SedLine Sedation Monitor Warnings and Cautions
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Caution: The PSI value may be elevated in the following situations:
• In patients receiving nitrous oxide or ketamine. These agents may result in
increased EEG activity power at higher frequencies, in the band > 12 Hz, and this
may present an EMG-like pattern.
• On patients with non-typical EEG patterns such as seizure activity.
• When there is significant EMG activity interfering with the EEG waveform.
Caution: Inaccurate PSI values may be caused by:
• Elevated artifact and other sources of electromagnetic interferences.
• Patients with neurological disorders such as stroke, tumor, metabolic disease or
traumatic brain injury.
Compliance Information
Warning: Changes or modifications not expressly approved by Masimo shall void the
warranty for this equipment and could void the user’s authority to operate the equipment.
Caution: Disposal of Product: Comply with local laws in the disposal of the instrument and/or
its accessories.
Caution: For FCC compliance information, refer to the Operator's Manual for Root.
General Information
Warning: The SedLine Module is intended only as an adjunct device in patient assessment. It
should not be used as the sole basis for diagnosis or therapy decisions. It must be used in
conjunction with clinical signs and symptoms.
Warning: Patient State Index (PSI) information shall be used in conjunction with other
indicators of patient state in the delivery of anesthetics.
Warning: SedLine performs continuous impedance measurements (at the sensor) in order to
check that the electrodes are firmly in place. The 83.33 Hz and 125 Hz impedance
measurement signals could interfere with other electronic monitoring equipment connected
to the patient.
Warning: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean
the SedLine Module. These substances affect the device’s materials and instrument failure
can result.
Caution: Impedance monitoring can interfere with other monitoring devices, in particular
evoked potential monitors.
Caution: Disabling impedance monitoring may lead to decreased signal quality and
decreased PSI reliability due to the user not being notified of inadequate electrode contact.
Note: Use and store the SedLine Module in accordance with specifications. See the
Specifications section in this manual.