SedLine Sedation Monitor
Safety Information, Warnings and Cautions
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10
Masimo
WARNING:
The SedLine Module may be used during electrocautery, but this may affect the
accuracy or availability of the parameters and measurements.
WARNING:
The SedLine Module may be used during defibrillation, but this may affect the
accuracy or availability of the parameters and measurements.
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.
CAUTION:
To minimize radio interference, other electrical equipment that emits radio
frequency transmissions should not be in close proximity to the SedLine Module.
CAUTION:
Do not place the SedLine Module on electrical equipment that may affect the
instrument, preventing it from working properly.
CAUTION:
Close proximity to high frequency interference may cause display artifacts. As a
mitigation, consider moving the SedLine Module away from the source of radiation, changing
the location of Root, or plugging Root into a different outlet if potential artifacts are
displayed.
CAUTION:
Train-of-Four stimulation on a patient’s face is not recommended. Doing so may
create EEG artifact, preventing calculation of PSi values.
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.
CAUTION:
To ensure that alarm limits are appropriate for the patient being monitored, check
the limits each time SedLine is used.
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.
CAUTION:
Replace the cable or sensor when a replace sensor or low SIQ message is
consistently displayed while monitoring consecutive patients after completing the low SIQ
troubleshooting steps listed in the troubleshooting section.
Note:
The SedLine electrodes detect electrical activity primarily EEG. Similar to other EEG
devices, electrical signals artifacts, such as ECG, EOG etc., may also be displayed when
present.
Note:
Use and store the SedLine Module in accordance with specifications. See the
Specifications section in this manual.
Note:
The anesthetic agents listed below were used in the comparison study* to evaluate the
improved performance of the current PSi on the SedLine Sedation Monitor:
