Stainless steel surgical instruments

Intended usethese instructions for use are valid for one-piece stainless steel surgical instruments, such as dental instruments, forceps, speculums, instruments for surgery (hammers, screwdrivers), scalpels, knives, retractors, spatulas, suture needles, stylets, curettes, strippers, scissors, blades, needle holders, chisels, hooks, mouth gags and dilators.

MaterialsThe materials used are stainless steels according to DIN EN ISO 7153-1.

WarningEven when new, instruments must be cleaned before their first sterilization. To do this, follow the cleaning protocol indicated in these instructions for use.

Visual tests before useBefore each use, the instruments must be carefully examined to verify their good condition and consequently their ability to function. Surface damage such as scratches, cracks, nicks, dents, and bent parts indicate that the instrument should not be used. Defective products should be repaired or disposed of as specified by the hospital. Damaged products must not be used under any circumstances.

DisposalInstruments that cannot be repaired or reprocessed should be disposed of according to hospital disposal guidelines.

HandlingInstruments should not be subjected to excessive stress by twisting or prying as this may cause cracks or other damage rendering the instruments inoperable

or expose them to brittleness which would render them unsafe in use. Risksinjury to nerves, vessels and tissues (a) Bleeding (b) Infections (c). Possible

complicationstheir frequency and severity depend on the type of examination performed and the careful handling of the instruments.

Storage of new instrumentsinstruments should be stored in their original packaging, in a dry, clean and dust-free environment at room temperature, with extremes between 5°C and 40°C, and at constant humidity. The distance between the storage shelf and the floor should be at least 30 cm.

Purpose / ScopeThis instruction manual is valid for standard surgical instruments of CIE production. The user decides based on his specialist knowledge whether the instrument is suitable for the intended use. Surgical instruments may only be used, cleaned, disinfected and sterilized by specially qualified professionals with specific knowledge for this type of work. Trained personnel are responsible for selecting instruments for certain applications or for use in the operating room. He is also responsible for the appropriate training and sufficient information transmitted to the personnel in the operating room. During use, the instruments may be in direct contact with mucous membranes and/or blood. Furthermore, the instruments can be subjected to projections of bodily fluids, even if these instruments are not in direct contact with the patient. Finally, the instruments can be contaminated during their use by soiled hands or gloves. It is therefore essential to follow the reprocessing instructions below. The process must be carried out in the order in which it is indicated, respecting the durations recommended at each stage and imperatively avoiding any delay between the examination, cleaning, disinfection and sterilization stages. Any waiting time at one of the steps can create favorable conditions for microbial growth which could minimize the effect of the following steps.

REPROCESSING INSTRUCTIONS

Practices to AvoidStainless steel instruments should not be placed in physiological saline (NaCl) solutions as prolonged contact may result in corrosion damage. Instruments should not be reprocessed with chemicals that may leave harmful residues or adversely affect materials and/or instrument performance if not properly rinsed. Do not use products not recommended in these instructions.

Preparation at the point of useThe instruments are supplied unsterilized and must be cleaned before use or even disinfected and sterilized if necessary. Cleaning is a fundamental step in the process, which requires careful attention. Disinfection and sterilization depend on the quality of the cleaning performed. The cleaning time depends on the size of the instrument and its complexity. Instruments with notches or racks must not be closed. Particular care should be taken to examine areas with openings, ridges, notches or other gaps.

Preparation for decontaminationStart reprocessing instruments as soon as possible after use. Instruments should be reprocessed in the open state if applicable. Instruments should be placed on suitable supports or trays. The nature of the supports or trays must not have a negative influence on the result of the cleaning, disinfection, rinsing or ultrasound treatment. Use racks and trays whose compatibility with decontamination equipment is proven by the hospital.

Manual pre-cleaning stepremove coarse soiling from the surface with a soft disposable cloth or paper towel, followed by immersing the instrument in cold tap water (<40°C) immediately after use for at least less than 5 minutes. Brush under cold tap water until all visible residue is removed. Openings, threads and other gaps should each be flushed with a water jet gun for at least 10 seconds in pulsed mode. Then immerse the instrument in an ultrasonic bath with an alkaline or enzymatic detergent (0.5%) and treat with ultrasound for 15 minutes at 40°C. Remove the instruments from the bath and rinse again with cold water. The cleaning bath should be changed at least once a day, or as often as necessary according to the judgment of the operator. Any soiling can influence the result of cleaning/ disinfection and can promote corrosion. Do not use fixative detergent or hot water (>40°C) as this may cause residue to settle which may influence the outcome of the overall reprocessing process. Oxidized instruments must imperatively be isolated for a specific treatment.

WarningDuring ultrasound treatment, use a device suitable for medical use and follow the recommendations of the manufacturers of cleaning and disinfection solutions. Place the instruments in the wire basket. The instruments should be placed in the ultrasonic cleaning bath with a frequency of about 40KHz. After ultrasonic cleaning, the instruments should be rinsed with clean water and dried. Overdosage of the cleaning/disinfection solution should be avoided. The metal basket of the ultrasound machine must be large and deep enough to guarantee complete immersion of the instruments. Instruments should be completely covered by the cleaning solution. Use only wire baskets, which do not negatively affect the cleaning result. Do not overload screened ponds. Fill all hinged and hollow spaces with the cleaning solution, free of air bubbles. Remove the instruments from the ultrasound machine then blow air through all the hinges to remove any remaining fluid.

Automated cleaningplace the instruments (open if applicable) on an instrument tray. Place the tray on an instrument holder in the washer-disinfector and start the

cycle1 minute of pre-cleaning with cold water draining, 3 minutes of pre-cleaning with cold water draining, 5 minutes of cleaning at 55° C with 0.5% alkaline solution or at 45°C with enzymatic detergent or 70:30 IPA solutions. Draining, 3 minutes neutralization with warm water (40°C) and draining neutralization for 2 minutes, rinsing with warm desalinated water (40°C), draining.

Manual cleaningIn case of manual cleaning, the cleaning process must be adapted to the pre-treatment. If you use a brush or sponge, it must be disinfected in a suitable solution. The detergents used must be compatible, in order to avoid any negative influence on the cleaning/disinfection result.

• The detergent must be suitable for the treatment of steel surgical instruments.
• The manufacturer's instructions regarding concentration and reaction time must be strictly observed. The cleaning solution should not be foamy and should be suitable for manual cleaning.
• Channels, non-removable joints and hollow parts must be thoroughly rinsed. If necessary, a high pressure hose can be used. Otherwise, always use a soft brush, not a hard brush for cleaning. Perform brushing and all other cleaning steps below the liquid surface to avoid splashing contaminated liquid.
• Rinse the instruments with clear water. Thoroughly dry the instruments for 5 minutes.
• The cleaning bath must be changed at least once a day, or as often as necessary according to the assessment of the situation by the operator.

Automated disinfectionAutomated thermal disinfection with desalinated water in the washer/disinfector taking into account national requirements regarding A0 value (confer ISO 15883). Instruments should be placed in such a way that the hinged and hollow spaces are completely and abundantly flushable. The peculiarities of the device model used must be taken into account by the operator. Close the machine, select the program. After the program ends, check that all program steps have been executed and that all control parameters are fulfilled. Open the machine and remove the instruments with disinfected hands or wearing new disposable gloves.

Automated dryingdrying of the external faces of the instruments by the drying cycle of the washer/disinfector. If necessary, additional manual drying can be done with a lint-free towel. Blow out instrument cavities using sterile compressed air. Dry hinged and hollow spaces with compressed air.

Chemical disinfectionmanual chemical disinfection follows manual cleaning. A detergent suitable for stainless steel surgical instruments should be used. Prepare the concentration of the disinfectant solution and soak the instruments according to the manufacturer's specifications. When instruments are placed in a disinfection solution, ensure that they are completely submerged and that no air bubbles form. Remove the instruments from the disinfectant solution with new disposable gloves. Manual disinfection is not the preferred method because it does not achieve the standardization of automated disinfection.

Hand DryDrying can be done with a lint-free towel. Blow out instrument cavities using sterile compressed air.

Functional tests and maintenancea visual cleanliness check (with a magnifying glass and/or with adequate lighting) and functional tests must always be carried out. If necessary, reprocess until instruments are visibly clean. Instruments with non-removable moving parts should be treated with special instrument oil (eg TK95100-00). Ratchet instruments must be closed in the first position. Defective or damaged instruments must be immediately sorted and sent for repair if applicable. Before sending them to the repair service, it is imperative that the instruments are sterilized.

Packagingsuitable packaging for sterilization according to ISO 11607 and EN 868, part: 1-10. Sterilization packaging depends on the method. The packaging has an influence on the sterilization result. The packaging must be chosen in such a way that the instruments fit in place. Use a sterilization indicator for the packaging and note the sterilization and expiration date on the said packaging.

Hot steam sterilizationsterilize instruments using a fractionated pre-vacuum process (according to ISO 13060 / ISO 17665-1) taking into account national requirements. The operator must judge the need to wear one or more personal protective equipment (PPE) adapted according to the case and the use made of the instrument. CIE does not recommend running extended cycles, with longer exposure times and/or higher temperatures than national standards, which may deviate from conventional sterilization cycles. Follow the standards of the country where the instrument is reprocessed. Recommended settings for the pre-vacuum cycle:

• 3 pre-vacuum phases with at least 60 millibars
• Heat to a minimum sterilization temperature of 134°C and a maximum temperature of 137°C
• Minimum holding time: 3 minutes to 5 minutes at 134°C
• Drying time: minimum 15 minutes.
• A Sterility Assurance Level of 10-6 must be achieved. Any deviation from the sterilization process recommended by CIE or national standards is beyond the responsibility of CIE. CIE does not recommend sterilizing with methods other than steam (i.e. EO, H2O2, O3). Due to the design of the surgical instruments and the materials used, it is not possible to determine a limited number of reprocessing cycles. The service life of surgical instruments is therefore determined by the function and wear of the instrument. The end of life of the product is also determined by visual inspection (with a magnifying glass and/or with adequate lighting) and damage caused by use. The unacceptable deterioration criteria (corrosion, discoloration, cracked joints, pitting) are used to make the decision to eliminate the device or to contact the CIE manufacturer for expertise.

WarningInstruments contaminated with blood or body fluids, which may contain blood-borne pathogens, should be cleaned and then receive an intermediate-level disinfection with a product with a registered claim for activity against hepatitis B. In certain clinical situations (eg, patients with Norovirus or Clostridium difficile infections, drug resistant organisms, etc.), nationally recommended isolation precautions may include the use of specific disinfectants and should be adhered to.

Storage of sterilized instrumentsstorage of sterilized instruments in appropriate packaging in a dry, clean and dust-free environment (closed cabinet) avoiding fluctuations in temperature and humidity. The storage period is to be determined by the user based on the visual and functional examination of the instruments.

Additional instructionsIf the solutions and machines indicated in this protocol are not available, it is the user's duty to validate his process. It is also the duty of the user to ensure that the reprocessing processes, including resources, materials and personnel, are capable of achieving the required results. The state of the art and national laws require that these processes and resources be validated and maintained correctly.

Guaranteethe products are made of high quality medical steel and are checked before sale. In the event of an error or inconvenience, contact our customer service or contact us via our materiovigilance address, indicated on this notice. CIE cannot provide any guarantee if the instruments are unsuitable for the procedure. This must be determined by the user. CIE assumes no liability for damage resulting from pure chance. CIE assumes no liability for damages resulting from violation of this notice. If the instruments are used on patients with Creutzfeldt-Jakob or HIV, CIE assumes no responsibility for the reprocessing and reuse of the instruments.

Explanation of the symbols used on the device or its packagingsee symbols section