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
15
those relying primarily on either ketamine or nitrous oxide/narcotics to
produce unconsciousness. Due to limited clinical experience in the following
applications, BIS™ values should be interpreted cautiously in patients with
known neurological disorders and those taking other psychoactive
medications.
Caution: Do not autoclave the BISx module or monitor. Autoclaving will
seriously damage both components.
Caution: Avoid liquid ingress to the Patient Interface Cable (PIC), which is an
integral part of the BISx module. Contact of fluids with the PIC sensor
connectors can interfere with PIC performance.
1.2.2. Electrical Issues
WARNING: Use only the power cord and power supply supplied by the
manufacturer. Never adapt the plug from the monitor to fit a non-standard
outlet.
WARNING: U.S.A. requirement: For proper grounding, the power receptacle
must be a three-wire grounded outlet. A hospital grade outlet is required.
Never adapt the three-prong plug from the monitor to fit a two-slot outlet. If
the outlet has only two slots, make sure that it is replaced with a three-slot
grounded outlet before attempting to operate the monitor.
WARNING: To avoid the risk of electric shock, the BIS™ Advance monitor must
only be connected to an AC power source with protective ground/earth.
WARNING: If the integrity of the AC power source with protective
ground/earth is in doubt, the BIS™ Advance monitor shall be operated from its
internal battery power source only.
WARNING: Electric Shock Hazard: Do not attempt to disconnect the power cord
with wet hands. Make certain that your hands are clean and dry before
touching the power cord.
WARNING: Electrical Shock Hazard: Do not remove battery compartment cover
during operation or while power is connected to monitor.
WARNING: Electrical Shock Hazard: The manufacturer's inspection of this
apparatus verified that the ground leakage current and the patient safety
current were less than the specified limits established by the applicable safety
standards. As a matter of safe practice, the institution should conduct periodic
tests to verify these currents.