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
Electromagnetic Compatibility Specifications
240
BIS™ Advance Monitor
Table 30. Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The BIS™ Advance monitor is intended for use in the electromagnetic
environment specified below. The customer or user of the BIS™ Advance
monitor should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment –
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV
air
± 8 kV contact
± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV
air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for
power supply
lines.
± 1 kV for
input/output
lines.
± 2 kV for
power supply
lines.
±1 kV for
input/output
lines.
Mains power quality
should be that of a typical
hospital environment.
Surge
IEC 61000-4-5
0.5 kV, 1.0 kV,
and 2.2 kV, line
to earth.
0.5 kV and 1.1
kV, line to line.
(0, 90, 180, and
270 degrees)
0.5 kV, 1.0 kV,
and 2.2 kV, line
to earth.
0.5 kV and 1.1
kV, line to line.
(0, 90, 180, and
270 degrees)
Mains power quality
should be that of a typical
hospital environment.
Voltage dips
IEC 61000-4-11
U
T
= 0%, 0.5
cycle (0, 45, 90,
135, 180, 225,
270, and 350
degrees)
U
T
= 0%, 0.5
cycle (0, 45, 90,
135, 180, 225,
270, and 350
degrees)
Mains power quality
should be that of a typical
hospital environment. If
the user of the BIS™
Advance monitor requires
continued operation