Safety Information - EDAN elite V5 User Manual

Patient Monitor User Manual
- BC: (BISx device used with Extend Sensor only) The BC numeric helps to quantify
suppression, reported as the number of EEG bursts per minute, where an EEG burst is
defined as a period of activity followed and preceded by inactivity (at least 0.5 second). The
BC numeric is valid when SQI ≥ 15% and SR ≥ 5%.
EMG bar graph: The EMG bar graph displays the power (in decibels) in the frequency range
70 Hz -110 Hz. This frequency range contains power from muscle activity (i.e.,
electromyography or "EMG") as well as power from other high-frequency artifacts. When
the indicator is low, it indicates that EMG activity is low. BIS monitoring conditions are
optimal when the bar is empty.
1 bar represents power in the 30-34 range.
2 bars represent power in the 35-39 range.
3 bars represent power in the 40-44 range.
4 bars represent power in the 45-49 range.
5 bars represent power in the 50-54 range.
6 bars represent power in the 55-59 range.
7 bars represent power in the 60-64 range.
8 bars represent power in the 65-69 range.
9 bars represent power in the 70-74 range.
10 bars represent power greater than 74.

18.2 Safety Information

1 Explosion hazard: Do not use the BISx device in a flammable atmosphere or where
concentrations of flammable anesthetics may occur.
2 The BISx device is not designed for use in MRI environment.
3 The use of accessory equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include: use of the accessory in the
patient vicinity; evidence that the safety certification of the accessory has been
performed in accordance to the appropriate IEC 60601-1 harmonized national
standard.
4 Due to elevated surface temperature, do not place the BISx device in prolonged
direct contact with patient's skin, as it may cause discomfort.
5 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.
WARNING
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Monitoring BIS