Orthofix Ltd
TrueLok System and TL-HEX TrueLok Hexapod System Instructions for Use
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PQTLK S 04/21 (0421217) 0123
EN
Instructions For Use (IFU) are subject to change; the most current version of each IFU is always available online Important information - please read prior to use See also instruction leaflet PQSCR (version D or higher) for implantable devices and related instruments and PQRMD for reusable medical devices
TRUELOK™ SYSTEMS Orthofix Srl Via delle Nazioni 9 - 37012 Bussolengo (VR) Italy Tel. 0039 (0) 45 6719000 - Fax 0039 (0) 45 6719380
MEDICAL DEVICE INFORMATION DESCRIPTION This leaflet refers to the TrueLok systems: the TrueLok™ system (TrueLok hereinafter) and the TL-HEX TrueLok Hexapod System™ (TL-HEX hereinafter). They are two configurations of the same modular circular external fixation system based on Ilizarov principles. The TrueLok consists of external supports (rings and footplates), struts and a variety of connection elements that build the external frame. The TL-HEX consists of external supports (rings and foot plates) and variable length struts to be used to build a hexapodal frame. TL-HEX frame is completed with the use of the TrueLok components. The external frame is connected to the bone by means of bone screws and wires. Application and removal of the TrueLok systems can be performed with Orthofix general orthopedic instrumentation. The TL-HEX strut lengths determine the relative position of the TL-HEX rings in space. Because the rings are attached to bone segments, their position indirectly determines the position of the bone segments. The Web-Based TL-HEX Software aids the surgeon in his/her use of the TL-HEX product and it can be accessed at: www.tlhex.com. The SW is able to calculate strut length adjustments for surgeon’s review and approval (see the SOFTWARE INFORMATION section in this document and TL-HEX Software User Guide available on the TL-HEX website). The TrueLok Systems may be used in hybrid frames with ProCallus Fixator and XCALIBER™ fixators. INTENDED PURPOSE AND INDICATIONS INTENDED PURPOSE The TrueLok systems are intended to provide bone fixation. INDICATIONS FOR USE The TrueLok systems are indicated for fractures, pseudarthrosis / non-unions, lengthening, joint arthrodesis and correction of bony or soft tissue deformities and defects (e.g. bone transport) in long bones and in the foot. The TL-HEX-ProCallus Fixator and TL-HEX-XCALIBER hybrid frames are indicated for proximal and distal tibia and distal femur fractures. CONTRAINDICATIONS DO NOT USE the TrueLok systems if a surgical candidate exhibits or is predisposed to any of the following contraindications: • Mental or physiological conditions who are unwilling or incapable of following postoperative care instructions as it could result in a treatment failure in the intended population. INTENDED PATIENTS Proper patient selection and the patient’s ability to comply with physician instructions and follow the prescribed treatment regimen will greatly affect the results. It is important to screen patients and select optimal therapy given physical and/or mental activity requirements and/or limitations. The TrueLok systems are intended to be used in adult and pediatric patients with the exception of newborns. INTENDED USERS The product is intended for use by Healthcare Professionals (HCP) only and such HCP must have full awareness of the appropriate orthopedic procedures and must be familiar with the devices, instruments and surgical procedures (including application and removal). NOTES FOR USE - IMPLANT REMOVAL Once the treatment with external fixation is complete, implant must be removed. HCP should consider premature removal in case of adverse events.
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DISCLAIMER The HCP is fully responsible for the selection of the appropriate treatment and of the relevant device for the patient (including post-operative care). MATERIAL The implants are made from an implant grade material that is specified on the product label. WARNINGS 1. All equipment should be carefully examined prior to use to assure proper working condition. If a component or instrument is believed to be faulty, damaged or suspect, it should NOT BE USED. 2. Patient weight: the risk of bending or breakage of the external fixation device may increase in obese or overweight patient that may place excessive loads on the device itself. 3. Patient occupation or activity: the risk of bending or breakage of the external fixation device during post-operative rehabilitation may increase if the patient carries out activities that involve lifting or heavy muscular activity, as these movements subject the device to forces that could cause it to break. 4. The locking screws on the rings and the strut locking bolt are retained and should never be removed for any reason. Rings and struts must be cleaned and sterilized in the assembled state with the locking screws in the ring and strut locking bolt only untightened. 5. Do not overtighten the stud locking screw in the ring and the strut locking bolt as this causes stripping of their threads. Final locking of the set screw of the TL-HEX rings is performed with torque driver 54-2236, which must be turned in a clockwise direction only. The torque wrench is pre-set at a specific value and a click indicates that the correct torque has been applied. Any attempt to unlock any screw using the torque wrench will damage its gearing. 6. When attaching ultrashort struts to the ring, do not insert both central studs into the same tab since this might cause interference between the two struts during assembly and correction maneuvers. Avoid horizontal placement of the struts. 7. The fixation device must never be subjected to bending, cutting or scratching as these could reduce the fixation frame’s resistance to stress and increase the risk of bending or breakage. 8. This device is not approved for fixation or attachment by means of screws to posterior elements (pedicles) of the cervical, thoracic or lumbar spinal column. PRECAUTIONS 1. In the case where the normal sensitivity of the limb is altered, abating the usual proprioceptive feedback, the fixation system may be subjected to greater loads than usual. Under these circumstances, the patient will have to be informed of the risk of excessive stress on the fixation system, and the physician should be especially attentive regarding problems associated with overloading, which might lead to loosening, bending or breakage of the components. In such situations, it is recommended the rigidity of the fixation system be increased compared to what is usually necessary. 2. During and after insertion of the implants, ensure their correct positioning under image intensification. 3. If choosing TL Rapid Struts, at least three struts should be used in each frame block when weightbearing. 4. When using the TL-HEX and choosing two 5/8 Rings, the openings can be orientated in the same direction (i.e. both open anteriorly, posteriorly, medially). The surgeon must check the feasibility of the frame before applying it on the patient to ensure that the position of the struts will not interfere with the soft tissues. If soft tissue interference may be created, this can be mitigated by adding a 3/8 ring to the 5/8 ring and transforming the latter into a full ring. With this procedure, an extra tab is added to the frame, which allows the surgeon to change the position of the struts and remove the soft tissue interference risk. As a result, two 5/8 rings can be applied with the opening on the same side (very useful in trauma cases). 5. The following steps outline the recommended method of screw insertion and fixation: a. A half pin fixation bolt is inserted into an appropriate hole of the ring. The half pin fixation bolt acts as a guide for half pin insertion. b. A K-wire is passed through the hole of the fixation bolt along the intended direction of the half pin insertion. Make a stab incision in the skin at this level. c. Use scissors or hemostats to make a track through the soft tissues to the bone with blunt dissection only. d. The desired half pin is inserted through the fixation bolt and soft tissue track, and drilled into the first bony cortex. Insertion through the second cortex should be done manually using the dedicated Orthofix T-wrench. e. The half pin fixation bolt is then secured firmly to the external support with a nut. 6. It is recommended to position at least one wire on the opposite side of the ring with respect to the other two wires. 7. Circular frames for use in the progressive correction of deformities should be preassembled and checked prior to application to ensure they provide the correction required and that their hinges are at the correct level. 8. Ensure that the TL Foot Alignment Support that interfaces with the patient’s skin is free from burrs or sharp edges. 9. Ensure that three TL Foot Alignment Supports are attached to one TL ring in order to achieve correct limb placement. The position of each Support shall be evaluated based on patient’s case. 10. Be sure that both adjustment knobs on the struts are pointing in the same (preferably proximal) direction. 11. If necessary, to avoid bending the wire, a space between the ring and the wire can be filled with a maximum of three spacing washers; if it is larger use a post, or remove the wire and reinsert in a different position. 12. Dynamization by loosening the micromovement locking nut and/or the central body locking nut of the monolateral fixator is not recommended in hybrid frames. 13. The fixation must be applied at such a distance from the skin as to allow post-surgical swelling and cleansing, bearing in mind that the stability of the fixation device depends on the distance between it and the bone. 14. The fracture or bone gap must be checked periodically during treatment, making any necessary adjustments to the fixation. An excessive or persistent gap can delay consolidation. 15. In patients undergoing callus distraction, the regenerated bone must be checked regularly and monitored radiologically. 16. The surgeon must evaluate the integrity of the construct at follow-up visits. All Orthofix devices should be used together with their corresponding Orthofix implants, components, accessories and instrumentation following the Operative Technique recommended by the manufacturer. Orthofix does not guarantee the safety and effectiveness of the TrueLok systems when used in conjunction with devices of other manufacturers or with other Orthofix devices if not specifically indicated in the Operative Technique. POSSIBLE ADVERSE EVENTS • Non-union or delayed union, malunion • Superficial infection • Deep infection • Loss of fixation • Bending, breakage or migration of the device • Additional surgery for soft tissue defects • Reoperation to replace a component or entire frame configuration 3
• Bone fracture during or after treatment • Bone loss or reduced bone density • Damage to surrounding tissues due to surgical trauma • Possible tension affecting the soft tissues and/or the frame during callus manipulation (e.g. corrections of bony deformity and/or bone lengthening) • Wound healing complications • Tissue necrosis • Joint contracture, dislocation, instability or loss of range of motion • Arthritic changes • Pain, discomfort or abnormal sensations due to the presence of the device • Complex Regional Pain Syndrome • Residual deformities, persistence or recurrence of the initial condition requiring treatment • Premature bone callus consolidation during distraction • Stiffness at surgery site • Compartment syndrome • Events caused by intrinsic risks associated with anesthesia and surgery A successful result is not achieved in every surgical case. Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical re-intervention to remove or replace the medical device. Preoperative and operative procedures including knowledge of surgical techniques and proper selection and placement of the device are important considerations in the successful utilization of the device by the HCP. MRI (Magnetic Resonance Imaging) SAFETY INFORMATION The TrueLok and the TL-HEX have not been evaluated for safety and compatibility in the MR (Magnetic Resonance) environment. They have not been tested for heating, migration, or image artifact in the MR environment. The safety of the TrueLok and the TL-HEX in the MR environment is unknown. Scanning a patient who has these devices may result in patient injury. EXPECTED CLINICAL BENEFITS AND PERFORMANCE CHARACTERISTICS OF THE DEVICE EXPECTED CLINICAL BENEFITS SIMPLE • Simple - The TrueLok system offers pre-assembled hinges, angular distractors, and other functional components that are easy to connect, align and operate • Simple - TrueLok hinges and angular distractors preserve their alignment even when temporarily disconnected during osteotomy, frame manipulation or component exchange • Simple - TrueLok linear and angular distractors require only one simple motion to effect adjustments • No need of a second surgery for removal (compared to internal fixation) • Quick and easy frame assembly • Easy adjustment: simple pull and click method for patient adjustment • Time-saving quick adjust struts don't interfere with hexapod struts: they can be easily mounted on the frame outside the OR, if needed • Easy access to surrounding tissues STABLE • Stable - The serrations machined on connection elements prevent undesired rotation and component loosening during treatment • Stable - Wire and half pin fixation bolts with serrations and grooves provide superior bone segment stabilization • Stability with proven limited movements at the bone site may enhance the bone healing and pain reduction • Stable and minimally invasive • Provides stable bone fixation that allows immediate functional rehabilitation • The device metal-plastic interface on angular and linear distractors is equally stable during and between adjustments • Stable- TL-Hex provides exceptional stability due to its unique aluminum-stainless steel and metalplastic interface VERSATILE • Versatility and modularity offered by a comprehensive external fixation system • Versatile - Full control of bone segments accomplished with the device allows precise movement of segments without compromising stability • Versatile - The distinctive strut design allows acute and gradual adjustment in deformity correction and complex trauma procedures • Corrects concurrent deformities and limb length discrepancies CHARACTERISTICS • Hardware and associated software allow accurate fragment positioning and manipulation, minimizing corrective errors • 0,5mm increments in the correction permits a gradual correction of the deformity • Allows for both soft tissue management and a stable biomechanical fixation • Keep bone segments aligned • Minimizes surgical trauma to anatomical structure • Preserves the blood supply and osteogenic potential of the tissues • Where indicated, provides for the application of dynamization to enhance the fracture healing process • Fracture stabilization without compromising fragile soft tissue envelope PERFORMANCE CHARACTERISTICS OF THE DEVICE • Fast locking: one set screw locks down both struts • Simple – The TL-HEX provides simplified Hardware and Software for both Deformity and Trauma management • TL-Hex: The intuitive and user friendly web-based TL-Hex software is empowering all surgeons who want a comprehensive support throughout pre/intra/post operative phase 4
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Unique strut head design increases frame stability Versatile - The TrueLok system modular nature allows customizable frame constructs to treat a variety of orthopedic conditions with fewer components Versatile - TrueLok hinges offer self-aligning flexibility during three dimensional frame adjustment Versatile - Lightweight (ring made out of aluminum) Lockable universal hinge on both ends of strut Aluminum rings make the system lighter The TL-HEX Magnification Marker is a device specifically developed to calibrate the magnification of the X-Ray (both in Anterior/Posterior and Medial/Lateral view) The Centering Pin Kit is used to locate the center of the reference support element (either ring or foot plate) that is one of the measurements required in the software Free wire placement at multiple levels and angulations prior to ring connection Aluminum ring: low profile, high stability, thickness: 9mm Lightweight, partially radiolucent aluminum rings Slotted Plates make it easier to connect different External Supports (Rings, Threaded Rods and Foot Plates) The distinctive strut design allows for independent rapid and gradual adjustments resulting in a greater overall adjustment range
SPECIFIC INFORMATION ON THE DEVICE • Specialized instrumentation is required to apply the fixation devices • Additional equipment might be required for the application and removal of the fixation devices, such as wire-cutters, hammers and electric drills • If the TL-HEX strut stud does not fully seat in the TL-HEX ring mounting hole, back out the locking screw to the stop • If choosing 300mm rings, use the 450mm or 550mm kirschner wires • To tension K-wires, the wire tensioner (54-1139) must be used and maintained according to instructions PQWTN • To tension Kirschner wires, the handle of the wire tensioning device should be opened to the fullest extent and the device fully inserted over the wire against the face of the slider unit, ensuring that at least 6cm of wire protrudes from the tensioning device • Additional information about some components of the TrueLok Systems may be available in specific instructions for use documents HYBRID FRAMES a. When a single ring frame is used in conjunction with a fixator (hybrid) the ring should initially always be supported by 2 evenly spaced reinforcement bars, spaced around the ring and attached to the bone screws at the other end of the fixator. If the fracture is stable, so that full load sharing is possible, the bars should be removed as soon as the patient is mobilised and the soft tissue swelling has decreased. If the fracture is unstable, the bars should be retained while the patient is mobilising weightbearing. They should not be removed until the bone is sufficiently consolidated to share the axial load, but they should be removed as part of a dynamisation process before the fixator is removed. b. For optimal stability, three wires (either with or without olive) should be applied. Tension the first two wires simultaneously. If a 5/8 ring is used, when possible complete it to a full ring prior to tensioning any wires. c. Where necessary, a supplementary bone screw should be used to equalise the distance between the fracture and the nearest fixation point on both sides. d. During screw insertion, when using a Universal Half Pin Fixation Bolt (part number 54-11530), care should be taken to avoid the soft tissues becoming attached to the screw, because this component cannot be used with a screw guide. e. Patient is allowed initial toe-touch weight bearing. Progressive weight bearing and physiotherapy should be established, according to the surgeon’s evaluation of the fracture stability and of the information derived from radiological assessment. SOFTWARE INFORMATION The Web-Based TL-HEX, TrueLok Hexapod System, Software aids the surgeon in his/her use of the TL-HEX product and it can be accessed at: www.tlhex.com. Please contact customer support tlhexcustomercare@ orthofix.com to update account information. The TL-HEX is a circular external fixator based on Ilizarov principles. The working segment of this frame consists of a hexapod made up of six variable length struts. The relative strut lengths determine the position of the rings in space. Because the rings are attached to bone segments, their position indirectly determines the position of the bone segments. The SW is able to calculate strut length adjustments for surgeon’s review and approval. This software needs three sets of parameters to perform the calculation (see TL-HEX Software User Guide, available on the TL-HEX website). With these sets of parameters, the computer will be able to calculate appropriate strut adjustments for surgeon’s review and approval. Identifiable information should not be entered into the data fields. The Software allows healthcare professionals to delete their own records. For further information, see TL-HEX Software User Guide and TL-HEX General Principles for the Frame Assembly. Warnings 1. TL-HEX should be used only after careful study of the below reference guides and after careful determination of appropriate parameter values. 2. Refer to the TL-HEX reference guides: TL-HEX General Principles for the Frame Assembly, and TL-HEX Software User Guide for more information related to use of hardware and software. These documents contain a complete description of hardware and software and important information, such as indications for use, contraindications, warnings, and precautions. 3. Improper use of the software could result in erroneous or inadvertent calculations. 4. The software must be used only with TL-HEX. The software is not compatible with devices of other manufacturers. 5. It is important to check that the software diagrams correspond to the deformity that is seen on the patient’s x-rays and/or clinically. 6. The surgeon must carefully review struts length adjustment calculations made by the SW for correctness and make sure print out is readable before giving it to the patient. 7. When using the software, click “Update Views“ after any changes to the parameters.
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Precautions Accurate inputs are critical for accurate results. Verify and double check all input parameters. Intraoperative placement of the TL-HEX Fixator according to preoperative plans is imperative to achieve predetermined results. If intraoperative conditions require a change to frame placement (eccentricity) or size (parameters), new strut lengths will be calculated by entering the new inputs into the program. Small changes may affect accuracy of outcome. The End of Correction Screen is intended to identify if any struts go out of range during the treatment schedule. The Report should be referenced for final strut position (acute and gradual) and strut type. Security Precautions User is advised to clear the browser history (temporary Internet files, cookies, etc.) after logging out of the TL-HEX application. Software Requirements Recommended Browser and Display Settings: The use of the TL-HEX software requires interaction with the surgeon to input radiographic measurements and other parameters, followed by a visual review of the resulting TL-HEX assembly. To ensure the best possible use of the software, check minimum requirements on the Software User’s Guide available at ifu.orthofix.it. RISKS DUE TO THE RE-USE OF “SINGLE USE” DEVICE Implantable Device* The “SINGLE USE” implantable device* of Orthofix is identified through symbol “ ” reported on the product label. After the removal from the patient, the implantable device* has to be discarded. The re-use of implantable device* introduces contamination risks for users and patients. The re-use of implantable device* cannot guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health risks for the patients. (*) Implantable device: any device intended to be totally/partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is considered an implantable device. Non Implantable Device The “SINGLE USE” non implantable device of Orthofix is identified through symbol “ ” reported on the label or indicated in the “Instructions For Use” supplied with the products. The re-use of a “SINGLE USE” non implantable device cannot guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health risks for the patients. STERILE & NON-STERILE PRODUCTS Orthofix devices are provided as STERILE or NON-STERILE and they are labeled as such. In the case of STERILE products, product integrity, sterility and performance are assured only if the packaging is undamaged. Do not use if packaging is compromised, unintentionally opened or if a component is believed to be faulty, suspect or damaged. The products supplied NON-STERILE require cleaning, disinfection and sterilization prior to use according to procedures reported in the following instructions. INSTRUCTIONS FOR PROCESSING AND REPROCESSING These reprocessing instructions have been written in accordance with ISO17664 and have been validated by Orthofix in compliance with international standards. It is the responsibility of the health care facility to ensure that the reprocessing is performed in accordance with instructions provided. Warnings • Devices labeled “FOR SINGLE USE ONLY” can be reprocessed multiple times before their first clinical use but must not be reprocessed for re-use. • Single use devices MUST NOT BE REUSED, as they are not designed to perform as intended after the first usage. Changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or material leading to diminished safety, performance and/or compliance with relevant specifications. Please refer to the device label to identify single or multiple use and/or cleaning and re-sterilization release. • The personnel that works with contaminated medical devices must follow safety precautions as per the procedure of the healthcare facility. • Aluminum based devices are damaged by alkaline (pH>7) detergents and solutions. Refer to PQALU for the list of Orthofix aluminum based devices. • Cleaning and disinfection solutions with a pH 7-10.5 are recommended. Cleaning and disinfection solutions with a higher pH should be used according to the material compatibility requirements stated on the detergent technical data sheet. • Detergents and disinfectants with fluoride, chloride, bromide, iodide or hydroxyl ions MUST NOT be used. • The contact with saline solutions should be minimized. • Complex devices such as those with hinges, lumens or mated surfaces must be thoroughly manually pre-cleaned before automated washing in order to remove soiling that accumulates in recesses. • If a device needs particular care in pre-cleaning, a product specific IFU is available in Orthofix website, that is accessible using the data matrix reported on the product labelling. • DO NOT use metal brushes or steel wool. Limitations on reprocessing • Repeated reprocessing has minimal effect on reusable fixators and instruments. • End of life is normally determined by wear and damage due to use. • Products labeled for Single Use only MUST NOT be reused regardless any reprocessing in a clinical setting. POINT OF USE It is recommended to reprocess the reusable medical devices as soon as is reasonably practicable in order to minimize the drying of soil and residuals. For optimal results, instruments should be cleaned within 30 minutes of use. DO NOT use a fixating detergent or hot water because this can cause the fixation of residue. CONTAINMENT AND TRANSPORTATION It is recommended to cover contaminated instruments during transportation in order to minimize the risk of cross contamination. All used surgical instruments must be regarded as contaminated. Follow the hospital protocols for handling contaminated and bio-hazardous materials. Handling, collection and transportation of used instruments must be strictly controlled to minimize any possible risks to patient, personnel and any area of the healthcare facility. 6
PREPARATION FOR CLEANING This procedure can be omitted in case of direct subsequent manual cleaning and disinfection. In case of highly contaminated reusable medical device before starting an automatic cleaning process, a pre-cleaning and a manual cleaning (described in the following paragraph) are recommended. Manual Pre-cleaning 1. Wear protective equipment following safety precautions to comply with the procedure of the healthcare facility. 2. Ensure that the cleaning receptacle is clean and dry, no visible foreign material can be present. 3. Fill the receptacle with sufficient cleaning solution. Orthofix recommends the use of a slightly alkaline enzymatic detergent solution based on a detergent containing <5% anionic surfactants and enzymes prepared using deionized water. 4. Carefully immerse the component in the solution in order to displace trapped air. 5. Scrub the device in the cleaning solution with a soft brush until all visible soiling is removed. Use a soft brush to remove residuals from lumens, rough or complex surfaces using a twisting motion. 6. Rinse cannulations with cleaning solution using a syringe. Never use metal brushes or steel wool. 7. Remove the device from the cleaning solution. 8. Brush the single components in running tap water. 9. Clean the single components using an ultrasonic device in a degassed cleaning solution. 10. Rinse the components in purified sterile water until all traces of cleaning solution are removed. Use a syringe in case of lumens or cannulations. 11. Remove item from rinse water and drain. 12. Carefully hand-dry using a clean, lint free cloth. CLEANING General considerations In these instructions Orthofix provides two methods of cleaning: a manual method and an automated method. Wherever applicable, the cleaning phase should start immediately after the pre-cleaning phase to avoid soil drying. The automated cleaning process is more reproducible and therefore more reliable, and the staff is less exposed to the contaminated devices andto cleaning agents used. Staff shall follow the safety precautions to comply with the procedure of the healthcare facility using protective equipment. In particular, staff should take note of the instructions provided by the cleaning agent manufacturer for correct handling and use of the product. Observe all instructions provided by the detergent’s manufacturer regarding the immersion time of the device in the cleaning agent/disinfectant and its concentration. The quality of the water used for diluting cleaning agents and for rinsing medical devices should be carefully considered. Manual cleaning 1. Wear protective equipment following safety precautions to comply with the procedure of the healthcare facility. 2. Ensure that the cleaning receptacle is clean and dry, no visible foreign material can be present. 3. Fill the receptacle with sufficient cleaning solution. Orthofix recommends the use of a slightly alkaline enzymatic cleaning solution. 4. Carefully immerse the component in the solution in order to displace trapped air; it is important to ensure that the cleaning solution reached all surfaces, including holes or cannulations. 5. Thoroughly scrub the device in the cleaning solution with a soft brush until all visible soiling is removed. Use a soft bristeled nylon brush to remove residuals from lumens, rough or complex surfaces using a twisting motion. 6. Rinse cannulations at least three times with cleaning solution using a syringe. Never use metal brushes or steel wool. 7. Remove the device from the cleaning solution. 8. Brush the single components in running tap water. 9. Put single components in ultrasonic device with degassed cleaning solution. Orthofix recommends the use of a detergent solution based on a detergent containing <5% anionic surfactants, non-ionic surfactants and enzymes, prepared using deionized water. Orthofix recommends on the basis of the validation performed to use an ultrasound frequency of 35kHz, power 300Weff, time 15 minutes. The use of other solutions and parameters shall be validated by the used and the concentration shall be in compliance with the detergent’s manufacturer technical datasheet. 10. Rinse the components in purified sterile water until all traces of cleaning solution are removed. 11. Rinse the cannulations, rough or complex surfaces at least three times with purified sterile water. When cannulations are present it is possible to use a syringe to facilitate this step. 12. Remove item from rinse water and drain. 13. If, after completion of the cleaning steps, some encrusted soil remained on the device and had to be removed with the brush, the cleaning step must be repeated as described above. 14. Carefully hand-dry using a clean, lint-free cloth. Manual disinfection 1. Ensure that the cleaning receptacle is clean and dry, no visible foreign material can to be present. 2. Fill the receptacle with sufficient disinfectant solution. Orthofix recommends the use of a 6% hydrogen peroxide solution for 30 minutes prepared using water for injection. 3. Carefully immerse the component in the solution in order to displace trapped air; it is important to ensure that the disinfectant solution reached all surfaces, including holes or cannulations. 4. Rinse cannulations, rough or complex surfaces at least three time with disinfectant solution. Use a syringe filled with disinfectant solution to rinse cannulations. 5. Remove the items from the solution and drain. 6. Soak in water for injection (WFI) to remove traces of disinfectant solution. 7. Rinse the cannulations at least three times with a syringe (filled with WFI). 8. Remove item from rinse water and drain. 9. Repeat the rinsing procedure as described above. 10. Carefully hand-dry using a clean, lint-free cloth. 11. Visually inspect and repeat manual cleaning and disinfection if necessary.
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Automatic cleaning and disinfection using washer-disinfector 1. Perform a pre-cleaning if necessary due to the contamination of the device. Take special care when the items to be cleaned contain or have: a. Cannulations b. Long blind holes c. Mating surfaces d. Threaded components e. Rough surfaces 2. Use a Washer-disinfector in compliance with EN ISO 15883 that is properly installed, qualified and regularly subjected to maintenance and testing. 3. Ensure that the cleaning receptacle is clean and dry, no visible foreign material can be present. 4. Ensure that the washer-disinfector and all services are operational. 5. Load the medical devices into the washer-disinfector. Place heavier devices in the bottom of the baskets. Products must be disassembled before placing them in the baskets according to the specific instructions provided by Orthofix. Wherever possible, all parts of disassembled devices should be kept together in one container. 6. Connect cannulations to the rinsing ports of the washer-disinfector. If no direct connection is possible, locate the cannulations directly on injector jets or in injector sleeves of the injector basket. Orient instruments into the automated washer’s carriers as recommended by the washer manufacturer. 7. Avoid contact between devices because movement during washing could cause damageto devices and the washing action could be compromised. 8. Arrange medical devices in order to locate the cannulations in vertical position and blind holes incline downwards to promote the leakage of any material. 9. Use approved thermal disinfection program. When using alkaline solutions, a neutralizer must be added. Orthofix recommends that cycle steps are at least as follows: a. Pre-cleaning for 4 min. b. Cleaning with the appropriate solution. Orthofix recommends the use of the detergent solution based on a detergent containing <5% anionic surfactants, non-ionic surfactants and enzymes, prepared using deionazied water for 10 min at 55°C. c. Neutralization with basic neutralizing agent solution. Orthofix recommends the use of a detergent solution based on citric acid, concentration 0,1% for 6 min. d. Final rinsing with deionised water for 3 min. e. Thermal disinfection at least 90°C or 194°F (max 95°C or 203°F) for 5 minutes or until A0=30000 is reached, The water used for thermal disinfection must be purified. f. Drying at 110°C for 40 minutes. When the instrument has a cannulation, an injector should be used to dry the internal part. The suitability of other solutions, concentration, time and temperature shall be checked and validated by the user following the detergent’s manufacturer technical datasheet. 10. Select and start a cycle according to the recommendations of the washer manufacturer. 11. On completion on the cycle, ensure that all stages and parameters have been achieved. 12. Wearing protective equipment unload the washer disinfector when it complete the cycle. 13. If necessary, drain off excess water and dry by using clean, linf.free cloth. 14. Visually inspect each device for remaining soil and dryness. If soil remains repeat the cleaning process as described above. MAINTENANCE, INSPECTION AND FUNCTION TESTING The following guidelines shall be applied to all Orthofix instruments that are labeled for multiple use. All functional checks and inspections described below also cover the interfaces with other instruments or components. The failure modes below may be caused by end of life of the product, improper use or improper maintenance. Orthofix does not typically specify the maximum number of uses for re-useable medical devices. The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses. Careful inspection and functional test of the device before use is the best method of determining the end of the serviceable life for the medical device. For sterile devices the end of life has been defined, verified and specified with an expiration date. The following general instructions apply to all Orthofix products: • All instruments and product components must be visually inspected under good light for cleanliness. If some areas are not clearly visible, use a 3% hydrogen peroxide solution to detect the presence of organic residuals. If blood is present, bubbling will be observed. After the inspection, the device shall be rinsed and drained as the instruction given above. • If visual inspection evidences that the device was not properly cleaned, repeat the cleaning and disinfection steps or discard the device. • All instruments and product components must be visually inspected for any signs of deterioration that may cause failure during use (such as cracks or damage to surfaces) and functions tested before being sterilized. If a component or instrument is believed to be faulty, damaged or suspect, it must NOT BE USED. • Products that show excessive fadind of marked product code, UDI and lot, thus preventing clear identification and traceability, must NOT BE USED. • Cutting instruments must be checked for sharpness. • When instruments form part of an assembly, check assembly with matching components. • Lubricate hinges and moving parts with an oil that does not interfere with steam sterilization as per manufacturer’s instructions before sterilization. Do not use silicone based lubricant or mineral oil. Orthofix recommends the use of a highly purified white oil composed by paraffinum liquidum of food and pharmaceutical grade. As a general preventive action Orthofix recommends following the instructions in the operative technique to avoid damages related to incorrect use. Specific instructions may be available for some product codes. These instructions are linked to the product code and are available in a dedicated Orthofix website. Moreover, it is important to follow the cleaning procedure suggested by Orthofix to avoid damages related to incorrect handling. PACKAGING In order to prevent contamination after sterilization Orthofix recommends using one of the following packaging systems: a. Wrap in compliance with EN ISO 11607, suitable for steam sterilization, and appropriate to protect the instruments or trays contained to mechanical damage. Orthofix recommends the use of a double wrap constituted of tri laminate non woven fabrics made of spunbond polypropylene and melt blown polypropylene (SMS).The wrap shall be resistant enough to contain devices up to 10kg. In the USA, a FDA cleared sterilization wrap must be used and compliance with ANSI/AAMI ST79 is mandatory In Europe, a sterilization wrap in compliance with EN 868-2 may be used. Fold the wrap to create a sterile barrier system according to a process validated as per ISO 11607-2. b. Rigid sterilization containers (such as Aesculap JK series rigid sterilization containers). In Europe, a container in compliance with EN 868-8 may be used. Do not include additional systems or instruments in the same sterilization container. Every other sterile barrier packaging not validated by Orthofix must be validated by the individual healthcare facility according to instruction from the manufacturer. When equipment and processes differ from those validated by Orthofix the health care facility should verify that sterility can be achived using parameters validated by Orthofix. Do not include additional systems or instruments in the sterilization tray. Note that sterility cannot be guaranteed if the sterilization tray is overloaded. The total weight of a wrapped instrument tray should not exceed 10kg. 8
STERILIZATION Steam sterilization according to EN ISO 17665 and ANSI/AMMI ST79 is recommended. Gas plasma, dry heat and EtO sterilization MUST BE avoided as they are not validated for Orthofix products. Use a validated, properly maintained and calibrated steam sterilizer. The steam quality must be appropriate for the process to be effective. Do not exceed 140°C (284°F). Do not stack trays during sterilization. Sterilize by steam autoclaving, utilizing a fractioned pre-vacuum cycle or gravity cycle according to the table below: Steam sterilizer type
Gravity
Pre-vacuum
Pre-vacuum
Pre-vacuum
Notes Minimum exposure Temperature Minimum exposure Time Drying Time Number of pulses
Not for use in EU 132°C (270°F) 15 minutes 30 minutes N/A
132°C (270°F) 4 minutes 30 minutes 4
Not for use in US 134°C (273°F) 3 minutes 30 minutes 4
WHO guidelines 134°C (273°F) 18 minutes 30 minutes 4
Orthofix recommends always to use a pre-vacuum cycle for steam sterilization. The Gravity cycle was validated but it is suggested only when no other options are available. The Gravity cycle was not validated for sterilization in rigid containers but only in wraps. CLEANING AGENT INFORMATION Orthofix used the following cleaning agents during validation of these processing recommendations. These cleaning agents are not listed in preference to other available cleaning agents which may perform satisfactorily: • For manual precleaning: Neodisher Medizym concentration 2% • For manual cleaning: Neodisher Mediclean concentration 2% • For automated cleaning: Neodisher Mediclean concentration 0,5% STORAGE Store the sterilized instrument in the sterilization packaging in a dry and clean environment at room temperature. DISCLAIMER The instructions provided above have been validated by Orthofix srl as being a true description for (1) processing a single-use device and a multiple use device for its first clinical use and (2) processing a multiple use device for its re-use. It remains the responsibility of the reprocessing officer to ensure that the reprocessing, as actually performed using equipment, materials and personnel in the reprocessing facility, achieves the desired result. This normally requires validation and routine monitoring of the process. The cleaning, disinfection and sterilization processes must be adequately recorded. Any deviation by the reprocessing officer from the instructions provided must be properly evaluated for effectiveness and potential adverse consequences, and must also be appropriately recorded. ADDITIONAL INFORMATION INFORMATION FOR THE PATIENT The HCP shall inform the patient that the medical device does not replicate a normal healthy bone and counsel him/her about the correct behavior after implantation. The patient must pay attention to premature weight bearing, load carrying and excessive activity levels. The HCP shall inform the patient about any known or possible restrictions regarding the exposure to reasonably foreseeable external influences or environmental condition and in undergoing specific diagnostic investigations, evaluation or therapeutic treatment after implantation. The HCP shall inform the patient about the need for periodic medical follow-up and of the removal of the medical device in the future. The HCP shall warn the patient about the surgical and residual risks and make him/her aware of possible adverse events. A successful result is not achieved in every surgical case. Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical reintervention to remove or replace the medical device. The HCP shall instruct the patient to report any unusual changes to the operative site or in device performance to his/her physician. The HCP shall instruct the patient to: • Make the adjustments or get help in making the adjustments as needed • Identify on the prescription when to return for a strut change and for follow-up visits • Check periodically that the strut reference lengths are according to the prescription • Report if adjustment schedule cannot be met • Report any adverse or unexpected effects (strut breakage or disengagement, components damage, clip dislodgement, lost prescription) NOTICE ABOUT SERIOUS INCIDENTS Report any serious incident involving a device to Orthofix Srl and the appropriate governing body in which the user and/or patient is established. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. MANUFACTURER CONTACT Please contact your local Orthofix sales representative for further details and ordering. Symbols presented below may apply or not to a specific product: refer to its label for applicability.
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Description
Symbol
Medical Device Consult instructions for use or consult electronic instructions for use
Caution: Consult instructions for use for important cautionary information
Single Use. Do not re-use
Orthofix note: discard appropriately after the use (treatment) on patient Sterile. Sterilised by irradiaton Non-sterile Double sterile barrier system
Catalogue number
Batch code Use-by date (year-month-day)
0123
CE marking in conformity to applicable European Medical Device Directives/Regulations Date of manufacture
Manufacture
Do not use if package is damaged and consult instructions for use Caution: Federal law (USA) restricts this device to sale by or on the order of a physician
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