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
Preparing the Monitor
BIS™ Advance Monitor
87
3.6.5. Start Procedure
To start the monitor, press and hold the ON/OFF button at the lower right side of the
monitor for up to 3 seconds. The system will indicate that it is initializing.
If no BISx module is connected to the monitor, the monitor will indicate Connect
BISx to start monitoring. In this case, the operator can enter Demo mode or
review recorded case data in Case Review mode. Monitoring cannot take place
without a BISx module. If a BISx module is connected without a sensor, the system
will indicate Connect sensor to start monitoring.
In a case where the system identifies that a BISx module and a sensor have been
connected, the system shall perform sensor initialization and a sensor check. If the
sensor is supported (reference Table 33. BIS™ Advance Monitor Components and
Sensors on page 252) and impedance values are in the acceptable range, the system
shall display patient data based on the information collected by the sensor. If there
are issues that prevent the system from reading information from this sensor, an on-
screen message will display this information.
Monitoring will now commence. After the sensor has been connected, make any
desired changes in settings, such as setting alarm limits. Reference 4.3.7 Changing
Alarms Settings on page 168 for alarm settings or 3.15 Settings and Maintenance on
page 128 for other settings. The settings set when a sensor is connected will remain
valid for that sensor (i.e., that case), but the system will revert to institutional defaults
when another sensor is connected and another case starts.
3.6.6. Terminating Monitoring with
the Monitor
In most use case scenarios, the caregiver will terminate monitoring with the BIS™
system when BIS™ monitoring is no longer needed for the patient, as the patient
starts to awaken.
If the patient is no longer sedated, the parameters will indicate that status. To end the
case and terminate monitoring, remove the sensor from the patient and disconnect
the sensor from the monitor.
Record the Case ID and download any relevant patient data (reference 5.4 Types of
Exported Data on page 188) to ensure that your documentation is complete.
Press the ON/OFF button at the front of the monitor. (Reference Figure 3. The BIS™
Monitor on page 44 for the location of this button.) If you press the button for 1.5
seconds, a dialog box will ask if you want to shut down, restart or cancel the action.