Monitoring Bispectral Index (BIS™)
Efficia CM Series Rack and Modules Instructions for Use 5-13
BIS Safety Information
BIS Safety Information
The BIS module is suitable in the presence of electro-surgery.
The CE Mark does not apply to the BIS Module.
Warnings Risk of Explosion:
• Explosion Hazard: Do not use the BIS module in a flammable atmosphere or where
concentrations of flammable anesthetics may occur. Equipment not suitable for use in
the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide.
Oxygen concentrations must be <25% and partial pressure <27.5 kPa when no other
oxidants are present.
Risk of Injury or Health Hazard:
• Be sure the monitor is mounted securely in place to avoid personal or patient injury.
• Due to elevated surface temperature, do not place BISX™ in prolonged direct contact
with patient’s skin, as it may cause discomfort.
• To prevent or minimize burns caused by a defective neutral electrode connection, use
caution when handling electrodes, transducers, and cables in the presence of high-
frequency surgical equipment. Verify that the equipment is working correctly before
each use.
• 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.
• To reduce the hazard of burns during use of high-frequency surgical equipment, the
sensor or electrodes should not be located between the surgical site and the electro-
surgical unit return electrode.
• The sensor must not be located between defibrillator pads when a defibrillator is used
on a patient connected to the BIS module. The BIS module provides protection for the
operator and patient during cardiac defibrillation. This protection is achieved via the
isolation barrier within the BISx.
• To minimize the risk of patient strangulation, the patient interface cable (PIC) must be
carefully placed and secured.
• Universal precautions shall be observed to prevent contact with blood or other
potentially infectious materials. Place contaminated materials in regulated waste
container.
• Do not mix disinfecting solutions (e.g., bleach and ammonia), as hazardous gases may
result.
Risk of performance degradation:
• Measurement accuracy may decrease temporarily while performing electro-surgery or
defibrillation. The recovery time is less than 10 seconds. This does not affect patient or
equipment safety.
• The monitor and its accessories must be tested by qualified service personnel at
regular intervals to ensure that performance has not been degraded by aging or
environmental conditions. Periodic performance verification tests can be performed,
as described in the Efficia CM Service Guide.
Risk of Electrode Placement:
• The conductive parts of electrodes or sensor and connectors should not contact other
conductive parts, including earth.
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