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™ Saved Data Files
198
BIS™ Advance Monitor
• Date - Month Day Year
• Time - HH:MM:SS - in 24-hour format
• Log type - ALARM or CLEAR
• Name of Event
• User Initialed event unique ID
Marker file
m
The Marker file will include the following data:
BIS R2 Revision Information, BIS R2 Serial
Number, Application revision, Platform revision,
Serial protocol revision, Hardware revision, BISx
module Revision Information, BISx module
serial number, BISx module Software revision,
BISx module Hardware revision, BISx module
Serial protocol revision, Algorithm revision, Case
ID, and current time for each line in marker file.
Offset
o
The Offset File will include the following data:
BIS R2 Revision, SAD, Delimiter Tab, NaN, SAD,
and Time
Raw EEG
r2 or r4
A Raw EEG data file (named LMMDDHHMM.r4a
for the 4-channel system and
LMMDDHHMM.r2a if using a 2-channel system).
For snapshots, raw EEG data records are
included in the Raw EEG file for 10 minutes
preceding the Snapshot, or less than 10
minutes if less than 10 minutes have between
the start of the case and the Snapshot.
Processed
variables file
sp
Processed data file, listing the BIS™ system
processed variables, including (but not limited
to): Spectral Edge Frequency (SEF 95), SEF 50,
Bispectral Index , Alternate BIS Value , Second
Alternate BIS Value, EMG, Signal Quality Index
(SQI), IMPEDANCE, Second artifact, BURST