Aspect Medical Systems XP PLATFORM A-2000 User manual

Aspect Medical Systems
A-2000TM XP PLATFORM
BISPECTRAL INDEXTM
(BISTM) MONITORING SYSTEM
SERVICE INFORMATION
MANUAL
Rx Only
©Copyright, 2009, Aspect Medical Systems. All rights reserved. Copying or other reproduction
of this document is prohibited without prior written consent of Aspect Medical Systems.
EC REP
Aspect Medical Systems, Inc. Aspect Medical Systems International B.V.
One Upland Road Rijnzathe 7d2
Norwood, MA 3454 PV De Meern
U.S.A. The Netherlands
(Tel) 617-559-7000 Tel: [phone]
(Tel) 888-BIS INDE(X) (U.S. only) Fax: [phone]
(Fax) 617-559-7400 [e-mail]
[e-mail]
www.aspectmedical.com 075-0014 1.04

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TABLE OF CONTENTS
1SAFETY PRECAUTIONS........................................................................................1-1
1.1 WARNINGS...........................................................................................................1-1
1.2 CAUTIONS............................................................................................................1-3
1.3 KEY TO SYMBOLS...............................................................................................1-5
2A-2000 SYSTEM OVERVIEW .................................................................................2-1
2.1 INTRODUCING THE A-2000 BIS MONITORING SYSTEM..................................2-1
2.1.1 PRINCIPAL COMPONENTS......................................................................................2-1
2.1.2 HOW THE A-2000 WORKS ....................................................................................2-2
2.2 INSTRUMENT IDENTIFICATION..........................................................................2-2
2.2.1 A-2000 MONITOR.................................................................................................2-2
2.2.2 A-2000 DIGITAL SIGNAL CONVERTER....................................................................2-2
2.2.3 SOFTWARE REVISION NUMBERS............................................................................2-2
2.3 PROPRIETARY INFORMATION AND DEVICES .................................................2-2
3PRINCIPLES OF OPERATION ...............................................................................3-1
3.1 HOW THE A-2000 MONITORING SYSTEM WORKS...........................................3-1
3.2 SYSTEM ARCHITECTURE...................................................................................3-1
3.2.1 THE DIGITAL SIGNAL CONVERTER (DSC) ..............................................................3-4
3.2.2 THE A-2000 MONITOR..........................................................................................3-6
3.2.3 A-2000 PRINTER ..................................................................................................3-7
3.3 SYSTEM FEATURES............................................................................................3-7
3.3.1 SYSTEM SELF CHECKS .........................................................................................3-7
3.3.2 DATA MEMORY.....................................................................................................3-8
3.3.3 SAVED SETTINGS..................................................................................................3-8
3.3.4 BATTERY OPERATION ...........................................................................................3-8
3.3.5 DATA TRANSFER AND SOFTWARE UPDATES ..........................................................3-8
3.3.6 PRINTED REPORTS ...............................................................................................3-9
4PREPARATION FOR USE AND INSTALLATION..................................................4-1
4.1 ENVIRONMENT....................................................................................................4-1
4.1.1 SHIPPING AND STORAGE ENVIRONMENT................................................................4-1
4.1.2 OPERATING ENVIRONMENT ...................................................................................4-1
4.1.3 POWER REQUIREMENTS AND SYSTEM GROUNDING ...............................................4-2
4.1.4 SITE PREPARATION:MOUNTING THE MONITOR ......................................................4-2
4.2 INSTRUMENT CONNECTIONS............................................................................4-3
4.2.1 DIGITAL SIGNAL CONVERTER CONNECTIONS .........................................................4-4
4.2.2 POWER CORD CONNECTIONS ...............................................................................4-4
4.2.3 PRINTER CONNECTOR ..........................................................................................4-4

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4.3 INSTALLATION AND VERIFICATION PROCEDURE..........................................4-5
5PREVENTIVE MAINTENANCE, CARE AND CLEANING ......................................5-1
5.1 CARE AND CLEANING ........................................................................................5-1
5.1.1 CLEANING THE MONITOR AND DIGITAL SIGNAL CONVERTER...................................5-1
5.1.2 DISINFECTING THE MONITOR AND DIGITAL SIGNAL CONVERTER .............................5-1
5.1.3 CLEANING THE MONITOR DISPLAY.........................................................................5-1
5.2 PREVENTIVE MAINTENANCE.............................................................................5-2
5.2.1 CHECKING THE BATTERY ......................................................................................5-2
5.2.2 CHECKING LEAKAGE CURRENT .............................................................................5-2
5.2.3 A-2000 MONITOR SYSTEM CHECKOUT PROCEDURE..............................................5-3
5.2.4 DSC CHECKOUT PROCEDURE...............................................................................5-4
5.2.5 PATIENT INTERFACE CABLE (PIC) CHECKOUT PROCEDURE ...................................5-4
5.2.6 PHYSICAL INTEGRITY INSPECTION .........................................................................5-5
6DIAGNOSTICS AND TROUBLESHOOTING..........................................................6-1
6.1 GENERAL TROUBLESHOOTING........................................................................6-1
6.2 A-2000 BIS MONITOR SYSTEM TROUBLESHOOTING PROCEDURE..............6-2
6.2.1 MONITOR TROUBLESHOOTING PROCEDURE ........................................................6-2
6.2.2 DSC TROUBLESHOOTING PROCEDURE..................................................................6-4
6.2.3 PIC AND SENSOR TROUBLESHOOTING PROCEDURE...........................................6-5
6.2.4 DSC CABLE PROBLEM ISOLATION .........................................................................6-6
6.3 STATUS MESSAGES AND OPERATOR ACTIONS ............................................6-7
7SERVICING THE A-2000 SYSTEM.........................................................................7-1
7.1 REPLACING MAJOR COMPONENTS.................................................................7-1
7.1.1 TO REPLACE THE PIC: ..........................................................................................7-1
7.1.2 TO REPLACE THE DSC:.........................................................................................7-2
7.1.3 TO REPLACE THE MONITOR:..................................................................................7-2
7.2 FUSE REMOVAL AND INSTALLATION...............................................................7-2
7.3 WHAT TO DO WITH ACOMPONENT THAT REQUIRES SERVICE....................7-3
7.4 REPACKAGING FOR SHIPPING AND STORAGE..............................................7-3
7.5 DISASSEMBLING AND REASSEMBLING THE DSC..........................................7-4
7.5.1 REQUIRED TOOLS AND SUPPLIES..........................................................................7-4
7.5.2 THE DSC CASE....................................................................................................7-5
7.5.3 THE DSC CABLES (MONITOR AND PIGTAIL)...........................................................7-9
7.5.4 DSC CHECKOUT AND SAFETY TESTS..................................................................7-10
8A-2000 SPECIFICATIONS ......................................................................................8-1
8.1 INTRODUCTION:..................................................................................................8-1
8.2 WARRANTY..........................................................................................................8-4
9APPENDIX I.............................................................................................................9-1

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9.1 SPARES AND ACCESSORIES LIST....................................................................9-1
9.2 SENSOR SIMULATOR: P/N: 186-0137 FOR USE WITH DSC-XP: ....................9-2
9.3 TEST SENSOR......................................................................................................9-3
9.4 SAFETY TESTER CONNECTION WITH PIC........................................................9-5
9.5 PLACEMENT OF PIC SECURING STRAP ON BIS MONITORING SYSTEM......9-6
10 APPENDIX II........................................................................................................10-1
10.1 A-2000 SIGNAL FLOW DIAGRAM.....................................................................10-1
10.2 A-2000 BLOCK DIAGRAM .................................................................................10-2
10.3 DSC WIRING DIAGRAM; DSC CONNECTOR (WIRE SIDE).................................10-3
10.4 WIRING DIAGRAM; MONITOR CABLE.............................................................10-4
10.5 WIRING DIAGRAM; PIGTAIL CABLE................................................................10-5

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TABLE OF FIGURES
Figure 2-1 The A-2000 BIS Monitoring System .........................................................................................2-3
Figure 2-2 Rear View of Monitor...............................................................................................................2-4
Figure 3-1 The A-2000 System Block Diagram..........................................................................................3-2
Figure 3-2 The A-2000 Signal Flow Diagram ...........................................................................................3-3
Figure 4-1 Pole Clamp...............................................................................................................................4-3
Figure 7-1 Placement of PIC Securing Strap on BIS Monitoring System..................................................7-1
Figure 7-2 Remove the ground shield securing screw.................................................................................7-6
Figure 7-3 Remove shield by sliding along pigtail cable............................................................................7-6
Figure 7-4 Carefully separate the two printed circuit boards.....................................................................7-7
Figure 7-5 For a new gasket, cable passages need to be carefully cut.......................................................7-8
Figure 7-6 Verify that the strain relief is fully secured in its recess............................................................7-9
Figure 9-1 BIS Sensor................................................................................................................................9-3
Figure 9-2 Connecting electrodes #2 and #4.............................................................................................9-4
Figure 9-3 Connecting electrode #3 with #4, and #1 with #2. ................................................................... 9-4
Figure 9-4 Safety Tester Contact Points ....................................................................................................9-5

ABOUT THIS MANUAL
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ABOUT THIS MANUAL
This manual contains information necessary for the customer to install, maintain, service, identify
and prepare for use the Aspect Medical System BIS™Monitoring System. Also included are
directions to diagnose, troubleshoot, and repair the system. A spare parts and accessories list
and system specifications are included.
This manual is intended to be used in combination with the A-2000™Operating Manual.
The A-2000 BIS Monitoring System is designed and manufactured using state-of-the-art
components and manufacturing processes. Field repair or customer repairs are therefore limited
by design to replacement of major component assemblies such as the Patient Interface Cable
(PIC), Digital Signal Converter (DSC), or the A-2000 Monitor itself.
This manual, in conjunction with the A-2000 Operating Manual, contains the maintenance and
diagnostic troubleshooting information necessary for customer qualified technical personnel to
test and replace those parts of the equipment that are replaceable by the customer. Aspect does
not authorize nor provide information to service or repair the internal components of the A-2000
Monitor.
Section I discusses important safety precautions. Before attempting to set up or service the
A-2000, please familiarize yourself with the safety information provided in this section.
Section II provides a functional overview of the A-2000, its principal components, and instrument
identification.
Section III describes the A-2000 monitor hardware and how it operates.
Section IV provides preparation for use and installation instructions, including environmental
considerations, instrument connections and system setup and check out.
Section V describes normal maintenance, care and cleaning procedures.
Section VI describes the A-2000 diagnostic tools and provides tables to aid in troubleshooting
the system.
Section VII describes the removal and replacement procedure for system components and how
to return a component for service. It also explains how to disassemble and reassemble the DSC
to replace cables. Note:
This manual was not designed for repairing the A-2000 BIS system to the level of
its electronic circuit boards. The manual is intended solely for the troubleshooting
and replacement of its major components or DSC cables.
Section VIII contains the A-2000 specifications and warranty.
Appendix I provides instructions for use for the Sensor Simulator and describes how to make a
test sensor. It also contains a list of spare parts and accessories.
Appendix II provides system diagrams.

ABOUT THIS MANUAL
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vi

SECTION I SAFETY PRECAUTIONS
____________________________________________________________________________
1-1
SECTION I
1 SAFETY PRECAUTIONS
INTRODUCTION
Caution:
Carefully read the A-2000 BIS Monitoring System Operating Manual entirely
before using the monitor in a clinical setting.
WARNINGS, CAUTIONS, AND NOTES
The terms warning, caution, and note have specific meanings in this manual.
•A WARNING advises against certain actions or situations that could result in personal injury
or death.
•A CAUTION advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure, although personal injury is unlikely.
•A NOTE provides useful information regarding a function or procedure.
KEY TO SYMBOLS
A key to the symbols used on the A-2000 appears at the end of this section.
1.1 WARNINGS
GROUND WIRE LEAKAGE CURRENT MUST BE CHECKED BY A QUALIFIED BIOMEDICAL
ENGINEERING TECHNICIAN WHENEVER INSTRUMENT CASE IS OPENED.
EXPLOSION HAZARD: DO NOT USE THE A-2000 IN A FLAMMABLE ATMOSPHERE OR
WHERE CONCENTRATIONS OF FLAMMABLE ANESTHETICS MAY OCCUR.
ELECTRICAL SHOCK HAZARD: DO NOT REMOVE MONITOR COVERS DURING
OPERATION OR WHILE POWER IS CONNECTED TO MONITOR.
ELECTRICAL SHOCK HAZARD: THE MANUFACTURER'S INSPECTION OF THIS
APPARATUS VERIFIED THAT THE GROUND LEAKAGE CURRENT AND THE PATIENT
SAFETY CURRENT WERE LESS THAN THE SPECIFIED LIMITS ESTABLISHED BY THE
APPLICABLE SAFETY STANDARDS. AS A MATTER OF SAFE PRACTICE, THE
INSTITUTION SHOULD CONDUCT PERIODIC TESTS TO VERIFY THESE CURRENTS.
SHOCK HAZARD: DO NOT ATTEMPT TO DISCONNECT THE POWER CORD WITH WET
HANDS. MAKE CERTAIN THAT YOUR HANDS ARE CLEAN AND DRY BEFORE TOUCHING
THE POWER CORD.
U.S.A. REQUIREMENT: FOR PROPER GROUNDING, THE POWER RECEPTACLE MUST BE
A THREE-WIRE GROUNDED OUTLET. A HOSPITAL GRADE OUTLET IS REQUIRED.
NEVER ADAPT THE THREE-PRONG PLUG FROM THE MONITOR TO FIT A TWO-SLOT
OUTLET. IF THE OUTLET HAS ONLY TWO SLOTS, MAKE SURE THAT IT IS REPLACED
WITH A THREE-SLOT GROUNDED OUTLET BEFORE ATTEMPTING TO OPERATE THE
MONITOR.

SECTION I SAFETY PRECAUTIONS
____________________________________________________________________________
1-2
IF THE INTEGRITY OF THE EXTERNAL PROTECTIVE EARTH GROUND IS IN DOUBT, THE
A-2000 SHALL BE OPERATED FROM ITS INTERNAL BATTERY POWER SOURCE ONLY.
FOR A-2000s USED OUTSIDE OF NORTH AMERICA: A HARMONIZED LINE CORD WITH
CONDUCTORS HAVING A CROSS SECTIONAL AREA GREATER THAN 0.75 mm2MUST BE
USED.
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSOR AND CONNECTORS,
INCLUDING THE NEUTRAL ELECTRODE, SHOULD NOT CONTACT OTHER CONDUCTIVE
PARTS, INCLUDING EARTH.
ANY PROCEDURES THAT REQUIRE THE REMOVAL OF THE DSC’s COVER AND
INTERNAL PARTS SHOULD BE PERFORMED BY A QUALIFIED BIOMEDICAL
ENGINEERING TECHNICIAN. POWER OFF THE UNIT BY DISCONNECTING FROM THE
MONITOR.
TO REDUCE THE HAZARD OF BURNS IN THE HIGH-FREQUENCY SURGICAL NEUTRAL
ELECTRODE CONNECTION, THE SENSOR OR ELECTRODES SHOULD NOT BE LOCATED
BETWEEN THE SURGICAL SITE AND THE ELECTRO-SURGICAL UNIT RETURN
ELECTRODE.
TO REDUCE THE HAZARD OF BURNS DURING USE OF BRAIN-STIMULATING DEVICES
(e.g., TRANSCRANIAL ELECTRICAL MOTOR EVOKED POTENTIAL), PLACE STIMULATING
ELECTRODES AS FAR AS POSSIBLE FROM THE BIS SENSOR AND MAKE CERTAIN THAT
SENSOR IS PLACED ACCORDING TO PACKAGE INSTRUCTIONS.
THE SENSOR MUST NOT BE LOCATED BETWEEN DEFIBRILLATOR PADS WHEN A
DEFIBRILLATOR IS USED ON A PATIENT CONNECTED TO THE A-2000.
TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT INTERFACE CABLE
(PIC) MUST BE CAREFULLY PLACED AND SECURED.
WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR SOLUTIONS OCCURS,
RE-TEST GROUND LEAKAGE CURRENT BEFORE FURTHER USE.
BE SURE THE MONITOR IS MOUNTED SECURELY IN PLACE TO AVOID PERSONAL
INJURY.
MONITOR IS NOT DESIGNED FOR USE IN MRI ENVIRONMENT.
UNIVERSAL PRECAUTIONS SHALL BE OBSERVED TO PREVENT CONTACT WITH BLOOD
OR OTHER POTENTIALLY INFECTIOUS MATERIALS. PLACE CONTAMINATED
MATERIALS IN REGULATED WASTE CONTAINER.
DO NOT MIX DISINFECTING SOLUTIONS (e.g., BLEACH AND AMMONIA), AS HAZARDOUS
GASES MAY RESULT.
WHEN CONNECTING EXTERNAL EQUIPMENT (e.g., DATA CAPTURE COMPUTER), THE
SYSTEM LEAKAGE CURRENT MUST BE CHECKED AND MUST BE LESS THAN THE
IEC601-1-1 LIMIT.