Orthofix Ltd

PSO Set Instrumentation Instructions

27 Pages

English ORTHOFIX PSO SET INSTRUMENTATION INSTRUCTIONS Manufactured by INSTRUMED INTERNATIONAL – Distributed by ORTHOFIX DESCRIPTION / MATERIAL COMPOSITION Surgical instruments within the PSO Set are manual medical tools designed solely for use in surgical procedures outlined by the Orthofix PSO Set Surgical Technique. Instruments are made from different materials including stainless steels and medical grade silicone that comply with the standards applicable to them. These materials are not implantable. PSO Set instruments do not contain any Latex components. USE Instruments contained within the PSO Set must be used in the manner prescribed in the Orthofix PSO Set Surgical Technique provided by Orthofix. Prior to using the instruments, the surgeon shall give full consideration to all aspects of the surgical intervention as well as to the limits of the instrumentation. Recommendations for use are provided in the Orthofix PSO Set Surgical Technique provided by Orthofix. POTENTIAL ADVERSE EFFECTS Incorrect maintenance, cleaning, or handling may render the instruments unsuitable for their intended use, cause corrosion, dismantling, distortion and/or breakage or cause injury to the patient or operating staff. As a result of the mechanical features required, the instruments contained in the PSO Set are made from NON-IMPLANTABLE materials. In the event an instrument breaks, no fragment must remain in the patient as this could cause post-operative complications and require further intervention. Below is a list, albeit not exhaustive, of potential complications:  Neurological lesion, paralysis, pain, lesion of the soft tissues, the visceral organs or the joints, in the event of incorrect use or breakage of the instruments.  Infection, if the instruments are not properly cleaned and sterilized.  Dural leaks, compression of vessels, damage to nerves or nearby organs as a result of slippage or poor positioning of a faulty instrument.  Damage caused by the involuntary releasing of the springs of certain instruments.  Damage caused by the instruments used to bend or cut in-situ due to excessive forces occurring when they are used.  Cutting the gloves or the skin of surgical staff.  Tissue lesions on the patient or surgical staff and/or an increase in operating time as a result of having to dissemble the instruments during surgery.  Crack, fracture or involuntary perforation of the bone.  PRE-OPERATIVE PRECAUTIONS Anyone using the PSO Set can obtain a Surgical Technique by requesting one from an Orthofix representative or distributor. Those using brochures published more than two years before the surgical intervention are advised to request an updated version from Orthofix directly. Do not use any instrument in a manner that it was not designed or intended for as described in the accompanying Surgical Technique. Misuse of instruments could have an adverse effect on the patient or staff. The devices may only be used by doctors who are fully familiar with the surgical technique required. The doctor operating must take care not to use the instruments to exert inappropriate stress on the spine or the implants and must scrupulously comply with any operating procedure described in the surgical technique provided by the implant manufacturer. For example, the forces exerted when repositioning an instrument in-situ must not be excessive as this is likely to causes injury to the patient. To reduce the risks of breakage, care must be taken not to distort the implants or nick, hit or score them with the instruments. Extreme care must be taken when the instruments are used near vital organs, nerves or vessels. Unless otherwise specified on the label, the instruments can be reused after decontamination, cleaning and sterilization. Any electrosurgical devices have the potential for providing an ignition source. Do not use in the presence of flammable substances. Ensure that any product intended for reuse is properly cleaned and sterilized to avoid any detrimental effects to the patient or staff. Orthofix P/N: AW-42-9901 Nemcomed Form: ME-0369 Rev 3 Revised 08/28/2014 WSG  1
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File Name: Orthofix Ltd - RD0068-0369 - PSO Set Instrumentation Instructions - 2020-01 - Rev A.pdf

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