Surgical Instruments are designed to perform specific functions such as cutting, grasping, clamping, dissecting, probing, retracting, draining, aspirating, suturing, or ligating. The use of an instrument for tasks other than those for which they are indicated may result in damaged or broken instruments. Proper cleaning, handling and sterilization and standard routine maintenance (such as sharpening, if applicable) will ensure that the Surgical Instruments perform as intended and will extend their useful life.
Our Surgical Instruments are supplied non-sterile and must be cleaned and sterilized prior to each use according to the procedures outlined in this document.
Before use, inspect the instruments for possible damage, wear or non-functioning parts. Carefully inspect the critical, inaccessible areas, joints and all movable parts. Damaged or defective instruments should not be used or processed.
Delicate Surgical Instruments require special handling to prevent damaging the tips. Use caution during cleaning and sterilization. A non-fibrous sponge should be used to wipe off all blood and debris. Do not apply excessive stress or strain at joints; misuse will result in misalignment or cracks at the box locks or jaws.
Rongeurs and bone cutting forceps should only be used to cut bone, never wire or pin. Do not twist or apply excessive stress during use. Wear appropriate protective gloves, eyewear and clothing when handling biologically contaminated instruments. Instruments manufactured from different metals should be processed separately to avoid electrolytic action between the different metals.
If a device is/was used in a patient with, or suspected of having Creutzfeld Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross-contamination.
Care and Handling
The procedures outlined below should be followed to ensure safe handling of biologically contaminated Surgical Instruments. All instruments must be sterilized before use.
Keep instruments moist and do not allow blood and/or bodily fluids to dry on the instruments. Remove gross contaminants with a steady stream of lukewarm/cool water (below 110°F/43°C). Rinse each instrument thoroughly. Do not use saline or chlorinated solutions. Open jaws of hinged instruments for cleaning. Give special attention to joints and serrations. Instruments having more than one part or piece must be disassembled to expose all surfaces to the cleaning process. Retain all parts to facilitate reassembly. Separate sharps and delicate Surgical Instruments. Avoid processing instruments of different metallic composition together.
If appropriate, disassemble Surgical Instruments prior to cleaning and sterilization. Do not soak instruments in hot water, alcohol, disinfectants or antiseptics to avoid coagulation of mucus, blood or other body fluids. Do not exceed two hours soaking in any solution. Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents. Microsurgical, plated and delicate instruments should be cleaned chemically or manually and should be processed in an ultrasonic cleaner. Carefully protect the tips of delicate micro-surgical Instruments throughout the entire cleaning and sterilization process.
Hand wash using a low-sudsing protein dissolving detergent. Follow manufacturers’ directions regarding concentration, temperature, contact time and reuse. Totally immerse instruments during cleaning to prevent aerosolization. Use a large syringe or pulsating water jet to thoroughly flush all channels and lumens with cleaning solution to remove debris. Use appropriate-sized, soft nylon brushes to clean the instruments and their parts.
Ultrasonic and Mechanical Cleaning
For ultrasonic cleaning, follow manufacturer’s specifications for water level, concentration levels of cleaning agent and temperature. When using mechanical washer, make sure all instruments stay properly in place and do not touch or overlap each other. Always follow the manufacturer’s specifications for automatic washer-sterilizers and use a free-rinsing, low-sudsing detergent with a neutral pH (6.0 – 8.5). Due to variations in water quality, the type of detergent and its concentration may require adjustment for optimal disinfection and cleaning.
Rinse all instruments thoroughly with tap water, deionized or distilled water to remove all traces of debris and cleansing agents. Make sure all internal lumens and ratchets are thoroughly rinsed.
Note: The decontamination procedure does not sterilize the instruments. Refer to and process the instruments as outlined in the STERILIZATION section. Select a proper product for high-level disinfection such as the glutaraldehyde-family of disinfectant products. Follow the cleaning agent’s recommended directions regarding concentration, temperature, contact time and solution re-use. Do not use high acid (pH 4 or lower) or high alkaline (pH 10 or higher) products for disinfection, such as bleach and bi-chloride of mercury. Completely immerse instruments in the disinfecting solution, including all lumens and shafts. Force solution into all areas and cavities. Thoroughly rinse with distilled water to remove all traces of disinfecting solution. USE STERILE WATER ON THE FINAL RINSE.
Instruments must be thoroughly dried and all residual moisture must be removed before they are stored. Use a soft, absorbent towel/cloth to dry external surfaces. Compressed air or a 70% alcohol rinse may be used to aid the drying process.
Lubrication / Assembly
Lubrication is essential every time instruments are processed. Special attention should be given to lubrication of joints, box locks, and movable parts. Only lubricate dry instruments. Do not use mineral oil, petroleum, or silicone-based products. To lubricate box locks and joints, use a non-silicone, water-soluble lubricant prior to sterilization. Reassemble instruments, as necessary, before assembly into baskets or trays. Inspect instruments for bent tips, pits, cracks, misalignment and corrosion. Remove stained, discoloured or damaged instruments. Mechanically test the working parts to verify that each instrument performs correctly. Close instruments with a ratchet lock in the first ratchet position before sterilization to avoid temperature-induced stress cracks in the joints.
Sterilization method and parameters Sterilize with steam, taking note of the following: The sterilization has to be done according to a validated steam sterilization procedure (e.g. in a sterilizer in conformance with EN 285/ANSI/AAMI/ ISO 11134-1993, ANSI/AAMI ST46-1993, and validated in conformance with EN 554/ISO 13683). In case of application of the fractionated vacuum procedure the sterilization has to be carried out for a minimum of 5 minutes at 134 °C and at 2 bar pressure.
Sterilization for the US market:
Sterilization of the device may be accomplished by steam or ethylene oxide (EtO) gas. SBH does not recommend the device be sterilized by “Flash” or chemical sterilization. Surgical instruments may also be placed within a rigid sterilization container for processing under generally accepted hospital in-use conditions. The recommended sterilization parameters are as follows:
Further information is also available on the following website: http://www.a-k-i.org.
Every product bearing the SBH name is guaranteed to be free of defects in workmanship and materials when used normally for its intended surgical purpose. Any product delivered from SBH, proving to be defective, will be replaced or repaired, at SBH’s discretion, at no charge to the customer. These warranties shall not apply to conditions or defects resulting from, but not limited to: negligence, improper use, improper cleaning and handling, improper opening techniques, unauthorized repair work, caustic or abrasive cleaners, or items modified or customized by the customer at the customer’s request.
Maintenance and Repair
If your instruments require repair or maintenance, return the instruments in the sturdy box with adequate foam, bubbles or other packaging material to protect the instruments. Send the packaged instruments to:
9620 Research Dr.
Irvine, CA 92618
United States of America
Returned Instruments for repair must have a statement which testifies that each instrument has been thoroughly cleaned and disinfected. Failure to supply evidence of cleaning and disinfection will result in a cleaning charge and delayed processing of your instrument repair.
Contact your SBH representative if you have any questions.