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Aspect BIS VIEW Service Information Manual

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BIS VIEW Monitoring
SERVICE INFORMATION MANUAL
Bispectral Index (BIS) Monitoring System
Aspect Medical Systems, Inc.
One Upland Road
Norwood, MA 02062 USA
(Tel) 617-559-7000
(Tel) 888-BIS INDE(X) (U.S. only) Tel: +31.30.662.9140
(Fax) 617-559-7400
bis_info@aspectms.com
www.aspectmedical.com
System
Aspect Medical Systems, Inc.
Rx only
EC REP
Aspect Medical Systems International B.V.
3454 PV De Meern
Rijnzathe 7d2
The Netherlands
Fax: +31.30.662.9150
amsint@aspectms.com
0123
075-1000 1.01

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  • Page 1 SERVICE INFORMATION MANUAL Aspect Medical Systems, Inc. Bispectral Index (BIS) Monitoring System Rx only EC REP 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.
  • Page 3 Aspect Medical Systems. BIS VIEW, BISx and the BISx logo are trademarks of Aspect Medical Systems, Inc. Aspect, Bispectral Index, BIS, the BIS logo, and Zipprep are trademarks of Aspect Medical...

  • Page 5: Table Of Contents

    ABOUT THIS MANUAL ........................I SAFETY PRECAUTIONS....................1-1 ..............................1-1 ARNINGS ..............................1-3 AUTIONS ............................1-6 EY TO YMBOLS BIS VIEW MONITORING SYSTEM OVERVIEW ............2-1 BIS VIEW M ................2-1 NTRODUCING THE ONITORING YSTEM .......................... 2-2 RINCIPAL OMPONENTS 2.2.1 The BIS VIEW Monitor ............................
  • Page 6 ........... 7-2 ONITORING YSTEM ROUBLESHOOTING ROCEDURE BIS VIEW S ..............7-4 YSTEM ESSAGES AND ORRECTIVE CTIONS SERVICING THE BIS VIEW SYSTEM................8-1 PIC........................... 8-1 EPLACING THE ..........................8-1 EPLACING THE ........................8-2 EPLACING THE ONITOR .......................... 8-3 EPLACING THE ATTERY .......................
  • Page 7 Figure 3 - Rear Panel ...................... 2-3 Figure 4 - The BISx and PIC ................... 2-4 Figure 5 - The BIS VIEW System Block Diagram ............3-2 Figure 6 - The BIS VIEW Data Flow Diagram ............... 3-3 Figure 7 - Pole Clamp ..................... 4-3 Figure 8 - Schematic of the BIS Sensor Simulator ............

  • Page 8: About This Manual

    A spare parts and accessories list and system specifications are included. This manual is intended to be used in combination with the BIS VIEW Monitoring System Operating Manual. The BIS VIEW Monitoring System is designed and manufactured using state-of-the-art components and manufacturing processes.
  • Page 9 Important Information about Using BIS Monitoring The BIS VIEW Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in their proper use. The system, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

  • Page 11: Safety Precautions

    • A NOTE provides useful information regarding a function or procedure. KEY TO SYMBOLS A key to the symbols that may appear on the BIS VIEW Monitoring System appears at the end of this section. Warnings GROUND WIRE LEAKAGE CURRENT MUST BE CHECKED BY A QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN WHENEVER INSTRUMENT CASE IS OPENED.
  • Page 12 REPLACED WITH A THREE-SLOT GROUNDED OUTLET BEFORE ATTEMPTING TO OPERATE THE MONITOR. IF THE INTEGRITY OF THE EXTERNAL PROTECTIVE EARTH GROUND IS IN DOUBT, THE BIS VIEW SHALL BE OPERATED FROM ITS INTERNAL BATTERY POWER SOURCE ONLY. THE CONDUCTIVE PARTS OF ELECTRODES OR SENSOR AND CONNECTORS, INCLUDING THE NEUTRAL ELECTRODE, SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING EARTH.

  • Page 13: Cautions

    APPROPRIATE IEC 60601-1 AND/OR IEC 60601-2-26 HARMONIZED NATIONAL STANDARD. 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 14 6 hours of charge time). After long periods of storage, charge the battery for 6 hours to assure full capacity. If the BIS VIEW monitor fails to operate reliably from the battery for approximately 45 minutes, battery replacement is required.
  • Page 15 A ground continuity test is not recommended. Important: The BIS VIEW systems comply with the European Medical Device Directive (MDD) and applicable regulatory requirements of the country distributed to and carry the Marking. Declarations of Conformity provided upon request where XXXX appropriate.

  • Page 16: 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 Caution: Hot Surface Storage Temperature Limits Type BF Equipment Type BF Equipment Defibrillator-proof Alternating Current (A/C) Direct Current (D/C)
  • Page 17 Therefore it is important to collect WEEE separately from other waste. Aspect Medical products are subject to the Directive and we therefore urge you to dispose of the equipment separately from ‘normal’ household waste and make sure that it is treated at an electronics recycler.
  • Page 18 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 Yellow Bell with dotted ‘X’ - Alarms Paused Red Bell with ‘X’...

  • Page 19: Bis View Monitoring System Overview

    45 minutes of automatic back-up battery power. The monitor is menu-driven. A detailed description of how the BIS VIEW Monitoring System works is included in the BIS VIEW Operating Manual. Please refer to the BIS VIEW Operating Manual for additional information.

  • Page 20: Principal Components

    The system is composed of a monitor, a BISx, a Patient Interface Cable (PIC), and BIS sensor. 2.2.1 The BIS VIEW Monitor 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 2. Soft Keys The four white “soft”...

  • Page 21: Figure 3 - Rear Panel

    SECTION 2 BIS VIEW MONITORING SYSTEM OVERVIEW _______________________________________________________________________ USB Port Reset Button (Type A) Serial Port USB Port (Type B) Battery/Power Power Cord Cover Receptacle Supply Clamp Shoe Figure 3 - Rear Panel Rear Panel The rear panel components are pictured in Figure 3. They include: two USB ports (Type A and B), the clamp shoe, an RS-232 port, the Reset button, the Battery/Power Supply cover, and the power cord receptacle.

  • Page 22: The Bisx And Patient Interface Cable (Pic)

    SECTION 2 BIS VIEW MONITORING SYSTEM OVERVIEW _______________________________________________________________________ 2.2.2 The BISx and Patient Interface Cable (PIC) The BISx receives, filters, and processes patient EEG signals. It is located close to the patient's head where the EEG signal is less subject to interference from other medical equipment.

  • Page 23: Proprietary Information And Devices

    Systems and may not be copied, reproduced or distributed without prior written permission. Portions of the BIS VIEW Monitoring System design are proprietary and are the subject of patents and patents pending. See the BIS VIEW Operating Manual for details.
  • Page 24 SECTION 2 BIS VIEW MONITORING SYSTEM OVERVIEW _______________________________________________________________________...

  • Page 25: Principles Of Operation

    EEG signals, digitally process the EEG data, and compute the processed parameters. The BIS VIEW monitor contains the circuits to display the waveforms and processed parameters. The PIC and BIS sensor are the patient connection for EEG signal acquisition.

  • Page 26: Figure 5 - The Bis View System Block Diagram

    Host Client Port CONNECTOR BOARD SPEAKER DISPLAY J103 CARD ENGINE MOTHER BOARD DISPLAY J100 BISx INTERFACE Connector BOARD J102 J101 SOFT KEYS Power ON/STANDBY BATTERY POWER SUPPLY SWITCH BIS VIEW MONITOR Figure 5 - The BIS VIEW System Block Diagram...

  • Page 27: The Bisx

    Host Port Port Figure 6 - The BIS VIEW Data Flow Diagram After passing through input protection circuits, the EEG signals are differentially amplified and filtered to remove DC and high frequency components. The signals are digitized by separate one bit sigma-delta analog to digital converters and sent to the Digital Signal Processor (DSP).
  • Page 28 SECTION 3 PRINCIPLES OF OPERATION _______________________________________________________________________ the channel and ground electrodes and detect if an electrode is disconnected. The BISx provides the patient isolation barrier that isolates the patient from the monitor electronics. 3.2.1.1 BISx Signal Conditioning The input protection circuits are designed to protect the input from damage by electric shock from sources such as electrostatic discharge (ESD) or defibrillation.
  • Page 29 SECTION 3 PRINCIPLES OF OPERATION _______________________________________________________________________ A/D Conversion There are two independent sigma-delta modulators for the two channels. These run at 16384 samples per second. Output from the two channels is multiplexed in a field programmable gate array (FPGA). Multiplexed with the EEG data is status information such as BISx identification, “lead off”...

  • Page 30: The Bis View Monitor

    BISx circuits. 3.2.2 The BIS VIEW Monitor The BIS VIEW monitor contains the circuits to enable the soft keys, to receive processed parameters from the BISx, to display the data on the screen, and to communicate with other devices via USB and RS-232 ports.

  • Page 31: System Features

    USB ports. Its mechanical construction includes ESD protection. 3.2.2.3 The Power Supply The BIS VIEW utilizes a commercial Class I medical-grade power supply which operates on AC power from 100-240 VAC, 50-60 Hz, with output of 12 VDC, 24 watt maximum. It charges the battery;...

  • Page 32: Diagnostic Codes

    3.3.2 Diagnostic Codes The BIS VIEW monitor provides diagnostic codes that may be helpful in tracing the source of particular signal characteristics caused by artifact or by unusual hardware or software conditions. Codes are displayed in the Message Region only if the user has requested them in the Diagnostics Menu.

  • Page 33: Bisx Data Memory

    SECTION 3 PRINCIPLES OF OPERATION _______________________________________________________________________ 3.3.4 BISx Data Memory The BISx stores processed EEG parameters, including the BIS value, with time and date of acquisition. History data stored in the BISx can be accessed by exporting it to a removable drive using the [Export Data] function.

  • Page 34: Data Transfer And Software Updates

    3.3.7 Data Transfer and Software Updates 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. It is also used to update the monitor and BISx software.

  • Page 35: Preparation For Use And Installation

    Before operation, wipe down all visible condensation and allow the system to reach equilibrium at room temperature. 4.1.2 Operating Environment The BIS VIEW Monitoring System is not designed for use in areas containing flammable gases or vapors. WARNING:...

  • Page 36: Power Requirements And System Grounding

    800 mm Hg (1500 feet below sea level) to 360mm Hg (20,000 feet above sea level) 4.1.3 Power Requirements and System Grounding The BIS VIEW Monitoring System requires a power source of 100-240 VAC, 50-60Hz. Current consumption is 0.7 ampere maximum. To protect operating personnel and patients, the monitor must be properly grounded.

  • Page 37: Figure 7 - Pole Clamp

    SECTION 4 PREPARATION FOR USE AND INSTALLATION _______________________________________________________________________ 4.1.4.1 Mounting the Monitor using the Pole Clamp To mount the monitor to a secure vertical pole (1/2" - 1½" in diameter): 1. Place pole within clamp bracket and tighten screw using the black finger knob. Make sure that there is enough space above the clamp so that you have a few inches to slide the monitor in from above.

  • Page 38: Instrument Connections

    4.2.2 Power Cord Connections The BIS VIEW Monitoring System is designed to use only 3-conductor IEC hospital-grade power cords. Cords must be type SJE, SJT, or SJO. Align power cord connector to power cord port and insert firmly. Check for a firm connection.
  • Page 39 SECTION 4 PREPARATION FOR USE AND INSTALLATION _______________________________________________________________________ • Verify that light to right of ON/Standby button is green. • Verify 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. •...
  • Page 40 SECTION 4 PREPARATION FOR USE AND INSTALLATION _______________________________________________________________________...

  • Page 41: Care And Cleaning

    SECTION 5 CARE AND CLEANING _______________________________________________________________________ 5 CARE AND CLEANING INTRODUCTION This section describes: • Care and cleaning procedures • Preventive maintenance Care and Cleaning WARNING! UNIVERSAL PRECAUTIONS SHALL BE OBSERVED TO PREVENT CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS. PLACE CONTAMINATED MATERIALS IN REGULATED WASTE CONTAINER.

  • Page 42: Cleaning The Monitor Display

    SECTION 5 CARE AND CLEANING _______________________________________________________________________ Caution: Do not autoclave the BISx or Monitor. Autoclaving will seriously damage both components. 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 screen with a mild solution of detergent and warm water or a commercial display screen cleaner, available through personal computer dealers.

  • Page 43: Preventive Maintenance

    PREVENTIVE MAINTENANCE _______________________________________________________________________ 6 PREVENTIVE MAINTENANCE INTRODUCTION The BIS VIEW system is designed so that no periodic adjustment or calibration is required. Suggested routine maintenance covered in this section includes: • Periodic physical integrity inspection • Replacing the PIC • System checkout •...

  • Page 44: System Checkout

    • Verify battery icon displays below BIS number. NOTE: Since the BIS VIEW monitor has a built in battery backup, the monitor will power up with or without AC power applied. This step assures that this part of the test is performed under battery power 6.

  • Page 45: Bisx Checkout Procedure

    PREVENTIVE MAINTENANCE _______________________________________________________________________ NOTE: Since the BIS VIEW monitor has a built-in battery backup, the monitor will power up with no AC power applied. This step assures that this part of the test is performed in AC operation. IF ANY FAILURES ARE NOTED: •...

  • Page 46: Patient Interface Cable (Pic) Checkout Procedure

    Procedure. See section 6.3.3 “Patient Interface Cable (PIC) Checkout Procedure.” 6.3.3 Patient Interface Cable (PIC) Checkout Procedure The successful completion of this test will verify function of the BIS VIEW system from the BISx circuits to the patient connector. Since the conductors used are located both in the BISx and the PIC, use a swapping technique to isolate the faulty component.
  • Page 47 SECTION 6 PREVENTIVE MAINTENANCE _______________________________________________________________________ • 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. • HIGH - An electrode is labeled “HIGH” if its impedance value is above 7.5 kilo ohms.

  • Page 48: Checking The Battery

    The battery must be tested periodically to verify that the BIS VIEW Monitoring System will continue to operate during power outages. To test: 1. Charge the BIS VIEW monitor by leaving it plugged into A/C power for at least 6 hours. The monitor charges while in either Standby mode (yellow light) or ON (green light).

  • Page 49: 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 user of the equipment.
  • Page 50 SECTION 6 PREVENTIVE MAINTENANCE _______________________________________________________________________ measured by connecting the patient connection terminals of a safety tester to a Sensor Simulator that is connected to the PIC. To check BISx patient isolation: 1. Connect the Sensor Simulator to the PIC in place of a sensor. (See Appendix.) 2.

  • Page 51: Diagnostics And Troubleshooting

    General Troubleshooting The BIS VIEW Monitoring System has both automatic and manual diagnostic features. These features check the BIS VIEW Monitoring System’s operability and status, and report software and hardware malfunctions. IF ANY FAILURES ARE NOTED, SEE SECTION 7.3 “BIS VIEW System Messages and Corrective Actions”...

  • Page 52: Bis View Monitoring System Troubleshooting Procedure

    The qualified user may replace the BISx cables by following the procedures in Section 8 “Servicing the BIS VIEW System.” If the cables or connectors are physically damaged, they will need to be replaced. If cables are suspect, the following may be of aid in determining which cable is defective.
  • Page 53 • If failure is noted, swap PIC with known good PIC cable and run again. • If failure repeats, the BISx or the BISx Bulkhead Connector is suspect. This failure may also be related to a PCB problem in the BISx in which case the BISx must be returned to Aspect for service.

  • Page 54: Bis View System Messages And Corrective Actions

    SECTION 7 DIAGNOSTICS AND TROUBLESHOOTING ________________________________________________________________________ BIS VIEW System Messages and Corrective Actions When an alarm is triggered, a message appears in the Message Region of the screen. Possible messages and the recommended operator actions are listed below: BIS VIEW Messages and Operator Actions...
  • Page 55 SECTION 7 DIAGNOSTICS AND TROUBLESHOOTING ________________________________________________________________________ Status Messages: Possible 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 56 SECTION 7 DIAGNOSTICS AND TROUBLESHOOTING ________________________________________________________________________ Status Messages: Possible 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 57 SECTION 7 DIAGNOSTICS AND TROUBLESHOOTING ________________________________________________________________________ Status Messages: Possible 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 58 SECTION 7 DIAGNOSTICS AND TROUBLESHOOTING ________________________________________________________________________ Status Messages: Possible Causes: Corrective Actions: Isoelectric EEG No discernible EEG activity If unintended: Detected [0031] is detected for sixty-three 1. Check patient vital signs, seconds; SR=100. dosage, etc. 2. Check leads for proper Note: This message connection and possible notifies user of a flatline...
  • Page 59 SECTION 7 DIAGNOSTICS AND TROUBLESHOOTING ________________________________________________________________________ Status Messages: Possible Causes: Corrective Actions: Sensor Invalid [0096] 1. Poor or contaminated 1. Connect/clean connection connection between between sensor and PIC. sensor and PIC. 2. Replace the sensor. 2. An incorrect or 3. Replace the PIC. defective sensor has 4.
  • Page 60 2. Drive “write protect” is “unlock” position. locked. 3. Replace drive. Contact 3. Drive is incompatible or your Aspect Technical defective. Service representative for a 4. Drive is full. list of compatible drives. 4. Replace drive.
  • Page 61 7. Verify that the drive is 3. Drive is not formatted formatted as FAT32. properly. 8. Replace drive. Contact 4. Drive is incompatible or your Aspect Technical defective. Service representative for a 5. Drive is full. list of compatible drives. 9. Replace drive.
  • Page 62 SECTION 7 DIAGNOSTICS AND TROUBLESHOOTING ________________________________________________________________________ 7-12...

  • Page 63: Servicing The Bis View System

    Sections 8.11 and 8.13 for instructions on packaging and shipping. The BIS VIEW Monitoring System is designed to be easily serviced by using the built in diagnostic routines (see Section 7 “Diagnostics and Troubleshooting”) and the major component swapping techniques described below.

  • Page 64: Replacing The Monitor

    SECTION 8 SERVICING THE BIS VIEW MONITORING SYSTEM Replacing the Monitor Parts Required: Tools Required: BIS VIEW Monitor P/N 185-0205 None To replace the monitor: 1. Put monitor in Standby mode by pressing the ON/Standby button. The light to the right of the button should be yellow or off.

  • Page 65: Replacing The Battery

    Battery Replacement Kit P/N 186-0208 Philips #2 screwdriver Caution: All repairs to the BIS VIEW Monitoring System should be made only by a qualified Biomedical Engineering Technician or other authorized personnel. To replace the battery, you will need a Philips #2 screwdriver. Follow the instructions below: 1.

  • Page 66: Replacing The Power Supply

    Tools Required: Power Supply Replacement Kit P/N 186-0216 Philips #2 screwdriver Caution: All repairs to the BIS VIEW Monitoring System should be made only by a qualified Biomedical Engineering Technician or other authorized personnel. WARNING: POWER SUPPLY IS INTERNALLY FUSED. REPLACE POWER SUPPLY ONLY WITH ASPECT MEDICAL SYSTEMS BIS VIEW POWER SUPPLY.

  • Page 67: Replacing The Clamp Shoe

    To replace the Clamp Shoe, you will need Philips #2 and #8 screwdrivers. The power supply must be removed to access the Clamp Shoe screws. Follow the instructions below: 1. Unplug A/C line cord from the BIS VIEW monitor. 2. Lay the monitor screen-side-down on a scratch-free work surface so that the Battery/Power Supply cover is accessible.

  • Page 68: Replacing The Bisx Monitor Interface Cable

    SERVICING THE BIS VIEW MONITORING SYSTEM Replacing the BISx Monitor Interface Cable Caution: All repairs to the BIS VIEW Monitoring System should 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.
  • Page 69 SECTION 8 SERVICING THE BIS VIEW MONITORING SYSTEM 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 BISx housing.
  • Page 70 SECTION 8 SERVICING THE BIS VIEW MONITORING SYSTEM ZIF open feature 6. Align the key feature on the bulkhead and the BISx unit. Attach the flex cable from the BISx to the ZIF connector on the replacement cable. ZIF closed 7.

  • Page 71: Replacing The Bisx Bulkhead Connector

    8. Using the screws provided, set the screws in the holes. Slowly tighten to 45 in-oz. Replacing the BISx Bulkhead Connector Caution: All repairs to the BIS VIEW Monitoring System should be made only by a qualified Biomedical Engineering Technician or other authorized personnel.

  • Page 72: Procedure

    SECTION 8 SERVICING THE BIS VIEW MONITORING SYSTEM 8.8.2 Procedure: 1. Disconnect BISx from the monitor and remove Patient Interface Cable from BISx. 2. Remove screws from the bulkhead. Discard screws. ZIF open 3. Open the ZIF connector by pulling away from the bulkhead.
  • Page 73 SECTION 8 SERVICING THE BIS VIEW MONITORING SYSTEM 4. Disconnect from the flex cable. Discard the old gasket. 5. Set the new gasket in the groove of the BISx housing. 8-11...
  • Page 74 SECTION 8 SERVICING THE BIS VIEW MONITORING SYSTEM Key feature ZIF open 6. Align the key feature on the bulkhead and the BISx unit. Attach the flex cable from the BISx to the ZIF connector on the replacement bulkhead. ZIF closed 7.

  • Page 75: Using The Reset Button

    “Appendix I.” 5. Perform a Patient Interface Cable (PIC) Checkout Procedure as described in Section 6.3.3. “PIC Checkout Procedure.” For more detail, refer to the BIS VIEW Monitoring System Operating Manual. 6. Perform a leakage (electrical safety test) according to the appropriate institution requirements.

  • Page 76: Performing A Software Update

    SERVICING THE BIS VIEW MONITORING SYSTEM 8.11 Performing a 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.

  • Page 77: What To Do With A Component That Requires Service

    Seal the package with reinforced packing tape rather than plastic or masking tape. Mark shipping or storage container FRAGILE. • If the repair or replacement is covered by warranty or service agreement, Aspect will bear the costs of shipping the repaired or replacement product back to the user. All other shipping costs shall be paid by the user.
  • Page 78 SECTION 8 SERVICING THE BIS VIEW MONITORING SYSTEM 8-16...

  • Page 79: Specifications And Warranty

    SPECIFICATIONS AND WARRANTY _______________________________________________________________________ 9 SPECIFICATIONS AND WARRANTY INTRODUCTION This section includes: • General specifications of the BIS VIEW monitor and accessories • Electromagnetic compatibility specifications • Warranty General Specifications This section lists specifications for the BIS VIEW Monitoring System.
  • Page 80 SECTION 9 SPECIFICATIONS AND WARRANTY _______________________________________________________________________ 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) EEG Sweep Speed: 25 mm/sec Computed Parameters: Bispectral Index, EMG, SR and Signal Quality Indicator User-defined Displays:...
  • Page 81 SECTION 9 SPECIFICATIONS AND WARRANTY _______________________________________________________________________ BISx Specifications: BISx: Weight: 10.0 oz (0.284 kg) including integral cable Dimensions: 3.75 in diameter x 2.5 in thick (9.5 cm x 6.3 cm) Cable Length: 9 ft (2.7 m) Integral BISx Cable 4 ½ ft (1.4 m) from BISx to sensor connector Analog to Digital Converter: Noise-shaped sigma-delta Sampling Rate:...
  • Page 82 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 83: Electromagnetic Compatibility Specifications

    Electromagnetic Compatibility Specifications The BIS VIEW Monitoring System requires special precautions regarding Electromagnetic Compatibility (EMC). The BIS VIEW system must be installed 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 84 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 Emissions test...
  • Page 85 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 Immunity...
  • Page 86 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. Immunity...
  • Page 87 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 88 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 89: Warranty

    Aspect. Aspect shall have no obligation to make repairs, replacements, or corrections which result, in whole or in part, from normal wear and tear. Aspect 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 Aspect or an Aspect-authorized distributor or (c) with respect to any product sold under a brand name other than Aspect Medical Systems, Inc.
  • Page 90 SECTION 9 SPECIFICATIONS AND WARRANTY _______________________________________________________________________ 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 91: Accessories And Spare Parts List

    Battery/ Power Supply Cover Assembly with Shoe Clamp 150-0272 Handle, VIEW monitor 675-0022 Cable wrap (Blue, hook & loop) MISCELLANEOUS: 180-0061 Empty carton, with foam, BIS VIEW 536-0044 RS-232 Cable, approx 6 ft. length 186-0170 J-Hooks 635-0007 Foot, rubber .75”...

  • Page 92: Sensor Simulator: P/N: 186-0137

    SECTION 10 APPENDIX I _______________________________________________________________________ 10.2 Sensor Simulator: P/N: 186-0137 Instructions for Use Insert 2CH/4CH BIS Sensor Simulator service tool into patient interface cable. Impedance test will be initiated by BIS Monitoring System when it detects that simulator has been inserted.

  • Page 93: Test Sensor

    SECTION 10 APPENDIX I _______________________________________________________________________ Electrode # Acceptance 4 - 6 8 - 17 3 - 5 2 - 4 Range in Kohms Figure 9 - BIS Sensor Simulator individual electrode impedance range Safety Testing: Leakage Current Leakage current testing should be performed by a qualified Engineering Technician or authorized personnel only.

  • Page 94: Figure 10 - Bis Sensor

    SECTION 10 APPENDIX I _______________________________________________________________________ Figure 10 - BIS Sensor 2. Place the end of a small paper clip at the midpoint of electrode #2 then lay it across electrode #4. (See Figure 11.) Figure 11 - Connecting electrodes #2 and #4. 3.
  • Page 95 SECTION 10 APPENDIX I _______________________________________________________________________ 5. Connect this Test Sensor to the PIC. All impedance tests should complete successfully, with low impedance values. Typical values using this alternative Test Sensor are less than 5 K ohms. The following chart shows expected Test Sensor values: Test Sensor Values Electrode # Typical...

  • Page 96: Safety Tester Connection With Pic

    _______________________________________________________________________ 10.4 Safety Tester Connection with PIC This procedure describes a method to connect a BIS VIEW Monitoring System to a safety tester. It uses a current date sensor to provide a contact point for the safety tester leads that correspond to the patient contact points of the BIS VIEW system.

  • Page 97: Data Flow Diagram

    11 APPENDIX II 11.1 Data Flow Diagram Patient Input Amplification Sigma-Delta FPGA Connection Protection and Filtering Modulators Digital Serial Signal BISx Comm. Processor (DSP) BIS VIEW Monitor Serial Key switch Comm. Color Host Processor Display RS-232 Host Port Port 11-1...

  • Page 98: Block Diagram

    P100 J301 J300 PROCESSOR BOARD Serial Reset Switch Host Client Port CONNECTOR BOARD SPEAKER DISPLAY J103 CARD ENGINE MOTHER BOARD DISPLAY J100 BISx INTERFACE Connector BOARD J102 J101 SOFT KEYS Power ON/STANDBY BATTERY POWER SUPPLY SWITCH BIS VIEW MONITOR 11-2...
  • Page 100 (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 Service Information: www.aspectmedical.com/ASRS Aspect Medical Systems International B.V. EC REP Rijnzathe 7d2 3454 PV De Meern The Netherlands Main Business Phone: +31.30.662.9140 Main Business Fax: +31.30.662.9150 Email: amsint@aspectms.com...

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