Mindray ePM 10M, Operator'S Manual

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20 - 2
20.2 BIS Safety Information
WARNING
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BIS monitoring is not intended for neonatal patients.
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The conductive parts of sensors and connectors should not come into contact with other conductive
parts, including earth.
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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 electrosurgical unit return electrode.
•
To reduce the hazard of burns during use of brain-stimulating devices (e.g., transcranial electrical
motor evoked potential), place stimulating electrodes as far as possible from the BIS sensor and
make certain that sensor is placed according to package instructions.
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The BIS sensor must not be located between defibrillator pads when a defibrillator is used on a
patient connected to the monitor.
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The clinical utility, risk/benefit and application of the BIS component have not undergone full
evaluation in the pediatric population.
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Due to limited clinical experience, for patients with neurological disorders, patients taking
psychoactive medication, and children under one year old, BIS values should be interpreted
cautiously.
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The BIS monitoring is a complex technology, intended for use only as an adjunct to clinical
judgment and training. Clinical judgment should always be used when interpreting BIS in
conjunction with other available clinical signs. Reliance on BIS alone for intraoperative anesthetic
management is not recommended.
•
Misinterpretation of BIS can result in incorrect administration of anesthetic agents and/or other
potential complications of anesthesia or sedation.
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BIS values should be interpreted cautiously with certain anesthetic combinations, such as those
relying primarily on either ketamine or nitrous oxide/narcotics to produce unconsciousness.
CAUTION
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Ensure that the BISx or BISx4 does not come into prolonged contact with your patient's skin, as it
may generate heat and cause discomfort.
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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.
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When using electro-convulsive therapy (ECT) equipment during BIS monitoring, place ECT
electrodes as far as possible from the BIS sensor to minimize the effect of interference. Certain ECT
equipment may interfere with the proper function of the BIS monitoring system. Check for
compatibility of equipment during patient setup.
•
The BIS measurement based on measuring the EEG signal is inherently very sensitive. Do not use
electrical radiating equipment close to the BISx or BISx4.
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Artifact may lead to inappropriate BIS values. Potential artifact may be caused by unusual or
excessive electrical interference or high EMG activity like shivering, muscle activity or rigidity,
sustained eye movements, head and body motion. Also, improper sensor placement and poor skin
contact (high impedance) may cause artifact and interfere with the measurement.
•
External radiating devices may disturb the measurement.
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Poor signal quality may lead to inappropriate BIS values.