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Indications, Safety, and WarningsIndicationsThe Opus™ vascular access kit is intended for single use by a trained physician to assist in vessel cannulation.ContraindicationThis device is not designed, sold, or intended for use except as indicated.Warnings and precautionsWarning: Only physicians trained and experienced with vessel cannulation should use this device.Warning: Vascular perforation is an inherent risk of any catheter placement, and that incorrect insertion or repositioning can cause damage to the vessels and anatomical structures.Warning: Patient and procedure selection is the responsibility of the physician.Warning: Carefully read all instructions prior to use. Observe all warnings and cautions. Failure to do so may result in complications.Warning: Do not re-sterilize. Do not reprocess. Reprocessing may compromise the sterility, biocompatibility, and functional integrity of the device. Reuse of this device may lead to patient cross contamination and/or device failure.Caution: Care and caution should be taken to avoid damage to vessels during cannulation, including but not limited to dissection or perforation. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use.Caution: Medtronic does not recommend a particular technique for the use of this device. The steps contained in the instructions discuss the Seldinger Technique of percutaneous entry and are for information purposes only. Each physician should evaluate their appropriateness according to individual patient condition and his or her medical training and experience.US-CV-2500091 v2.0

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