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VENTRICULOSTOMY RESERVOIR SET (Selker Design)

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VENTRICULOSTOMY RESERVOIR SET (Selker Design) Integra LifeSciences Production Corporation 11 Cabot Boulevard Mansfield, MA 02048 USA Integra LifeSciences Services (France) Immeuble Séquoïa 2 97 Allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest – France LCN 825-1626-85 Rev P 02/20 1372777-3 ©2020 Integra LifeSciences Corporation. All rights reserved. This page is intentionally left blank. Ventriculostomy Reservoir Set 1 ENGLISH F. Reservoir A. Suture tab G. Pen B. Suture tab H. Nylon reservoir C. Cap I. Pen D. Cap J. Groot E. Reservoir K. Klein F. Reservoir G. Plug ITALIANO H. Nylon reservoir A. Linguetta di sutura I. Plug B. Linguetta di sutura J. Large C. Coperchio K. Small D. Coperchio E. Serbatoio FRANÇAIS F. Serbatoio A. Languette de suture G. Tappo B. Languette de suture H. Serbatoio in nylon C. Capuchon I. Tappo D. Capuchon J. Grande E. Réservoir K. Piccolo F. Réservoir G. Bouchon ESPAÑOL H. Réservoir nylon A. Borde de sutura I. Bouchon B. Borde de sutura J. Grand C. Tapa K. Petit D. Tapa E. Reservorio DEUTSCH F. Reservorio A. Nahtlasche G. Obturador B. Nahtlasche H. Reservorio de nailon C. Kappe I. Obturador D. Kappe J. Grande E. Reservoir K. Pequeño F. Reservoir G. Stöpsel PORTUGUÊS H. Réservoir nylon A. Patilha de sutura I. Stöpsel B. Patilha de sutura J. Groß C. Tampa K. Klein D. Tampa E. Reservatório NEDERLANDS F. Reservatório A. Hechtdraadlipje G. Tampão B. Hechtdraadlipje H. Reservatório de nylon C. Dop I. Tomada D. Dop J. Grande E. Reservoir K. Pequeno i Ventriculostomy Reservoir Set 2 ii ENGLISH IMPORTANT INFORMATION Please Read Before Use Ventriculostomy Reservoir Set (Selker Design) STERILE EO Description The Ventriculostomy Reservoir Set contains a Selker Design reservoir with preassembled cap and plug, a ventricular catheter, and a stylet. The Selker Design reservoir is a flat base nylon reservoir. Attached to the reservoir is a radiopaque silicone rubber cap with a nylon plug inserted in the lumen of the side arm. The plug is left in place for simple ventriculostomy and is removed when the reservoir is connected to the HOLTER®-Valve System. The cap is equipped with four tabs to aid suturing. The reservoir is available in large (82-1619) and small (82-1618). See Figure 1. The 15 cm straight, ventricular catheter is a radiopaque silicone rubber catheter, with a nominal inside diameter of 1.5 mm and a nominal outside diameter of 3.1 mm. The stainless steel stylet is furnished for inserting the catheter into a ventricle or other intracranial cavity. Indications The Ventriculostomy Reservoir Set is indicated for use to gain access to the cerebral ventricles or other intracranial cavities for the purpose of diagnostic studies or therapeutic drug administration with or without a shunting device.1–4 When used with a shunting device, the Ventriculostomy Reservoir is also indicated for use as the proximal fluid pathway.1–4 Contraindications This device is not designed, sold, or intended for use except as indicated. Magnetic Resonance Imaging (MRI) Information The Ventriculostomy Reservoir Set, catalog numbers 82-1618 and 82-1619, have no materials that are metallic or conducting and, therefore, are “MR Safe” in accordance with the American Society for Testing and Materials (ASTM) Standard F2503. WARNING Ventricular catheter obstruction5,6 and subcutaneous leakage of cerebrospinal fluid2 have been reported in the use of ventricular catheters and reservoirs and must be assumed to be potential complications in the use of the Ventriculostomy Reservoir Set. 1 PRECAUTIONS Inspect the sterile package carefully. Do not use if: • the package or seal appears damaged, • contents appear damaged, or • the expiry date has passed. Exercise extreme care to prevent the silicone rubber components from coming in contact with towels, drapes, talc, and other granular or linty surfaces. Silicone rubber is very electrostatic, attracting airborne particles and surface contaminants which could produce tissue reaction. Since silicone rubber has a low cut and tear resistance, stainless steel ligatures should not be used, and ligatures should not be tied too tightly. The stylet is for a single use only. Observe aseptic technique throughout placement and use of the Ventriculostomy Reservoir Set. Sterility 2 This product is for SINGLE USE ONLY; DO NOT RESTERILIZE. Use aseptic technique in all phases of handling. Integra LifeSciences will not be responsible for any product that is resterilized, nor will we accept for credit or exchange any product that has been opened but not used. Integra Single Use devices have not been designed to undergo or withstand any form of alteration, such as disassembly, cleaning or re-sterilization, after a single patient use. These devices are intended to come into contact with the central nervous system and the ability does not currently exist to destroy possible contaminates such as Creutzfeldt-Jakob Disease. Reuse can also compromise device performance and any usage beyond the design intent of this single-use device can result in unpredictable use hazards or loss of functionality. (THIS STATEMENT APPLIES TO NON- IMPLANTABLE COMPONENTS ONLY.) As long as the individual package of the Ventriculostomy Reservoir Set is not opened or damaged, the product is sterile. Recommended Instructions for Use The instructions printed below are a general guide provided for informational purposes only. The physician may wish to alter procedural details in light of his or her own clinical judgment and experience. 1. Distend the pericranium with saline to separate it from the galea. 2. Fashion a half-moon incision over the parieto-occipital scalp area. 3. Reflect the skin and galea with the pericranium remaining attached to the skull. 4. Open the pericranium with a half-moon incision, positioned so the pericranial flap will be reflected opposite the scalp flap. 5. Perform a standard small burr hole, large enough to accommodate the ventricular catheter. 2 6. Electrocoagulate and penetrate the dura and arachnoid with a #11 blade, using the Bovie to maintain hemostasis. 7. Using the enclosed stylet, introduce the ventricular catheter through the dural opening and advance it into the lateral ventricle. NOTE: It is recommended that the catheter tip be located in the frontal horn of the ventricle of the non-dominant hemisphere whenever possible.1 8. Remove the stylet; free flow of the cerebrospinal fluid should occur. Clamp the catheter with a rubber-shod hemostat or other device suitable for use on silicone rubber. Simple Ventriculostomy 1. Secure the nylon plug in the lumen of the side arm with 3-0 or 4-0 silk ligatures. 2. Connect the reservoir to the ventricular catheter using 3-0 or 4-0 silk ligatures. The reservoir should be flush against the skull. 3. Replace the pericranial flap over the reservoir and secure by placing a suture through the pericranium to each tab on the reservoir cap. Suture the pericranial flap in place. 4. Close the scalp using sutures of choice. With HOLTER Valve System 1. Remove the nylon plug from the lumen of the side arm. 2. Make the appropriate connections to the HOLTER Valve and distal catheter. Injection To inhibit coring of the reservoir cap, a HUBER™-point needle (24- or 26- gauge) should be used to penetrate the dome. Insert the needle at an oblique angle to achieve the greatest yield of CSF and to prevent the needle point from piercing the ventricular catheter (Figure 2).7 References 1. Rickham PP, Penn IA: The place of the ventriculostomy reservoir in the treatment of myelomeningoceles and hydrocephalus. Dev Med Child Neurol 7:296–301, 1965. 2. Ratcheson RA, Ommaya AK: Experience with the subcutaneous cerebrospinal fluid reservoir. N Engl J Med 279:1025–1031, 1968. 3. Diamond RD, Bennett JE: A subcutaneous reservoir for intrathecal therapy of fungal meningitis. N Engl J Med 288:186–188, 1973. 4. Thomas GG, Cudmore RE: The advantages of a ventriculostomy reservoir with a HOLTER valve system. J Pediatr Surg 11:63–67, 1976. 5. Forrest DM, Cooper DGW: Complications of ventriculo-atrial shunts. J Neurosurg 27:506–512, 1968. 6. Becker DP, Nulsen FE: Control of hydrocephalus by valve- regulated venous shunt: avoidance of complications in prolonged shunt maintenance. J Neurosurg 27:215–226, 1968. 3 7. Yonekawa Y, Nishikawa M, Egli M, et al: A clinical and experimental study of meglumine iocarmate: a complication of positive contrast ventriculography. Surg Neurol 5:167–170, 1976. 8. Sommers M, “Examination of the physical and imaging effects of non-ferromagnetic neurosurgical implants on magnetic resonance imaging scans (M.R.I.),” (July, 1984). A report based on comprehensive studies at Children’s Hospital, Chicago, IL. PRODUCT INFORMATION DISCLOSURE INTEGRA LIFESCIENCES CORPORATION (“INTEGRA”) HAS EXERCISED REASONABLE CARE IN THE SELECTION OF MATERIALS AND THE MANUFACTURE OF THESE PRODUCTS. INTEGRA WARRANTS THAT THESE PRODUCTS SHALL CONFORM TO THE PRODUCT LIMITED WARRANTY AS PROVIDED IN THE PRODUCT LABELING OR APPLICABLE PRODUCT CATALOG. THIS WARRANTY IS EXCLUSIVE, AND INTEGRA DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. INTEGRA SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE OF THESE PRODUCTS. INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS. Codman and Holter are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. Huber is a trademark of Becton, Dickinson, and Co. FRANÇAIS INFORMATIONS IMPORTANTES À lire avant utilisation Ensemble réservoir de ventriculostomie (type Selker) STERILE EO Description L’ensemble réservoir de ventriculostomie contient un réservoir de type Selker avec un capuchon et un bouchon préassemblés, un cathéter ventriculaire et un stylet.
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  • Do You Know Your Kitchen Equipment?

    Do You Know Your Kitchen Equipment?

    Cardinal Ice Equipment, Inc. Cardinal Ice Equipment, Inc. 3311 Gilmore Industrial Blvd. 1315 Read Street Unit I Louisville, KY 40213 Evansville, IN 47710 T 502 966 4579 T 812 468 8550 F 502 966 4098 F 812 468 8560 Do You Know Your Kitchen Equipment? 1. Every good chef needs an assortment of knives at his disposal. What type of knife would be best suited for slicing up a loaf of sour dough? Fillet knife Chef's knife Serrated knife Paring knife 2. This special utensil is commonly used to remove the top part of the skin from fruit like oranges and lemons. Grater Peeler Zester Scoop 3. Which of the following items listed below does not fit with the others? Sieve Colander Strainer Ricer Manitowoc American Blue Air True 3M Water Sinks & Ice Range Refrigeration Manufacturing Filtration Tables Multiplex Delfield Servend WelBilt RDI Ice Bags Cardinal Ice Equipment, Inc. Cardinal Ice Equipment, Inc. 3311 Gilmore Industrial Blvd. 1315 Read Street Unit I Louisville, KY 40213 Evansville, IN 47710 T 502 966 4579 T 812 468 8550 F 502 966 4098 F 812 468 8560 Do You Know Your Kitchen Equipment? 4. One very specialized tool found in the kitchen drawer has the singular purpose of cutting out small balls of fruit. It is called a ________ baller. Pineapple Melon Cantaloupe Jackie 5. A bain-marie can be used in the kitchen to melt chocolate or make custards and sauces. What is it more commonly known as? Crockpot Double boiler Browning tray Pressure cooker 6. This interesting kitchen aid is a perforated pot with a hand turned scraper.