Datex-Ohmeda S-5 Service Manual M-BIS

Datex-Ohmeda

S/5TM BIS Module

Technical Reference Manual Slot

P.O. Box 7550, Madison WI 53707-7550, USA Tel. 1-608-221-1551 Fax 1-608-222-9147
www.us.datex-ohmeda.com
mailto:product.support.ussub@us.datex-ohmeda.com

All specifications are subject to change without notice.

Document No. 800 3476

April 2002

Datex-Ohmeda Division, Instrumentarium Corp.
P.O. Box 900, FIN-00031
DATEX-OHMEDA, FINLAND
Tel. +358 10 394 11 Fax +358 9 146 3310
www.datex-ohmeda.com
Instrumentarium Corp. All rights reserved.

Table of contents

TABLE OF CONTENTS
BIS Module, M-BIS
TABLE OF CONTENTS I
TABLE OF FIGURES II
TABLE OF TABLES II
INTRODUCTION 1
1 SPECIFICATIONS 3
1.1 General specifications ..............................................................................................................................3
1.1.1 BIS Module......................................................................................................................................3
1.1.2 Digital Signal Converter, DSC ............................................................................................................3
1.1.3 Environmental specifications ............................................................................................................3
1.2 Technical specifications............................................................................................................................3
2 FUNCTIONAL DESCRIPTION 5
2.1 Measurements principle ...........................................................................................................................5
2.2 Sensor Check ...........................................................................................................................................5
2.3 Main components.....................................................................................................................................7
2.3.1 Digital Signal Converter, DSC ............................................................................................................7
2.3.2 BIS Module......................................................................................................................................8
2.4 Connectors and signals.............................................................................................................................9
2.4.1 Module bus connector......................................................................................................................9
2.4.2 H8 programming connectors pin order...............................................................................................9
2.4.3 BIS Engine connectors pin order......................................................................................................10
2.4.4 Keys ..............................................................................................................................................10
3 SERVICE PROCEDURES 11
3.1 General service information.....................................................................................................................11
3.2 Service check .........................................................................................................................................11
3.2.1 Recommended tools ......................................................................................................................11
3.3 Disassembly and reassembly..................................................................................................................15
4 TROUBLESHOOTING 16
4.1 Troubleshooting chart .............................................................................................................................16
4.2 Messages...............................................................................................................................................17
4.3 Troubleshooting flowchart .......................................................................................................................18
5 SERVICE MENU 19
5.1 BIS service menu....................................................................................................................................20
5.1.1 Module service page ......................................................................................................................20
5.1.2 Sensor...........................................................................................................................................24
5.1.3 Setup.............................................................................................................................................26
6 SPARE PARTS 27
6.1 Spare part list.........................................................................................................................................27
6.1.1 M-BIS ............................................................................................................................................27
7 EARLIER REVISIONS 29
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Datex-Ohmeda S/5 monitors
APPENDICES A, B 31
SERVICE CHECK FORM A-1
APPENDIX B, HOW TO READ HEX NUMBERS B-1

TABLE OF FIGURES

Figure 1 Measurement setup .............................................................................................................................1
Figure 2 BIS sensor check..................................................................................................................................5
Figure 3 BIS measurement system block diagram............................................................................................... 7
Figure 4 Block diagram of setup.........................................................................................................................8
Figure 5 BIS module disassembly and reassembly............................................................................................15
Figure 6 BIS module troubleshooting flowchart ................................................................................................. 18
Figure 7 Exploded view of module box and BIS module .....................................................................................27

TABLE OF TABLES

Table 1 Module bus connector (X1) pin description............................................................................................ 9
Table 2 Connector pinning for H8 programming connector................................................................................. 9
Table 3 Connector pinning for DSC and BIS Engine connectors........................................................................10
Table 4 Connector pinning BIS Engine power connector ..................................................................................10
Table 5 Connector pinning for BIS Engine serial data connector.......................................................................10
Table 6 Key connector pin assignments...........................................................................................................10
Table 7 Module general status........................................................................................................................21
Table 8 BIS Engine status ..............................................................................................................................21
Table 9 BIS Engine and DSC error messages ...................................................................................................22
Table 10 DSC status....................................................................................................................................25
Table 11 Sensor status................................................................................................................................25
Table 12 BE powup stat...............................................................................................................................25
Table 13 HEX to binary conversion ...............................................................................................................B-1
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INTRODUCTION

This Technical Reference Manual Slot provides information for the maintenance and service of the Datex-Ohmeda S/5 BIS Module, M-BIS. The BIS module is a single width plug-in module designed for use with the S/5 monitors. Later in this manual modules can be called w/o system name Datex-Ohmeda S/5.
BIS, and the BIS logo are trademarks of Aspect Medical Systems Inc., and are registered in the USA, EU and other countries. Later in this manual Aspect Medical Systems Inc. will be called Aspect.
Please see also the Technical Reference Manual of the S/5 monitor for system specific information e.g. related documentation, conventions used, symbols on equipment, safety precautions, system description, system installation, interfacing, functional check and planned maintenance.
The BIS module is indicated for monitoring the state of the brain by data acquisition of EEG signals. BIS may be used as an aid in monitoring the effects of certain anesthetic agents. The raw EEG signals are processed to produce a single number, ranging from 100 for a patient being wide awake to 0 in the absence of brain activity.
Calculated parameters are:
S/5 BIS Module, M-BIS
Bispectral Index, BIS
Suppression Ratio, SR
Electromyograph EMG
Signal Quality Index, SQI
The calculated parameters can be selected on the display, and trended, (excluding SQI). Module has two user keys, BIS for BIS menu and Check Sensor for impedance check.
3
1
2
1
4
2
4
3
Figure 1 Measurement setup
(1) Module with BIS measurement capability, M-BIS
(2) Digital Signal Converter
(3) Patient Interface Cable
(4) BIS Sensor
NOTE: M-BIS module functions only with monitor software versions 02 or later.
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Datex-Ohmeda S/5 monitors
Accessories
The BIS measurement is based on Aspect Medical Systems Inc. technology, and all accessories are developed and manufactured by Aspect. NOTE: Only Aspect accessories can be used with the M-BIS module.
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1 SPECIFICATIONS

1.1 General specifications
1.1.1 BIS Module
Module size, W × D × H 37 × 180 × 112 mm/1.5 × 7.1 × 4.4 in Module weight 0.3 kg/0.7 lbs Power consumption 2.2 W
1.1.2 Digital Signal Converter, DSC
DSC size, W × D × H 66 × 108 × 25 mm/2.6 × 4.3 × 1.0 in DSC weight 0.134 kg/0.3 lbs Integral DSC Cable length 3.6m / 12.5 ft Patient Interface Cable (PIC Plus) length 1.2m / 4 ft
S/5 BIS Module, M-BIS
1.1.3 Environmental specifications
Operating temperature +10 … +40°C storage temperature -25 … +70°C relative humidity 10 … 95%, non -condensing atmospheric pressure 700 … 1060 mbar
Protection against electrical shock Type BF
1.2 Technical specifications
Parameter specifications
BIS EEG
Epoch duration 2 seconds Artifact rejection automatic EEG scales 25 to 400 µV EEG sweep speeds 12.5 / 25 / 50 mm /sec Bispectral index (BIS) 0 to 100 Signal quality index (SQI) 0 to 100 EMG 30 to 80 db (70 to 110 Hz) Suppression ratio (SR) 0 to 100 % Update rate 1 second for BIS index Filters 2 - 70 Hz bandpass (default) / 0.25Hz highpass
Smoothing rate 15 seconds, default in S/5 AM and CAM
30 seconds, default in S/5 CCM and CCCM
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DSC
Analog to digital converter noise-shaped sigma-delta Sampling rate 16384 samples/second Resolution 16 bits at 256 samples/second Input impedance >50 Mohms Noise < 0,3µV RMS (2.0µV peak-to-peak) 0.25 to 50 Hz Common mode rejection 110 dB at 50/60 Hz to earth ground (Isolation mode) Bandwith 0.16 to 450 Hz
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2 FUNCTIONAL DESCRIPTION

2.1 Measurements principle
The BIS measurement is based on EEG signals, these are processed as BIS index. The BIS sensor is placed on the patient’s forehead to acquire the high-resolution signals required. These EEG signals are transferred to digital signal converter DSC that amplifies and digitizes the EEG signal and sends it to the module. The module calculates BIS index and sends it to the monitor via MBUS.
BIS measurement on the monitor screen
The waveform field shows the BIS EEG waveform. The following BIS related data appears in digit fields and graphical trends (except SQI):
BIS number indicates the patient’s level of hypnosis, ranging from 100 for wide awake to 0 in the absence of brain activity.
Signal Quality Index (SQI ) bar graph indicates the quality of the EEG signal in the range of 0 to
100.
S/5 BIS Module, M-BIS
Electromyograph (EMG) bar graph represents the absolute power in the 70 to 110 Hz frequency band and ranges from 30 to 55 dB. This frequency band contains power from muscle activity (electromyograph) as well as power from high frequency artifacts.
Suppression ratio (SR) number indicates the percentage of suppressed (flatline) EEG detected over the last 63 seconds. It ranges from 0 to 100%.
2.2 Sensor Check
Sensor check is performed automatically at the beginning of each case when the sensor is attached to the patient interface cable (monitor). An initial check-up message is shown at digit field together with an appropriate sensor picture. The information of the passed or failed sensor check is printed to this picture at each electrode’s location. The BIS measurement can’t continue if the first sensor check fails. In such case a message “Sensor check failed” is shown at the digit and waveform field.
Figure 2 BIS sensor check
Continuous checking of the reference and signal electrodes and periodic checking of the ground electrode is performed by default. It can be switched off by selecting appropriate comand from menu – message “Automatic check off” will appear. Sensor check can be started manually by pushing a module key or selecting appropriate command from menu. Manual sensor check can be useful e.g. when AEP's are being monitored at the same time, as the continuous sensor check
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Datex-Ohmeda S/5 monitors
might disturb the AEP measurement.
During periodic ground checks, the signal disappears momentarily and the message “Checking sensor” is printed in the digit and waveform fields. Also, all BIS calculation stops during this check, and no measurement values are shown.
CAUTION Continuous impedance check may need to be disabled if the 1 nA 128 Hz
impedance check signal interferes with other equipment such as evoked potential.
WARNING Make sure that the electrodes, sensor and connectors do not touch any
electrically conductive material, including earth.
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2.3 Main components
BIS measurement chain is composed of Aspect BIS Sensor, Aspect digital signal converter, M-BIS module containing Aspect BIS Engine board and Datex-Ohmeda’s interfacing board, and host monitor. Block diagram of the system below.
M-BIS Module
S/5 BIS Module, M-BIS
BIS Interfac ing Boar d
Controller
DSC
data
Serial
Digital signal
Measurement
Power
BIS Engine
Power
Digital Signal
Converter
Patient Isolation
Control
PIC+
Keys
MBUS
Serial
data
Power
Host Monitor
BIS Sensor
Figure 3 BIS measurement system block diagram
2.3.1 Digital Signal Converter, DSC
The digital signal converter, DSC, receives, amplifies and digitizes patient EEG signals. It is placed close to the patient's head where the EEG signal is less subject to interference from other medical equipment. The digital signal converter is connected to the module with a 3.6m long shielded cable and to the BIS sensor with 1.2m long patient interface cable, see Figure 1. For BIS Sensor related documentation refer to BIS documentation by Aspect, Inc.
CAUTION Do not autoclave the DSC. Do not open it for any reason.
MBIS_meas_blockdiag.vs d
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Datex-Ohmeda S/5 monitors
WARNING When using the electrosurgery unit, ensure proper contact of the ESU return
electrode to the patient to avoid burns at monitor measurement sites. Also ensure that the ESU return electrode is near the operating area.
WARNING Radiated field strengths above 1V/m may cause erroneous measurements at
various frequencies. Do not use electrical radiating equipment close to the DSC.
2.3.2 BIS Module
Aspect BIS Engine
The BIS Module provides Bispectral index values to monitor. The BIS Engine processes the digital signal from DSC and outputs the BIS index and other supporting parameters through the asynchronous serial connection. The BIS Engine outputs the BIS Index, raw EEG, EMG, Signal Quality Index (SQI), Suppression Ratio (SR) and electrode impedance’s. The BIS Engine software includes Aspects' proprietary algorithm for BIS calculation.
BIS interfacing board
The BIS interfacing board supplies the data from BIS Engine to the monitor via module bus. As well the module accepts commands from the monitor via module bus. In addition, the module provides supply voltages and all the required control signals to the BIS Engine and DSC.
Controller H8 has on-chip RAM and FLASH ROM, external SRAM and EEPROM.
Figure 4 Block diagram of setup
Keys
M-BIS Module
BIS Interfacing Board
SRAM EEPROM
H8 Controller
FLASH
Power
Aspect BIS Engine
data
Serial
Prog
RS485
RESET
MBUS
Serial
data,
Power
Host Monitor
BIS Interface board Block.vsd
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