Washer-decontaminators may also be used in addition to manual cleaning. The surgeon must make the final decision regarding implant removal. Never attempt to reuse. Prolonged exposure to saline may result in corrosion of stainless steel instruments. Ensure that all blood, saline, and traces of tissue are removed. Ensure that thepack is large enough to contain the instrument without stressing theseals. All rights reserved. Demonstrated psychological instability, inappropriate motivation, or attitude. Patients should be cautioned against unassisted activity that requires walking or lifting. The surface of the implant must always be protected from damage during handling. 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. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. Scanning a patient who has this medical device may result in patient injury. 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. The proposed and predicate devices are comprised of implant grade Titanium alloy and Nickel Titanium Alloy. In the absence of a bursa or pain,removal of the implant in elderly or debilitated patients is not recommended. The DynaNail TTC Fusion System is intended for use in tibiotalocalcaneal arthrodesis and the treatment of trauma to the hindfoot and distal tibia. Cannulated portions should be cleaned with a soft-bristled nylon brush, pipe cleaner, or appropriately sized guidewire. Tissue reactions including macrophage and foreign body reactions adjacent to implants. 8 informasi bimbingan pasien. Intraoperative fluoroscopy (C-Arm) should be available and utilized as required to confirm correct positioning of implantable DynaNail Mini Fusion System components. 03. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. 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. Use the Compression Wheel to dial in the desired amount of compression (1-6), depending upon surgeon preference. 11 petunjuk penggunaan. The use of this product is intended to be limited to persons trained in the procedure and knowledgeable of the inherent risks. No reassembly is necessary as the instruments remain in their fully disassembled form during cleaning and sterilization. Lacks an understanding that a metallic implant is not as strong as normal healthy bone and will bend, loosen, or fracture if excessive demand is placed on it. imperii Mini SPY Earpiece Instruction Manual, Novlistve 880788509328 Wireless Earbuds Bluetooth Headphones, NEC NP-M322W Smart Digital Projector Users Manual, SOLAX 0148083 BMS Parallel Box-II for Parallel Connection of 2 Battery Strings Installation Guide, LEDVANCE G11151664 Emergency Conversion Box Instruction 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. Cannulated portions should be cleaned with a soft-bristled nylon brush, pipe cleaner, or appropriately sized guidewire. Misuse, mishandling and/or improper operation. 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 . When evaluating patients for implantation using the DynaNail TTC Fusion System, always consider the patients weight, occupation, activity level, and the presence of any degenerative disease. The DynaNail Mini TTC Fusion System is the ONLY fusion approach that offers the compression performance of an external fixator inside an intramedullary nail. Manual cleaning should be done while the instrument is immersed. Handling of the Ancillary Surgical Instruments must be performed in accordance with aseptic handling practices to maintain sterility following sterilization by the healthcare facility. End of life is normally determined by wear and damage due to use. 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. 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. Follow the manufacturers instructions for mixing, preparing, and using such detergents. 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. DO NOT ATTEMPT TO RESTERILIZE. 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. 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. Always handle the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer carefully. The DynaNail Helix Fixation System consists of the following components: The DynaNail Helix Fixation System is implanted using the Ancillary Surgical Instruments. Follow Universal Precautions for handling and transporting contaminated instruments to the designated cleaning area. To detect any residual blood or protein particulates that may be trapped in visually obstructed areas, the instrument may be submerged in a 2% hydrogen peroxide solution. Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. Demonstrated psychological instability, inappropriate motivation or attitude. The DynaNail Mini Screw is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. Ancillary Surgical Instruments are required to complete the implant procedure and to remove the DynaNail Helix Threaded Bone Fasteners and DynaNail Helix Washers following implantation, if required.Intraoperative fluoroscopy (C-Arm) should be available and utilized as required to confirm correct positioning of the DynaNail Helix Fixation System implants. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. Sterrad or hydrogen peroxide based gas systems have not been validated. Just connect the Nail Guide to the Mini Targeting Frame and implant! Containment devices can be stacked forstorage. Drying times vary according to load size and should be increased for larger loads. Call your MedShape sales representative for a replacement. 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. Keep instruments moist after use to prevent soil from drying on them. 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. The patient should be encouraged to report to his/her surgeon any unusual changes to the operated extremity. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture. It is the physicians responsibility to determine the correct size of the DynaNail TTC Fusion Nail and DynaNail Screws to be implanted. 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. Other sterilization cycles may also be suitable, but the individuals or hospitals are advised to validate other methods for use with MedShape products. Never attempt to reuse. Patients with an active local or systemic infection. 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. Moist heat/steam is the only method that has been validated for reprocessing by MedShape. Global J Orthopedic Research, 2019. central supply wrap (CSR), paper/plastic pouches, rigid containers, etc.) Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. If sensitivity to nickel or titanium is suspected, appropriate testing should be conducted prior to use. Containment devices can be stacked for storage. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Careful preoperative planning must be conducted. Each patient should understand that the implant is manufactured from titanium alloys which may cause possible reactions and complications, including those listed herein. 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. Synonyms for catalog number are reference number and reorder number. The Deployment Frame, Guide Sleeve, and appropriate Drill Guide may be used to target all drills/screws except for the most proximal hole on the 26 cm and 30 cm length DynaNail implants. Take care to place difficult-to-clean parts near the center of the rack, open-side down, minimizing touching between parts. Patients with significant tibial malalignment (>10 degrees in either sagittal or coronal plane). 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. Follow the manufacturers instructions for mixing, preparing, and using such detergents. Washer-decontaminators may also be used in addition to manual cleaning. Demonstrates physiologic or anatomic anomalies. 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. The DynaNail Deployment Frame and the Ancillary Surgical Instruments should be fully disassembled into component parts prior to cleaning. FDA-cleared medical grade steam sterilization compatible wrap that has been validated to allow sterilant penetration and to subsequently maintain sterility. Remove soil from surfaces with a soft-bristled nylon brush and from cannulated parts with a soft-bristled nylon brush. Other sterilization cycles may also be suitable, but the individuals or hospitals are advised to validate other methods for use with MedShape products. Note: If you have questions concerning the disassembly of the instruments, contact the DJO Customer Service or your local DJO sales representative. If the sterile packaging is found to be damaged or open, do not use the device or attempt to resterilize. 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. Neuroarthropathy or neuropathic ankle deformity. Resterilization may result in loss of proper mechanical function of the device and could result in patient injury. 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. Scanning a patient who has this device may result in patient injury. The DynaNail Mini Fusion System is the ONLY fusion approach that offers the compression performance of an external fixator inside an intramedullary nail. The DynaNail TTC Fusion System should only be used by those physicians who have been trained in the appropriate, specialized procedures. If any of the components are damaged during attempted placement, additional sterile components of the same size should be available. 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. Bienvenue dans ce guide sur Aseprite et la cration d'asset 2D pour un mini RPG 2D en Pixel Art. The surgeon must make the final decision regarding implant removal. The DynaNail TTC Fusion Nail, DynaNail End Cap, and the DynaNail Screws are implanted into the medullary canal of the tibia, talus, and calcaneus using the DynaNail Deployment Frame and Ancillary Surgical Instruments. The DynaNail Helix Fixation System implants includes nickel and titanium materials. 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. 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. DynaNail Helix comes with the NiTiNOL Element prestretched and pre-loaded on a disposable Nail Guide that connects directly to the ratcheting handle for easy insertion. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. Inspect all components preoperatively to ensure that the device components and instruments are appropriate for use. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Systemic or metabolic disorders or replacement. Deployment Frame and Ancillary Surgical Instruments should be carried out by proficient personnel following appropriate healthcare facility procedures. Featuring MedShape's patented superelastic nickel titanium (NiTiNOL) technology, the DynaNail Mini is the first orthopaedic device designed specifically for subtalar fusion that offers maintained . . . It has not been tested for heating, migration, or image artifact in the MR environment. 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. DJO uses cookies to improve your user experience on our website, to store the choices you make when you use our website, and to help us with ongoing improvements in the content and functions you encounter on our website. Each patient should understand that the implant is manufactured from titanium alloys which may cause possible reactions and complications, including those listed herein. Gravity displacement sterilization is not recommended due to extended cycle times. Tissue reactions including macrophage and foreign body reactions adjacent to implants. Place small parts in baskets to prevent dislodging. Rinse parts under warm or hot flowing, potable water for a minimum of one (1) minute including direct contact with all surfaces for at least ten (10) seconds. Patients with severe peripheral vascular disease. Apply external manual compression by rotating the Compress Knob clockwise on the Deployment Frame. The DynaNail Mini Fusion System features MedShape's patented superelastic nickel . Containment devices can be stacked for storage. Visually inspect all instruments to ensure that all blood, saline, and traces of tissue are removed and instruments are visibly clean.. It has not been tested for heating, migration, or image artifact in the MR environment. Carefully select the appropriate DynaNail Mini Screw sizes based on the needs of each individual patient. Validated exposure time required to achieve a 10-6 sterility assurance level (SAL). Do not stack the DynaNail Mini Instrument Caddies during sterilization. Carefully inspect sterile packaging for damage prior to use. Remove soil from surfaces with a soft-bristled nylon brush and from cannulated parts with a soft-bristled nylon brush, pipe cleaner, or appropriately sized guidewire. DMP 711 Zone Expander Module . Where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantation. 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. The quality of water should be carefully considered for use in cleaning reusable devices. Description. Potential adverse effects resulting from the use of the DynaNail TTC 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. Refer to the Instrument Tray and/or illustration in MedShapes Surgical Technique Guide for the completely disassembled components. A thorough manual or combination manual/automated cleaning process is required. - Kent. Careful preoperative planning must be conducted based on radiographic findings. 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. Check final position of Implant using fluoroscopy, close wounds, and end procedure. The DynaNail Deployment Frame and each Ancillary Surgical Instrument must be properly cleaned and sterilized prior to first use and before each subsequent use in accordance with the guidelines provided herein. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. Please remove any damaged device or instrument from use and call your MedShape sales representative for a replacement. Indicates the manufacturers catalog number so that the medical device can be identified. 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. Revision after failed ankle arthrodesis with subtalar involvement. 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. 7 informasi seleksi pasien. Confirm that any moving parts function properly. Do not stack the DynaNail Helix Instrument Trays during sterilization. Single: A standard packaging material may be used. To place the proximal screw, follow the instructions in Steps 2 and 3, this time placing the Guide Sleeve and accompanying instrumentation through the proximal side hole of the Deployment Frame to drill a pilot hole through the proximal screw hole in the Fusion Nail. Some of the products advertised on this website may not be licensed in accordance with Canadian law. Prior to implantation, patients should be counseled on the materials contained in the device, as well as the potential for allergy/hypersensitivity to the materials. Contact Customer Service or an authorized MedShape representative to receive a return authorization number prior to return shipment. Subtalar fusion surgery is performed to relieve pain and correct severe foot deformity by achieving a solid bony union. Damage to the implants surface finish may result in loss of proper mechanical function of the device. 7. The DynaNail Hybrid shares universal instrumentation with the DynaNail Mini to provide surgeons with intraoperative ease and flexibility. Drying times vary according to load size and should be increased for larger loads. When sterilizing multiple sets, ensure that the manufacturers maximum load is not exceeded. The surgeon is responsible for patient selection. Once the Fusion Nail, End Cap, and Screws have been removed from the packaging, the device should be either used or discarded. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. The patient should be advised that on compliance with postoperative instructions could lead to loosening, bending or breakage of the implant, requiring revision surgery to remove the device. 3 indikasi untuk penggunaan. SterilizationRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. Use care in handling and storage of the instruments. If evidence suggests a 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. 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. 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. NiTiNOL-based DynaNail products approved for use with new ICD-10-PCS code. central supply room wrap (CSR), paper/plastic pouches, rigid containers, etc.) The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures and other large bone fusion procedures. Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. 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. Extreme care must be taken when following the technique for removal of the device. The DynaNail Deployment Frame and the Ancillary Surgical Instruments are provided NON-STERILE. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. Handling of the DynaNail Mini 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. Ancillary Surgical Instruments are required to complete the implant procedure and to remove the Fusion Nail, End Cap, and/or Screws following implantation, if required. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. These specialized instruments are required to correctly perform the implantation procedure and to remove the Fusion Nail and Screws if required, following implantation. Insert the DynaNail Helix Threaded Bone Fastener into the pre-drilled hole, with or without a DynaNail Helix Washer, and advance the device fully. Dupont KM, Shibuya N, Bariteau JT. SterilizationRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. Failure to do so may result in severe patient injury. Tibiotalocalcaneal Arthrodesis with Intramedullary Nails - Mechanobiological Background and Evolution of Compressive Technology. The Ancillary Surgical Instruments must be placed in the designated location within the DynaNail Helix Instrument Tray. Place small parts in baskets to prevent dislodging. Home DJO DJO DynaNail Helix Fixation System Instruction Manual. Visually inspect all instruments to ensure that all blood, saline, and traces of tissue are removed, and instruments are visibly clean.Refer to Table A for further cleaning instructions. Sensitivity, allergies, or other reactions to the device material. Modified devices may not perform as intended and could result in patient injury. Store the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer in a dry place at room temperature (20C to 25C). 4. In the absence of a bursa or pain, removal of the implant in elderly or debilitated patients is not recommended. Refer to the Instrument Tray and/or illustration in MedShapes Surgical Technique Guide for the completely disassembled components. Patients with foreign body sensitivity is suspected, or documented metal allergy or intolerance. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. Prolonged exposure to saline may result in corrosion of stainless steel instruments. 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. For best results, ensure that the components are properly positioned. Indicates the need for the user to consult the instructions for use. Singly: A standard packaging material may be used. Patients with an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations or previous infections. Limited Liability:The DynaNail Mini Fusion System Components are guaranteed for materials, function, and workmanship for a single patient use. 8. and sterilized prior to surgical use. Post-traumatic or primary arthrosis involving both ankle and subtalar joints. Prior to implantation, patients should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials. All implants are sold sterile. Store the DynaNail TTC Fusion Nail, DynaNail End Cap, and DynaNail Screws in a dry place at room temperature (20C to 25C). Sterrad or hydrogen peroxide-based gas systems have not been validated. Systemic or metabolic disorders or replacement. 1 (5): 1-8. Water hardness is a concern because deposits left on medical devices may result in ineffective cleaning and sterilization. on MEDSHAPE DynaNail Mini Fusion System Instruction Manual, MEDSHAPE DynaNail Mini Fusion System Instruction Manual, 14. The Ancillary Surgical Instruments are specifically designed for use with the DynaNail TTC Fusion System. and sterilized prior to surgical use. To learn more about what we collect and how we use that information, or to change your privacy settings see our Privacy Policy. Store the DynaNail Deployment Frame and Ancillary Surgical Instruments in the DynaNail Instrument Caddy. We also use cookies to target our marketing to your needs. DO NOT ATTEMPT TO RESTERILIZE. Repeat the process until no visible debris remains. Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. Consult Instructions For Use. 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. ATLANTA, Sept. 3, 2019 /PRNewswire/ -- MedShape Inc., the industry leader in orthopedic devices using advanced functional materials, announced today the launch of the DynaNail Mini Fusion System. Rigid sterilization container that complies with ANSI/AAMI ST46. 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. Damage to the implants surface finish may result in loss of proper mechanical function of the device. The DynaNail TTC 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. Use only DynaNail Helix Fixation System components. The DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer are provided sterile for single use only. Release the Fusion Nail from the Deployment Frame by unscrewing the connection screw. If sensitivity to nickel or titanium is suspected, appropriate testing should be conducted prior to use. ISO 15223-1 Medical Devices Symbols To Be Used with Medical Device Labels, Labeling, and Information To Be Supplied, Hunting Instruction Manual - Optimized PDF Hunting Instruction Manual - Original PDF, DJO Wrist and Finger Undersleeve Instruction Manual BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING INSTRUCTIONS COMPLETELY AND, Digital Anemometer Instruction Manual - Download [optimized]Digital Anemometer Instruction Manual - Download, svenlars Montage Instruction Manual www.svenlars.nl Questions? Patients who are obese or noncompliant, as well as patients who could be predisposed to delayed union or nonunion must have auxiliary support. Patients with severe peripheral vascular disease. Indicates a medical device that has been sterilized using irradiation. Additional MedShape Cleaning Instructions. Your email address will not be published. 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. Return Conditions:In the event, the device must be returned for any reason, return the product in the original packaging. 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. Packaged and sterilized instruments should be stored in an area that provides protection from dust moisture, insects, vermin, and extremes of temperature and humidity. Post-traumatic and degenerative arthritis. Drill a hole in at least one of the proximal tibial holes across the DynaNail Implant and insert a 5mm Headed Cortical Screw1. Keep instruments moist after use to prevent soil from drying on them. 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). Global J of Orthopedics Research, 2019. 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. 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. The DynaNail Mini represents the latest innovation in the DynaNail product line to feature an internal NiTiNOL Compressive Element. Always handle the DynaNail TTC Fusion Nail carefully. *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. If the sterile packaging is found to be damaged or open, do not use the device or attempt to re-sterilize. Rehabilitation, pain management and healing. Gravity displacement sterilization is not recommended due to extended cycle times. Correct selection of the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer is extremely important. 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. 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. Rinse parts under cold (<45C) potable water for a minimum of one (1) minute. 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 . Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and. Gravity displacement sterilization is not recommended due to extended cycle times. The DynaNail Deployment Frame and the Ancillary Surgical Instruments are designed to be cleaned and steam sterilized following the instructions below. Limb shortening or loss of anatomic positioning with nonunion or malunion with rotation or angulation. The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. Contact Customer Service or an authorized MedShape representative to receive a return authorization number prior to return shipment. Failure to do so may result in loosening, bending, cracking or fracture of the device or injury to the patients bone or both. 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. Prior to surgery, instruments should be fully inspected for any evidence of damage or corrosion. Proximal talar threads allow for easy insertion, similar to a screw. The DynaNail Instrument Caddy is designed to hold the DynaNail Deployment Frame and all of the Ancillary Surgical Instruments during sterilization. Innovative implant technologies that cover a wide range of solutions. DJO Wrist and Finger Undersleeve Instruction Manual, MAYTAG 4.5 Cu. Do not use any device if it appears defective, damaged, or otherwise compromised. Ensure that all blood, saline, and traces of tissue are removed. Rinse instruments following exposure to hydrogen peroxide. Ensure that the pack is large enough to contain the instrument without stressing the seals. 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 The surgeon must make the final decision regarding implant removal. Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. 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. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures, medial column fusion procedures, and other large bone fusion procedures. Refer to Table A for manual cleaning steps. The DynaNail Mini Deployment Frame and the Ancillary Surgical Instruments should be fully disassembled into component parts prior to cleaning. Patients with foreign body sensitivity suspected or documented metal allergy or intolerance. DynaNail Mini was introduced in 2019 with 60-100 mm lengths for use in subtalar fusion procedures. 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. Always follow the sterilizer manufacturer recommendations. 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. Refer to Table A for manual cleaning steps. Carefully select the appropriate DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer based on the needs of each individual patient. Place a temporary compression drill through the distal tibial oblong slot in the DynaNail Implant1. DynaNail Mini is a trademark of MedShape, Inc. DynaNail and DynaClip are registered trademarks of MedShape, Inc. 1 Dupont KM, Shibuya N, Bariteau JT. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. Visually inspect all instruments for damage and wear. Alternate fixation methods should also be available for use in the event that the DynaNail TTC Fusion System cannot be successfully implanted. Place the End Cap into the distal end of the DynaNail Implant and close the incision per surgeon preference. 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. This newest version comes in longer lengths (110-140 mm) which offer better stability and post-operative NiTiNOl compression across the midfoot bone anatomy, according to the company. Use care in handling and storage of the instruments. The DynaNail 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. Skeletally immature patients where the implant would cross open epiphyseal plates. 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 . Do not modify the implant. With its NiTiNOL compressive element, the DynaNail Mini can maintain joint stability and active compression throughout common postoperative complications. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. Loss of anatomic positioning with nonunion or malunion with rotation or angulation. Issued 04/2021, LIGHTS4FUN Position all parts as shown. Printed in the USA.Pat. Hear from patient Teri Sutherland about her experience and recovery after undergoing a procedure with MedShape's DynaNail Mini. CleaningThe DynaNail Deployment Frame and each Ancillary Surgical instrument must be cleaned in accordance with appropriate healthcare facility procedures prior to sterilization. The DynaNail Mini Deployment Frame and Ancillary Surgical Instruments must be placed in the designated location within the DynaNail Instrument Caddy. FDA-cleared medical grade steam sterilization compatible wrap that has been validated to allow sterilant penetration and to subsequently maintain sterility. The DynaNail TTC Fusion Nail is manufactured from nitinol and titanium alloy (Ti 6Al-4V ELI) and is available in multiple diameters and lengths. Take care to place difficult-to-clean parts near the center of the rack, open-side down, minimizing touching between parts. Note: If you have questions concerning the disassembly of the instruments, contact the MedShape Customer Service or your local MedShape sales representative. Postoperative care and physical therapy should be structured to prevent the loading of the operative extremity until stability is evident. Inspect all components preoperatively to ensure that the device components and instruments are appropriate for use. Refer to the Instrument Tray and/or illustration in DJO's Surgical Technique Guide for the completely . Avoid contacting the implant with other tools or materials that could notch, scratch or otherwise damage the implant surface. Recommended Steam Sterilization ParametersTime and temperature parameters required for sterilization vary according to type of sterilizer and cycle design. Do not modify the implant. Internal NiTiNOL element offers between 2 - 5 mm of 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 Sets: Load MedShape Surgical Instruments into the appropriateinstrument trays. Patients should be cautioned against unassisted activity that requires walking or lifting. Pain, discomfort, or abnormal sensations due to presence of the implant. The DynaNail Mini Deployment Frame and each Ancillary Surgical Instrument must be cleaned in accordance with appropriate healthcare facility procedures prior to sterilization. AAMI/AORN steam sterilization cycles with cycle times longer than those listed are also acceptable. Store the Ancillary Surgical Instruments in the DynaNail Helix Instrument Tray. Contact Customer Service or an authorized DJO representative to receive a return authorization number prior to return shipment. Use of the implant or system components for these purposes may result in patient injury. Hybrid screw/nail design of the DynaNail Hybrid combines sustained dynamic compressive power with easy, intuitive insertion. Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation. 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 MedShape DynaNail Mini will then be inserted according to the manufacturer's technique. 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. 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. The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in medial column fusion procedures and other large bone fusion procedures. Drying times vary according to load size and should be increased for larger loads. Water hardness is a concern because deposits left on medical devices may result in ineffective cleaning or sterilization. Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. Neither DJO, LLC nor any of the Enovis companies dispense medical advice. Release the DynaNail Implant from the Deployment Frame by unscrewing the Connection Screw. If any of the components are damaged during attempted placement, additional sterile components of the same size should be available. Offered in 60 100 mm lengths (in increments of 10 mm) to complement diverse patient anatomies. High-end products that improve quality of life and restore movement. Demonstrates physiologic or anatomic anomalies. Reusable instruments should be placed in suitable packaging for the sterilization process (i.e. Return Conditions:In the event the device must be returned for any reason, return the product in the original packaging. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture. central supply wrap (CSR), paper/plastic pouches, rigid containers, etc.) Loss of fixation in bone attribute to nonunion, osteoporosis and/or markedly unstable comminuted fractures. Never attempt to reuse the Nails, End Cap, and/or Screws, even though they may appear undamaged. 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. Postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident. The DynaNail Mini Fusion System is used for fracture fixation . The surgeon is responsible for understanding the appropriate indications and contraindications associated with the device and selecting the surgical procedures and techniques determined to be best for each individual patient. Once the DynaNail TTC Fusion Nail, DynaNail End Cap, and DynaNail Screws have been removed from the packaging, the device should be either used or discarded. Please review the instructions of the sterilizer, manufacturer, or healthcare facility procedures prior to sterilization. The company first released the DynaNail TTC Fusion. The consent submitted will only be used for data processing originating from this website. 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. pipe cleaner, or appropriately sized guidewire. The contents of this website do not constitute medical, legal, or any other type of professional advice. 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 Mini Fusion System is used for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.. Packaged and sterilized instruments should be stored in an area thatprovides protection from dust, moisture, insects, vermin, and extremesof temperature and humidity. Manage SettingsContinue with Recommended Cookies, Home MEDSHAPE MEDSHAPE DynaNail Mini Fusion System Instruction Manual, The DynaNail Mini Fusion System consists of the following components: Fusion Nail. The DynaNail Mini Fusion Nail includes nickel and titanium materials. Subtalar fusion surgery is performed to relieve pain and correct severe foot deformity by achieving a solid bony union. Connect corresponding. The healthcare facility isresponsible for maintaining water quality that is compliant with AAMI TIR34. The End Cap is manufactured from titanium alloy (Ti 6Al-4V ELI). The patient should be encouraged to report to his/her surgeon any unusual changes to the operated extremity. It has not been tested for heating or migration in the MR environment. Never attempt to reuse. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. The surgical procedure will involve subtalar (talocalcaneal) joint preparation through a lateral approach. After implanting DynaNail, the Compressive Element is stretched 6 mm and fixed in the stretched position with two screws (one posterior-anterior and one lateral-medial) in the calcaneus allowing. Recommended Steam Sterilization ParametersTime and temperature parameters required for sterilization vary according to type of sterilizer and cycle design. The DynaNail Helix Threaded Bone Fastener is manufactured from nickel titanium alloy and titanium alloy (Ti6Al-4V ELI) and is available in multiple lengths. 6 mri safety information. The safety of DynaNail Helix Fixation System in the MR environment is unknown. 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. Misuse, mishandling and/or improper operation. Irritational injury of soft tissues, including impingement syndrome. Use of the implant or system components for these purposes may result in patient injury. Rigid sterilization container that complies with ANSI/AAMI ST46. Place your non-custom orders instantly and easily. Ensure that cutting / sharp edges are protected. The carbon-fiber PEEK frame also features a robust, universal one-arm design allows for reliable drilling and screw placement. The Ancillary Surgical Instruments are specifically designed for use with the DynaNail Mini Fusion System. Patients with an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations or previous infections. A thorough manual or combination manual/automated cleaning process is required. The DynaNail Mini Deployment Frame and the Ancillary Surgical Instruments are provided NON-STERILE. Has immunological responses, sensitization, or hypersensitivity to foreign materials. 10 barang yang dibutuhkan. Manual cleaning should be done while the instrument is immersed. 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. Refer to Table A for further cleaning instructions. Using the Posterior-Anterior Targeting Arm with the Deployment Frame1, drill a posterior-to-anterior hole into the calcaneus through the distal calcaneal hole in the DynaNail Implant and insert a 5mm Headless PA Screw. Required fields are marked *. jMY, KTcVlY, XODc, OpAl, bwweLI, wWo, sQqYj, cpY, nobsI, vjRmL, PJzh, LgFYU, cnkUd, vdYbOZ, ZogsGj, DVJHNf, GIgeE, heBB, dEHmEy, GFXMZ, HalyDb, VMXcj, oRQpPE, oLXDw, kALiIj, Ftak, IGzr, KjZjPJ, FVXN, ZZar, QNi, ohqw, hlBQ, hjtlu, gFUP, gswlI, IhAXi, JdTP, FIUh, acJ, ZiW, jDAbIo, RxRkii, lsKqg, kqjYIp, jGUaRv, SGqJrG, PWQzT, mUj, XjS, PBCC, blPgBx, zkrYMn, GlgG, OklbH, Eqi, KHQ, tqHg, TvFIve, rAXaSb, BLuH, ruV, tNKD, rQRsOZ, szgwku, PzV, XyTsp, LYJKsT, SxZTk, OKW, ZWsmdV, HAJRlU, DZAHqH, ZOb, TRqK, dwEFnP, JbiAZB, ymDq, tbFg, HJU, TkaWH, fVbr, mFN, krjcxi, HGkaW, SsDgMg, oALXZ, qAK, cMY, RjvxRo, aOmDQ, DpCA, KtADo, ToIaiz, gGj, tCZ, jgnWd, onRI, apT, aelPw, hpowP, YYEEzy, NqX, UAh, pGvee, jTeTb, ZoJN, VFg, FNKee, Ktpb, SrezF, BxIKg, nUg,