Orthofix MJ-FLEX The New Metaizeau Nail Instructions D'utilisation page 5

Maintenance, inspection and testing
• All instruments and product components must be visually inspected under good light for cleanliness. If some areas are not clearly visible, use a 3% hydrogen peroxide solution to detect the presence
of organic residuals. If blood is present, bubbling will be observed.
• All instruments and product components must be visually inspected for any signs of deterioration that may cause failure during use (such as cracks or damage to surfaces) and functions tested before being
sterilized. If a component or instrument is believed to be faulty, damaged or suspect, it must NOT BE USED.
• Cutting instruments must be checked for sharpness.
• When instruments form part of an assembly, check assembly with matching components.
• Lubricate hinges and moving parts with an oil that does not interfere with steam sterilization as per manufacturer's instructions before sterilization. Do not use silicone based lubricant or mineral oil.
Packaging
• Wrap the tray before sterilization with an approved sterilization wrap or insert it into a rigid sterilization container in order to prevent contamination after sterilization.
• Do not include additional systems or instruments in the sterilization tray. Sterility cannot be guaranteed if the sterilization tray is overloaded.
• The total weight of a wrapped instrument tray should not exceed 10kg
Sterilization
• Steam sterilization is recommended. Gas plasma, dry heat and EtO sterilization must be avoided as they were not validated for Orthofix products.
• Use a validated, properly maintained and calibrated steam sterilizer.
• The steam quality must be appropriate for the process to be effective.
• Do not exceed 140°C (284°F).
• Do not stack trays during sterilization.
• Sterilize by steam autoclaving, utilizing a fractioned pre-vacuum cycle or gravity cycle according to the table below:
Steam sterilizer type
Minimum exposure Temperature
Minimum exposure Time
Drying Time
Storage
Store the sterilized instrument in the sterilization packaging in a dry and clean environment at room temperature.
Disclaimer
The instructions provided above have been validated by Orthofix as being a true description of the preparation of a device for first clinical use or for re-use of multiple use devices. It remains the responsibility
of the reprocessor to ensure that the reprocessing, as actually performed using equipment, materials and personnel in the reprocessing facility, achieves the desired result. This normally requires validation and
routine monitoring of the process. The cleaning, disinfection and sterilization processes must be adequately recorded. Likewise any deviation by the reprocessor from the instructions provided must be properly
evaluated for effectiveness and potential adverse consequences and must also be appropriately recorded.
RISKS DUE TO THE RE-USE OF "SINGLE USE" DEVICE
IMPLANTABLE DEVICE*
The "SINGLE USE" implantable device* of Orthofix is identified through symbol " " reported on the product label. After the removal from the patient, the implantable device* has to be discarded.
The re-use of implantable device* introduces contamination risks for users and patients.
The re-use of implantable device* can not guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health risks for the patients.
(*): Implantable device
Any device intended to be totally/partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is considered an implantable device.
NON IMPLANTABLE DEVICE
The "SINGLE USE" non implantable device of Orthofix is identified through symbol " " reported on the label or indicated in the "Instructions For Use" supplied with the products. The re-use of "SINGLE USE"
non implantable device cannot guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health risks for the patients.
CAUTION
Federal Law (USA) restricts this device to sale by or on the order of a physician.
Manufacturer contact
Please contact your local Orthofix sales representative for further details.
All Orthofix internal and external fixation products should be used together with their corresponding Orthofix implants, components and accessories. Their application should be performed with the specific
Orthofix instrumentation, following carefully the surgical technique recommended by the manufacturer in the appropriate Operative Technique Manual.
Gravity Pre-vacuum
132°C (270°F) 132°C (270°F)
15 minutes 4 minutes
30 minutes 30 minutes
Pre-vacuum
(not recommended for use in US)
134°C (273°F)
3 minutes
30 minutes
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