186-0201-DS

Indications, Safety, and WarningsIndications And Contraindications The BIS™ Complete Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The system, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS™ index, one of the Complete Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS™ index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation. No known contraindications listed for the BIS™ Complete Monitoring System. Warnings

Explosion hazard: do not use the BIS™ complete system in a flammable atmosphere or where concentrations of flammable anesthetics may occur.

The BIS™ complete system is not designed for use in MRI environment.

Use only the power cord supplied by the manufacturer. Never adapt the plug from the monitor to fit a non-standard outlet.

Cautions

Do not set the Target Range alarm limits to extreme values that render the monitoring system useless. Ensure Target Range alarm limits are appropriate for each patient.

Do not block ventilation inlet holes on the underside of monitor.

Do not open BISX™ unit for any reason. The seal to prevent liquids from entering the BISX™ unit may be damaged if opened.

Adverse Event Any serious incident that occurs in relation to the device or its accessories should be reported to Covidien and to the national competent authority. See Instructions for Use for a full list of warnings and cautions

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