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
Software License Agreement
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BIS™ Advance Monitor
HEREIN, ALL PRODUCTS ARE SUPPLIED “AS IS” WITHOUT WARRANTY OF ANY KIND,
EITHER EXPRESS OR IMPLIED.
7.11. Software License
Agreement
The computer software (“Licensed Software”) loaded on the BIS™ Complete monitor
(“System”) is licensed, not sold, to you for use only under the terms of this license.
Covidien (“Covidien”) reserves any rights not expressly granted to you. You own the
System, but Covidien retains all ownership rights and title to the Licensed Software
itself.
1. LICENSE: You are hereby granted the non-exclusive right to use the Licensed
Software solely with the specific System on which the Licensed Software was
provided to you.
2. RESTRICTIONS: You shall not transfer the Licensed Software in any manner from
the System to any other computer or system without the prior written consent of
Covidien. You shall not distribute copies of the Licensed Software or its related
documentation to others. You shall not modify or translate the Licensed Software or
its related documentation without the prior written consent of Covidien. The
Licensed Software contains trade secrets and to protect them you may not
decompile, reverse engineer, disassemble, or otherwise reduce the Licensed
Software to a human-perceivable form. If you transfer the System, you have the right
to transfer the Licensed Software provided that the transferee agrees to be bound by
the terms and conditions of this License Agreement.
3. TERMINATION: This License remains effective until terminated. This License will
terminate automatically without notice from Covidien if you fail to comply with any
term or provision of this License. Upon termination of this License, you may not make
any further use of the Licensed Software.
4. LIMITED WARRANTY: THE LICENSED SOFTWARE IS PROVIDED “AS IS” WITHOUT
WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION ANY WARRANTY WITH RESPECT TO ITS MERCHANTABILITY OR ITS
FITNESS FOR ANY PARTICULAR PURPOSE. COVIDIEN DOES NOT WARRANT THAT THE
FUNCTIONS CONTAINED IN THE LICENSED SOFTWARE WILL MEET YOUR
REQUIREMENTS OR THAT THE OPERATION OF THE LICENSED SOFTWARE WILL BE
UNINTERRUPTED OR ERROR FREE OR THAT SUCH ERRORS IN THE LICENSED
SOFTWARE WILL BE CORRECTED.