GE CARESCAPE, User Manual

Page: 394 / 548

Bispectral index
WARNING
This monitor uses a component modular device in deriving the
Bispectral index (BIS) purchased from Covidien. It is important
to recognize this index is derived using solely that company’s
proprietary technology. It is recommended that clinicians
have reviewed applicable information on its utility and/or risks
in published articles and literature/web site information from
Covidien ( www.covidien.com ) or contact that company itself if
they have clinical-based BIS questions relating to this module
portion of the GE monitor. Failure to do so could potentially
result in incorrect administration of anesthetic agents and/or
other potential complications of anesthesia or sedation. We
recommend that clinicians also review the following practice
advisory (that includes a section on BIS monitoring): The
American Society of Anesthesiologists, Practice Advisory for
Intraoperative Awareness and Brain Function Monitoring
(Anesthesiology 2006; 104:847-64). Clinicians are also
recommended to maintain current knowledge of government
regulatory, practice or research information on BIS and
related topics.
WARNING
Misinterpretation of BIS can result in incorrect administration
of anesthetic agents and/or other potential complications of
anesthesia or sedation.
BIS cautions
CAUTION
Due to elevated surface temperature, do not place the BIS
device in prolonged direct contact with the patient’s skin, as it
may cause discomfort.
CAUTION
The BIS measurement based on measuring the EEG signal is
inherently very sensitive. Radiated electromagnetic fields may
cause erroneous measurements at various frequencies. Do
not use electrical radiating equipment close to the BISx or
DSC. Details regarding radiated field strengths are given in
the technical specifications.
CAUTION
Automatic sensor check may need to be disabled if the 1
nA 128 Hz impedance check signal interferes with other
equipment, such as EEG module with evoked potentials
measurement.
CAUTION
The BIS module has been designed to operate with a
disposable BIS sensor. Only use recommended sensors.
CAUTION
Do not use the BIS sensor if the sensor gel is dry. To avoid
dryout, do not open the pack until you are ready to use the
sensor.
CAUTION
Check the sensor expiration date on the sensor package. Do
not use expired sensors.
CAUTION
If skin rash or any unusual symptom develops, discontinue the
BIS measurement and remove the sensor.
394 CARESCAPE Modular Monitors 2062971-001