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
Safety Information
BIS™ Advance Monitor
21
equipment may interfere with the proper function of the BIS™ Advance
monitor. Check for compatibility of equipment during patient setup.
Caution: The BIS™ Advance monitor 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 7.7 Electromagnetic Compatibility Specifications on page 237.
Caution: When connecting or disconnecting the BISx module, take care not to
touch the exposed contacts of either connector. Damage due to electrostatic
discharge may result.
1.2.9. Notes
Note: Important: The BIS™ Advance monitor complies with the MDR- EU
Medical Device Regulation 2017/745 and applicable regulatory requirements
of the country distributed to and carry the CE Marking. Declarations of
Conformity provided upon request where appropriate.
Note: Read this entire manual carefully before using the monitor in a clinical
setting. The monitor shall be used only according to the instructions that
appear in this manual.
Note: Use of the host system with sensor along with a neurostimulator may
cause neurostimulator malfunction or diminished neurostimulator
effectiveness.
Note: The system provides protection against defibrillation, without loss of any
operator settings or stored data, and shall continue to perform its intended
functions within 30 seconds after exposure to defibrillation voltage, as
specified in IEC 80601-2-26 and IEC 60601-2-26.
Note: The battery pack supplied with this monitor should not be used with
other devices.
Note: Since the case storage capacity of the monitor is limited, it is
recommended to download cases when the case ends, to avoid accidental
erasure of case data.