S5 BIS-Module Technical Reference Manual Slot April 2002

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

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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

ii Document No. 800 3476

S/5 BIS Module, M-BIS

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: • 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

2

4

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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S/5 BIS Module, M-BIS

1

SPECIFICATIONS

1.1 General specifications 1.1.1

BIS Module Module size, W × D × H Module weight Power consumption

1.1.2

37 × 180 × 112 mm/1.5 × 7.1 × 4.4 in 0.3 kg/0.7 lbs 2.2 W

Digital Signal Converter, DSC DSC size, W × D × H DSC weight Integral DSC Cable length Patient Interface Cable (PIC Plus) length

1.1.3

66 × 108 × 25 mm/2.6 × 4.3 × 1.0 in 0.134 kg/0.3 lbs 3.6m / 12.5 ft 1.2m / 4 ft

Environmental specifications Operating temperature storage temperature relative humidity atmospheric pressure

+10 … +40°C -25 … +70°C 10 … 95%, non -condensing 700 … 1060 mbar

Protection against electrical shock

Type BF

1.2 Technical specifications Parameter specifications BIS EEG Epoch duration Artifact rejection EEG scales EEG sweep speeds Bispectral index (BIS) Signal quality index (SQI) EMG Suppression ratio (SR) Update rate Filters

2 seconds automatic 25 to 400 µV 12.5 / 25 / 50 mm /sec 0 to 100 0 to 100 30 to 80 db (70 to 110 Hz) 0 to 100 % 1 second for BIS index 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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Datex-Ohmeda S/5 monitors DSC Analog to digital converter Sampling rate Resolution Input impedance Noise Common mode rejection Bandwith

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noise-shaped sigma-delta 16384 samples/second 16 bits at 256 samples/second >50 Mohms < 0,3µV RMS (2.0µV peak-to-peak) 0.25 to 50 Hz 110 dB at 50/60 Hz to earth ground (Isolation mode) 0.16 to 450 Hz

S/5 BIS Module, M-BIS

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. 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 5 Document No. 800 3476

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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S/5 BIS Module, M-BIS

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 BIS Interfacing Board

Keys MBUS Serial data Power

Serial data

Power

Controller

Host Monitor

Power

Digital signal

BIS Engine

DSC

PIC+

BIS Sensor

Figure 3

2.3.1

MBIS_meas_blockdiag.vsd

Measurement

Control

Digital Signal Converter Patient Isolation

BIS measurement system block diagram

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.

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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.

M-BIS Module BIS Interfacing Board SRAM

EEPROM

H8 Controller

RS485 RESET

Serial data

Power

FLASH

Prog

Aspect BIS Engine

Figure 4

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Block diagram of setup

MBUS Serial data, Power

Host Monitor

BIS Interface board Block.vsd

Keys

S/5 BIS Module, M-BIS

2.4 Connectors and signals 2.4.1

Module bus connector 13

1

25

14

Table 1

2.4.2

Module bus connector (X1) pin description

PIN

Name

Description

1

Reset_ RS485

Module Bus Reset +

8

Nreset_ RS485

Module Bus Reset -

6

Data_ RS485

Module Bus Data +

5

Ndata_ RS485

Module Bus Data -

3

+15VD

+15V Supply voltage

7

GND

Ground

13

GND

Ground

15

GND

Ground

22

RS232_TXD

BIS-Engine SW update, data out, no monitor use

23

RS232_RXD

BIS-Engine SW update, data in, no monitor use

24

+5,1V

+5V Supply voltage

25

+5,1V

+5V Supply voltage

Other

NC

Not Connected

H8 programming connectors pin order 10

2

9

1

Table 2

Connector pinning for H8 programming connector

PIN

Name

Description

1 2 3 4 5 6 7 8 9 10

GND PRG_FB TxD RxD /RESET VDD PRG_VCC MODE.2/BOOT PCFB CODE_RES

Ground Program feedback Data output to programmer Data input from programmer RESET input from programmer Power input from programmer Programming voltage from programmer Control input from programmer Programmer Connector feedback / GND Coding resistor output to programmer

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2.4.3

BIS Engine connectors pin order Table 3

Connector pinning for DSC and BIS Engine connectors

PIN Redel

Name

PIN Samtec

Description

1

DSC_OUTA

2

Power out A

2

DSC_OUTB

4

Power out B

3

DSC_IN

6

Data input

4

DGND

7,8,9,10

Ground

5

Chassis Ground

1,3,5,

Ground

Table 4

Connector pinning BIS Engine power connector

PIN

Name

Description

1, 2

+12V

+12V Power output for BE

5,6,7,8

+5V

+5V Power output for BE

3,4,9,10

GND

Ground

Table 5

2.4.4

Connector pinning for BIS Engine serial data connector

PIN

Name

Description

1

RS232_RXD

Data input to BE

2

TTL_RXD

Data input to BE

3

RS232_TXD

Data output from BE

4

TTL_TXD

Data output from BE

5

NC

Not Connected

6

NC

Not Connected

7

RS232_RESET

Reset input to BE

8

/TTL_RESET

/RESET input to BE

9

GND

Ground

10

/USE_TTL

TTL/RS232 selection input to BE

Keys Table 6

Key connector pin assignments

PIN

Name

Description

1

GND

Ground /NC

2

Key 1

Key 1, right

3

Key 2

Key 2 left

4

GND

Ground

5

GND

Ground / Shield

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5

1

S/5 BIS Module, M-BIS

3

SERVICE PROCEDURES

3.1 General service information Field service of the M-BIS is limited to replacing faulty circuit boards or mechanical parts. Faulty circuit boards should be returned to Datex-Ohmeda for repair. Datex-Ohmeda is always available for service advice. Please provide the unit serial number, full type designation, and a detailed description of the fault. The Datex-Ohmeda BIS Simulator (order No. 900509) is recommended for functional checks.

CAUTION

Only trained personnel with appropriate equipment should perform the tests and repairs outlined in this section. Unauthorized service may void warranty of the unit.

3.2 Service check These instructions include complete procedures for a service check. The service check should be performed after any service repair. However, the service check procedures can also be used for determining possible failures. The procedures should be performed in ascending order. The instructions include a check form, Service check form, which should be filled in when performing the procedures. The mark

? in the instructions means that the check form should be signed after performing

the procedure.

The procedures are designed for monitors with S/5 monitor software of revision 02.

3.2.1

Recommended tools

Tool

Order No.

BIS Simulator or

900509

BIS Sensor simulator

900508

Notes

Screwdriver

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•

Detach the module box by removing the two screws from the back of the module. Be careful with the loose latch and spring pin for locking.

1.

Check internal parts: −

screws are tightened properly

−

cables are connected properly

−

there are no loose objects inside the module

? 2.

Check external parts of the module: − the front cover and the front panel sticker are intact − connectors are intact and are attached properly − the module box, latch and spring pin for locking are intact Reattach the module box

? 3.

Check the external parts of the Digital Signal Converter − - the cover and the panel stickers are intact − - cables and their connections are intact Do not connect DSC to the module yet

? Turn the monitor on and wait until the normal monitoring screen appears. •

Configure the monitor screen so that information regarding the BIS measurement is shown:

Monitor Setup - Screen 1 Setup – Waveform Fields – Field1 – BIS EEG Others – BIS – Scale - 100uV Others – BIS – Smoothing Rate 15s 4.

Installation Plug in the module. Check that it goes in smoothly and engages properly

?

5.

Recognition of module Check that the module is recognized, i.e. the BIS header with related information appears in the chosen waveform field and ‘Cable off’ message is shown on field.

?

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S/5 BIS Module, M-BIS 6.

Enter the service menu:

Monitor Setup - Install/Service (password 16-4-34) - Service (password 26-23-8) Record the information regarding the module software of M-BIS by selecting SCROLL VERS and turning the ComWheel. Note! DSC related data will appear only when the DSC is connected for the first time after start-up.

?

7.

Recognition of DSC Connect the PIC+ cable to the DSC. Connect the DSC to the module. - Check that the DSC is recognized (DSC related data appears to the page) - Check that ‘No sensor’ appears to the selected waveform field.

? 8.

Enter the BIS module service menu: Parameters - More… - BIS Check that the ‘Mod Mon Timeouts’, ‘ Mon Mod Bad checksums’ , ‘ Mod Mon Bad Checksums’, ‘ Bad Checksums from BIS’ values in the module view are not increasing faster than by 5 per second. Check that the memories of the module have passed the internal memory test, i.e. ‘RAM’, ‘ROM’ and ‘EEPROM’ all state OK.

?

9.

Check the BIS and Sensor Check membrane keys of the module. Stay in the module view and press each key for at least one second and check that the key being pressed is identified, i.e. the corresponding PRESSED text appears in the service menu.

?

10. Check that ‘ Messages from BE ’ are increasing steadily.

?

13 Document No. 800 3476

Datex-Ohmeda S/5 monitors 11. Go to the Sensor page. Check that - no sensor is identified - mains frequency is set correctly - check that ‘ BE powerup test’, ‘DSC selftest Ch1’ and ‘DSC selftest Ch2’ all show PASs (if not, go to BIS Setup page, perform DSC Test and check the results again)

? 12. Sensor check Connect the BIS simulator to the PIC+ cable. See that ‘Checking sensor’ text and image appear. Wait for a while seconds and check that all sensors show PASS. Check that the ‘Sensor type’ shows Demo Sensor.

? 13. Check that the ‘BIS’, ‘SQI’ and ‘SR’ values are between 0..1000, and the ‘EMG’ value between 0..10000. Note! If Sensor simulator 900508 is used, the values can be out of the given range.

?

14. Go to the Module page Check that no BIS Engine errors appear.

? 15. Perform sensor check by pressing ‘Check Sensor’ and verify sensor passes.

?

16. Perform an electrical safety check and a leakage current test.

?

17. Check that the module functions normally after performing the electrical safety check.

?

18. Clean the module with suitable detergent.

?

•

14 Document No. 800 3476

Fill in all necessary documents.

S/5 BIS Module, M-BIS

3.3 Disassembly and reassembly

Figure 5

BIS module disassembly and reassembly

Disassemble the M-BIS in the following way. 1.

Remove the two screws from the back of the module.

2.

Pull the module box slowly rearward and detach it from main body. Be careful with the loose latch and spring locking pin.

3.

Detach the BIS Engine board by removing the four screws located at the corners of the board and disconnecting the front panel connector cable.

4.

Detach the interface board by removing the two screws located near the front panel frame, disconnect the cable and pull out the front panel frame.

To reassemble the module, reverse the order of the disassembly steps.

CAUTION

When reassembling the module, make sure that the cables are reconnected properly.

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4

TROUBLESHOOTING

4.1 Troubleshooting chart Trouble

Cause

Treatment

No BIS waveforms on screen.

BIS waveforms not selected on screen.

Sensor impedance check is not available on menus. Sensor impedance check fails

Sensor is not connected to the DSC or DSC is not connected to the module Sensor poorly attached

Press Monitor Setup key and select BIS waveforms on the screen. Connect the sensor and the DSC

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Attach the sensor by following the sensor instructions

S/5 BIS Module, M-BIS

4.2 Messages The messages below will appear in the BIS digit field (DF), BIS waveform field (WF) or at the message field (MF) at the upper section of the Datex-Ohmeda S/5 patient monitor display. Message

Location

Cause

Treatment

Cable off BIS cable off No Sensor No BIS Sensor

DF MF DF MF

DSC cable is not connected to the module.

Connect the DSC to the module

Sensor is not connected to PIC+ cable or PIC+ cable is not connected to the DSC

Incompatible sensor

DF

Incompatible DSC

DF

Sensor check failed BIS sensor check failed

DF

Sensor is not recognized. Sensor is not a BIS sensor. Current module hw/sw is incompatible with this DSC E.g. DSC-2 Sensor check failed, one or more of the electrode impedances exceeds the threshold.

Connect the Sensor to the PIC+ cable Connect the PIC+ cable to the DSC Replace sensor and then PIC+ cable. Connect correct type of sensor Make sure PIC connector is clean and dry Connect correct type of DSC

Poor signal

DF

Checking sensor

DF

Checking Sensor – message stays more than 2 min. Automatic check off

DF

DF

Replace Sensor

DF

High BIS impedance

DF

Artifact

DF

Module error

DF

DSC Error

DF MF

Demo data

MF

MF

Artifacts, or the amount of EMG activity prevents calculating BIS, data excluded. SQI < 50 Sensor check in progress. Can be either the initial sensor check, manual check or the periodic check. Sensor check fails, the sensor is not attached to the patient while connected to the PIC+ cable Continuous sensor checking has been turned off The sensor has passed its use by date The sensor has been used for 24h Sensor is not attached properly to the patient Non-EEG data such as EMG, eyeblinks or shivering present. BIS Engine failure for more information see service page description The DSC is not communicating or operating properly. This may occur during the use of electrocautery device. For more information see service page description BIS simulator is connected

Reattach the sensor to the patient by following the sensor instructions Replace the sensor Check PIC+ cable and then DSC Check the sensor then the PIC cable. Reattach the sensor to the patient by following the sensor instructions Wait until the check has been performed

Attach the sensor to the patient and press the Check Sensor button on the module front panel Turn the check on from the BIS menu Replace with a new sensor Check the cable connections Reattach the sensor to the patient by following the sensor instructions Wait for good data Replace the BIS Engine

Replace the DSC If the message persists, the BIS Engine may require service.

Disconnect the BIS simulator

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