Mindray WATO EX-65, Operator'S Manual

Page: 134 / 276

10-2
10.3 Safety Information
For patients with neurological disorders, patients taking psychoactive medication, and
children under one year of age, BIS values should be interpreted cautiously.
WARNING
z
The conductive parts of sensors and connectors should not come into contact with
other conductive parts, including earth.
z
To reduce the hazard of burns in the high-frequency surgical neutral electrode
connection, the BIS sensor should not be located between the surgical site and the
electro-surgical unit return electrode.
z
The BIS sensor must not be located between defibrillator pads when a defibrillator
is used on a patient.
z
The BIS component using on our monitor is purchased from Aspect Medical
System. It is important to recognize this index is derived using solely that
company's proprietary technology. Therefore, it is recommended that clinicians
have reviewed applicable information on its utility and/or risks in published
articles and literature/web site information from Aspect Medical Systems, Inc. or
contact that company itself at www.aspectmedical.com, if you have clinical-based
BIS questions relating to this module portion of the patient monitor. Failure to do
so could potentially result in the 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 FDA or other federal-based regulatory, practice or research information on BIS
and related topics.
z
The Bispectral Index is a complex technology, intended for use only as an adjunct
to clinical judgment and training.
z
The clinical utility, risk/benefit and application of the BIS component have not
undergone full evaluation in the pediatric population.