Operator's Manual
Table Of Contents
- 1. Introduction
- 1.1. Introduction
- 1.2. Safety Information
- 1.3. Device Description
- 1.4. Intended Purpose
- 1.5. BIS™ Advance Monitor System Indications and Contraindications
- 1.6. Patient Target Groups
- 1.7. Intended Users
- 1.8. Essential Performance
- 1.9. Adverse Events (Residual Risks)
- 1.10. The BIS™ Advance Parameters
- 1.11. Symbols
- 2. The BIS™ Advance Monitor — Equipment and Supplies
- 2.1. The BIS™ Advance System
- 2.2. Parts of the System
- 3. Installation and Preparation for Use
- 3.1. Operating Environment
- 3.2. Power Requirements and Battery Use
- 3.3. Battery Operation
- 3.4. Mounting the Docking Station
- 3.5. Preparing the Docking Station
- 3.6. Preparing the Monitor
- 3.7. Home Screen
- 3.8. Four-Channel Monitoring
- 3.9. Home Screen Trend Graphs
- 3.10. Home Screen Numeric Section
- 3.11. Home Screen Menus
- 3.12. Home Screen Options
- 3.13. Secondary Trend Selection
- 3.14. Home Screen Audio Alarm Settings
- 3.15. Settings and Maintenance
- 3.16. Info Options
- 3.17. Quick Reference Checklist
- 4. Operating the BIS™ Advance Monitoring System
- 4.1. Preparing for Operation
- 4.2. Cases
- 4.3. Alarms and Messages
- 4.4. Chart Data
- 4.5. Menu Map
- 4.6. Institutional Settings
- 5. Data Storage, Transfer, and Export
- 5.1. Cybersecurity and Data Integrity
- 5.2. Monitor Data Memory
- 5.3. BISx Data Memory
- 5.4. Types of Exported Data
- 5.5. Live Case Export
- 5.6. Saved Cases Export
- 5.7. Recording a Snapshot Event
- 5.8. BIS™ Saved Data Files
- 5.9. Logs Export
- 5.10. Viewing and Printing Saved Data in PDF Format
- 6. Service and Maintenance
- 6.1. Introduction
- 6.2. Servicing the BIS™ Advance Monitor
- 6.3. Battery Handling
- 6.4. Cleaning the BIS™ Advance Monitor
- 6.5. Instrument Identification
- 7. Diagnostics and Troubleshooting
- 7.1. Diagnostics
- 7.2. Troubleshooting
- 7.3. Administrator Mode
- 7.4. Demo Mode
- 7.5. Glossary
- 7.6. Specifications
- 7.6.1. General Specifications
- 7.6.2. Operating Environments
- 7.6.3. Power Supply
- 7.6.4. Battery Specifications
- 7.6.5. Controls and Connectors
- 7.6.6. Alarms
- 7.6.7. Display
- 7.6.8. Sound Pressure Data
- 7.6.9. BIS Specifications
- 7.6.10. EEG Specifications
- 7.6.11. BISx Module Specifications
- 7.6.12. Software/GUI Specifications
- 7.7. Electromagnetic Compatibility Specifications
- 7.8. Product Compliance
- 7.9. BIS™ Advance Components, Accessories, and Documentation
- 7.10. Warranty
- 7.11. Software License Agreement
Essential Performance
28
BIS™ Advance Monitor
Frequency response 201.12.1.105 The output at 0.5 Hz and 50 Hz is within
71 % to 110 % of the output obtained
with a 5 Hz sine wave input signal:
4-channel: 101.7% at 0.5 Hz; 95.8% at 50
Hz
2-channel: 104.8% at 0.5 Hz; 90.4% at 50
Hz
Common mode
rejection
201.12.1.106 4-channel: max output signal is 39 µv p-
v (peak to valley)
2-channel: max output signal is 47 µv p-
v (peak to valley)
1.8.1. EEG Particular Standard (IEC
60601-2-26, 3rd Edition)
With regard to immunity to electromagnetic interference, the standard states the
following:
• May show temporary degradation during discharges
• Shall resume normal operation after ESD within 30 seconds.
Within this context, normal operation for the BIS™ monitoring
system means the EEG wave shall appear on the BIS™ monitor
within 30 seconds .
• Shall not lose operator settings or stored data
• Shall continue to perform its intended purpose
It is possible, and acceptable per the standard, for the BIS™ monitoring system to
experience a temporary loss of function, or degradation of behavior, due to an EMC
Immunity, that could require operator intervention, provided that the system
resumes normal operation (i.e., displays the EEG analog signal) within 30 seconds.
Depending on the type of error the BIS™ system detects if exposed to significant
electromagnetic interference, the following are examples of operator intervention:
• Pressing a button on the touch-screen