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
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1.2.6. Alarms
WARNING: Check Target Range alarm limits to ensure they are appropriate for
the patient being monitored with each use. Ensure Target Range alarm limits
do not exceed the standard thresholds set by the institution.
WARNING: If you plan to monitor the patient using alarms, do not set the
Target Range alarm limits to extreme values that render the monitoring
system ineffective. Ensure Target Range alarm limits are appropriate for each
patient.
WARNING: If you plan to monitor the patient using alarms, do not pause,
disable or decrease the audible alarm volume until you verify that the patient
is being monitored by other means, such as direct observation, as this could
compromise patient safety.
WARNING: If you plan to monitor the patient using alarms, do not decrease the
adjustable alarm volume below ambient sound levels. Decreasing the alarm
volume below ambient levels might impede operator recognition of the
audible alarm, which might lead to patient harm during an alarm situation.
WARNING: BIS™ monitoring is intended for use as an adjunct to clinical
judgment and training. Clinical judgment should always be used when
interpreting BIS™ in conjunction with other available clinical signs. Reliance on
BIS™ alone for intraoperative anesthetic management is not recommended.
1.2.7. Sensors
WARNING: Please note that 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.
WARNING: Use of the BIS Advance system with sensor during external
defibrillation may lead to shunting of defibrillator energy, causing
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.