Orthofix Ltd
Orthofix Lateral Angled and Anterior Disc Prep Surgical Instrumentation System Instructions
30 Pages

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Orthofix Lateral Angled and Anterior Disc Prep Surgical Instrumentation System Instructions For Use Translations available (click on language to advance to translation): LANGUAGE English (EN) French (Français - FR) German (Deutsch - DE) Italian (Italiano - IT) Portuguese (Português – PT) Spanish (Español – ES)
Catalog Number Description Orthofix ALIF Disc Prep 22mm Cobb Elevator 10-6503-220-02 6mm Small Curette, Straight 10-6504-060-02 4mm Small Curette, Up 10-6504-042-02 6mm Small Curette, Down 10-6504-064-02 8mm Large Curette, Straight 10-6504-080-02 8mm Large Curette, Up 10-6504-082-02 8mm Large Curette, Down 10-6504-084-02 Ring Curette 10-6505-090-02 Anatomical Rasp 10-6508-150-02 Chisel 10-6501-160-02 Long Annulotomy Blade Holder 10-6514-010-00 2mm Pituitary Rongeur 10-6511-020-00 4mm Pituitary Rongeur 10-6511-040-00 6mm Pituitary Rongeur 10-6511-060-00 2mm Kerrison Rongeur 10-6512-020-00 4mm Kerrison Rongeur 10-6512-040-00 6mm Kerrison Rongeur 10-6512-060-00 5mm Sypert Rongeur 10-6513-050-00 10mm Sypert Rongeur 10-6513-100-00 Ratcheting Distractor 10-6510-114-00 ALIF Disc Prep Instrument Case 1 6378-100-101 ALIF Disc Prep Instrument Case 2 6378-100-201 ALIF Disc Prep Case 1 - Base 6378-150-102 ALIF Disc Prep Case 2 - Base 6378-150-202 ALIF Disc Prep Case 1 - Curettes Tray 6378-154-101 ALIF Disc Prep Case 1 - Auxiliary Tray 6378-154-201 ALIF Disc Prep Case 2 - Distractor/Syperts 6378-154-301 Tray ALIF Disc Prep Case 2 6378-154-401 Pituitaries/Kerrisons Tray 10-6500-100-00
ALIF Disc Prep Instrumentation System, Case 1
10-6500-200-00
ALIF Disc Prep Instrumentation System, Case 2
RD_IFU-18002-0005 Rev. A
Catalog Number
Description
Orthofix Skyhawk® Lateral Angled 10-5503-182-01 18mm Cobb Elevator, Up 10-5503-184-01 18mm Cobb Elevator, Down 10-5503-222-01 22mm Cobb Elevator, Up 10-5503-224-01 22mm Cobb Elevator, Down 10-5504-042-01 4mm Curette, Up 10-5504-044-01 4mm Curette, Down 10-5504-062-01 6mm Curette, Up 10-5504-064-01 6mm Curette, Down 10-5506-092-01 9mm Scraper Curette 10-5508-102-01 Rasp, Up 10-5508-104-01 Rasp, Down 10-5518-150-01 Malleable Slide 10-5511-046-00 Pituitary Rongeur, Left 10-5511-048-00 Pituitary Rongeur, Right 6314-100-101 Disc Prep Angled Instruments Case 6314-150-102 Lateral Angled Case – Base 6314-152-101 Lateral Angled Case – Lid 6314-154-101 Lateral Angled Case – Pituitary Tray 6314-154-201 Lateral Angled Case – Curette Tray 6314-154-301 Lateral Angled Case – Cobbs/Rasps Tray 10-5500-100-00 Lateral Angled Instrumentation System
Languages and Part Lists
English EN Lateral Angled and Anterior Disc Prep Surgical Instrumentation System Instructions INTENDED USE The Disc Preparation Surgical Instrumentation Systems are intended to offer a comprehensive set of surgical instruments to prepare the intervertebral disc space for interbody spinal fusion. INTENDED USER PROFILE • •
Surgical procedures should be performed only by persons having adequate training and familiarity with surgical techniques including progressive reaming procedures. Consult medical literature relative to techniques, complications and hazards prior to performance of any surgical procedure. Before using the product, all instructions regarding its safety features must be read carefully.
DEVICE DESCRIPTION • • • • •
Surgical instruments comprising fixed assemblies, simple hinged instruments and simple assemblies generally composed of medical grade stainless steels, titanium, aluminum and silicone rubber. Instrument case and trays may consist of different materials including stainless steels, aluminum and silicone mats. Devices are supplied NON-STERILE and must be inspected, cleaned and sterilized before each use. Devices are critical and require terminal sterilization. Devices are not implantable.
WARNINGS • • • • • • • • •
Avalign recommends thorough manual and automated cleaning of medical devices prior to sterilization. Automated methods alone may not adequately clean devices. Devices should be reprocessed as soon as possible following use. Instruments must be cleaned separately from cases and trays. All cleaning agent solutions should be replaced frequently before becoming heavily soiled. Prior to cleaning, sterilization and use, remove all protective caps carefully. All instruments should be inspected to ensure proper function and condition. Do not use instruments if they do not perform satisfactorily. The sterilization methods described have been validated with the devices in predetermined placement locations per the case and tray designs. Areas intended for specific devices shall contain only those devices. Risk of damage – The surgical instruments are precision devices. Careful handling is important for the accurate functioning of the devices. Improper external handling can cause the devices to malfunction. Use caution when handling sharp instruments to avoid injury. Wash the instrument case and trays with an aluminum safe, neutral pH detergent to avoid faded surface colors and deterioration of anodized surfaces. If a device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross-contamination.
CAUTION
Federal U.S. Law restricts this device to sale, distribution, and use, by, or on order of a physician. LIMITATIONS ON REPROCESSING Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and damage due to use. DISCLAIMER It is the responsibility of the reprocessor to ensure reprocessing is performed using equipment, materials and personnel in the reprocessing facility and achieves the desired result. This requires validation and routine monitoring of the process. Any deviation by the reprocessor from the instructions provided must be properly evaluated for effectiveness and potential adverse consequences.
RD_IFU-18002-0005 Rev. A
English
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Reprocessing Instructions TOOLS AND ACCESSORIES Water Cleaning Agents Accessories
Equipment
Cold Tap Water (< 20°C / 68°F) Hot Tap Water (> 40°C / 104°F) Deionized (DI) or Reverse Osmosis (RO) Water (ambient) Neutral Detergent pH 6.0-8.0 i.e. Liqui-nox, Valsure Assorted Sizes of Brushes and/or Pipe Cleaners with Nylon Bristles Sterile Syringes or equivalent Absorbent, Low Lint Disposable Cloths or equivalent Soaking Pans Medical Compressed Air Ultrasonic Cleaner (Sonicator) Automated Washer
POINT-OF-USE AND CONTAINMENT 1)
2) 3)
Follow health care facility point of use practices. Keep devices moist after use to prevent soil from drying and remove excess soil and debris from all surfaces, crevices, sliding mechanisms, hinged joints, and all other hard-to-clean design features. Follow universal precautions and contain devices in closed or covered containers for transport to central supply. All devices must be cleaned in the completely open and disassembled (i.e. taken apart) configuration.
MANUAL CLEANING 4)
Prepare neutral pH enzymatic detergent per vendor’s directions. Enzol® enzymatic detergent is recommended at a preparation of 1 oz./gallon using lukewarm water. 5) Fully immerse device in the prepared detergent per labeling instructions. Allow device to soak for a minimum of 1 minute. 6) Actuate all movable parts during the soak time to allow complete penetration of detergent to hard to reach areas. 7) Scrub the device, using a soft bristled brush (may also include a syringe and pipe cleaner), paying particular attention to movable parts, crevices, and other hard to reach areas until all visible soil has been removed. a) For lumen devices, flush internal lumens with detergent using an appropriately sized syringe at least 7 times with a minimum of 15mL of detergent. If available, use flush ports for flushing. 8) Prepare neutral pH enzymatic detergent in the sonicator (as per vendor directions) and sonicate the instruments for a minimum of 10 minutes. Note: Enzyme solution shall be changed when it becomes grossly contaminated (bloody and/or turbid). 9) Rinse all surfaces and crevices in running reverse osmosis or deionized (RO/DI) water for a minimum of 3 minutes to remove any residual detergent or debris. a) For lumen devices, flush internal lumens a minimum of 3 times with RO/DI water (minimum of 15mL) using an appropriately sized syringe. If available, use flush ports for flushing. 10) Dry the instrument with a clean, soft cloth. Filtered, compressed air may be used to aid drying. 11) Visually examine each instrument for cleanliness. If visible soil remains, repeat cleaning procedure. AUTOMATED CLEANING Note: All devices must be manually pre-cleaned prior to any automated cleaning process, follow steps 1-7. Steps 8-11 are optional but advised. 12) Clean devices within a washer/disinfector utilizing the equipment and detergent manufacturers’ instructions per the below minimum parameters. Detergent Type & Phase Time (minutes) Temperature Concentration Pre-wash 1 02:00 Cold Tap Water N/A Enzyme Wash 02:00 Hot Tap Water Enzyme Detergent Rinse 1 01:00 Hot Tap Water N/A Purified Water Rinse 00:10 146-150°F / 63-66°C N/A Drying 15:00 194°F / 90°C N/A 13) Dry excess moisture using an absorbent cloth. Dry any internal areas with filtered, compressed air. 14) Visually examine each instrument for cleanliness. If visible soil remains, repeat cleaning procedure.
RD_IFU-18002-0005 Rev. A
English
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DISINFECTION • • • •
Devices must be terminally sterilized (See § Sterilization). Avalign instruments are compatible with washer/disinfector time-temperature profiles for thermal disinfection per ISO 15883. Load the devices in the washer-disinfector according to the manufacturer’s instructions, ensuring that the devices and lumens can drain freely. The following automated cycles are examples of validated cycles: Recirculation Time (min.) 1 5
Phase Thermal Disinfection Thermal Disinfection
Water Temperature >90°C (194°F) >90°C (194°F)
Water Type RI/DO Water RI/DO Water
INSPECTION AND FUNCTIONAL TESTING • • •
Check for smooth movement of hinges. Locking mechanisms should be free of nicks. Devices with broken, cracked, chipped or worn parts should not be used, but should be replaced immediately. Lubricate instruments before autoclaving with Instra-Lube, or a steam permeable instrument lubricant.
PACKAGING • • • •
Only FDA cleared sterilization packaging materials should be used by the end user when packaging the devices. The end user should consult ANSI/AAMI ST79 or ISO 17665-1 for additional information on steam sterilization. Sterilization Wrap o Cases may be wrapped in a standard, medical grade sterilization wrap using the AAMI double wrap method or equivalent. Rigid Sterilization Container o For information regarding rigid sterilization containers, please refer to appropriate instructions for use provided by the container manufacturer or contact the manufacturer directly for guidance.
STERILIZATION Sterilize with steam. The following are minimum cycles required for steam sterilization of Avalign devices:
Double Wrapped Instrument Case:
• •
•
•
Cycle Type Prevacuum
Temperature 132°C (270°F)
Exposure Time 4 minutes
Pulses 4
Drying Time 30 minutes
Gravity Displacement
132°C (270°F)
15 minutes
N/A
30 minutes
The operating instructions and guidelines for maximum load configuration of the sterilizer manufacturer should be followed explicitly. The sterilizer must be properly installed, maintained, and calibrated. Time and temperature parameters required for sterilization vary according to the type of sterilizer, cycle design, and packaging material. It is critical that process parameters be validated for each facility’s individual type of sterilization equipment and product load configuration. A facility may choose to use different steam sterilization cycles other than the cycle suggested if the facility has properly validated the cycle to ensure adequate steam penetration and contact with the devices for sterilization. Note: rigid sterilization containers cannot be used in gravity steam cycles. Water droplets and visible signs of moisture on sterile packaging/wrap or the tape used to secure it may compromise the sterility of the processed loads or be indicative of a sterilization process failure. Visually check outside wrap for dryness. If there are water droplets for visible moisture observed the pack or instrument tray is considered unacceptable. Repackaging and re-sterilize the packages with visible signs of moisture.
STORAGE • •
After sterilization, instruments should remain in sterilization packaging and be stored in a clean, dry cabinet or storage case. Care should be taken when handling devices to avoid damaging the sterile barrier.
RD_IFU-18002-0005 Rev. A
English
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MAINTENANCE • •
Attention: Apply lubricant only on the connecting elements (locking mechanism) and moving parts. Discard damaged, worn or non-functional devices.
WARRANTY • •
All products are guaranteed to be free from defects in material and workmanship at the time of shipping. Avalign instruments are reusable and meet AAMI standards for sterilization. All our products are designed and manufactured to meet the highest quality standards. We cannot accept liability for failure of products which have been modified in any way from their original design.
CONTACT • Notice to Patient and User: Any serious incident that has occurred in relation to the medical devices should be reported to the manufacturer and the competent authority of the EU Member State in which the user and/or patient is established.
Authorized Representative Case and Tray: Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands
Manufactured by: Avalign Technologies 8727 Clinton Park Drive Fort Wayne, IN 46825 1-877-289-1096 www.avalign.com [email protected]
Authorized Representative Instruments: Instrumed GmbH (dba Avalign German Specialty Instruments) Unter Buchsteig 3 78 532 Tuttlingen, Germany
Distributed by: Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056 (214) 937-2000 Australian Sponsor: Emergo Australia Level 20, Tower II Darling Park 201 Sussex Street Sydney, NSW 2000 Australia
Label Glossary Symbol
Title and Translations
Symbol
Manufacturer and
Title and Translations Consult Instructions for Use
Date of Manufacture Authorized Representative in the European Community
Caution
Lot Number / Batch Code
Federal Law (USA) restricts this device to sale by or on the order of a physician
Catalogue Number
Medical Device
Not Sterile
RD_IFU-18002-0005 Rev. A
English
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