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SECTION 11 APPENDIX II

________________________________________________________________

SECTION 11

APPENDIX II

11.1

Data Flow Diagram

Patient
Connection

BISx

Input
Protection

Amplification
and Filtering

Sigma-Delta
Modulators

FPGA

Digital
Signal
Processor
(DSP)

Serial
Comm.

BIS VISTA Monitor

Host Processor

Serial
Comm.

Color
Display

RS-232
Port

USB
Host
Port

Содержание BIS VISTA

Страница 1: ...Aspect Medical Systems Inc Aspect Medical Systems International B V One Upland Road 3454 PV De Meern Norwood MA 02062 USA Rijnzathe 7d2 0123 Tel 617 559 7000 The Netherlands Tel 888 BIS INDE X U S on...

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Страница 3: ...rights reserved Copying or other reproduction of this document is prohibited without prior written consent of Aspect Medical Systems BIS VISTA BISx and the BISx logo are trademarks of Aspect Medical...

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Страница 5: ...des 3 7 3 3 3 Monitor Data Memory 3 7 3 3 4 BISx Data Memory 3 8 3 3 5 Saved Settings 3 8 3 3 6 Battery Operation 3 8 3 3 7 Data Transfer and Software Updates 3 9 4 PREPARATION FOR USE AND INSTALLATIO...

Страница 6: ...Tools Required 8 6 8 7 2 Procedure 8 6 8 8 REPLACING THE BISX BULKHEAD CONNECTOR 8 9 8 8 1 Parts and Tools Required 8 9 8 8 2 Procedure 8 10 8 9 CALIBRATING THE TOUCH SCREEN 8 13 8 10 USING THE RESET...

Страница 7: ...The BIS VISTA System Block Diagram 3 2 Figure 6 The BIS VISTA Data Flow Diagram 3 3 Figure 7 Pole Clamp 4 3 Figure 8 Schematic of Sensor Simulator Circuit 10 2 Figure 9 Sensor Simulator 10 3 Figure 1...

Страница 8: ...g processes Field repair or customer repairs are therefore limited by design to replacement of major component assemblies such as the Patient Interface Cable PIC BISx or the power supply and battery o...

Страница 9: ...r procedure KEY TO SYMBOLS A key to the symbols used on the BIS VISTA Monitoring System appears at the end of this section 1 1 Warnings THE USE OF ACCESSORY EQUIPMENT NOT COMPLYING WITH THE EQUIVALENT...

Страница 10: ...RY UNIVERSAL PRECAUTIONS SHALL BE OBSERVED TO PREVENT CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS PLACE CONTAMINATED MATERIALS IN REGULATED WASTE CONTAINER WHENEVER AN EVENT SUCH AS S...

Страница 11: ...AL UNIT RETURN ELECTRODE THE SENSOR MUST NOT BE LOCATED BETWEEN DEFIBRILLATOR PADS WHEN A DEFIBRILLATOR IS USED ON A PATIENT CONNECTED TO THE BIS VISTA SYSTEM TO MINIMIZE THE RISK OF PATIENT STRANGULA...

Страница 12: ...battery a few times to get full charge capacity If the BIS VISTA monitor fails to operate reliably from the battery for approximately 45 minutes battery replacement is required The BIS VISTA monitor...

Страница 13: ...equipment in the vicinity due to electromagnetic interference EMI If this occurs Increase separation between devices Re orient device cabling Plug devices into separate outlet circuit branches Refer...

Страница 14: ...by Underwriters Laboratories Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 and IEC60601 2 26 Recognized under the Component Recognition Program of...

Страница 15: ...t Accompanying Documents USB B Attention USB B function Consult Accompanying Documents Caution Hot Surface Alternating Current D C Current Battery Location Reset Button Packaging Labelling Storage Tem...

Страница 16: ...rating on Battery No Battery is Installed in Monitor Ringing Bell Icon Alarm Sounding Green Bell Icon Alarms Active Yellow Bell with Dotted Line X Alarms Paused Red Bell with X Alarms Silenced A green...

Страница 17: ...d as an aid in monitoring the effects of certain anesthetic agents Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with...

Страница 18: ...r The front panel of the BIS VISTA monitor contains the Touch Screen BISx port and the ON Standby button See Figure 2 Touch Screen The BIS VISTA monitor is designed so that all controls with the excep...

Страница 19: ...g and the system is in Standby mode When it is not lit no A C power is available to the unit pressing the ON Standby button will start up the monitor using the battery Clamp Shoe Serial Port USB Port...

Страница 20: ...ent clip on the BISx is used to secure it in a convenient location near the patient s head 2 3 Instrument Identification BIS VISTA Monitor Monitor identification information is permanently marked on t...

Страница 21: ...nd Devices Information and descriptions contained in this guide are the property of Aspect Medical Systems and may not be copied reproduced or distributed without prior written permission Portions of...

Страница 22: ...SECTION 2 BIS VISTA MONITORING SYSTEM OVERVIEW _______________________________________________________________________ 2 6...

Страница 23: ...ing digital signal processing techniques then sends the data to the monitor for display The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in...

Страница 24: ...ort J4 DIGITIZER BOARD PROCESSOR BOARD BISx P102 P103 Patient P101 P100 J301 J300 CONNECTOR BOARD J1 J12 J11 BATTERY ON STANDBY SWITCH SPEAKER J8 J1 DISPLAY J2 POWER SUPPLY MOTHER BOARD BIS VISTA MONI...

Страница 25: ...nt to the Digital Signal Processor DSP The DSP filters the signals and computes the processed variables The results are passed to the monitor for display 3 2 1 The BISx The BISx contains the inputs am...

Страница 26: ...hile the digital signal processor measures the resulting voltage BIS monitoring is performed while combined impedance is checked The BISx measures the individual electrode impedance during a sensor ch...

Страница 27: ...is contained in a small custom designed plastic case see Figure 4 It is connected to the monitor via the Monitor Interface Cable and connects to the BIS sensor via the Patient Interface Cable PIC Both...

Страница 28: ...l mounting and electrical connections for the serial and USB ports Its mechanical construction includes ESD protection 3 2 2 3 The Power Supply The power supply operates on AC power from 100 240 VAC 5...

Страница 29: ...ck Sensor Check Electrode impedance is tested when the BISx and PIC are connected and is monitored continuously unless the user has turned impedance checking off in the menu system Caution Continuous...

Страница 30: ...he current Monitor Mode I II III or IV The Save Settings option is disabled when in Battery Backup Low Power condition The following settings are not saved by the Save Settings option Impedance Checki...

Страница 31: ...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...

Страница 32: ...SECTION 3 PRINCIPLES OF OPERATION _______________________________________________________________________ 3 10...

Страница 33: ...essure 360 mmHg to 800 mmHg Protect the monitor from sudden temperature changes that can lead to condensation within the instrument To minimize condensation avoid moving the system between heated buil...

Страница 34: ...receptacle WARNING FOR PROPER GROUNDING THE POWER RECEPTACLE MUST BE A THREE WIRE GROUNDED OUTLET A HOSPITAL GRADE OUTLET IS REQUIRED NEVER ADAPT THE THREE PRONG PLUG FROM THE MONITOR TO FIT A TWO SL...

Страница 35: ...de monitor down to fit The bottom of the clamp shoe should be seen well below the bottom of the pole clamp and the monitor should snap securely into place Figure 7 Pole Clamp To remove the monitor pre...

Страница 36: ...Cable into the BISx port on the front of the monitor Once connected the BISx need not be disconnected again However if you wish to disconnect the BISx cable from the monitor carefully grasp the conne...

Страница 37: ...ify all self tests complete successfully A beep tone sounds Verify next screen says Connect BISx 4 Connect BISx to monitor Connect PIC and sensor to BISx Verify screen says BISx Initialization Complet...

Страница 38: ...SECTION 4 PREPARATION FOR USE AND INSTALLATION _______________________________________________________________________ 4 6...

Страница 39: ...pen the towel with detergent and lukewarm water to aid in cleaning After cleaning wipe the PIC connector ends with alcohol and allow to dry completely Residual moisture inside the connector may affect...

Страница 40: ...s Avoid liquid ingress to the Patient Interface Cable Contact of fluids with the PIC sensor connectors can interfere with PIC performance 5 1 3 Cleaning the Monitor Display Clean the monitor display s...

Страница 41: ...n Section 8 9 Calibrating the Touch Screen 6 1 Physical Integrity Inspection Periodically check the system BIS VISTA monitor BISx PIC for physical damage to cases and associated cables and connectors...

Страница 42: ...BISx 4 Connect BISx to monitor with PIC and sensor Verify screen says BISx Initialization Complete Verify SENSOR CHECK begins 5 Disconnect power cord from rear of monitor Verify OPERATING ON BATTERY...

Страница 43: ...tor Checkout Procedure start up the monitor with the BISx disconnected Verify that the screen message Connect BISx displays 2 Connect the BISx that you are testing Verify that the screen message Conne...

Страница 44: ...n the sensor and PIC are connected to the BISx It may also be initiated by pressing the SENSOR CHECK touch key The message Sensor Check in Progress appears When the sensor successfully passes the test...

Страница 45: ...Range Electrode Typical Range 1 5 K Ohms 4 6 K Ohms 1 1 K Ohms 1 2 K Ohms 2 10 K Ohms 8 17 K Ohms 2 1 K Ohms 1 3 K Ohms 4 4 K Ohms 3 5 K Ohms 4 1 K Ohms 1 2 K Ohms 3 3 K Ohms 2 4 K Ohms 3 1 K Ohms 1...

Страница 46: ...ys have the leakage current checked after a saline or blood spill or immediately after a major surge in the house electrical system and after every time the monitor case has been opened Keep in mind t...

Страница 47: ...necting to isolated conductive parts and measuring the current from those parts to earth The patient connection terminals of many safety testers can be used for this purpose The patient leakage curren...

Страница 48: ...SECTION 6 PREVENTIVE MAINTENANCE _______________________________________________________________________ 6 8...

Страница 49: ...ostics run automatically the first time the unit is powered on after the battery or power supply have been replaced or after the Reset button has been pressed Software image checksums and trend data m...

Страница 50: ...c troubleshooting information necessary for qualified technical personnel to test and replace those parts of the equipment that are replaceable by the customer Aspect does not authorize nor provide in...

Страница 51: ...gnized the Monitor cable is likely suspect This failure may also be related to a PCB problem in the BISx in which case the BISx must be replaced If test indicates PASS continue to step 2 2 Connect Sen...

Страница 52: ...connections 2 Replace Monitor Interface Cable 3 Replace the BISx 4 Replace monitor 13 Re prep Sensor 1 Incorrect sensor application 2 Poor sensor connections 3 Sensor Check fails 4 Defective PIC 5 Def...

Страница 53: ...is less than half of the level desirable for optimal monitoring conditions This may occur as the result of artifact such as those generated from motion or eyeblinks 1 Artifact such as those generated...

Страница 54: ...may be interfering with EEG recognition 3 PIC is defective 4 BISx is defective Note This message may occur as the results of artifact non EEG signal such as those generated from motion patient movemen...

Страница 55: ...r is running on the battery The battery keeps the monitor operating for approximately 45 minutes when the battery is fully charged 1 Restore the AC power 2 Verify power cord 3 Replace power supply 34...

Страница 56: ...ecessary 1000 1999 Unrecoverable BISx Error 1 Poor connection between BISx monitor cable and monitor 2 Defective BISx 3 Defective monitor 1 Unplug BISx from monitor and plug in again 2 Replace the BIS...

Страница 57: ...______________________________________________ 7 9 Status Messages Causes Corrective Actions 6000 6999 Snapshot Error Operating system has noted that the snapshot process has not completed correctly 1...

Страница 58: ...SECTION 7 DIAGNOSTICS AND TROUBLESHOOTING ________________________________________________________________________ 7 10...

Страница 59: ...erface Cable PIC Plus P N 186 0107 None To replace the PIC unplug the PIC cable from the BISx Bulkhead Connector by grasping the connectors NOT the cable and firmly pulling the two sections apart To a...

Страница 60: ...from the front of the monitor To do this grasp the connector on the BISx Monitor Interface Cable and pull DO NOT twist or pull on the cable 4 If necessary dismount monitor from pole clamp by removing...

Страница 61: ...Follow the instructions below 1 Unplug A C line cord from the monitor 2 Lay monitor screen side down on a scratch free work surface so that the Battery Power Supply cover is accessible 3 Remove 4 scr...

Страница 62: ...Follow the instructions below 1 Unplug A C line cord from the BIS VISTA monitor 2 Lay the monitor screen side down on a scratch free work surface so that the Battery Power Supply cover is accessible 3...

Страница 63: ...Supply cover is accessible 3 Remove 4 screws from the Battery Power Supply cover and remove the cover The power supply is located inside the cover 4 Unplug squeeze and pull to remove the power supply...

Страница 64: ...ly the parts and tools specified Use of any others may damage the instrument 8 7 1 Parts and Tools Required Parts Required Tools Required BIS VISTA Host Cable Replacement Kit P N 186 0201 AMS includes...

Страница 65: ...VICING THE BIS VISTA MONITORING SYSTEM 8 7 3 Open the ZIF connector by pulling away from the bulkhead 4 Disconnect from the flex cable Discard the old gasket 5 Set the new gasket in the groove of the...

Страница 66: ...the flex cable from the BISx to the ZIF connector on the replacement cable 7 Ensure that the flex cable is fully inserted into the ZIF and close the ZIF connector by pushing toward the bulkhead Carefu...

Страница 67: ...ould be made only by a qualified Biomedical Engineering Technician or other authorized personnel Use only the parts and tools specified Use of any others may damage the instrument 8 8 1 Parts and Tool...

Страница 68: ...VISTA MONITORING SYSTEM 8 10 8 8 2 Procedure 1 Disconnect BISx from the monitor and remove Patient Interface Cable from BISx 2 Remove screws from the bulkhead 3 Open the ZIF connector by pulling away...

Страница 69: ...SECTION 8 SERVICING THE BIS VISTA MONITORING SYSTEM 8 11 4 Disconnect from the flex cable Discard the old gasket 5 Set the new gasket in the groove of the BISx housing...

Страница 70: ...h the flex cable from the BISx to the ZIF connector on the replacement bulkhead 7 Ensure that the flex cable is fully inserted into the ZIF and close the ZIF connector by pushing toward the bulkhead C...

Страница 71: ...with a ballpoint pen paper clip or other similar tool 8 11 BISx Checkout and Safety Tests 1 Perform DSC Self Test See Section 7 2 2 The BISx Checkout Procedure or refer to the BIS VISTA Monitoring Sys...

Страница 72: ...The Technical Service phone number is printed on the back cover of this manual The RMA number must appear on the outside of the shipping container Use the original shipping container if available or e...

Страница 73: ...g System General Specifications Product Description BIS Bispectral Index monitoring system for display of processed data and real time EEG waveforms Monitor Weight 4 5 lbs 2 kg Monitor Dimensions 7 5...

Страница 74: ...Full Scale EEG Sweep Speeds 25 mm sec Computed Parameters Bispectral Index Suppression Ratio EMG Signal Quality Index and Burst Count User defined Displays Trend and real time EEG waveforms Update Ra...

Страница 75: ...e x 2 5 in high 9 5 cm x 6 3 cm 9 ft 2 7 m Integral BISx Cable 4 ft 1 4 m from BISx to sensor connector Analog to Digital Converter Noise shaped sigma delta Sampling Rate 16 384 samples second Resolut...

Страница 76: ...t leakage current allowable in single fault condition is not exceeded when a voltage equal to 1 1 times the highest rated AC supply voltage is applied between the applied part and earth The circuitry...

Страница 77: ...9 2 1 Accessories The BIS VISTA Monitoring System complies with the requirements of IEC 60601 1 2 2001 when used with the accessories listed in Section 2 of the Operating Manual In addition the BIS V...

Страница 78: ...RF Emissions CISPR 11 Group 1 The BIS VISTA Monitoring System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in near...

Страница 79: ...be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typi...

Страница 80: ...ms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 V 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the BIS VISTA system including cables than the recommende...

Страница 81: ...le radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagn...

Страница 82: ...mmunications equipment Rated maximum output power of equipment W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2...

Страница 83: ...ereof If Aspect 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 shippin...

Страница 84: ...LAR PURPOSE ASPECT 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 ASPECT...

Страница 85: ...x ACCESSORIES 150 0037 Pole Clamp Assembly 150 0058 BIS VISTA Monitor Stand 186 0104 BIS Sensor Dispenser 186 0137 Sensor Simulator 817 0014 GCX 12 Pivot Support Arm w 7 Up Post 817 0015 GCX 16 Pivot...

Страница 86: ...NOTE The life expectancy of the Sensor Simulator is 25 connect disconnect cycles S1 S4 connect to 4 input signal pins on the PIC The Inputs and are where one connects the test signals to test the BIS...

Страница 87: ...procedure to make a Test Sensor 1 Remove a new sensor from its plastic carrier sheet and place on flat surface with the adhesive facing up NOTE Be careful that gel does not leak onto hands or connect...

Страница 88: ...Fold electrode 1 over onto electrode 2 Figure 12 Connecting electrode 3 with 4 and 1 with 2 5 Connect this Test Sensor to the PIC All impedance tests should complete successfully with low impedance va...

Страница 89: ...2 Connect PIC Patient Interface Cable sensor cable to other end of BISx 3 Verify sensor for test is of current date code Connect sensor to PIC cable 4 Remove gel and green pad from each sensor contac...

Страница 90: ......

Страница 91: ..._______ SECTION 11 11 APPENDIX II 11 1 Data Flow Diagram Patient Connection BISx Input Protection Amplification and Filtering Sigma Delta Modulators FPGA Digital Signal Processor DSP Serial Comm BIS V...

Страница 92: ...2 USB Client J3 Serial Port J4 DIGITIZER BOARD PROCESSOR BOARD BISx P102 P103 Patient P101 P100 J301 J300 CONNECTOR BOARD J1 J12 J11 BATTERY ON STANDBY SWITCH SPEAKER J8 J1 DISPLAY J2 POWER SUPPLY MOT...

Страница 93: ......

Страница 94: ...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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