Danmeter CSM 2 User manual

Cerebral State Monitor
Model CSM 2
User Manual
Rx only
Danmeter A/S
Kildemosevej 13, DK-5000 Odense C, Denmark
Tel.: [phone]
Fax: [phone]
e-mail: [email protected]
www.danmeter.com

Table of Contents
1About this Manual .............................................................................................................................1
1.1 Device description ..................................................................................................................1
1.2 Indications for Use..................................................................................................................1
1.3 List of Symbols .......................................................................................................................2
2Installation and Preparation..............................................................................................................2
3Skin Preparation and Sensor Positioning..........................................................................................3
4Description of the Device ..................................................................................................................4
4.1 General Overview....................................................................................................................4
4.2 Keys and Controls Overview....................................................................................................5
4.3 Light Indicators.......................................................................................................................6
4.4 Description of Keys.................................................................................................................6
4.5 Operation Display Modes........................................................................................................7
4.6 Setup Menu.............................................................................................................................9
4.7 Settings.................................................................................................................................10
4.8 Events...................................................................................................................................11
4.9 CSM Parameters ...................................................................................................................12
5Principle of Operation .....................................................................................................................14
5.1 High Quality Amplifier............................................................................................................14
5.2 Measurement Principle .........................................................................................................14
5.3 CSI Scale...............................................................................................................................15
5.4 EMG ......................................................................................................................................16
5.5 Burst Suppression Indicator .................................................................................................16
5.6 Artifact and Noise Control.....................................................................................................16
6CSM Battery / CSM Power Operation...............................................................................................17
6.1 Using CSM Power and CSM Rechargeable Batteries.............................................................17
7Data Recording via CSM Link...........................................................................................................18
7Data Recording via CSM Link...........................................................................................................19
7.1 CSM Link Software ................................................................................................................19
7.2 CSM Link ...............................................................................................................................19
8Specifications ..................................................................................................................................21
9Accessories.....................................................................................................................................22
10 Maintenance....................................................................................................................................22
11 Troubleshooting..............................................................................................................................24
12 System and Error Messages ...........................................................................................................26
13 Safety and Warranty........................................................................................................................26
14 Service and Contacts.......................................................................................................................28
15 Technical description.......................................................................................................................30

This manual is published by Danmeter A/S, who reserves the right to improve and modify the
contents without prior notice. Modifications will, however, be published in future editions. All rights
reserved.
Cerebral State Monitor, CSM & CSI are trademarks of Danmeter A/S
Products manufactured by Danmeter A/S, Kildemosevej 13, DK-5000 Odense C, Denmark
US-English
PN 561105003-04
Declaration of Conformity:
Danmeter A/S hereby declares that the Cerebral State Monitor complies with the following
standards:
 EN (IEC) 60601-1,
 EN (IEC) 60601-1-2,
 EN (IEC) 60601-2-26
 UL 60601-1:2003
 CAN/CSA-C22.2 No. 601.1-M90
 CAN/CSA-C22.2 No. 601.1S1-94
 CSA 601.1 Amendment 2:1998
 CAN/CSA 601-2-26

Cerebral State Monitor - CSM DFU Page 1
1 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.
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.
1.1 Device description
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).
1.2 Indications for Use
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.
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.
Caution:
Federal law (U.S.A.) restricts this device to sale, distribution, and use by or on the order of a
p
hysician.