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Aspect Medical Systems BIS VIEW Operating Manual

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BIS VIEW™ Monitoring System
Aspect Medical Systems, Inc.
One Upland Road
Norwood, MA 02062
U.S.A.
(Tel) 617-559-7000
(Tel) 888-BIS INDE(X) (U.S. only)
(Fax) 617-559-7400
bis_info@aspectms.com
www.aspectmedical.com
OPERATING MANUAL
EC REP
Aspect Medical Systems International B.V.
Rijnzathe 7d2
3454 PV De Meern
The Netherlands
Tel: +31.30.662.9140
Fax: +31.30.662.9150
amsint@aspectms.com
Rx only
0123
070-0089
1.01

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  • Page 1 BIS VIEW™ Monitoring System OPERATING MANUAL Rx only EC REP Aspect Medical Systems, Inc. Aspect Medical Systems International B.V. One Upland Road Rijnzathe 7d2 Norwood, MA 02062 3454 PV De Meern U.S.A. The Netherlands (Tel) 617-559-7000 Tel: +31.30.662.9140 0123 (Tel) 888-BIS INDE(X) (U.S. only) Fax: +31.30.662.9150...
  • Page 3 BIS VIEW is a trademark of Aspect Medical Systems, Inc. Aspect, Bispectral Index, BIS, the BIS logo, BISx, the BISx logo and Zipprep are trademarks of Aspect Medical Systems, Inc. and are registered in the U.S.A., E.U. and other countries.

  • Page 5: Table Of Contents

    Site Preparation: Mounting the Monitor ..................... 2-4 2.2.5.1 Mounting the Monitor using the Pole Clamp ................2-4 2.2.5.2 Optional Mounting Accessories ....................2-5 The BIS VIEW Monitoring System – Equipment and Supplies ......2-6 2.3.1 The BIS VIEW Monitor........................... 2-7 2.3.1.1 Front Panel............................2-7 2.3.1.2...
  • Page 6 3.6.5 Diagnostics .............................. 3-18 3.6.6 Demo Case.............................. 3-18 Ending a Case ......................3-19 Data Transfer ......................3-19 How the BIS VIEW Monitoring System Works ............. 3-20 3.9.1 Bispectral Index (BIS) ..........................3-21 3.9.2 System Self-Checks..........................3-22 3.9.3 Data Memory ............................3-23 3.9.4...
  • Page 7 Advanced Diagnostics ..........................6-4 BIS VIEW System Messages and Corrective Actions..........6-5 Using the Reset button ..................... 6-11 What to do if the BIS VIEW Monitoring System Requires Service..... 6-11 APPENDIX I: MENUS, PROCESSED VARIABLES AND GLOSSARY. 7-1 Menu Map ........................7-1 Menu Listing .........................
  • Page 8 Electromagnetic Compatibility Specifications ............8-5 8.2.1 Accessories..............................8-5 8.2.2 IEC 60601-1-2:2001 Electromagnetic Compatibility Guidance ............8-6 Warranty ........................8-11 Software License Agreement................... 8-13 List of Patents ......................8-15...
  • Page 9 Figure 1 - Symbol Key (page 1 of 2) ..................... 1-6 Figure 2 - Pole Clamp........................2-5 Figure 3 - The BIS VIEW Monitoring System................2-6 Figure 4 - Rear Panel ........................2-8 Figure 5 - BISx and PIC........................ 2-10 Figure 6 - Connecting the PIC.......................

  • Page 10: About This Manual

    Keep this Operating Manual with the BIS VIEW monitor for use by the operator. This manual is also intended to be a service information manual for service technicians or biomedical engineering personnel.

  • Page 11: Introducing The Bis View Monitoring System

    EEG signals. The BIS VIEW system processes raw EEG signals to produce a single number, called the Bispectral Index™, or BIS, which correlates with the patient's level of hypnosis.
  • Page 12 Bispectral Index During Anesthesia” Clinician’s Pocket Guide available on the website and through your local Aspect Representative. For more information, please contact Aspect Medical Systems at (800) 442-2051. If you require additional information on the use of BIS, please contact Aspect Medical Systems...

  • Page 13: Safety Precautions

    • A NOTE provides useful information regarding a function or procedure. KEY TO SYMBOLS A key to the symbols used on the BIS VIEW system appears at the end of this section. Warnings EXPLOSION HAZARD: DO NOT USE THE BIS VIEW SYSTEM IN A FLAMMABLE ATMOSPHERE OR WHERE CONCENTRATIONS OF FLAMMABLE ANESTHETICS MAY OCCUR.
  • Page 14 ATTEMPTING TO OPERATE THE MONITOR. IF THE INTEGRITY OF THE EXTERNAL PROTECTIVE EARTH GROUND IS IN DOUBT, THE BIS VIEW SYSTEM SHALL BE OPERATED FROM ITS INTERNAL BATTERY POWER SOURCE ONLY. BE SURE THE MONITOR IS MOUNTED SECURELY IN PLACE TO AVOID PERSONAL OR PATIENT INJURY.

  • Page 15: Cautions

    CASE IS OPENED BY A QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN. POWER SUPPLY IS INTERNALLY FUSED. REPLACE POWER SUPPLY ONLY WITH ASPECT MEDICAL SYSTEMS BIS VIEW POWER SUPPLY. Cautions Read this entire manual carefully before using the monitor in a clinical setting.
  • Page 16 SAFETY PRECAUTIONS ______________________________________________________________________ The BIS VIEW system has been designed to operate with a BIS sensor. The sensor is a silver/silver chloride electrode array that utilizes Aspect's patented Zipprep™ technology and uses a proprietary connector. Use of other electrodes is not recommended.
  • Page 17 The BIS VIEW monitor may not power up entirely if battery power is low. If that should occur, connect unit to wall power and press the Reset button. (Refer to Section 6.4 “Using the Reset Button”).

  • Page 18: Key To Symbols

    SECTION 1 SAFETY PRECAUTIONS ______________________________________________________________________ Key to Symbols Caution, Consult Data I/O, RS-232 Serial Port Accompanying Documents Universal Serial Bus: Universal Serial Bus: USB-A USB-B Type A Type B Storage Temperature Limits Caution: Hot Surface Type BF Equipment Type BF Equipment Defibrillator-proof Alternating Current (A/C) Direct Current (D/C)
  • Page 19 SECTION 1 SAFETY PRECAUTIONS ______________________________________________________________________ Operating on Battery No Battery is Installed in Monitor Ringing Bell Icon – High Priority Alarm Condition exists. The alarm sounds unless the alarm key has been pressed to silence it. Yellow Bell with dotted ‘X’ - Alarms Paused Red Bell with ‘X’...
  • Page 20 SECTION 1 SAFETY PRECAUTIONS ______________________________________________________________________...

  • Page 21: System Setup And Preparation For Use

    SECTION 2 2 SYSTEM SETUP AND PREPARATION FOR USE ____________________________________________________ INTRODUCTION This section provides setup instructions for the Aspect BIS VIEW Monitor, BISx, and accessories. It includes: • Setup checklist • Proper environment • Required equipment and supplies • Cable connections •...

  • Page 22: Environment

    Before operation, wipe down all visible condensation and allow the system to reach equilibrium at room temperature. 2.2.2 Operating Environment The BIS VIEW Monitoring System is not designed for use in areas containing flammable gases or vapors. WARNING:...

  • Page 23: Power Requirements And System Grounding

    USB ports) are separated from live parts by double insulation, a ground continuity test does not apply to these parts. The components of the BIS VIEW Monitor that are connected to protective earth are contained within its enclosure and are not accessible to the user of the equipment.

  • Page 24: Electromagnetic Compatibility Requirements

    IEC 60601-1, as indicated on the labeling on the rear of the monitor. 2.2.4 Electromagnetic Compatibility Requirements The BIS VIEW Monitoring System should be used only with the power cord and accessories recommended and supplied by Aspect Medical Systems, Inc. The system must be set up and put into use according to the specifications described in Section8.2 “Electromagnetic...

  • Page 25: Optional Mounting Accessories

    SECTION 2 SYSTEM SETUP AND PREPARATION FOR USE ______________________________________________________________________ Figure 2 - Pole Clamp To remove the monitor, press tab on top of clamp shoe before sliding monitor up. The pole clamp may be locked onto the monitor so that the two do not get separated. To do this: 1.

  • Page 26: The Bis View Monitoring System - Equipment And Supplies

    SYSTEM SETUP AND PREPARATION FOR USE ______________________________________________________________________ The BIS VIEW Monitoring System – Equipment and Supplies The BIS VIEW Monitoring System consists of the following basic components: • BIS VIEW Monitor (P/N 185-0205) • BISx (P/N 185-0145-AMS) • Patient Interface Cable (PIC) •...

  • Page 27: The Bis View Monitor

    ______________________________________________________________________ 2.3.1 The BIS VIEW Monitor 2.3.1.1 Front Panel The front panel of the BIS VIEW monitor contains four soft keys, an alarm key, the BISx port and the ON/Standby button. See Figure 3. 2.3.1.2 Soft Keys The four white “soft” keys directly under the BIS VIEW screen are used to make all selections.

  • Page 28: Rear Panel

    SECTION 2 SYSTEM SETUP AND PREPARATION FOR USE ______________________________________________________________________ 2.3.1.5 Rear Panel The rear panel components are pictured in Figure 4. They include: two USB ports (Type A and B), the Reset button, an RS-232 port, the Battery/Power Supply cover, and the clamp shoe.

  • Page 29: Integral Battery

    BIS monitor (and the BISx if it is attached) in the unlikely case that it is required. See Section 6.4 “Using the Reset Button.” The Battery/Power Supply cover contains the BIS VIEW monitor’s power supply and allows access to its battery.

  • Page 30: Bisx

    (e.g., more than 1 month) it may be necessary to cycle (charge, then discharge) the battery a few times to get full charge capacity. If the BIS VIEW monitor fails to operate reliably from the battery for approximately 45 minutes, battery replacement is required.

  • Page 31: Patient Interface Cable (Pic)

    After you have familiarized yourself with the safety information in the introductory section of this manual and have prepared a suitable environment, follow these steps to prepare the BIS VIEW system for operation. 1. Connect the BISx to the monitor Holding the cylindrical connector with the flat side up, plug the BISx Monitor Interface Cable into the BISx port on the front of the monitor.

  • Page 32: Start Procedure

    SECTION 2 SYSTEM SETUP AND PREPARATION FOR USE ______________________________________________________________________ Start Procedure 2.5.1 Starting the Monitor for the First Time To start the instrument for the first time, after it has been reset with the RESET button, or after battery replacement: 1.

  • Page 33: Initial Menu Settings

    SYSTEM SETUP AND PREPARATION FOR USE ______________________________________________________________________ Initial Menu Settings Before using the BIS VIEW monitor for the first time, you may need to select the proper language and set the current date and time. Other setting options are discussed in detail in Section 3.

  • Page 34: Save Settings

    Date and time cannot be changed while a case is in progress. 2.6.3 Save Settings The BIS VIEW monitor will always start up configured to settings that have been saved in memory. These settings appear in the “Saved Settings” list. When a user changes a setting, the change is recorded in the “Active Settings”...

  • Page 35: Operating The Bis View Monitoring System

    Prepare sensor site and place the BIS sensor on the patient in accordance with the instructions included on the sensor packaging. Caution: The BIS VIEW Monitoring System has been designed to operate with a BIS sensor. The sensor is a silver/silver chloride electrode array that utilizes Aspect's patented Zipprep technology and uses a proprietary...
  • Page 36 RETURN ELECTRODE. THE SENSOR MUST NOT BE LOCATED BETWEEN DEFIBRILLATOR PADS WHEN A DEFIBRILLATOR IS USED ON A PATIENT CONNECTED TO THE BIS VIEW SYSTEM. TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT INTERFACE CABLE (PIC) MUST BE CAREFULLY PLACED AND SECURED.

  • Page 37: Figure 6 - Connecting The Pic

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ 4. Attach the BIS Sensor to the PIC Release Button PIC Sensor Sensor tab Connector Figure 6 - Connecting the PIC To insert the sensor into the PIC, line up as shown and insert the sensor tab into the PIC sensor connector until an audible “click”...

  • Page 38: Sensor Check

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ Sensor Check The Sensor Check tests the impedance of each electrode on the BIS sensor to verify that it is within an acceptable range for monitoring. A Sensor Check is initiated automatically when the sensor and PIC are connected to the BISx.
  • Page 39 SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ PASS - An electrode passes if the impedance for that electrode is less than 7.5 kilo ohms. The ground electrode (element #2) must be less than 30 kilo ohms to pass.

  • Page 40: Bis Number Display Screen

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ BIS Number Display Screen The BIS Number Display Screen is the default screen display. Once the sensor check has successfully completed, monitoring begins and the BIS Number Display Screen appears. This screen displays the following information: The BIS value •...

  • Page 41: Battery Icon

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ 3.3.2 Battery Icon The battery icon is displayed in the title bar above the BIS number or in the top right corner of the screen when the monitor and BISx are running on battery power. When the battery icon is filled with green bars, the battery is fully charged.

  • Page 42: Signal Quality Indicator

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ 3.3.4 Signal Quality Indicator The Signal Quality Indicator (SQI) is a measure of the signal quality for the EEG channel source and is calculated based on impedance data, artifact, and other variables. The SQI bar graph is displayed in the title bar above the BIS number.

  • Page 43: Soft Key Screen Selections

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ 3.3.8 Soft Key Screen Selections From the BIS Number screen, the user may use the four soft keys to: Initiate a Sensor Check • Change the screen display to the BIS Trend Display Screen with Sensor Status •...

  • Page 44: Bis Trend Graph

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ 3.4.1 BIS Trend Graph The BIS Trend Graph plots the values of the Bispectral Index over a 1 hour time period. The BIS trend is indicated with a thick line and its unit labels appear on the left axis. The current date and time display in the top right section of the screen (See Figure 9 and Figure 10).

  • Page 45: Menu Selections

    Trend/EEG See instructions in Section 3.6.3.1 “Screen Options.” Menu Selections Before using the BIS VIEW monitor for the first time, you may want to update the monitor with your desired screen settings and the current date and time. You should also familiarize yourself with the various menu options available.

  • Page 46: Export Data

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ BIS value, no BIS number displays. Note that SR will only appear if the “Display SR” option was selected in the “Screen Options” menu. To access Chart Data: 1. Press [MENU] to access the Main Menu.

  • Page 47: Setup

    3.6.3.1 Screen Options The Screen Options Menu includes the following: • BIS Display: The BIS VIEW may be set so that the most frequently used screen display becomes the default screens. There are three screen choices: o The BIS Number Display Screen, o The BIS Trend Display Screen with Sensor Status o The BIS Trend Display Screen with EEG.

  • Page 48: Alarms: The Alarms Menu

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ upper right corner of the screen. When SR reaches 100%, the message “Isoelectric EEG detected” will notify the user. • Secondary Variable: EMG can be plotted as a secondary variable on the BIS Trend graph.

  • Page 49: Target Range

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ 3.6.3.2.1 Target Range To aid in patient management, a target range of desired BIS values may be set. When the Target Range is activated, the selected range displays on the BIS Trend Graph. When the Target Alarm is ON, an alarm notifies the user whenever the patient’s BIS value falls outside...

  • Page 50: Alarm Volume Menu / Test Alarm Volume

    ACTIVE]. See instructions in Section 3.6.3.5 “Settings.” 3.6.3.3 Smoothing Rate: The Smoothing Rate Menu The BIS VIEW system offers three choices of smoothing rates over which the BIS value is averaged: • 10 seconds: Provides increased responsiveness to state changes, such as induction or awakening.

  • Page 51: Date/Time

    Date and time cannot be changed while a case is in progress. 3.6.3.5 Settings: Active and Saved Monitor Settings The BIS VIEW monitor will always start up configured to settings that have been saved in memory. These settings appear in the “Saved Settings” list. When a user changes a setting in the menu system, the change is recorded in the “Active Settings”...

  • Page 52: Maintenance

    Use of the Maintenance Menu is covered in Section 6, “Diagnostics and Troubleshooting.” 3.6.5 Diagnostics Contact Aspect Medical Systems, Inc. for instructions on use of the Diagnostic Menu. See the back cover of this manual for contact information. To display the Diagnostic Menu: 1.

  • Page 53: Ending A Case

    Note: The BIS VIEW can remain plugged in to A/C power at all times. Data Transfer Three ports on the rear of the BIS VIEW monitor facilitate data transfer. The USB (Type A) port is used to export data to a removable drive and to update monitor and BISx software.

  • Page 54: How The Bis View Monitoring System Works

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ WARNINGS: THE USE OF ACCESSORY EQUIPMENT NOT COMPLYING WITH THE EQUIVALENT SAFETY REQUIREMENTS OF THIS EQUIPMENT MAY LEAD TO A REDUCED LEVEL OF SAFETY OF THE RESULTING SYSTEM. CONSIDERATION RELATING TO THE CHOICE SHALL INCLUDE: •...

  • Page 55: Bispectral Index (Bis)

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ This chart reflects a general association between clinical state and BIS values. Ranges are based on results from a multi-center study of the BIS involving the administration of specific anesthetic agents. BIS values and ranges assume that the EEG is free of artifacts that can affect its performance.

  • Page 56: System Self-Checks

    “GROUND CHECK” displays on the screen Diagnostics The BIS VIEW monitor provides diagnostic codes to assist the user in tracing the source of any problems that may occur. Codes are displayed in the Message Region only if the user has requested them in the Diagnostic Menu.

  • Page 57: Data Memory

    SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ 3.9.3 Data Memory The monitor stores recorded trend data with time and date of acquisition. The duration of trend data stored is approximately 72 hours. When the memory is full, the oldest data are automatically erased as new data are stored.
  • Page 58 SECTION 3 OPERATING THE BIS VIEW MONITORING SYSTEM ______________________________________________________________________ 3-24...

  • Page 59: Quick Reference Guide

    Safety Precautions” (Section 1 of this manual). BASIC OPERATION If the BIS VIEW system has already been set up, but has been put into Standby mode (after a previous surgery, for example), proceed as follows: 1. Verify that all power and other cables are connected properly.
  • Page 60 SECTION 4 QUICK REFERENCE GUIDE ______________________________________________________________________...

  • Page 61: Preventive Maintenance, Care And Cleaning

    SECTION 5 PREVENTIVE MAINTENANCE, CARE AND CLEANING ______________________________________________________________________ SECTION 5 5 PREVENTIVE MAINTENANCE, CARE AND CLEANING INTRODUCTION This section describes: • Care and cleaning procedures • Routine maintenance • Technical documentation • Instrument Identification. Care and Cleaning WARNING: UNIVERSAL PRECAUTIONS SHALL BE OBSERVED TO PREVENT CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS.

  • Page 62: Maintenance

    Maintenance The BIS VIEW monitor is designed so that no periodic adjustment or calibration is required. Suggested routine maintenance includes: periodic checking of cable integrity, system checkout, checking the battery, and checking leakage current. Instructions on replacing the battery and power supply are included in this section should replacement be necessary.

  • Page 63: Checking The Battery

    Aspect part number 186-0208. Note: The BIS VIEW may not power up entirely if battery power is low. If that should occur, connect unit to wall power and press the Reset button. Refer to Section6.4 “Using the...

  • Page 64: Replacing The Battery

    Figure 13 - Replacing the Power Supply WARNING: POWER SUPPLY IS INTERNALLY FUSED. REPLACE POWER SUPPLY ONLY WITH ASPECT MEDICAL SYSTEMS BIS VIEW POWER SUPPLY. To replace the power supply, you will need a Philips #2 screwdriver. Follow the instructions...

  • Page 65: Checking Leakage Current

    USB ports) are separated from live parts by double insulation, a ground continuity test does not apply to these parts. The components of the BIS VIEW Monitor that are connected to protective earth are contained within its enclosure and are not accessible to the...

  • Page 66: Technical Documentation

    Ground wire leakage typically can be performed automatically by connecting the A/C power cord of the BIS VIEW Monitor into a safety tester. The enclosure leakage may be measured by any safety test equipment that is capable of connecting to isolated conductive parts and measuring the current from those parts to earth.

  • Page 67: Instrument Identification

    Monitor identification information is permanently marked on the rear panel. This information includes instrument model and serial numbers, patent numbers, power ratings, cautions, and the Aspect Medical Systems’ shipping address. BISx The BISx identification information is permanently marked on the rear panel of the BISx.
  • Page 68 SECTION 5 PREVENTIVE MAINTENANCE, CARE AND CLEANING ______________________________________________________________________...

  • Page 69: Diagnostics And Troubleshooting

    Maintenance Menu appears. 6.1.1 Software Update The BIS VIEW system software may be updated by attaching a removable drive containing the update to the USB port on the rear of the monitor. The progress of the update displays on the monitor screen. When the update is complete, the user is asked to reset the system.

  • Page 70: Default Settings

    For more information on Active and Saved Settings, see Section 3.6.3.5 “Settings: Active and Saved Monitor Settings.” 6.1.3 Language The BIS VIEW monitor is designed to support multiple languages, including: English, French, German, Italian, Spanish, Portuguese, Swedish and Dutch. If the screen does not display the desired language, follow these steps: To change the language: 1.

  • Page 71: Diagnostics

    ACTIVE]. See instructions in Section 2.6.3 “Save Settings.” Diagnostics The Diagnostics Menu contains functions to test and maintain the BIS VIEW system. If you should experience a problem with the BIS VIEW system, Aspect’s Technical Service Department will direct you in using these functions. To contact Aspect, please refer to the back cover of this manual.

  • Page 72: Diagnostic Codes

    ______________________________________________________________________ 6.2.2 Diagnostic Codes If you are experiencing problems with the BIS VIEW system, Aspect’s Technical Service may direct you to turn the Diagnostic Codes ON so that numeric diagnostic values will be displayed in the Message Region of the screen.

  • Page 73: Bis View System Messages And Corrective Actions

    It is a good idea to write down the exact status message number when it occurs and have that information available if you should need service. See Section 6.5 “What to do if the BIS VIEW Monitoring System Requires Service.”...
  • Page 74 SECTION 6 DIAGNOSTICS AND TROUBLESHOOTING ______________________________________________________________________ Status Messages: Causes: Corrective Actions: Sensor Disconnected 1. Disconnected sensor. 1. Connect the sensor. [0014] 2. Poor or contaminated 2. Connect/clean connection connection between between sensor and PIC. sensor and PIC. 3. Connect the PIC. 3.
  • Page 75 SECTION 6 DIAGNOSTICS AND TROUBLESHOOTING ______________________________________________________________________ Status Messages: Causes: Corrective Actions: Excessive Artifact The Signal Quality is less 1. If ARTIFACT label Detected in Signal than half of the level appears above the EEG [0027] desirable for optimal waveform box, attempt to monitoring conditions.
  • Page 76 SECTION 6 DIAGNOSTICS AND TROUBLESHOOTING ______________________________________________________________________ Status Messages: Causes: Corrective Actions: Data unavailable due The signal quality is too low 1. If ARTIFACT label to poor signal quality to accurately calculate a BIS appears above the EEG [0028] value. The BIS value and waveform box, attempt to other trend variables that identify and eliminate...
  • Page 77 SECTION 6 DIAGNOSTICS AND TROUBLESHOOTING ______________________________________________________________________ Status Messages: Causes: Corrective Actions: Operating On Battery The AC power has been lost 1. Restore the AC power. Backup [0033] and the monitor is running 2. Verify power cord. on the battery. The battery 3.
  • Page 78 SECTION 6 DIAGNOSTICS AND TROUBLESHOOTING ______________________________________________________________________ Status Messages: Causes: Corrective Actions: Unrecoverable A system error has 1. Follow on-screen Monitor Error occurred. The monitor may instructions (if any). [2000-2999] stop operating. This can 2. Turn the monitor off, then occur if the BISx is on again.

  • Page 79: Using The Reset Button

    The Reset button is located on the back panel of the monitor. If necessary, the software can be reset by accessing this button with a ballpoint pen, paper clip or other similar tool. What to do if the BIS VIEW Monitoring System Requires Service Contact your local distributor to determine where servicing will occur.
  • Page 80 SECTION 6 DIAGNOSTICS AND TROUBLESHOOTING ______________________________________________________________________ 6-12...

  • Page 81: Appendix I: Menus, Processed Variables And Glossary

    Target Range > Monitor Error Log > Alarm Volume > BISx Connection History > Test Alarm Volume > Clear Trend Data > HOME | ▲ | ▼ |SELECT BACK | ▲ | ▼ |SELECT Figure 14 - BIS VIEW Menu Map...

  • Page 82: Menu Listing

    SECTION 7 APPENDIX I: MENUS, PROCESSED VARIABLES, AND GLOSSARY ______________________________________________________________________ Menu Listing Menu Menu Item Options Bold Default values appear in Main Menu Chart Data 1, 5, 10 or 15 minutes chart interval Export Data Setup Maintenance Diagnostics Demo Case Run/Stop Setup Screen Options...

  • Page 83: Processed Eeg Variables

    SECTION 7 APPENDIX I: MENUS, PROCESSED VARIABLES, AND GLOSSARY ______________________________________________________________________ Maintenance Software Update Default Settings View or Restore Factory Defaults Language English French German Portuguese Spanish Dutch Italian Swedish Diagnostics Impedance Checking On/Off Diagnostic Codes On/Off System Configuration Advanced Diagnostics Advanced DSC Self Test Diagnostics...

  • Page 84: Glossary

    BISx The BISx is the small unit that attaches to the BIS VIEW monitor via its own monitor cable, and attaches to a BIS sensor via the Patient Interface Cable (PIC). It acquires and processes EEG information and sends it to the monitor for display.
  • Page 85 SECTION 7 APPENDIX I: MENUS, PROCESSED VARIABLES, AND GLOSSARY ______________________________________________________________________ Montage Standardized electrode locations. Patient Interface Cable (PIC) The cable that connects the BIS sensor to the BISx. Signal Quality Indicator (SQI) A measure of the signal quality for the EEG channel source that is calculated based on impedance data, artifact, and other variables.
  • Page 86 SECTION 7 APPENDIX I: MENUS, PROCESSED VARIABLES, AND GLOSSARY ______________________________________________________________________...

  • Page 87: Appendix Ii: Specifications, Warranty, Software License Agreement And Patents

    8 APPENDIX II: SPECIFICATIONS, WARRANTY, SOFTWARE LICENSE AGREEMENT AND PATENTS Specifications This section lists specifications for the BIS VIEW Monitoring System. General Specifications: • Product Description: BIS (Bispectral Index) monitoring system for display of processed data and real-time EEG waveforms •...
  • Page 88 SECTION 8 APPENDIX II: SPECIFICATIONS, WARRANTY, SOFTWARE LICENSE AGREEMENT AND PATENTS _________________________________________________________________ EEG Specifications: • Epoch Duration: 2 seconds • Artifact Rejection: Automatic • Input Amplifier Range +/- 1 mV • EEG Scales: One Channel Display: 25 μV/div (+/- 50 μV full scale) •...
  • Page 89 SECTION 8 APPENDIX II: SPECIFICATIONS, WARRANTY, SOFTWARE LICENSE AGREEMENT AND PATENTS _________________________________________________________________ BISx Specifications: • BISx: 10.0 oz (0.284 kg) including integral cable Weight: 3.75 in diameter x 2.5 in thick Dimensions: (9.5 cm x 6.3 cm) 9 ft (2.7 m) Integral BISx Cable Cable Length: 4 ½...
  • Page 90 1.1 times the highest rated AC supply voltage is applied between the applied part and earth. The circuitry inside the BIS VIEW monitor is isolated from the mains in accordance with IEC60601-1. Patient isolation is accomplished within the BISx.

  • Page 91: Electromagnetic Compatibility Specifications

    Electromagnetic Compatibility Specifications The BIS VIEW Monitoring System requires special precautions regarding Electromagnetic Compatibility (EMC). The BIS VIEW system must be set up and put into service according to the EMC guidance information provided in this section. Portable and mobile radio frequency communications equipment can affect the operation of the BIS VIEW Monitoring System.
  • Page 92 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The BIS VIEW Monitoring System is intended for use in the electromagnetic environment specified below. The customer or user of the BIS VIEW system should assure that it is used in such an environment...
  • Page 93 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The BIS VIEW system is intended for use in the electromagnetic environment specified below. The customer or user of the BIS VIEW system should assure that it is used in such an environment...
  • Page 94 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The BIS VIEW Monitoring System is intended for use in the electromagnetic environment specified below. The customer or user of the BIS VIEW system should assure that it is used in such an environment.
  • Page 95 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BIS VIEW system is used exceeds the applicable RF compliance level above, the BIS VIEW system should be observed to verify normal operation.
  • Page 96 Communications Equipment and the BIS VIEW Monitor The BIS VIEW Monitoring System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the BIS VIEW system can help prevent electromagnetic interference by maintaining a minimum distance...

  • Page 97: Warranty

    _________________________________________________________________ Warranty Aspect warrants to the initial Purchaser that the BIS VIEW monitor and the BISx (“Warranted Product”) will be free from defects in workmanship or materials, when given normal, proper, and intended usage for a period of one year (“Warranty Period”) from the date of its initial shipment to Purchaser.
  • Page 98 SECTION 8 APPENDIX II: SPECIFICATIONS, WARRANTY, SOFTWARE LICENSE AGREEMENT AND PATENTS _________________________________________________________________ THIS WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY FOR ASPECT’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.

  • Page 99: Software License Agreement

    _________________________________________________________________ Software License Agreement The computer software (“Licensed Software”) loaded on the BIS VIEW monitor (“System”) is licensed, not sold, to you for use only under the terms of this license. Aspect Medical Systems, Inc. (“Aspect”) reserves any rights not expressly granted to you. You own the System, but Aspect retains all ownership rights and title to the Licensed Software itself.
  • Page 100 Agreement will remain in full force and effect. Should you have any questions concerning this License Agreement, you may contact Aspect by writing to Aspect Medical Systems, Technical Service, at the address listed on the back cover of this manual.

  • Page 101: List Of Patents

    SECTION 8 APPENDIX II: SPECIFICATIONS, WARRANTY, SOFTWARE LICENSE AGREEMENT AND PATENTS _________________________________________________________________ List of Patents (US) 4,907,597 ● ● ● ● (US) 5,010,891 (Europe) 0,468,999 (Australia) 638,708 (Canada) 2,051,683 (Japan) 3,136,408) ● ● (US) 5,320,109 (Europe) 0,610,365; 0,898,234 Canada 2,122,032; 2,434,275 (Europe) 0,665,728 ●...
  • Page 104 (888) BIS-INDE(X)…press (6), or (800) 442-7688 … press (6) Technical Service: (800) 442-2051 Email: bis_info@aspectms.com Web: www.aspectmedical.com EC REP Aspect Medical Systems International B.V. Rijnzathe 7d2 3454 PV De Meern The Netherlands Main Business Phone: +31.30.662.9140 Main Business Fax: +31.30.662.9150 Email:...

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