CooperSurgical Inc

RUMI II Adapter Directions for Use

24 Pages

RUMI II Adapter ®  Following steam sterilization, allow all components to cool to room temperature. Sudden changes in temperature may damage the components. Note: The parameters listed above are only a recommendation. Sterility of the device is the responsibility of the hospital or site performing the sterilization. (Refer to the sterilizer’s manufacturer’s manual for detail about the sterilization unit.)  53468 Directions for Use (English)  DISPOSAL Dispose of in accordance with all applicable Federal, State and local Medical/Hazardous waste practices.  NON-STERILE STERILIZE BEFORE USE CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.  EXPLANATION OF SYMBOLS REF Reorder Number LOT Batch Code  LATEX  !  Latex Free ATTENTION: See instructions for use.  RX ONLY CAUTION: U.S. Federal law restricts this device to sale  DEVICE DESCRIPTION The RUMI® II Adapter is a reusable device that is used to attach the RUMI® II Uterine Manipulator Handle to the Uterine Positioning System™ exclusively.  by or on the order of a physician. PRECAUTIONS AND WARNINGS Product conforms to the Medical Device Directive 93/42/EEC EC REP  Authorized Representative in the European Community.  Neutrad® is a registered trademark of Decon Labs, Inc. All other marks bearing the symbols “TM” and “®” are trademarks and registered trademarks of CooperSurgical, Inc. © 2011 CooperSurgical, Inc. All rights reserved.  • Failure to properly follow instructions for the RUMI II Adapter (Adapter), including instructions supplied with the Uterine Positioning System (UPS, 371550-03) and the RUMI II Uterine Manipulator Handle (Manipulator Handle, UMH650), may lead to injury and result in improper functioning of the system. • The Adapter is only intended for use with the RUMI II Manipulator Handle and the UPS. Use of this device with any other Manipulator is not recommended, and could lead to injury and improper functioning of the device. • Surgical procedures requiring vaginal instrumentation are not sterile. Conventional operating room procedures for maintaining sterility must be observed when the UPS is in use. • The Adapter is supplied non-sterile and must be cleaned and sterilized prior to use. • Verify that the correct Adapter is being used with the Manipulator Handle. • Refer to the UPS Directions for Use for further instructions. • ALWAYS position the patient and the OR table prior to attaching the UPS to the Manipulator Handle. • ALWAYS have the patient under general endotracheal anesthesia when the UPS is attached to the Manipulator Handle. CONTRAINDICATIONS Refer to the Manipulator Handle Directions for Use for applicable contraindications of the device.  Manufactured for:  Made in the USA 95 Corporate Drive Trumbull, CT 06611 USA Phone: (800) 243-2974 Fax: (800) 262-0105 www.coopersurgical.com 37331 • Rev. B • 3/11  International Phone: (203) 601-9818 Fax: (203) 601-4747  CAUTION U.S. Federal law restricts this device to sale by or on the order of a physician.  EC REP Leisegang Feinmechanik GmbH Leibnizstraße 32 D-10625, Berlin GERMANY  37331 • Rev. B • 3/11
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