BIS VISTA User manual

BIS VISTA™Monitoring System
OPERATING MANUAL
Rx only
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 0123
(Tel) 617-559-7000 Tel: [phone]
(Tel) 888-BIS INDE(X) (U.S. only) Fax: [phone]
(Fax) 617-559-7400 [email protected]
[email protected]
www.aspectmedical.com
070-0069 3.00

BIS VISTA™Monitoring System
OPERATING MANUAL
©Copyright, 2008, Aspect Medical Systems, Inc. All rights reserved. Copying or other
reproduction of this document is prohibited without prior written consent of Aspect
Medical Systems, Inc.
BIS VISTA is a trademark of Aspect Medical Systems, Inc.
Aspect, Bispectral Index, BIS, the BIS logo, BISx, the BISx logo and Zipprep are trademarks
of Aspect Medical Systems, Inc. and are registered in the U.S.A., E.U. and other countries.

TABLE OF CONTENTS
ABOUT THIS MANUAL........................................................................................ i
INTRODUCING THE BIS VISTA MONITORING SYSTEM............................ ii
1SAFETY PRECAUTIONS........................................................................... 1-1
1.1 Warnings....................................................................................................................... 1-1
1.2 Cautions........................................................................................................................1-3
1.3 Key to Symbols ............................................................................................................ 1-6
2INSTALLATION AND PREPARATION FOR USE ................................ 2-1
2.1 BIS VISTA 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 Electromagnetic Compatibility Requirements.................................................................................... 2-3
2.2.5 Site Preparation: Mounting the Monitor ............................................................................................. 2-4
2.2.5.1 Mounting the Monitor using the Pole Clamp .......................................................................... 2-4
2.2.5.2 Optional Mounting Accessories................................................................................................. 2-5
2.3 The BIS VISTA Monitoring System – Equipment and Supplies ............................. 2-6
2.3.1 BIS VISTA Monitor .................................................................................................................................. 2-7
2.3.1.1 Front Panel...................................................................................................................................... 2-7
2.3.1.2 Touch Screen ................................................................................................................................. 2-7
2.3.1.3 ON/Standby button ...................................................................................................................... 2-7
2.3.1.4 Rear Panel....................................................................................................................................... 2-7
2.3.1.5 Integral Battery .............................................................................................................................. 2-9
2.3.2 BISx ........................................................................................................................................................... 2-10
2.3.3 Patient Interface Cable (PIC)............................................................................................................... 2-11
2.3.4 BIS Sensors .............................................................................................................................................. 2-11
2.4 Cable Connections..................................................................................................... 2-11
2.5 Start Procedure / Standby Mode ............................................................................. 2-12
2.5.1 Starting the Monitor for the First Time ............................................................................................ 2-12
2.5.2 Starting the Monitor from Standby Mode......................................................................................... 2-12
2.6 Initial Menu Settings.................................................................................................. 2-12
2.6.1 Language Selection................................................................................................................................. 2-13
2.6.2 Date and Time........................................................................................................................................ 2-13
2.6.3 View/Save Settings.................................................................................................................................. 2-13

3OPERATING THE BIS VISTA MONITORING SYSTEM....................... 3-1
3.1 Preparing for Operation ............................................................................................. 3-1
3.2 Sensor Check................................................................................................................ 3-3
3.3 BIS Trend Data Screen ............................................................................................... 3-6
3.3.1 BIS (Bispectral Index) Value................................................................................................................... 3-6
3.3.2 Signal Quality Indicator........................................................................................................................... 3-6
3.3.3 Electromyograph (EMG) Indicator ....................................................................................................... 3-7
3.3.4 EEG Waveform Display .......................................................................................................................... 3-7
3.3.5 Message Region ........................................................................................................................................ 3-7
3.3.6 BIS Trend Graph ...................................................................................................................................... 3-8
3.3.7 Additional Screen Information .............................................................................................................. 3-9
3.3.7.1 Battery Icon.................................................................................................................................... 3-9
3.3.7.2 USB Export Icon............................................................................................................................ 3-9
3.3.7.3 Print Icon....................................................................................................................................... 3-10
3.3.7.4 Extend Mode ................................................................................................................................ 3-10
3.3.7.5 Suppression Ratio (SR) Number .............................................................................................. 3-10
3.3.7.6 Burst Count (Bursts/Minute) .................................................................................................... 3-10
3.4 Main Screen Touch Keys........................................................................................... 3-11
3.4.1 Alarm Touch Keys ................................................................................................................................. 3-11
3.4.2 Menu, Home, Sensor Check and Review Touch Keys................................................................... 3-12
3.5 Menu Selections ......................................................................................................... 3-13
3.5.1 Target Range ........................................................................................................................................... 3-13
3.5.2 Secondary Variable ................................................................................................................................ 3-15
3.5.3 Chart Data............................................................................................................................................... 3-16
3.5.4 Alarm Volume......................................................................................................................................... 3-17
3.5.5 BIS/EEG Display Modes......................................................................................................................... 3-18
3.5.6 View/Save Settings.................................................................................................................................. 3-18
3.5.7 Help........................................................................................................................................................... 3-19
3.5.8 Snapshot................................................................................................................................................... 3-20
3.5.9 Display Suppression Ratio (SR)........................................................................................................... 3-20
3.5.10 Monitor Mode ................................................................................................................................... 3-21
3.5.11 Export Data ....................................................................................................................................... 3-22
3.5.12 BIS Smoothing Rate.......................................................................................................................... 3-24
3.5.13 Print (Snapshot)................................................................................................................................. 3-25
3.5.14 Configuration Information .............................................................................................................. 3-26
3.5.15 EEG Channels.................................................................................................................................... 3-26
3.5.16 Date and Time................................................................................................................................... 3-27
3.5.17 Language ............................................................................................................................................. 3-28
3.5.18 Filters................................................................................................................................................... 3-28
3.5.19 Impedance Checking ........................................................................................................................ 3-29
3.5.20 Maintenance Menu............................................................................................................................ 3-30
3.5.21 Demo Case ........................................................................................................................................ 3-30
3.5.22 Diagnostic Menu ............................................................................................................................... 3-30
3.6 Reviewing and Printing Stored Trend Data............................................................ 3-31
3.6.1 Review Mode Touch Keys ................................................................................................................... 3-31
3.6.2 Printing Stored Data.............................................................................................................................. 3-33
3.7 EEG Display ................................................................................................................ 3-34

3.8 Ending a Case ............................................................................................................. 3-34
3.9 Data Transfer ............................................................................................................. 3-35
3.10 How the BIS VISTA Monitoring System Works.................................................... 3-36
3.10.1 Bispectral Index (BIS)....................................................................................................................... 3-37
3.10.2 Artifact Detection............................................................................................................................. 3-37
3.10.3 System Self-Checks........................................................................................................................... 3-37
3.10.4 Monitor Data Memory .................................................................................................................... 3-38
3.10.5 BISx Data Memory ........................................................................................................................... 3-38
3.10.6 Battery Operation ............................................................................................................................ 3-39
4QUICK REFERENCE GUIDE..................................................................... 4-1
5PREVENTIVE MAINTENANCE, CARE AND CLEANING.................... 5-1
5.1 Care and Cleaning ....................................................................................................... 5-1
5.2 Maintenance ................................................................................................................. 5-2
5.2.1 Replace the PIC (Patient Interface Cable) .......................................................................................... 5-2
5.2.2 Checking Cable Integrity ........................................................................................................................ 5-3
5.2.3 System Checkout ..................................................................................................................................... 5-3
5.2.4 Checking the Battery............................................................................................................................... 5-4
5.2.5 Replacing the Battery .............................................................................................................................. 5-4
5.2.6 Replacing the Power Supply................................................................................................................... 5-5
5.2.7 Checking Leakage Current..................................................................................................................... 5-6
5.3 Technical Documentation .......................................................................................... 5-7
5.4 Instrument Identification ............................................................................................ 5-7
6DIAGNOSTICS AND TROUBLESHOOTING ........................................ 6-1
6.1 Maintenance Menu....................................................................................................... 6-1
6.1.1 Display BISx Connection History ......................................................................................................... 6-1
6.1.2 Serial Protocol .......................................................................................................................................... 6-1
6.1.3 Software Update....................................................................................................................................... 6-2
6.1.4 Restore Default Settings for All Modes............................................................................................... 6-2
6.1.5 Calibrate Touch Screen.......................................................................................................................... 6-2
6.2 Diagnostic Menu .......................................................................................................... 6-3
6.2.1 Diagnostic Codes ..................................................................................................................................... 6-3
6.2.2 DSC Self Test............................................................................................................................................ 6-3
6.3 BIS VISTA System Messages and Corrective Actions ............................................ 6-4
6.4 Using the Reset button ............................................................................................. 6-11
6.5 What to do if the BIS VISTA Monitoring System Requires Service.................... 6-11
7APPENDIX I: MENUS, PROCESSED VARIABLES AND GLOSSARY. 7-1

7.1 Menu Map ..................................................................................................................... 7-1
7.2 Menu Listing ................................................................................................................. 7-2
7.3 Processed EEG Variables ............................................................................................ 7-4
7.4 Glossary......................................................................................................................... 7-5
8APPENDIX II: SPECIFICATIONS, WARRANTY AND SOFTWARE
LICENSE AGREEMENT..................................................................................... 8-1
8.1 Specifications................................................................................................................ 8-1
8.2 Electromagnetic Compatibility Specifications ......................................................... 8-5
8.2.1 Accessories................................................................................................................................................ 8-5
8.2.2 IEC 60601-1-2:2001 Electromagnetic Compatibility Guidance ...................................................... 8-6
8.3 Warranty .................................................................................................................... 8-11
8.4 Software License Agreement................................................................................... 8-13

TABLE OF FIGURES
Figure 1 - Symbol Key (page 1 of 3) .............................................................................................1-6
Figure 2 - Pole Clamp...................................................................................................................... 2-4
Figure 3 - The BIS VISTA Monitoring System........................................................................... 2-6
Figure 4 - Rear Panel ....................................................................................................................... 2-8
Figure 5 - BISx and PIC................................................................................................................ 2-10
Figure 6 - Connecting the PIC....................................................................................................... 3-3
Figure 7 - Sensor Check Graphic Screen (Values not Shown).................................................. 3-4
Figure 8 - Sensor Check Graphic Screen with Values Shown................................................... 3-5
Figure 9 - Screen Features – BIS Trend Data Screen................................................................. 3-6
Figure 10 - BIS Trend Data Screen with Battery Icon, Target Range, SR, and Burst Count3-9
Figure 11 - Alarm Touch Keys ....................................................................................................3-11
Figure 12 - Menu, Home, Sensor Check and Review Mode Touch Keys............................. 3-12
Figure 13 - Target Range............................................................................................................... 3-13
Figure 14 - Secondary Variable .................................................................................................... 3-15
Figure 15 - Chart Data................................................................................................................... 3-16
Figure 16 - Alarm Volume............................................................................................................ 3-17
Figure 17 - BIS/EEG Display Modes ........................................................................................ 3-18
Figure 18 - View/Save Settings.................................................................................................... 3-18
Figure 19 - Help ............................................................................................................................. 3-19
Figure 20 - Snapshot...................................................................................................................... 3-20
Figure 21 - Display SR................................................................................................................... 3-20
Figure 22 - Monitor Mode Settings ............................................................................................. 3-21
Figure 23 - Export Data................................................................................................................ 3-22
Figure 24 - Smoothing Rate.......................................................................................................... 3-24
Figure 25 - “Print” Touch Key .................................................................................................... 3-25
Figure 26 - Configuration Information....................................................................................... 3-26
Figure 27 - EEG Channels ........................................................................................................... 3-26
Figure 28 - Date and Time............................................................................................................ 3-27
Figure 29 - Language Menu.......................................................................................................... 3-28
Figure 30 - Filters........................................................................................................................... 3-28
Figure 31 - Impedance Checking ON/OFF.............................................................................. 3-29
Figure 32 - Review Screen (Case Mode)..................................................................................... 3-31
Figure 33 - Review Screen (Cursor Mode) ................................................................................. 3-32
Figure 34 - EEG Display .............................................................................................................. 3-34
Figure 35 - BIS Range Guidelines ............................................................................................... 3-36
Figure 36 - Replacing the Power Supply....................................................................................... 5-5
Figure 37 - Diagnostic Codes ON/OFF...................................................................................... 6-3
Figure 38 - BIS VISTA Menu Map ............................................................................................... 7-1

i
ABOUT THIS MANUAL
This Operating Manual contains all of the information you need to set up and operate the
Aspect Medical Systems BIS VISTA™Monitoring System. 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 BIS VISTA monitor for use by the operator. This
manual is also intended to be a service information manual for service technicians or
biomedical engineering personnel.
Before attempting to set up or use the BIS VISTA system, please familiarize yourself
with the safety information provided in this section.