Orthofix Ltd
Ankle Hindfoot nailing System Instructions For The Safe Processing
146 Pages

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PQ AHR B 03/18
EN
Instructions For Use are subject to change; the most current version of each Instruction For Use is always available online.
Instructions for the Safe Processing of the
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ORTHOFIX® ANKLE HINDFOOT NAILING SYSTEM Orthofix Srl Via delle Nazioni 9 - 37012 Bussolengo (VR) Italy Tel. 0039 (0) 45 6719000 - Fax 0039 (0) 45 6719380 RX Only
Attention, see instructions for use PQ AHN.
Implants (nails, screws and end caps) of the Orthofix Ankle Hindfoot Nailing System are supplied only in STERILE version. Once an implant comes in contact with any human tissue or bodily fluid, it should not be resterilized and used. Please discard all contaminated implants. Instrumentation of the Orthofix Ankle Hindfoot Nailing System are supplied only in NOT STERILE version. 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: Detergents and disinfectants with fluoride, chloride, bromide, iodide MUST NOT be used.
Targeting Assembly
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INSTRUCTIONS FOR PROCESSING NEW DEVICES SUPPLIED “NON-STERILE” PRIOR TO THEIR FIRST USE AND FOR REPROCESSING OF REUSABLE DEVICES FOR SUBSEQUENT RE-USE General • 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. • Follow hospital protocols when handling contaminated and bio-hazardous materials. INSPECTION and MAINTENANCE • All instruments and product components should be visually inspected for cleanliness and any signs of deterioration that may cause failure during use (such as cracks or damage to surfaces) and functions tested before being used. 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. Wherever possible, all parts of disassembled devices should be kept together in one container. Recommended Orthofix decontamination process The following sequence of decontamination processes is recommended for reprocessing and rendering them safe for subsequent clinical use. 1. CLEANING AND DISINFECTION 2. STERILIZATION Preparation at the point of use of used devices • All used surgical instruments should be regarded as contaminated. Their handling, collection and transportation should be strictly controlled to minimize any possible risks to patients, personnel and any area of the healthcare facility. • It is recommended that instruments are reprocessed as soon as is reasonably practicable following use, putting them inside a sink filled with sterile cold water (< 40°C) immediately after use. 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. Remove surface contamination with a soft tissue. • Ensure that items are securely and safely packaged during transport to the decontamination area. STEP 1: Preparation for Cleaning - Disassembling
(177100) (177120) (177125)
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(177110)
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1 Unscrew the Nail Attachment Rod (177110) from Targeting Assembly simply by turning it anti-clockwise. 2 Unscrew the Heel Cup (177125) by turning it by hand anti-clockwise.
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3 (177026)
(A)
3 Remove Locking Cams (177026) and untighten Locking Screw (A).
4 135°
4 Depress button (351350) on Distal Targeting Arm (177120), align the WHITE dot of the Distal Targeting Arm with the BLACK dot on the shaft of the Proximal Targeting Arm (177100) and remove the Proximal Targeting Arm. STEP 2: Cleaning and disinfection • Cleaning is an essential pre-requisite to ensure effective disinfection or sterilization. • The preferred method of decontamination of used devices is described in the following section. Option 1: Manual cleaning 1) Soak the single components in the cleaning solution. Orthofix recommends the use of a pH-neutral cleaning agent with enzymes. Please refer to detergent’s manufacturer datasheet for concentration of the solution, required time and temperature. Orthofix recommends that the items are soaked for at least 20min at 40°C. 2) Brush the single components in the cleaning solution with a surface soft brush until all visible soiling is removed. Use a soft brush to remove residuals from lumens.
For the Targeting Assembly take special care in: • cleaning the threaded hole at the end of the Nail Attachment Rod (177110) Threaded hole (177110)
• cleaning the internal threads of the compression nut of the Heel Cup (177125)
(177125)
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• cleaning threaded and non-threaded holes in the Distal Targeting Arm (177120)
(177120)
• cleaning Proximal Targeting Arm (177100)
(177100)
• cleaning the internal threads of the Nut on the Targeting Assembly (177100)
(177100)
• cleaning the threads and threaded holes of all instruments
3) Ultrasonic clean the single components in a degassed cleaning solution. Orthofix recommends the use of a slightly alkaline solution containing trisodium nitrilotriacetate, 2,2’-iminodiethanol, diethanolamine. Please refer to detergent’s manufacturer datasheet for concentration of the solution, required time and temperature. Orthofix recommends that the items are cleaned for at least 15min at 31,6°C. 4) Brush the single components in running tap water (30sec). 5) Carefully hand-dry using absorbent, non-shedding cloth or industrial dryer. 6) Rinse the components in sterile deionized water. 7) Carefully hand-dry using absorbent, non-shedding cloth or industrial dryer. 5
Option 2: Automated cleaning 1) Place all the test instruments into washer baskets. 2) Orient instruments into the automated washer’s carriers as recommended by the washer manufacturer. 3) Orthofix recommends the use of a slightly alkaline solution containing trisodium nitrilotriacetate, 2,2’-iminodiethanol, diethanolamine. Please refer to detergent’s manufacturer datasheet for concentration of the solution, required time and temperature. Orthofix recommends that cycle parameters are at least as follows: 1. prewash at low temperatures (20°C) for 4 minutes 2. main wash at 55°C for 10 minutes 3. rinse with demineralized water for 3 minutes 4. thermal disinfect at 90°C with a holding time of 5 minutes. 4) Carefully hand-dry using absorbent, non-shedding cloth or industrial dryer. 5) Rinse the components in sterile deionized water 6) Carefully hand-dry using absorbent, non-shedding cloth or industrial dryer. STEP 3: Sterilization PACKAGING: Where products are to be packaged to maintain their sterility after sterilization and to prevent damage 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. • STERILIZATION: Sterilize by steam autoclaving, utilizing a fractioned pre-vacuum cycle or gravity cycle according to the table below. Trays must be wrapped using FDA approved sterilization wraps made of a nonwoven blend of cellulose and polyester. Steam Sterilizer type Preconditioning pulses Exposure Temperature Minimum Holding Time Drying Time
Gravity N/A 132°C (270°F) 15 minutes 30 minutes
Pre-vacuum 4 pulses 132°C (270°F) 4 minutes 30 minutes
STEP 4: Storage Store the sterilized instrument 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 should be adequately recorded. Likewise any deviation by the reprocessor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences and should also be appropriately recorded”. All Orthofix internal and external fixation products should be used together with their corresponding Orthofix implants, components and accessories. Their application should be performed with the specific Orthofix instrumentation, following carefully the surgical technique recommended by the manufacturer in the appropriate Operative Technique Manual.
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All Orthofix internal and external fixation products should be used together with their corresponding Orthofix implants, components and accessories. Their application should be performed with the specific Orthofix instrumentation, following carefully the surgical technique recommended by the manufacturer in the appropriate Operative Technique Manual.
Description
Symbol
Consult instructions for Use
Single use. Do not reuse
STERILE. Sterilised by irradiation
NON STERILE
NON STERILE Catalogue number
Lot number
Expiry date (year-month-day)
0123
CE marking in conformity to applicable European Directives/Regulations
Date of manufacture
Manufacturer
Do not use if package is opened or damaged
MR
MR
Symbol for MR conditional. This means an item has been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use.
Symbol for MR unsafe. This means an item is known to pose hazards in all MRI environments.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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