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About this Manual
This manual is intended to assist the user in operating the Cerebral State Monitor (CSM) in a safe
and effective manner.
This version of the manual was originally drafted, approved and supplied by Danmeter A/S in English.
Before operating the monitor read this manual thoroughly, with particular attention to all
warnings and cautions.
Note:
Although the monitor is built and tested to exacting specifications, it is not intended to
replace the supervision of level of consciousness monitoring by medical personnel. The user
should become thoroughly familiar with the features, operations, and accessories of the
monitor and exercise vigilance in its utilization.
WARNINGS
are directions which, if not followed, could cause fatal or serious injury to an
operator, patient or any other person.
CAUTIONS
are directions which, if not followed, could cause damage to the equipment
described in this manual and/or any other equipment or goods, and/or cause
environmental pollution.
NOTES
are intended to highlight unusual points as an aid to the operator.
Device description
1.1
The Cerebral State Monitor (CSM) is a non-invasive measurement tool for use by trained healthcare
professionals to measure the level of consciousness (LOC) in all areas of the hospital. Based on
EEG, an index (CSI) is calculated, which is used in the estimation of LOC. The CSM displays the CSI
but does not perform any data interpretation (i.e., all data interpretation is performed by a
physician).
Indications for Use
1.2
The monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition of
EEG signals of the anesthetized or sedated patient in all areas of the hospital.
Caution:
Federal law (U.S.A.) restricts this device to sale, distribution, and use by or on the order of a
physician.
Cerebral State Monitor - CSM DFU
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