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PRECAUTION

• The position, or movement, of the patient and the BcSs-PICNIW-1000 Sensor is known to affect the signal being recorded. As a result, if multiple recording sessions are obtained on the same patient, consistent positioning of the patient and device will lead to more comparable recordings

• Contact brain4care to receive training before operating the BcSs-PICNIW-1000 Sensor. The sensor may only be used by qualified individuals who have successfully completed training with a brain4care representative.

• Read and understand the content of this user guide before use.

• Manually clean and disinfect the device components before and after each patient’s monitoring session.

• Do not subject the device to autoclave or other thermal disinfection or sterilization processes.

• Perform corrective maintenance once a year, and if abnormal performance is observed.

• All modifications and repairs must be exclusively performed by brain4care.

• When disinfecting the sensor pin be careful to not apply excessive force.

• If the device functionalities are lost due to EM disturbances, the waveform may not be accurate.

• Ensure that your mobile device is set up with a strong password, not used in root mode, nor with unverified applications installed.

• Verify with your facility’s clinical engineering team which receiver will match the monitor module plug in your caregiving area.

• If the Essential Performance is lost due to EM disturbances, the waveform may not be accurate.

• Be cautious when handling the headband due to risk of strangulation. Also avoid touching simultaneously the patient and a non medical device due to risk of electrical shock

• The use of the B4C wireless sensor adjacent to or stacked with other equipment should be avoided. If such use is necessary, the device and the other equipment should be observed to verify that they are operating normally

• Only original charging cables and accessories shipped with the B4C System should be used. Do not use them in any other equipment or device. The use of accessories other than those specified may result in increased emissions or decreased immunity of the device.

• The B4C System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the B4C System helps to prevent electromagnetic interference by maintaining a minimum distance of 30cm (12 inches) between portable or mobile RF communication equipment (transmitters) and the B4C System.

• The B4C System may be affected by equipment that emits RF signals in the environment in which it is installed. Using the device close to RFID readers can cause temporary loss of wireless functionalities.