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Patient Monitoring System Operator’s Manual Supplement for the BIS®/EEG Module Supplement Software Version 1 2006694-002
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127( The information in this supplement only applies to BIS/EEG Module software version 1. Due to continuing product innovation, specifications in this manual are subject to change without notice.
Listed below are GE Medical Systems Information Technologies trademarks used in this document. All other trademarks contained herein are the property of their respective owners. SOLAR and TRAM-RAC are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office. © GE Medical Systems Information Technologies, 2001, 2002. All rights reserved.
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CE Marking Information
CE Marking Information Compliance The BIS/EEG Module bears CE mark CE-0459 indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. The product is in radio-interference protection class A in accordance with EN 55011. The country of manufacture can be found on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility - Medical Electrical Equipment”. The safety and effectiveness of this device has been verified against previously distributed devices. Although all standards applicable to presently marketed devices may not be appropriate for prior devices (i.e., electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. See user’s information.
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CE Marking Information
General Information
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This manual is an integral part of the product and describes its intended use. It should always be kept close to the equipment. Observance of the manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.
The symbol documents.
Information which refers only to certain versions of the product is accompanied by the model number(s) of the product(s) concerned. The model number is given on the nameplate of the product.
The warranty does not cover damages resulting from the use of accessories and consumables from other manufacturers.
GE Medical Systems Information Technologies is responsible for the effects on safety, reliability, and performance of the product, only if:
means ATTENTION: Consult accompanying
assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE Medical Systems Information Technologies;
the electrical installation of the relevant room complies with the requirements of the appropriate regulations; and,
the device is used in accordance with the instructions for use.
All publications conform with the product specifications and applicable IEC publications on safety and essential performance of electromedical equipment as well as with applicable UL and CSA requirements and AHA recommendations valid at the time of printing.
The GE Medical Systems Information Technologies quality management system complies with the international standards DIN EN ISO 9001 and EN 46001, and the Council Directive on Medical Devices 93/42/EEC Annex II.
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Contents
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Introduction... 1 About This Supplement... 3 Document Purpose... 3 Revision History... 3 Illustrations and Names... 3 Safety... 4 Intended Use... 4 Complete Safety Information... 4 Cautions... 4 BIS/EEG Module... 5 Compatibility... 5 Digital Signal Converter... 6 BIS DSC... 7 EEG DSC... 8
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BIS Monitoring... 9 Introduction... 11 Considerations for Using BIS... 11 BIS Sensor Placement... 12 Three-Electrode Sensor Placement... 12 Four-Electrode Sensor Placement... 14 Impedance Test... 14 BIS Setup Checklist... 15 BIS Range Guidelines... 16 BIS Monitoring Features... 17 BIS Parameter Window... 17 BIS Spectral Display... 18
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BIS Menu... 20 Spectra Setup Menu... 20 Display Popup Menu... 22 Smoothing Option... 22 BIS Limits Menu... 23 Sensor Check Option... 23 BIS Setup Menu... 24 Resume BIS Option... 24 EEG Waveform Menu... 25 EEG Waveform Scale... 25 BIS Trends Menu... 26 BIS Ranges Option... 26 Speed Option... 26 BIS Status Messages... 27 BIS Reference Literature... 29
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EEG Monitoring... 31 Introduction... 33 Definitions of Terms... 33 EEG Electrodes... 35 EEG Electrode Placement... 36 International 10-20 Electrode Placement System... 36 Regional Lead Placements... 39 Generic “X” Lead Placement... 40 Commonly Used Electrode Montages... 40 Skin Preparation... 42 Applying Electrodes... 43 EEG Setup Checklist... 45 EEG Monitoring Features... 46 EEG Parameter Window... 46 EEG Spectral Display... 47 EEG Menu... 50 Spectra Setup Menu... 50 Display Popup Menu... 53 Waveform On/Off Menu... 54 EEG Scale Popup Menu... 54 Parameter Display Popup Menu... 54 Fast Look Information Window... 55 Montage Menu... 56 EEG Setup Menu... 57 Impedance Check Information Window... 59
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EEG Trends Menu... 60 EEG Help Option... 61 Speed Option... 61 EEG Status Messages... 62 EEG Reference Literature... 64
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For your notes
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Introduction
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Introduction: About This Supplement
About This Supplement Document Purpose This document SUPPLEMENTS your patient monitor operator’s manual. It provides information specific to the BIS/EEG module. This document provides information on NEW features, which may not be included in your monitor operator’s manual. You MUST refer to the appropriate monitor operator’s manual for important safety information and complete monitoring system operating instructions.
Revision History Each page of the document has the document part number and revision letter at the bottom of the page. The revision letter changes each time the document is updated. Revision
Date
Comment
A
7 June 2001
Initial release of this document.
B
5 February 2002
Document revised for editorial changes.
C
11 November 2002
Document revised to address different patient monitor user interfaces.
Illustrations and Names All illustrations in this supplement are provided as examples only. They may not necessarily reflect your monitoring setup or data displayed on your monitor. In this supplement, all names appearing in examples and illustrations are fictitious. The use of any real person’s name is purely coincidental.
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Introduction: Safety
Safety Intended Use The BIS/EEG module is intended to monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room, and for clinical research. The BIS, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.
Complete Safety Information The safety information (e.g., warnings, cautions) presented in this section and throughout this document represents ONLY information that may not be contained in the host monitor operator’s manual. You MUST refer to the appropriate host monitor operator’s manual for complete safety information, including some warnings and cautions that may be applicable to monitoring BIS or EEG with the BIS/EEG module.
Cautions &$87,216 Do not autoclave the digital signal converter. Autoclaving will seriously damage the component. Continuous impedance checking may need to be disabled if the impedance check signal interferes with other equipment.
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Introduction: BIS/EEG Module
BIS/EEG Module The BIS/EEG module can be used to monitor bispectral index (BIS) or an electroencephalograph (EEG). The module, when installed in a Tram-rac® 4A module housing, collects the appropriate physiological data and sends it to a GE Medical Systems Information Technologies monitor for display.
913A
BIS/EEG Module 127( BIS® and Bispectral Index® are registered trademarks of Aspect Medical Systems. 127( The BIS/EEG module is classified as a Type B applied part (
).
Signal input isolation is achieved through the digital signal converter.
Compatibility The BIS/EEG module has varying levels of compatibility with different GE Medical Systems Information Technologies monitors. The compatibility is dependent on the version of software the monitor is running. Some monitors also only support BIS monitoring, not EEG monitoring. Contact your GE Medical Systems Information Technologies sales/service representative if you have questions regarding compatibility.
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Introduction: Digital Signal Converter
Digital Signal Converter The BIS/EEG module must be connected to a digital signal converter (DSC). The DSC contains the EEG amplifiers and analog filters, and digitizes the resulting waveforms for transmission to, and processing by, the host monitor. It amplifies and digitizes the EEG signal close to the patient, limiting the effect of ambient noise sources. The DSC is connected to a flexible cable that plugs into the connector on the front of the BIS/EEG module. The type of digital signal converter connected to the BIS/EEG module determines which parameter (BIS or EEG) will appear on the monitor display. BIS DSCs are used for BIS monitoring. EEG DSCs are used for EEG monitoring.
:$51,1* CABLES - Route all cables away from patient’s throat to avoid possible strangulation.
&$87,21 Do not open the digital signal converter for any reason. The seal to prevent liquids from entering the digital signal converter may be damaged if opened. Service or repairs must be performed only by qualified biomedical technicians.
If a Solar® 8000M monitor is being used as the host monitor, BIS and EEG can be monitored at the same time. This requires that two BIS/EEG modules are in the Tram-rac housing. One module must be connected to a BIS DSC for BIS monitoring, and the other module must be connected to an EEG DSC for EEG monitoring. 127( Other host monitors and monitor configurations are not capable of monitoring BIS and EEG simultaneously. Additionally, the Solar 8000M monitor can display data from two different BIS sources at the same time. One parameter window can display BIS from the BIS/EEG module in the Tram-rac housing. Another BIS parameter window can be displayed when a BIS monitor is connected to the Octanet connectivity device. Waveforms and menu options are available for BIS when the BIS/EEG module is the BIS source. Only a parameter window is available when the BIS source is a BIS monitor connected to the Octanet connectivity device.
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Introduction: Digital Signal Converter
BIS DSC The BIS DSC is used for BIS monitoring. 127( The BIS DSC signal input is a high-insulation port and it is defibrillator-proof (
).
The isolated patient connection ensures patient safety and protects the device during defibrillation and electrosurgery.
914A
BIS DSC
Patient Interface Cable A patient interface cable runs from the BIS DSC and connects to the BIS sensor. The sensor is attached to the patient.
:$51,1* To minimize the risk of patient strangulation, the patient interface cable must be carefully placed and secured.
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Introduction: Digital Signal Converter
EEG DSC The EEG DSC is used for traditional EEG monitoring. It has connectors for 10 electrodes. This includes one reference electrode and one ground electrode.
:$51,1* The EEG DSC is equipped with a safety lead adapter. Use only electrodes that have 1.5 mm DIN standard safety lead connectors. Do not remove the safety lead adapter from the EEG DSC.
127( The EEG DSC signal input is isolated, but it is not defibrillator-proof (
).
915A
EEG DSC
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BIS Monitoring
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BIS Monitoring: Introduction
Introduction The Bispectral Index™ (BIS) is a processed EEG variable which may be used as an aid in monitoring the effects of certain anesthetic agents, and is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS/EEG module is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS is computed in real-time using three steps: 1. The raw EEG signal is broken down second by second, and the segments that have artifact are identified and removed. 2. The BIS module calculates the bispectral index by combining EEG features associated with anesthetic effect. 3. The index is modified to reflect the amount of suppressed EEG signal in the raw waveform. The resulting BIS values range from 100, representing a patient that is wide awake, to 0 for the absence of brain electrical activity. A BIS value below 70 indicates a very low probability of recall, and BIS below 60 is associated with unconsciousness. Since BIS is an absolute value, baseline information about the patient is not required for monitoring. Refer to page 16 for BIS range guidelines.
Considerations for Using BIS Clinical judgement should always be used when interpreting the BIS in conjunction with other available clinical signs. Reliance on the BIS alone for intraoperative anesthetic management is not recommended. As with any monitored parameter, artifacts and poor signal quality may lead to inappropriate BIS values. Potential artifacts may be caused by poor skin contact (high impedance), muscle activity or rigidity, head and body motion, sustained eye movements, improper sensor placement and unusual or excessive electrical interference. Due to limited experience in the following applications, BIS values should be interpreted cautiously in patients with known neurological disorders, those taking psychoactive medications, and in children below the age of one.
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BIS Monitoring: BIS Sensor Placement
BIS Sensor Placement :$51,1* The BIS sensor must not be located between defibrillator pads when a defibrillator is used on a patient connected to the BIS/EEG module. Death or serious injury could result.
&$87,216 The BIS/EEG module has been designed to operate with a disposable BIS sensor. The sensor is a silver/silver chloride electrode array that utilizes Aspect Medical Systems’ patented Zipprep® technology and uses a proprietary connector. Do not use other types of electrodes. Single use only. Do not reuse. Due to intimate skin contact, reuse may pose a risk of infection. If skin rash or other unusual symptom develops, stop use and remove. Do not use if sensor is dry. To avoid dryout, do not open pack until ready to use. Limited to short-term use (maximum of 24 hours). Do not cut sensor components, as this can result in improper operation.
There are two types of BIS sensors, a three-electrode sensor and a fourelectrode sensor. Follow the appropriate placement instructions below, based on how many electrodes your sensor has.
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