary according to load size and should be increased for larger loads. The DynaNail Mini represents the latest innovation in the DynaNail product line to feature an internal NiTiNOL Compressive Element. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. When utilizing an automated cleaner follow equipment manufacturers instructions for use, incorporating low foaming. Alternate fixation methods should also be available for use if the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer cannot be successfully implanted. Repairs or modifications performed other than by DJO or a DJO authorized repair facility. Recommended Steam Sterilization ParametersTime and temperature parameters required for sterilization vary according to type of sterilizer and cycle design. DJO Wrist and Finger Undersleeve Instruction Manual, MAYTAG 4.5 Cu. Do not rely upon automated cleaning using a washer/disinfector alone as this may not be effective for devices and instruments with cannulations, blind holes, mated surfaces and other complex features. Release the Fusion Nail from the Deployment Frame by unscrewing the connection screw. 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. 11 petunjuk penggunaan. Following the presoak the instruments should be wiped or scrubbed using a brush, cloth or sponge that does not mar the surface of the instrument. First used clinically under a limited market release in 2019, the DynaNail Mini has been implanted by over 50 orthopedic surgeons in over 50 hospitals across the United States.. The surgeon is responsible for patient selection. Patients who are obese or noncompliant, as well as patients who could be predisposed to delayed union or nonunion must have auxiliary support. Contact DJO customer service for replacements. The patient should not have unrealistic expectations regarding the results that the surgery and implant may provide. The DynaNail Mini Fusion System is designed for use in subtalar fusion and medial column fusion as well as the fusion of other large bones in the foot and ankle. Irritational injury of soft tissues, including impingement syndrome. Place small parts in baskets to prevent dislodging. [emailprotected], Your email address will not be published. The physician must determine if the device is appropriate for patients having any of the following physical or emotional conditions: It is the responsibility of the surgeon to provide the patient with appropriate information prior to surgery. Drug and/or alcohol and/or smoke addiction and/or abuse. A thorough manual or combination manual/automated cleaning process is required. Each surgeon must evaluate the appropriateness of the device and the procedure used to implant the device based on his/her own training and experience. End of life is normally determined by wear and damage due to use. The healthcare facility is responsible for in-house procedures for the reassembly, inspection and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. Failure to do so may result in severe patient injury. Patients have an intact asymptomatic subtalar joint. The surfaces of the implants must always be protected from damage during handling. 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. Handling of the DynaNail Deployment Frame and the Ancillary Surgical Instruments must be performed in accordance with aseptic handling practices to maintain sterility following sterilization by the healthcare facility. It is the physicians responsibility to determine the correct size of the Fusion Nail and Screws to be implanted. If the sterile packaging is found to be damaged or open, do not use the device or attempt to resterilize. Singly: A standard packaging material may be used. Do not modify the implant. The DynaNail Deployment Frame and the Ancillary Surgical Instruments should be fully disassembled into component parts prior to cleaning. When evaluating patients for implantation using the DynaNail Mini Fusion System, always consider the patients weight, occupation, activity level and the presence of any degenerative disease. The surface of the implant must always be protected from damage during handling. Extreme care must be taken when following the technique for removal of the device. 8. Use the Compression Wheel to dial in the desired amount of compression (1-6), depending upon surgeon preference. The DynaNail Mini Screw is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. 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. Knowledge of appropriate surgical techniques, instrumentation, proper selection and placement of implants and postoperative patient care and management are essential to a successful outcome. Carefully select the appropriate DynaNail Screw sizes based on the needs of each individual patient. and sterilized prior to surgical use. The surface of the implant must always be protected from damage during handling. Rinse parts under cold (<45C) potable water for a minimum of one (1) minute. It is important that adequate cleaning be carried out prior to sterilization. Patients with foreign body sensitivity is suspected, or documented metal allergy or intolerance. The adequacy of any healthcare facility sterilization procedure must be suitably tested. CLEANING AND STERILIZATION PROCEDURES. Moist heat/Steam is the only method that has been validated for reprocessing by MedShape. PRECAUTIONSThe DynaNail Helix Fixation System should only be used by those physicians who have been trained in the appropriate, specialized procedures. Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation. 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. 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 DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. No reassembly is necessary as the instruments remain in their fully disassembled form during cleaning and sterilization. Postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident. If sensitivity to nickel or titanium is suspected, appropriate testing should be conducted prior to use. 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. Serious postoperative complications may occur from use of the implant in a patient who: This device contains NiTiNOL, an alloy of nickel and titanium. Validated exposure temperature required to achieve a 10-6 sterility assurance level (SAL). The patient should be encouraged to report to his/her surgeon any unusual changes to the operated extremity. To minimize possible interference risks during medical imaging such as magnetic resonance imaging (MRI), advise the patient to mention that he/she was implanted with a metallic device. In the US, users should only use sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have been clearly the US FDA for the selected sterilization cycle specifications (132C, 4 minutes). Ancillary Surgical Instruments are required to complete the implant procedure and to remove the DynaNail. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. Lester ELECTRICAL ChargerConnect App User Guide, mXion PWD 2-Channel Function Decoder User Manual, amber connect ANC200 Instant C200 Cigarette Lighter GNSS Tracker User Guide, mXion RD6 6-Channel Relay Decoder User 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. Prior to surgery, the surgeon should discuss with the patient all possible risks versus potential benefits of treatment considering the patients preoperative condition and expectations for improvement in his/her condition postoperatively. Indicates the need for the user to consult the instructions for use. (DEPLOYMENT FRAME AND ANCILLARY SURGICAL INSTRUMENTATION ONLY) These general recommendations are provided as a guide only. Never attempt to reuse the devices, even though they may appear undamaged. It is important that adequate cleaning be carried out prior to sterilization. Carefully inspect sterile packaging for damage prior to use. Failure to immobilize the ankle during healing may result in bending and/or breakage of the device and/or failed fusion. Do not use device if it appears defective, damage or otherwise compromised. Contaminated instruments should be transported to the area for cleaning in a way that avoids contamination of personnel and hospital.1.Use flowing water and disposable wipes to remove excess soil.2.Presoak the instruments with an enzymatic solution for a minimum of five (5) minutes.3Following the presoak the instruments should be wiped or scrubbed using a brush, cloth or sponge that does not mar the surface of the instrument.4.Rinse parts under cold (<45C) sterile water for a minimum of one (1) minute.5Repeat the process until no visible debris remains.6.Soak the instruments in Ultra Clean System Low Foam Detergent (pH neutral) for a minimum of one (1) minute. Table A. Misuse, mishandling and/or improper operation. Hear from patient Teri Sutherland about her experience and recovery after undergoing a procedure with MedShape's DynaNail Mini. 4. Sensitivity, allergies, or other reaction to the device material. Unlike traditional screws that lose compression post-operatively, the DynaNail Hybrid maintains compression up to 5 mm of bone settling or resorption depending on implant length.1, The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures, medial column fusion procedu. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. Misuse, mishandling and/or improper operation. instruments should be fully inspected for any evidence of damage or corrosion. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. You can find the 0.25 dB compression point just as easily. 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 . Other sterilization cycles may also be suitable, but the individuals or hospitals are advised to validate other methods for use with MedShape products. It has not been tested for heating, migration, or image artifact in the MR environment. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you. Loss of anatomic positioning with nonunion or malunion with rotation or angulation. 6. In the case of very small dimension cannulations, a wire can be used to ensure that foreign material has been removed from the cannulation. 7. Refer to Table A for manual cleaning steps. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. Limited LiabilityThe DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer are guaranteed for materials, function, and workmanship for a single patient use.The Ancillary Surgical Instruments are guaranteed to be free from defects due to materials or workmanship and have a one (1) year limited warranty.DJO shall not be liable, expressly or implied for any damage which might arise or be caused, whether by the customer or by any of the users of the product, as a result of: 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 DJOS PART. A thorough manual or combination manual/automated cleaning process is required. Tibiotalocalcaneal Arthrodesis with. Never attempt a surgical procedure with defective, damaged or otherwise compromised instruments or implants. Manual cleaning should be done while the instrument is immersed. Please remove any damaged device or instrument from use and call your DJO sales representative for a replacement. Lacks an understanding that a metallic implant is not as strong as a normal healthy bone and will bend, loosen, or fracture if excessive demand is placed on it. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Home DYNANAIL DYNANAIL TTC Fusion System Instructions. All instruments should be thoroughly cleaned. If any of the components are damaged during attempted placement, additional sterile components of the same size should be available. Patients with severe peripheral vascular disease. Water hardness is a concern because deposits left on medical devices may result in ineffective cleaning or sterilization. Turn the Manual Compression Knob on the Deployment Frame to apply external manual compression. The DynaNail Miniu00ae Fusion System is designed for use in subtalar fusion and medial column fusion as well as the fusion of other large bones in the foot and ankle. Packaged and sterilized instruments should be stored in an area that provides protection from dust moisture, insects, vermin, and extremes of temperature and humidity. Drill a lateral-to-medial hole into the calcaneus through the proximal calcaneal hole across the DynaNail implant and insert a 5mm Headed Cortical Screw1. Correct selection of the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer is extremely important. Unwillingness to accept the possibility of multiple surgeries for revision or replacement. Hybrid screw/nail design of the DynaNail Hybrid combines sustained dynamic compressive power with easy, intuitive insertion. NOTE: Synonyms for batch code are lot number and batch number.. The Fusion Nail, End Cap, and Screws are supplied sterile for single use only. Patients with an active local or systemic infection. Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation. Moist heat/steam is the only method that has been validated for reprocessing by DJO. The DynaNail TTC Fusion System includes nickel and titanium materials. Additional MedShape Cleaning Instructions. Once the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer have been removed from the packaging, the devices should be either used or discarded. The Ancillary Surgical Instruments should not be reused if visible deterioration such as corrosion or damage resulting from use or handling is evident. Packaged and sterilized instruments should be stored in an area thatprovides protection from dust, moisture, insects, vermin, and extremesof temperature and humidity. The surgeon is responsible for patient selection. Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. All cleaning and sterilization of the DynaNail. The safety of DynaNail Helix Fixation System in the MR environment is unknown. Store the DynaNail Mini Fusion System Components in a dry place at room temperature (20oC to 25oC). The DynaNail Mini features a. The physician should always have a full inventory of sterile DynaNail Helix Threaded Bone Fasteners and DynaNail Helix Washers on hand at the time of surgery to ensure availability of the optimum size for the patient. DMP 711 Zone Expander Module . Note: If you have questions concerning the disassembly of the instruments, contact the DJO Customer Service or your local DJO sales representative. The consent submitted will only be used for data processing originating from this website. Knowledge of appropriate surgical techniques, instrumentation, proper selection and placement of implants and postoperative patient care and management are essential to a successful outcome. Use only DynaNail Helix Fixation System components. Validated exposure time required to achieve a 10-6 sterility assurance level (SAL). Store the DynaNail TTC Fusion Nail, DynaNail End Cap, and DynaNail Screws in a dry place at room temperature (20C to 25C). The DynaNail Helix Fixation System has not been evaluated for safety and compatibility in the MR environment. These specialized instruments are required to correctly perform the DynaNail implantation procedure and to remove the DynaNail TTC Fusion Nail and DynaNail Screws if required, following implantation. Damage to the implants surface finish may result in loss of proper mechanical function of the device. Failure to do so may result in loosening, bending, cracking or fracture of the device or injury to the patients bone or both. Remove the temporary compression drill and insert a 5mm Cortical Headed Screw. 5 potensi efek samping. All implants are sold sterile. Tibiotalocalcaneal Arthrodesis with Intramedullary Nails Mechanobiological Background and Evolution of Compressive Technology. The DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer are provided sterile for single use only. Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. 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. DEVICE DESCRIPTION The DynaNail Mini Fusion System consists of the following components: Fusion Nail DynaNail Mini Fusion Nail DynaNail Mini Hybrid Fusion Nail End Cap Screws The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. The DynaNail Mini Fusion System is designed for use in subtalar fusion and medial column fusion as well as the fusion of other large bones in the foot and ankle. The DynaNail Mini Deployment Frame and Ancillary Surgical Instruments are guaranteed to be free from defects due to materials or workmanship and have a one (1) year limited warranty.MedShape shall not be liable, expressly or implied for any damage which might arise or be caused, whether by the customer or by any of the users of the product, as a result of: 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. 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