PARCUS MEDICAL
Parcus Ratcheting Handle Directions for Use
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Parcus Ratcheting Handle Important Product Information Produktinformationsblatt Información Importante sobre el Producto Informations Importantes sur le Produit Directions for Use Gebrauchsanleitung Instrucciones de uso Mode d’emploi
Parcus Ratcheting Handle
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Indications: The Parcus Ratcheting Handle is designed to interface with a variety of screwdriver shafts, bone taps and punches manufactured by Parcus Medical.
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Warnings: Instruments are provided non-sterile. Clean and sterilize prior to each use. Disassemble instruments with removable parts prior to cleaning and sterilization. During cleaning of tight lumina or drill holes special attention might be required. USA – RX ONLY – Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare practitioner.
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Advice: Devices which cannot be reprocessed by the following processes are labeled accordingly. Individual procedures accompanying those devices must be followed. In case of damage, the device should be reprocessed before returning to the manufacturer for repair.
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Reprocessing Limitations: Repeated reprocessing has minimal effect upon manual instruments. End of life is determined by wear and damage due to use.
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Preparation at the Point of Use: Remove gross soiling by submerging the instrument into cold water (<40°C) immediately after use. Don’t use a fixating detergent or hot water (>40°C) as this can cause the fixation of residue which may influence the result of the reprocessing process. Remove surface contamination with paper tissue.
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Containment / Transportation: Follow hospital protocols when handling contaminated and bio-hazardous materials. Instrument should be cleaned within 30 minutes after use to minimize the potential of staining, damage, and drying.
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Preparation for Decontamination: If possible, the devices must be reprocessed in a disassembled or open state.
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Pre-Cleaning: Not required.
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Cleaning: Manual Cleaning Process: • Rinse under running tap water (<40°C) until all visible soil has been removed. If needed, a soft bristle brush should be used to remove visible soil. • Submerge instruments in an enzymatic detergent (if ultrasonic bath is used, ultrasonic process of 3 minutes and ultrasonic frequency of 35 kHz have been shown to be effective.) Follow detergent manufacturer’s instructions. • Rinse the instrument under running tap water to remove the detergent.
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Disinfection: Manual Cleaning Process: • Submerge instruments in a disinfection detergent according to the detergent manufacturer’s instructions. • Rinse the instrument with sterile water to remove the detergent.
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Automated Cleaning: • Dry the outside of instrument through drying cycle of washer/disinfector. If needed, additional manual drying can be performed using a lint-free towel. Insufflate cavities of instruments by using sterile compressed air.
Inspection / Functional Testing: A. B. C. D. E.
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Automated Cleaning: • Automated Thermal Disinfection in washer/disinfector under consideration of national requirements in regards to A –Value. º
Drying: Manual Cleaning Process: • Dry the instrument with a lint-free towel. The instrument may never be heated up >140°C. To avoid water residues, insufflate cavities of instruments by using sterile compressed air.
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Automated Cleaning: • 4 minutes pre-washing with cold water (<40°C); • 6 minutes washing with 0,5% alkaline detergent at 55°C; 3 minutes neutralizing with warm water (>40°C) • 2 minutes intermediate rinsing with warm water (>40°C). • Follow automated washing machine manufacturer’s instructions.
Carefully inspect each device to ensure that all visible blood and soil have been removed. Visually inspect for damage and / or wear. Check the action of moving parts (such as hinges and box-locks) to ensure smooth operation throughout the intended range of motion. Check instruments with long slender features (particularly rotating instruments) for distortion. Where instruments form part of a larger assembly check that the devices assemble readily with mating components. Note: If damage or wear is noted that may compromise the function of the instrument, do not use the instrument, and notify the appropriate responsible person.
Packaging: Appropriate packaging for sterilization.
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Sterilization: A. B.
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Sterilize instruments by applying a fractionated pre-vacuum process (according DIN EN 554 / ISO 11134) under consideration of the respective country requirements. We have validated and recommend using the following parameters for the fractionated pre-vacuum process or gravity-process: 132°C – 137°C / 270° – 278, 6°F, (pressure depends on the temperature), 4 and < 20 minutes temperature holding time. Flash sterilization is not allowed on instruments with lumen!
Storage: Storage of sterilized instruments in a dry, clean and dust-free environment at modest temperatures of 5°C to 40°C.
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Maintenance: Lubricate moving parts with commercial water-based surgical grade instrument lubricant (such as instrument milk) to reduce friction and wear. Follow lubricant manufacturer’s instructions.
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Additional Advice: It is the duty of the use to ensure that the reprocessing processes are followed; that resources and materials are available to capable personnel; and that hospital protocols are followed.
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Directions for Use: A. B. C.
Connect the desired accessory shaft to the Parcus Ratcheting Handle by pulling the locking collar of the driver towards the proximal end of the driver. Insert the accessory shaft until it is fully engaged in the Ratcheting Screwdriver Handle. It will be necessary to align the flats of the shaft to the slot of the driver to fully seat the shaft. A fully seated shaft should allow the collar to slide towards the distal tip of the shaft, locking it in position.