PARCUS MEDICAL
Parcus Medical Switching Stick Directions for Use
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Parcus Medical Switching Stick 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 Medical Switching Stick 1. Indications: The Parcus Switching Stick is designed to assist in the movement of cannulated instruments in and out of the various joints and to maintain the orientation and location of holes prepared in bone. The Switching Stick is designed to work with various Drill Guides and cannulas commonly used in arthroscopic procedures. 2. Warnings: A. This product is intended for use by or on the order of a physician. B. Do not use this product if it is bent or there is visible damage. C. This product is not intended for use as an implant. 3. Material: This device is manufactured from a Stainless Steel Alloy. The materials used in the manufacture of this device that are intended to be placed inside the body are radio-opaque and can, therefore, be detected with conventional X-Ray or fluoroscopy. 4. Inspection: A. Inspect the device for damage at all stages of handling. B. If damage is detected, consult the manufacturer for guidance. 5. Cleaning: A. Immediate rinsing and cleaning after use with an enzymatic detergent will effectively remove and prevent drying of adherent blood, tissue, etc. B. Scrub device with a soft brush, paying special attention to areas where debris might accumulate. Always avoid any harsh materials that can scratch or mar the surface of the device. C. Rinse the device thoroughly with water following the cleaning process. D. The device should be placed in an ultrasonic cleaning unit and processed according to the unit’s directions. E. The device should be rinsed thoroughly with water following the ultrasonic process. 6. Sterilization: This product is a non-sterile item that must be cleaned and sterilized prior to use. The following table provides recommended minimum sterilization parameters that have been validated by Parcus -6 Medical to provide a 10 sterility assurance level (SAL):
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Cycle Type
Minimum Temperature
Minimum Exposure Time (Wrapped)
Gravity
132°C / 270°F
15 minutes
Pre-vacuum
132°C / 270°F
4 minutes
Minimum Dry Time 30 minutes
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Drying times vary according to load size and should be increased for larger loads 7. Directions for use: A. Place the Switching Stick through a skin portal and pass an instrument, with a cannulation large enough to accommodate its diameter, over the Switching Stick and into the joint. B. Conversely, the Switching Stick may be used to exchange a previously placed cannulated instrument, with another, by placing the Switching Stick through the first instrument. The first instrument is extracted, leaving the Switching Stick behind. The second instrument is then passed over the Switching Stick and into the joint. C. The Switching Stick may be used as a marker to assist the surgeon in marking the location and directional orientation of holes drilled in bone. After using a drill bit through a guide to create a hole in the targeted bone, the drill is removed from the guide and replaced with the Switching Stick. The user should insure that the Switching Stick is inserted into the full depth of the hole. The guide is then removed leaving the Switching Stick behind to preserve the integrity of the hole and mark its location.