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Stryker Spine Instrumentation Instructions

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English  EN NOLI135N12 REV 07 09/2022  STRYKER SPINE INSTRUMENTATION INSTRUCTIONS  UK Responsible Person Stryker UK Ltd. Stryker House Hambridge Road Newbury Berkshire RG14 5AW  EN  Stryker Spine 2 Pearl Ct. Allendale, NJ 07401 U.S.A.  0459 Stryker European Operations B.V. Herikerbergweg 110 1101 CM Amsterdam The Netherlands Copyright © 2022 Stryker  Description / Material Composition Surgical instruments supplied by STRYKER Spine are manual medical tools designed solely for use in the fitting of STRYKER Spine implants. They are made of different materials including stainless steel, aluminium, titanium and plastics (silicone, acetal, etc) that comply with the standards applicable to their specific material composition. However these materials are not implantable. STRYKER Spine instruments do not contain natural rubber (such as: natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation). Use STRYKER Spine instruments must be used in the manner described in the Surgical Technique brochures provided by STRYKER Spine. Unless labelled for single use, this instrument may be re-used. Prior to using the instruments, the surgeon shall have given careful consideration to all aspects of the surgical intervention as well as to the limits of the instrumentation. Recommendations for use are provided in the Surgical Technique brochures available from STRYKER Spine representatives. Under no circumstances may STRYKER Spine instruments be used to fit components from other manufacturers, if STRYKER Spine instruments are used in such cases the company shall not be liable for the operation of the resulting unit. Likewise, STRYKER Spine implants may only be implanted with the appropriate instruments supplied by STRYKER Spine. STRYKER Spine shall not be liable for implants implanted using other manufacturer’s instruments. Reuse Instruments labelled as single use shall not be reused. While a single-use instrument may appear undamaged, the instrument may have acquired contaminants that compromise sterility and/or blemishes, nicks or latent compromise of its integrity. 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. Below is a list, albeit not exhaustive, of potential complications: ƒ 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. ƒ Infection, if the instruments are not properly cleaned and sterilized. ƒ Dural leaks, compression of vessels, damage to nerves or nearby organs as a result of slippage or poor positioning of a faulty instrument. ƒ Damage caused by the involuntary releasing of the springs of certain instruments. ƒ Damage caused by the instruments used to bend or cut in-situ due to excessive forces occurring when they are used. ƒ Cutting the gloves or the skin of surgical staff. ƒ 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. ƒ Crack, fracture or involuntary perforation of the bone. As a result of the mechanical features required, most of the instruments are made of non implantable materials. In the event an instrument breaks, no fragment must remain in the patient as this could cause post-operative complications such as allergies, infections, or complications of a biological nature associated with the release of metal components, possibly requiring further intervention. Packaging y STRYKER Spine instruments may be supplied either sterile or non-sterile in instrument containers or individual packaging. Instruments sold sterile are always presented in individual packaging and will be clearly labelled as sterile on the package label. The sterilization method applied is indicated on the product label. The sterile instrument packaging must be intact at the time of receipt and the integrity of the packaging shall be checked prior to use. The containers and the packaging of the instruments must be intact when received. The packaging materials must be removed prior to sterilization. Examination Prior to Use For instruments sold sterile: y Before utilization, it is necessary to verify the sterility expiration date, which is indicated as the “use by” date. Stryker Spine cannot be held responsible for use of its products after their expiration date. y Pre-sterilized instruments must not be allowed to come into contact with any disinfectant product or solution. y It is recommended to verify the integrity of the original package before use. Sterility is ensured only if there is no trace of damage to the packaging. y In case of damage to the packaging, or after opening of the packaging, re-sterilization of the instrument is strictly forbidden, regardless of the method that might be employed. y Instruments should be visually examined for damage by doctors and staff in operating centers prior to and after surgery. For instruments designed for single use (sold non-sterile): y It is recommended to verify the integrity of the instrument and original package before use. y Instruments should be visually examined for damage by doctors and staff in operating centers prior to surgery. For instruments designed for re-use: y The life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage. Great care must be taken of the instruments to ensure that they remain in good working order. y Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery. y The examination shall include a visual and functional inspection of the working surfaces, articulation points, and springs. It should also include verifying all welded connections, that all components are present, and the cleanliness of the orifices and cavities, as well as the absence of any cracks, distortion, impact, corrosion or other change. For instruments with articulations, lubrication may be necessary. Using a silicone lubricating cream is recommended. y Special attention should be paid to the clamping keys, especially to the hexagonal shank bits. The latter must not be blunt as this could compromise the clamping of the fittings and lead to a risk of detaching. Similarly instruments designed to cut bone such as reamers, rakers etc, must be rigorously inspected for sharpness. y Special attention should be paid to the screwdrivers. It is crucial that they are used for the purpose they were designed for, as specifically indicated in the Surgical Technique of each product line. y Certain surgical intervention requires the use of instruments which include a measuring function. These are to be inspected for wear and the clear visibility of any surface markings. y STRYKER Spine and its representatives are available to help carry out proper instrument inspections. y STRYKER Spine shall not be responsible in the event of the use of instruments that are damaged, incomplete, show signs of excessive wear and tear, or that have been repaired or sharpened outside the control of STRYKER Spine. Any faulty instruments must be replaced prior to any intervention. Recommendations For Instruments Provided Sterile y Products may be stored at room temperature and withstand the normal transportation conditions. y Products not labeled as sterile are not sterile. y Do not use if package is opened or damaged or after the “Use by” date on the label has expired. y Stryker shall not be responsible for the use of products presenting package deterioration or expiration of shelf life. y Care must be taken to prevent contamination of instrument after opening of package. PRE-CLEANING / CLEANING AND STERILIZATION PROCEDURE RECOMMENDED FOR NON-STERILE MEDICAL DEVICE For safety reasons, non-sterile devices must be pre-cleaned, cleaned and sterilized prior to use. Moreover, for good maintenance, reusable instruments must be pre-cleaned, cleaned and sterilized immediately after surgery following the sequence of steps described in the following chart.  1
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