Aspect A-2000 BIS Manuale utente

Aspect Medical Systems

A-2000™

BISPECTRAL INDEX™(BIS™)

MONITORING SYSTEM

OPERATING MANUAL

Rx only

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 02062 3454 PV De Meern

U.S.A. The Netherlands

(Tel) 617-559-7000 Tel: +31.30.662.9140

(Tel) 888-BIS INDE(X) (U.S. only) Fax: +31.30.662.9150 0123

(Fax) 617-559-7400 amsint@aspectms.com

bis_info@aspectms.com

www.aspectmedical.com 070-0015 3.04

Considerations for Using BIS Monitoring

Clinical judgment 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

clinical experience in the following applications, BIS values should be interpreted cautiously in

patients with known neurological disorders, those taking other psychoactive medications and in

children below the age of one.

TABLE OF CONTENTS

ABOUT THIS MANUAL.....................................................................................................I

INTRODUCING THE A-2000 BIS MONITORING SYSTEM.............................................. II

INDICATIONS FOR USE..................................................................................................II

INTRODUCTION............................................................................................................... II

1SAFETY PRECAUTIONS........................................................................................1-1

1.1 WARNINGS...........................................................................................................1-1

1.2 CAUTIONS............................................................................................................1-3

1.3 KEY TO SYMBOLS...............................................................................................1-5

2INSTALLATION AND PREPARATION FOR USE..................................................2-1

2.1 A-2000 BIS MONITOR INSTALLATION AND CHECKOUT .................................2-1

2.2 ENVIRONMENT....................................................................................................2-2

2.2.1 SHIPPING AND STORAGE ENVIRONMENT ................................................................2-2

2.2.2 OPERATING ENVIRONMENT ...................................................................................2-2

2.2.3 POWER REQUIREMENTS AND SYSTEM GROUNDING ...............................................2-3

2.2.4 SITE PREPARATION:MOUNTING THE MONITOR ......................................................2-3

2.3 THE A-2000 BIS MONITORING SYSTEM -EQUIPMENT AND SUPPLIES.........2-5

2.3.1 THE BIS MONITOR................................................................................................2-6

2.3.2 DIGITAL SIGNAL CONVERTER (DSC) ...................................................................2-10

2.3.3 PATIENT INTERFACE CABLE (PIC) .......................................................................2-10

2.3.4 BIS SENSOR.......................................................................................................2-10

2.3.5 A-2000 SYSTEM CONFIGURATIONS .....................................................................2-11

2.3.6 PLATFORM COMPATIBILITY CONSIDERATIONS ......................................................2-12

2.3.7 UPGRADING A-2000 STANDARD SYSTEMS...........................................................2-12

2.4 CABLE CONNECTIONS.....................................................................................2-13

2.5 START PROCEDURE.........................................................................................2-13

2.6 MENU SETTINGS ...............................................................................................2-13

2.6.1 LANGUAGE SELECTION MENU .............................................................................2-14

2.6.2 TIME/DATE .........................................................................................................2-14

2.6.3 SAVE SETTINGS..................................................................................................2-14

3OPERATING THE A-2000.......................................................................................3-1

3.1 PREPARING FOR OPERATION...........................................................................3-1

3.2 THE SENSOR CHECK AND SENSOR INTEGRITY CHECK................................3-3

3.3 THE BIS TREND SCREEN DISPLAY ...................................................................3-5

3.3.1 THE BIS (BISPECTRAL INDEX)NUMERIC REGION ...................................................3-5

3.3.2 THE SIGNAL QUALITY REGION...............................................................................3-6

3.3.3 THE MESSAGE REGION .........................................................................................3-7

3.3.4 GRAPHIC DISPLAY REGION ...................................................................................3-7

3.4 THE A-2000 SOFTWARE MENUS AND MENU SELECTIONS............................3-9

3.4.1 MENU NAVIGATION: ..............................................................................................3-9

3.4.2 THE SETUP MENU...............................................................................................3-10

3.4.3 THE ADVANCED SETUP MENU .............................................................................3-12

3.4.4 DISPLAY PARAMETER SETUP ..............................................................................3-16

3.4.5 THE DIAGNOSTIC MENU ......................................................................................3-18

3.4.6 ALARM MENU .....................................................................................................3-18

3.4.7 LANGUAGE SELECTION MENU .............................................................................3-21

3.4.8 SENSOR DATA DISPLAY SCREEN AND SYSTEM CONFIGURATION MENU ................3-21

3.5 ALTERNATIVE DISPLAYS.................................................................................3-22

3.5.1 THE DSA DISPLAY:.............................................................................................3-22

3.5.2 THE EEG DISPLAY..............................................................................................3-23

3.5.3 THE BIS LOG DISPLAY ........................................................................................3-24

3.6 REVIEWING STORED TREND DATA ................................................................3-27

3.7 ENDING ACASE ................................................................................................3-28

3.8 DATA TRANSFER ..............................................................................................3-28

3.9 SOFTWARE UPDATES......................................................................................3-29

4QUICK REFERENCE GUIDE ..................................................................................4-1

5FEATURES AND CAPABILITIES ...........................................................................5-1

5.1 HOW THE A-2000 MONITORING SYSTEM WORKS...........................................5-1

5.2 SYSTEM FEATURES............................................................................................5-1

5.2.1 BISPECTRAL INDEX (BIS) ......................................................................................5-1

5.2.2 SIGNAL QUALITY INDEX (SQI) ...............................................................................5-1

5.2.3 ELECTROMYOGRAPH (EMG) INDICATOR ................................................................5-2

5.2.4 ELECTROENCEPHALOGRAM (EEG) WAVEFORM DISPLAY .......................................5-2

5.2.5 FILTERS ...............................................................................................................5-2

5.2.6 SUPPRESSION RATIO (SR)....................................................................................5-2

5.2.7 BURST COUNT (BURSTS/MIN) ............................................................................5-2

5.2.8 DENSITY SPECTRAL ARRAY (DSA) ........................................................................5-3

5.2.9 BIS LOG DISPLAY .................................................................................................5-3

5.2.10 ARTIFACT DETECTION .........................................................................................5-3

5.2.11 EVENT MARKERS ................................................................................................5-3

5.2.12 START AND END OF CASE BARS /CASE ID...........................................................5-3

5.2.13 LIMIT ALARMS .....................................................................................................5-3

5.2.14 BIS TREND SMOOTHING......................................................................................5-4

5.2.15 EVENT PRINTING.................................................................................................5-4

5.2.16 LANGUAGES........................................................................................................5-4

5.2.17 TIME/DATE AND CLEAR DATA MEMORY................................................................5-4

5.2.18 SENSOR DATA DISPLAY (BIS XP PLATFORM ONLY)..............................................5-4

5.2.19 ICU MODE /EXTEND MODE.................................................................................5-4

5.2.20 SYSTEM SELF-CHECKS .......................................................................................5-5

5.2.21 DATA MEMORY ...................................................................................................5-5

5.2.22 SAVED SETTINGS................................................................................................5-6

5.2.23 BATTERY OPERATION..........................................................................................5-6

5.2.24 DATA TRANSFER AND SOFTWARE UPDATES.........................................................5-6

5.2.25 PRINTED REPORTS .............................................................................................5-7

6PREVENTIVE MAINTENANCE, CARE AND CLEANING ......................................6-1

6.1 CARE AND CLEANING ........................................................................................6-1

6.2 ROUTINE MAINTENANCE...................................................................................6-2

6.3 FUSE REPLACEMENT.........................................................................................6-3

6.4 SYSTEM CHECKOUT...........................................................................................6-4

6.5 TECHNICAL DOCUMENTATION.........................................................................6-5

6.6 INSTRUMENT IDENTIFICATION..........................................................................6-5

7DIAGNOSTICS AND TROUBLESHOOTING..........................................................7-1

7.1 THE DIAGNOSTIC MENU.....................................................................................7-1

7.1.1 DSC SELF-TEST...................................................................................................7-2

7.1.2 DISPLAY SELF-TEST .............................................................................................7-2

7.1.3 SENSOR DATA DISPLAY (BIS XP PLATFORM ONLY)................................................7-2

7.1.4 CLEAR DATA.........................................................................................................7-3

7.1.5 DIAGNOSTIC CODES .............................................................................................7-3

7.1.6 IMPEDANCE CHECKING .........................................................................................7-3

7.1.7 SYSTEM CONFIGURATION MENU ...........................................................................7-3

7.2 SYSTEM ERROR MESSAGE ALARMS...............................................................7-5

7.3 WHAT TO DO IF THE A-2000 REQUIRES SERVICE.........................................7-10

8SPECIFICATIONS, WARRANTY AND SOFTWARE LICENSE AGREEMENT .....8-1

8.1 SPECIFICATIONS.................................................................................................8-1

8.2 WARRANTY..........................................................................................................8-4

8.3 SOFTWARE LICENSE AGREEMENT..................................................................8-6

9APPENDIX...............................................................................................................9-1

9.1 APPENDIX I–PROCESSED EEG VARIABLES ..................................................9-1

9.2 A-2000 MENU MAP...............................................................................................9-2

9.3 MENU LISTING.....................................................................................................9-5

TABLE OF FIGURES

Figure 1 - Symbol Key....................................................................................................1-5

Figure 2 Pole Clamp .....................................................................................................2-4

Figure 3 The A-2000 BIS Monitoring System................................................................2-5

Figure 4 Front Panel (Example Illustration)...................................................................2-6

Figure 5 Front Panel Controls .......................................................................................2-7

Figure 6 Rear Panel ......................................................................................................2-8

Figure 7 BIS Sensor Connections...............................................................................2-12

Figure 8 Connecting the PIC (BIS XP Platform and XP Compatible) ...........................3-2

Figure 9 The Sensor Check (BIS Standard and BIS Pediatric sensors) .......................3-3

Figure 10 The Sensor Check (BIS Quatro and BIS Extend) .........................................3-4

Figure 11 - Screen Regions and Features.....................................................................3-5

Figure 12 The BIS Trend Display with BIS Extend Sensor in Use................................3-7

Figure 13 The BIS Trend Display..................................................................................3-8

Figure 14 Menu Navigation ...........................................................................................3-9

Figure 15 Main Screen with Setup Menu and Trend Display......................................3-10

Figure 16 The Advanced Setup Menu ........................................................................3-12

Figure 17 The Display Parameter Setup screen .........................................................3-16

Figure 18 The Alarm Menu .........................................................................................3-18

Figure 19 The Language Selection Menu ...................................................................3-21

Figure 20 The Density Spectral Array (DSA) Display .................................................3-22

Figure 21 The EEG Display ........................................................................................3-23

Figure 22 The BIS Log Display – Current Case..........................................................3-24

Figure 23 The BIS Log Display – Review Mode .........................................................3-25

Figure 24 Main Screen with Trend Review .................................................................3-27

Figure 25 The Diagnostic Menu ....................................................................................7-1

Figure 26 Sensor Data Display .....................................................................................7-2

Figure 27 The System Configuration Menu ..................................................................7-3

ABOUT THIS MANUAL

This Operating Manual contains all of the information you need to set up and operate the

Aspect Medical Systems’ A-2000 BIS Monitoring System (Figure 3). It also includes

specific cleaning and test procedures you may occasionally be required to perform.

Although this manual is intended for trained medical personnel, it does not assume prior

knowledge or experience with operator-programmable medical electronics devices.

Keep this Operating Manual with the A-2000 for use by the operator. This manual is

also intended to be a service information manual for service technicians or biomedical

engineering personnel.

Section 1 discusses important "Safety Precautions." Before attempting to set up or use

the A-2000, please familiarize yourself with the safety information provided in this

section.

Section 2 covers A-2000 installation, including system checkout, environmental

considerations, equipment and supplies needed, basic connections and setup.

Section 3 explains how to operate the A-2000 under normal conditions. It also covers

advanced features such as software updates and data transfer.

Section 4 serves as a quick reference for users who are already familiar with the

system.

Section 5 discusses the features and capabilities of the A-2000 system.

Section 6 covers normal care and cleaning procedures and maintenance, which should

be performed by the operator on a regular basis.

Section 7 covers diagnostics and troubleshooting and includes a summary of error

messages and actions that should be taken by the operator.

Section 8 details the system specifications, product warranty, and the software license

agreement.

Section 9 provides additional information on processed variables, and a menu map and

listing.

INTRODUCING THE A-2000 BIS MONITORING SYSTEM

INDICATIONS FOR USE

The Aspect A-2000 EEG Monitor with BIS is intended for use under the direct

supervision of a licensed healthcare practitioner or by personnel trained in its proper

use. The BIS Monitor 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 may be used as an aid in monitoring the effects of certain anesthetic agents.*

Use of BIS monitoring to help guide anesthetic administration may be associated with

the reduction of the incidence of awareness with recall in adults during general

anesthesia and sedation.

INTRODUCTION

The A-2000 BIS Monitoring System is a user-configurable patient monitoring system

designed to monitor the hypnotic state of the brain based on acquisition and processing

of EEG signals. The A-2000™processes raw EEG signals to produce a single number,

called the Bispectral Index, or BIS, which correlates with the patient's level of hypnosis.

The A-2000 monitor display consists of:

•The current BIS number

•Trend plots of processed EEG parameters

•Raw EEG waveforms in real time

•Density Spectral Arrays (DSA)

•Numeric BIS log

•Various signal quality indicators (EMG, SQI).

•Suppression Ratio and Burst Count number.

The system performs self-tests to ensure that the monitor and its components are

functioning properly and that impedance levels of patient sensors are within acceptable

limits. Easy-to-use menus allow the user to mark events, review and clear stored data,

and change the data display.

* Gan TJ, Glass P, Windsor A, Payne F, Rosow C, Sebel P, Manberg P. Bispectral

Index Monitoring Allows Faster Emergence and Improved Recovery from

Propofol, Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology October 1997;

(4) 87:808-15.

SECTION 1 SAFETY PRECAUTIONS

______________________________________________________________________

1-1

SECTION 1

1 SAFETY PRECAUTIONS

INTRODUCTION

Caution:

Carefully read this entire manual 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 WHENEVER

INSTRUMENT CASE IS OPENED BY A QUALIFIED BIOMEDICAL ENGINEERING

TECHNICIAN.

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. WHENEVER AN EVENT SUCH AS SPILLAGE OF

BLOOD OR SOLUTIONS OCCURS, RE-TEST BEFORE FURTHER USE.

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.

SECTION 1 SAFETY PRECAUTIONS

______________________________________________________________________

1-2

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.

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.

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.

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.

BE SURE THE MONITOR IS MOUNTED SECURELY IN PLACE TO AVOID

PERSONAL OR PATIENT INJURY.

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.

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