BIS VISTA Monitoring
System
SERVICE INFORMATION MANUAL
Aspect Medical Systems, Inc.
Bispectral Index (BIS) Monitoring System
Rx only
EC REP
Aspect Medical Systems, Inc.
One Upland Road
Norwood, MA 02062 USA
(Tel) 617-559-7000
(Tel) 888-BIS INDE(X) (U.S. only)
(Fax) 617-559-7400
bis_info@aspectms.com
www.aspectmedical.com
Aspect Medical Systems International B.V.
3454 PV De Meern
Rijnzathe 7d2
0123
The Netherlands
Tel: +31.30.662.9140
Fax: +31.30.662.9150
amsint@aspectms.com
075-0015
1.00
BIS VISTA Monitoring
System
SERVICE INFORMATION MANUAL
Aspect Medical Systems, Inc.
Bispectral Index (BIS) Monitoring System
 Copyright, 2006, Aspect Medical Systems. All 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 Systems, Inc.
Aspect, Bispectral Index, BIS, the BIS logo, and Zipprep are trademarks of Aspect Medical
Systems, Inc. and are registered in the USA., EU and other countries.
TABLE OF CONTENTS
ABOUT THIS MANUAL ............................................................................................................. VIII
1
SAFETY PRECAUTIONS.................................................................................................... 1-1
1.1
1.2
1.3
2
BIS VISTA MONITORING SYSTEM OVERVIEW ........................................................... 2-1
2.1
2.2
2.2.1
2.2.2
2.3
2.4
3
WARNINGS ................................................................................................................................................. 1-1
CAUTIONS ................................................................................................................................................... 1-4
KEY TO SYMBOLS ........................................................................................................................................ 1-6
INTRODUCING THE BIS VISTA MONITORING SYSTEM .......................................................................... 2-1
PRINCIPAL COMPONENTS .......................................................................................................................... 2-2
The BIS VISTA Monitor........................................................................................................................................ 2-2
The BISx and Patient Interface Cable (PIC) ................................................................................................... 2-4
INSTRUMENT IDENTIFICATION .................................................................................................................. 2-4
PROPRIETARY INFORMATION AND DEVICES ............................................................................................ 2-5
PRINCIPLES OF OPERATION .......................................................................................... 3-1
3.1
HOW THE BIS VISTA MONITORING SYSTEM WORKS ........................................................................... 3-1
3.2
SYSTEM ARCHITECTURE ............................................................................................................................. 3-1
3.2.1
The BISx................................................................................................................................................................... 3-3
3.2.2
The BIS VISTA Monitor........................................................................................................................................ 3-5
3.3
SYSTEM FEATURES ....................................................................................................................................... 3-6
3.3.1
System Self Checks ............................................................................................................................................... 3-6
3.3.2
Diagnostic Codes ................................................................................................................................................... 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 INSTALLATION ......................................................... 4-1
4.1
ENVIRONMENT ............................................................................................................................................ 4-1
4.1.1
Shipping and Storage Environment .................................................................................................................. 4-1
4.1.2
Operating Environment........................................................................................................................................ 4-1
4.1.3
Power Requirements and System Grounding................................................................................................. 4-2
4.1.4
Site Preparation: Mounting the Monitor ......................................................................................................... 4-2
4.2
INSTRUMENT CONNECTIONS.................................................................................................................... 4-4
4.2.1
Connecting the BISx.............................................................................................................................................. 4-4
4.2.2
Power Cord Connections...................................................................................................................................... 4-4
4.3
INSTALLATION AND VERIFICATION PROCEDURE .................................................................................... 4-4
5
CARE AND CLEANING...................................................................................................... 5-1
5.1
CARE AND CLEANING................................................................................................................................ 5-1
5.1.1
Cleaning the Monitor and BISx.......................................................................................................................... 5-1
5.1.2
Disinfecting the Monitor and BISx .................................................................................................................... 5-1
5.1.3
Cleaning the Monitor Display............................................................................................................................. 5-2
6
PREVENTIVE MAINTENANCE ......................................................................................... 6-1
6.1
PHYSICAL INTEGRITY INSPECTION ............................................................................................................ 6-1
6.2
SYSTEM CHECKOUT ................................................................................................................................... 6-1
6.2.1
Monitor Checkout Procedure.............................................................................................................................. 6-2
v
6.2.2
BISx Checkout Procedure .................................................................................................................................... 6-3
6.2.3
Patient Interface Cable (PIC) Checkout Procedure....................................................................................... 6-4
6.3
CHECKING THE BATTERY .......................................................................................................................... 6-5
6.4
CHECKING LEAKAGE CURRENT ................................................................................................................ 6-6
7
DIAGNOSTICS AND TROUBLESHOOTING ................................................................. 7-1
7.1
7.2
7.3
8
SERVICING THE BIS VISTA SYSTEM.............................................................................. 8-1
8.1
8.2
8.3
8.4
8.5
8.6
8.7
8.7.1
8.7.2
8.8
8.8.1
8.8.2
8.9
8.10
8.11
8.12
8.13
9
GENERAL TROUBLESHOOTING ................................................................................................................. 7-1
BIS VISTA MONITORING SYSTEM TROUBLESHOOTING PROCEDURE................................................... 7-2
BIS VISTA SYSTEM MESSAGES AND CORRECTIVE ACTIONS .................................................................. 7-4
REPLACING THE PIC................................................................................................................................... 8-1
REPLACING THE BISX ................................................................................................................................. 8-1
REPLACING THE MONITOR ........................................................................................................................ 8-2
REPLACING THE BATTERY .......................................................................................................................... 8-3
REPLACING THE POWER SUPPLY ............................................................................................................... 8-4
REPLACING THE CLAMP SHOE ................................................................................................................... 8-5
REPLACING THE MONITOR INTERFACE CABLE ........................................................................................ 8-6
Parts and Tools Required .................................................................................................................................... 8-6
Procedure:................................................................................................................................................................ 8-6
REPLACING THE BISX BULKHEAD CONNECTOR ..................................................................................... 8-9
Parts and Tools Required .................................................................................................................................... 8-9
Procedure:..............................................................................................................................................................8-10
CALIBRATING THE TOUCH SCREEN ........................................................................................................ 8-13
USING THE RESET BUTTON ..................................................................................................................... 8-13
BISX CHECKOUT AND SAFETY TESTS..................................................................................................... 8-13
WHAT TO DO WITH A COMPONENT THAT REQUIRES SERVICE .......................................................... 8-14
REPACKAGING FOR SHIPPING AND STORAGE........................................................................................ 8-14
SPECIFICATIONS AND WARRANTY ............................................................................. 9-1
9.1
GENERAL SPECIFICATIONS ......................................................................................................................... 9-1
9.2
ELECTROMAGNETIC COMPATIBILITY SPECIFICATIONS ............................................................................ 9-5
9.2.1
Accessories............................................................................................................................................................... 9-5
9.2.2
IEC 60601-1-2:2001 Electromagnetic Compatibility Guidance............................................................... 9-6
9.3
WARRANTY .............................................................................................................................................. 9-11
10
APPENDIX I........................................................................................................................ 10-1
10.1
10.2
10.3
10.4
11
ACCESSORIES AND SPARE PARTS LIST ..................................................................................................... 10-1
SENSOR SIMULATOR: P/N: 186-0137 ........................................................................................... 10-2
TEST SENSOR............................................................................................................................................. 10-3
SAFETY TESTER CONNECTION WITH PIC.............................................................................................. 10-5
APPENDIX II ...................................................................................................................... 11-7
11.1
11.2
DATA FLOW DIAGRAM ............................................................................................................................ 11-7
BLOCK DIAGRAM ..................................................................................................................................... 11-8
vi
TABLE OF FIGURES
Figure 1 - Symbol Key (page 1 of 3)................................................................................ 1-6
Figure 2- The BIS VISTA Monitoring System.................................................................. 2-2
Figure 3 - Rear Panel ...................................................................................................... 2-3
Figure 4 - The BISx and PIC ........................................................................................... 2-4
Figure 5 - 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 10 - BIS Sensor................................................................................................... 10-3
Figure 11 - Connecting electrodes #2 and #4. .............................................................. 10-4
Figure 12 - Connecting electrode #3 with #4, and #1 with #2. .................................... 10-4
Figure 13 - Safety Tester Contact Points....................................................................... 10-5
vii
ABOUT THIS MANUAL
_______________________________________________________________________
ABOUT THIS MANUAL
This manual contains information necessary for the customer to install, maintain, service,
identify and prepare for use Aspect Medical Systems’ BIS VISTA Monitoring System. Also
included are directions to diagnose, troubleshoot, and repair the system. A spare parts and
accessories list and system specifications are included.
This manual is intended to be used in combination with the BIS VISTA Monitoring System
Operating Manual.
The BIS VISTA Monitoring System is designed and manufactured using state-of-the-art
components and manufacturing 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 of the BIS VISTA monitor.
This manual, in conjunction with the BIS VISTA Monitoring System Operating Manual,
contains the maintenance and diagnostic troubleshooting information necessary for
customer qualified technical personnel to test 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 BIS VISTA monitor, with the exception of
the power supply and battery.
Before attempting to set up or service the BIS VISTA Monitoring System, please familiarize
yourself with the safety information provided in Section 1 of this manual.
viii
SECTION 1
SAFETY PRECAUTIONS
________________________________________________________________________
SECTION 1
1 SAFETY PRECAUTIONS
INTRODUCTION:
Caution:
Carefully read the BIS VISTA Monitoring System Operating Manual
entirely before using the monitor in a clinical setting.
WARNINGS, CAUTIONS, AND NOTES
The terms warning, caution, and note have specific meanings in this manual.
•
•
•
A WARNING advises against certain actions or situations that could result in
personal injury or death.
A CAUTION advises against actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure, although personal injury is
unlikely.
A NOTE provides useful information regarding a function or 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 SAFETY REQUIREMENTS OF THIS EQUIPMENT MAY
LEAD TO A REDUCED LEVEL OF SAFETY OF THE RESULTING SYSTEM.
CONSIDERATION RELATING TO THE CHOICE SHALL INCLUDE:
• USE OF THE ACCESSORY IN THE PATIENT VICINITY
• EVIDENCE THAT THE SAFETY CERTIFICATION OF THE
ACCESSORY HAS BEEN PERFORMED IN ACCORDANCE TO THE
APPROPRIATE IEC 60601-1 AND/OR IEC 60601-2-26 HARMONIZED
NATIONAL STANDARD.
WHEN CONNECTING EXTERNAL EQUIPMENT (e.g., DATA CAPTURE
COMPUTER), THE SYSTEM LEAKAGE CURRENT MUST BE CHECKED
AND MUST BE LESS THAN THE IEC 60601-1 LIMIT.
EXPLOSION HAZARD: DO NOT USE THE BIS VISTA SYSTEM IN A
FLAMMABLE ATMOSPHERE OR WHERE CONCENTRATIONS OF
FLAMMABLE ANESTHETICS MAY OCCUR.
MONITOR IS NOT DESIGNED FOR USE IN MRI ENVIRONMENT.
1-1
SECTION 1
SAFETY PRECAUTIONS
________________________________________________________________________
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-SLOT OUTLET. IF THE OUTLET HAS ONLY
TWO SLOTS, MAKE SURE THAT IT IS 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 VISTA SYSTEM SHALL BE OPERATED FROM ITS
INTERNAL BATTERY POWER SOURCE ONLY.
FOR BIS VISTA SYSTEMS USED OUTSIDE OF NORTH AMERICA: A
HARMONIZED LINE CORD WITH CONDUCTORS HAVING A CROSS
SECTIONAL AREA GREATER THAN 0.75 mm2 MUST BE USED.
BE SURE THE MONITOR IS MOUNTED SECURELY IN PLACE TO AVOID
PERSONAL OR PATIENT INJURY.
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 SPILLAGE OF BLOOD OR SOLUTIONS
OCCURS, RE-TEST BEFORE FURTHER USE.
DO NOT MIX DISINFECTING SOLUTIONS (e.g., BLEACH AND AMMONIA),
AS HAZARDOUS GASES MAY RESULT.
ELECTRICAL SHOCK HAZARD: THE MANUFACTURER'S INSPECTION OF
THIS APPARATUS VERIFIED THAT THE GROUND LEAKAGE CURRENT
AND THE PATIENT SAFETY CURRENT WERE LESS THAN THE
SPECIFIED LIMITS ESTABLISHED BY THE APPLICABLE SAFETY
STANDARDS. AS A MATTER OF SAFE PRACTICE, THE INSTITUTION
SHOULD CONDUCT PERIODIC TESTS TO VERIFY THESE CURRENTS.
ELECTRICAL SHOCK HAZARD: DO NOT REMOVE MONITOR COVERS
DURING OPERATION OR WHILE POWER IS CONNECTED TO MONITOR.
GROUND WIRE LEAKAGE CURRENT MUST BE CHECKED WHENEVER
INSTRUMENT CASE IS OPENED BY A QUALIFIED BIOMEDICAL
ENGINEERING TECHNICIAN.
POWER SUPPLY IS INTERNALLY FUSED. REPLACE POWER SUPPLY ONLY
WITH ASPECT MEDICAL SYSTEMS BIS VISTA POWER SUPPLY.
1-2
SECTION 1
SAFETY PRECAUTIONS
________________________________________________________________________
ENSURE THAT THE BISx DOES NOT COME INTO PROLONGED
CONTACT WITH PATIENT’S SKIN, AS IT MAY GENERATE HEAT AND
CAUSE DISCOMFORT.
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSOR AND
CONNECTORS, INCLUDING THE NEUTRAL ELECTRODE, 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 LOCATED BETWEEN THE SURGICAL
SITE AND THE ELECTRO-SURGICAL 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 STRANGULATION, THE PATIENT
INTERFACE CABLE (PIC) MUST BE CAREFULLY PLACED AND SECURED.
SHOCK HAZARD: DO NOT ATTEMPT TO DISCONNECT THE POWER
CORD WITH WET HANDS. MAKE CERTAIN THAT YOUR HANDS ARE
CLEAN AND DRY BEFORE TOUCHING THE POWER CORD.
CONSIDERATIONS WHEN USING ELECTRO CONVULSIVE THERAPY
(ECT) EQUIPMENT DURING BIS MONITORING:
SEPARATE ECT ELECTRODES FROM THE BIS SENSOR AS MUCH AS
POSSIBLE TO MINIMIZE THE EFFECT OF INTERFERENCE.
CERTAIN ECT EQUIPMENT MAY INTERFERE WITH THE PROPER
FUNCTION OF THE BIS MONITORING SYSTEM. CHECK FOR
COMPATIBILITY OF EQUIPMENT DURING PATIENT SETUP.
1-3
SECTION 1
SAFETY PRECAUTIONS
________________________________________________________________________
1.2
Cautions
Read this entire manual carefully before using the monitor in a clinical setting.
To turn off all A/C power, disconnect power cord from A/C outlet. Battery can be
removed to shut down unit completely.
Continuous impedance checking may need to be disabled if the 1 nanoampere 128
Hz impedance check signal interferes with other equipment (e.g., evoked potential
monitors).
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 connector can interfere with PIC performance.
Check the battery periodically by operating a BIS VISTA monitor that has been
disconnected from the wall socket and that has been charged to full capacity (at least
6 hours of charge time). After long periods of storage (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 VISTA monitor fails to operate reliably from the battery
for approximately 45 minutes, battery replacement is required.
The BIS VISTA monitor contains an internal lithium ion battery. The battery must
be removed by a qualified service 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 a replacement battery: Aspect part number 186-0208.
All repairs to the BIS VISTA 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.
Using accessories other than those specified may result in increased electromagnetic
emissions or decreased electromagnetic immunity of the BIS VISTA Monitoring
System.
The BIS VISTA Monitor should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the BIS VISTA monitor should
be observed to verify normal operation in the configuration in which it will be used.
Do not block ventilation inlet holes on the underside of monitor.
1-4
SECTION 1
SAFETY PRECAUTIONS
________________________________________________________________________
Do not open the BISx for any reason. The seal to prevent liquids from entering the
BISx may be damaged if opened. Service or repairs must be performed only by
qualified biomedical technicians.
The BIS VISTA 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.
Do not disconnect the BISx during the software upgrade.
The BIS VISTA 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 electromagnetic interference (EMI). If this
occurs:
• Increase separation between devices
• Re-orient device cabling
• Plug devices into separate outlet circuit branches
Refer to Section 9.2 “Electromagnetic Compatibility Specifications.”
When connecting or disconnecting BISx, take care not to touch the exposed contacts
of either connector. Damage due to electrostatic discharge may result.
All work involving opening the instrument case must be performed in a static-safe
environment to prevent damage to electronic components and assemblies. This
environment includes the operator, work area and tools, and any other test or storage
items that might touch the monitor or BISx assemblies.
Important:
The BIS VISTA systems comply with the European Medical Device Directive
(MDD) and applicable regulatory requirements of the country distributed to and
carry the CEXXXX Marking. Declarations of Conformity provided upon request
where appropriate.
1-5
SECTION 1
SAFETY PRECAUTIONS
________________________________________________________________________
1.3
Key to Symbols
Manufacturer
EC REP
Authorized Representative in the European Community
Conformité Européenne (CE) Marking of Conformity to European
Medical Device Directive. CEXXXX represents the Notified Body
number
Classified 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
Underwriters Laboratories Inc.
Latex-free product
Type BF Equipment
Type BF Equipment Defibrillator-proof
Crossed out wheelie bin indicates separate treatment from general
waste at end of life
Attention, Consult Accompanying Documents
Attention, Data I/O, RS-232 Serial Port, Consult Accompanying
Documents
Figure 1 - Symbol Key (page 1 of 3)
1-6
SECTION 1
SAFETY PRECAUTIONS
________________________________________________________________________
Attention, USB-A, Host. Consult Accompanying Documents
USB-A
Attention, USB-B function. Consult Accompanying Documents
USB-B
Caution: Hot Surface
Alternating Current
D/C Current
Battery Location
Reset Button
Packaging Labelling:
Storage Temperature Limits, Fragile, Do Not Get Wet, and This
Side Up
Monitor Power ON
Monitor Power OFF or Standby Mode
Figure 1 - Symbol Key (page 2 of 3)
1-7
SECTION 1
SAFETY PRECAUTIONS
________________________________________________________________________
Operating 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 box denotes ON or active condition.
A red box with an ‘X’ denotes OFF or cancel.
Figure 1 - Symbol Key (page 3 of 3)
1-8
SECTION 2
BIS VISTA MONITORING SYSTEM OVERVIEW
_______________________________________________________________________
SECTION 2
2 BIS VISTA MONITORING SYSTEM
OVERVIEW
2.1
Introducing the BIS VISTA Monitoring
System
The BIS VISTA Monitoring System is intended for use under the direct supervision of a
licensed healthcare practitioner or by personnel trained in its proper use. The BIS VISTA
Monitor 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.
The BIS may be used 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 recall in adults during general anesthesia and sedation.
The BIS VISTA Monitoring System processes raw EEG signals to produce a single number,
called the Bispectral Index, or BIS, which correlates to the patient’s level of hypnosis. It
operates from an AC power source of 100V to 240V, 50/60Hz, and provides approximately
45 minutes of automatic back-up battery power.
The monitor is menu-driven with on-screen touch keys. A detailed description of how the
BIS VISTA Monitoring System works is included in the BIS VISTA Operating Manual.
Please refer to the BIS VISTA Operating Manual for additional information.
2-1
SECTION 2
BIS VISTA MONITORING SYSTEM OVERVIEW
_______________________________________________________________________
BIS VISTA monitor
BIS sensor
Patient Interface
Cable (PIC)
Monitor
Interface
Cable
BISx
Figure 2- The BIS VISTA Monitoring System
2.2
Principal Components
The system is composed of a monitor, a BISx, a Patient Interface Cable (PIC), and BIS
sensor.
2.2.1 The BIS VISTA Monitor
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 exception of the
ON/Standby button) are accessible by touching a designated area on the monitor screen.
This area is called a touch key. The touch keys are designed to function even when the user
is wearing examination gloves.
2-2
SECTION 2
BIS VISTA MONITORING SYSTEM OVERVIEW
_______________________________________________________________________
ON/Standby button
The ON/Standby button is located in the lower right corner of the monitor and is used to
put the monitor in ON or in Standby mode. When the small LED light to the right of the
ON/Standby button is green, the unit is running and providing power to the BISx. When it
is yellow, the battery is charging 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.
USB Port
(Type A)
Reset Button
Serial Port
USB Port
(Type B)
Power Cord
Receptacle
Battery/Power
Supply Cover
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.
The clamp shoe allows the monitor to slide into the pole clamp so that it can be attached to
a ½" – 1 ½" diameter vertical pole.
2-3
SECTION 2
BIS VISTA 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.
Bulkhead Connector
Monitor Interface
Cable
PIC
Figure 4 - The BISx and PIC
The BISx is shown in Figure 4. Its long flexible Monitor Interface Cable connects to the
front of the monitor. The Patient Interface Cable (PIC) connects the BIS sensor to the
BISx.
The attachment 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 the rear panel. This
information includes instrument model and serial numbers, power ratings, cautions, and the
Aspect Medical Systems shipping address.
BISx
The BISx identification information is permanently marked on its rear panel. This
information includes instrument model and serial numbers and cautions.
The PIC
The Patient Interface Cable lot number is stamped on the cable itself.
Software Revision Numbers
Software revision numbers may be displayed by pressing the “Configuration Information”
touch key in the menu system.
2-4
SECTION 2
BIS VISTA MONITORING SYSTEM OVERVIEW
_______________________________________________________________________
2.4
Proprietary Information and 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 the BIS VISTA Monitoring System design are proprietary and are the subject of
patents and patents pending. See the BIS VISTA Operating Manual for details.
2-5
SECTION 2
BIS VISTA MONITORING SYSTEM OVERVIEW
_______________________________________________________________________
2-6
SECTION 3
PRINCIPLES OF OPERATION
_______________________________________________________________________
SECTION 3
3 PRINCIPLES OF OPERATION
INTRODUCTION
This section includes:
• How the BIS VISTA Monitoring System works
• The architecture of the BIS VISTA monitor and BISx
• System Features
3.1
How the BIS VISTA Monitoring System
Works
The BIS VISTA Monitoring System consists of:
• The BIS monitor with built-in battery backup and detachable power cord
• The BISx
• Aspect’s Patient Interface Cable (PIC) and BIS sensor.
A sensor placed on the patient’s head transmits EEG signals to the BISx. The BISx filters
the data, analyzes it for artifact and processes it using 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 order to
provide easier pattern recognition of changes over time during the recording.
3.2
System Architecture
Hardware is divided into three main components: the monitor, the BISx, and the Patient
Interface Cable (PIC) with BIS sensor. The BISx contains the circuits that acquire and
digitize the EEG signals, digitally process the EEG data, and compute the processed
parameters. The BIS VISTA monitor contains the circuits to display the waveforms and
processed parameters. The PIC and BIS sensor are the patient connection for EEG signal
acquisition.
A block diagram depicting the monitor subassemblies appears in Figure 5. A data flow
diagram appears in Figure 6.
3-1
SECTION 3
PRINCIPLES OF OPERATION
_______________________________________________________________________
BISx
Patient
Bulkhead
DIGITIZER
BOARD
P103
P102
P101
P100
J301
J300
PROCESSOR
BOARD
Reset
Switch
SW1
USB
Host
J2
USB
Client
J3
Serial
Port
J4
CONNECTOR BOARD
J1
SPEAKER
J11
BACKLIGHT
INVERTER
J13
DISPLAY
J7
TOUCH
PANEL
J3
J12
CARD
ENGINE
J4A
MOTHER
BOARD
P4A
J2
P4C
J4B
BISx
Connector
J4C
P4B
J9
J1
J8
ON/STANDBY
SWITCH
BIS VISTA MONITOR
BATTERY
POWER SUPPLY
Figure 5 - The BIS VISTA System Block Diagram
3-2
AC
Power
SECTION 3
PRINCIPLES OF OPERATION
_______________________________________________________________________
Patient
Connection
Input
Protection
Amplification
and Filtering
Sigma-Delta
Modulators
Serial
Comm.
BISx
FPGA
Digital
Signal
Processor
(DSP)
BIS VISTA Monitor
Serial
Comm.
Color
Display
Host Processor
USB
Host
Port
RS-232
Port
Figure 6 - The BIS VISTA 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). 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, amplifiers, and digitizers for two channels of EEG, and
contains the circuits to digitally process the EEG data and compute the processed
parameters. It has a single point connection that connects via a Patient Interface Cable (PIC)
to a BIS sensor. The sensor and PIC contain circuits for identifying them to the monitor.
This permits the monitor to configure automatically.
The BISx contains circuits for injecting self-test voltages into the amplifier inputs. It
constantly monitors the combined source impedance from the sensor electrodes and is able
to measure the individual impedance of the channel and ground electrodes.
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PRINCIPLES OF OPERATION
_______________________________________________________________________
3.2.1.1 BISx Signal Conditioning
The input protection circuits are designed to protect the input from destruction by electric
shock from sources such as electrostatic discharge (ESD) or defibrillation. The protection
circuits also reduce the effects of high frequency ambient noise from sources such as electrocautery and other devices.
Input signals are amplified by instrumentation amplifiers, which have a fixed gain. The
amplifiers have DC servos, which remove the signals below high pass cutoff frequency. In
the event of amplifier overload, the servos are changed to a higher frequency to facilitate fast
recovery (blocking) under control of the host processor.
Each channel is further amplified to the level required by the A/D converters. The
amplifiers also serve as filters to prevent aliasing by the converters.
3.2.1.2 BISx Impedance Testing
In the default state of the BISx the combined channel electrodes’ impedance is continuously
checked. A small current (approximately 1 nanoampere) is injected into each electrode at 128
Hz, just above the EEG band. The resulting voltages are measured. Equal but opposite
currents are injected into the (+) and (-) electrodes simultaneously while 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 check by injecting
current into the REF electrode only. Individual electrode impedance is derived by
subtracting the resulting value from the combined value. BIS monitoring is interrupted while
individual impedance is checked.
The ground electrode impedance is also measured while injecting current into the REF
electrode. BIS monitoring is interrupted while the ground impedance is checked. Ground
impedance checking occurs when a sensor check is performed and thereafter on a 10-minute
schedule during patient monitoring.
The impedance check signal can occasionally interfere with other monitoring equipment
connected to the patient. Evoked potential monitors are particularly susceptible because they
use a wide bandwidth. The automatic impedance check feature can be turned off by selecting
“Impedance Checking – OFF.” (See Operating Manual for specific instructions).
3.2.1.3 BISx Processor and Communications Circuits
The BISx contains: an analog to digital (A/D) converter for each channel, the monitor
interface, the sensor interface and the power supply circuits. A crystal controlled BISx
master clock is on this board. This clock is the system’s BIS processing clock.
A/D Conversion
There are two independent sigma-delta modulators for the two channels. These run at 16384
samples per second.
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SECTION 3
PRINCIPLES OF OPERATION
_______________________________________________________________________
Test Signal
A calibrated test signal is generated during the DSC Self Test. The signal is a 2 Hz square
wave of approximately +/-50µV. It is applied to the inputs of the differential amplifiers,
resulting in a test of the entire signal path except for the input connections and protection
circuits. During the Self Test, noise, gain and frequency response are checked.
Interface to the Monitor
Output from the two channels are multiplexed in a field programmable gate array (FPGA).
Multiplexed with the EEG data is status information such as BISx identification,
“lead off” indication, and power supply faults.
The BISx decodes the control information coming from the monitor via a command line.
Commands such as “block” amplifier saturation and conduct impedance tests are
transmitted.
BISx Power Supply (Patented technology)
The BISx derives power from the monitor. Power supply circuitry produces the necessary
voltages for operation. Power for patient-connected circuits is provided through a
transformer. These circuits are isolated for patient safety.
3.2.1.4 The BISx Mechanicals
The BISx 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 cables are strain relieved. The cables and the BISx
Bulkhead Connector (used to attach the PIC to the BISx) can be replaced, if necessary, by
the user. The attachment clip on the back of the BISx may be used to secure it to a
convenient location near the patient’s head.
There are no ventilation holes in the BISx case. It will not leak when splashed with liquids.
The case is electrically shielded both to prevent spurious emissions from the BISx and to
prevent externally caused interference with the BISx circuits.
3.2.2 The BIS VISTA Monitor
The BIS VISTA monitor contains the circuits to enable the touch screen, 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.
The monitor also contains the circuits for powering the monitor and the BISx. An on board
annunciator generates alarm sounds.
A block diagram depicting the monitor subassemblies appears in Figure 5. A data flow
diagram appears in Figure 6. The signals are acquired, digitized, filtered, and processed by
the BISx. The BISx multiplexes the signals onto the BISx communications line. The data are
de-multiplexed in the monitor for display.
3-5
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PRINCIPLES OF OPERATION
_______________________________________________________________________
The Main board controls all input and outputs, power, data memory, and clock functions.
The Card Engine controls the screen display.
The Connector board connects the reset button, USB and serial ports to the main board.
There are two USB ports. The USB Type A port is used to export data to a removable drive.
It is also used to upgrade monitor and BISx software. The RS-232 serial port can be used to
transfer data from the monitor.
3.2.2.1 The BISx Interface
The BISx interface is composed of two unidirectional bi-phase encoded serial lines, one
going to the BISx and another bringing data from the BISx.
The power to the interface is under software control. An overcurrent detector circuit
monitors current to the BISx. If the current exceeds the expected value, the power is shut
off to the BISx by the hardware and the user is notified.
3.2.2.2 The Interconnect Board
The Interconnect board provides the physical 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, 50-60 Hz, with output of 12
VDC, 24 watt maximum. It charges the battery; 7.2 V (nominal), 2150 mA hr. Signals are
provided to the processor to indicate AC FAIL, RESET, and LOW BATTERY. The power
supply contains internal fuses.
Caution:
To turn off all A/C power, disconnect power cord from A/C outlet.
Battery can be removed to shut down unit completely.
3.2.2.4 The Battery
The battery is for backup use only. The battery includes temperature and current control
elements, and has a nominal output of 7.2 volts DC. The battery charges whenever the BIS
VISTA monitor is plugged into A/C power. It is capable of supporting monitor operation
for approximately 45 minutes.
Note:
The BIS VISTA 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 8.10 “Using the Reset Button”).
3.3
System Features
3.3.1 System Self Checks
The BIS VISTA monitor has several self-checking features to ensure that the system is
operating properly. These include:
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SECTION 3
PRINCIPLES OF OPERATION
_______________________________________________________________________
3.3.1.1 System Check
Software image checksums and trend data memory are tested and repaired if necessary
when the system is powered up for the first time, after a new battery or power supply are
installed, or after the system has been reset.
3.3.1.2 Equipment and Connection Checks
The system checks continuously to be sure that the BISx, the PIC, and patient sensors are
operating properly and have not become disconnected.
3.3.1.3 DSC Self Test
The DSC Self Test tests the digital signal acquisition and conversion functions of the BISx.
It is a thorough test of the entire signal processing chain. The DSC Self Test may be initiated
from the Diagnostics Menu (See Section 6.2.2., “The BISx Checkout Procedure”)
3.3.1.4 Sensor Integrity Check
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.
3.3.1.5 Impedance Check (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 impedance checking may need to be disabled if the 1
nanoampere 128 Hz impedance check signal interferes with other
equipment, e.g., evoked potential monitors.
3.3.2 Diagnostic Codes
The BIS VISTA 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 Diagnostics Menu.
3.3.3 Monitor Data Memory
The monitor stores recorded trend data with time and date of acquisition. The duration of
trend data stored is approximately 72 hours. Trend memory can be viewed on the screen by
pressing the [Trend Review] key or, while a case is in progress, by using the Review arrow
key [◄] .
Information on the current sensor can be viewed in the “Configuration Information”
Screen.
When the memory is full, the oldest data are automatically erased as new data are stored.
Memory will be retained even if the battery has been discharged and remains when the
monitor is in the power off condition.
3-7
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. The duration of BISx data stored is approximately
1200 hours.
To view BISx history for a specific case, the user must first identify which BISx was in use
during the case by looking up the BISx serial number in the Maintenance Menu’s “BISx
Connection History.” The appropriate serial number BISx can then be connected to any
monitor to export its History Data.
When the BISx memory is full, the oldest data are automatically erased as new data are
stored. Memory will be retained even if the monitor battery has been discharged and remains
when the monitor and BISx are powered off.
3.3.5 Saved Settings
Whenever the monitor is started up from Standby mode, it reverts to user settings that have
been set up and then saved using the [Save Settings] touch key. Settings are saved to the
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 Checking (always
returns to ON), Filters (returns to ON), and Display Type (returns to BIS).
To restore factory settings to the current Monitor Mode, use the [View/Save Settings]
function. To restore the factory settings to all modes, press [Restore Default Settings for
All Modes] in the Maintenance Menu.
3.3.6 Battery Operation
In the event of a power failure or interruption of power during a procedure, the monitor
automatically switches to back-up battery operation. A fully charged battery will provide
approximately 45 minutes of operation. When the system is running on battery, a battery
icon displays next to the BIS number, indicating the battery status. When the battery reaches
a low power condition, the monitor beeps and the battery symbol displayed on the screen
changes color from green to orange. In addition, a “Battery Power Low” message blinks
continuously in the Message area of the screen.
The Save Settings feature is disabled when the battery power is low. Battery recharge time is
approximately 6 hours.
Caution:
To turn off all A/C power, disconnect power cord from A/C outlet.
Battery can be removed to shut down unit completely.
3-8
SECTION 3
PRINCIPLES OF OPERATION
_______________________________________________________________________
3.3.7 Data Transfer and Software Updates
Three ports on the rear of the BIS VISTA 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. BIS values and other EEG data may also be acquired from the monitor using
the RS-232 serial port. To connect to a personal computer, please contact Aspect Medical
Systems Technical Service for instructions. (See back cover for contact information.)
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:
• USE OF THE ACCESSORY IN THE PATIENT VICINITY
• EVIDENCE THAT THE SAFETY CERTIFICATION OF THE
ACCESSORY HAS BEEN PERFORMED IN ACCORDANCE
TO THE APPROPRIATE IEC 60601-1 AND/OR IEC 60601-2-26
HARMONIZED NATIONAL STANDARD.
WHEN CONNECTING EXTERNAL EQUIPMENT (e.g., DATA
CAPTURE COMPUTER), THE SYSTEM LEAKAGE CURRENT
MUST BE CHECKED AND MUST BE LESS THAN THE IEC
60601-1 LIMIT.
NOTE:
When software is updated, all previously recorded data and monitor configuration settings
will be lost. Therefore, configuration settings should be recorded before the software update
is performed.
3-9
SECTION 3
PRINCIPLES OF OPERATION
_______________________________________________________________________
3-10
SECTION 4
PREPARATION FOR USE AND INSTALLATION
_______________________________________________________________________
SECTION 4
4 PREPARATION FOR USE AND
INSTALLATION
INTRODUCTION
This section provides an overview of installation information for service personnel working
with the Aspect BIS VISTA Monitoring System. Please see the BIS VISTA Monitoring
System Operating Manual for full installation instructions.
• Environment
• Instrument connections
• Installation and verification procedure
4.1
Environment
4.1.1 Shipping and Storage Environment
The monitor and its accessories can be stored or shipped within the following environmental
limits. Note that these limits apply to non-operational storage and shipping situations.
Temperature
Humidity
Pressure
-10°C to +60°C
15% to 95% (non-condensing)
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
buildings and outside storage. Once moved inside, allow the monitor to stabilize in the
unopened shipping container at the inside ambient temperature before unpacking and
placing into service. Before operation, wipe down all visible condensation and allow the
system to reach equilibrium at room temperature.
4.1.2 Operating Environment
The BIS VISTA Monitoring System is not designed for use in areas containing flammable
gases or vapors.
WARNING!
EXPLOSION HAZARD: DO NOT USE THE BIS VISTA SYSTEM
IN A FLAMMABLE ATMOSPHERE OR WHERE
CONCENTRATIONS OF FLAMMABLE ANESTHETICS MAY
OCCUR.
MONITOR IS NOT DESIGNED FOR USE IN MRI
ENVIRONMENT.
Temperature: The BIS VISTA monitor is designed to operate safely at a room temperature
of 0°C to 40°C. Conditions that exceed these limits could affect reliability.
4-1
SECTION 4
PREPARATION FOR USE AND INSTALLATION
_______________________________________________________________________
Humidity: The monitor is designed to operate within specifications at a relative noncondensing humidity of 15% to 95%.
Pressure: The monitor will operate satisfactorily at or above sea level, and is unaffected by
extremes or changes in altitude within atmospheric pressures of 360 mmHg to 800 mmHg.
4.1.3 Power Requirements and System Grounding
The BIS VISTA 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.
Accordingly, the monitor is equipped with a hospital grade line cord. The power cord
grounds the system to the power line ground when plugged into an appropriate three-wire
receptacle.
WARNING!
FOR PROPER GROUNDING, THE POWER RECEPTACLE
MUST BE A THREE-WIRE GROUNDED OUTLET. A HOSPITAL
GRADE OUTLET IS REQUIRED. NEVER ADAPT THE THREEPRONG PLUG FROM THE MONITOR TO FIT A TWO-SLOT
OUTLET. IF THE OUTLET HAS ONLY TWO SLOTS, MAKE
SURE THAT IT IS 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 VISTA MONITOR
SHALL BE OPERATED FROM ITS INTERNAL BATTERY
POWER SOURCE ONLY.
FOR BIS VISTA SYSTEMS USED OUTSIDE OF NORTH
AMERICA - A HARMONIZED LINE CORD WITH
CONDUCTORS HAVING A CROSS SECTIONAL AREA
GREATER THAN 0.75 mm2 MUST BE USED.
4.1.4 Site Preparation: Mounting the Monitor
Aspect Medical Systems, Inc. strongly recommends permanent mounting of the BIS VISTA
monitor to the anesthesia machine to enhance safety and facilitate ease-of-use. Please
contact your local representative or Aspect to discuss mounting options.
WARNING!
BE SURE THE MONITOR IS MOUNTED SECURELY IN PLACE
TO AVOID PERSONAL OR PATIENT INJURY.
4-2
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.
2. Line up the clamp shoe (on back of monitor) with the slot on pole clamp and slide
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, 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. Line up the clamp shoe (on back of monitor) with the slot on pole clamp and slide
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.
2. Make sure that set screw hole on pole clamp aligns with corresponding hole on clamp
shoe.
3. Remove black knob screw from pole clamp.
4-3
SECTION 4
PREPARATION FOR USE AND INSTALLATION
_______________________________________________________________________
4. Using the Allen wrench supplied, secure pole clamp to monitor with the set screw
provided.
5. Replace black knob screw.
6. To attach to pole, place pole within clamp bracket and tighten screw using the black
finger knob.
4.1.4.2 Optional Mounting Accessories
For information on optional mounting accessories, request Aspect’s “Monitor Mounting
Solutions” booklet (part number 070-0031).
4.2
Instrument Connections
Detailed connection instructions are provided in the BIS VISTA Operating Manual.
4.2.1 Connecting the BISx
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.
Once connected, the BISx need not be disconnected again. However, if you wish to
disconnect the BISx cable from the monitor, carefully grasp the connector and pull.
DO NOT pull on the cable.
2. Connect the PIC to the BISx
Attach the gray connector of the Patient Interface Cable to the BISx.
Note:
Connect with the BIS logo facing up for proper pin alignment. To disconnect the PIC, grasp
the connector housing and pull firmly. DO NOT pull apart by the cable wire.
4.2.2 Power Cord Connections
The BIS VISTA Monitoring System is designed to use only 3-conductor IEC hospital-grade
power cords. Cords must be type SJE, SJT, or SJO. Check for a firm connection.
4.3
Installation and Verification Procedure
1. Open packages and inspect for all components:
• Monitor
• Power cord
• Pole clamp
• BISx
• PIC (Patient interface cable, connects BISx to patient)
2. Connect power cable to monitor, plug power plug into appropriate wall outlet.
4-4
SECTION 4
PREPARATION FOR USE AND INSTALLATION
_______________________________________________________________________
•
Verify that light to right of ON/Standby button is yellow.
3. Start up monitor by pressing the ON/Standby button (lower right corner).
• 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.
• Verify screen says, “BISx Initialization Complete.”
• Verify SENSOR CHECK begins.
5. Disconnect power cord from rear of monitor.
• Verify ‘OPERATING ON BATTERY BACKUP’ is displayed.
• Verify battery icon displays below BIS number.
6. Reconnect power cord.
• Verify battery icon is not displayed below BIS number.
• Verify “OPERATING ON BATTERY BACKUP” is not displayed.
7. End of install.
4-5
SECTION 4
PREPARATION FOR USE AND INSTALLATION
_______________________________________________________________________
4-6
SECTION 5
CARE AND CLEANING
_______________________________________________________________________
SECTION 5
5 CARE AND CLEANING
INTRODUCTION
This section describes:
• Care and cleaning procedures
• Preventive maintenance
5.1
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.
5.1.1 Cleaning the Monitor and BISx
Clean any spillage of blood or solutions on either the monitor or BISx as soon as possible.
Dried blood is very difficult to remove. Use lint-free absorbent towels for spill cleanups.
Dampen 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 BISx performance.
5.1.2 Disinfecting the Monitor and BISx
Use lint-free absorbent towels dampened with a 10% bleach solution, or a commercial
disinfectant (e.g. Lysol® Professional Disinfectant Foam Cleaner Spray or PDI Germicidal
Disposable Wipes).
After cleaning, dry all areas except the monitor display screen (see below) with a lint-free
absorbent paper towel. Wipe the BISx and PIC connector ends with alcohol and allow to dry
completely.
WARNING!
WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR
SOLUTIONS OCCURS, RE-TEST GROUND LEAKAGE
CURRENT BEFORE FURTHER USE.
DO NOT MIX DISINFECTING SOLUTIONS (e.g., BLEACH AND
AMMONIA) AS HAZARDOUS GASES MAY RESULT.
5-1
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. To avoid
scratching the screen, never use abrasive cleaners.
5-2
SECTION 6
PREVENTIVE MAINTENANCE
_______________________________________________________________________
SECTION 6
6 PREVENTIVE MAINTENANCE
INTRODUCTION
The BIS VISTA system is designed so that no periodic adjustment or calibration is required.
Suggested routine maintenance covered in this section includes:
• Periodic checking of cable integrity
• System checkout
• Checking the battery
• Checking leakage current
Instructions on replacing cables, connectors, the battery, the power supply and the clamp
shoe are included in Section 8, “Servicing the BIS VISTA System” if replacement is
necessary. In the event that the touch screen needs calibration, follow the instructions in
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.
1. Inspect the cases of the monitor and the BISx to ensure that plastic is not cracked or
broken.
2. Inspect the gasket seal around the case joining surfaces to insure the integrity of the
splash resistance seal.
3. Inspect the cables and strain relief mechanisms.
4. Inspect the connectors for damage, faulty strain relief or contamination.
6.2
System Checkout
A system checkout should be done periodically to verify that all system components are in
working order. To test the system from the BISx to the BIS sensor, you will need a Sensor
Simulator (Part Number 186-0137) or a Test Sensor (See Appendix I for more information).
Follow the instructions below for System Checkout.
6-1
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PREVENTIVE MAINTENANCE
_______________________________________________________________________
6.2.1 Monitor Checkout Procedure
The successful completion of this test will verify that the monitor is functioning and that all
operator input (touch keys) and output (display and audio alarm) are OK.
IF ANY FAILURES ARE NOTED, SEE SECTION 7.3, “BIS
VISTA System Messages And Corrective Actions”.
1. Disconnect the BISx from the monitor.
2. Connect power cord to monitor. Plug power plug into appropriate wall outlet.
• Verify that the light to the right of the ON/Standby button is yellow.
3. Start up monitor by pressing the ON/Standby button (lower right corner).
• Verify that the light to the right of the 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 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 BACKUP’ is displayed.
• Verify battery icon displays below BIS number.
NOTE:
Since the BIS VISTA 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. Reconnect power cord.
• Verify battery icon is not displayed below BIS number.
• Verify ‘OPERATING ON BATTERY BACKUP is not displayed.
NOTE:
Since the BIS VISTA 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:
• Verify AC power outlet (wall outlet) is supplying AC Volts of 110vac to 240vac at a
frequency of 50hz to 60hz. Move power cord to known good outlet.
• Verify AC power cord is good. Swap power cord with known good one.
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PREVENTIVE MAINTENANCE
_______________________________________________________________________
•
•
If monitor runs on battery when it is plugged in to AC power, the power supply may
need replacement.
If failure continues after above actions, the monitor will need to be serviced, see
section 8.12, “What To Do With a Component That Requires Service.”
7. End of monitor checkout.
6.2.2 BISx Checkout Procedure
Periodically the BISx and associated cables and connectors should be inspected for physical
damage and verification that the BISx will pass the DSC Self Test. Begin this procedure with
the system components disconnected. The successful completion of this test verifies that the
BISx circuits are functioning properly and that it is recognized by and communicates with
the monitor.
IF ANY FAILURES ARE NOTED, SEE SECTION 7.3, “BIS
VISTA System Messages And Corrective Actions”.
1. Using a known good BIS VISTA monitor (see Section6.2.1 “Monitor 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 “Connect sensor or cable” displays.
3. Press the [MENU] touch key to access menu options.
4. Press [Next] twice until the “Diagnostics” option is displayed.
5. Press [Diagnostics].
6. Press [DSC Self Test] to initiate the test.
• Verify that the display shows “DSC Self Test Results: PASS.” This takes
approximately 20 seconds. Note that test results are posted in 4 tests for 2
channels. If a test fails, the failed test displays either “***” or the word, “FAIL.”
7. Press [Return to Previous Menu] and repeat the DSC Self Test while flexing
cables to see if intermittent opens or shorts exist.
IF ANY FAILURES ARE NOTED:
• Swap BISx with known good one to verify that problem does not exist with the
monitor.
• If failure is isolated to this BISx, it will need to be serviced. See section 8.12 “What
To Do With a Component That Requires Service.”
8. Press [HOME] to exit. If PIC and Sensor are available, perform PIC Checkout
Procedure. See section 6.2.3 “Patient Interface Cable (PIC) Checkout Procedure.”
6-3
SECTION 6
PREVENTIVE MAINTENANCE
_______________________________________________________________________
6.2.3 Patient Interface Cable (PIC) Checkout Procedure
The successful completion of this test will verify function of the BIS VISTA 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.
Use a Sensor Simulator or make a Test Sensor for this test. See Section 10.3 “Test Sensor”
for details.
IF ANY FAILURES ARE NOTED, SEE SECTION 7.3, “BIS
VISTA System Messages And Corrective Actions”.
1. Using a known good BIS VISTA monitor (see section 6.2.1 “Monitor Checkout
Procedure) and a known good BISx (see section 6.2.2 “BISx Checkout Procedure)
connect the PIC that you are testing to the BISx, and connect the BISx to the BIS
VISTA monitor.
2. Press the monitor’s ON/Standby button to start up the monitor and BISx. At the
completion of the power up self-test, verify that the screen message “Connect sensor
or cable” displays.
3. Connect a Sensor Simulator (see Section 10.2) or Test Sensor (see Section 10.3) to
the PIC cable.
4. A sensor check is initiated automatically when 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, the BIS Trend screen displays.
5. If the Sensor Check is not immediately successful, the Sensor Check Graphic
Screen displays automatically. This screen shows a sensor with each electrode
numbered. Colors indicate the status of each electrode.
• White hollow circle – No status is available (Lead is off).
• Green circle – The electrode impedance is within the acceptable range.
• Red blinking circle – The electrode impedance is not within the acceptable range.
The impedance value for each electrode, in kilo ohms, appears on the screen along
with its status:
• 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. As long as the combined impedance of electrodes #1 and #3 and the
combined impedance of electrodes #1 and #4 are less than 15 kilo ohms, the
sensor check will be considered successful.
• NOISE - If the signal from the electrode goes beyond the measurable range, the
label “NOISE” displays.
• LEAD OFF - If the impedance check indicates that the electrode is not in
contact with the patient, the label “LEAD OFF” displays.
6-4
SECTION 6
PREVENTIVE MAINTENANCE
_______________________________________________________________________
6. If the Sensor Check is successful, repeat the test by pressing the [SENSOR
CHECK] touch key. The Sensor Check Graphic Screen displays. During the test
sequence, flex the cable and connections at the PIC/SENSOR, and PIC/BISx
connections. Note that gentle flexing of these cables and connectors should not
cause the Sensor Check to fail.
NOTE:
Sensor Check is used in clinical application as an indicator of the patient’s
skin conductivity. When used with a Sensor Simulator or Test Sensor, the
Sensor Check serves to test the cable conductors of the BISx and PIC, and
the status indications noted above indicate the ability of the BISx and PIC to
conduct the sensor check signal. Values that are too high indicate a need to
investigate and possibly replace the PIC or BISx.
Expected Impedance Values
Sensor Simulator Values
Electrode #
1
2
4
3
6.3
Typical
5 K Ohms
10 K Ohms
4 K Ohms
3 K Ohms
Test Sensor Values
Range
4-6 K Ohms
8-17 K Ohms
3-5 K Ohms
2-4 K Ohms
Electrode #
1
2
4
3
Typical
1 K Ohms
1 K Ohms
1 K Ohms
1 K Ohms
Range
1-2 K Ohms
1-3 K Ohms
1-2 K Ohms
1-2 K Ohms
Checking the Battery
The battery must be tested periodically to verify that the BIS VISTA Monitoring System will
continue to operate during power outages. To test:
1. Charge the BIS VISTA 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).
2. Disconnect the A/C cord from the wall supply.
3. Verify that the BIS VISTA Monitoring System operates reliably for 45 minutes.
4. Recharge the battery.
WARNING
ELECTRICAL SHOCK HAZARD: DO NOT REMOVE MONITOR
COVERS DURING OPERATION OR WHILE POWER IS
CONNECTED TO MONITOR.
GROUND WIRE LEAKAGE CURRENT MUST BE CHECKED
WHENEVER INSTRUMENT CASE IS OPENED BY A
QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN.
Caution:
Check the battery periodically by operating a BIS VISTA monitor that
has been disconnected from the wall socket and that has been charged
to full capacity (at least 6 hours of charge time). After long periods of
6-5
SECTION 6
PREVENTIVE MAINTENANCE
_______________________________________________________________________
storage (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 VISTA monitor fails to operate reliably from the battery for
approximately 45 minutes, battery replacement is required.
The BIS VISTA monitor contains an internal lithium ion battery. The
battery must be removed by a qualified service 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 a replacement battery: Aspect part number 186-0208.
If the battery requires replacement, see Section 8.4, “Replacing the Battery”.
6.4
Checking Leakage Current
Leakage current is a primary indicator of electrical shock hazard to personnel making contact
with any exposed outer surface of the equipment. Each BIS VISTA system is carefully
checked at the factory to verify that leakage current meets the UL60601-1 and IEC60601-1
safety standards.
The BIS VISTA monitor should be checked routinely for leakage current at least
once a year. Always 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 that liquids such as saline and Ringer’s as well
as blood are all excellent conductors of electricity. Avoid touching any part of the system
with wet hands. Always work with clean, dry hands.
WARNING!
ELECTRICAL SHOCK HAZARD: THE MANUFACTURER’S
INSPECTION OF THIS APPARATUS VERIFIED THAT THE
GROUND LEAKAGE CURRENT AND THE PATIENT SAFETY
CURRENT WERE LESS THAN THE SPECIFIED LIMITS
ESTABLISHED BY THE APPLICABLE SAFETY STANDARDS. AS
A MATTER 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.
Leakage Current testing should be performed by a qualified Biomedical Engineering
Technician or authorized personnel only.
The BIS VISTA Monitoring unit does not contain a Protective Earth Stud (GND Stud).
Since the exposed metal parts on the rear of the BIS VISTA Monitor (Communication serial
port and 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 VISTA Monitor that are
connected to protective earth are contained within its enclosure and are not accessible to the
6-6
SECTION 6
PREVENTIVE MAINTENANCE
_______________________________________________________________________
user of the equipment. However, as stated in the operating manual, an enclosure leakage
current test should be performed on the exposed metal parts and should be checked
periodically to ensure that the integrity of the equipment’s insulation system is maintained.
The leakage current test should include measurement of ground wire leakage, enclosure
leakage, and patient leakage.
Ground wire leakage typically can be performed automatically by connecting the A/C power
cord of the BIS VISTA 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. The patient connection terminals of many
safety testers can be used for this purpose. The patient leakage current of the BISx can be
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 Section 10.2
“Sensor Simulator P/N 186-0137”.)
2. Short the two circular terminals at the end of the simulator using conventional
methods such as jumpers or alligator clips. Wire attached with screws will work also.
3. Connect the test lead to the shorted terminals. Make sure that you are not touching
the simulator beyond this point.
4. Proceed to test instrument for leakage current as per established facility protocols
and procedures for safety testing of medical devices.
6-7
SECTION 6
PREVENTIVE MAINTENANCE
_______________________________________________________________________
6-8
SECTION 7
DIAGNOSTICS AND TROUBLESHOOTING
________________________________________________________________________
SECTION 7
7 DIAGNOSTICS AND
TROUBLESHOOTING
INTRODUCTION
This section explains:
• General troubleshooting using built in diagnostic tools
• BIS VISTA Monitoring System troubleshooting procedure.
• Status messages, causes, and corrective actions
7.1
General Troubleshooting
The BIS VISTA Monitoring System has both automatic and manual diagnostic features.
These features check the BIS VISTA Monitoring System’s operability and status, and report
software and hardware malfunctions.
IF ANY FAILURES ARE NOTED, SEE SECTION 7.3 “BIS
VISTA System Messages and Corrective Actions”
The power-up diagnostics 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 memory are tested and repaired if necessary.
The automatic diagnostics run continuously in the background while the unit operates.
These procedures check the BISx for the following conditions: interface faults, disconnect,
lead off, and power faults.
The manual diagnostics are operator initiated using the monitor touch keys and menu
choices. These procedures check the digital signal converter function within the BISx.
NOTE:
The manual diagnostics can be run safely while the patient is connected to
the BIS VISTA Monitoring System; however, running the diagnostics will
temporarily disrupt monitoring. Do not run the DSC Self Test during
electro-cautery as it may erroneously indicate a failure of the BISx.
7-1
SECTION 7
DIAGNOSTICS AND TROUBLESHOOTING
________________________________________________________________________
7.2
BIS VISTA Monitoring System
Troubleshooting Procedure
The BIS VISTA Monitoring System consists of three major components: Monitor, BISx,
and PIC/Sensor. By using the three-step Checkout Procedure and a component swapping
technique, the component at fault can easily be determined.
Use the Checkout procedures in Section 6.2 “System Checkout” to test function of each
component. The steps of this checkout procedure include:
• Monitor; test monitor and battery power functions
• BISx; recognition and DSC Self Test
• PIC and Sensor; recognition and Sensor Check test
Consult Section 7.3 “BIS VISTA System Messages and Corrective Actions” for messages
that may occur and the appropriate action to take.
Consult Section 8 “Servicing the BIS VISTA System” for directions on replacing
components and handling components that require service.
BISx Cable Problem Isolation
Note:
This BIS VISTA Monitoring System Service Information Manual contains
the maintenance and diagnostic 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
information to service or repair the internal electronic components of the
BISx or the BIS VISTA monitor.
The qualified user may replace the BISx cables by following the procedures in Section 8
“Servicing the BIS VISTA 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.
The Monitor Interface Cable (monitor connector to BISx) is an 11-conductor cable that
handles all communications to/from the BISx. It uses two twisted pair and a ground for
digital data transmission and for the clock transitions that are used to generate power in the
BISx housing. Therefore, failure in this cable is usually seen as failure to recognize the BISx
(“Connect BISx” message).
The Patient Interface Cable (PIC) is a 10-lead conductor that brings in the patient’s EEG
signal and also provides information about the sensor connected. If this cable fails, the
system may indicate that the sensor is not connected or is illegal, or the Sensor Check may
fail or restart on its own.
7-2
SECTION 7
DIAGNOSTICS AND TROUBLESHOOTING
________________________________________________________________________
Problem Isolation Procedure: Use the following sequence to determine the most probable
cable:
1. With no sensor connected, run DSC Self Test (see Section 7.2.2 “BISx Checkout
Procedure):
• If test fails or will not start, or the BISx is not recognized, 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 Sensor Simulator or Test Simulator. Run Sensor Check (see Section 7.2.3
“PIC Chekcout Procedure)
• 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.
7-3
SECTION 7
DIAGNOSTICS AND TROUBLESHOOTING
________________________________________________________________________
7.3
BIS VISTA 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 VISTA Messages and Operator Actions
Status Messages:
Causes:
Corrective Actions:
01
Connect BISx
1.
2.
3.
4.
1. Connect BISx. Verify all
cable 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. Defective BISx.
1. Read Instructions on
sensor package and re-prep
sensor.
2. Check sensor connections.
3. Re-prep again or replace
sensor. Verify Sensor
Check passes.
4. Replace the PIC.
5. Replace BISx Bulkhead
Connector or replace BISx.
14
Sensor Disconnected
1. Disconnected sensor.
2. Poor or contaminated
connection between
sensor and PIC.
3. Disconnected PIC.
4. Defective PIC.
5. Defective BISx.
1. Connect the Sensor.
2. Connect/clean connection
between sensor and PIC.
3. Connect the PIC.
4. Replace the PIC.
5. Replace BISx Bulkhead
Connector or replace BISx.
BISx disconnected.
Defective BISx cable.
Defective BISx.
Defective monitor.
7-4
SECTION 7
DIAGNOSTICS AND TROUBLESHOOTING
________________________________________________________________________
Status Messages:
Causes:
Corrective Actions:
16
Last Sensor Check
Failed
1. At least one element of
sensor has too high
impedance, and EXIT
pressed (before sensor
check completes).
2. Incorrect sensor
application.
3. Poor sensor connection.
4. Defective PIC.
5. Defective sensor.
6. Defective BISx.
1. Verify Sensor Check
passes.
2. Read Instructions on
sensor package and reapply sensor.
3. Check sensor connection.
4. Replace the PIC.
5. Replace sensor.
6. Replace BISx Bulkhead
Connector or replace BISx.
27
Excessive Artifact
Detected in Signal
The Signal Quality 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. If ARTIFACT label
appears above the EEG
waveform box, attempt to
identify and eliminate
artifact source.
2. If EMG bar is illuminated,
attempt to determine and
eliminate cause.
3. Verify Sensor Check
passes. If not, replace PIC.
4. Replace BISx Bulkhead
Connector or replace BISx.
1. Artifact, such as those
generated by motion or
eyeblinks, is causing loss
of EEG recognition.
2. EMG Bar indicates
electrical activity that
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
movement or eyeblinks) or
the presence of electrocautery, warming blankets,
or other devices
7-5
SECTION 7
DIAGNOSTICS AND TROUBLESHOOTING
________________________________________________________________________
Status Messages:
Causes:
Corrective Actions:
28
Data unavailable due
to poor signal quality
The signal quality is too low
to accurately calculate a BIS
value. The BIS value and
other trend variables that
are adversely affected by
artifact are not displayed
1. Artifact, such as those
generated by motion or
eyeblinks, is causing loss
of EEG recognition.
2. EMG Bar indicates
electrical activity that
may be interfering with
EEG recognition.
3. PIC is defective.
4. BISx is defective.
1. If ARTIFACT label
appears above the EEG
waveform box, attempt to
identify and eliminate
artifact source.
2. If EMG bar is illuminated,
attempt to determine and
eliminate cause.
3. Verify Sensor Check
passes. If not, replace PIC.
4. Replace BISx Bulkhead
Connector or replace BISx.
Note: This message may
occur as the results of
artifact (non-EEG signal)
such as those generated
from motion (patient
movement or eyeblinks) or
the presence of electrocautery, warming blankets,
or other devices.
BIS Out of Target
Range
29 – Low
30 – High
The BIS has fallen outside
the target range set by the
user.
7-6
1. Check patient.
2. Take note of BIS at limit
set by user.
SECTION 7
DIAGNOSTICS AND TROUBLESHOOTING
________________________________________________________________________
Status Messages:
Causes:
Corrective Actions:
31
Isoelectric EEG
Detected
No discernible EEG activity
is detected for several
minutes; SR=100.
If unintended:
1. Check patient vital signs,
dosage, etc.
2. Check leads for proper
connection and possible
shorts.
3. Verify Sensor Check
passes.
4. Verify DSC Self test
passes.
5. Verify PIC. Use Test
Sensor or Sensor Simulator
and Sensor Check.
Note: This message
notifies user of a flatline
EEG. This is a normal
condition when Sensor
Simulator or Test Sensor is
connected.
33
Operating On Battery
Backup
The AC power has been lost 1. Restore the AC power.
and the monitor is running
2. Verify power cord.
on the battery. The battery
3. Replace power supply.
keeps the monitor operating
for approximately 45
minutes (when the battery is
fully charged).
34
Battery Power Low
There are only a few
minutes of battery life left.
Restore AC power to avoid
automatic shutdown.
92, 93
Sensor Ground Fault
Problem is detected relating
to sensor ground electrode.
1. Disconnect and examine
sensor connection. Clean
any contamination present.
2. Replace sensor if necessary.
3. Replace PIC.
4. Replace BISx Bulkhead
Connector or replace BISx.
94
Sensor Overcurrent
Sensor is using too much
current.
1. Disconnect and examine
sensor connection. Clean
any contamination.
2. Replace sensor if necessary.
3. Replace PIC.
4. Replace BISx Bulkhead
Connector or replace BISx.
95
No more Uses for this
Sensor
Sensor has been connected
and disconnected too many
times.
Replace the sensor.
7-7
SECTION 7
DIAGNOSTICS AND TROUBLESHOOTING
________________________________________________________________________
Status Messages:
Causes:
Corrective Actions:
96
Sensor Invalid
1. Poor or contaminated
connection between
sensor and PIC.
2. Defective sensor.
3. Defective PIC.
4. Defective BISx.
1. Connect/clean connection
between sensor and PIC.
2. Replace the sensor.
3. Replace the PIC.
4. Replace BISx Bulkhead
Connector or replace BISx.
109
Sensor Used for Over
24 Hours
Sensor has been sending
data for more than 24 hours
Replace sensor
202
Sensor Expired
1. Sensor expiration date
has passed
2. Time and date are
incorrect
1. Replace Sensor
2. Verify current time and
date; Reset if necessary
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 BISx or the
Monitor Interface Cable.
3. Replace the monitor
2000-2999
Unrecoverable
Monitor Error
A system error has
occurred. The monitor may
stop operating.
1. Turn the monitor off, then
on again.
2. Reset monitor.
3. Replace monitor.
3000-3999
Data Export Error
The data export was not
successful.
1. Removable drive is not
connected properly to
USB(A) port.
2. Drive is incompatible or
defective.
3. Drive is full.
1. Check connection.
2. Replace drive.
3. Replace drive.
4000-4999
Software Update Error
A software error has
occurred.
1. Restart monitor.
2. Reset monitor.
3. Replace monitor.
5000-5999
Trend Memory Error
A memory error has
occurred.
1. Restart monitor.
2. Reset monitor.
3. Replace monitor.
7-8
SECTION 7
DIAGNOSTICS AND TROUBLESHOOTING
________________________________________________________________________
Status Messages:
Causes:
Corrective Actions:
6000-6999
Snapshot Error
Operating system has noted
that the snapshot process
has not completed correctly.
1.
2.
3.
4.
7-9
Retry snapshot.
Restart monitor.
Reset monitor.
Replace monitor.
SECTION 7
DIAGNOSTICS AND TROUBLESHOOTING
________________________________________________________________________
7-10
SECTION 8
SERVICING THE BIS VISTA MONITORING SYSTEM
_______________________________________________________________________
SECTION 8
8 SERVICING THE BIS VISTA SYSTEM
INTRODUCTION
This section provides instructions for replacing the PIC, BISx, and the monitor, and for
removing and replacing parts of the monitor and the BISx. If a component needs to be
serviced, please consult Sections 8.12 and 8.13 for instructions on packaging and shipping.
The BIS VISTA 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. Replacement part numbers are listed in
Section 10.1, “Accessories and Spare Parts List.”
8.1
Replacing the PIC
Parts Required:
Tools Required:
Patient Interface 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 attach the replacement PIC cable to the BISx, align and press the PIC and BISx
connectors together firmly.
8.2
Replacing the BISx
Parts Required:
Tools Required:
BIS VISTA BISx with Patient Interface Cable;
P/N 185-0145-AMS
None
To replace the BISx:
Disconnect the BISx from the front of the monitor. To do this, carefully grasp the
connector on the BISx Monitor Interface Cable and pull. DO NOT twist or pull on the
cable.
If necessary, unplug the PIC cable from the BISx by grasping the connector (NOT the
wires!) and firmly pulling it out of the BISx Bulkhead Connector.
To install the replacement BISx, hold the cylindrical connector with the flat side up (at 12
o’clock position) and insert firmly into BISx port on front of monitor.
To re-attach the PIC cable, align the PIC and BISx connectors and press together firmly.
8-1
SECTION 8
8.3
SERVICING THE BIS VISTA MONITORING SYSTEM
Replacing the Monitor
Parts Required:
Tools Required:
BIS VISTA Monitor P/N 185-0151
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.
2. Unplug the power cable from the wall and remove it from its receptacle in the rear
of the monitor.
3. Disconnect the BISx 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 set screw from clamp,
then depressing top of clamp shoe (blue plastic clip at top of aluminum pole clamp)
and slide the monitor up and off of the clamp.
5. To install the replacement monitor, insert power cord into receptacle on rear of
monitor.
6. To install the BISx, hold the cylindrical connector with flat side up (at 12 o’clock
position) and insert firmly into BISx port on front of monitor.
7. Re-mount pole clamp assembly.
8-2
SECTION 8
8.4
SERVICING THE BIS VISTA MONITORING SYSTEM
Replacing the Battery
Parts Required:
Tools Required:
Battery Replacement Kit P/N 186-0208
Philips #2 screwdriver
Caution:
All repairs to the BIS VISTA 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. 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 screws from the Battery/Power Supply cover and remove the cover. Note
the position of the battery cable.
4. Squeeze the battery connector latch to disengage it from the back of the monitor and
remove the old battery.
5. Lay the new battery in the recess with the wires at the top, and plug in the connector.
6. Replace the cover and four screws (hand-tighten only) and reconnect the A/C power
cord.
8-3
SECTION 8
8.5
SERVICING THE BIS VISTA MONITORING SYSTEM
Replacing the Power Supply
Parts Required:
Tools Required:
Power Supply Replacement Kit P/N 186-0216
Philips #2 screwdriver
Caution:
All repairs to the BIS VISTA 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 VISTA
POWER SUPPLY.
To replace the power supply, you will need a Philips #2 screwdriver. 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. 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 battery and the power supply connectors.
5. Remove screws from the power supply bracket and remove the old power supply.
6. Insert new power supply into the cover, lining up the A/C power receptacle with the
cutout in the cover.
7. Reconnect the power supply.
8. Reconnect the battery.
9. Replace the cover and 4 screws (hand-tighten only) and reconnect the A/C power
cord.
8-4
SECTION 8
8.6
SERVICING THE BIS VISTA MONITORING SYSTEM
Replacing the Clamp Shoe
Parts Required:
Tools Required:
Shoe Clamp Replacement Kit P/N 186-0217
Philips #2 and #8 screwdrivers
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 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. 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 connector.
5. Remove screws from the power supply bracket and remove the power supply.
6. Remove the three screws that attach the Clamp Shoe to the back panel.
7. Replace the Clamp Shoe and attach it to the back panel with the three new screws
provided in the kit (hand-tighten only).
8. Insert power supply into the cover, lining up the A/C power receptacle with the
cutout in the cover.
9. Reconnect the power supply.
10. Replace the cover and 4 screws (hand-tighten only) and reconnect the A/C power
cord.
8-5
SECTION 8
8.7
SERVICING THE BIS VISTA MONITORING SYSTEM
Replacing the Monitor Interface Cable
Caution:
All repairs to the BIS VISTA 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.
8.7.1 Parts and Tools Required
Parts Required:
Tools Required:
BIS VISTA Host Cable Replacement Kit;
P/N 186-0201-AMS includes:
BISx Monitor Interface Cable P/N
175-0061-GA
Gasket, P/N 150-0187
Torx head screws, P/N 606-0008
Torque screwdriver with Torx bit size T-7.
8.7.2 Procedure:
1. Disconnect BISx from the monitor.
2. Remove screws from the bulkhead of the old Monitor Interface Cable.
8-6
SECTION 8
SERVICING THE BIS VISTA 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.
8-7
SECTION 8
SERVICING THE BIS VISTA MONITORING SYSTEM
ZIF open
Key
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. Ensure that the flex cable is fully inserted into the ZIF and close the ZIF connector
by pushing toward the bulkhead. Carefully feed the flex cable into the housing and
seat the cable bulkhead to the BISx housing.
8-8
SECTION 8
SERVICING THE BIS VISTA MONITORING SYSTEM
8. Set the screws in the holes. Slowly tighten to 45 in-oz.
8.8
Replacing the BISx Bulkhead Connector
Caution:
All repairs to the BIS VISTA 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.
8.8.1 Parts and Tools Required
Parts Required:
Tools Required:
BISx Bulkhead Replacement Kit P/N 195-0052
includes:
BISx Bulkhead,
P/N 175-0052
Gasket, P/N 150-0187
Torx head screws, P/N 606-0008
Torque screwdriver with Torx bit size
T-7.
8-9
SECTION 8
SERVICING THE BIS VISTA 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.
ZIF open
3. Open the ZIF connector by pulling away from the bulkhead.
8-10
SECTION 8
SERVICING THE BIS VISTA 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
SECTION 8
SERVICING THE BIS VISTA 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. Ensure that the flex cable is fully inserted into the ZIF and close the ZIF connector
by pushing toward the bulkhead. Carefully feed the flex cable into the housing and
seat the bulkhead to the BISx housing.
8-12
SECTION 8
SERVICING THE BIS VISTA MONITORING SYSTEM
8. Set the screws in the holes. Slowly tighten to 45 in-oz.
8.9
Calibrating the Touch Screen
The Touch Screen is calibrated at the factory and does not need to be re-calibrated on a
regular basis. However, if necessary, the touch screen may be calibrated by selecting
[Calibrate Touch Screen] from the Maintenance Menu. Follow the on-screen instructions.
8.10 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.
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 System Operating Manual.
2. Verify that all test sections PASS.
3. Install a known good PIC cable.
4. Connect a Sensor Simulator or Test Sensor tool as described in Section 10
“Appendix I.”
5. Perform a Patient Interface Cable (PIC) Checkout Procedure as described in Section
7.2.3. “PIC Checkout Procedure.” For more detail, refer to the BIS VISTA
Monitoring System Operating Manual.
6. Perform a leakage (electrical safety test) according to the appropriate institution
requirements.
7. If appropriate, perform a Hipot test according to institution requirements.
8. End of Procedure.
8-13
SECTION 8
SERVICING THE BIS VISTA MONITORING SYSTEM
8.12 What to do with a Component that Requires
Service
Contact your local distributor to determine where servicing will occur. Aspect’s Technical
Service Department will assist you in isolating the problem to a specific component. Have
the equipment available when you call so that you can supply the appropriate serial numbers
and a detailed description of the problem. If it becomes necessary to return a unit directly to
Aspect Medical Systems, follow the procedure below:
•
Contact Aspect’s Technical Service Department to obtain a Returned Materials
Authorization (RMA) number. (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 equivalent packaging to protect
the product. Seal the package with plastic shipping tape rather than masking tape.
Mark shipping or storage container FRAGILE.
•
If the repair or replacement is covered by the warranty, 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.
8.13 Repackaging for Shipping and Storage
If it becomes necessary to return the monitor to the factory, use the original shipping
container to protect the product. Seal the package with reinforced packing tape rather than
plastic or masking tape. Mark shipping container FRAGILE.
8-14
SECTION 9
SPECIFICATIONS AND WARRANTY
_______________________________________________________________________
SECTION 9
9 SPECIFICATIONS AND WARRANTY
INTRODUCTION
This section includes:
• General specifications of the BIS VISTA monitor and accessories
• Electromagnetic compatibility specifications
• Warranty
9.1
General Specifications
This section lists specifications for the BIS VISTA Monitoring 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 in wide x 8 in high x 5 in deep
(19 cm x 20.3 cm x 12.7 cm)
Display Size:
4 in high x 5.25 in wide (10 cm x 13 cm)
Digital Output:
USB ports A, B, RS232 serial port
Power Requirements:
100-240 VAC, 50-60 Hz, 0.7 ampere max.
Electrical Safety:
Conforms to: UL 60601-1, IEC 60601-2-26,
CAN/CSA-C22.2#601.1
Battery Backup:
45 minutes at full operation
Recharge Time: 6 hours
Software Updates:
User-via USB port (Type A)
9-1
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SPECIFICATIONS AND WARRANTY
_______________________________________________________________________
EEG Specifications:
Epoch Duration:
2 seconds
Artifact Rejection:
Automatic
EEG Scales:
25 µV/div (+/- 1 mV 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 Rate:
1 second for BIS number, 10 seconds for Trend
Event Markers:
User selected
Alarms:
Auditory and visual, user adjustable limits
Filters:
ON (2 – 70 Hz with notch) or OFF (.25 – 100 Hz)
Mode:
Sensor automatically selects mode.
9-2
SECTION 9
SPECIFICATIONS AND WARRANTY
_______________________________________________________________________
BISx Specifications:
BISx:
Weight:
Dimensions:
Cable Length:
10.0 oz (0.284 kg) including integral cable
3.75 in wide x 2.5 in high
(9.5 cm x 6.3 cm)
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:
16,384 samples/second
Resolution:
16 Bits at 256 samples/second
Input Impedance:
50 Mohms typical
Noise:
< 0.3 µV RMS (2.0 µV peak-to-peak);
0.25 Hz to 50 Hz
Common Mode Rejection:
(Isolation mode)
110 dB at 50/60 Hz to earth
ground
Frequency/Bandwidth:
0.16 – 450 Hz
9-3
SECTION 9
SPECIFICATIONS AND WARRANTY
_______________________________________________________________________
Type of Protection against Electric Shock of the System:
Class 1: Equipment in which protection against electric shock does not rely on basic
insulation only, but which includes an additional safety precaution. Means are provided for
the connection of the equipment to the protective earth conductor in the fixed wiring of the
installation in such a way that accessible metal parts cannot become live in the event of a
failure of the basic insulation.
Degree of Protection against Electric Shock of the System:
Type BF: Equipment providing a degree of protection against electric shock regarding
allowable leakage currents and reliability of the protective earth ground connection with an
F-type applied part. An F-type applied part 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 rated AC supply voltage is applied
between the applied part and earth. The circuitry inside the BIS VISTA monitor is isolated
from the mains in accordance with UL60601-1. Patient isolation is accomplished within the
BISx.
Degree of Protection against effects of Cardiac Defibrillation:
The BIS VISTA system provides protection for the operator and patient during cardiac
defibrillation. This protection is achieved via the isolation barrier within the BISx.
Degree of Protection against the Ingress of Water:
Monitor degree of protection rating: IPX2 (ingress of water vertically dripping).
BISx degree of protection rating: IPX4 (splash proof).
Mode of Operation of the System:
Continuous: Operation under normal load for a normal period without exceeding the
specified limits of temperature.
Classification:
MEDICAL ELECTRONIC EQUIPMENT
CLASSIFIED BY UNDERWRITERS LABORATORIES INC. WITH RESPECT TO
ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH UL 60601-1, IEC 60601-1, IEC 60601-2-26,
CAN/CSA-C22.2#601.1.
9-4
SECTION 9
SPECIFICATIONS AND WARRANTY
_______________________________________________________________________
9.2
Electromagnetic Compatibility Specifications
The BIS VISTA Monitoring System requires special precautions regarding Electromagnetic
Compatibility (EMC). The BIS VISTA 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 VISTA Monitoring System. Refer to the EMC guidance information and Cautions
provided in this manual.
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 VISTA system must be used only with the power cord provided.
When using the Software Upgrade Device to load new versions of software into the BIS
VISTA monitor, no cables or other accessories should be connected to the device. The BIS
VISTA monitor should be connected to the mains through the appropriate power cord, and
the Software Upgrade Device should be plugged into the USB-A connector on the back of
the device.
Caution:
Using accessories other than those specified may result in increased
electromagnetic emissions or decreased electromagnetic immunity of
the BIS VISTA Monitoring System.
9-5
SECTION 9
SPECIFICATIONS AND WARRANTY
_______________________________________________________________________
9.2.2 IEC 60601-1-2:2001 Electromagnetic Compatibility
Guidance
This section provides the appropriate specification tables for the BIS VISTA Monitoring
System as per IEC 60601-1-2.
Guidance and Manufacturer’s Declaration - Electromagnetic
Emissions
The BIS VISTA Monitoring System is intended for use in the electromagnetic environment
specified below. The customer or user of the BIS VISTA system should assure that it is used
in such an environment
Emissions test
Compliance
Electromagnetic
Environment Guidance
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
nearby electronic equipment.
RF Emissions
CISPR 11
Class A
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Complies
The BIS VISTA Monitoring
System is suitable for use in all
establishments, other than
domestic and those directly
connected to the public lowvoltage power supply network
that supplies buildings used
for domestic purposes.
Caution:
The BIS VISTA system should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the BIS
VISTA monitor should be observed to verify normal operation in the
configuration in which it will be used.
9-6
SECTION 9
SPECIFICATIONS AND WARRANTY
_______________________________________________________________________
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity
The BIS VISTA system is intended for use in the electromagnetic environment specified
below. The customer or user of the BIS VISTA system should assure that it is used in such
an environment
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines.
±1 kV for
input/output
lines.
±2 kV for power
supply lines.
±1 kV for
input/output
lines.
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Mains power quality should
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 typical hospital
environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines.
IEC 61000-4-11
<5% UT (>95%
dip in UT)
for 0.5 cycle.
40% UT (60%
dip in UT)
for 5 cycles.
70% UT (30%
dip in UT)
for 25 cycles.
<5% UT (>95%
dip in UT)
for 5 sec.
<5% UT (>95%
dip in UT)
for 0.5 cycle.
40% UT (60% dip
in UT)
for 5 cycles.
70% UT (30% dip
in UT)
for 25 cycles.
<5% UT (>95%
dip in UT)
for 5 sec.
Mains power quality should
be that of a typical hospital
environment. If the user of
the BIS VISTA system
requires continued operation
during power mains
interruptions longer than 45
minutes, it is recommended
that the BIS VISTA monitor
be powered by an
uninterruptible power supply
or an additional battery.
Power frequency
(50/60 Hz)
magnetic field.
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of typical
location in a typical hospital
environment.
9-7
SECTION 9
SPECIFICATIONS AND WARRANTY
_______________________________________________________________________
NOTE: UT is the AC mains voltage prior to the application of the test level.
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity
The BIS VISTA Monitoring System is intended for use in the electromagnetic environment
specified below. The customer or user of the BIS VISTA system should assure that it is used
in such an environment.
Immunity
Test
IEC 60601 Compliance Electromagnetic
Test Level Level
Environment - Guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
BIS VISTA system, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
Recommended separation
distance
d = 1.2 P
3V
d = 1.2 P , 80 MHz to 800 MHz
d = 2.3 P , 800 MHz to 2.5 GHz
3 V/m
3 V/m
80 MHz to 2.5
GHz
where P is the maximum output
power rating of the transmitter in
watts according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by
electromagnetic site surveya, should
be less than the compliance level in
each frequency range.b Interference
may occur in the vicinity of
equipment marked with the
following
symbol:
9-8
SECTION 9
SPECIFICATIONS AND WARRANTY
_______________________________________________________________________
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile 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 electromagnetic site survey should be
considered. If the measured field strength in the location in which the BIS VISTA system is
used exceeds the applicable RF compliance level above, the BIS VISTA system should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may by be necessary, such as reorienting or relocating the BIS VISTA systemb
Over the frequency ranges 150kHz to 80 MHz field strength should be less than 3 V/m.
9-9
SECTION 9
SPECIFICATIONS AND WARRANTY
_______________________________________________________________________
Recommended Separation Distances between Portable and
Mobile RF Communications Equipment and the BIS VISTA
Monitor
The BIS VISTA Monitoring System is intended for use in the electromagnetic environment
in which radiated RF disturbances are controlled. The customer or user of the BIS VISTA
system can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the BIS
VISTA system as recommended below, according to the maximum output power of the
communications equipment.
Rated
maximum
output power
of equipment
Separation distance according to frequency of
transmitter
m
W
150 kHz to 80 MHz
d = 1.2 P
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
80 MHz to 800 MHz 800 MHz to 2.5
GHz
d = 1.2 P
d = 2.3 P
0.12
0.23
0.38
0.73
1.2
2.3
3.8
7.3
12
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency ranges
applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
9-10
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SPECIFICATIONS AND WARRANTY
_______________________________________________________________________
9.3
Warranty
Aspect warrants to the initial Purchaser that the BIS VISTA 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. Excluded from this warranty are expendable
components and supply items such as, but not limited to, electrodes, cables, and prep
solutions. Aspect’s obligations under this warranty are to repair or replace any Warranted
Product (or part thereof) that Aspect reasonably determines to be covered by this warranty
and to be defective in workmanship or materials provided that the Purchaser has given
notice of such warranty claim within the Warranty Period and the Warranted Product is
returned to the factory with freight prepaid. Repair or replacement of Products under this
warranty does not extend the Warranty Period.
To request repair or replacement under this warranty, Purchaser should contact Aspect
directly (see contact information on the back cover of this manual). Aspect will authorize
Purchaser to return the Warranted Product (or part thereof) to Aspect. Aspect shall
determine whether to repair or replace Products and parts covered by this warranty and all
Products or parts replaced shall become Aspect’s property. In the course of warranty service,
Aspect may but shall not be required to make engineering improvements to the Warranted
Product or part thereof. 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 shipping costs shall be paid by Purchaser. Risk of loss or
damage during shipments under this warranty shall be borne by the party shipping the
Product. Products shipped by Purchaser under this warranty shall be packaged in the original
shipping container or equivalent packaging to protect the Product. If Purchaser ships a
Product to Aspect in unsuitable packaging, any physical damage present in the Product on
receipt by Aspect (and not previously reported) will be presumed to have occurred in transit
and will be the responsibility of Purchaser.
This warranty does not extend to any Warranted Products or part thereof: that have been
subject to misuse, neglect, or accident; that have been damaged by causes external to the
Warranted Product, including but not limited to failure of or faulty electrical power; that
have been used in violation of Aspect’s instructions; that have been affixed to any
nonstandard accessory attachment; on which the serial number has been removed or made
illegible; that have been modified by anyone other than Aspect; or that have been
disassembled, serviced, or reassembled by anyone other than Aspect, unless authorized by
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.
9-11
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. 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 IN CONNECTION
THEREWITH. ASPECT SHALL NOT BE LIABLE FOR ANY INCIDENTAL,
SPECIAL, OR CONSEQUENTIAL LOSS, DAMAGE OR EXPENSE (INCLUDING
WITHOUT LIMITATION LOST PROFITS) DIRECTLY OR INDIRECTLY ARISING
FROM THE SALE, INABILITY TO SELL, USE OR LOSS OF USE OF ANY
PRODUCT. EXCEPT AS SET FORTH HEREIN, ALL PRODUCTS ARE SUPPLIED
“AS IS” WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED.
9-12
SECTION 10
APPENDIX I
_______________________________________________________________________
SECTION 10
10 APPENDIX I
10.1 Accessories and Spare Parts List
MAJOR COMPONENTS AND SENSORS:
185-0151
185-0145-AMS
186-0107
186-0106
186-0200
186-0160
536-0047
BIS VISTA Monitor
BISx
PIC+, for BISx
BIS Quatro Sensor
BIS Pediatric (XP) Sensor
BIS Extend Sensor
Power Cord 10’ North America
MANUALS:
070-0031
070-0069
075-0015
080-0233
Mounting Options Manual
BIS VISTA Monitoring System Operating Manual (English)
BIS VISTA Service Information Manual (English)
Clinician’s Guide to the Bispectral Index
ACCESSORIES:
150-0037
150-0058
186-0104
186-0137
817-0014
817-0015
817-0011
817-0012
Pole Clamp Assembly
BIS VISTA Monitor Stand
BIS Sensor Dispenser
Sensor Simulator
GCX 12” Pivot Support Arm w/7” Up-Post
GCX 16” Pivot Support Arm w/7” Up-Post
GCX 7” Channel & Adapter for Draeger Narkomed
GCX 7” Channel w/Dovetail Attachment for Ohmeda
PARTS:
186-0208
186-0216
186-0217
186-0201-AMS
195-0052
151-0009
675-0022
194-0039
Battery Replacement Kit
Power Supply Replacement Kit
Shoe Clamp Replacement Kit
BIS VISTA Host Cable (Monitor Cable) Replacement Kit
BISx Bulkhead Replacement Kit
Battery/ Power Supply Cover Assembly with Shoe Clamp
Cable wrap (Blue, hook & loop)
Label “DO NOT DISCARD”
MISCELLANEOUS:
180-0085
536-0044
186-0170
Empty carton, with foam, BIS VISTA
RS-232 Cable, approx 6 ft. length
J-Hooks
10-1
SECTION 10
APPENDIX I
_______________________________________________________________________
10.2 SENSOR SIMULATOR: P/N: 186-0137
Description of device:
The Sensor Simulator is a service tool that allows for the verification of proper impedance
values being detected by the BIS VISTA Monitoring System during the Sensor Check. This
test is part of the initial test that each system performs. The simulator also allows for safety
testing of the system in the field by allowing connection of the test equipment to the
monitor via the Patient Interface Cable (PIC).
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 VISTA system.
Figure 8 - Schematic of Sensor Simulator Circuit
Test types allowed:
Sensor Check:
The Sensor Check tests and verifies that the monitor is reporting the proper impedance
values provided by the Sensor Simulator. This procedure verifies functionality of the BIS
VISTA Monitoring System. See Section 7.2.3 “PIC Checkout Procedure” for instructions.
Safety Testing: Leakage Current
Leakage Current testing should be performed by a qualified Biomedical Engineering
Technician or authorized personnel only. See Section 6.4 “Checking Leakage Current” for
instructions.
10-2
SECTION 10
APPENDIX I
_______________________________________________________________________
Figure 9 - Sensor Simulator
10.3 Test Sensor
Use the following 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 connector during this
procedure.
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.)
10-3
SECTION 10
APPENDIX I
_______________________________________________________________________
#1
#2
#4
#3
Figure 11 - Connecting electrodes #2 and #4.
3. Fold electrode #3 over onto electrode #4, pressing adhesive surfaces together and
making sure the paper clip remains in place.
4. 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 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 #
1
2
4
3
Typical
Range
1 K ohm
1 K ohm
1 K ohm
1 K ohm
1-2 K ohms
1-3 K ohms
1-2 K ohms
1-2 K ohms
10-4
SECTION 10
APPENDIX I
_______________________________________________________________________
10.4 Safety Tester Connection with PIC
This procedure describes a method to connect an BIS VISTA 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 VISTA system.
1.
2.
3.
4.
5.
Connect BISx (Digital Signal Converter) cable to BIS VISTA monitor.
Connect PIC (Patient Interface Cable - sensor) cable to other end of BISx.
Verify sensor for test is of current date code. Connect sensor to PIC cable.
Remove gel and green pad from each sensor contact point.
Connect safety tester leads per tester instructions to sensor contact point pads (i.e.
via alligator clips).
6. Apply power to the BIS VISTA system per safety tester instructions. Make required
leakage measurements.
7. Disconnect and dispose of sensor. NOTE: DO NOT discard PIC or BISx. These
are re-usable components.
BIS
VISTA
M i
BISx
Patient Interface
Cable (PIC)
Contact points for
safety tester.
See steps 4 and 5.
Figure 13 - Safety Tester Contact Points
10-5
SECTION 11
APPENDIX II
________________________________________________________________
SECTION 11
11 APPENDIX II
11.1 Data Flow Diagram
Patient
Connection
Input
Protection
Amplification
and Filtering
Sigma-Delta
Modulators
Serial
Comm.
BISx
BIS VISTA Monitor
Serial
Comm.
Color
Display
Host Processor
USB
Host
Port
RS-232
Port
FPGA
Digital
Signal
Processor
(DSP)
SECTION 11
APPENDIX II
_______________________________________________________________________
11.2 Block Diagram
BISx
Patient
Bulkhead
DIGITIZER
BOARD
P103
P102
P101
P100
J301
J300
PROCESSOR
BOARD
Reset
Switch
SW1
USB
Host
J2
USB
Client
J3
Serial
Port
J4
CONNECTOR BOARD
J1
SPEAKER
J11
BACKLIGHT
INVERTER
J13
DISPLAY
J7
TOUCH
PANEL
J3
J12
CARD
ENGINE
J4A
MOTHER
BOARD
P4A
J2
P4C
J4B
J1
BISx
Connector
J4C
P4B
J9
J8
ON/STANDBY
SWITCH
BIS VISTA MONITOR
BATTERY
POWER SUPPLY
AC
Power
Contact Information for:
Aspect Medical Systems, Inc.
One Upland Road
Norwood, MA 02062
U.S.A.
Main Business Phone: (617) 559-7000
Main Business Fax:
(617) 559-7400
Customer Service:
(888) BIS-INDE(X)…press (6), or
(800) 442-7688 … press (6)
Technical Service:
(800) 442-2051
Email:
Web:
EC REP
bis_info@aspectms.com
www.aspectmedical.com
Aspect Medical Systems International B.V.
Rijnzathe 7d2
3454 PV De Meern
The Netherlands
Main Business Phone:
Main Business Fax:
Email:
+31.30.662.9140
+31.30.662.9150
amsint@aspectms.com