Orthofix Ltd
ORTHOFIX INTERNAL FIXATION SYSTEM Instructions for Use
173 Pages

Preview
Page 1
PQINF I 02/22 (0424727)
EN Instructions For Use are subject to change; the most current version of each Instruction For Use is always available online
0123
Important information - please read prior to use See also instruction leaflet PQRMD for reusable medical devices
ORTHOFIX® INTERNAL FIXATION SYSTEM RX ONLY
Orthofix Srl Via delle Nazioni 9 - 37012 Bussolengo (VR) Italy Tel. 0039 (0) 45 6719000 - Fax 0039 (0) 45 6719380
DESCRIPTION & INDICATIONS FOR USE The Orthofix Internal Fixation Systems consist of Intramedullary Nailing Implants for femur and tibia, and Fragment Fixation System Implants. These implants are intended as a means of bone stabilization in the management of fractures and in reconstructive surgery. They are not intended to replace normal healthy bone or to withstand the stresses of full weightbearing, particularly in unstable fractures or in the presence of non union, delayed union or incomplete healing. The use of external supports (e.g. walking aids) is recommended as a part of the treatment. Intramedullary Nailing Implants are indicated in: 1. Traumatic fractures of the diaphysis provided that the epiphyses are closed, so that two locking screws can be inserted outside the fracture both proximally and distally. 2. Pathological fractures. 3. Re-fractures. 4. Non-unions. 5. Reconstructive surgery. For 2, 3, 4 and 5 above, the limitations are the same as in item 1. Fragment Fixation System Implants are indicated in: 1. Fractures 2. Bony ligament avulsions 3. Osteotomies All Orthofix implants are intended for professional use only. Surgeons who supervise the use of Orthofix implants must have full awareness of orthopaedic fixation procedures as well as adequate understanding of the philosophy of the Orthofix System. To promote the proper use of its fixation system, and establish an effective promotional and training tool, Orthofix has developed several manuals of the relevant information (i. e. general philosophy, surgical application, etc.), called “Operative Techniques”. These manuals are available as a complimentary service for surgeons who have adopted the Orthofix system. If you wish to receive a personal copy of one or more of these manuals, which are available in several languages, please contact Orthofix or its local authorized representative, with a description of the medical device to be used. CONTRAINDICATIONS The Orthofix Internal Fixation System is not designed or sold for any use except as indicated. Use of the Intramedullary Nailing Implants is contraindicated in the following situations: 1. Active infection. 2. General medical conditions including: impaired blood supply, pulmonary insufficiency (i.e. ARDS, fat embolism) or latent infection. 3. Patients with psychological or neurological conditions, who are unwilling or incapable of following instructions for post-operative care. 4. Foreign body sensitivity. Where material sensitivity is suspected, tests should be made prior to implantation. Use of the Fragment Fixation System is contraindicated in the following situation: Foreign body sensitivity. Where material sensitivity is suspected, tests should be made prior to implantation. The presence of active infection. WARNINGS & PRECAUTIONS 1 Correct selection of the implant model and size is extremely important. 2 The Orthofix Tibial Nailing System: tibial nails are either solid (8mm and 9mm diameter) or cannulated (10 mm, 11mm, 12mm and 13mm diameter). Smaller diameter nails are inserted without or with minimal reaming. Unreamed nails are strong enough to support a stable tibial fracture in most cases, and should cause less damage to the bone vasculature. An unreamed nail is therefore recommended for all fractures where the external blood supply of the tibia has been disturbed. These include most open fractures, and closed fractures with soft tissue damage of Tscherne types CII and CIII. The usual diameter for an unreamed nail is 9mm, but an 8mm nail may be needed for smaller diameter bones. Sizes above 9mm will nearly always require some reaming. The position and stability of the fracture is also relevant: an unstable or severely comminuted fracture, or a fracture in the metaphyseal area, may need a larger nail for adequate stabilization, and would therefore need to be inserted after reaming. Reaming and nail insertion should not be performed in the presence of an inflated tourniquet, since this may lead to bone or muscle necrosis, and/or compartment syndrome. 3 Calcaneo-Tibial Nails: in particular selected cases a retrograde nail may be inserted through the heel and across the ankle joint into the distal tibia, for the purpose of arthrodesing the ankle joint. As with the antegrade nail, adequate reaming should be performed for the diameter of nail chosen, the correct locking screws should be inserted, and the operative technique followed carefully. Adequate countersinking of the locking screw heads should be performed to prevent skin irritation. The nail should be dynamised at the correct time to encourage final union. 2
4
5
6 7 8 9 10 11 12 13 14 15
16
17 18 19
20
21 22 23 24 25 26 27
The Orthofix Femoral Nailing System: to reduce the driving force on the nail and the potential risk of nail damage or fracture comminution, reaming to a width 2 mm greater than the diameter of the proposed nail is recommended. In young patients it is advisable to widen the proximal 10 cm of the femur only by a further 1-2 mm to accommodate the larger proximal 90 mm of the nail. Thus, for a 12/10 mm nail, the proximal 10 cm should be reamed to 13 mm. This is not usually necessary in older patients with softer bone. The distal locking screws of the nail should not be inserted close to the fracture line, as effective screw fixation may be compromised, causing implant failure or loss of fixation. i. After reaming, but prior to nail implantation, the relevant internal nail template should be used. This enables the surgeon to check the amount of reaming to permit nail insertion without hammering; assess nail length accurately, and identify correct positions for the distal locking screws. ii. In very heavy or uncooperative patients, the 13/11 mm or 13/12 mm nail should be used if adequate reaming can be achieved. Again, a stronger nail may be needed if there is severe comminution of the fracture, with little or no bony integrity. The Retrograde Femoral Nailing System: this system has been developed for the established indication of inserting a femoral nail from the distal end of the bone, for the fixation of fractures or in selected reconstruction procedures. With the exception of the entry point, the same proviso’s are indicated as for the antegrade femoral nailing system. Careful reading of the operative technique is essential prior to carrying our any procedure. It is essential that the distal end of the nail is recessed beneath the bone surface, to avoid subsequent damage to the knee joint. The use of a retrograde nailing system in the femur is not recommended in open fractures, or if there is an open wound in the knee. The inevitable risk of infection is around 5%, and this may lead to a septic arthritis of the knee. Alternative methods of treating the fracture should be considered. When using compression locking screws with a retrograde femoral nail to treat intracondylar fractures, particular care should be taken to achieve and maintain the reduction before nail insertion, and to choose the correct locking screw length. The screw should then be locked with a compression nut, taking care not to overtighten. When indicated where the soft tissues are thin, the heads of nail locking screws should be recessed with the appropriate tool to prevent skin irritation. For both Femoral and Tibial nails, a mechanical targeting system is provided as part of the instrumentation. It is very important that the anterior hole for the stabilising rod is drilled in the centre of the bone, over the nail. If any doubt exists about this, the position should be checked with X-rays before drilling the hole. No guarantee is given that this system will work every time. In very distal fractures, it is important to ensure that the more proximal of the two or three distal locking screws is at least 1 cm distal to the fracture line. It is also important that the proximal locking screws are not inserted close to the fracture line, as effective screw fixation may be compromised, causing implant or fixation failure. Fracture distraction for any time should be avoided during the operation, and fractures should never be locked in distraction, since this may cause delayed union and/or compartment syndrome. Correct handling of the instrumentation and implant is extremely important. Surgical theatre staff should avoid any notching or scratching of the implants, as these factors may produce internal stresses which may become a focus for possible implant breakage. If any of the aluminium instruments (the black parts) are hammered, they will be damaged and must be replaced. Hammering of the nails may only be performed through the locking rods, which are made of hardened steel, or with specifically designed insertion tools. Bending of the Fragment Fixation System implant during insertion must be avoided, since this may lead to breakage of the implant. When the chamfer is close to the cortex, the speed of insertion must be reduced. Wherever a Kirschner wire or Guide Wire is used to guide a cannulated reamer, drill bit or screw into position, the following precautions should be taken: A) The Kirschner or Guide Wire should always be NEW and should NEVER be reused B) The wire should be checked before insertion to exclude any scratches or bends in the wire; if any are found it should be discarded. C) During the introduction of any instrument or implant over a wire, the surgeon should screen the wire tip as continuously as possible to exclude inadvertently driving the wire further than intended. D) During each pass of the instrument or implant, the surgeon should check that there is no bony or other debris built up on the wire or inside the instrument or implant which might cause it to bind on the wire and push it forward. It is impossible to clean the inside of a cannulated drill bit adequately to exclude organic or other debris remaining after use. CANNULATED DRILL BITS SHOULD THEREFORE NEVER BE REUSED. THEY ARE SINGLE PATIENT USE ONLY. If they are to be used for a second time on the same patient, the surgeon must check that the drill bit is free from obstruction, by removing it from the power unit and passing a wire through it. Even when they are new, we recommend that a wire is passed down a cannulated drill bit prior to use, to check that the lumen is free from obstruction. Any fixation device may break if subjected to the increased loading caused by delayed or non-union. Careful monitoring of the progress of healing must be undertaken in all patients. If callus is slow to develop, other measures may be required to promote its formation, such as dynamisation of the implant, a bone graft, or exchanging the implant for a larger one. It is also important to avoid continued stabilization with a locked small diameter nail of a fracture with delayed union, after 12 weeks in the tibia or 16 weeks in the femur, because of the risk of fatigue failure of the implant. If no callus is visible on X-ray at this time, a second intervention should be considered. Advice on weightbearing after insertion of a retrograde femoral nail. A) In intra-articular fractures, there should be complete non weightbearing for the first six weeks. B) General advice: partial weightbearing (15 kg) after wound healing, increasing slowly up to full weightbearing when there is radiological evidence of callus formation. C) In unstable fractures, toe touching initially, increasing to a maximum of 30 kg, progressing to full weightbearing only when there is radiological evidence of callus formation. D) With 10 mm nails, partial (15 Kg) up to maximum of 50% body weight, increasing to full weightbearing only when there is radiological evidence of bridging callus formation. E) If possible avoid the situation of an unstable fracture fixed with a 10 mm diameter nail. Where this cannot be avoided, the surgeon should take particular care to ensure that the above recommendations for weightbearing are carried out. Implants, nail end caps, locking screws and Fragment Fixation System implants must never be reused. Patients should be instructed to report any adverse or unanticipated effects to the treating surgeon. Nuclear Magnetic Resonance imaging should not be used in any segment to which an implant is applied. Removal of the device: the surgeon should make the final decision whether an implant can be removed. Implant removal should be followed by adequate post-operative management to avoid refracture. If the patient is older with a low activity level, the surgeon may decide not to remove the implant, thus eliminating the risks involved in a second surgical procedure. To lock the extractor on to the Fragment Fixation System implant, the knob should be turned counter-clockwise. 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. Additional equipment may be required for fixation application and removal such as soft tissue retractors, flexible reaming set, cannulated drills, etc.
POSSIBLE ADVERSE EFFECTS 1. Non-union or delayed union, which may lead to implant breakage. 2. Metal sensitivity, or allergic reaction to a foreign body. 3. Pain, discomfort, or abnormal sensations due to the presence of the device. 4. Nerve damage due to surgical trauma. 5. Bone necrosis. 3
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. Important 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 which require surgical reintervention to remove or replace the internal fixation device. Preoperative and operative procedures including knowledge of surgical techniques and proper selection and placement of the internal fixation devices are important considerations in the successful utilization of Orthofix internal fixation devices by the surgeon. Proper patient selection and the patient’s ability to comply with physician instructions and follow 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. If a surgical candidate exhibits any contraindication or is predisposed to any contraindication, DO NOT USE Orthofix Internal Fixation implants. Materials The Orthofix Internal Fixation System is comprised of stainless steel and aluminium alloy components. Those components which come into contact with patients are made of surgical grade stainless steel. STERILE & NON-STERILE Product Orthofix provides certain internal fixation devices STERILE while others are provided NON-STERILE. Please review the product label to determine the sterility of each device. Sterile Devices or kits provided STERILE are labelled as follows: Contents of package are STERILE unless package is opened or damaged. Do not use if package is opened or damaged. Non-Sterile Unless otherwise noted, Orthofix internal fixation components are provided NON-STERILE. Orthofix recommends that all NON-STERILE components be properly cleaned and sterilized following the recommended cleaning and sterilization procedures. Product integrity and performance are assured only if the packaging is undamaged. 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 healthcare 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 in a clinical setting. • 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 requirements. • The personnel that works with contaminated medical devices must follow safety precautions as per the procedure of the healthcare facility. • 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. • 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 to remove soiling that accumulates in recesses.If a device needs particular care in pre-cleaning, a product specific IFU is available on the Orthofix website, which 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 devices for which reprocessing is allowed. • End of life is normally determined by wear and damage due to use. • Products labeled for Single Use only MUST NOT be reused regardless of any reprocessing in a clinical setting. POINT OF USE Reprocess the reusable medical devices as soon as is reasonably practicable 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 these can cause the fixation of residue. CONTAINMENT AND TRANSPORTATION Cover contaminated instruments during transportation 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. PREPARATION FOR CLEANING This procedure can be omitted in case of direct subsequent manual cleaning and disinfection. In the case of a highly contaminated reusable medical device, before starting an automatic cleaning process, a pre-cleaning and a manual cleaning (described below) are recommended. Manual Pre-cleaning 1. Wear protective equipment in compliance with the safety precautions and procedures of the healthcare facility. 2. Ensure that the cleaning receptacle is clean and dry; no visible foreign material can be present. 4
3.
Fill the receptacle with sufficient detergent 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 to displace trapped air. 5. Scrub the device in the cleaning solution with a soft bristle nylon brush until all visible soiling is removed. Use a soft bristle nylon brush to remove residuals from lumens, with a twisting motion on rough or complex surfaces. 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 absorbent not shedding cloth. CLEANING General considerations 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 and to the cleaning agents used. Staff shall comply with the safety precautions and procedures of the healthcare facility regarding the use of 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 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 in compliance with the safety precautions and procedures 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 to displace trapped air; ensure that the cleaning solution reached all surfaces, including holes or cannulations. 5. Thoroughly scrub the device in the cleaning solution with a soft bristle nylon brush until all visible soiling is removed. Use a soft bristle nylon brush to remove residuals from lumens, with a twisting motion on rough or complex surfaces. 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 an ultrasonic device with degassed cleaning solution at 2% for 10 minutes. 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 using an ultrasound frequency of 35kHz, power = 300 Weff, time 15 minutes. The use of other solutions and parameters shall be validated by the user and the concentration shall be in compliance with the detergent manufacturer’s 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 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, the cleaning steps must be repeated as described above. 14. Carefully hand-dry using absorbent not shedding cloth. Manual disinfection 1. Ensure that the cleaning receptacle is clean and dry; no visible foreign material can 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 to displace trapped air; ensure that the disinfectant solution reached all surfaces, including holes or cannulations. 4. Rinse cannulations, rough or complex surfaces at least three times 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 absorbent not shedding cloth. 11. Visually inspect and repeat manual cleaning and disinfection if necessary. 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. 5
4. 5. 6. 7. 8. 9.
10. 11. 12. 13. 14.
Ensure that the washer-disinfector and all services are operational. 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. 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. Avoid contact between devices because movement during washing could cause damage to devices and the washing action could be compromised. Arrange medical devices to locate the cannulations in a vertical position and so blind holes incline downwards to promote the leakage of any material. 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 minutes; b. Cleaning with the appropriate 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 for 10 minutes 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 minutes; d. Final rinsing with deionized water for 3 minutes; e. Thermal disinfection at least 90°C or 194° F (max 95 °C or 203° F) for 5 minutes or until A0=3000 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 manufacturer’s technical datasheet. Select and start a cycle according to the recommendations of the washer manufacturer. On completion of the cycle, ensure that all stages and parameters have been achieved. Wearing protective equipment unload the washer disinfector when it completes the cycle. If necessary, drain excessive water and dry by using absorbent not shedding cloth. 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-usable 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 testing of the device before use are the best methods 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 per 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 fading 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 on 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 from 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 instructions from the manufacturer. When equipment and processes differ from those validated by Orthofix the healthcare facility should verify that sterility can be achieved 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. 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: 6
Steam sterilizer type
Gravity
Pre-vacuum
Pre-vacuum
Pre-vacuum
Notes
Not for use in EU
-
Not for use in US
WHO guidelines
Minimum exposure Temperature
132° C (270° F)
132° C (270° F)
134° C (273° F)
134° C (273° F)
Minimum exposure Time
15 minutes
4 minutes
3 minutes
18 minutes
Drying Time
30 minutes
30 minutes
30 minutes
30 minutes
Number of pulses
N/A
4
4
4
Orthofix recommends always using a pre-vacuum cycle for steam sterilization. The Gravity cycle was validated for wraps only, and it is suggested only when no other options are available. The Gravity cycle was not validated for sterilization in rigid containers. 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. 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 that 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% Orthofix is only responsible for safety and effectiveness for the initial patient use of the internal fixation devices. The institution or practitioner bears full responsibility for any subsequent uses of the devices. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. 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* must be disposed of properly. The re-use of implantable device* introduces contamination risks for users and patients. The re-use of implantable device* can not guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health risks for the patients. (*): Implantable device Any device which is intended: 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 also considered an implantable device. NON IMPLANTABLE DEVICE The “SINGLE USE” non implantable device of Orthofix is identified through symbol reported on the label or are indicated in the “Instructions For Use” supplied with the products. The re-use of “SINGLE USE” non implantable device can not guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health risks for the patients. All Orthofix internal and external fixation products should be used together with their corresponding Orthofix implants, components and accessories. Their application should be performed with the specific Orthofix instrumentation, following carefully the surgical technique recommended by the manufacturer in the appropriate Operative Technique Manual.
7
Symbol
Description 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
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
8