Orthofix GALAXY UNYCO SYSTEM, Инструкция

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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.
IMPORTANT: The Power Drill Torque Limiter and the Limited Torque Wrench 99-93567 must be discarded 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 and Sterilization
WARNINGS
Aluminum based instruments are damaged by alkaline (pH>7) detergents and solutions. Anodised coating is damaged by detergents with free halogen ions or
sodium hydroxide. Detergents and disinfectants with fluoride, chloride, bromide, iodide or hydroxyl ions MUST NOT be used.
Limitations and restrictions on reprocessing
PRODUCTS LABELED FOR SINGLE-USE MUST NOT BE REUSED. Repeated reprocessing has minimal effect on reusable
instruments. End of life is normally determined by wear and damage due to use.
INSTRUCTIONS FOR PROCESSING NEW DEVICES SUPPLIED “NON-STERILE” PRIOR TO THEIR FIRST USE
General
• Unless supplied sterile, all Orthofix medical devices must be sterilized prior to surgical use.
• A new product means any device taken out of its original Orthofix packaging.
Recommended decontamination process
The following sequence of processes is recommended for rendering Orthofix UNYCO devices which are supplied non-sterile safe for their first clinical use:
1. CLEANING
2. STERILIZATION
Preparation for cleaning of new products
• When applicable, the devices should be disassembled completely.
• Wherever possible, all parts of disassembled devices should be kept together in one container.
STEP 1: Cleaning of new products
• REMOVE products from their original packaging. All equipment should be carefully examined prior to use to assure proper working condition.
• THOROUGHLY CLEAN with a woven-non woven tissue soaked using a solution of 70% medical grade alcohol and 30% distilled water or with compatible detergent. Detergents
with fluoride, chloride, bromide, iodide or hydroxyl ions MUST NOT be used.
• RINSE with sterile distilled water
STEP 2: Drying
• Carefully hand-dry using absorbent, non-shedding cloth or industrial hot air dryer, or place in a drying cabinet for 20 minutes at 110° C.
STEP 3: Preliminary inspection
• All instruments and product components should be visually inspected for cleanness and any signs of deterioration, that may cause failure in use (such as cracks or damage to
surfaces) and functions tested before being sterilized. Visually inspect for residual dirt/debris. If any dirt/debris remains repeat cleaning process until not dirt/debris can be
visually detected.
• 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.