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STEAM STERILIZER TYPE
GRAVITY DISPLACEMENT
WRAPPED
DYNAMIC-AIR-REMOVAL / PRE-VACUUM
WRAPPED
Preconditioning pulses
N/A
4 pulses
Exposure Temperature
132° C (270° F)
132° C (270° F)
Exposure Time
15 minutes
4 minutes
Drying Time
30 minutes
30 minutes
sodium hydroxide] must not be used; Orthofix recommends use of 0,5% phenolic
disinfectant solution immersion at 50°C (122°F) for 15 minutes (ultrasound frequency 50/60 Hz).
III.
Switch on and leave for required time to degas the water.
IV.
Remove lid and carefully immerse the item in the fluid ensuring that any air contained within the item is
displaced. Irrigate cannulated devices.
V.
Re-place the lid and leave for the time recommended (15 minutes).
VI.
Switch off, lift the lid, remove the item and drain before transferring to a clean-rinse receptacle.
VII. Rinse thoroughly with clean water, ensuring irrigation of lumen devices, and drain.
VIII. Carefully hand-dry using absorbent, non-shedding cloth, industrial hot air dryer or place in a drying cabinet.
IX.
Complete the documentation.
X.
Proceed with sterilization.
STEP 3: Drying
Carefully hand-dry using absorbent, non-shedding cloth or industrial hot air dryer, or place in a drying cabinet.
STEP 4:
• All instruments and product components should be visually inspected for cleanness and any signs of deterioration
Inspection,
that may cause failure in use (such as cracks or damage to surfaces) and functions tested before being sterilized
maintenance
(see detailed Operative Technique Manuals and Instructions for use). Particular attention should be given to:
and testing
- Cannulated devices (NB: cannulated drill-bits are single-patient use only)
- Cutting edges: Discard blunt or damaged instruments
- Locking mechanisms should be checked for action.
• If a component or instrument is believed to be faulty, damaged or suspect, it should NOT BE USED.
• When instruments form part of an assembly, check assembly with matching components.
• Lubricate all parts, whenever required (see detailed Operative Technique Manuals).
STEP 5:
• PACKAGING: Where products are to be packaged to maintain their sterility after sterilization and to prevent damage
Sterilization
of the instrument prior to use, an appropriate medical grade packaging material should be used. The pack should be
large enough to contain the instruments without stressing the seals.
• STERILIZATION CONTAINERS: Instruments may be loaded into a dedicated (Orthofix) instrument tray,
or general-purpose sterilization tray. Cutting edges should be protected and the recommended content or maximum
weight not exceeded as indicated by manufacturer. Trays must be wrapped using FDA cleared sterilization wraps
made of a nonwoven blend of cellulose and polyester.
• STERILIZATION: Orthofix recommends to sterilize by steam, using a gravity displacement or dynamic-air-removal
cycle according to the parameters reported in the table below:
• Processed items should be stored in clean and secure stores to avoid damage or tampering.
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Страница 107: ...4 132 C 270 F 132 C 270 F 15 4 30 30 3 1 FDA Orthofix Orthofix 30 Orthofix 107...
Страница 108: ...Orthofix Orthofix 1 2 3 1 108...
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Страница 119: ...1 1 0 3 40 C 104 F 30 I II III IV V VI VII VIII IX X XI 119...
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Страница 130: ...Orthofix 130...
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Страница 163: ...1 Orthofix 1 30 Orthofix 1 1 Orthofix 1 Orthofix 1 2 3 1 0 3 40 C 104 F 30 163...
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