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
Warranty
BIS™ Advance Monitor
261
To request repair or replacement under this warranty, Purchaser should contact
Covidien directly (see contact information on the back cover of this manual).
Covidien will authorize Purchaser to return the Warranted Product (or part thereof) to
Covidien. Covidien shall determine whether to repair or replace Products and parts
covered by this warranty and all Products or parts replaced shall become Covidien’s
property. In the course of warranty service, Covidien may but shall not be required to
make engineering improvements to the Warranted Product or part thereof. If
Covidien reasonably determines that a repair or replacement is covered by the
warranty, Covidien shall bear the costs of shipping the repaired or replacement
Product to Purchaser. All other shipping costs shall be paid by Purchaser. Risk of loss
or damage during shipments under this warranty shall be borne by the party
shipping the Product. Products shipped by Purchaser under this warranty shall be
packaged in the original shipping container or equivalent packaging to protect the
Product. If Purchaser ships a Product to Covidien in unsuitable packaging, any
physical damage present in the Product on receipt by Covidien (and not previously
reported) will be presumed to have occurred in transit and will be the responsibility
of Purchaser.
This warranty does not extend to any Warranted Products or part thereof: that have
been subject to misuse, neglect, or accident; that have been damaged by causes
external to the Warranted Product, including but not limited to failure of or faulty
electrical power; that have been used in violation of Covidien’s instructions; that have
been affixed to any nonstandard accessory attachment; on which the serial number
has been removed or made illegible; that have been modified by anyone other than
Covidien; or that have been disassembled, serviced, or reassembled by anyone other
than Covidien, unless authorized by Covidien. Covidien shall have no obligation to
make repairs, replacements, or corrections which result, in whole or in part, from
normal wear and tear. Covidien makes no warranty (a) with respect to any products
that are not Warranted Products, (b) with respect to any products purchased from a
person other than Covidien or an Covidien-authorized distributor or (c) with respect
to any product sold under a brand name other than Covidien.
THIS WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY FOR COVIDIEN’S
PRODUCTS, EXTENDS ONLY TO THE PURCHASER, AND IS EXPRESSLY IN LIEU OF ANY
OTHER EXPRESS OR IMPLIED WARRANTIES INCLUDING WITHOUT LIMITATION ANY
WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
COVIDIEN’S MAXIMUM LIABILITY ARISING OUT OF THE SALE OF THE PRODUCTS OR
THEIR USE, WHETHER BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE,
SHALL NOT EXCEED THE ACTUAL PAYMENTS RECEIVED BY COVIDIEN IN
CONNECTION THEREWITH. COVIDIEN SHALL NOT BE LIABLE FOR ANY INCIDENTAL,
SPECIAL, OR CONSEQUENTIAL LOSS, DAMAGE OR EXPENSE (INCLUDING WITHOUT
LIMITATION LOST PROFITS) DIRECTLY OR INDIRECTLY ARISING FROM THE SALE,
INABILITY TO SELL, USE OR LOSS OF USE OF ANY PRODUCT. EXCEPT AS SET FORTH