Johnson & Johnson accuratus swiss Información Importante página 2

These instructions apply to reusable non-sterile surgical instruments, supplied by Accuratus AG, and intended for reprocessing
in a health care facility setting.
The instruments used to implant orthopaedic prostheses do not have an indefinite function life. All reusable instruments are
subjected to repeated stresses related to bone contact, impaction and routing, cleaning and sterilization process. It is essential
that the surgeon and operating theatre staff are fully conversant with the appropriate surgical technique for the instruments
and associated implant, if any.
CAUTION: These instructions DO NOT APPLY to single-use devices.
These reprocessing instructions have been validated as being capable of preparing reusable instruments for reuse. It is the
responsibility of the re-processor to ensure that the reprocessing is performed using appropriate equipment, materials, and
personnel to achieve the desired result. This normally requires validation and routine monitoring of the process. Any deviation
from these instructions should be evaluated for effectiveness and potential adverse consequences.
WARNINGS
Limitations on
Reprocessing
Decontamination
Considerations
- CJD
Reprocessing Instructions
Care at the
• Remove debris, tissue or bone fragments. Remove excessive soil with a disposable wipe.
Point of Use • Immerse instruments in a neutral pH detergent solution or water to prevent drying
• Avoid prolonged exposure to saline to minimize the chance of corrosion.
Containment & • Reprocess instruments as soon as possible after use.
Transportation
• Universal precautions for handling bio-hazardous materials should be observed.
Preparation for
• For instruments that require disassembly for cleaning, perform disassembly as shown in the
Cleaning
INSTRUCTIONS FOR USE
Subtilis® Range of Surgical Instruments produced by Accuratus AG
• Do not exceed 140 °C during reprocessing steps.
• Highly alkaline conditions can damage products with aluminium parts.
• Complex devices, such as those with tubes, hinges, retractable features, mated surfaces,
and textured surfaces, require special attention during cleaning. Manual pre-cleaning of
such device features is required before automated cleaning processing.
• Avoid exposure to hypochlorite solutions, as these will promote corrosion.
• Ensure that no instruments or pieces of instruments are left in the surgical site prior to
closure, as they may not be detectable using imaging techniques such as X-ray or MRI
and patient injury may result.
• Repeated processing has minimal effects on instrument life and function.
• End of useful life is generally determined by wear or damage in surgical use.
• Damaged instruments should be repaired by the recognized manufacturer or replaced
to prevent potential patient injury.
Under certain classifications of risk, the World Health Organization (WHO), or local regulatory
authorities recommend special CJD (Creutzfeldt-Jakob Disease) inactivation processing
procedures. Consult WHO and local regulations for further information.
and encrustation of surgical soil.
applicable disassembly diagram for that instrument.
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