Operator's Manual

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Table Of Contents

1. Introduction
1.1. Introduction
- 1.1.1. Safety Symbol Definitions
1.2. Safety Information
- 1.2.1. General
- 1.2.2. Electrical Issues
- 1.2.3. Battery Cautions
- 1.2.4. Burn Hazards
- 1.2.5. EMC Issues
- 1.2.6. Alarms
- 1.2.7. Sensors
- 1.2.8. Cautions
- 1.2.9. Notes
1.3. Device Description
1.4. Intended Purpose
- 1.4.1. BIS™ Monitor
- 1.4.2. BISx and BISx4 Modules
- 1.4.3. BIS™ Sensors
- 1.4.4. BIS™ Cables
1.5. BIS™ Advance Monitor System Indications and Contraindications
1.6. Patient Target Groups
1.7. Intended Users
1.8. Essential Performance
- 1.8.1. EEG Particular Standard (IEC 60601-2-26, 3rd Edition)
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
- 2.2.1. BIS™ Monitor
- 2.2.2. Adapter Cable
- 2.2.3. Docking Station
- 2.2.4. BISx Module
- 2.2.5. BIS Sensors
- 2.2.6. The BIS™ Sensor Simulator
3. Installation and Preparation for Use
3.1. Operating Environment
3.2. Power Requirements and Battery Use
3.3. Battery Operation
- 3.3.1. Battery Pack General Information
- 3.3.2. Battery Pack Removal and Installation
- 3.3.3. Battery and Power Usage
3.4. Mounting the Docking Station
3.5. Preparing the Docking Station
3.6. Preparing the Monitor
- 3.6.1. Connecting the Monitor
- 3.6.2. Connecting a Sensor to a Patient
- 3.6.3. Sensor Check
  - 3.6.3.1. Manual Sensor Check
  - 3.6.3.2. Ground Check and Combined Sensor Check
- 3.6.4. Case ID
- 3.6.5. Start Procedure
- 3.6.6. Terminating Monitoring with the Monitor
3.7. Home Screen
3.8. Four-Channel Monitoring
3.9. Home Screen Trend Graphs
- 3.9.1. BIS Trend Graph
- 3.9.2. Secondary Variables
- 3.9.3. EEG Display
- 3.9.4. DSA Display
- 3.9.5. ASYM Graph
3.10. Home Screen Numeric Section
- 3.10.1. BIS™ Number
- 3.10.2. EMG
- 3.10.3. SQI (Signal Quality Indicator)
- 3.10.4. Burst Count
- 3.10.5. SR (Suppression Ratio)
- 3.10.6. ST (Suppression Time)
- 3.10.7. SEF (Spectral Edge Frequency)
- 3.10.8. MF (Median Frequency)
- 3.10.9. Home Screen Indicators and Messages
3.11. Home Screen Menus
- 3.11.1. Main Menu Settings
- 3.11.2. Left Bar Menu
- 3.11.3. Alarm Status Displayed on Home Screen
3.12. Home Screen Options
3.13. Secondary Trend Selection
3.14. Home Screen Audio Alarm Settings
3.15. Settings and Maintenance
- 3.15.1. Setting up Language, Date and Time
- 3.15.2. MPM Configuration
- 3.15.3. Advanced User Settings
- 3.15.4. 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
- 4.2.1. Case Storage
- 4.2.2. Case Review
4.3. Alarms and Messages
- 4.3.1. Alarm and Message Types
- 4.3.2. Alarms
- 4.3.3. Messages
- 4.3.4. Alarm Display
- 4.3.5. Alarm Limits
- 4.3.6. Audio Alarms Pause and Silence
- 4.3.7. Changing Alarms Settings
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
- 5.9.1. BISx Module Connection History
- 5.9.2. Sensor Connection History
- 5.9.3. Monitor Log
- 5.9.4. System Log
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
- 6.4.1. Cleaning the BIS™ Advance Monitor and BISx Module
- 6.4.2. Disinfecting the BIS™ Advance System
- 6.4.3. Cleaning the Monitor Display
6.5. Instrument Identification
- 6.5.1. Permanent Identification Marking
- 6.5.2. Configuration Data on Monitor
7. Diagnostics and Troubleshooting
7.1. Diagnostics
- 7.1.1. DSC Self-Test
- 7.1.2. EEG Filters
- 7.1.3. Impedance Checking
- 7.1.4. Artifact Detection
7.2. Troubleshooting
7.3. Administrator Mode
- 7.3.1. Accessing Administrator Mode
- 7.3.2. Administrator Mode Actions
  - 7.3.2.1. Administrator Mode Settings
  - 7.3.2.2. Administrator Mode Maintenance
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

265

Covidien IIc, 15 Hampshire Street, Mansfield,

MA, 02048 USA

Medtronic BV, Earl Bakkenstraat 10, 6422 PJ

Heerlen, The Netherlands