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.

Cerebral State Monitor - CSM DFU Page 2
1.3 List of Symbols
Type BF equipment
On / Off
Attention, consult accompanying documents
Do not dispose of in refuse collection. Dispose of at a recycling
station or equivalent in accordance with directive 2002-96-EC WEEE.
2 Installation and Preparation
The Cerebral State Monitor system CSM007 includes the following:
Cerebral State Monitor CSM Wireless Link
Patient Cable CSM Software CD
Rechargeable 9V Battery User manual (this document)
Power Adapter (2 pieces) Power Cable (2 pieces)
RS-232 Cable/USB Cable Carrying case
Velcro strip 1.7x0.9” Clip for patient cable
For replacement accessories, refer to chapter 9
Note
The performance of the CSM monitor by EEG acquisition, processing and calculation of the
CSM parameters and waveforms in the CSM monitor are ONLY guaranteed by the
manufacture when using the CSM Procedure Pack, part no. DMX005.
The possibility to use standard ECG electrodes is NOT RECOMMENDED

Cerebral State Monitor - CSM DFU Page 3
3 Skin Preparation and Sensor Positioning
To ensure low sensor impedance, clean skin with mild soap and water is recommended as a skin
cleanser.
The CSM Procedure Pack contains a skin preparation product and 3 neuro sensors.
Dry-abrade the skin gently using the skin prep product or with a dry wash cloth or gauze, to remove
the non-conductive skin layer. See diagram below.
Position of the three sensors from your CSM Procedure Pack according the diagram below
Shown above is a left sided setup; right sided is also acceptable. Place sensors at the side farthest
from the surgical area.
The advanced signal processing of the monitor ensures that a deviation in the positioning of the
sensors up to 2 cm (0.78 in) has no significant influence on the index. However, it is recommended
to place the sensors on an area of the skull where only a few muscle fibers are present in order to
achieve the best quality signal.
Middle of forehead
Left side of forehead
Mastoid left side
Note: Alcohol is not recommended as a skin cleanser; it leaves a film layer that may cause
high sensor impedance. If alcohol is used, ensure 30 second dry time.
Caution:
- Make sure no part of the sensors is in contact with any other conductive parts including
earth/ground.
- If skin rash or other unusual symptoms develop, remove sensors from patient.
- Change sensors every 24 hours to check skin integrity.
Note: Once the sensors have been secured on the skin, attach the color-coded wires on the
patient cable to appropriate sensor.
Note: The performance of the CSM is only guaranteed by the manufacturer when the CSM
Procedure Pack is used.

Cerebral State Monitor - CSM DFU Page 4
4 Description of the Device
4.1 General Overview
Battery lid Battery
compartment
Patient cable
connection
CSM
power/charge
connection
On/Off
-
+

Cerebral State Monitor - CSM DFU Page 5
4.2 Keys and Controls Overview
2
RED Error
light
Error
Charge
Mute
Set
Display
Event
3
GREEN Power
adapter
5
Mute
key
7
Display
key
1
On/Off 4
Display
area
6
Set Event
key
8
Event Type
key
9
Control
key

Cerebral State Monitor - CSM DFU Page 6
4.3 Light Indicators
2RED Error light
Lights up when neuro sensor error situations are detected
3 Lights when power adapter is connected
4.4 Description of Keys
1 Power On
Press once
1 Power Off
Press and hold until “Power Off” bar disappears
1 Wireless Link connection, disconnection or reconnection
Press twice within 1 second
5 Mute key Mutes alarms
6 Set Event key / Set link
7 Display key
Changes between graphical and information screen
7a - For immediate impedance update. Press down firmly for one second
8 Event key
Select event type / Select link (accessory)
9 Control key
Used for menu selection of parameter settings
9a - Use the Control key to scroll in the menus or set values
9b - Select a submenu or function
9c - Go back one menu level