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
Device Description
BIS™ Advance Monitor
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Note: Canada, avis d'Industry Canada (IC)
Cet appareil est conforme avec Industrie Canada exemptes de licence RSS
standard(s).
Son fonctionnement est soumis aux deux conditions suivantes : (1) cet appareil
ne doit pas causer d'interférence et (2) cet appareil doit accepter toute
interférence, notamment les interférences qui peuvent affecter son
fonctionnement.
Note: Radio Frequency (RF) Exposure Information
The radiated output power of the Wireless Device is below the Industry
Canada (IC) radio frequency exposure limits. The Wireless Device should be
used in such a manner such that the potential for human contact during
normal operation is minimized.
This device has been evaluated for and shown compliant with the IC Specific
Absorption Rate (“SAR”) limits when operated in portable exposure conditions.
Note: Informations concernant l'exposition aux fréquences radio (RF):
La puissance de sortie émise par l’appareil de sans fil est inférieure à la limite
d'exposition aux fréquences radio d'Industry Canada (IC). Utilisez l’appareil de
sans fil de façon à minimiser les contacts humains lors du fonctionnement
normal.
Ce dispositif a été évalué pour et démontré conforme à la Taux IC d'absorption
spécifique ("SAR") des limites lorsqu'il est utilisé dans des conditions
d'exposition portatifs.
Note: This device complies with part 15 of the FCC rules. Operation is subject
to the following conditions:
• The device may not cause harmful interference, and
• This device must accept any interference received, including interference that
may cause undesired operation.
Note: This Class B digital apparatus meets all requirement of the Canadian
Interference-Causing Equipment Regulations. Cet appareil numérique de la
classe B respecte toutes les exigences de Règlement sur le matériel brouilleur
du Canada.
1.3. Device Description
The BIS™ Advance monitor is a user-configurable patient monitoring system
designed to monitor the hypnotic state of the brain based on acquisition and
processing of EEG signals. The monitor processes raw EEG signals to produce a single
number, called the Bispectral Index™, or BIS™ value, which correlates with the