PMSENS71-A-20

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<h2>Indications, Safety, and Warnings</h2> <p>The INVOS™ adult rSO<sub>2</sub> sensor has been designed for use with the INVOS™ 7100 and 5100C cerebral/somatic monitoring systems for monitoring of site-specific regional oxygen saturation (rSO<sub>2</sub>) in adult patients weighing > 40 kilograms.</p> <h3>Indications for use</h3> <p>The INVOS™ adult rSO<sub>2</sub> sensor is indicated for single patient use when cerebral/somatic monitoring of site-specific regional oxygen saturation (rSO<sub>2</sub>) is required in patients weighing > 40 kilograms). This sensor is only intended to be used with INVOS™ near infrared spectroscopy (NIRS) technology including monitoring systems and devices integrated with INVOS™ NIRS technology. For additional information regarding setup and use of the INVOS™ system including indications for use, contraindications, warnings, and cautions, consult the monitoring system operator's manual.</p> <h3>Contraindications</h3> <p>The INVOS™ adult rSO<sub>2</sub> sensor is contraindicated for use on patients who exhibit allergic reactions to the adhesive tape.</p> <h3>Warnings</h3> <ul> <li>The sensor is designed for external use only as described in the instructions. Do not use the sensors internally or over compromised skin for any reason.</li> <li>Do not use the INVOS™ system in the presence of flammable anesthetics or in other flammable environments.</li> <li>The INVOS™ system should not be used as the sole basis for diagnosis or therapy. It is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.</li> <li>Disconnect the sensor from the patient during magnetic resonance imaging (MRI) scanning. Induced current may cause burns.</li> <li>Environments with excessive ambient light such as bright sunlight or strong operating room lighting may require loosely covering the area of the sensor with an opaque drape.</li> </ul> <h3>Cautions</h3> <ul> <li>Make sure all connectors are fully engaged and free from moisture. Moisture intrusion may cause poor performance or no readings at all.</li> <li>Use of an electrosurgical/electrocautery instrument in the vicinity of the INVOS™ system may interfere with the signal and result in no readings.</li> <li>Use care when placing or removing sensor. Do not place on broken or undeveloped skin.</li> <li>To avoid pressure sores do not apply pressure (e.g., headbands, wraps, tape, or any additional adhesives) to sensor.</li> <li>Do not immerse the INVOS™ system or sensor in any liquids as they may cause electric shock hazard or damage the device.</li> <li>If two sensors are placed in close proximity to each other on a patient, the same preamplifier should be connected to both sensors to avoid poor performance.</li> </ul>

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