![]() ![]() All For other information, refer to the above-listed manuals. This addendum covers the Early Warning Score (EWS) operation of the Rad-97 device. 38281/LAB-9275 and equivalent translations.38053/LAB-9103 and equivalent translations.Operator’s Manual, Rad-97™ Pulse CO-Oximeter® This addendum provides updates to the following: The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.ħ Related Posts Addendum, Rad-97 Operator’s Manual: All other trademarks and registered trademarks are property of their respective owners. Rad-97™, SpOC™, and TIR-1™ are trademarks of Masimo Corporation. ![]() Patents: ®, Masimo® and Pulse CO-Oximeter®, PVi®, rainbow®, RRa®, SpCO®, SpHb®, and SpMet® are federally registered trademarks of Masimo Corporation. 60601-1:2008, andĪpplicable Particular (EN/ISO 8:2011) and related Collateral (IECĦ:2006) Standards for which the product has been found to comply by Intertek. WITH RESPECT TO ELECTRIC SHOCK, FIRE, AND MECHANICAL HAZARDS ONLYĪNSI/AAMI ES 60601-1:2005, CAN/CSA C22.2 No. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions.ĮU authorized representative for Masimo Corporation: See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions.įor professional use. Notice: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents.ĬAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be used for any processes, procedures, experiments, or any other use for which the device is not intended or cleared by the applicable regulatory authorities, or in any manner inconsistent with the directions for use or labeling. Do not operate Rad-97 without completely reading and understanding these instructions. General knowledge of pulse oximetry and an understanding of the features and functions of Rad-97 are prerequisites for its proper use. There may be information provided in this manual that is not relevant to your system. These operating instructions provide the necessary information for the proper operation of all models of the Rad-97. ![]()
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