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
BIS™ Advance Monitor System Indications and Contraindications
BIS™ Advance Monitor
25
For both the 2-channel and the 4-channel systems, BIS™ monitoring is implemented
as follows: A sensor placed on the patient’s head transmits EEG signals to the BISx
module. The BISx module filters the data, analyzes it for artifacts 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 Table 1. The BIS™ Advance Monitor Parameters, on
page 31. This data is displayed on the screen according to the preferences set by the
user in the menu system.
1.4. Intended Purpose
The ELECTROENCEPHALOGRAPHY INSTRUMENTS are intended to monitor the state
of the brain and may be used to guide anesthetic administration.
1.4.1. BIS™ Monitor
The ELECTROENCEPHALOGRAPHY INSTRUMENTS are intended to monitor the state
of the brain and may be used to guide anesthetic administration.
1.4.2. BISx and BISx4 Modules
The ELECTROENCEPHALOGRAPHY INSTRUMENTS – HARDWARE ACCESSORIES
calculate parameters which are used to support monitor functions.
1.4.3. BIS™ Sensors
The ELECTROENCEPHALOGRAPHY INSTRUMENTS – CONSUMABLES collects electrical
signals which are used to support monitor functions.
1.4.4. BIS™ Cables
The ELECTROENCEPHALOGRAPHY INSTRUMENTS – HARDWARE ACCESSORIES
transmits electrical signals which are used to support monitor functions.
1.5. BIS™ Advance Monitor
System Indications and
Contraindications