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
20
BIS™ Advance Monitor
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.
1.2.8. Cautions
Caution: Do not block inlet holes on the monitor as this may prevent
ventilation constriction or affect the audio output of the monitor.
Caution: Do not open the BISx unit for any reason. The seal to prevent liquids
from entering the BISx unit may be damaged if it is opened.
Caution: Service or repairs must be performed only by qualified biomedical
technicians.
Caution: Any changes or modifications not expressly approved by the grantee
of this device could void the user's authority to operate the equipment.
Caution: The USB port on the monitor and the USB port on the docking station
are intended only for the connection of a USB flash drive; do not use these
ports for any other use.
Caution: The BIS™ Advance monitor has been validated for use only with the
BIS™ sensor. The sensor is a silver/silver chloride electrode array that utilizes
Covidien's connector and Zipprep™ technology. Electrodes or sensors that are
not validated for use with the monitor may not work properly and may not
produce the expected results. Also, electrodes or sensors that are not validated
for use with the monitor have not undergone a data integrity analysis and may
potentially pose a data security risk. For a list of sensors, reference Table 33.
BIS™ Advance Monitor Components and Sensors on page 252.
Caution: To completely remove power from the monitor: disconnect power
cord from the power receptacle of the monitor, then remove the battery from
the monitor.
Caution: Continuous impedance checking may need to be disabled if the 1
nanoampere 128 Hz impedance check signal interferes with other equipment
(e.g., evoked potential monitors).
Caution: Considerations when using Electro-Convulsive Therapy (ECT)
equipment during BIS™ monitoring: Place ECT electrodes as far as possible
from the BIS™ sensor to minimize the effect of interference. Certain ECT