Orthofix AGILE NAIL Gebrauchsanweisung Seite 4

IMPORTANT
A successful result is not achieved in every surgical case. Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical re-intervention to remove
or replace the internal fixation device.
Preoperative and operative procedures including knowledge of surgical techniques and proper selection and placement of the device are important considerations in the successful utilization of the devices by
the surgeon.
Proper patient selection and the patient's ability to comply with physician instructions and follow the prescribed treatment regimen will greatly affect the results. It is important to screen patients and select
optimal therapy given physical and/or mental activity requirements and/or limitations. If a surgical candidate exhibits any contraindication or is predisposed to any contraindication, DO NOT USE the ORTHOFIX
Agile Nail
.
MRI SAFETY INFORMATION
The Orthofix Agile Nail has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of
The Orthofix Agile Nail in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
INFORMATION
Instructions for processing and reprocessing
These instructions apply to Orthofix Agile Nail system fixation devices and instruments.
These reprocessing instructions were written in accordance with ISO17664 and have been validated by Orthofix in compliance with international standards. It is the responsibility of the health care facility to
ensure that the reprocessing is performed in accordance with instructions and to perform validation and routine monitoring of the process. Any deviation from these instructions is responsibility of the health
care facility in charge of reprocessing
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 must be 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;
• 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 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 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;
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