Cleaning, Sterilization And Maintenance - Orthofix G-Beam Fusion Beaming System Gebrauchsanweisung

STERILE & NON-STERILE Product
Orthofix provides certain devices STERILE while others are provided NON-STERILE. Please review the product label to determine the sterility of each device.
Sterile
Devices or kits provided STERILE are labeled as such. Contents of package are STERILE unless package is opened or damaged. Do not use if package is opened or damaged.
Non-Sterile
Unless otherwise noted, Orthofix external fixation components are provided NON-STERILE. Orthofix recommends that all NON-STERILE components be properly cleaned and sterilized following the recommended
cleaning and sterilization procedures. Product integrity and performance are assured only if packaging is undamaged.

CLEANING, STERILIZATION AND MAINTENANCE

Cleaning is an essential pre-requisite to ensure effective disinfection or sterilization. All instruments (including trays) must be thoroughly cleaned prior to use and after each re-use of the instruments. Cleaning may be
done following the validated cleaning process described below and using washing instruments and machines validated by the hospital.
Warnings
• The personnel that works with contaminated medical devices must follow safety precautions as per the procedure of the healthcare facility.
• Aluminium based instruments are damaged by alkaline (pH>7) detergents and solutions.
• Cleaning solutions with a pH 7-9.5 are recommended. Cleaning solutions with an higher pH value must be avoided.
• Detergents and disinfectants with fluoride, chloride, bromide, iodide or hydroxyl ions MUST NOT be used. The contact with saline solutions should be minimized.
• Complex devices such as those with hinges, lumens or mated surfaces must be thoroughly manually pre-cleaned before automated washing in order to remove soiling that accumulates in recesses.
Limitations and restrictions on reprocessing
• Repeated reprocessing has minimal effect on reusable fixators and instruments;
• End of life is normally determined by wear and damage due to use;
• Products labeled for Single Use only must not be reused regardless any reprocessing;
Point of use
• It is recommended that instruments are reprocessed as soon as is reasonably practicable following use, putting them inside a sink filled with cold water (< 40°C) or a neutral pH solution for at least
10 minutes and removing gross soiling with a soft cloth or a soft brush.
• Don't use a fixating detergent or hot water as this can cause the fixation of residue which may influence the result of the reprocessing process.
Containment and transportation
• Follow hospital protocols when handling contaminated and bio-hazardous materials. Used instruments should be covered to minimize the risk of cross contamination.
• All used surgical instruments must be regarded as contaminated. Their handling, collection and transportation must be strictly controlled to minimize any possible risks to patients, personnel and any area
of the healthcare facility.
Preparation for decontamination
• Disassemble the devices where applicable. See Orthofix operative techniques for further details.
Cleaning: Manual
1. Soak the single components in the cleaning solution. Orthofix recommends the use of a pH-neutral enzymatic cleaning agent. Please refer to detergent' s manufacturer datasheet for concentration of the solution,
required time and temperature.
2. Thoroughly scrub the single components in the cleaning solution with a soft brush for at least 5 minutes or until all visible soiling is removed. Metal brushes should be avoided. Use a soft brush to remove
residuals from lumens using a twisting motion and use a syringe filled with detergent if necessary. When cleaning hinges make sure that all areas are reached.
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.
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