C-QUR * CentriFX * O3FA Filament Coated Polypropylene Mesh

Transcription

1 C-QUR * CentriFX * O3FA Filament Coated Polypropylene Mesh Instructions For Use

2 Instructions For Use Device Tracking Labels The enclosed Device Tracking Labels should be attached to the patient/hospital records. Description C-QUR CentriFX Mesh is a sterile, knitted polypropylene monofilament mesh material for tissue reinforcement with a bio-absorbable, animal derived oil coating (O3FA) composed of fatty acids, lipids and glycerides, coated on the monofilaments. The C-QUR CentriFX Mesh three dimensional shape and filament coated surface allows for anatomical positioning and placement during laparoscopic inguinal hernia repair. The medial edge of C-QUR CentriFX Mesh is marked for ease of placement. Indications for Use C-QUR CentriFX Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material. Contraindications 1. Do not use C-QUR CentriFX Mesh in infants, children, or pregnant women whereby future growth may be compromised by use of such material. 2. Do not use C-QUR CentriFX Mesh for pelvic floor repair, pelvic organ prolapse (POP) repair or surgical treatment of stress urinary incontinence (SUI). 3. Do not use C-QUR CentriFX Mesh where tissue may be contaminated or infected. Warnings 1. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. 2. For single use only. Do not reuse, reprocess, repackage or resterilize. Reuse, reprocessing, repackaging and/or resterilization may compromise the structural integrity of the device and/or lead to device failure potentially resulting in injury to the patient. Reuse, reprocessing, repackaging and/or resterilization may also create a risk of device contamination. Contamination of the device may lead to patient injury, illness or death. 3. This device is supplied sterile. Please inspect packaging to ensure it is intact and not damaged prior to use. Do not use if package is damaged or opened. 4. Adequate mesh fixation is required to minimize post-operative complications and recurrence. The fixation technique, method and products used (including sutures, tacks, staples or other means) is left to the discretion of the surgeon to optimize clinical outcomes. 5. It is important to orient C-QUR CentriFX Mesh correctly to prevent recurrence. The absorbable coating is located on the polypropylene monofilaments of the mesh and is NOT a tissue separating layer. Avoid direct contact with the viscera (intestines) to minimize the possibility of adhesions. Do not use a C-QUR CentriFX Mesh in patients where tissue separation is of particular concern. 6. To minimize the risk of recurrence when repairing hernias, the mesh should be large enough to extend beyond the margins of the defect. Precautions 1. Please read all instructions prior to use. 2. Inspect the C-QUR CentriFX Mesh for any noticeable damage to the knit construction of the mesh. Do not use a C-QUR CentriFX that has any noticeable damage or disruption to the knit construction of the mesh as this may lead to device failure. 3. Care should be taken to ensure the mesh is cut cleanly to avoid disrupting the monofilament knit structure or coating at the cut location. 4. Do not apply excessive force to the mesh during insertion through the trocar. If the C-QUR CentriFX Mesh does not easily deploy down the trocar, remove the trocar and insert the mesh through the skin incision. 5. Handling of mesh should be with clean sterile gloves and/or instruments. 6. Careful attention to surgical mesh handling, suture, staple or tack fixation is required in the presence of nerves and vessels in the surgical field. Adverse Reactions Complications that may occur with the use of any surgical mesh include, but are not limited to pain, inflammation, infection, allergic reaction, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs. The patient should be advised to contact the physician should an adverse reaction occur. Handling and Operative Techniques Open Sterile Package: Peel open the package. C-QUR CentriFX Mesh is packaged in a preformed tray for handling in the sterile field. Open the preformed tray. Mesh must be removed from the preformed tray using proper sterile technique prior to use. The preformed tray is not for implantation. en Some variation in the color of C-QUR CentriFX Mesh is expected as the O3FA coating is manufactured using an animal derived oil which may vary in color. Sizing: C-QUR CentriFX Mesh should be shaped, sized and anchored taking into consideration the anatomical location as well as the patient s posture and weight. In order to minimize disruption of the fixation points, C-QUR CentriFX Mesh should be sized and positioned so that it extends beyond the margins of the defect. C-QUR CentriFX Mesh can be shaped and sized using surgical scissors. Ensure the mesh is cut cleanly to avoid disrupting the monofilament knit structure or coating at the cut location. Trocar Insertion: C-QUR CentriFX Mesh should be rolled tightly about its long axis (lengthwise). A minimum sized trocar of 12 mm is recommended for laparoscopic delivery of the mesh. Do not apply excessive force to the mesh during insertion through the trocar. If the C-QUR CentriFX Mesh does not easily deploy down the trocar, remove the trocar and insert the mesh through the skin incision. Orientation: It is important to orient C-QUR CentriFX Mesh correctly for proper function. The edge of the mesh containing the medial markers is to be placed medially to ensure that the mesh adequately covers and conforms to the inguinal anatomy in order to help prevent and avoid recurrence. Fixation: Careful attention to suture, staple and/or tack placement and spacing will help prevent excessive tension or disruption of the mesh material and/or underlying tissue. It is recommended that sutures, staples and/or tacks be placed a minimum of 6.5 mm from the edge of the mesh and spaced 2 cm apart from each other for best results. MRI Compatibility C-QUR CentriFX Mesh is MR Safe. Sterilization and Storage C-QUR CentriFX Mesh is an Ethylene Oxide sterilized single use device. Store in a Controlled Room Temperature of 25 ºC (77 ºF) or less. Brief exposure up to 40 ºC (104 ºF) is acceptable. Symbols Used On Product Labels h CATALOGUE NUMBER g BATCH CODE DIMENSIONS BOX QUANTITY PEEL HERE TO OPEN SMALL MEDIUM LARGE EXTRA LARGE H USE-BY DATE B DO NOT RESTERILIZE MR SAFE UPPER LIMIT OF TEMPERATURE IQ STERILIZED USING ETHYLENE OXIDE L DO NOT USE IF PACKAGE IS DAMAGED YCAUTION i CONSULT INSTRUCTIONS FOR USE D DO NOT RE-USE CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY MANUFACTURER

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24 en O3FA Filament Coated Polypropylene Mesh fr de es it pt nl da sv fi no el pl ja zh ar cs hu ko ru tr CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. C-QUR CentriFX Mesh is manufactured by Atrium Medical Corporation / 40 Continental Blvd., Merrimack, NH / * Maquet is a Trademark and/or Registered Trademark of MAQUET GMBH, its subsidiaries, and/or affiliates in the United States and/or other countries. Maquet is registered in United States Patent and Trademark Office. Atrium, C-QUR, and CentriFX are Trademarks and/or Registered Trademarks of Atrium Medical Corp., its subsidiaries, and/or affiliates in the United States and/or other countries. Atrium, C-QUR, and CentriFX are registered in United States Patent and Trademark Office. Copyright 2015 Atrium Medical Corp. or its affiliates. All rights not expressly granted are reserved. Printed in USA Part No AW Rev AA Atrium Medical Corporation 40 Continental Boulevard Merrimack, New Hampshire USA Phone: VISAMED GmbH Kastellstr. 8 D Karlsruhe-Germany MAQUET Australia Pty Ltd Level 2, 4 Talavera Road Macquarie Park NSW 2113 Phone: +61-(0)