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Aspect Medical Systems

A-2000™

BISPECTRAL INDEX

™

(BIS

™

)

MONITORING SYSTEM

OPERATING MANUAL

Rx only

reproduction of this document is prohibited without prior written consent of Aspect
Medical Systems.

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

(Tel) 888-BIS INDE(X) (U.S. only)

Fax: +31.30.662.9150

0123

(Fax)

617-559-7400

[email protected]

[email protected]
www.aspectmedical.com 070-0015

3.04

Содержание A-2000 BIS

Страница 1: ...ibited without prior written consent of Aspect Medical Systems EC REP Aspect Medical Systems Inc Aspect Medical Systems International B V One Upland Road Rijnzathe 7d2 Norwood MA 02062 3454 PV De Meer...

Страница 2: ...quality may lead to inappropriate BIS values Potential artifacts may be caused by poor skin contact high impedance muscle activity or rigidity head and body motion sustained eye movements improper se...

Страница 3: ...IPMENT AND SUPPLIES 2 5 2 3 1 THE BIS MONITOR 2 6 2 3 2 DIGITAL SIGNAL CONVERTER DSC 2 10 2 3 3 PATIENT INTERFACE CABLE PIC 2 10 2 3 4 BIS SENSOR 2 10 2 3 5 A 2000 SYSTEM CONFIGURATIONS 2 11 2 3 6 PLA...

Страница 4: ...1 5 1 HOW THE A 2000 MONITORING SYSTEM WORKS 5 1 5 2 SYSTEM FEATURES 5 1 5 2 1 BISPECTRAL INDEX BIS 5 1 5 2 2 SIGNAL QUALITY INDEX SQI 5 1 5 2 3 ELECTROMYOGRAPH EMG INDICATOR 5 2 5 2 4 ELECTROENCEPHAL...

Страница 5: ...NU 7 1 7 1 1 DSC SELF TEST 7 2 7 1 2 DISPLAY SELF TEST 7 2 7 1 3 SENSOR DATA DISPLAY BIS XP PLATFORM ONLY 7 2 7 1 4 CLEAR DATA 7 3 7 1 5 DIAGNOSTIC CODES 7 3 7 1 6 IMPEDANCE CHECKING 7 3 7 1 7 SYSTEM...

Страница 6: ...ure 12 The BIS Trend Display with BIS Extend Sensor in Use 3 7 Figure 13 The BIS Trend Display 3 8 Figure 14 Menu Navigation 3 9 Figure 15 Main Screen with Setup Menu and Trend Display 3 10 Figure 16...

Страница 7: ...e safety information provided in this section Section 2 covers A 2000 installation including system checkout environmental considerations equipment and supplies needed basic connections and setup Sect...

Страница 8: ...o monitor the hypnotic state of the brain based on acquisition and processing of EEG signals The A 2000 processes raw EEG signals to produce a single number called the Bispectral Index or BIS which co...

Страница 9: ...s section 1 1 WARNINGS GROUND WIRE LEAKAGE CURRENT MUST BE CHECKED WHENEVER INSTRUMENT CASE IS OPENED BY A QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN EXPLOSION HAZARD DO NOT USE THE A 2000 IN A FLAMM...

Страница 10: ...ECTRODE SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS INCLUDING EARTH TO REDUCE THE HAZARD OF BURNS IN THE HIGH FREQUENCY SURGICAL NEUTRAL ELECTRODE CONNECTION THE SENSOR OR ELECTRODES SHOULD NOT BE LOCAT...

Страница 11: ...not allow other instruments to block airflow Do not block ventilation inlet holes on the underside of monitor Do not open Digital Signal Converter for any reason The seal to prevent liquids from enter...

Страница 12: ...ere with PIC performance The A 2000 system complies with the electromagnetic compatibility requirements of EN60601 1 2 Operation of this device may affect or be affected by other equipment in the vici...

Страница 13: ...n to the mains OFF power disconnection from the mains Audible Alarm Silenced Operating on Battery Type BF Equipment Type BF Equipment Defibrillator proof Attention Consult Accompanying Documents J1 At...

Страница 14: ...___________________________________________________________ 1 6 Fuse Replace only with same Type and Rating Equipotential Alternating Current Dangerous Voltage Protective Earth ground Storage Temperat...

Страница 15: ...ate wall outlet 3 Power up monitor by pressing power switch lower right side of case Verify beep tone as power switch is activated Verify fan rear case wall moves air outward Verify all power on self...

Страница 16: ...can lead to condensation within the instrument To minimize condensation avoid moving the system between heated buildings and outside storage Once moved inside allow the monitor to stabilize in the un...

Страница 17: ...CONDUCTORS HAVING A CROSS SECTIONAL AREA GREATER THAN 0 75 mm2 MUST BE USED 2 2 4 Site Preparation Mounting the Monitor Aspect Medical Systems Inc strongly recommends permanent mounting of the A 2000...

Страница 18: ...f the clamp shoe should be seen well below the bottom of the pole clamp and the monitor should snap securely into place 2 Make sure that set screw hole on pole clamp aligns with corresponding hole on...

Страница 19: ...onverter DSC Patient Interface Cable PIC BIS Sensor Detachable Power Cord A pole clamp is also included however its use is optional The exact model of DSC PIC and compatible sensors depends on the sys...

Страница 20: ...f the BIS Monitor contains the Digital Signal Converter DSC port and the controls needed for normal operation See Figure 4 B s Menu Exit Select Silence DSC Review 50 50 BIS 100 80 60 40 20 0 80 70 60...

Страница 21: ...d to zoom time out or in increase or decrease reporting intervals The SELECT key is used to move between options within a menu selection to confirm an entry and to answer yes to a question Figure 5 Fr...

Страница 22: ...ING REPLACE FUSES ONLY WITH ONE OF THE FOLLOWING PARTS Aspect P N 430 0006 1 25 Amps 250V 5x20mm Littelfuse 217 Series 1 25 Amps 250V 5x20mm Wickmann 193 Series 1 25 Amps 250V 5x20mm ALWAYS REPLACE BO...

Страница 23: ...The A 2000 system complies with the electromagnetic compatibility requirements of EN60601 1 2 Operation of this device may affect or be affected by other equipment in the vicinity due to electromagne...

Страница 24: ...technician and disposed of or recycled in accordance with the national laws of the country Contact Aspect Medical Systems Inc or the local distributor for servicing of battery 2 3 2 Digital Signal Co...

Страница 25: ...ith a DSC 3 BIS Sensor Plus where sold is also compatible with the BIS XP Platform and XP Compatible Systems 2 3 5 1 The BIS XP Platform The BIS XP Platform represents Aspect s top of the line BIS mon...

Страница 26: ...186 0125 English DSC XP PIC Plus Operating Manual A 2000 BIS XP Platform PIC Plus Adapter 186 0126 PIC Plus Adapter Operating Manual available separately A 2000 XP Compatible Also available is the Ped...

Страница 27: ...nnect the PIC grasp the connector housing and pull firmly DO NOT pull apart by the cable wire 2 5 START PROCEDURE To start the instrument 1 Attach one end of the power cord to the rear panel of the mo...

Страница 28: ...ng the up or down arrows 3 Press SELECT 4 Highlight Time Date using the up or down arrows 5 Press SELECT until the date or time value you wish to update appears in reverse video 6 Use the up or down a...

Страница 29: ...____________________ 2 15 3 Press SELECT 4 Highlight Save Settings using the up or down arrows 5 Press SELECT to save setting changes The current settings will be saved and the system will exit to the...

Страница 30: ...SECTION 2 INSTALLATION AND PREPARATION FOR USE ______________________________________________________________________ 2 16...

Страница 31: ...operly connected the DSC and PIC cables and completed the settings in the Setup and Advanced Setup Menus follow these steps to prepare the A 2000 system for operation 1 Power ON and System Check Press...

Страница 32: ...OF PATIENT STRANGULATION THE PATIENT INTERFACE CABLE PIC MUST BE CAREFULLY PLACED AND SECURED 3 Secure the DSC Using the attachment clip secure the DSC to a convenient location near the patient s head...

Страница 33: ...___________________ 3 3 3 2 THE SENSOR CHECK AND SENSOR INTEGRITY CHECK A Sensor Check is initiated automatically when the sensor and PIC are connected to the DSC It may also be initiated by the user...

Страница 34: ...ned impedance is over the 15 kilo ohms limit you will need to re prep the electrodes and check all connections The monitor will continue to check impedance until it is acceptable NOISE If the signal f...

Страница 35: ...BIS Name Bar Event Marker Artifact Bar Horizontal time Scale Battery Alarm Icons BIS Name BIS Value End Case Bar Start Case Bar Date Time Case ID Signal Quality Index Bar Electromyograph Bar Figure 1...

Страница 36: ...high frequency artifacts A low level of EMG is indicated when the bar is not present or at the left side of the graph 3 3 2 3 The Electroencephalogram EEG Waveform Display Filtered EEG waveforms are d...

Страница 37: ...tral Index over a 1 hour time period The BIS trend is indicated with a thick line and its unit markings appear on the left axis The name BIS is displayed above the left corner of the graph Figures 12...

Страница 38: ...XIT then selecting EVENT from the Setup Menu Event markers are shown as arrows at the bottom of the Trend Display If alarm limits for BIS have been set in the Alarm Menu they will appear as horizontal...

Страница 39: ...lso used to halt certain procedures such as the sensor check and to answer no to a question The left and right arrow keys are generally used to enter Review mode and to scroll data backward and forwar...

Страница 40: ...Feb 2000 12 55 02 Event Sensor Check BIS Smoothing Rate secs 15 30 Advanced Setup Display Type Trend DSA to Exit Press Setup Menu 100 80 60 40 20 0 80 70 60 50 40 30 12 10 12 20 12 30 12 40 12 50 13...

Страница 41: ...arrows to move to the next menu item or 5 Press MENU EXIT to exit The system always defaults to the Trend display BIS Smoothing Rate secs The A 2000 offers two choices of smoothing rates over which th...

Страница 42: ...e Trend Graph Selecting SR will plot the suppression ratio Selecting EMG will plot electromyograph or high frequency signal detection Selecting SQI will plot the signal quality index Selecting BURSTS...

Страница 43: ...e that alters its clocks at the beginning or end of Daylight Savings Time When a time date is entered that is earlier than the current time date in the monitor all data memory will be erased The promp...

Страница 44: ...ows 5 Press SELECT Use of the Diagnostic Menu is covered in Section 7 Diagnostics and Troubleshooting Alarm Menu Allows the user to set the BIS high and low limit alarms To display the Alarm Menu 1 Pr...

Страница 45: ...nfigured to settings that have been saved in memory To save the current configuration settings 1 Press MENU EXIT to access the Setup Menu 2 Highlight Advanced Setup using the up or down arrows 3 Press...

Страница 46: ...ro or a BIS Extend sensor is connected When Dual EEG Display is turned ON the Signal Quality Region of the screen displays an additional channel of EEG that can be used for equipment troubleshooting p...

Страница 47: ...EXIT to access the Setup Menu 2 Highlight Advanced Setup using the up or down arrows 3 Press SELECT 4 Highlight Display Parameter Setup using the up or down arrows 5 Press SELECT 6 Highlight EEG Sweep...

Страница 48: ...rows to move to the next menu item or 9 Press MENU EXIT to exit Alternatively when BIS Log display is active press the up or down arrows to increase or decrease the interval respectively To permanentl...

Страница 49: ...rning a limit alarm OFF differs from pressing the front panel SILENCE in that OFF disables audible and visible alarms for the BIS alarm limit only The Alarm Silence key disables all audible alarms but...

Страница 50: ...end is automatically activated when a BIS Extend Sensor is in use or when ICU mode is on To change the Alarm Silence button to suspend rather than cancel the audible alarm 1 Press MENU EXIT to access...

Страница 51: ...nguage is selected 6 Use the up or down arrows to highlight Return to Advanced Setup Menu and press SELECT This will redisplay the Advanced Setup Menu in the selected language 7 To make sure that the...

Страница 52: ...distribution over time The DSA is plotted using absolute spectra with a power scale of 0 0625 4 V The frequency scale is shown on the horizontal axis with a range from 0 30 Hz A 95 spectral edge marke...

Страница 53: ...m Menu and these limits have been reached the BIS number in the upper left corner of the screen will alternately display as a solid or outlined numeric character or blink depending on the signal quali...

Страница 54: ...MG SR Suppression Ratio SQI Signal Quality Index and BURST Burst Count values during the previous one minute period Event markers arrows display when an event is noted When signal quality is very low...

Страница 55: ...e minute interval is recommended for continuous reporting of any changes in BIS values The one minute sample containing a marked event is always displayed MENU EXIT In Current Case Mode press the Menu...

Страница 56: ...urst Count is available only when a BIS Extend sensor is in use When signal quality is poor below 50 an asterisk is displayed next to the SQI value When signal quality is very low the BIS SR and Burst...

Страница 57: ...r display Use the SELECT key to highlight the secondary trend you want to display When the printer is available you may print screen data First find the case you want to print using the REVIEW mode fe...

Страница 58: ...the cable wires Remove BIS Sensor from patient Be sure to leave the PIC with the monitor so that it is not inadvertently discarded If this is the last procedure of the day press the button on the rig...

Страница 59: ...the power on As soon as the updating device is detected the message Software Update Device Detected appears on the screen 4 Press SELECT to initiate the update Press MENU EXIT to skip update and the...

Страница 60: ...SECTION 3 OPERATING THE A 2000 ______________________________________________________________________ 3 30...

Страница 61: ...The Patient Interface Cable to the short DSC pigtail extending from the DSC unit 2 Press the button on the right side of the monitor to turn the power on The system will initiate a self test to ensure...

Страница 62: ...rs OFF Change the EEG sweep speed Change the EEG amplitude Change the default BIS Log interval Press MENU EXIT from the Main Screen to get to the Setup Menu then select Advanced Menu From the Advanced...

Страница 63: ...ort protocol Enable disable extended memory recording Change the monitor to ICU mode Press MENU EXIT from the Main Screen to get to the Setup Menu then select Advanced Setup Menu From the Advanced Set...

Страница 64: ...SECTION 4 QUICK REFERENCE GUIDE ______________________________________________________________________ 4 4...

Страница 65: ...iables and a description of each is provided in Appendix I These data are displayed on the screen according to the preferences set by the user in the Setup Menus 5 2 SYSTEM FEATURES 5 2 1 Bispectral I...

Страница 66: ...end variables i e BIS EMG SR and SQI but will affect the DSA display Viewing the EEG signal without filters may aid in troubleshooting signal problems 5 2 6 Suppression Ratio SR Range 0 100 Suppressio...

Страница 67: ...5 BURST is not reported Note that Burst Count is only reported when a BIS Extend sensor is in use The time interval at which the BIS is reported can be set to 1 5 15 or 60 minutes in the Display Param...

Страница 68: ...g the event Up to 30 seconds of EEG data A 2000 setup and configuration information Note that only one event is saved in memory Pressing the Event marker a second time overwrites the previous record 5...

Страница 69: ...XP Platform only This test begins each time that a sensor is connected to the PIC It checks to make certain that a valid unexpired sensor is in use Impedance Check Sensor Check Electrode impedance is...

Страница 70: ...y symbol is blinking Battery recharge time is approximately 4 hours with the monitor ON Note The monitor must be powered ON to recharge the battery 5 2 24 Data Transfer and Software Updates Data may b...

Страница 71: ...TION 5 FEATURES AND CAPABILITIES ______________________________________________________________________ 5 7 5 2 25 Printed Reports A printer port connector allows connection to the Aspect A 2000 Print...

Страница 72: ...SECTION 5 FEATURES AND CAPABILITIES ______________________________________________________________________ 5 8...

Страница 73: ...towels for spill cleanups Dampen the towel with detergent and lukewarm water to aid in cleaning After cleaning wipe the PIC connector end with alcohol and allow to dry completely Residual moisture ins...

Страница 74: ...ery for at least 4 hours If the A 2000 fails to operate reliably from the battery for 20 minutes battery replacement is required WARNING ELECTRICAL SHOCK HAZARD DO NOT REMOVE MONITOR COVERS DURING OPE...

Страница 75: ...ER OF SAFE PRACTICE THE INSTITUTION SHOULD CONDUCT PERIODIC TESTS TO VERIFY THESE CURRENTS WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR SOLUTIONS OCCURS RE TEST BEFORE FURTHER USE 6 3 FUSE REPLACEME...

Страница 76: ...rom SENSOR CHECK screen by passing impedance check or by exiting with MENU EXIT key 6 Disconnect power cord from rear of monitor Verify OPERATING ON BATTERY BACKUP E33 is displayed Verify battery icon...

Страница 77: ...and replace those parts of the equipment that are replaceable by the customer Aspect does not authorize nor provide information to service or repair the internal components of the A 2000 6 6 INSTRUMEN...

Страница 78: ...SECTION 6 PREVENTIVE MAINTENANCE CARE AND CLEANING ______________________________________________________________________ 6 6...

Страница 79: ...nu is designed to help you trace the source of problems you may be experiencing with the A 2000 system It may be accessed by selecting Advanced Setup from the Setup Menu then selecting Diagnostic Menu...

Страница 80: ...ervice representative See Section 7 3 What to do if the A 2000 Requires Service 7 1 2 Display Self Test To test the screen display this test may be selected from the Diagnostic Menu The user is instru...

Страница 81: ...ears in reverse video Then use the arrows to go to the next option or press MENU EXIT to exit 7 1 6 Impedance Checking The A 2000 continually checks impedance levels during a procedure by generating a...

Страница 82: ...o 409 hours of active monitoring These values are accessible to the user via the BIS Log display This information will remain in memory until overwritten and can also be retrieved with the assistance...

Страница 83: ...ercurrent The run time diagnostics tries up to three times to clear this error condition If it doesn t work the DSC or monitor may require service E03 Message Operator Action DSC Power Regulation The...

Страница 84: ...problem persists DSC may require service Replace DSC E15 See E13 Re prep Sensor E16 Message Operator Action Last Sensor Check Failed The operator aborted the last Sensor Check operation while the test...

Страница 85: ...requires service E33 Message Operator Action Operating on Battery Backup The AC power has been lost and the monitor is running on the battery The battery keeps the monitor operating for approximately...

Страница 86: ...Error E66 Message Operator Action Printer out of Paper Check the printer Make sure that it has paper If the error persists the printer requires service E67 E82 E85 Message Operator Action Printer Err...

Страница 87: ...ly connected to the A 2000 E91 Message Operator Action Event Marking Disabled The ability to mark an event has been temporarily disabled It will be re enabled when event data extraction has been compl...

Страница 88: ...A number The Technical Service phone number is printed on the back cover of this manual The RMA number should appear on the outside of the shipping container Please provide the model number serial num...

Страница 89: ...imensions 7 0 in wide x 6 8 in high x 4 0 in deep 17 5 cm x 16 9 cm x 10 cm Digital Signal Converter Weight Dimensions Cable Length 10 0 oz 0 284 kg including integral cable 2 6 in wide x 1 00 in high...

Страница 90: ...S Log and real time EEG waveforms Update Rate 1 second for BIS Index 10 seconds for Trend DSA Event Markers User selected Alarms Auditory and visual user adjustable limits Filters ON 2 70 Hz with notc...

Страница 91: ...rt is isolated from all other parts of the equipment to such a degree that the patient leakage current allowable in single fault condition is not exceeded when a voltage equal to 1 1 times the highest...

Страница 92: ...ect reasonably determines that a repair or replacement is covered by the warranty Aspect shall bear the costs of shipping the repaired or replacement Product to Purchaser All other shipping costs shal...

Страница 93: ...XIMUM 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 ASPECT IN CONNECTION THEREWIT...

Страница 94: ...sassemble or otherwise reduce the Licensed Software to a human perceivable form If you transfer the System you have the right to transfer the Licensed Software provided that the transferee agrees to b...

Страница 95: ...ws of the Commonwealth of Massachusetts If any provision of this License Agreement shall be held by a court of competent jurisdiction to be contrary to law that provision will be enforced to the maxim...

Страница 96: ...SECTION 8 SPECIFICATIONS WARRANTY AND SOFTWARE LICENSE AGREEMENT 8 8...

Страница 97: ...dance data artifact and other variables Not affected by Suppression Ratio 0 0 100 0 EMG The absolute power in the 70 110 Hz range The power value is reported in dB with respect to 0 0001 V2 All the ar...

Страница 98: ...Setup Menu BIS Log Interval Dual EEG Display OFF ON Filters OFF ON EEG Sweep Speed mm sec minutes EEG Amplitude uv div 5 10 25 50 100 15 25 30 1 5 15 60 Diagnostic Menu to Exit Press DSC Self Test Di...

Страница 99: ...S Engine Revision FPGA Revision Run Time Serial Number BIS Usage 3 00 3 00 1 13 1 06 567891 C002033 125 PIC Sensor Type 4 DSC Type 8 Clear Data System Configuration Menu DSC FPGA 2 0 1 6 Sensor Data D...

Страница 100: ...SECTION 9 APPENDIX 9 4...

Страница 101: ...e Diagnostic Menu DSC Self Test Display Self Test Sensor Data Display Sensor Data Screen Clear Data Diagnostic Codes OFF ON Impedance Checking OFF ON System Configuration Menu Serial Port Protocol AS...

Страница 102: ......

Страница 103: ......

Страница 104: ...59 7400 Customer Service 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...

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