Important Safety Information for XTRA/XVAC
1. INDICATIONS FOR USE / INTENDED PURPOSE
EU/International: XTRA is indicated for use for intraoperative recovery of blood, washing of blood collected in the postoperative period and preoperative sequestration (with indirect patient connection). The XVAC is indicated for use for intraoperative and postoperative recovery of blood for autotransfusion procedures. Intraoperative blood salvage is widely employed in surgical procedures where blood loss occurs during the course of the operation, whereas postoperative blood salvage is used in surgical procedures where bleeding may occur during the postoperative course. Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.
US: The XTRA Autotransfusion System is indicated for intraoperative and postoperative recovery of blood, washing of the processed blood and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.
The XVAC is indicated for use only with the XTRA, an autologous blood recovery system indicated for intra- and post-operative autotransfusion, as well as for pre-operative sequestration.
There are no known contraindications for the XTRA. However, the use of blood processed by this device may be contraindicated under some circumstances. The responsibility for the use of the device in all cases belongs solely to the physician in charge.
The device must be used in accordance with the instructions for use. For a complete listing of warnings, please refer to the Instructions for Use which accompany each product
The XTRA must be used only with XTRA disposables. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. For a complete listing of precautions/cautions please refer to the Instructions for Use which accompany each product
The devices should be used by qualified and skilled personnel, able to follow the indications and instructions for use contained in the information provided by the manufacturer. Please contact us through our website to receive instructions for use containing full prescribing information including indications, contraindications, warnings, precautions and adverse events.
The information contained in this summary represents partial excerpts taken from the product labeling. The information is not intended to serve as a substitute for a complete and through understanding of the device nor does this information represent full disclosure of all pertinent information concerning the use of this product.
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