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
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BIS™ Advance Monitor
1.2.4. Burn Hazards
WARNING: Due to elevated surface temperature, do not place the BISx module
in prolonged direct contact with patient’s skin, as it may cause discomfort.
WARNING: The conductive parts of electrodes or sensor and connectors should
not contact other conductive parts, including earth.
WARNING: To reduce the hazard of burns during use of high-frequency
surgical equipment (in the event of a defect in the neutral electrode
connection of the high frequency surgical equipment), the sensor or
electrodes should not be located between the surgical site and the electro-
surgical unit return electrode.
WARNING: To reduce the hazard of burns during use of brain-stimulating
devices (e.g., transcranial electrical motor evoked potential), place stimulating
electrodes as far as possible from the BIS sensor and make certain that sensor
is placed according to package instructions. The sensor must not be located
between defibrillator pads when a defibrillator is used on a patient connected
to the BIS™ Advance monitor.
1.2.5. EMC Issues
WARNING: Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the BIS™ Advance monitoring system,
including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
WARNING: The proximity of an AC/DC power supply can significantly reduce
the performance of the BISx module. All power supplies, including the
dedicated power supply provided with the BIS™ Advance monitor, must be
placed at least 30 cm away from the BISx module, the cables connected to the
BISx module, the BIS™ sensor, and the patient.
WARNING: Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment, especially during
use with a defibrillator, could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper
operation.