186-0106

Indications, Safety, and WarningsIndications for useThe BIS™ sensor is applied directly to the patient’s skin to enable recordings of electrophysiological (such as EEG) signals.

Identification of a substance that is not contained or present within the product or packaging.

Do not use if the package is opened or damaged.

WarningTo reduce the hazard of burns during use of brain-stimulating devices (e.g., transcranial electrical motor evoked potential), place stimulating electrodes as far as possible from the bis sensor and place sensor according to instructions.CautionPatient position may increase the risk of skin irritation on the forehead. With patients in prone position, consider minimizing pressure on the sensor.Notes

Do not use if the sensor is dry. To avoid drying out, do not open the pack until it is ready for use.

Due to intimate skin contact, reuse may pose risk of infection. If skin rash or other unusual symptoms develop, stop use and remove.

The sensor is limited to short-term use (maximum 24 hours).

Do not cut the sensor, as this will result in improper operation.

Upon removal, slight redness of skin may occur and typically resolve within a short period of time.

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