Service Manual
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GE Healthcare
BIS/EEG Module Service Manual
BIS/EEG Module English 2006694-001 © 2001, 2002, 2010 General Electric Company All rights reserved.
NOTE: Due to continuing product innovation, specifications in this manual are subject to change without notice. NOTE: For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies. Listed below are GE Medical Systems Information Technologies trademarks. 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.
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BIS/EEG Module
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Contents
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Introduction... 1-1 Manual Information... 1-2 Purpose... 1-2 Intended Audience... 1-2 Product References... 1-2 Revision History... 1-2 Safety Information... 1-3 Responsibility of the Manufacturer... 1-3 Intended Use... 1-3 Definitions of Warnings, Cautions, and Notes... 1-4 Equipment Symbols... 1-5 Service Information... 1-6 Service Requirements... 1-6 Equipment Identification... 1-6
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Equipment Overview... 2-1 BIS/EEG System Components... 2-2 Module... 2-2 Compatibility... 2-2 BIS DSC... 2-2 EEG DSC... 2-3 Solar 8000M Patient Monitor... 2-3 Solar 9500 Information Monitor... 2-4 Tram–rac 4A Housing... 2-4 Technical Specifications... 2-5 Insert Module... 2-7
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Maintenance... 3-1 Maintenance Schedule... 3-2 Recommended Maintenance... 3-2 Recommended Frequency... 3-2 Safety Tests... 3-2 Inspection and Cleaning... 3-3
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Visual Inspection...3-3 Cleaning Precautions...3-3 Exterior Cleaning...3-3 Cables and Leadwires...3-4 Checkout Procedure... 3-5 General...3-5 Required Tools/Equipment...3-5 Preparation...3-6 BIS Test (BIS DSC)...3-6 EEG Test (EEG DSC)...3-7 Electrical Safety Tests... 3-9 Recommendations...3-9 Required Tests...3-9 Test Conditions...3-9 Current Leakage Tests...3-10 Preparation...3-10 Patient (Source) Leakage Current Test...3-11 Patient (Sink) Leakage Current Test...3-12 Completion...3-13 PM Form... 3-14 Repair Log... 3-15
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Troubleshooting... 4-1 General Fault Isolation... 4-2 First Things to Ask...4-2 Visual Inspection...4-2 Troubleshooting... 4-4 Procedure...4-4 Monitor Error Messages...4-7 BIS...4-7 EEG...4-9 Theory of Operation... 4-11 General BIS/EEG Module Overview...4-11 Detailed BIS/EEG Module Architecture...4-13 Microcontrollers And Digital Signal Processor...4-14 Reset Generation...4-14 Clock Generation...4-14 XILINX XCS05 FPGA...4-15 22V10 Programmable Logic Device (PLD)...4-15 Aspect BIS/EEG Module PCB Power Supply...4-16 BIS/EEG Module Input Power Requirements...4-16
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Green/Yellow Display LED... 4-16 Green... 4-16 Yellow... 4-17 Module Connectors... 4-18 Tram-rac Interface Connector (J1)... 4-18 DSC Communication (P1)... 4-20 DSC Communication (Internal–A1 J10D and A2 J3)... 4-20 BIS Engine PCB Power (Internal–A1 J10C and A2 J6)... 4-21 BIS Engine Asynchronous Serial Interface (Internal–A1 J10A and A2 J5)... 4-22 Software Updates... 4-23
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Assembly Parts Lists and Drawings... 5-1 Ordering Parts... 5-2 General... 5-2 Field Replaceable Units... 5-2 Disassembly Procedures... 5-3 Aspect BIS/EEG Module PCB and BIS Engine... 5-3 Replacing the Aspect BIS/EEG Module PCB... 5-5 Replacing the BIS Engine... 5-6 Replacing the Front Panel Cable Assembly (W1)... 5-7 Reassembly... 5-7 Testing... 5-8 BIS/EEG Module–Parts List2004182-001A... 5-9 BIS/EEG Module–Exploded View2004182-001A... 5-10
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PCB Parts Lists and Drawings... 6-1 Aspect BIS/EEG Module PCB Theory of Operation... 6-2 Detailed Architecture... 6-3 Microcontrollers... 6-3 Processor Memory... 6-4 Reset Generation... 6-5 Clock Generation... 6-6 LED Display Indicators... 6-6 Xilinx XCS05 FPGA... 6-7 22V10 Programmable Logic Device (PLD)... 6-9 Aspect BIS/EEG Module PCB Power Supply... 6-9 80C152 Microcontroller Memory Map... 6-11 MC68332 Microcontroller Memory Map... 6-11
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PCB Connectors... 6-13 J1 RAC Interface...6-13 J10C, BIS Engine Power...6-15 J10A, BIS Engine Asynchronous Serial Interface...6-16 J10D, DSC Communication...6-16 J5, DSC Communication...6-17 J10B, MC68332 Background Debug Mode Connector...6-17 J4A AND J4B, RS232 Port 1 and Port 2...6-17 PCB BIS/EEG Module–Parts List2005541-001A... 6-18 Parts Location Diagram2005541-001A... 6-22 Schematic Diagrams2005541-001A... 6-23
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2006694-001D
Introduction
BIS/EEG Module
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Introduction: Manual Information
Manual Information Purpose This manual provides technical information for maintaining the equipment. Use it as a guide for maintenance and electrical repair of parts considered field repairable.
Intended Audience Users of this manual are expected to have a background in electronics, including analog and digital circuitry with RF and microprocessor architectures. It is intended for service representatives and technical personnel who maintain, troubleshoot, or repair this equipment.
Product References The BIS/EEG module supports both the Solar 8000M Patient Monitor and the Solar 9500 Information Monitor. Unless specified, this manual refers to them as the Solar monitor or the host monitor.
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 whenever the document is updated.
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Revision
Comment
A
Initial release.
B
Updated to support disk kit 1B.
C
Updated to support Main code 1B (disk kit 1C).
D
Updated manual for addendum revision. No changes were made to the content of the manual.
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Introduction: Safety Information
Safety Information Responsibility of the Manufacturer GE Medical Systems Information Technologies is responsible for the effects of safety, reliability, and performance only if:
Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE Medical Systems Information Technologies, Inc;
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.
Intended Use This device is intended for use under the direct supervision of a licensed health care practitioner. This device is not intended for home use. Federal law restricts this device to be sold by or on the order of a physician. Contact GE Medical Systems Information Technologies for information before connecting any devices to the equipment that are not recommended in this manual. Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601 medical electrical systems standard. Periodically, and whenever the integrity of the device is in doubt, test all functions. The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:
Use of the accessory in the PATIENT VICINITY; and
Evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601 harmonized national standard.
If the installation of the equipment, in the USA, uses 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit.
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Introduction: Safety Information
Definitions of Warnings, Cautions, and Notes Warnings, cautions, and notes are used throughout this manual to designate a degree or level of hazardous situations. Hazard is defined as a source of potential injury to a person. DANGER indicates an imminent hazard which, if not avoided, will result in death or serious injury.
WARNING indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury.
CAUTION indicates a potential hazard or unsafe practice which, if not avoided, could result in minor personal injury or product/property damage. NOTE provides application tips or other useful information to assure that you get the most from your equipment.
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Introduction: Safety Information
Equipment Symbols The following symbols appear on the equipment.
ATTENTION: Consult accompanying documents before using the equipment. Defibrillator-proof type BF equipment: type BF equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment is type B equipment with an F-type isolated (floating) part. The paddles indicate the equipment is defibrillator proof. Type BF applied part: type BF equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment is type B equipment with an F-type isolated (floating) part; however, the lack of paddles indicates the equipment is NOT defibrillator proof. Type B equipment: type B equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Manufacturer name and address.
European authorized representative.
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Introduction: Service Information
Service Information Service Requirements
Refer equipment servicing to GE Medical Systems Information Technologies authorized service personnel only.
Any unauthorized attempt to repair equipment under warranty voids that warranty.
It is the user’s responsibility to report the need for service to GE Medical Systems Information Technologies or to one of their authorized agents.
Failure on the part of the responsible individual, hospital, or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.
Regular maintenance, irrespective of usage, is essential to ensure that the equipment will always be functional when required.
Equipment Identification Every GE Medical Systems Information Technologies device has a unique serial number for identification. The serial number appears on the product label on the base of each unit.
D 0 XX 0005 G XX Month Manufactured A = January B = February C = March D = April E = May F = June G = July H = August J = September K = October L = November M = December
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Year Manufactured 0= 2000 1= 2001 2= 2002 3= 2003 (and so on)
Product Code Two-character product descriptor
Product Sequence Number Manufacturing number (of total units manufactured.)
BIS/EEG Module
Division F = Cardiology G = Monitoring N = Freiburg Hellige
Device Characteristics One or 2 letters that further describe the unit, for example: P = prototype not conforming to marketing specification R = refurbished equipment S = special product documented under Specials part numbers U = upgraded unit
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Equipment Overview
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Equipment Overview: BIS/EEG System Components
BIS/EEG System Components Module The BIS/EEG module shown below calculates the Bispectral Index and other processed EEG variables based on artifact-free epochs of data. The BIS Engine reports processed variables once every second. The BIS/EEG module is used with a Tram–rac 4A.
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Figure 1: BIS/EEG Module
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.
BIS DSC A BIS DSC, patient interface cable (PIC), and BIS Sensor electrode are required for BIS monitoring. Simultaneous use of two BIS/EEG modules is acceptable when one is connected to a BIS DSC and one is connected to an EEG DSC. Simultaneous use of two BIS/EEG modules is unacceptable when both are connected to a BIS DSC or to a EEG DSC.
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Figure 2: BIS DSC with Patient Interface Cable (PIC)
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Equipment Overview: BIS/EEG System Components
EEG DSC The EEG DSC can monitor two or four channels of EEG in bipolar or referential mode. Simultaneous use of two BIS/EEG modules is acceptable when one is connected to a BIS DSC and one is connected to a EEG DSC. Simultaneous use of two BIS/EEG modules is unacceptable when both are connected to a BIS DSC or to an EEG DSC.
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Figure 3: EEG DSC with 20 Foot Extension Cable
Solar 8000M Patient Monitor The Solar 8000M patient monitor (software version 3 or later) consists of a Solar 8000M processing unit with compatible display. The processing unit is the center of the Solar 8000M Patient Monitoring system. It provides the user controls, the processors to communicate with various patient monitoring modules, and it analyzes patient data. It can display up to eight different waveforms at one time.
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Figure 4: Solar 8000M
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Equipment Overview: BIS/EEG System Components
Solar 9500 Information Monitor The basic Solar 9500 Information Monitor (software version 3 or later) consists of a Solar 9500 processing unit, a compatible touchscreen display, and one or more acquisition devices. The processing unit is the heart of the system. Primary user controls are provided by the touchscreen display but a keyboard and mouse may also be used.
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Figure 5: Solar 9500
Tram–rac 4A Housing The Tram–rac housing (remote acquisition case) acquires patient data for the patient monitor. The Tram-rac Housing Service Manual has more information. The Solar monitor and the Tram–rac 4A (software version 6C or later) housing support the BIS/EEG module. Shown below is a Tram-rac 4A housing.
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Figure 6: Tram–rac 4A Housing
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Equipment Overview: Technical Specifications
Technical Specifications Table 1. Performance Specifications Item
Description
Measurement Range Suppression Ratio (SR) Spectral Edge Frequency (SEF) Median Frequency Bispectral Index (BIS) Total Power (AMP) Electromyogram (EMG) Signal Quality Index (SQI)
0.0-100.0% (in 0.1% steps over the last 63 seconds) 0.50-30.00 Hz @ 95% in 0.01 Hz steps 0.50-30.00 Hz @ 50% in 0.01 Hz steps, EEG DSC only 0-100.0 in 0.1 steps, BIS DSC only 0.0-100.0 dB in 0.01 dB units where 0 dB = 0.0001 mV2 0.0-100.0 dB in 0.01 dB units where 0 dB = 0.0001 mV2 0.0-100.0% in 0.1% steps
EEG Waveforms
Number of channels: BIS DSC: 1 EEG DSC: 1, 2 or 4 channels Sampling rate: Normal mode: 128 or 256 sps Transmission of EEG waveforms may be enabled or disabled with a software command.
Filter options for filtered EEG waveforms sent to host monitor (256 samples/second only)
Normal mode: High-pass: 0.25, 1.0, 2.0 Hz Low-pass: none, 30, 50, 70 Hz Notch: none, 50, 60, 50 & 60 Hz
Table 2. Power Requirements Item
Description
Maximum Power Consumption
+16.5V, 300mA +5V, 2mA
Table 3. Environmental Specifications
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Item
Description
Operating Conditions
Refer to the monitor specifications.
Storage Conditions Temperature Relative Humidity
–40 C to +70 C (–40 F to +158 F) 0 to 95% (non-condensing)
Altitude
–305 to 1830m (–1000 to 6,000ft.)
Atmospheric Pressure
645 to 795mmHg (860 to 1060hPa)
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Equipment Overview: Technical Specifications
Table 4. Physical Specifications Item
Description
Height
4.0 cm (1.6 in)
Width
11.4 cm (4.5 in)
Depth
28.6 cm (11.25 in)
Weight
0.52 Kg (1.15 lb)
Cooling Method
Natural convection
Heat Dissipation
20Btu/Hr (6W), maximum
Table 5. Compatible Host Monitors, Tram-racs
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Host Monitor/Tram-rac
Software Version
Solar 8000M
3 or later
Solar 9500
3 or later
Tram-rac 4A
6C or later
Certification
UL 2601-1 Classified. UL Classified for CAN/CSA C22.2 No. 601.1. CE Marking for the 93/42/EEC medical Device Directive. IEC 60601-1 Certified. IEC 60601-2-26 Certified.
Warranty
One year (accessories may differ)
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Equipment Overview: Insert Module
Insert Module 1.
Insert the BIS/EEG module into any slot of a Tram-rac 4A housing.
Figure 7: Insert BIS/EEG Module 2.
Connect a DSC assembly to the BIS/EEG connector on the module. Make sure the following events take place.
The front panel Status LED of the module illuminates steady green after all self-tests are complete.
The module identifies itself on the monitor screen with a patient parameter box.
NOTE The module can not identify itself on the monitor if a DSC is not connected. 3.
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If the module does not identify itself on the screen and the DSC is connected, refer to Chapter 4, “Troubleshooting” . Otherwise, go to Chapter 3, “Maintenance” and perform the Chapter 3, “Checkout Procedure” and Chapter 3, “Electrical Safety Tests” .
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Equipment Overview: Insert Module
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