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
Intended Users
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BIS™ Advance Monitor
The BIS™ Advance monitor system is intended for use under the direct supervision of
a licensed healthcare practitioner or by personnel trained in its proper use. The
system, and all its associated parameters, is intended for use on adult and pediatric
patients within a hospital or medical facility providing patient care to monitor the
state of the brain by data acquisition of EEG signals.
The BIS™ index, one of the BIS™ Advance monitor system output parameters, may be
used as an aid in monitoring the effects of certain anesthetic agents; and its usage
with certain anesthetic agents may be associated with a reduction in primary
anesthetic use and a reduction in emergence and recovery time.
Use of the BIS™ index for monitoring to help guide anesthetic administration may be
associated with the reduction of incidence of awareness with recall in adults during
general anesthesia and sedation. No known contraindications are listed in either the
BIS™ Advance monitor operator's manual or in the BIS™ Sensor IFUs.
1.6. Patient Target Groups
The BIS™ Extend and Bilateral Sensors are intended for adult patients, while the BIS
Pediatric Sensor is intended for pediatric patients. These sensors are designed for
application to the frontal/temporal area to enable recordings of electrophysiological
signals, such as EEG. They are low impedance, single patient use, disposable
electrode sensors, intended to be used in conjunction with the rest of the BIS™
Advance monitor system.
1.7. Intended Users
The BIS™ Advance monitor and BISx and BISx4 modules are intended to be used
under the direct supervision of a licensed healthcare practitioner, or by personnel
trained in their proper use. The system (and all of its associated parameters) is
intended for use on pediatric and adult patients within a hospital or medical facility. It
provides patient care to monitor the state of the brain by data acquisition of EEG
signals.
The BIS™ education site, www.biseducation.com, offers relevant information and
published articles on the clinical use of the BIS™ Advance system. In addition, there is
a “Monitoring Consciousness Using the Bispectral Index during Anesthesia” Clinician’s
Pocket Guide in English available on the website and through your local Medtronic
representative.