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Before using the instruments for the first time, as well as before each subsequent use and before returning them for repair or servicing, they must be cleaned, disinfected and sterilized in accordance with our instrument processing instructions, which are available later in this product guide.
The instruments may only be used for their intended purpose in the specified medical fields, with use being restricted to adequately trained and qualified personnel. The treating physician or user is responsible for selecting the right instrument(s) for the surgical task/application at hand as well as for their safe handling. This includes ensuring an adequate level of training, knowledge and experience.
Before each use, the instruments must be thoroughly inspected for damage such as fractures, cracks or deformation, as well as for functional reliability. Special attention must be paid to cutting edges, tips, joints, box locks, ratchets and all movable parts. If wear, corrosion, deformation, porosity or other damage is detected, the instrument should be immediately withdrawn from service.
Due to their alloy, stainless steel instruments typically develop a passive film in the form of a protective layer. However, this film does not protect them well against chemical attack by chloride ions and aggressive media and liquids!
Therefore, in addition to the instrument manufacturer's endeavours to select the right materials and process them carefully, the user must make an important contribution by ensuring proper instrument processing along with adequate and regular care.
To treat our reusable surgical instruments correctly, we recommend using the following procedures:
Effective ultrasonic cleaning requires placing the surgical instruments into suitable sterilization trays or wire baskets in an open condition. As the use of plain warm water alone cannot produce satisfactory results, it is necessary to add a suitable cleaning agent. Be sure to observe and follow the manufacturer's instructions regarding concentration as well as temperature.
Since an excessive dirt content of the cleaning solution has an adverse effect on the cleaning results, the solution must be replaced at regular intervals in accordance with the manufacturer's instructions. In the same manner, prescribed immersion or ultrasonic treatment times must be strictly observed. As a rule, ultrasonic cleaning must always be followed by a rinsing cycle. Be sure to check the instruments (where applicable) for loosened components after the ultrasonic bath. To prevent water spots ("spotting"), fully demineralized or distilled water should be used for the final rinse.
1. The solutions employed for chemical disinfection must always be used in accordance with the manufacturer's instructions.
2. Pure water must be used for preparing the dilutions specified for the chemical disinfectants. The addition of detergents is not permitted. The manufacturer's instructions regarding exposure times and concentration must be duly observed in each case.
3. Disinfecting solutions must be prepared afresh every day. Extended/ multiple use can easily lead to the following problems:
a. Increased concentration due to evaporation (corrosion risk)
b. Excessive dirt load (corrosion risk plus lower effectiveness)
4. Following disinfection, it is important to rinse all items sufficiently under clear running water. To prevent the formation of water spots, the use of fully demineralized water is highly recommended.
5. Immediately after completion of the cleaning and rinsing cycles, surgical instruments must be sufficiently dried.
Following cleaning, the instruments must be macroscopically clean, i.e. free from visible dirt or deposits. Instruments with stains or spots must be withdrawn from service at once and given special treatment. All movable parts, working tips and (scissor) blades should be inspected with particular care. If damage or malfunction is detected, the instrument should also be withdrawn from service immediately.
The term "care" refers to the application of instrument oil/milk to the surfaces of surgical instruments (especially to movable parts such as joints). "Instrument oil" means physiologically safe paraffin oil as specified by the German Pharmacopoeia (DAB 8) or equivalent regulations (European or US Pharmacopoeia), while "instrument milk" refers to a white-oil-in-water emulsion.
As a rule, surgical instruments must be subjected to regular care, which means each time before a functional test is carried out. At the same time, it is important to prevent "gumming" of the joints due to an accumulative effect, especially in instruments that are continuously in use.
Prior to sterilization, the instruments must be adequately packaged, e.g. using containers that meet DIN EN 868-8 requirements, or wrapping them with suitable packaging materials.
The packaging method used must comply with the relevant standards (e.g. the EN 868 or ISO 11607 series of standards).
The following parameters are recommended:
For pre-vacuum cycles, a 4-minute exposure time at 270°F/132°C.
Caution: Time required for sterilizer to reach temperature is not included in the times given.
This is based on instructions in Steam Sterilization and Sterility Assurance in Health Care Facilities (ANSI/AAMI ST46-2002-5.8.1 and 5.8.2.)
A Sterility Assurance Level (SAL) of 10 -6 has been validated in accordance with AAMI Standards and Recommended Practices, Sterilization in Health Care Facilities, TIR No. 12, and Sterilization of healthcare products - Requirements for validation and routine control - Industrial moist heat sterilization (ANSI/AAMI/ISO 11134:1993) 4.2, 4.3, A4.2.1, A4.2.2, A5.3.1.1,A5.3.1.2,A5.3.1.3,A6.1.2 and A6.6. The validation includes protocols, specifications, pass/fail criteria, results and procedures describing when the instructions must be re-qualified.
Sterilization must be performed according to a validated steam sterilization method, e.g. using a sterilizer satisfying EN 285/ANSI/AAMI/ISO 11134-1993 or ANSI/AAMI ST46-1993 requirements, validated in accordance with EN 554/ISO 13683.
It is essential to keep the steam free from any foreign bodies such as rust particles and other impurities. This helps to prevent instrument corrosion or surface damage caused by deposits. The steam used for sterilization must comply with DIN 58946, Part 7. The user instructions provided by the steam sterilizer manufacturer must be duly observed. Instruments incorporating locks or ratchets must be sterilized in an open condition or with the ratchet set to the first notch.
In specific, the following sources should be observed for cleaning, disinfection and sterilization:
Frequent reprocessing has only a minor influence on the service life of surgical instruments, which is mainly a function of use-related wear and tear or damage. Please dispose of your instruments in accordance with relevant local regulations, or have them properly recycled, once they have reached the end of their life cycle.
Safety notice: The responsibility for proper instrument cleaning, disinfection and sterilization lies with the operator/user of the product. Be sure to observe and follow all relevant national regulations (incl. relevant restrictions)!
Onyx Fine Instruments accepts no liability for direct or consequential damage caused by improper use, handling, processing, sterilization or maintenance. Unauthorised instrument repair (by firms or persons not specifically authorized by Onyx Fine Instruments to perform such work) shall void the warranty given!
Non-observance of these notices, as well as improper handling or use of products supplied by us, will void your rights under the warranty. Consequently, Onyx Fine Instruments shall not be liable for any resulting damage in such cases.