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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: 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. 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.
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1 Point of Use
> Remove gross soil
2 Transport to processing area
> Avoid damage > Transfer contaminated instruments in closed container > Minimize time before cleaning ,< 2 hrs is recommended
3 Preparation for cleaning
> Dis-assemble if necessary per assemble / dis-assemble instructions
4 Manual
4’ Automatic
4.1 Manual Pre-Cleaning
> Soak in cleaning solution per manufacturer instructions > A minimum of 15 minutes is recommended > Clean with soft brush or cleaning wires > Rinse thoroughly in tap water for a minimum of 1 min > Dry and inspect
4.1’ Pre-Cleaning
4.2 Manual Cleaning
> Soak in Ultrasonic bath per manufacturer instructions > A minimum of 15 minutes is recommended > Clean with soft brush or cleaning wires > Rinse thoroughly in tap water for a minimum of 1 min > Dry and inspect
4.2’ Washer Disinfector
5 Inspection
> Wash per manufacturer cleaner instructions > A0 value>3000 (i.e.90 °C, 5 min) > Rinse > Dry and inspect
> Check soil traps > Check straightness > Check for damage and/or corrosion
6 Preparation for Sterilization
> Suitable packaging
7 Sterilization
> See sterilization procedure below
8 Storage
> Soak in cleaning solution per manufacturer instructions > A minimum of 15 minutes is recommended > Clean with soft brush or cleaning wires > Rinse thoroughly in tap water for a minimum of 1 min > Dry and inspect
> Control environment > Control storage time
Sterilization Procedure Recommended for Non-Sterile Medical Devices Medical Devices should be sterilized in their container by means of moist heat steam sterilization in an autoclave in accordance with standard hospital procedure. The recommended sterilization methods have been validated according to ISO 17665-1 to obtain a Sterility Assurance Level (SAL) of 10-6. Steam Sterilization with Commercially Available Sterilization Wrap The following ranges of parameters have been validated on wrapped containers in fully-loaded autoclaves. MINIMAL STERILIZATION CONDITIONS: Prevacuum (Porous Load) steam sterilization autoclave: y Temperature: 132°C (270°F) y Exposure Time: 4 Minutes y Dry Time: 45 Minutes CAUTION: For products being used in the United States (USA), an FDA-cleared sterilization wrap is required to wrap the sterilization containers. Outside the USA Steam Sterilization Parameters for Wrapped Trays and Instruments Prevacuum (Porous Load) steam sterilization autoclave: y Temperature: 134°C (273°F) y Exposure Time: 3 Minutes y Dry Time: 45 Minutes The autoclave must be validated by the hospital and regularly checked to guarantee the recommended sterilization temperature is reached for the entire exposure time. If after having followed this sterilization method there is still water in the sterilization containers or on/inside the device, the device must be dried, and sterilization repeated. Drying times for instruments processed in containers and wrapped trays can vary depending upon the type of packaging, type of instruments, type of sterilizer, and total load. A minimum dry time of 45 minutes is recommended, but to avoid wet packs, extended dry times greater than 45 minutes may be needed. See Extended Dry Time Table in the Stryker Spine Instructions for: Cleaning, Sterilization, Inspection, and Maintenance of Non-Sterile Medical Devices NSRDEV_RG. For large loads verification of dry times by the health care provider is recommended. Steam Sterilization with FDA-Cleared Rigid Containers Option*: In order to ensure proper sterilization of Stryker Spine devices when using the Aesculap SterilContainer (JN series) reusable, rigid sterilization containers, the information below must be followed: 1. Only the following Aesculap reusable rigid container configuration, FDA-cleared, shall be used in a pre-vacuum steam sterilization cycle for use in the USA: y JN442 – Aesculap SterilContainer, Full Size, 6-inch height, Perforated Bottom y JK489 – Aesculap SterilContainer, Full Size, 2000 Lid, Aluminum y US994 – Filter Paper, 7 ½ inches Round, Single Use
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2. Only the following Aesculap reusable rigid container configuration, FDA-cleared, shall be used in a pre-vacuum steam sterilization cycle for use outside the USA: y JN442 – Aesculap SterilContainer, Full Size, 6-inch height, Perforated Bottom y JK489 – Aesculap SterilContainer, Full Size, 2000 Lid, Aluminum y JK095 – Round Filter Paper with process indicator, CE marked, Single Use 3. Aesculap SterilContainer instructions for use must be followed. If questions arise regarding the use of the Aesculap SterilContainer reusable, rigid sterilization container, Stryker Spine recommends contacting Aesculap directly for guidance 4. Sterilization instructions: a. No more than two (2) individual Stryker Spine tray inserts can be placed directly into the Aesculap SterilContainer (JN Series) reusable, rigid sterilization container (perforated bottom) b. Stryker Spine devices must be placed in their designated locations within the tray inserts. Stryker Spine’s single devices or modules/caddies/racks may be placed into an Aesculap basket (JF223R or similar) which can be loaded into the Aesculap SterilContainer reusable, rigid sterilization containers. NOTE: Devices must be placed such that individual devices are not stacked and remain in an open position to allow uniform exposure to steam. c. Stryker Spine Container lids must be removed prior to use with the Aesculap reusable, rigid sterilization container d. Stryker Spine devices were validated under the following USA sterilization parameters for a pre-vacuum, three pulse steam cycle: y Temperature: 132°C (270°F) y Exposure Time: 4 minutes y Cycle Dry Time: 30 minutes e. Stryker Spine devices were validated under the following outside the USA sterilization parameters for a pre-vacuum, three pulse steam cycle: y Temperature: 134°C (273°F) y Exposure Time: 3 minutes y Cycle Dry Time: 30 minutes f. Reusable, rigid sterilization containers must not be stacked within the autoclave, as doing so may negatively impact ventilation and sterilization. Note: Instruments may be individually wrapped and sterilized. Specialty devices MUST be individually wrapped and sterilized. * Exceptions: Stryker Spine AVS ARIA System and AVS AL PEEK Spacer System must not be sterilized using reusable, rigid sterilization containers. These systems shall be sterilized according to the Steam Sterilization with FDA-Cleared/Commercially Available Sterilization Wrap Instructions above. Refer to Stryker Spine Instructions for: Cleaning, Sterilization, Inspection, and Maintenance of Non-Sterile Medical Devices NSRDEV_RG Appendix 2 Rigid Container Compatibility for Device Sets for the complete list of device sets in scope of rigid container sterilization. WARNING: y Do not use solvents, abrasive cleaners, metal brushes, or abrasive pads. Cleaning agents with aldehydes, bromine, iodine, active chlorine, or chloride as the active ingredient are corrosive to stainless steel and are not to be used. The parameters identified in this document are the minimum for effective cleaning and sterilization of Stryker Spine instruments. Use of high pH cleaning solutions will reduce the life of instruments. Stryker Spine recommends using a pH neutralizer to limit damage to instruments, as exposure to high pH is known to strip protective coatings from metals, especially aluminum. In circumstances where sterilization temperature and exposure time required by the hospital is greater than the temperature and time recommended in this document, the effectiveness of the cycle for the purposes of sterilization is assured. However, extended cycle temperature and time may accelerate wear, or otherwise affect the life and function of the instrument. Instruments should be examined for wear or damage prior to use. For additional information refer to Stryker Spine Instructions for: Cleaning, Sterilization, Inspection, and Maintenance of Non-Sterile Medical Devices NSRDEV_RG. PRE-OPERATIVE PRECAUTIONS Anyone using STRYKER Spine products can obtain a Surgical Technique by requesting one from a distributor or from STRYKER Spine directly. Those using brochures published more than two years before the surgical intervention are advised to request an updated version. STRYKER Spine 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 STRYKER Spine. 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 unless otherwise specified by the applicable STRYKER Spine Surgical Technique. 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. CAUTION Federal law (U.S.A) restricts this device to sale by or on the order of a licensed physician. Extracting a device y To obtain the best possible results, the same instruments used to implant a device or instruments specifically designed for extraction must be used. y To limit the stresses on the implants and the instruments, it is advisable to remove the bone and/or tissue from the area around the implant before performing extraction maneuvers. Storage The instruments are packaged in individual packages or in containers. After they are used they must be stored in a clean, dry and temperate place. Complaints Any health professional having a complaint or grounds for dissatisfaction relating to the identity, quality, durability, reliability, safety, effectiveness or performance of a device should notify STRYKER Spine or its representative. Moreover, if a device has malfunctioned, or is suspected of having malfunctioned, STRYKER Spine or its representative must be advised immediately. If a STRYKER Spine product has ever worked improperly and could have caused or contributed to the death of or serious injury to a patient, the distributor or STRYKER Spine must be informed as soon as possible by telephone, fax or in writing. For all complaints, please give the name and reference along with the batch number of the component(s), your name and address and a detailed description of the event to help STRYKER Spine understand the causes of the complaint. For further information or complaints, please contact: Stryker Spine 2 Pearl Court, Allendale, NJ07401-1677 USA Tel +1-201-760-8000
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