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Operator’s Manual
TM
BIS
Complete Monitoring System
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COVIDIEN, COVIDIEN with logo, and Covidien logo are U.S. and international trademarks of Covidien
AG. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks
of a Covidien company.
©2013-2017 Covidien.
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Table of Contents
1 Introduction
1.1 About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2 Introducing the BIS™ Complete Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
2 Safety Precautions
2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.2 Key to Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.3 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.4 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.5 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.6 Key to Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
3 Installation and Preparation for Use
3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 BIS Complete Monitor Installation and Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.3 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3.3.1 Shipping and Storage Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
3.3.2 Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3.3.3 Power Requirements and System Grounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
3.3.4 Electromagnetic Compatibility Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
3.3.5 Site Preparation: Mounting the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
3.4 The BIS™ Complete Monitoring System—Equipment and Supplies . . . . . . . . . . . . 3-6
3.4.1 BIS™ Complete Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
3.4.2 BISX™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11
3.4.3 Patient Interface Cable (PIC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12
3.4.4 BIS Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12
3.5 Cable Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
3.6 Start Procedure / Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
3.6.1 Starting the Monitor for the First Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
3.6.2 Starting the Monitor from Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
3.6.3 Power-Up Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
3.7 Initial Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
3.7.1 Language Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
3.7.2 Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
3.7.3 View/Save Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
4 Operating the BIS™ Complete Monitoring System
4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 Preparing for Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
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4.3 Sensor Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.4 BIS™ Trend Data Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.4.1 BIS (Bispectral Index) Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.4.2 Signal Quality Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.4.3 Electromyograph (EMG) Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.4.4 EEG Waveform Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
4.4.5 Message Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.4.6 BIS™ Trend Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
4.4.7 Additional Screen Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
4.5 Main Screen Touch Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
4.5.1 Alarm Touch Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11
4.5.2 Menu, Home, Sensor Check and Review Touch Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12
4.6 Menu Selections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
4.6.1 Target Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13
4.6.2 Secondary Variable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14
4.6.3 Chart Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15
4.6.4 Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
4.6.5 BIS™/EEG Display Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17
4.6.6 View/Save Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18
4.6.7 Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20
4.6.8 Snapshot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20
4.6.9 Display Suppression Ratio (SR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20
4.6.10 Monitor Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21
4.6.11 Export Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22
4.6.12 BIS Smoothing Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25
4.6.13 Print (Snapshot) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25
4.6.14 Configuration Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
4.6.15 EEG Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
4.6.16 Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
4.6.17 Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29
4.6.18 Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29
4.6.19 Impedance Checking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-30
4.6.20 Maintenance Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-31
4.6.21 Demo Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-31
4.6.22 Diagnostic Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-31
4.7 Reviewing and Printing Stored Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32
4.7.1 Review Mode Touch Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-32
4.7.2 Printing Stored Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-33
4.8 EEG Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
4.9 Ending a Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
4.10 Data Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36
4.11 How the BIS™ Complete Monitoring System Works . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36
4.11.1 Bispectral Index (BIS™) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-38
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4.11.2 Artifact Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-38
4.11.3 System Self-Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-38
4.11.4 Monitor Data Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-39
4.11.5 BISX Data Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-39
4.11.6 Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-40
4.11.7 The BIS™ Bilateral System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-40
5 Quick Reference Guide
5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2 Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
6 Preventive Maintenance, Care and Cleaning
6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2 Care and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2.1 Cleaning the Monitor and BISX™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
6.2.2 Disinfecting the Monitor and BISX™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2.3 Cleaning the Monitor Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
6.3 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.3.1 Replace the PIC (Patient Interface Cable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.3.2 Checking Cable Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
6.3.3 System Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
6.3.4 Checking the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.3.5 Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5
6.3.6 Replacing the Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
6.3.7 Checking Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
6.4 Technical Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.5 Instrument Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.5.1 BIS™ Complete Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.5.2 BISX™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7
6.5.3 Software Revision Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
7 Diagnostics and Troubleshooting
7.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Maintenance Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2.1 Display BISX Connection History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2.2 Serial Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
7.2.3 Software Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.2.4 Restore Default Settings for All Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
7.2.5 Audio Off Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
7.2.6 Calibrate Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Operator’s Manual v
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7.3 Diagnostic Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.3.1 Diagnostic Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.3.2 DSC Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.4 BIS™ Complete System Messages and Corrective Actions . . . . . . . . . . . . . . . . . . . . . 7-4
7.5 Using the Reset button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
7.6 What to do if the BIS™ Complete Monitoring System Requires Service . . . . . . . . 7-12
A Menus, Processed Variables and Glossary
A.1 Menu Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
A.2 Menu Listing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.3 Processed EEG Variables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
A.4 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
B Specifications, Warranty and Software License Agreement
B.1 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
B.1.1 General Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1
B.1.2 EEG Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
B.1.3 BISX™ Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2
B.1.4 Product Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3
B.1.5 Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3
B.1.6 Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
B.2 Electromagnetic Compatibility Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
B.2.1 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
B.2.2 IEC 60601-1-2:2001 Electromagnetic Compatibility Guidance . . . . . . . . . . . . . . . . . . . . . . . . . B-5
B.3 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-10
B.4 Software License Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11
vi Operator’s Manual
Page 7
List of Figures
Figure3-1. Pole Clamp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Figure3-2. The BIS Complete Monitoring System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Figure3-3. Rear Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Figure3-4. BISX and PIC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Figure4-1. Connecting the PIC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Figure4-2. Sensor Check Graphic Screen (Values not Shown). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Figure4-3. Sensor Check Graphic Screen with Values Shown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Figure4-4. Screen Features – BIS Trend Data Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Figure4-5. BIS™ Trend Data Screen with Battery Icon, Target Range, SR, and Burst Count. . . . . . . . . . . . . . 4-9
Figure4-6. Target Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Figure4-7. Secondary Variable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Figure4-8. Chart Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Figure4-9. Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Figure4-10. BIS/EEG Display Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Figure4-11. View/Save Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Figure4-12. Passkey Entry Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Figure4-13. Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
Figure4-14. Snapshot. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
Figure4-15. Display SR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Figure4-16. Export Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Figure4-17. Smoothing Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Figure4-18. Print Touch Key. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
Figure4-19. Configuration Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27
Figure4-20. EEG Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27
Figure4-21. Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28
Figure4-22. Language Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29
Figure4-23. Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Figure4-24. Impedance Checking ON/OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Figure4-25. Review Screen (Case Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32
Figure4-26. Review Screen (Cursor Mode). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
Figure4-27. EEG Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
Figure4-28. BIS Range Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37
Figure4-29. The BIS Complete Bilateral Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41
Figure4-30. Sensor Check (Values not Shown). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-42
Figure4-31. Sensor Check with Values Shown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43
Figure4-32. BIS Number Display/Bilateral Touch Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-44
Figure4-33. Main Display (DSA) and Small Display (BIS Trend) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-44
Figure4-34. DSA Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-45
Figure4-35. BIS Trend Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-46
Figure4-36. Four-channel EEG with ASYM Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-47
Figure4-37. Bilateral Display Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-48
Figure4-38. Secondary Variable Menu (Bilateral). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49
Figure4-39. Chart Data Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-50
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Page 8
Figure4-40. Demo Case. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-51
Figure6-1. Replacing the Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Figure7-1. Audio Off Reminder ON/OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Figure7-2. Diagnostic Codes ON/OFF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
FigureA-1. BIS™ Complete Menu Map. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
viii Operator’s Manual
Page 9
List of Tables
Table2-1. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Table2-2. Symbol Key. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Table3-1. Current vs. Legacy BIS Complete Monitoring System Product Names. . . . . . . . . . . . . . . . . . . . . . 3-6
Table3-2. Summary of Cables used with the BIS Complete Monitoring System . . . . . . . . . . . . . . . . . . . . . . 3-7
Table4-1. Alarm Touch Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Table4-2. Menu, Home, Sensor Check and Review Mode Touch Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Table4-3. Monitor Mode Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Table7-2. Low-Priority Alarm Conditions - Messages and Corrective Actions. . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Table7-1. High-Priority Alarm Conditions - Messages and Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Table7-3. Other System Messages and Corrective Actions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
TableB-1. Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
TableB-2. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions. . . . . . . . . . . . . . . . . . . B-5
TableB-3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity. . . . . . . . . . . . . . . . . . . B-6
TableB-4. Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and the BIS Complete Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8
TableB-5. Proximity Field Immunity Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9
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x Operator’s Manual
Page 11
1 Introduction
1.1 About This Manual
This Operator’s Manual contains all of the information you need to set up and operate the
Covidien BIS™ Complete 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 operatorprogrammable medical electronics devices.
Keep this Operator’s Manual with the BIS Complete 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 Complete system, please familiarize yourself
with the safety information provided in this chapter.
Note:
Within this manual the terms BISX™ and BIS™ LoC 2 Channel are used interchangeably. For additional
information, see Table3-1.on page 3-6.
1.2 Introducing the BIS™ Complete Monitoring System
The BIS Complete 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 BIS Complete system 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 BIS Complete monitor display consists of:
• The current BIS number
• Raw EEG waveforms in real time
• Various signal quality indicators (EMG, SQI)
• Trend graphs of processed EEG parameters
• Suppression Ratio (if requested by the user)
• Alarm Indicator and Messages
1-1
Page 12
Introduction
Burst Count number (when a BIS Extended Use Sensor is in use)
•
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. Touch screen
menus allow the user to change the data display and review stored data.
Important Information about Using BIS™ Monitoring
The BIS EEG Complete Monitor System is intended for use under the direct supervision of a licensed
healthcare practitioner or by personnel trained in its proper use. The system, and all its associated
parameters, 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 Index, one of the Complete Monitor output parameters, may be used as an aid in
monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic
agents may be associated with a reduction in primary anesthetic use and a reduction in emergence
and recovery time.
Use of the BIS Index for monitoring to help guide anesthetic administration may be associated with
the reduction of incidence of awareness with recall in adults during general anesthesia and
sedation.
BIS is a complex monitoring technology intended for use as an adjunct to clinical judgment and
training. Clinical judgment should always be used when interpreting BIS in conjunction with other
available clinical signs. Reliance on 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. BIS values should also be interpreted
cautiously with certain anesthetic combinations, such as those relying primarily on either ketamine
or nitrous oxide/narcotics to produce unconsciousness. Due to limited clinical experience in the
following applications, BIS values should be interpreted cautiously in patients with known
neurological disorders and those taking other psychoactive medications.
The BIS education site, www.biseducation.com, offers relevant information and published articles
on the clinical use of BIS. In addition, there is a “Monitoring Consciousness Using the Bispectral
Index during Anesthesia” Clinician’s Pocket Guide available on the website and through your local
Covidien Representative.
For more information, please contact Covidien at (800) 442-2051. If you require additional
information on the use of BIS, please contact Covidien at 800-442-8655 or 617-559-7655 if calling
from outside of the USA.
1-2 Operator’s Manual
Page 13
2 Safety Precautions
2.1 Introduction
Carefully read this entire manual before using the monitor in a clinical setting.
2.2 Key to Symbols
A key to the symbols that may appear on the BIS™ Complete system appears at the end of this
chapter.
2.3 Safety Symbol Definitions
Table2-1.Safety Symbol Definitions
Symbol Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of the
product.
Note
Notes provide additional guidelines or information.
2-1
Page 14
Safety Precautions
Warnings
2.4
WARNING:
Explosion hazard: do not use the BIS™ Complete system in a flammable atmosphere or where
concentrations of flammable anesthetics may occur.
WARNING:
Monitor is not designed for use in MRI environment.
WARNING:
Use only the power cord supplied by the manufacturer. Never adapt the plug from the monitor to
fit a non-standard outlet.
WARNING:
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.
WARNING:
If the integrity of the external protective earth ground is in doubt, the BIS Complete system shall
be operated from its internal battery power source only.
WARNING:
Be sure the monitor is mounted securely in place to avoid personal or patient injury.
WARNING:
The BIS Complete Monitor should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the BIS Complete Monitor should be observed to verify
normal operation in the configuration in which it will be used.
WARNING:
When connecting external equipment (e.g., data capture computer), the system leakage current
must be checked and must be less than the IEC 60601-1-1 limit.
WARNING:
Using accessories other than those specified may result in increased electromagnetic emissions or
decreased electromagnetic immunity of the BIS Complete Monitoring System.
2-2 Operator’s Manual
Page 15
WARNING:
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.
• Evidence that the safety certification of the accessory has been performed in accordance to the
appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.
WARNING:
Due to elevated surface temperature, do not place BISX™ in prolonged direct contact with
patient’s skin, as it may cause discomfort.
WARNING:
The conductive parts of electrodes or sensor and connectors should not contact other conductive
parts, including earth.
Warnings
WARNING:
To reduce the hazard of burns during use of high-frequency surgical equipment, the sensor or
electrodes should not be located between the surgical site and the electro-surgical unit return
electrode.
WARNING:
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 BIS™
Complete system.
WARNING:
To minimize the risk of patient strangulation, the patient interface cable (PIC) must be carefully
placed and secured.
WARNING:
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.
WARNING:
Universal precautions shall be observed to prevent contact with blood or other potentially
infectious materials. Place contaminated materials in regulated waste container.
Operator’s Manual 2-3
Page 16
Safety Precautions
WARNING:
Do not mix disinfecting solutions (e.g., bleach and ammonia), as hazardous gases may result.
WARNING:
Electrical Shock Hazard: Do not remove monitor covers during operation or while power is
connected to monitor.
WARNING:
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.
WARNING:
Whenever an event such as spillage of blood or solutions occurs, re-test ground leakage current
before further use.
WARNING:
Leakage current must be checked by a qualified biomedical engineering technician whenever
instrument case is opened.
WARNING:
Power supply is internally fused. Replace power supply only with Covidien BIS Complete power
supply.
WARNING:
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the BIS Complete
Monitoring System, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
WARNING:
Check Target Range alarm limits to ensure they are appropriate for the patient being monitored
with each use. Ensure Target Range alarm limits do not exceed the standard thresholds set by the
institution.
WARNING:
Do not decrease the adjustable alarm volume below ambient sound levels. Decreasing the alarm
volume below ambient levels may compromise patient safety.
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Cautions
2.5
Caution:
Read this entire manual carefully before using the monitor in a clinical setting. Do not autoclave
the BISX™ or Monitor. Autoclaving will seriously damage both components.
Caution:
Do not set the Target Range alarm limits to extreme values that render the monitoring system
useless. Ensure Target Range alarm limits are appropriate for each patient.
Caution:
Do not block ventilation inlet holes on the underside of monitor.
Caution:
Do not open BISX for any reason. The seal to prevent liquids from entering the BISX may be
damaged if opened.
Cautions
Caution:
Service or repairs must be performed only by qualified biomedical technicians.
Caution:
The BIS™ Complete system has been designed to operate with a BIS sensor. The sensor is a silver/
silver chloride electrode array that utilizes Covidien's patented Zipprep™ technology and uses a
proprietary connector. Use of other electrodes is not recommended.
Caution:
To completely remove power from the unit: put the monitor in Standby mode, disconnect power
cord from the power receptacle of the monitor, then remove the battery from the monitor.
Caution:
Continuous impedance checking may need to be disabled if the 1 nanoampere 128 Hz impedance
check signal interferes with other equipment (e.g., evoked potential monitors).
Caution:
Considerations when using Electro-Convulsive Therapy (ECT) equipment during BIS monitoring:
Place ECT electrodes as far as possible from the BIS sensor to minimize the effect of interference.
Certain ECT equipment may interfere with the proper function of the BIS monitoring system.
Check for compatibility of equipment during patient setup.
Operator’s Manual 2-5
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Safety Precautions
Caution:
Check the battery periodically by operating a BIS Complete monitor that has been disconnected
from the wall socket and that has been charged to full capacity (at least 6 hours of charge time).
After long periods of storage, charge the battery for 6 hours to assure full capacity. If the BIS
Complete monitor fails to operate reliably from the battery for approximately 45 minutes, battery
replacement is required.
Caution:
BIS Complete monitor contains an internal Lithium ion battery. The battery must be removed
The
by a qualified service technician and disposed of or recycled in accordance with the national laws
of the country. Contact Covidien or the local distributor for a replacement battery: Coviden part
number 186-0208.
Caution:
Avoid liquid ingress to the Patient Interface Cable. Contact of fluids with the PIC sensor connector
can interfere with PIC performance. Service or repairs must be performed only by qualified
biomedical technicians.
Caution:
The BIS™ Complete system complies with the electromagnetic compatibility requirements of IEC
60601-1-2. Operation of this device may affect or be affected by other equipment in the vicinity
due to electromagnetic interference (EMI). If this occurs:
• Increase separation between devices.
• Re-orient device cabling.
• Plug devices into separate outlet circuit branches.
• Reference Electromagnetic Compatibility Specifications, page B-4.
Caution:
Do not disconnect the BISX™ during the software update.
Caution:
When connecting or disconnecting BISX, take care not to touch the exposed contacts of either
connector. Damage due to electrostatic discharge may result.
Important: The BIS Complete systems comply with the European Medical Device Directive
(MDD) and applicable regulatory requirements of the country distributed to and carry the
CEXXXX Marking. Declarations of Conformity provided upon request where appropriate.
2-6 Operator’s Manual
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Key to Symbols
p
2.6
Symbol Description
Single use
Caution, consult
accompanying
documents
Key to Symbols
Table2-2.Symbol Key
Latex Free product
Do Not Reuse
Caution: Consult Accompanying Documents
Fragile
Follow Instructions for Use
Consult Instructions for Use
Storage Temperature Limits
Packaging Labeling: Fragile
Packaging Labeling: Do Not Get Wet
Packaging Labeling: This Side Up
This side u
Operator’s Manual 2-7
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Safety Precautions
Table2-2.Symbol Key (Continued)
Symbol Description
Recyclable
Product marked with the “e” does not contain any toxic or hazardous
substances or elements, and is green and environmental. The
product can be recycled.
Product marked with a number contains certain toxic or hazardous
substances or elements, and can be used safely during its
Environment-Friendly Use Period (EFUP). The product should be
recycled. The Environment-Friendly Use Period is valid only when the
product is operated under the conditions defined in the product
manual.
Crossed out wheelie bin indicates separate treatment from general
waste at end of life
1
Type BF Equipment
Type BF Equipment Defibrillator-proof
Alternating Current
Direct Current (D/C)
Caution: Hot Surface
Classified by Underwriters Laboratories Inc.® with respect to electric
shock, fire and mechanical hazards only, in accordance with
UL 60601-1 and IEC60601-2-26
2-8 Operator’s Manual
Page 21
Table2-2.Symbol Key (Continued)
Symbol Description
Conformité Européenne (CE) Marking of Conformity to European
Medical Device Directive. CEXXXX represents the Notified Body
number
Recognized under the Component Recognition Program of
Underwriters Laboratories Inc.
Authorized Representative in the European Community
Catalog Number
Not connected to protective earth
Manufacturer
Key to Symbols
Manufacturer Date
Use by YYYY-MM-DD or YYYY-MM
Batch Code
Serial Number
Data I/O, RS-232 Serial Port
USB-A Universal Serial Bus: Type A
USB-B Universal Serial Bus: Type B
Battery Location
Reset Button
Monitor Power ON
Operator’s Manual 2-9
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Safety Precautions
Table2-2.Symbol Key (Continued)
Symbol Description
Monitor Power OFF or Standby Mode
PVC-free product
Operating on Battery
No Battery is Installed in Monitor
USB Drive: Data Export is in Progress
A Printable File Is Being Transferred to the USB Drive
Green Bell Icon – Alarms Active
Yellow Bell with Countdown Timer – Alarms Paused
Red Bell with ‘X’ – Alarms Silenced
NOTE: When alarms are silenced, an audible reminder sounds at 3-
minute intervals. This reminder can be disabled via the Maintenance
Menu (passkey protected).
A green box denotes ON or active condition.
A red box with an ‘X’ denotes OFF or cancel.
1. In regards to European Union Directive 2006/66/EC on batteries and accumulators and waste batteries and accumulators:
The Batteries Directive, 2006/66/EC, introduced new requirements, effective September 26, 2008, regarding removability of batteries from
waste equipment in EU Member States. To comply with this Directive, this device has been designed for safe removal of the batteries at
end-of-life by a qualified service technician. Infected units should be de-contaminated before they are sent for recycling, in accordance
with Care and Cleaning (6.2) of this manual.
In regards to European Union Directive 2002/96/EC on waste electrical and electronic equipment (WEEE). All waste electrical and
electronic equipment (WEEE) should be disposed of and collected separately. This product is Electrical and Electronic Equipment and
should be disposed of in accordance with national and local legislation and requirements.
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3 Installation and Preparation for Use
3.1 Introduction
This chapter provides installation instructions for the BIS™ Complete Monitor, BISX™, and
accessories. It includes:
• Installation checklist
• Proper environment
• Required equipment and supplies
• Cable connections
• Start and shutdown procedures
• Initial menu settings
3.2 BIS Complete Monitor Installation and Checkout
1. Open packages and inspect for all components:
• Monitor
• Power cord
• Pole clamp
• BISX
• PIC (Patient interface cable, connects BISX to patient)
Sensors are sold separately. For a list of available sensors please contact Covidien or your local
distributor.
3-1
Page 24
Installation and Preparation for Use
2. Connect power cable to monitor, plug power plug into appropriate wall outlet. Ensure that the outlet
used for the monitor is easily accessible; disconnection from the outlet is the only way to completely
remove AC power to the monitor.
• Verify that light to right of ON/Standby button is yellow.
3. Start up monitor by pressing the ON/Standby button (lower right corner).
• Verify that light to right of ON/Standby button is green.
• Verify all self-tests complete successfully.
• Verify next screen says “Connect BISX™.”
4. Connect BISX with PIC to monitor.
• Verify screen says, “BISX Initialization Complete.”
• Verify screen says “Connect sensor or cable.”
5. Connect PIC and sensor.
• Verify SENSOR CHECK begins.
6. Disconnect power cord from monitor.
• Verify ‘OPERATING ON BATTERY BACKUP’ is displayed.
• Verify battery icon displays below BIS™ number.
7. Reconnect power cord.
• Verify battery icon is not displayed below BIS banner.
• Verify “OPERATING ON BATTERY BACKUP” is not displayed.
8. End of install.
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Environment
3.3
3.3.1 Shipping and Storage Environment
The monitor and its accessories can be stored or shipped within the following environmental
limits. Note that these limits apply to non-operational storage and shipping situations.
Temperature -10°C to +60°C (14°F to 140°F)
Humidity 15% to 95% (non-condensing)
Pressure 800 mm Hg (1500 feet below sea level) to
360mm Hg (20,000 feet above sea level)
Protect the monitor from sudden temperature changes that can lead to condensation within the
instrument. To minimize condensation, avoid moving the system between heated buildings and
outside storage. Once moved inside, allow the monitor to stabilize in the unopened shipping
container at the inside ambient temperature before unpacking and placing into service. Before
operation, wipe down all visible condensation and allow the system to reach equilibrium at room
temperature.
Environment
3.3.2 Operating Environment
The BIS™ Complete Monitoring System is not designed for use in areas containing flammable
gases or vapors.
WARNING:
Explosion hazard: do not use the BIS Complete system in a flammable atmosphere or where
concentrations of flammable anesthetics may occur.
WARNING:
Monitor is not designed for use in MRI environment.
The BIS Complete monitor is designed to operate safely under the following conditions.
Conditions outside these ranges could affect reliability.
Temperature 0°C to +40°C (32°F to 104°F)
Humidity 15% to 95% (non-condensing)
Pressure 800 mm Hg (1500 feet below sea level) to
360mm Hg (20,000 feet above sea level)
Operator’s Manual 3-3
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Installation and Preparation for Use
3.3.3 Power Requirements and System Grounding
The BIS Complete Monitoring System requires a power source of 100–240 VAC, 50–60Hz. Current
consumption is 0.7 ampere maximum.
To protect operating personnel and patients, the monitor must be properly grounded.
Accordingly, the monitor is equipped with a hospital grade line cord. The power cord grounds the
system to the power line ground when plugged into an appropriate three-wire receptacle.
WARNING:
Use only the power cord supplied by the manufacturer. Never adapt the plug from the monitor to
fit a non-standard outlet.
WARNING:
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.
WARNING:
If the integrity of the external protective earth ground is in doubt, the BIS Complete monitor shall
be operated from its internal battery power source only.
3.3.4 Electromagnetic Compatibility Requirements
The BIS™ Complete Monitoring System should be used only with the power cord and accessories
recommended and supplied by Covidien. The system must be installed and put into use
according to the specifications described in Electromagnetic Compatibility Specifications (B.2).
Caution:
The BIS Complete system complies with the electromagnetic compatibility requirements of IEC
60601-1-2. Operation of this device may affect or be affected by other equipment in the vicinity
due to electromagnetic interference (EMI). If this occurs:
• Increase separation between devices.
• Re-orient device cabling.
• Plug devices into separate outlet circuit branches.
• Refer to Electromagnetic Compatibility Specifications (B.2).
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3.3.5 Site Preparation: Mounting the Monitor
Covidien strongly recommends permanent mounting of the BIS Complete monitor to the
anesthesia machine to enhance safety and facilitate ease-of-use. Please contact your local
representative or Covidien to discuss mounting options.
WARNING:
Be sure the monitor is mounted securely in place to avoid personal or patient injury.
Mounting the Monitor using the Pole Clamp
To mount the monitor to a secure vertical pole (1/2" – 1½" in diameter):
1. Place pole within clamp bracket and tighten screw using the black finger knob. Make sure that there
is enough space above the clamp so that you have a few inches to slide the monitor in from above.
2. Line up the clamp shoe (on back of monitor) with the slot on pole clamp and slide monitor down to
fit. The bottom of the clamp shoe should be seen well below the bottom of the pole clamp, and the
monitor should snap securely into place.
Environment
Figure3-1.Pole Clamp
To remove the monitor, press tab on top of clamp shoe before sliding monitor up.
Operator’s Manual 3-5
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Installation and Preparation for Use
The pole clamp may be locked onto the monitor so that the two do not get separated. To do this:
1. Line up the clamp shoe (on back of monitor) with the slot on pole clamp and slide monitor down to
fit. The bottom of the clamp shoe should be seen well below the bottom of the pole clamp and the
monitor should snap securely into place.
2. Make sure that set screw hole on pole clamp aligns with corresponding hole on clamp shoe.
3. Remove black knob screw from pole clamp.
4. Using the Allen wrench supplied, secure pole clamp to monitor with the set screw provided.
5. Replace black knob screw.
6. To attach to pole, place pole within clamp bracket and tighten screw using the black finger knob.
3.4 The BIS™ Complete Monitoring System—Equipment and
Supplies
The BIS Complete Monitoring System consists of the following basic components:
• BIS Complete Monitor
• BISX™
• Patient Interface Cable (PIC)
• BIS Sensor
• Detachable Power Cord
Sensors are sold separately. For a list of available sensors please contact Covidien or your local
distributor.
A pole clamp is also included; however its use is optional. Contact Covidien or your local
representative for information on additional equipment and accessories.
Product names for some components of the BIS Complete Monitoring System have changed. For
current vs. legacy product names, refer to Table3-1.
Table3-1.Current vs. Legacy BIS Complete Monitoring System Product Names
Product Name Legacy
Product Name
BIS Complete
Monitor
BIS Vista
Monitor
Description or Application Part Number
BIS monitor that can be used with either a 2 or
4 Channel LoC device.
Monitor is connected to the LoC device by a
BIS Host Cable which is packaged with the
LoC device.
185-0151
186-1100
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The BIS™ Complete Monitoring System—Equipment and Supplies
Table3-1.Current vs. Legacy BIS Complete Monitoring System Product Names (Continued)
Product Name Legacy
Description or Application Part Number
Product Name
LoC 2 Channel BISX Processes 2 channels of EEG information (one
side of the brain) and calculates an index (0-
100) that provides a direct measure of the
patient's level of consciousness.
Connects to a BIS sensor by the 10-pin Patient
Interface Cable (PIC) which is packaged with
the LoC device.
LoC 4 Channel BISX4 Processes 4 channels of EEG information
(both sides of the brain) and calculates an
index (0-100) that provides a direct measure
of the patient's level of consciousness.
Connects to a BIS sensor by the 12-pin Patient
Interface Cable (PIC) which is packaged with
the LoC device.
BIS Sensors
Quatro Quatro Sensor for adult patients undergoing general
anesthesia or sedation.
Extend Extend Sensor for adult patients undergoing general
anesthesia or sedation in environments such
as the ICU.
185-1014-xxx
185-1016-xxx
186-0106
186-0160
Pediatric Pediatric Sensor for pediatric patients ages four and up. 186-0200
Bilateral Bilateral Sensor that detects hemispheric differences
186-0212
in the brain (for advanced monitoring
applications).
Requires use of the LoC 4 Channel device.
Table3-2.Summary of Cables used with the BIS Complete Monitoring System
Cable Location Comment
AC Power Back of Monitor Provided by Manufacturer
USB (Type A)
1
Back of Monitor Provided by Customer
USB (Type A) Port is used with
removable drive only
RS-232 Back of Monitor Provided by Customer
(1m < Length < 3m)
Monitor Interface Cable Front of Monitor - Side of LoC Provided by Manufacturer
(see BISX™ Specifications (B.1.3))
Patient Interface Cable Side of LoC - BIS Sensor Provided by Manufacturer
(see BISX™ Specifications (B.1.3))
1. USB (Type B) Port is for manufacturing use only. See Data Transfer (4.10).
Operator’s Manual 3-7
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Installation and Preparation for Use
Figure3-2.The BIS Complete Monitoring System
1 Monitor Interface Cable 4 Patient Interface Cable (PIC)
2 BIS™ Complete Monitor 5 BISX™
3 BIS™ Sensor
BIS™ Complete Monitor
3.4.1
Front Panel
The front panel of the BIS Complete monitor contains the Touch Screen, BISX™ port and the ON/
Standby button. See Figure 3-2.
Touch Screen
The BIS Complete monitor is designed so that all controls (with the exception of the ON/Standby
button) are accessible by touching a designated area on the monitor screen. This area is called a
touch key. The touch keys are designed to function even when the user is wearing examination
gloves.
ON/Standby Button
The ON/Standby button is located in the lower right corner of the monitor and indicates whether
the monitor is ON or in Standby mode. When the small LED light to the right of the ON/Standby
3-8 Operator’s Manual
Page 31
button is green, the unit is running and providing power to the BISX. When it is yellow, the battery
is charging and the system is in Standby mode. When it is not lit, no A/C power is available to the
unit; pressing the ON/Standby button will start up the monitor using the battery.
Rear Panel
The rear panel components are pictured in Figure 3-3. They include: two USB ports (Type A and
B), the clamp shoe, an RS-232 port, the Reset button, the Battery/Power Supply cover, and the
power cord receptacle.
Note:
Do not touch the patient and the RS-232 or USB ports at the same time.
The BIS™ Complete Monitoring System—Equipment and Supplies
Figure3-3.Rear Panel
1 Battery/Power Supply Cover 5 Serial Port
2 USB Port (Type B) 6 Power Cord Receptacle
3 USB Port (Type A) 7 Clamp Shoe
4 Reset Button
There are two USB ports on the rear of the monitor. The Type A port is used to export data to a
removable drive. It is also used to update monitor and BISX™ software.
The clamp shoe allows the monitor to slide into the pole clamp so that it can be attached to a
½" – 1 ½" diameter vertical pole.
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Installation and Preparation for Use
The RS-232 serial port can be used to transfer data from the monitor.
WARNING:
When connecting external equipment (e.g., data capture computer), the system leakage current
must be checked and must be less than the IEC 60601-1-1 limit.
WARNING:
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
• Evidence that the safety certification of the accessory has been performed in accordance to the
appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.
Under normal operation, power is cycled through the ON/Standby button. The Reset button can
be used to reset the software functions of the BIS™ monitor (and the BISX™ if it is attached) in the
unlikely case that it is required. See Using the Reset button (7.5).
The Battery/Power Supply cover contains the BIS Complete monitor’s power supply and allows
access to its battery.
The power cord receptacle, located on the side of the Battery/Power Supply cover, is used to
plug in the power cord provided by the manufacturer. It provides power to the monitor and to
the BISX when it is attached.
Caution:
The BIS Complete Monitoring System complies with the electromagnetic compatibility
requirements of IEC 60601-1-2. Operation of this device may affect or be affected by other
equipment in the vicinity due to electromagnetic interference (EMI). If this occurs:
• Increase separation between devices.
• Re-orient device cabling.
• Plug devices into separate outlet circuit branches.
• Refer to Electromagnetic Compatibility Specifications (B.2).
Integral Battery
A rechargeable lithium ion battery inside the monitor provides approximately 45 minutes of backup power when power cannot be supplied via the power cord. Recharge time is approximately 6
hours. The battery charges continually as long as the unit is plugged into A/C power.
When the system is running on battery, a battery icon displays indicating the battery status. A
battery icon with four green bars indicates that the battery is fully charged. When the battery
reaches a low power condition, the monitor beeps and the battery symbol displayed on the
3-10 Operator’s Manual
Page 33
screen changes color. In addition, a “Battery Voltage Low” message blinks in the Message area of
the screen.
Caution:
Check the battery periodically by operating a BIS™ Complete monitor that has been disconnected
from the wall socket and that has been charged to full capacity (at least 6 hours of charge time).
After long periods of storage, charge the battery for 6 hours to assure full capacity. If the BIS
Complete monitor fails to operate reliably from the battery for approximately 45 minutes, battery
replacement is required.
Caution:
The BIS Complete monitor contains an internal lithium ion battery. The battery must be removed
by a qualified service technician and disposed of or recycled in accordance with the national laws
of the country. Contact Covidien or the local distributor for a replacement battery.
3.4.2 BISX™
The BIS™ Complete Monitoring System—Equipment and Supplies
Figure3-4.BISX and PIC
1 Monitor Interface Cable 2 Patient Interface Cable (PIC)
The BISX receives, filters, and processes patient EEG signals. It is located close to the patient's head
where the EEG signal is less subject to interference from other medical equipment.
The BISX is shown in Figure 3-4. Its long flexible Monitor Interface Cable connects to the front of
the monitor. The Patient Interface Cable (PIC) connects the BIS sensor to the BISX.
The attachment clip on the BISX is used to secure it in a convenient location near the patient's
head.
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Installation and Preparation for Use
WARNING:
Due to elevated surface temperature, do not place BISX in prolonged direct contact with patient’s
skin, as it may cause discomfort.
Caution:
Do not open BISX™ for any reason. The seal to prevent liquids from entering the BISX may be
damaged if opened. Service or repairs must be performed only by qualified biomedical
technicians.
3.4.3 Patient Interface Cable (PIC)
Covidien BIS™ Sensor Patient Interface Cable (PIC) (see Figure 3-2) connects the BISX to the BIS
sensor.
3.4.4 BIS Sensors
The sensor is the single use component of the BIS Monitoring System and should be replaced
after each use. For details on how to apply the sensor to the patient and how to connect to the
BIS Monitoring System, refer to the BIS Sensor instructions for use. All sensors, including the BIS
Extended Use Sensor, utilize the monitor’s saved settings (such as smoothing rate).
3.5 Cable Connections
After you have familiarized yourself with the safety information in the introductory section of this
manual and have prepared a suitable environment, follow these steps to prepare the BIS
Complete system for operation.
1. Connect the BISX to the monitor
Holding the cylindrical connector with the flat side up, plug the BISX Monitor Interface Cable into the
BISX port on the front of the monitor.
Once connected, the BISX need not be disconnected again. However, if you wish to disconnect the
BISX cable from the monitor, carefully grasp the connector and pull. DO NOT pull on the cable.
2. Connect the PIC to the BISX
Attach the gray connector of the Patient Interface Cable to the BISX.
Note:
Connect with the BIS logo facing up for proper pin alignment. To disconnect the PIC, grasp the
connector housing and pull firmly. DO NOT pull apart by the cable wire.
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Start Procedure / Standby Mode
Start Procedure / Standby Mode
3.6
3.6.1 Starting the Monitor for the First Time
To start the instrument for the first time, after it has been reset with the RESET button, or after
battery replacement:
1. Attach one end of the power cord to the receptacle on the left side of the monitor.
2. Plug the other end of the power cord into a properly grounded hospital-grade AC power outlet. A
yellow light illuminates to the right of the ON/Standby button.
3. Press the ON/Standby button. The light changes to green and diagnostics tests run to verify that the
system is operating properly. A beep indicates that the tests are complete. If there is a problem, the
system halts and an error message appears. Error messages are explained in the Troubleshooting
section of this manual.
When not in use, the monitor should be placed in Standby mode. To put the system in Standby
mode, press and hold the ON/Standby button for two seconds before releasing. The light will
change from green to yellow. If the monitor is running on battery, the light will go off completely.
3.6.2 Starting the Monitor from Standby Mode
When the monitor is in Standby mode (yellow light), you may start it by pressing the ON/Standby
button. The light will change to green.
When not in use, the monitor should be placed in Standby mode. To put the system in Standby
mode, press and hold the ON/Standby button for two seconds before releasing. The light will
change from green to yellow. If the monitor is not connected to A/C power, the light will go off
completely.
3.6.3 Power-Up Messages
At power-up, one of the following messages appears in the Message Region of the screen,
depending on how the monitor was previously shut down:
• “Factory settings restored” — This message appears at each power-up after a normal shutdown.
See Table 4-3 on page 4-21 for the factory settings. (Mode I is the default.)
• “Previous settings restored. Unexpected shutdown” — This message appears at power-up after
an unexpected shutdown, such as a power failure.
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Installation and Preparation for Use
Initial Menu Settings
3.7
Before using the BIS™ Complete monitor for the first time, you may need to select the proper
language and set the current date and time. Other setting options are discussed in detail in
Operating the BIS™ Complete Monitoring System (4).
The BIS Complete monitor utilizes a touch screen. To access the Menus, press the [MENU]
icon on the left side of the screen. Press the [Next] or [Previous] touch keys to scroll
through the menu options. At any time you may press the [HOME] touch key to return to
the main display screen.
3.7.1 Language Selection
The BIS™ Complete monitor is designed to support multiple languages. If the screen does not
display the desired language, follow these steps:
To change the language:
1. Press [MENU].
2. Press [Next] to go to the second menu, then [Next] again to go to the third menu.
3. Press [Language]. The current language is displayed.
4. Use the [+] or [-] keys to scroll through the list of languages until the desired language appears. All
screens will now display in the selected language.
5. Press [HOME] to return to the main screen.
3.7.2 Date and Time
To set the current date and time:
1. Press [MENU].
2. Press [Next] to go to the second menu, then [Next] again to go to the third menu.
3. Press [Date and Time]. A new screen displays the current date and time. “Day” is displayed in blue
letters.
4. Use the up and down arrows to set the day of the month.
5. Press [Month]. “Month” is displayed in blue letters.
6. Use the up and down arrows to set the month.
7. Repeat this process for the “Year,” “Hour,” “Minute” and “Second” displays.
8. When you have finished, you may press [Return to Previous Menu] or press [HOME] to return to the
main screen.
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Note:
The time/date is initially set for the Eastern Standard or Eastern Daylight Time zone (USA). It will be
necessary for you to change the time twice per year using the Time/Date feature if you are located in
a time zone that alters its clocks at the beginning or end of Daylight Savings Time.
3.7.3 View/Save Settings
The BIS™ Complete monitor will always start up configured to settings that have been saved in
memory.
To save the current configuration settings,
1. Press [MENU].
2. Press [View/Save Settings]. The current settings display.
3. Press [Save Active]. A passkey is required to save the settings (see View/Save Settings (4.6.6) for
information about entering the passkey). The message, “Settings Saved” appears. The settings
displayed will be saved except as noted below.
Initial Menu Settings
4. Press [Previous] or [HOME] to exit.
Note:
• The “Save Active” option is disabled when in Battery Backup-Low Power condition.
• The following settings are not saved by the “Save Active” option: Impedance Checking (always
Settings are set and saved for the current Monitor Mode only. See Monitor Mode (4.6.10).
See View/Save Settings (4.6.6) for instructions on restoring factory default values.
returns to ON), Filters (returns to ON), and Display Type (returns to BIS).
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Installation and Preparation for Use
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4 Operating the BIS™ Complete Monitoring
System
4.1 Introduction
This chapter covers:
• Preparing for operation
• The sensor check
• The monitor screen display
• Software menus and menu selections
• Reviewing stored data
• The EEG display
• Ending a case
Read this chapter before operating the monitor in a clinical setting.
4.2 Preparing for Operation
After you have familiarized yourself with the safety information in the introductory section of
this manual, prepared a suitable environment, properly connected the BISX™ and PIC cables,
and completed the initial settings described in Installation and Preparation for Use (3), follow
these steps to prepare the BIS™ Complete Monitoring System for operation.
1. Startup and System Check
Press the ON/Standby button on the lower right corner of the monitor to start the monitor. The light
changes from yellow to green, and the system initiates a self-test to make sure that all equipment is
operating properly.
2. Attach BIS Sensor to Patient
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Prepare sensor site and place the BIS sensor on the patient in accordance with the instructions
included on the sensor packaging.
Caution:
The BIS Complete Monitoring System has been designed to operate with a BIS sensor. The
sensor is a silver/silver chloride electrode array that utilizes Covidien’s patented Zipprep™
technology and uses a proprietary connector. Use of other electrodes is not recommended.
WARNING:
The conductive parts of electrodes or sensor and connectors should not contact other
conductive parts, including earth.
WARNING:
To reduce the hazard of burns during use of high-frequency surgical equipment, the sensor or
electrodes should not be located between the surgical site and the electro-surgical unit return
electrode.
WARNING:
The sensor must not be located between defibrillator pads when a defibrillator is used on a
patient connected to the BIS Complete system.
WARNING:
To minimize the risk of patient strangulation, the patient interface cable (PIC) must be carefully
placed and secured.
WARNING:
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the BIS
Complete Monitoring System, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
3. Secure the BISX™
Using the attachment clip, secure the BISX to a convenient location near the patient's head.
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4. Attach the BIS™ Sensor to the PIC
Sensor Check
Figure4-1.Connecting the PIC
To insert the sensor into the PIC, line up as shown and insert the sensor tab into the PIC sensor
connector without pausing, until an audible “click” is heard. The blank side of the sensor tab (i.e. the
side without the computer chip) should be facing up.
Note:
When disconnecting the sensor, press the release button on the PIC.
The Sensor Integrity Check is initiated each time that a sensor is connected to the PIC to make
certain that a valid, unexpired sensor is in use.
4.3 Sensor Check
The Sensor Check tests the impedance of each electrode on the BIS sensor to verify that it is within
an acceptable range for monitoring. A Sensor Check is initiated automatically when the sensor
and PIC are connected to the BISX. It may also be initiated by the user by pressing the [Sensor
Check] touch key.
1 PIC Sensor Connector 3 Sensor Tab
2 Release Button
The message, “Sensor Check in Progress” appears. When the sensor successfully passes the test,
the Main Screen displays and monitoring begins.
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If the sensor does not immediately pass the test, or if the user has manually initiated the test, the
Sensor Check Graphic Screen displays. This screen shows the sensor with each electrode
numbered. Colors indicate the status of each electrode:
• Hollow circle – No status is available. The electrode label will appear after a few seconds.
• Green circle with Checkmark – The electrode impedance is within the acceptable range. When all
circles are green, monitoring can begin.
• Red blinking circle with ‘X’ – The electrode impedance is not within the acceptable range. Press the
edges of the sensor to ensure adhesion and then press each circle for 5 seconds to ensure proper
contact. Check all connections. If the problem persists, remove sensor, clean skin thoroughly, and
reapply sensor or apply new sensor in accordance with instructions on the sensor packaging.
• Gray circle with Question Mark – The electrode impedance cannot be determined due to electrical
interference (noise) from another source. Monitoring will not commence until the source of the noise
has been removed and all electrodes have passed the sensor check.
If the user has requested the Sensor Check and all electrodes pass the test, the circles return to
their original display color (blue) and the label, “PASS” displays at the bottom of the screen.
Figure4-2.Sensor Check Graphic Screen (Values not Shown)
If user action is required, messages in the message region of the screen issue instructions.
The monitor continues updating the values until all impedance values are acceptable. The [EXIT]
touch key allows the user to exit the screen before the test has completed, however, the Sensor
Check impedance test must be successfully completed before normal processing resumes.
For more detailed impedance information, press the [Show Values] touch key.
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Sensor Check
Figure4-3.Sensor Check Graphic Screen with Values Shown
In this display, the impedance value for each electrode, in kilo ohms, appears on the screen along
with its status:
• PASS — An electrode passes if the impedance for that electrode is less than 7.5 kilo ohms. The ground
electrode (electrode #2) must be less than 30 kilo ohms to pass.
• HIGH — An electrode is labeled “HIGH” if its impedance value is above 7.5 kilo ohms (30 kilo ohms for
the ground electrode). As long as the combined impedance of electrodes #1 and #3 and the
combined impedance of electrodes #1 and #4 are less than 15 kilo ohms, and the ground electrode is
less than 30 kilo ohms, the sensor check will be considered successful.
• NOISE — If the signal from the electrode goes beyond the measurable range, the label “NOISE”
displays.
• POOR CONTACT — If the impedance check indicates that the electrode is not in contact with the
patient, the label “POOR CONTACT” displays.
To return to the previous display, press the [Hide Values] touch key.
To save this screen as the default screen, return to the menu system, press the [View/Save
Settings] touch key, then press [Save Active].
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BIS™ Trend Data Screen
4.4
Once the sensor check has successfully completed, monitoring begins and the corresponding
information appears on the screen.
Figure4-4.Screen Features – BIS Trend Data Screen
1 Sensor Check Touch Key 11 Case ID
2 Menu/Home Touch Key 12 Secondary Variable
3 Alarm Pause/Silence Touch Key 13 Target Range
4 BIS Trend Unit Labels 14 Secondary Variable Unit
Labels
5 Primary Variable Name 15 Trend Time Scale
6 BIS Value 16 BIS Trend
7 Signal Quality Indicator 17 Secondary Trend
8 EMG Indicator 18 Snapshot Event Marker
9 EEG Waveform 19 Artifact Bar
10 Current Time and Date 20 Review Arrow
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BIS™ Trend Data Screen
4.4.1 BIS (Bispectral Index) Value
The current numeric value of the BIS is displayed in the upper left corner of the screen. The BIS
number is displayed and continuously updated during all display modes as long as signal quality
is sufficient.
4.4.2 Signal Quality Indicator
The Signal Quality Indicator (SQI) is a measure of the signal quality for the EEG channel source and
is calculated based on impedance data, artifact, and other variables. It is displayed in the upper
left corner of the screen, to the right of the “BIS” label. Signal quality is optimal when all five bars
of the SQI icon are green. When signal quality is too low to accurately calculate a BIS value, the BIS
value and other trend variables that are adversely affected by artifact will not be displayed on the
screen.
4.4.3 Electromyograph (EMG) Indicator
The EMG bar graph displays the power (in decibels) in the frequency range 70–110 Hz. This
frequency range contains power from muscle activity (i.e., electromyography or “EMG”) as well as
power from other high-frequency artifacts. When the indicator is low, it indicates that EMG activity
is low. BIS™ monitoring conditions are optimal when the bar is empty.
1 bar represents power in the 30–38 range
2 bars represent power in the 39–47 range
3 bars represent power in the 48–55 range
4 bars represent power greater than 55.
4.4.4 EEG Waveform Display
Filtered electroencephalogram (EEG) waveforms are displayed above the BIS trend graph with a
sweep rate of 25 millimeters per second and a scale of 25 microvolts (1 channel) or 50 microvolts
(2 channels) per division. One or two channels of EEG may be displayed in this area. EEG filters can
be turned off, if desired.
An alternate screen display is available to view the waveforms in a larger format. Refer to EEG
Display (4.8) for information.
4.4.5 Message Region
The Message Region is a space reserved for status and error messages. These messages are
prioritized so that a high priority message displays before a lower priority message.
BIS Complete has two alarm priorities (High and Low) and information messages. The background
color of the message indicates its priority:
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Message Priority Background Color
High Red (Flashing)
Low Yellow (Solid)
Information only Dark Blue or Grey
Diagnostic codes may be displayed above the messages by activating them in the Diagnostic
Menu. Specific error messages are explained in the Troubleshooting section of this manual
(Chapter 7).
4.4.6 BIS™ Trend Graph
The BIS Trend Graph plots the values of the Bispectral Index over time. The BIS trend is indicated
with a thick line and its unit labels appear on the left axis. The name BIS is displayed above the left
corner of the graph and the current date and time display in the center. (See Figure 4-4 and
Figure 4-5.)
On the right, a unique Case ID number is displayed. A new case number is assigned when a new
sensor is attached to the PIC and passes the Sensor Check.
If a target range for BIS has been set, the target area displays as either a colored bar or two
horizontal lines showing the upper and lower target ranges (depending on the user setting). If the
BIS value falls outside of the target range, a message displays in the Message Region of the screen,
and if an audible alarm was requested in the target range setup screen, the alarm sounds (unless
alarms have been silenced). The alarm continues to sound until the BIS value returns to the target
range or the alarm is silenced by pressing the alarm touch key. See Target Range (4.6.1) for more
information.
A secondary variable may be added to the display by selecting “Suppression Ratio,” “EMG,”
“Signal Quality” or “Bsts/Minute” as a secondary variable in the menu system. See Secondary
Variable (4.6.2) for instructions. The secondary trend is shown with a thin line and its unit labels
appear on the right axis. The secondary trend name is displayed above the right corner of the
graph. Note that Burst Count is only available as a secondary variable when a BIS Extend Sensor is
in use.
During periods of poor signal quality, an artifact bar appears along the horizontal axis at the
bottom of the graph. When signal quality is considered too low to calculate a BIS value, the bar
becomes bright yellow and any trend variables that are adversely affected by artifact will not be
displayed.
A Data Snapshot may be taken to save up to 10 minutes of data leading up to a significant event.
A Data Snapshot Marker (a camera icon) displays at the bottom of the BIS Trend Graph at the
time the snapshot was taken. Only one set of data is saved in memory at a time. When a second
snapshot is taken, the snapshot marker from the first snapshot changes from a camera to a
diamond and its data are overwritten. Snapshot data may be saved to a removable drive. To
export snapshot data, see Export Data (4.6.11). To save snapshot data in a printable (PDF) format,
see Print (Snapshot) (4.6.13).
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BIS™ Trend Data Screen
If desired, EEG may be displayed in place of the BIS Trend Graph by selecting the EEG display
mode in the menu system. See BIS™/EEG Display Modes (4.6.5) for details. During the sensor check
procedure, this area of the screen is used to issue instructions and report current status.
Figure4-5.BIS™ Trend Data Screen with Battery Icon, Target Range, SR, and Burst Count
1 Battery Icon
2 Extend Mode Indicator
3 Burst Count
4.4.7
Additional Screen Information
4 Suppression Ratio
5 Target Range
Battery Icon
The battery icon is displayed below the BIS number when the monitor and BISX™ are running on
battery power. When the battery icon contains four green bars, the battery is fully charged. When
the icon turns orange, the battery is nearly depleted.
If an empty battery icon displays on the screen with a slash across it, there is no battery in the
monitor.
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USB Export Icon
The USB Export icon is displayed below the BIS number during data export to a removable
USB drive inserted in the rear of the monitor.
Print Icon
The Print icon is displayed below the BIS™ number while printable files are being written
to a removable USB drive inserted in the rear of the monitor.
Extend Mode
The message, “EXTEND MODE ON,” displays below the BIS number when a BIS Extended Use
Sensor is in use. Note that the monitor automatically changes to the smoothing rate that was set
in Mode II (ICU) when a BIS Extend Sensor is attached.
Suppression Ratio (SR) Number
The Suppression Ratio (SR) is displayed in the upper right corner of the screen only when it has
been requested by the user. Suppression ratio is a calculated parameter designed to indicate
when an isoelectric (flatline) condition may exist. Suppression ratio is the percentage of time over
the last 63-second period that the signal is considered to be in the suppressed state. For example:
SR=11 (isoelectric over 11% of the last 63 second review).
When SR reaches 100%, the message “Isoelectric EEG Detected” will notify the user. Suppression
ratio can be plotted over time as a secondary trend on the BIS Trend Graph.
Burst Count (Bursts/Minute)
When a BIS Extended Use Sensor is in use, the Burst Count is displayed above the EEG waveform
display. Burst Count is an alternative method of quantifying suppression, reported as the number
of EEG bursts per minute. The system defines a “burst” as a short period of EEG activity, preceded
and followed by periods of inactivity. When the signal quality is low or when the Suppression
Ratio is less than 5, the Burst Count is not displayed.
The Burst Count may also be graphed as a secondary variable on the BIS Trend Graph.
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Main Screen Touch Keys
Main Screen Touch Keys
4.5
4.5.1 Alarm Touch Keys
Alarms sound to alert the user to possible problems with the patient or the equipment. Alarm
conditions are prioritized so that high priority alarms take precedence over lower priority alarms.
The user may silence all alarms. Alarm volume may be set in the menu system.
Table4-1.Alarm Touch Keys
A green bell icon indicates that the alarms are active and will sound if activated.
Pressing this icon changes the alarm status to “Alarms Paused” and the yellow
bell icon displays.
Alarms Active
A yellow bell indicates that all alarms have been silenced for two minutes. A
countdown timer counts down the seconds until the alarm sounds again.
Pressing this icon changes the alarm status to “Alarms Silenced” and the red
bell icon displays.
Alarms Paused
Alarms Silenced
The red bell with a solid “X” over it indicates that all alarms have been silenced
indefinitely. Pressing this icon restores the active alarms and the green bell icon
displays.
NOTE: When alarms are silenced, an audible reminder sounds at 3-minute
intervals. This reminder can be disabled via the Maintenance Menu (passkey
protected).
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4.5.2 Menu, Home, Sensor Check and Review Touch Keys
Table4-2.Menu, Home, Sensor Check and Review Mode Touch Keys
The MENU/HOME touch key:
The [MENU] touch key is used to enter the Menu system.
When a menu displays, the [MENU] touch key becomes the [HOME] touch key.
The [HOME] touch key is used to return to the main display screen.
The SENSOR CHECK touch key:
This touch key is used to begin a sensor impedance check. Sensor Check is
initiated automatically when the PIC and sensor are attached to the BISX™. You
may initiate another check at any time by selecting this option.
When an automatic check has been completed successfully, the screen will exit
automatically. Otherwise, the user may press the [EXIT] key at any time to exit.
For details on the sensor check procedure, refer to Sensor Check (4.3).
The Review Mode Arrow
This touch key is used to enter Review Mode
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Menu Selections
Menu Selections
4.6
Before using the BIS™ Complete monitor for the first time, you may want to update the monitor
with your desired screen settings and the current date and time. You should also familiarize
yourself with the various menu options available. This section describes the menu options
available and how they work. These menu options are discussed below. For more detail on what
the settings mean, refer to BIS™ Trend Data Screen (4.4).
4.6.1 Target Range
To access the Target Range, press [MENU].
Figure4-6.Target Range
To aid in patient management, a target range of desired BIS values may be set. When the Target
Range is activated, the selected range displays on the BIS Trend Graph. The BIS Complete monitor
will notify the user when the patient’s BIS value is outside of the intended range. The Target Range
menu has four components:
1. Activating the Target Range feature so that the range displays on the BIS Trend Graph.
2. Setting the Target Range display format (colored band or two horizontal lines).
3. Setting the audible alarm to sound when a BIS value falls outside of the range.
4. Setting a Target Range of desired BIS values.
Caution:
Do not set the Target Range alarm limits to extreme values that render the monitoring system
useless. Ensure Target Range alarm limits are appropriate for each patient.
To set the Target Range options, press [Target Range]. The Target Range Screen displays.
1. To activate the Target Range so that it displays on the BIS™ Trend Graph, or deactivate it so that it does
not, press [Target Range Active].
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When the Target Range is active, a green box displays.
•
• When the Target Range is inactive, a red box with an ‘X’ displays.
2. To change the Target Range display format, press the [Target Range Format] touch key. When the
left side of the [Target Range Format] key is illuminated, the Target Range will display as a colored
band. When the right side of the [Target Range Format] touch key is illuminated, the Target Range
displays as a pair of horizontal lines denoting the upper and lower limits.
3. To activate or deactivate the target alarm, press [Target Alarm].
• A green bell indicates that the Target Alarm is active. Alarms will sound when the BIS value falls
outside of the Target Range, unless the alarms have been silenced on the main screen.
• A red bell with an ‘X’ indicates that the Target Alarm is inactive. Audible Target Alarms will not
sound.
4. The Target Range upper (High) and lower (Low) limits are displayed between minus and plus signs. To
change the Target Range, use the [+] and [-] touch keys to increase or decrease the Target Range
limits. Each key press will change the limit by a factor of 5. The system will not allow the difference
between the upper and lower limits to be less than 5. A high value of 100 = none, and a low of 0 =
none.
To permanently save this change, press the [View/Save Settings] touch key in the menu system,
then press [Save Active].
Note:
A passkey is required to save settings. See View/Save Settings (4.6.6).
4.6.2 Secondary Variable
To access Secondary Variable, press [MENU].
Figure4-7.Secondary Variable
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Menu Selections
This option allows the user to add a secondary trend variable to the Trend Graph:
• Selecting “Suppression Ratio” will plot the suppression ratio.
• Selecting “EMG” will plot electromyograph or high frequency signal detection.
• Selecting “Signal Quality” will plot a number (0–100) that indicates the quality of the EEG signal
received and processed.
• Selecting “Bursts/Minute” will plot the burst count in number of bursts per minute. Note that this is
available only when a BIS™ Extend Sensor is attached to the PIC. If a BIS Extend Sensor is not connected,
this menu option does not appear.
• Selecting “None” removes the secondary variable from the graph.
To specify a secondary variable:
1. Press [MENU] to access menu options.
2. The [Secondary Variable] touch key displays the options available. The current setting displays in
green.
3. Press the desired touch key (Suppression Ratio, EMG, Signal Quality, Bursts/Minute, or None).
4. When the desired setting is displayed in green letters, press [Return to Previous Menu] or [HOME]
to exit.
To permanently save this change, press the [View/Save Settings] touch key in the menu system,
then press [Save Active].
Note:
A passkey is required to save settings. See View/Save Settings (4.6.6).
4.6.3 Chart Data
To access Chart Data press [MENU].
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When selected, this option provides a listing of BIS™, SQI and EMG values at a selected interval, so
that they can be recorded on the patient chart. The charting interval can be changed by the user.
Available intervals are 1, 5, 10, 15, 30, and 60 minutes. If a data snapshot was taken during the case,
the snapshot icon appears on the chart at the corresponding time.
Figure4-8.Chart Data
To chart data:
1. Press [MENU] to enter the menu system.
2. Press the [Chart Data] touch key. The Chart display appears.
3. To change the charting interval, use the [+] and [-] touch keys. Available intervals are 1, 5, 10, 15, 30
and 60 minutes.
4. Use the [] and [] arrows to scroll through the data.
5. Press [Return to Previous Menu] or [HOME] to exit.
4.6.4 Alarm Volume
To access Alarm Volume, press [MENU].
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The alarm volume can be set within a range, from low to high. The user may listen to the loudness
of the current alarm by pressing the “Test” button.
WARNING:
Do not decrease the adjustable alarm volume below ambient sound levels. Decreasing the alarm
volume below ambient levels may compromise patient safety.
Menu Selections
Figure4-9.Alarm Volume
To change the Alarm Volume:
1. Press [Alarm Volume]. The Alarm Volume screen appears.
2. Press a number from 1-5 on the touch screen to select the desired volume.
3. Press and hold the “Test” key to listen to the alarm volume you have set.
4. When the volume is set to the desired level, press [Return to Previous Menu] or press [HOME] to exit.
To permanently save this change, press the [View/Save Settings] touch key in the menu system,
then press [Save Active].
Note:
A passkey is required to save settings. See View/Save Settings (4.6.6).
4.6.5 BIS™/EEG Display Modes
To access BIS/EEG Display Modes, press the [MENU] touch key.
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The main display area of the BIS Complete monitor can display either BIS Trend Graph or the EEG.
(Refer to EEG Display (4.8) for more information.) The [BIS/EEG] touch key displays the current
display mode (BIS or EEG) in green letters. To change the display, press the [BIS/EEG] key to
toggle back and forth between the two display modes until the desired mode appears in green
letters.
Press [HOME] to exit.
The system defaults to the BIS Trend Data Screen display.
4.6.6 View/Save Settings
To access the View/Save Settings function, press [MENU].
Figure4-10.BIS/EEG Display Modes
Whenever the monitor is started up from Standby mode, it reverts to user settings that have been
set up and then saved using the [Save Active] touch key on the View/Save Settings screen.
Settings are saved to the current Monitor Mode (I, II, III, or IV).
Note:
Mode I default values, not the user settings, are always present at first power-up.
Figure4-11.View/Save Settings
WARNING:
Check Target Range alarm limits to ensure they are appropriate for the patient being monitored
with each use. Ensure Target Range alarm limits do not exceed the standard thresholds set by the
institution.
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Menu Selections
Operating settings may be changed for an individual use. However, to save settings, a passkey is
required. Only qualified personnel (as determined by hospital administration) are authorized to
save changes to system operating parameters. Passkey information is available in the Service
Manual.
To view or save the current configuration settings, press [View/Save Settings]. The current
settings display on the screen. Settings that are active but have not been saved are displayed in
yellow.
Save Active: Press this touch key to save the settings on display (the “Active” Settings) to the
current Monitor Mode.
Enter the passkey using the numerical buttons provided, then press [OK].
Figure4-12.Passkey Entry Screen
The message “Settings Saved” appears.
The settings displayed will be saved except as noted below:
• The “Save Active” option is disabled when in Battery Backup-Low Power condition.
• The following settings are not saved by the “Save Active” option: Impedance Checking (always returns
to ON), Filters (returns to ON), and Display Type (returns to BIS™).
Settings are set and saved for the current Monitor Mode only. See Monitor Mode (4.6.10).
Restore Saved: Press this touch key to return the current settings to the previously saved
settings. This applies to the current Monitor Mode only.
Restore Default: Press this touch key to restore the factory default settings. This applies to the
current Monitor Mode only. This restores the default values until the next time the monitor is restarted. To permanently restore the default settings for the selected monitor mode, press
[Restore Default] and then press [Save Active].
To restore the factory settings to all Monitor Modes, go to the Maintenance Menu and press
[Restore Default Settings for All Modes].
To save settings for all monitor modes, each mode must be selected and saved separately.
Press [Previous] or [HOME] to exit.
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4.6.7 Help
To access Help, press [MENU].
The [Help] touch key allows the user access to information on use of the BIS Complete
Monitoring System including: sensor placement, BIS guidelines, troubleshooting and system
features. Press the [Help] key, then follow the on-screen instructions.
4.6.8 Snapshot
To access the Snapshot function, press [MENU].
Figure4-13. Help
Figure4-14.Snapshot
This option is used during operation to mark a significant event on the trend screen display and
to save the previous 10 minutes of data leading up to the event. Snapshot data is saved in
memory until another snapshot is taken.
To take a data Snapshot, press [Snapshot]. The event is immediately marked with a snapshot
marker (a camera icon) on the time scale of the BIS™ Trend Graph. If a snapshot is already in
memory, the message “Warning: Snapshot in memory will be erased. Press ‘Save Snapshot’
button to save new snapshot” notifies the user. If the new snapshot is saved, the previous
snapshot marker displayed on the time scale changes to a diamond, and the new snapshot
marker displays as the camera icon.
Snapshot data may be sent to a removable drive. To export snapshot data, see Export Data (4.6.11).
For snapshot data in a printable (PDF) format, see Print (Snapshot) (4.6.13).
4.6.9 Display Suppression Ratio (SR)
To access Display SR:
1. Press [MENU].
2. Press [Next].
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The user may choose whether or not to display the Suppression Ratio (SR) on the main screen.
To change the setting, press [Display SR].
• When the key shows a green box, the Suppression Ratio will display on the main screen.
• When the key shows a red box with an ‘X’, the Suppression Ratio will not be displayed.
To permanently save this change for the current Monitor Mode, press the [View/Save Settings]
touch key in the menu system, then press [Save Active].
Note:
A passkey is required to save settings. See View/Save Settings (4.6.6).
Menu Selections
Figure4-15.Display SR
4.6.10 Monitor Mode
To access Monitor Mode:
1. Press [MENU].
2. Press [Next].
The BIS™ Complete monitor has four preset configurations (I, II, III, and IV) for use in different types
of cases. Each mode has its own settings, which are set up during installation.
WARNING:
Check Target Range alarm limits to ensure they are appropriate for the patient being monitored
with each use. Ensure Target Range alarm limits do not exceed the standard thresholds set by the
institution.
The default settings for each mode are shown in Table4-3.
Table4-3.Monitor Mode Settings
Variable Default Value
I II III IV
Trend Time Scale
(hours)
Alarm Volume 3 3 3 3
Target Range Inactive Inactive Inactive Inactive
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Variable Default Value
Table4-3.Monitor Mode Settings (Continued)
I II III IV
Target Alarms
Audible
Target Range
Display Format
BIS Smoothing Rate 15 30 10 15
Display SR on Main
Screen
Secondary Variable EMG EMG EMG EMG
Maximum Number
of EEG Channels
Charting Interval 15 minutes 15 minutes 15 minutes 15 minutes
Sensor Check Values Hide Hide Hide Hide
1. Only two channels display unless a BIS Bilateral Sensor and BISX4™ are in use.
On On On On
Color Bar Color Bar Color Bar Color Bar
No Yes No No
111
1
4
Settings may be changed for the current mode. When the settings are saved using the “View/Save
Settings” function, they are saved for the current mode only.
Factory settings for the current mode may be restored using the “View/Save Settings” function.
To restore factory settings for all modes, use “Restore Default Settings for All Modes” in the
Maintenance Menu.
To change the monitor mode:
1. Press [MENU] to access menu options.
2. Press [Monitor Mode].
3. Press the desired Mode.
4. Press [Return to Previous Menu] or press [HOME] to exit.
To permanently restore the default settings, press [Restore Default] and then press [Save
Active].
Note:
A passkey is required to save settings. See View/Save Settings (4.6.6).
4.6.11 Export Data
To access the Export Data function:
1. Press [MENU].
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Menu Selections
2. Press [Next].
Figure4-16.Export Data
This selection allows the user to send data to a removable drive via the USB port (Type A) at the
rear of the monitor, or to a device connected to the monitor’s serial port. For a list of acceptable
USB drives, please contact Covidien. (Contact information is listed on the back cover of this
manual.)
The various types of data that may be exported are listed below.
• Live Data: When this option is selected, live case data (BIS™ values, SQI, EMG and unfiltered EEG
waveforms) are exported. Live data files are named using the format LMMDDHHMM, where ‘L’ stands
for Live Data, MM is the two-digit month, DD the two-digit day, HH is the two-digit hour and MM the
two-digit minute that the data were exported.
• History Data: When this option is selected, case data stored in the BISX™ are exported. BIS values, SQI
and EMG are reported at one-minute intervals. History data files are named using the format
HMMDDHHMM, where the initial ‘H’ stands for History data, followed by the two-digit month, day,
hour, and minute that the data were exported.
• BISX Connection History: This option reports which BISX units were connected to the monitor. The
BISX serial number and the date and time of each connect and disconnect are noted. Files are named
using the format nx_bisxcDDMMYYYYHHMMSS_SNxxxxxxx.log, where ‘nx_bisxc’ stands for BISX
Connection, followed by the two-digit day and month, four-digit year, and two-digit hour, minute, and
second that the data file was created and xxxxxxx is the monitor serial number.
• Monitor Error Log: This option reports all system errors, including those related to the monitor, BISX,
PIC or sensor. The monitor error log contains monitor critical events, as well as any monitor errors. Files
are named using the format:
nx_errorDDMMYYYYHHMMSS_SNXXXXXXXX.log
where DDMMYYYYHHMMSS is the time stamp (day, month, year, hour, minute, second) reflecting the
first error in the file. XXXXXXXX is the monitor serial number, which may be up to 8 alpha-numeric
characters.
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Examples of entries in the error log are:
29 Mar 2015 14:58:23,[NNNN],Sensor Disconnected
29 Mar 2015 14:58:18,[NNNN],Sensor Invalid
where [NNNN] is a unique error number.
The log is maintained when system power is cycled and/or lost, but time of power event is not
necessarily captured. The last 5000 event entries are downloaded to a single file. Events are
downloaded in reverse time order (latest event first).
• Sensor Data: This option lists sensor information stored in the BISX. Files are named using the format
SDMMDDHHMM where ‘SD’ indicates Sensor Data, followed by the two-digit month, day, hour and
minute that the data were exported.
• Snapshot: This option sends the most recent snapshot data. Files are named using the format
SMMDDHHMM where ‘S’ stands for Snapshot, followed by the two-digit month, day, hour and minute
that the data were exported.
Information on the data file format may be obtained by contacting Covidien. (See back cover for
contact information.)
BIS is not processed during History Data or Sensor Data Exports. For all other exports, when a case
is in process, the BIS number will continue to update and display during the export process.
In order to export data, the system must be powered ON and the BISX must be connected to the
monitor. If the removable drive has a “write protect” switch, it must be set to the “unlock” position.
Plug the removable drive into the USB-A port on the back of the monitor. To export data:
1. Press the [Export Data] touch key. The display shows the data types available for export.
2. Press the desired data type, then press [Begin Export].
3. Export begins. If you press [Return to Home Menu] the export process will continue to run in the
background. The status of the export can be viewed at any time by selecting [Export] from the Menu
system.
4. During Export, the USB Export icon displays on the screen below the BIS™ number. (See USB Export Icon,
page 4-10.)
5. When the export status screen displays “100% complete,” the drive may be removed from the back of
the monitor. To stop Live Export, press [Stop Export] before removing the drive.
To exit while the export is still running, press [HOME]. To stop the export, press [Stop Export].
Caution:
Do not remove drive while export is in progress.
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4.6.12 BIS Smoothing Rate
To access the BIS Smoothing Rate:
1. Press [MENU].
2. Press [Next].
Figure4-17.Smoothing Rate
The BIS Complete system offers three choices of smoothing rates over which the BIS value is
averaged:
• 10 seconds: Provides increased responsiveness to state changes, such as induction or awakening. This
is the default setting for Monitor Mode III.
• 15 seconds: This is the default setting for Monitor Modes I and IV.
Menu Selections
• 30 seconds: Provides a smoother trend with decreased variability and sensitivity to artifact. This is the
default setting for Monitor Mode II.
To change the Smoothing Rate, press the [BIS Smoothing Rate] touch key. The current
Smoothing Rate displays in green letters. Press the key until the desired rate displays in green.
Press [HOME] to exit.
To permanently save this change, press the [View/Save Settings] touch key in the menu system,
then press [Save Active].
Note:
A passkey is required to save settings. See View/Save Settings (4.6.6).
4.6.13 Print (Snapshot)
Snapshot and Review data may be printed from the BIS™ Complete monitor. To print Review data,
see Reviewing and Printing Stored Trend Data (4.7). To print Snapshot data, use the Print menu
selection. To access Print:
1. Press [MENU].
2. Press [Next].
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This Print option allows the user to create a PDF file of the most recent Snapshot data and send
it to a removable drive on the USB-A port. The removable drive can then be used to transfer the
data to a personal computer for viewing or printing.
To “Print” Snapshot (send a printable file to a removable drive):
1. Attach the removable drive to the USB-A port.
2. Press [MENU], then [Next] to get to the second menu.
3. Press [Print], then press [Snapshot].
4. A Print icon appears below the BIS number while the data transfer is in process. (See Print Icon, page 4-
10.)
Figure4-18.Print Touch Key
5. When the message “PDF creation completed” appears (or the Print icon disappears from the screen),
the drive may be removed from the back of the monitor.
Each PDF file contains up to 4 pages; each page contains 30 seconds of data. The file name begins
with “EEG” and is followed by: the case ID number, the date of the earliest stored data for the case,
and the page range. For example, the file name EEG_AH5F_20070118_pgs1-4.pdf is a file
containing 4 pages of snapshot data from case # AH5F, and the earliest data available for that case
is from January 18, 2007.
Files for a particular case are stored in a folder. The folder name starts with ‘EEG’ followed by the
case ID number and the two-digit day and month, four-digit year, and two-digit hour, minute and
second that the printing was started. For example, the folder EEG_AH5F – 18012007112722
includes all of the files relating to case ID #AH5F, and the data for that case was printed on January
18, 2007 at 11:27:22.
4.6.14 Configuration Information
To access Configuration Information:
1. Press [MENU].
2. Press [Next].
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Figure4-19.Configuration Information
This option displays the current Monitor Mode and its settings, including:
• Monitor: Hardware and software revisions and the monitor serial number.
• BISX™: Serial number, revisions and checksum.
Menu Selections
• Sensor: Lot code, serial number and sensor type.
• Languages: Language revision numbers.
4.6.15 EEG Channels
To access EEG Channels:
1. Press [MENU].
2. Press [Next] to get to the next menu.
3. Press [Next] to get to the third menu.
Figure4-20.EEG Channels
The BIS™ Complete monitor has the ability to display one or two channels of filtered EEG. To
change the EEG display press the [EEG] touch key until the desired number of channels (1 or 2) is
displayed in green. Press [HOME] to exit.
4.6.16 Date and Time
To access Date and Time:
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1. Press [MENU].
2. Press [Next] to get to the next menu.
3. Press [Next] to get to the third menu.
Figure4-21.Date and Time
To set the current date and time:
1. Press [Date and Time]. A new screen displays the current date and time. “Day” is displayed in blue
2. Use the up and down arrows to set the day of the month.
3. Press [Month]. “Month” is displayed in blue letters.
4. Use the up and down arrows to set the month.
5. Repeat this process for the “Year,” “Hour,” “Minute” and “Second” displays.
6. Press [Apply change].
7. When you have finished, you may press [Return to Previous Menu] or press [HOME] to return to the
Note:
The time/date is initially set for the Eastern Standard or Eastern Daylight Time zone (USA). It will be
necessary for you to change the time twice per year using the Time/Date feature if you are located in a
time zone that alters its clocks at the beginning or end of Daylight Savings Time.
When time is set to an earlier hour, the following message appears on the screen: “Processing the
requested change will result in loss of all data collected since [Date and Time]. Press ‘Return to
Previous Menu’ to return to Date and Time Menu with no changes. Press ‘Apply change’ to apply
the requested change”.
letters.
main screen.
Date and time cannot be changed while a case is in progress.
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4.6.17 Language
To access Language:
1. Press [MENU].
2. Press [Next] to get to the next menu.
3. Press [Next] to get to the third menu.
Menu Selections
Figure4-22.Language Menu
The BIS™ Complete monitor is designed to support multiple languages. If the screen does not
display the desired language, follow these steps to change the language:
1. Press [Language]. The current language is displayed.
2. Use the [+] or [-] keys to scroll through the list of languages until the desired language appears. All
screens will now display in the selected language.
3. Press [HOME] to return to the main screen.
4.6.18 Filters
To access Filters:
1. Press [MENU].
2. Press [Next] to get to the next menu.
3. Press [Next] to get to the third menu.
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The BIS™ Complete system uses filters to screen out undesirable interference from the raw EEG
signal display. The Notch filter includes filters for both 50 and 60 Hz. Filters ON or OFF does not
affect processing of the Trend variables (i.e., BIS, EMG, and SR). Viewing the EEG signal without
filters may aid in troubleshooting signal problems. If you prefer to observe the raw EEG without
the filters, they may be turned off.
To turn the Filters off, press [Filters].
• When the key shows a green box, the filters are ON.
• When the key shows a red box with an ‘X’, the filters are OFF.
This change is not saved with the Save Settings option. Filters will default to ON.
Figure4-23.Filters
4.6.19 Impedance Checking
To access Impedance Checking:
1. Press [MENU].
2. Press [Next] to get to the next menu.
3. Press [Next] to get to the third menu.
Figure4-24.Impedance Checking ON/OFF
The BIS™ Complete system continually checks impedance levels during a procedure by
generating a 128 Hz test signal. Occasionally this signal may interfere with other equipment. If this
becomes a problem, you may turn off the continuous impedance checking. Impedance levels will
still be tested at startup, but once they pass, they will not be tested again until a new case is
begun.
To turn continuous impedance checking off, press [Impedance Checking]. The key display will
change from a green box to a red box with an ‘X’. Press [HOME] to return to the main screen. The
message, “Impedance Checking Off” will display on the screen during processing.
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Note:
Turning off continuous impedance checking will not be saved by the “Save Settings” feature. The next time
the monitor is started up or a new sensor is connected, the monitor will re-enable continuous impedance
checking.
4.6.20 Maintenance Menu
The Maintenance Menu includes maintenance functions to test, update and restore settings to
the monitor and BISX™.
To display the Maintenance Menu:
1. Press [MENU] to access the menu options.
2. Press [Next] to proceed to the next menu.
3. Press [Next] again to proceed to the third menu.
4. Press [Maintenance Menu]. The Maintenance Menu appears.
Menu Selections
Use of the Maintenance Menu is covered in Diagnostics and Troubleshooting (7).
4.6.21 Demo Case
To access Demo Case:
1. Press [MENU].
2. Press [Next] to get to the next menu.
3. Press [Next] to get to the third menu.
4. Press [Demo Case] to go to the Demo Case Menu.
This option allows the user to run a demonstration case. Press the [Demo Case] touch key to
initiate a Demo Case. The Main Screen appears, with the heading, “Demo Case.” To stop the
demonstration, follow the instructions above to access the [Demo Case] touch key and press the
touch key.
Note:
The Demo Case function uses pre-stored simulated case data. It should not be used during patient
monitoring at any time.
4.6.22 Diagnostic Menu
To display the Diagnostic Menu:
1. Press [MENU] to access the menu options.
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2. Press [Next] to proceed to the next menu.
3. Press [Next] again to proceed to the third menu.
4. Press [Diagnostic Menu]. The Diagnostic Menu appears.
Contact Covidien for instructions on use of the Diagnostic Menu. See back cover for contact
information.
4.7 Reviewing and Printing Stored Trend Data
The BIS™ Complete stores up to 72 hours of trend information. This information may be viewed
using the monitor’s “Review Mode.” To enter the Review Mode, press the blue [] arrow key on
the Main Screen display. The screen indicates that you are viewing Trend Review data.
The BIS numeric display for the current procedure will continue to be updated and parameter
alarms will continue to be announced during Review Mode.
Figure4-25.Review Screen (Case Mode)
1 Snapshot Markers 2 Print Icon Touch Key
Review Mode Touch Keys
4.7.1
Press the [Rewind] touch key to move the display backward in time. To move to the beginning
of the current case, press [Case Start]. If the case start is already displayed, you may press
[Previous Case Start] to view the previous case. If the earliest case in memory is displayed, the
key notifies the user that it has reached the “Beginning of BIS™ Trend Memory.”
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Reviewing and Printing Stored Trend Data
Press the [Advance] touch key to move forward in time. To move to the beginning of the next
case, press [Next Case Start]. If the final data of the last case in memory is displayed, the key
notifies the user that it has reached the “End of BIS Trend Memory.”
The Review Mode screen displays a secondary trend plot if one has been selected in the menu
system. To add or change the secondary trend, press the secondary variable touch key until the
desired variable is displayed in green letters. Note that Burst/Minute will only display if a BIS
Extend Sensor was used for the case.
Figure4-26.Review Screen (Cursor Mode)
Cursor Mode may be entered by pressing the [Cursor] touch key. Cursor mode allows the user
to view BIS and secondary variable data for specific points on the trend graph. When the user
touches the screen in the review display area, a box displays the time corresponding to the area
touched, along with the BIS and secondary variable data. When the signal quality is not sufficient
to calculate these values, they appear as asterisks.
In Cursor Mode, the “Rewind” and “Advance” keys are replaced by “Step Backward” and “Step
Forward” keys. When these keys are pressed and released, they move the data displayed 10
seconds forward or backward in time. When they are pressed and held, they move the data
displayed 60 seconds forward or backward in time.
To return to “Case Mode,” press the [Case] touch key.
To return to the main display, press [TREND REVIEW EXIT].
A print icon touch key is located in the upper right corner of the trend graph.
4.7.2 Printing Stored Data
Stored case data can be transferred via a removable drive to a personal computer for viewing or
printing. For information on printing Snapshot data, see Print (Snapshot) (4.6.13).
To create a PDF of the currently displayed case data,
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1. Attach a removable drive to the USB-A port.
2. Press the print icon touch key located in the upper right corner of the BIS™ Trend graph (see Figure 4-
25). A set of printable PDF files is created for the currently displayed case and sent to the USB drive.
3. A Print icon appears below the BIS number while the data transfer is in process. (See Print Icon, page 4-
10.)
4. When the message “PDF creation completed” appears (or the Print icon disappears from the screen),
the drive may be removed from the back of the monitor.
Each PDF file contains up to 6 pages, with each page displaying 1 hour of trend data. The data
include: the date, case ID number, case start and end time, the BIS trend graph, and a chart
displaying the BIS value, SQI and EMG at one-minute time intervals. If the case was longer than 6
hours, an additional file is created in the same directory.
The name of each file begins with “BIS” and is followed by: the case ID number, the date of the
earliest stored data for this case, and the page range. For example, the file name
BIS_AH5F_20070118_pgs1-6.pdf is a file of BIS data from case # AH5F, which started on January
18, 2007 and consists of 6 pages of data.
Files for a particular case are stored in a folder. The folder name starts with ‘BIS’ followed by the
case ID number and the two-digit day and month, four-digit year, and two-digit hour, minute and
second that the PDF creation was started. For example, the folder BIS_AH5F – 18012007112722
includes all of the files relating to case ID #AH5F, and the data for that case was printed on January
18, 2007 at 11:27:22.
4.8 EEG Display
This display is a larger version of the EEG waveform display, shown in place of the BIS™ Trend
Graph. Filtered EEG waveforms are displayed with a sweep rate of 25 millimeters per second and
a scale of 25 microvolts per division (one channel display) or 50 µV per division (two channel
display). EEG filters can be turned off in the menu system. When the EEG Display has been
selected, a small version of the BIS Trend Graph is displayed in the top right corner of the screen.
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Ending a Case
4.9
Ending a Case
Figure4-27.EEG Display
When the case has finished:
• Disconnect the patient sensor from the PIC by pressing the release button on the connector and then
pulling the connectors apart. DO NOT pull apart by the cable wires.
• Remove BIS sensor from patient. Disposable sensors are single-use only.
• Be sure to leave the PIC with the monitor so that it is not inadvertently discarded.
• If this is the last procedure of the day, press and hold the ON/Standby button for two seconds before
releasing to put the BIS Complete monitor in Standby mode (a yellow light displays).
• Clean the BIS Complete system between uses. See Care and Cleaning (6.2).
WARNING:
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.
Note:
The BIS™ Complete can remain plugged in to A/C power at all times.
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Data Transfer
4.10
Three ports on the rear of the BIS Complete monitor facilitate data transfer. The USB (Type A) port
is used to export data to a removable drive and to update monitor and BISXQ* software. See the
following sections for use of the USB-A port:
• Export Data (4.6.11)
• Print (Snapshot) (4.6.13)
• Printing Stored Data (4.7.2)
• Software Update (7.2.3)
An RS-232 port is available to connect the monitor to a patient monitoring or recordkeeping
system using an ASCII or Binary serial port protocol. See Serial Protocol (7.2.2).
The USB (Type B) port is for manufacturer’s use only.
WARNING:
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
• Evidence that the safety certification of the accessory has been performed in accordance to the
appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.
WARNING:
When connecting external equipment (e.g., data capture computer), the system leakage current
must be checked and must be less than the IEC 60601-1-1 limit.
4.11 How the BIS™ Complete Monitoring System Works
A sensor placed on the patient’s head transmits EEG signals to the BISX™. The BISX filters the data,
analyzes it for artifact and processes it using digital signal processing techniques, then sends the
data to the monitor for display. The purpose of processing the EEG waveform data is to extract
characteristic features from the complex signal in order to provide easier pattern recognition of
changes over time during the recording. A list of the processed variables and a description of each
is provided in Menus, Processed Variables and Glossary (A). These data are displayed on the screen
according to the preferences set by the user in the menu system.
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Figure4-28.BIS Range Guidelines
This chart reflects a general association between clinical state
and BIS™ values. Ranges are based on results from a multi-center
study of the BIS involving the administration of specific
anesthetic agents. BIS values and ranges assume that the EEG is
free of artifacts that can affect its performance. Titration of
anesthetics to BIS range should be dependent upon the
individual goals established for each patient. These goals and
associated BIS ranges may vary over time and in the context of
patient status and treatment plan.
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4.11.1 Bispectral Index (BIS™)
Range = 0 – 100
The Bispectral Index is a continuous processed EEG parameter that correlates to the patient’s level
of hypnosis, where 100 = awake and 0 = flat line EEG. BIS was designed to correlate with
“hypnotic” clinical endpoints (sedation, lack of awareness, and memory) and to track changes in
the effects of anesthetics on the brain. BIS is displayed as a number in the upper left corner of the
screen and is plotted over time on the BIS Trend Graph. When signal quality is too low to
accurately calculate a BIS value, the BIS number is not displayed.
4.11.2 Artifact Detection
The BIS Complete Monitoring System is designed to provide only highly reliable data. It is
therefore programmed not to display data that has been corrupted by artifact. Artifact bars
appear on the display whenever artifact is detected. In addition, a message appears whenever the
signal cannot be processed due to excessive artifact.
4.11.3 System Self-Checks
The BIS Complete monitor has several self-checking features to ensure that the system is
operating properly. These include:
System Check
Initiated when the unit is started up, this test makes certain that system software and hardware
components are functioning properly.
Equipment and Connection Checks
The system checks continuously to be sure that the BISX™, the PIC, and patient sensors are
operating properly and have not become disconnected.
DSC Self-Test
The DSC Self-Test tests the digital signal acquisition and conversion functions of the BISX. It is a
thorough test of the entire signal processing chain inside the BISX. It does not test the PIC or
sensor. The DSC Self-Test may be initiated in the Diagnostics Menu. See Diagnostic Menu (7.3).
Sensor Integrity Check
This test begins each time that a sensor is connected to the PIC. It checks to make certain that a
valid, unexpired sensor is in use.
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Impedance Check (Sensor Check)
Electrode impedance is tested when the BISX™ and PIC are connected and is monitored
continuously unless the user has turned impedance checking off in the menu system.
Caution:
Continuous impedance checking may need to be disabled if the 1 nanoampere 128 Hz impedance
check signal interferes with other equipment, e.g., evoked potential monitors.
Ground Check
A test is performed immediately after every sensor check and at 10-minute intervals during
monitoring to check the status of the patient ground connection. During the test, the EEG display
shows a flat line and the message “GROUND CHECK” displays on the screen.
Diagnostics
The BIS™ Complete monitor provides diagnostic codes to assist the user in tracing the source of
any problems that may occur. Codes are displayed above the Message Region only if the user has
requested them in the Diagnostic Menu.
How the BIS™ Complete Monitoring System Works
4.11.4 Monitor Data Memory
The monitor stores recorded trend data with time and date of acquisition. The duration of trend
data stored is approximately 72 hours. Trend memory can be viewed on the screen in Review
Mode.
When the memory is full, the oldest data are automatically erased as new data are stored. Memory
will be retained even if the battery has been discharged and remains when the monitor is in the
power off condition.
4.11.5 BISX Data Memory
The BISX stores processed EEG parameters, including the BIS value, with time and date of
acquisition. History data stored in the BISX can be accessed by exporting it to a removable drive
using the “Export Data” function. The duration of BISX data stored is approximately 1200 hours.
To view BISX history for a specific case, the user must first identify which BISX was in use during
the case by looking up the BISX serial number in the Maintenance Menu’s “BISX Connection
History.” The appropriate serial number BISX can then be connected to any monitor to export its
History Data.
When the BISX™ memory is full, the oldest data are automatically erased as new data are stored.
Memory will be retained even if the monitor battery has been discharged and remains when the
monitor and BISX are powered off.
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4.11.6 Battery Operation
In the event of a power failure or interruption of power during a procedure, the monitor
automatically switches to back-up battery operation. A fully charged battery will provide
approximately 45 minutes of operation. When the system is running on battery, a battery icon
displays next to the BIS™ number, indicating the battery status. When the battery reaches a low
power condition, the monitor beeps and the battery symbol displayed on the screen changes
color from green to orange. In addition, a “Battery Voltage Low” message blinks continuously in
the Message area of the screen.
The Save Settings feature is disabled when the battery power is low. Battery recharge time is
approximately 6 hours. The battery charges continually as long as the unit is plugged into A/C
power.
Caution:
To completely remove power from the unit: put the monitor in Standby mode, disconnect power
cord from the power receptacle of the monitor, then remove the battery from the monitor.
Note:
The BIS Complete monitor may not power up entirely if battery power is low. If that should occur, connect
unit to wall power and attempt to power the unit on again. If the unit will not power on, perform a reset
of the unit using the button located at the rear of the monitor. Refer to Using the Reset button (7.5).
4.11.7 The BIS™ Bilateral System
This section contains supplementary information for a Covidien BIS™ Complete Monitoring
System when it is used with the BISX4™, PIC-4 and BIS Bilateral Sensor.
Note:
Within this manual the "BISX4" and "BIS LoC 4 Channel" are used interchangeably.
Overview
The BIS™ Bilateral System was designed to allow the user to record and display four channels of
EEG; two from each side of the brain. The system consists of the BIS Complete Monitor, the BISX4™,
the PIC-4 and a BIS Bilateral Sensor. This section describes the additional features and options
available when the BIS Bilateral System is in use.
The system acquires four channels of EEG data, calculates BIS numbers and other variables for the
left and right sides of the brain, and reports them to the monitor for display. The user selects which
side of the brain is shown most prominently on the screen. (See Bilateral Display Menu, page 4-47.)
The designation ‘L’ (left) or ‘R’ (right) denotes which side of the brain is displayed. In addition, data
from the left side of the brain display in yellow, while data from the right side display in blue. BIS
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is calculated the same way as for Covidien’s two-channel sensors (e.g. Quatro), using two EEG
channels from the left side of the head for BIS L and two EEG channels from the right side for BIS R.
Figure4-29.The BIS Complete Bilateral Monitoring System
1 BIS™ Complete Monitor 3 PIC-4
2 BIS™ Bilateral Sensor 4 BISX4™
Using the BIS™ Bilateral System
System setup is the same as setup for two-channel monitoring, except that a BISX4™, PIC-4, and
BIS Bilateral Sensor are used. To begin:
1. Verify that all power and other cables are connected properly.
• The BISX4 long cable to the BISX™ port on the monitor.
• The PIC-4 to the BISX4.
2. Press the button in the right corner of the monitor to turn the monitor and BISX4 on.
3. Prepare sensor site and place BIS™ Bilateral Sensor on the patient in accordance with manufacturer’s
instructions.
4. Using the attachment clip, secure the BISX4 to a convenient location near the patient’s head.
5. Insert the BIS sensor tab into the PIC connector without pausing until fully engaged.
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Note:
When disconnecting the sensor, press the release button on the PIC.
Note:
The BISX and BISX4 have unique PIC cables and are not interchangeable.
Sensor Check
The Sensor Check procedure for the BIS™ Bilateral Sensor is the same as for other BIS sensors. See
Table3-1.If the sensor does not immediately pass the test, or if the user has manually initiated the
test, the Sensor Check Graphic Screen displays. This screen shows the sensor with each electrode
labeled. Bilateral sensors have electrodes labeled: RT, RE, C, G, LE and LT.
Figure4-30.Sensor Check (Values not Shown)
Colors indicate the status of each electrode:
• Hollow circle — No status is available. The electrode label will appear after a few seconds.
• Green circle with check mark — The electrode impedance is within the acceptable range. When all
circles are green, monitoring can begin.
• Red blinking circle with ‘X’ — The electrode impedance is not within the acceptable range. Press
the edges of the sensor to ensure adhesion and then press each circle for 5 seconds to ensure proper
contact. Check all connections. If the problem persists, remove sensor, clean skin thoroughly, and
reapply sensor or apply new sensor in accordance with instructions on the sensor packaging.
• Gray circle with question mark — The electrode impedance cannot be determined due to
electrical interference (noise) from another source. Monitoring will not commence until the source of
the noise has been removed and all electrodes have passed the sensor check.
If the user has requested the Sensor Check and all electrodes pass the test, the circles return to
their original display color (blue) and the label, “PASS” displays at the bottom of the screen.
If user action is required, messages in the message region of the screen issue instructions.
For more detailed impedance information, press the [Show Values] touch key.
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Figure4-31.Sensor Check with Values Shown
In this display, the impedance value for each electrode, in kilo ohms, appears on the screen along
with its status:
• PASS — An electrode passes if the impedance for that electrode is less than 7.5 kilo ohms. The ground
electrode (G) must be less than 30 kilo ohms to pass.
• HIGH — An electrode is labeled “HIGH” if its impedance value is above 7.5 kilo ohms (30 kilo ohms for
the ground electrode). As long as the combined impedance of electrodes C and T and the combined
impedance of electrodes C and E are less than 15 kilo ohms, and the ground electrode impedance is
less than 30 kilo ohms, the sensor check will be considered successful.
• NOISE — If the signal from the electrode goes beyond the measurable range, the label “NOISE”
displays.
• POOR CONTACT — If the impedance check indicates that the electrode is not in contact with the
patient, the label “POOR CONTACT” displays.
Screen Displays
The Bilateral Screen Display consists of three main areas; the BIS™ Number Display, the Main
Display, and the Small Display. See Figure 4-33.
BIS Number Display/Bilateral Touch Key
During bilateral monitoring, the BIS Number, SQI, and EMG data displayed on the screen are from
the hemisphere of the brain that was selected for display in the Bilateral Display Menu. (See
Bilateral Display Menu, page 4-47.) The letter L (Left) or R (Right) above the BIS number indicates
which side is displayed.
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Figure4-32.BIS Number Display/Bilateral Touch Key
During bilateral monitoring, the BIS Number region of the screen functions as a touch key.
Pressing this key allows the user to enter and exit the Bilateral Menu. See Bilateral Display Menu,
page 4-47.
Main Display and Small Display
The lower half of the screen is the Main Display area. Users may select whether to view DSA, EEG
or BIS Trend data in this area. The upper right section of the screen is the “Small Display” area. Users
may select whether to view BIS Trend, EEG or ASYM (Asymmetry) data in this area. See Bilateral
Display Menu, page 4-47 for instructions.
Figure4-33.Main Display (DSA) and Small Display (BIS Trend)
1 BIS™ Number Area 3 Main Display Area
2 Small Display Area
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Density Spectral Array (DSA) Display
The Density Spectral Array (DSA), indicated only for “monitoring the state of the brain,” shows
changes in the power spectrum distribution over a thirty minute time period. The DSA represents
the power spectra ranging from 49-94 dB with respect to .0001 µV RMS. The color bar to the right
of the time scale shows the range of colors used to indicate minimum and maximum power. The
frequency scale is shown on the horizontal axis with a range from 0 – 30 Hz.
Figure4-34.DSA Display
1 Maximum Power 2 Minimum Power
A white Spectral Edge line is superimposed on the graph where 95% of the total power lies on
one side of the line (toward the inside of the graph) and 5% lies on the other. The Spectral Edge
Frequency value (SEF) displays above the graph.
The ASYM graph in the center of the screen shows the degree of asymmetry in EEG power
between the left and right hemispheres. For more detail, refer to ASYM Display, page 4-47.
DSA data may be sent to a removable drive in a PDF format for transfer to a personal computer.
See Bilateral Display Menu, page 4-47.
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BIS™ Trend Data Display
Figure4-35.BIS Trend Display
The BIS Trend Display plots BIS values from the hemisphere of the brain that was selected in the
Bilateral Display Menu. (See Bilateral Display Menu, page 4-47.) The letter L (Left) or R (Right) above
the BIS number indicates which side is displayed. Note that the target range applies only to the
side of the brain that was selected by the user.
To view BIS Trend lines from both sides of the brain, the user may select BIS as a secondary
variable. Data from the left side of the brain display in yellow. Data from the right side display in
blue. Additional secondary variables are also available. See Additional Secondary Variables, page 4-
49.
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EEG Waveform Display
Figure4-36.Four-channel EEG with ASYM Display
When EEG is selected as the Main Display, the screen shows up to 4 channels of EEG. Filtered EEG
waveforms are displayed with a sweep rate of 25 millimeters per second and a scale of 25
microvolts per division (one channel display) or 50 microvolts per division (two or four channel
display). The number of EEG channels displayed can be set in the menu system. Data from the left
side of the brain display in yellow. Data from the right side display in blue.
When EEG is selected as the Small Display, one or two channels of EEG (from the temple
electrode) are displayed. The one-channel display shows EEG from the side of the brain that was
selected by the user in the Bilateral Display Menu. (See Figure 4-37.)
ASYM Display
Asymmetry (ASYM) is a processed variable indicating the percentage of EEG power present in left
or right hemispheres with respect to total (left and right) EEG power. Asymmetry data is indicated
only for “monitoring the state of the brain.” Asymmetry graphical data may be plotted as part of
the DSA Display, or independently as the "Small Display". (See Figure 4-34 and Figure 4-36.) The
ASYM scale begins at 20% at the center line and runs left or right to 100%. Asymmetry data less
than 20% are not displayed on the graph, but are available in the Chart Data screen. The time scale
appears on the left side of the graph. Fifteen minutes of data are shown at a time on the Small
Display; thirty minutes of data are shown on the DSA Display.
Menu Items
Bilateral Display Menu
The “Bilateral” Menu selection appears only when a BISX4™ is attached to the monitor and can
only be accessed when a BIS™ Bilateral Sensor is attached to the BISX4 (via the PIC-4).
To access Bilateral (the Bilateral Display Menu):
1. Press [MENU].
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2. Press [Next].
Note:
The Bilateral Display Menu can also be accessed by pressing the BIS Number during four-channel bilateral
monitoring.
Figure4-37.Bilateral Display Menu
When a BISX4™ and the BIS™ Bilateral Sensor are attached to the monitor, this menu allows the
user to determine how data is displayed.
Main Display: This refers to the area that normally displays the BIS Trend information. The Main
Display options are:
• BIS — BIS Trend Graph from the selected side of the brain (L or R)
• EEG — Up to four channels of EEG
• DSA — The Density Spectral Array for both sides of the brain
Small Display: This refers to the upper right portion of the screen, which normally displays EEG
waveforms. The Small Display options are:
• BIS™ — BIS Trend Graph of the selected side. Note that this is not available when BIS Trend has been
selected as the large display.
• EEG — One or two channels of EEG. The channels reported are from the temple electrodes. Note that
this is not available when EEG has been selected as the large display.
• ASYM — The degree of asymmetry between the left and right hemispheres of the brain, over time.
Note that this is not available when DSA has been selected as the large display.
BIS L BIS R: This key allows the user to select which side of the brain (L – Left, or R – Right) displays
most prominently. Note that the Target Range, if set, applies only to the side of the brain that is
selected here.
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Although data shown may be from only one side of the brain, messages are reported for both
sides of the brain. Messages are labeled with “L” when they are specific to the left side of the brain
and with “R” when they are specific to the right side.
DSA Print: This option converts up to two hours of DSA data into a PDF format and sends it to a
removable drive attached to the USB-A port on the rear of the monitor.
Trend Review: The Trend Review touch key is available in the Bilateral Display Menu. The Trend
Review Screen allows the user to select the additional secondary variables listed in Additional
Secondary Variables, page 4-49.
To change the Bilateral Display:
1. Attach the BISX4™ and a BIS Bilateral Sensor to the monitor (or start the Bilateral Demo Case).
2. Press [MENU] to access menu options.
3. Press [Next] to get to the next menu.
4. Press [Bilateral]. The Bilateral Display Menu appears.
5. Press the Large Display touch key until the desired option (BIS, EEG, or DSA) displays in green.
6. Press the Small Display touch key until the desired option (BIS, EEG, or ASYM) displays in green.
7. Press the [BIS L BIS R] touch key until the brain hemisphere (L – Left or R – Right) to be displayed
appears in green letters.
8. Press [HOME] to exit.
Additional Secondary Variables
Figure4-38.Secondary Variable Menu (Bilateral)
When the BIS™ Bilateral Sensor and BISX4™ are connected to the monitor, additional secondary
variables can be selected from the Secondary Variable Menu. The selected variable is plotted on
the BIS Trend graph. The additional secondary variables are:
• Bursts/Minute — The number of bursts per minute.
• BIS — When BIS is selected as the secondary variable, BIS values for both sides of the brain are plotted
on the BIS Trend graph. Data from the left side of the brain are shown in yellow, and data from the right
side are shown in blue.
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sBIS (BIS Variability Index) — This number represents the standard deviation of the BIS variable over
•
the last three minutes.
• sEMG (EMG Variability Index) — This number represents the standard deviation of the EMG value
over the last three minutes.
Chart Data
The data reported on the Chart Data Screen are from the side of the brain that was selected to
display in the Bilateral Display Menu. BIS™ data from the left side are displayed in yellow. BIS data
from the right side are displayed in blue. Asymmetry data are also displayed, with the designation
‘L’ or ‘R’ to indicate the corresponding part of the brain. In the Figure above, ASYM of 0 indicates
no asymmetry, and R2 denotes 2% asymmetry to the right side. Note that unlike the ASYM data
graphed in DSA or ASYM "Small Display", ASYM in Chart Data represents the full 0 to 100% range
of Asymmetry.
Figure4-39.Chart Data Screen
BIS/EEG Display Mode
The BIS™/EEG Display Mode option is not available when a BIS Bilateral Sensor is attached via
BISX4™. Use the Bilateral Display Menu to change the display mode. See Bilateral Display Menu,
page 4-47.
EEG Channels
When the BIS Bilateral Sensor is attached, the user may select one, two, or four channels of filtered
EEG for display. The default number of channels when a Bilateral Sensor is attached is determined
by the number of channels set and saved in Monitor Mode IV.
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Demo Case
Figure4-40.Demo Case
When Demo Case is selected from the Menu system, the user may choose “Dual Channel” or
“Bilateral” for the Demonstration by pressing the appropriate touch key.
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5 Quick Reference Guide
5.1 Introduction
This “Quick Reference Guide” is intended only as an operating checklist for users already familiar
with the BIS™ Complete monitor. Do not proceed unless you have read the “Safety Precautions”
(Chapter 2 of this manual).
5.2 Basic Operation
If the BIS Complete system has already been installed, but has been put into Standby mode
(after a previous surgery, for example), proceed as follows:
1. Verify that all power and other cables are connected properly.
• The BISX™ long cable to the BISX port on the monitor.
• The Patient Interface Cable to the BISX unit.
2. Press the button in the right corner of the monitor to turn the monitor and BISX on. The button light
will turn from yellow to green. The system will initiate a self-test to ensure that all equipment is
operating properly.
3. Prepare sensor site and place BIS sensor on the patient in accordance with manufacturer’s
instructions.
4. Using the attachment clip, secure the BISX to a convenient location near the patient’s head.
5. Insert the BIS sensor tab into the PIC connector until fully engaged.
You are now ready to begin monitoring. For detailed operating instructions and software
configuration, read Chapter 3 and Chapter 4. Current settings may be viewed at any time by
viewing the appropriate menu.
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6 Preventive Maintenance, Care and Cleaning
6.1 Introduction
This chapter describes:
• Care and cleaning procedures
• Routine maintenance
• Technical documentation
• Instrument Identification.
6.2 Care and Cleaning
WARNING:
Universal precautions shall be observed to prevent contact with blood or other potentially
infectious materials. Contaminated materials should be disposed of in accordance with national
and local waste disposal legislation and requirements.
6.2.1 Cleaning the Monitor and BISX™
Clean any spillage of blood or solutions on either the monitor or BISX as soon as possible. Dried
blood is very difficult to remove. Use lint-free absorbent towels for spill cleanups. Dampen the
towel with detergent and lukewarm water to aid in cleaning. After cleaning, wipe the PIC
connector ends with alcohol and allow to dry completely. Residual moisture inside the
connector may affect BISX performance.
6.2.2 Disinfecting the Monitor and BISX™
Use lint-free absorbent towels dampened with a 10% bleach solution, or a commercial
disinfectant (e.g., Lysol™* Professional Disinfectant Foam Cleaner Spray or PDI
Germicidal Disposable Wipes).
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After cleaning, dry all areas except the monitor display screen (see below) with a lint-free
absorbent paper towel. Wipe the BISX and PIC connector ends with alcohol and allow to dry
completely.
WARNING:
Whenever an event such as spillage of blood or solutions occurs, re-test leakage current before
further use.
WARNING:
Do not mix disinfecting solutions (e.g., bleach and ammonia) as hazardous gases may result.
Caution:
Do not autoclave the BISX or Monitor. Autoclaving will seriously damage both components.
Caution:
Avoid liquid ingress to the Patient Interface Cable. Contact of fluids with the PIC sensor connectors
can interfere with PIC performance.
6.2.3 Cleaning the Monitor Display
Clean the monitor display screen with a mild solution of detergent and warm water or a
commercial display screen cleaner, available through personal computer dealers. To avoid
scratching the screen, never use abrasive cleaners.
6.3 Maintenance
The BIS™ Complete monitor is designed so that no periodic adjustment or calibration is required.
Suggested routine maintenance includes: periodic checking of cable integrity, system checkout,
checking the battery, and checking leakage current. Instructions on replacing the battery and
power supply are included in this section should replacement be necessary. In the event that the
touch screen needs calibration, follow the instructions in Calibrate Touch Screen (7.2.6).
Caution:
Service or repairs must be performed only by qualified biomedical technicians.
6.3.1 Replace the PIC (Patient Interface Cable)
The Patient Interface Cable (also known as the PIC cable) is considered a consumable part of the
system and is expected to wear out due to normal usage. The internal wires and/or connector
contacts may fail with fatigue over time or become contaminated with foreign material. This is an
expected occurrence, as it is with any equipment that utilizes lead wires or patient connection
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cables. Therefore, it is recommended that the PIC cable be tested on a periodic basis (see System
Checkout (6.3.3)) and replaced if it has been in service for more than two years.
The PIC cable date of manufacture is printed on each cable and is located on a white label
wrapped around the PIC cable. The manufacturing date code is identified in one of the following
methods:
• “PIC+ mmddyy” (month, day, year)
• “PIC+ mm/dd/yy” (month, day, year)
• “nnnnnnwwyy” (where ww is week and yy is year)
Replacing the PIC cable is an important routine maintenance action which will improve the
reliability of the BIS™ monitoring system.
6.3.2 Checking Cable Integrity
The BIS Complete System should be inspected periodically to ensure that all cables are in working
order, with no cuts in electrical insulation. Cables can be flexed during the system checkout (See
System Checkout (6.3.3)) to ensure there are no loose wires.
Maintenance
6.3.3 System Checkout
A system checkout should be done annually to verify that all system components are in working
order. Follow the instructions below for System Checkout.
1. Disconnect the BISX™ from the monitor.
2. Connect power cable to monitor, plug power plug into appropriate wall outlet.
• Verify that the light to the right of the ON/Standby button is yellow.
3. Start up monitor by pressing the ON/Standby button (lower right corner).
• Verify that the light to the right of the ON/Standby button is green.
• Verify all self-tests complete successfully.
• Verify next screen says “Connect BISX.”
4. Connect BISX with PIC to monitor.
• Verify screen says, “BISX Initialization Complete.”
• Verify that screen says, “Connect sensor or cable.”
5. Connect PIC and sensor.
• Verify SENSOR CHECK begins.
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6. Disconnect power cord from monitor.
• Verify ‘OPERATING ON BATTERY BACKUP’ is displayed.
• Verify battery icon displays below BIS™ number.
7. Reconnect power cord.
• Verify battery icon is not displayed below BIS banner.
• Verify ‘OPERATING ON BATTERY BACKUP is not displayed.
8. End of checkout.
6.3.4 Checking the Battery
Check the battery periodically by operating a BIS Complete monitor that has been disconnected
from the wall socket and that has been charging the battery for at least 6 hours. If the monitor fails
to operate reliably from the battery for approximately 45 minutes, battery replacement is
required.
WARNING:
Electrical Shock Hazard: Do not remove monitor covers during operation or while power is
connected to monitor.
WARNING:
Leakage current must be checked by a qualified biomedical engineering technician whenever
instrument case is opened.
Caution:
Check the battery periodically by operating a BIS Complete monitor that has been disconnected
from the wall socket and that has been charged to full capacity (at least 6 hours of charge time).
After long periods of storage, charge the battery for 6 hours to assure full capacity. If the BIS
Complete monitor fails to operate reliably from the battery for approximately 45 minutes, battery
replacement is required.
Caution:
The BIS Complete monitor contains an internal lithium ion battery. The battery must be removed
by a qualified service technician and disposed of or recycled in accordance with the national laws
of the country. Contact Covidien or the local distributor for a replacement battery.
Note:
The BIS Complete monitor may not power up entirely if battery power is low. If that should occur, connect
unit to wall power and press the Reset button. Refer to Using the Reset button (7.5).
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6.3.5 Replacing the Battery
To replace the battery, you will need a Philips #2 screwdriver. Follow the instructions below:
1. Unplug A/C line cord from the monitor.
2. Lay monitor screen-side-down on a scratch-free work surface so that the Battery/Power Supply cover
is accessible.
3. Remove 4 screws from the Battery/Power Supply cover and remove the cover. Note the position of the
battery cable.
4. Squeeze the battery connector latch to disengage it from the back of the monitor and remove the old
battery.
5. Lay the new battery in the recess with the wires at the top, and plug in the connector.
6. Replace the cover and four screws (hand-tighten only) and reconnect the A/C power cord.
6.3.6 Replacing the Power Supply
Maintenance
WARNING:
Power supply is internally fused. Replace power supply only with Covidien BIS™ Complete power
supply.
To replace the power supply, you will need a Philips #2 screwdriver. Follow the instructions below:
1. Unplug A/C line cord from the BIS™ Complete monitor.
Figure6-1.Replacing the Power Supply
2. Lay the monitor screen-side-down on a scratch-free work surface so that the Battery/Power Supply
cover is accessible.
3. Remove 4 screws from the Battery/Power Supply cover and remove the cover. The power supply is
located inside the cover.
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4. Unplug (squeeze and pull to remove) the battery and the power supply connectors.
5. Remove screws from the power supply bracket and remove the old power supply.
6. Insert new power supply into the cover, lining up the A/C power receptacle with the cutout in the
cover.
7. Reconnect the power supply.
8. Reconnect the battery.
9. Replace the cover and 4 screws (hand-tighten only) and reconnect the A/C power cord.
6.3.7 Checking Leakage Current
Leakage current is a primary indicator of electrical shock hazard to personnel making contact with
any exposed outer surface of the equipment. Each BIS Complete monitor is carefully checked at
the factory to verify that leakage current meets the UL60601-1 and IEC60601-1-1 safety standards.
The BIS Complete monitor should be checked routinely for leakage current at least once a
year.
Always have the leakage current checked after a saline or blood spill, or immediately after a major
surge in the house electrical system and after every time the monitor case has been opened.
Keep in mind that liquids such as saline and Ringer’s as well as blood are all excellent conductors
of electricity. Avoid touching any part of the system with wet hands. Always work with clean, dry
hands.
WARNING:
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.
The BIS™ Complete Monitoring unit does not contain a Protective Earth Stud (GND Stud). Since
the exposed metal parts on the rear of the BIS Complete Monitor (Communication serial port and
USB ports) are separated from live parts by double insulation, a ground continuity test does not
apply to these parts. The components of the BIS Complete Monitor that are connected to
protective earth are contained within its enclosure and are not accessible to the user of the
equipment. However, as stated in the operating manual, an enclosure leakage current test should
be performed on the exposed metal parts and should be checked periodically to ensure that the
integrity of the equipment’s insulation system is maintained. The leakage current test should
include measurement of ground wire leakage, enclosure leakage, and patient leakage.
Ground wire leakage typically can be performed automatically by connecting the A/C power cord
of the BIS Complete Monitor into a safety tester. The enclosure leakage may be measured by any
safety test equipment that is capable of connecting to isolated conductive parts and measuring
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Technical Documentation
the current from those parts to earth. The patient connection terminals of many safety testers can
be used for this purpose. The patient leakage current can be measured by connecting the patient
connection terminals of a safety tester to the patient input connection (the PIC) of the BISX™.
The BIS Complete Monitor has been certified by Underwriters Laboratories to comply with
IEC60601-1, as indicated on the labeling on the rear of the monitor.
6.4 Technical Documentation
The BIS Complete 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), BISX, the BIS Complete Monitor itself, the battery, power supply and pole clamp. Periodic
software updates are possible via the USB-A port.
This BIS Complete Operator’s 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. Covidien does not authorize nor provide
information to service or repair the internal components of the BIS Complete monitor or the BISX.
6.5 Instrument Identification
6.5.1 BIS™ Complete Monitor
Monitor identification information is permanently marked on the rear panel. This information
includes instrument model and serial numbers, power ratings, cautions, and the Covidien’s
shipping address.
6.5.2 BISX™
The BISX identification information is permanently marked on the rear panel of the BISX. The
information includes instrument model and serial numbers, patent numbers, cautions, and the
Covidien’s shipping address.
6.5.3 Software Revision Numbers
Software revision numbers are displayed in the Configuration Information screen.
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