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
Parts of the System
BIS™ Advance Monitor
57
defibrillation to be ineffective. In emergency use when defibrillation is
required to save a patient's life, ineffective defibrillation may result in death.
WARNING: The sensor is not intended to collect EEG, ECG, or other
electrophysiological signals for interpretation; the signals collected are
intended for use solely for calculating the BIS™ parameter.
WARNING: Use of the host system with sensor during electroconvulsive
therapy (ECT) may result in a corrupted EEG signal.
Caution: Dispose of the sensor in accordance with current medical standards
and applicable national regulations for biologically hazardous waste.
Note: Use of the host system with sensor along with a neurostimulator may
cause neurostimulator malfunction or diminished neurostimulator
effectiveness.
Select the appropriate sensor.
A list of sensors appears in Table 34. BIS™ Advance Accessories on page 252. The
sensors are also seen in Figure 13. BIS™ Advance Sensors on page 58. It is important to
use the correct sensor for your current patient and monitoring situation; a Quatro,
Extend or Pediatric sensor for use with a BISx module or a BISx4 to monitor patients
on two channels, or a Bilateral sensor for use with a BISx4 module to monitor patients
on 4 channels (in both hemispheres of the brain).
The patient sensor is intended for single patient use.
The sensors are consumable products with a defined lifetime and expiry date. An
expired sensor or a sensor that has been used beyond its defined lifetime may pass
the sensor check (depending on various use parameters), but it is strongly
recommended to avoid use of expired sensors and replace sensors after 24 hours.
Use of expired or over-used sensors may cause degraded performance.
When a sensor is attached to the system, the system will automatically perform a
sensor check. All of the sensor’s electrodes must receive a pass grade in order for the
sensor check to pass and measurement to proceed.