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
14
BIS™ Advance Monitor
WARNING: Be sure the monitor is mounted securely in place to avoid personal
or patient injury.
WARNING: The BIS™ Advance monitor should not be used adjacent to or
stacked with other equipment. If adjacent or stacked use is necessary, the
monitor should be observed to verify normal operation in the configuration in
which it will be used.
WARNING: To minimize the risk of patient strangulation, the patient interface
cable (PIC) (which is an integral part of the BISx module) must be carefully
placed and secured.
WARNING: Universal precautions shall be observed to prevent contact with
blood or other potentially infectious materials. Place contaminated materials
in a container designated for regulated waste. The BISx module and the
monitor should be cleaned using approved cleaning materials only.
WARNING: The monitor is not designed for use in MRI environment.
WARNING: The software shall reset all settings with defined default values to
Institutional Defaults upon the end of each case, excluding Institutional
Default Language settings. The software will also reset all settings (including
language) to Institutional Defaults upon the restart of the monitor. However, if
a sensor for which certain settings were set (as described in 3.15.3 Advanced
User Settings on page 131, and whether changes were performed by a user or
administrator) is re-attached, the monitor will apply the settings that were in
place when that sensor was used last time.
WARNING: When no longer in use, this electronic equipment must be recycled
or disposed of properly. Follow local ordinances for the safe disposal of
electronic equipment.
WARNING: No modification of this equipment or its accessories is allowed.
WARNING: BIS™ Advance monitoring technology is intended for use as an
adjunct to clinical judgment and training. Clinical judgment should always be
used when interpreting BIS™ values in conjunction with other available clinical
signs. Reliance on BIS™ values alone for intraoperative anesthetic
management is not recommended. As with any monitored parameter, artifacts
and poor signal quality may lead to inappropriate BIS™ values. Potential
artifacts may be caused by poor skin contact (high impedance), muscle activity
or rigidity, head and body motion, sustained eye movements, improper sensor
placement and unusual or excessive electrical interference. BIS™ values should
also be interpreted cautiously with certain anesthetic combinations, such as