Intended Use/Indications for Use
Monitoring Bispectral Index (BIS™)
5-2 Efficia CM Series Rack and Modules Instructions for Use
The BIS measurement module is a single slot module that fits into any of the four slot
positions available in the Efficia rack.
The person responsible for installation, maintenance and use of the equipment should
make sure that this is working properly and in compliance with the procedures and
restrictions of use listed in this manual (e.g. environmental radiation, flammable gases,
temperature and humidity). The person responsible should also make sure that all users
and operators of the equipment are trained in their use and maintenance, and that they
have access to this manual.
Figure 5-1 Efficia Rack and BIS Module
Note: All exterior surfaces of the BIS measurement module and its accessories are latex-free.
Intended Use/Indications for Use
BIS is intended for use under the direct supervision of a licensed healthcare practitioner
or by personnel trained in its proper use. The system, and all its associated parameters, is
intended for use on adult and pediatric patients within a hospital or medical facility
providing patient care to monitor the state of the brain by data acquisition of EEG signals.
BIS is a complex monitoring technology intended for use as an adjunct to clinical
judgment and training.
The BIS module is suitable in the presence of electrosurgery.
Warning The Efficia CMS200 Central Station (revision B.01 or below) does not support waveforms
and parameter values from the Efficia CM Series C.00 Gas or BIS modules. For Gas or BIS
waveforms and parameter values, refer to the patient monitor and not the CMS Central
Station.
BIS module
Efficia rack
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