Orthofix AGILE NAIL Gebrauchsanweisung Seite 5

3. Rinse the single components in running tap water;
4. Ultrasonic clean the single components in a degassed cleaning solution. Orthofix recommends the use of a pH-neutral enzymatic or slightly alkaline solution. Please refer to detergent's manufacturer
datasheet for concentration of the solution, required time and temperature;
5. Rinse the components in sterile or freshly prepared purified water;
6. Carefully hand-dry using absorbent, non-shedding cloth or industrial dryer for at least five minutes.
Cleaning: Automated
• When the devices to be cleaned have lumens or present complexity, a preliminary manual cleaning may be required.
• Use a validated, properly maintained and calibrated washer disinfector;
1. Place all the instruments into washer baskets.
A. Place heavier devices in the bottom of the baskets.
B. Connect cannulations to the proper injector jets.
C. Wherever possible, all parts of disassembled devices should be kept together in one container.
2. Orient instruments into the automated washer's carriers as recommended by the washer manufacturer.
3. Orthofix recommends the use of a pH-neutral enzymatic or slightly alkaline solution. When using alkaline solutions, a neutralizer must be added. Please refer to detergent's manufacturer datasheet for
concentration of the solution, required time and temperature.
Orthofix recommends that cycle steps are at least as follows:
A. Prewash at low temperatures;
B. Main wash at 40-60°C for at least 5 minutes;
C. Rinse with demineralized water;
D. Thermal disinfection at 90-95°C for at least 5 minutes;
4. Rinse the components in sterile or freshly prepared purified water;
5. Carefully hand-dry using absorbent, non-shedding cloth or industrial dryer.
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 a sterilization wrap approved in compliance with the local requirements (in USA: FDA-cleared).
• Do not or 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 appropriated 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 Gravity
Minimum exposure Temperature 132°C (270°F)
Minimum exposure Time 15 minutes
Drying Time 30 minutes
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.
Pre-vacuum Pre-vacuum (not recommended for use in US)
132°C (270°F) 134°C (273°F)
4 minutes 3 minutes
30 minutes 30 minutes
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