075 0014XPServInfo
075 0014XPServInfo
A-2000TM XP PLATFORM
BISPECTRAL INDEX TM
(BIS TM) MONITORING SYSTEM
SERVICE INFORMATION
MANUAL
Rx Only
© Copyright, 2009, Aspect Medical Systems. All rights reserved. Copying or other reproduction
of this document is prohibited without prior written consent of Aspect Medical Systems.
EC REP
1.1 WARNINGS...........................................................................................................1-1
1.2 CAUTIONS ............................................................................................................1-3
1.3 KEY TO SYMBOLS ...............................................................................................1-5
i
4.3 INSTALLATION AND VERIFICATION PROCEDURE..........................................4-5
9 APPENDIX I .............................................................................................................9-1
ii
9.1 SPARES AND ACCESSORIES LIST....................................................................9-1
9.2 SENSOR SIMULATOR: P/N: 186-0137 FOR USE WITH DSC-XP: ....................9-2
9.3 TEST SENSOR......................................................................................................9-3
9.4 SAFETY TESTER CONNECTION WITH PIC........................................................9-5
9.5 PLACEMENT OF PIC SECURING STRAP ON BIS MONITORING SYSTEM ......9-6
10 APPENDIX II ........................................................................................................10-1
iii
TABLE OF FIGURES
iv
ABOUT THIS MANUAL
_____________________________________________________________________________
This manual contains information necessary for the customer to install, maintain, service, identify
and prepare for use the Aspect Medical System BIS™ 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 A-2000™ Operating Manual.
The A-2000 BIS 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), Digital Signal Converter (DSC), or the A-2000 Monitor itself.
This manual, in conjunction with the A-2000 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 A-2000
Monitor.
Section I discusses important safety precautions. Before attempting to set up or service the
A-2000, please familiarize yourself with the safety information provided in this section.
Section II provides a functional overview of the A-2000, its principal components, and instrument
identification.
Section III describes the A-2000 monitor hardware and how it operates.
Section IV provides preparation for use and installation instructions, including environmental
considerations, instrument connections and system setup and check out.
Section VI describes the A-2000 diagnostic tools and provides tables to aid in troubleshooting
the system.
Section VII describes the removal and replacement procedure for system components and how
to return a component for service. It also explains how to disassemble and reassemble the DSC
to replace cables.
Note:
This manual was not designed for repairing the A-2000 BIS system to the level of
its electronic circuit boards. The manual is intended solely for the troubleshooting
and replacement of its major components or DSC cables.
Appendix I provides instructions for use for the Sensor Simulator and describes how to make a
test sensor. It also contains a list of spare parts and accessories.
v
ABOUT THIS MANUAL
_____________________________________________________________________________
vi
SECTION I SAFETY PRECAUTIONS
____________________________________________________________________________
SECTION I
1 SAFETY PRECAUTIONS
INTRODUCTION
Caution:
Carefully read the A-2000 BIS Monitoring System Operating Manual entirely
before using the monitor in a clinical setting.
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 A-2000 appears at the end of this section.
1.1 WARNINGS
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.
1-1
SECTION I SAFETY PRECAUTIONS
____________________________________________________________________________
FOR A-2000s USED OUTSIDE OF NORTH AMERICA: A HARMONIZED LINE CORD WITH
CONDUCTORS HAVING A CROSS SECTIONAL AREA GREATER THAN 0.75 mm2 MUST BE
USED.
ANY PROCEDURES THAT REQUIRE THE REMOVAL OF THE DSC’s COVER AND
INTERNAL PARTS SHOULD BE PERFORMED BY A QUALIFIED BIOMEDICAL
ENGINEERING TECHNICIAN. POWER OFF THE UNIT BY DISCONNECTING FROM THE
MONITOR.
1-2
SECTION I SAFETY PRECAUTIONS
____________________________________________________________________________
ALWAYS REPLACE BOTH FUSES TOGETHER, EVEN IF ONLY ONE HAS FAILED.
1.2 CAUTIONS
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
Read the entire A-2000 Operating Manual carefully before using the monitor in a clinical
setting.
All repairs to the A-2000 Monitoring System should be made only by a qualified
Biomedical Engineering Technician or other authorized personnel.
Do not autoclave the Digital Signal Converter or Monitor. Autoclaving will seriously
damage both components.
Do not block fan output. Keep at least three 3 inches of unobstructed space between rear
of instrument and wall and other instruments. Do not allow other instruments to block
airflow. Do not block ventilation inlet holes on the underside of monitor.
Do not open Digital Signal Converter. The seal to prevent liquids from entering the Digital
Signal Converter may be damaged if opened. Service or repairs must be performed only
by qualified biomedical technicians.
Using accessories other than those specified may result in increased electromagnetic
emissions or decreased electromagnetic immunity of the BIS Monitoring System.
Each BIS sensor type has its own placement method. Be sure to carefully follow the
appropriate package directions.
The A-2000 has been designed to operate with a disposable 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.
Considerations when using Electro Convulsive Therapy (ECT) equipment during BIS™
monitoring: Place ECT electrodes as far as possible from the BIS sensor 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 I SAFETY PRECAUTIONS
____________________________________________________________________________
Check the battery periodically, by operating an A-2000 that has been disconnected from
the wall socket and that has been charging the battery for at least 4 hours. 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 A-2000 fails to operate
reliably from the battery for 20 minutes, battery replacement is required.
Avoid liquid ingress to the PIC. Contact of fluids with the PIC sensor connectors can
interfere with PIC performance.
The A-2000 Monitor should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the A-2000 monitor should be observed to verify
normal operation in the configuration in which it will be used.
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 DSC assemblies.
Use only the parts and tools specified. Use of any others may damage the instrument.
Handle PCBs only by board edges to avoid contamination (moisture, skin oils, etc.) on
PCB and component surfaces!
When connecting or disconnecting Digital Signal Converter, take care not to touch the
exposed contacts of either connector. Damage due to electrostatic discharge may result.
Bispectral Index, BIS, the BIS logo, and Zipprep are trademarks of Aspect Medical Systems, Inc.
and are registered in the U.S.A., E.U. and other countries.
1-4
SECTION I SAFETY PRECAUTIONS
____________________________________________________________________________
Use by
Do not Reuse YYYY-MM-DD or
YYYY-MM
Authorized Representative in
EC REP the European Community
Catalog Number
1-5
SECTION I SAFETY PRECAUTIONS
____________________________________________________________________________
*Contact Aspect Medical Systems International B.V. for a Return Materials Authorization (RMA)
number. According to the WEEE Directive 2002/96/EC, all waste electrical and electronic
equipment (EEE) should be disposed of and collected separately and treated according to the
best available and environmentally friendly techniques.
EEE contains hazardous substances to the (human) environment but also EEE is a valuable
resource of new raw materials. Therefore it is important to collect WEEE separately from other
waste.
Aspect Medical products are subject to the Directive and we therefore urge you to dispose of the
equipment separately and make sure that it is treated at an electronics recycler. Please contact
your municipality or the nearest collection site and dispose of waste equipment there and make
sure the discarded equipment does not end-up in the ‘normal’ household waste.
1-6
SECTION II A-2000 SYSTEM OVERVIEW
____________________________________________________________________________
SECTION II
2 A-2000 SYSTEM OVERVIEW
Aspect Medical Systems A-2000 BIS Monitoring System is intended to monitor the state of the
brain by data acquisition of EEG signals in the intensive care unit, operating room, and for clinical
research. The BIS, a processed EEG variable, may be used as an aid in monitoring the effects of
certain anesthetic agents.
The A-2000 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 a minimum 20 minutes of automatic back-up battery power.
The monitor is menu-driven with fixed keys for choosing the options available.
2.1.1.1 Monitor
The monitor contains the operator control panel, an electro-luminescent display screen, and
connectors for the digital signal converter and printer.
The left [←] and right [→] arrow keys are used to enter Review
mode and to scroll data backward and forward in time. In the BIS
Log, they show the previous [←] or next [→] screen of data .
The [MENU/EXIT] key is used to enter and exit the Setup Menu.
In Review mode it will return the user to the main screen. It is
also used to halt certain procedures, such as the sensor check,
and to answer "no" to a question.
The up [↑] and down [↓] arrows are used to move from one menu
selection to another. They are also used to increment and
decrement values. In the BIS Log, they are used to zoom time
out or in (increase or decrease reporting intervals).
2-1
SECTION II A-2000 SYSTEM OVERVIEW
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2-2
SECTION II A-2000 SYSTEM OVERVIEW
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BIS Monitor
Monitor
Interface DSC
Cable
DSC Pigtail
Patient Interface
Cable (PIC)
Sensor
2-3
SECTION II A-2000 SYSTEM OVERVIEW
____________________________________________________________________________
Fan
Clamp
Shoe
Fuse
Holder
Potential
Equalization
Terminal Serial
Port
AC Line Printer
Connection Port
2-4
SECTION III PRINCIPLES OF OPERATION
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SECTION III
3 PRINCIPLES OF OPERATION
INTRODUCTION
This section includes:
Sensors placed on the patient's head transmit EEG signals to the Digital Signal Converter. The
DSC amplifies and digitizes these signals, then sends them to the monitor. The monitor software
filters the data, analyzes it for artifact, and processes it using digital signal processing techniques.
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.
Hardware is divided into three main components: the monitor, the digital signal converter (DSC)
and the Patient Interface Cable (PIC) with BIS Sensor. The A-2000 monitor contains the circuits
for monitor control, digitally processing the EEG data, computing the processed parameters, and
displaying the waveforms and processed parameters. The circuits to acquire and digitize the
EEG signals reside in the Digital Signal Converter (DSC). The PIC and Sensor are the patient
connection for EEG signal acquisition.
A block diagram depicting the monitor subassemblies appears in Figure 3-1. A signal flow
diagram appears in Figure 3-2.
3-1
SECTION III PRINCIPLES OF OPERATION
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DSC
Patient J1 PREAMP
J2 J3 J4
J4 J2 J3
COMM J1
BOARD
INTERCONNECT BOARD
J8 J1
KEYBOARD
These connectors are
internal to the board and DISPLAY
are mated as shown.
MONITOR
3-2
SECTION III PRINCIPLES OF OPERATION
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DSC
Monitor
After passing through input protection circuits in the DSC, 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. The outputs from the converters are multiplexed
onto the DSC communications line and de-multiplexed in the monitor prior to being fed to the Digital
Signal Processor (DSP). The DSP filters the signals and computes the processed variables. The
results are passed to the host CPU for display.
3-3
SECTION III PRINCIPLES OF OPERATION
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The montage mode switches follow the protection circuits. These switches configure the inputs
appropriately for the sensor. The 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.
The DSC can also measure the individual electrode impedance 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.
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” in the Diagnostics Menu (See Operating Manual for specific instructions).
3-4
SECTION III PRINCIPLES OF OPERATION
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Test Signal
A calibrated test signal is generated on the communications board during 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 self test noise, gain and frequency response are checked.
The communications board decodes the control information coming from the host via a command
line. Commands such as “block” amplifier saturation and conduct impedance tests are transmitted.
There are no ventilation holes in the DSC case. It will not leak when splashed with liquids.
The case is electrically shielded both to prevent spurious emissions from the DSC and to prevent
externally caused interference with the DSC circuits.
3-5
SECTION III PRINCIPLES OF OPERATION
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The monitor also contains the circuits for powering the monitor, DSC, and companion printer.
Printer function is not available on battery backup.
A block diagram depicting the monitor subassemblies appears in Figure 3-1. A signal flow
diagram appears in Figure 3-2. The signals are acquired and digitized by the DSC. The DSC
multiplexes the signals onto the DSC communications line. The EEG signals are de-multiplexed
in the monitor and fed to the Digital Signal Processor (DSP). The processor filters and down-
samples them, calculates the processed parameters, and outputs the data display.
The serial port is standard RS-232. This port is used to communicate between the A-2000 and an
attached device. The device may be a data capture computer (PC) or a software upgrade device.
Software and firmware can be downloaded through this serial port.
The printer interface is a non-standard serial type with extra lines for printer keys and printer
control and status. It is designed to interface with a Seiko printer interface board.
The power to the interface is under software control. An overcurrent detector circuit monitors current
to the DSC. If the current exceeds the expected value, the power is shut off to the DSC by the
hardware, and the DSP, the Host, and the user are notified.
3-6
SECTION III PRINCIPLES OF OPERATION
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System Check
Initiated when the unit is powered on, this test makes certain that system software and hardware
components are functioning properly.
DSC Self-Test
The Digital Signal Converter self-test is a thorough test of the entire signal processing chain
including the signal processing computers. The DSC self-test may be initiated in the Diagnostic
Menu (see Section 6.2.2).
Display Self-Test
This self-test, also found in the Diagnostic Menu (see Section VI), performs a thorough test of the
screen display functions. This test will not be performed while the monitor is operating on battery
backup.
3-7
SECTION III PRINCIPLES OF OPERATION
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Impedance Check
Electrode impedance is tested when the DSC and PIC are connected and is monitored
continuously unless the user has turned impedance checking off in the Diagnostic Menu.
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.
Diagnostics
The A-2000 provides diagnostic codes to assist the user in tracing the source of many problems
that may occur. Codes are displayed in the right corner of the message region only if the user
has selected them in the Diagnostic Menu.
NOTE:
The monitor must be powered ON to recharge the battery.
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 601-1 AND/OR IEC 601-1-1
HARMONIZED NATIONAL STANDARD.
3-8
SECTION III PRINCIPLES OF OPERATION
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NOTE:
When software is upgraded, 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 III PRINCIPLES OF OPERATION
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3-10
SECTION IV PREPARATION FOR USE AND INSTALLATION
__________________________________________________________________________
SECTION IV
4 PREPARATION FOR USE AND INSTALLATION
INTRODUCTION
This section provides an overview of installation information for service personnel working with
the Aspect A-2000 BIS Monitor System. Please see the A-2000 BIS Monitoring System Operating
Manual for full installation instructions.
• Environment
• Instrument connections
• Installation and verification procedure
4.1 ENVIRONMENT
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.
WARNING:
EXPLOSION HAZARD: DO NOT USE THE A-2000 IN A FLAMMABLE
ATMOSPHERE OR WHERE CONCENTRATIONS OF FLAMMABLE
ANESTHETICS MAY OCCUR.
Temperature. The Aspect A-2000 Monitor is designed to operate safely at a room temperature
of 5 degrees C to 40 degrees C. Conditions that exceed these limits could affect reliability.
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
SECTION IV PREPARATION FOR USE AND INSTALLATION
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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 3-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 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.
WARNING!
BE SURE THE MONITOR IS MOUNTED SECURELY IN PLACE TO
AVOID PERSONAL OR PATIENT INJURY.
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.
4-2
SECTION IV PREPARATION FOR USE AND INSTALLATION
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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. 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.
4-3
SECTION IV PREPARATION FOR USE AND INSTALLATION
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4-4
SECTION IV PREPARATION FOR USE AND INSTALLATION
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4-5
SECTION IV PREPARATION FOR USE AND INSTALLATION
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4-6
SECTION V PREVENTIVE MAINTENANCE, CARE AND CLEANING
_____________________________________________________________________________
SECTION V
5 PREVENTIVE MAINTENANCE, CARE AND CLEANING
INTRODUCTION
This section describes:
WARNING:
UNIVERSAL PRECAUTIONS SHALL BE OBSERVED TO PREVENT
CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS
MATERIALS. PLACE CONTAMINATED MATERIALS IN REGULATED WASTE
CONTAINER.
After cleaning, dry all areas except the monitor display screen (see below) with a lint-free
absorbent paper towel. Wipe the PIC and DSC pigtail 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.
Caution:
Do not autoclave the Digital Signal Converter or Monitor. Autoclaving will
seriously damage both components.
Avoid liquid ingress to the PIC. Contact of fluids with the PIC sensor
connectors can interfere with PIC performance.
5-1
SECTION V PREVENTIVE MAINTENANCE, CARE AND CLEANING
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1. Charge the A-2000 by leaving it plugged in with the power ON for 4 hours.
Note:
The monitor must be powered ON to recharge the battery.
Caution:
Periodically check the battery by operating an A-2000 that has been
disconnected from the wall socket and which has been charging the
battery for at least four hours. After long periods of storage (e.g. > 1 month)
it may be necessary to cycle (discharge, then charge) the battery a few
times to get full charge capacity. If the A-2000 fails to operate reliably from
the battery for twenty minutes, battery replacement is required.
WARNING:
ELECTRICAL SHOCK HAZARD: DO NOT REMOVE MONITOR COVERS
DURING OPERATION OR WHILE POWER IS CONNECTED TO MONITOR.
The A-2000 should be routinely checked for leakage current at least once a year. (See
Appendix I). Always check the leakage current 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.
5-2
SECTION V PREVENTIVE MAINTENANCE, CARE AND CLEANING
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WARNINGS:
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.
2. Connect power cable to monitor, plug power plug into appropriate wall outlet.
4. Connect DSC with PIC and Sensor (or Test Sensor or Sensor Simulator, see Appendix I).
• Verify DSC test completes.
• Verify SENSOR CHECK screen displays.
5. Exit from SENSOR CHECK screen by passing impedance check or by exiting with
MENU/EXIT key.
5-3
SECTION V PREVENTIVE MAINTENANCE, CARE AND CLEANING
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1. Using a known good A-2000 monitor (see section 6.2.1), power up the A-2000 and verify the
screen message “Connect DSC Cable to Front of Monitor” displays.
2. Connect the DSC that you are testing and verify the screen message “Connect Sensor to
DSC” displays.
3. Perform DSC Self Test. See section 6.2.2
4. Repeat DSC Self test while flexing cables to see if intermittent opens or shorts exist.
5. If PIC and Sensor are available, perform PIC Checkout Procedure. See section 6.2.3.
6. Repeat Sensor check while flexing cable to see if intermittent opens or shorts exist.
1. Using a known good A-2000 monitor (see section 6.2.1) and a known good DSC (see section
6.2.2.) connect the PIC to be tested to the DSC and the DSC to the A-2000 monitor.
2. Power ON the A-2000 monitor and DSC. At the completion of the power up self-test, verify
that the screen message “Connect Sensor to DSC” displays.
3. Connect a Sensor Simulator (see Appendix 9.2) or Test Sensor (see Appendix 9.3) to the
PIC cable. Press firmly together.
5-4
SECTION V PREVENTIVE MAINTENANCE, CARE AND CLEANING
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4. A sensor check is initiated automatically when the sensor and PIC are connected to the DSC.
(It may also be initiated by the user in the Setup Menu.) 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 must be less than 100 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 is less than 15 kilo ohms, the Sensor Check will be
considered successful. If the combined impedance is over the 15 kilo ohms limit, you will
need to re-prep the electrodes and check all connections. The monitor will continue to
check impedance until it is acceptable.
NOISE - If the signal from the electrode goes beyond the measurable range, the label
"NOISE" will appear.
LDOFF - If a lead is too loose or disconnected, the label "LDOFF" will appear.
5. 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, it serves the purpose of
verifying the DSC and PIC cable conductors. Therefore the status indications called out
above need to be interpreted as conditions relating to the DSC and PIC ability to conduct the
sensor check signal. Values that are too high must be investigated as possible failures to be
repaired.
6. Repeat the Sensor Check. Press the MENU/EXIT key, then press ARROW key to highlight
the SENSOR CHECK line on the menu. Press SELECT key to initiate the Sensor Check
routine again. During the Test sequence, flex the cable and connections at the PIC/SENSOR,
and PIC/DSC and also the DSC box to Patient end cable. Note that gentle flexing of these
cables and connectors should not cause the Sensor Check to fail.
Periodically check the system (A-2000 Monitor, DSC, PIC cable) for physical damage to cases,
and associated cables and connectors.
1. Inspect the cases of the monitor and the DSC to insure 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.
5-5
SECTION V PREVENTIVE MAINTENANCE, CARE AND CLEANING
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5-6
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
SECTION VI
6 DIAGNOSTICS AND TROUBLESHOOTING
INTRODUCTION
The A-2000 BIS Monitor System has three built-in diagnostic features:
• Power-Up
• Automatic
• Manual
These features check the BIS Monitoring System’s operability, status, and also report software
and hardware malfunctions.
The power-up diagnostics run automatically each time that you turn on the Monitor unit. These
procedures check the software, system memory, speaker, display, serial ports, timer/counters,
BIS Engine, real-time clock, Data Memory and Setup Memory. This level of diagnostic is
described in detail in the monitor’s operating manual.
The automatic diagnostics run continuously in the background while the unit operates. These
procedures check the Digital Signal Converter for the following conditions: interface faults,
disconnect, lead off, and power faults. This level of diagnostic also checks other monitor
functions; please reference this detail in the monitor’s operating manual.
The manual diagnostics are operator initiated using the monitor keys and menu choices. These
procedures check for the proper functioning of the Digital Signal Converter. This level of
diagnostic also can be used to check other monitor functions; please reference this detail in the
monitor’s operating manual.
NOTE:
The manual diagnostics can be run safely while the patient is connected to the
BIS Monitor unit; however, running the diagnostics will temporarily disrupt
monitoring. Do not run DSC self test during electro-cautery as it may
erroneously indicate a failure.
6-1
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
The A-2000 System consists of three major components: Monitor, DSC, and PIC/Sensor. By
using this three-step procedure and a component swapping technique, the component at fault
can easily be determined. The steps of this test procedure are:
• Monitor
• DSC recognition and self test
• PIC and Sensor
Following the test procedure is a MESSAGE AND OPERATOR ACTION section that describes
appropriate actions for messages that may occur.
See Section 7 for directions on replacing components and handling components that require
service.
Note:
The successful completion of this test will verify the monitor is functioning and all
operator input (keyswitch) and output (display and audio alarm) are OK.
NOTE:
Since the A2000 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.
6-2
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
NOTE:
Since the A2000 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 in Battery operation.
Note:
This test will not be performed when the unit is on battery backup.
• Verify that all Pixels illuminate. If there is a problem, see section 7 for instructions on
replacing the monitor.
• Press Menu/Exit, Menu/Exit.
8. Proceed to DSC section.
6-3
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
Note:
The successful completion of this test will verify the DSC is recognized and
communicates with the monitor. It also verifies the handling circuits are
functioning properly to and from the DSC.
1. With no Sensor connected, plug DSC into the front of Monitor case.
• Verify monitor display reads “Connect Sensor to DSC”
2. Press Menu/Exit key, then highlight and Select “ADVANCED SETUP”, then highlight and
Select “DIAGNOSTIC MENU”, then highlight and Select “DSC SELF TEST”
• Verify display shows “DSC Test Results: PASS” (this takes approximately 20 seconds).
Note that test results are posted in 4 tests for 2 channels. The numbers are not important,
but if the test fails, *** or the word FAIL will indicate which test is at fault.
3. Press Menu/Exit key, and re-run DSC SELF TEST, this time moving cables, flexing near
connectors to check for intermittent connections or conductors. To execute, highlight and
select DSC SELF TEST.
• Verify display shows “DSC Test Results: PASS” (this takes approximately 20 seconds).
6-4
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
Notes:
The successful completion of this test will verify the BIS system from the DSC
circuits to the patient connector. Since the conductors used are located both in
the DSC 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 Appendix I for
details.
3. Press Menu/Exit, then highlight and select Sensor Check. As Sensor Check executes this
time, flex the cables and connectors from the DSC up to the sensor, to check for intermittent
connections or conductors.
• Verify that the Sensor Check begins, and each element displays a number, then says
PASS.
4. End of procedure.
6-5
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
Note:
This A-2000 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 DSC or the A-2000 Monitor.
The qualified user may replace the DSC cables by following the procedures in Chapter 7. In
cases of obvious damage, pulled connectors or crushed cables, the need to replace the cables is
known. If cables are suspect, the following may be of aid in determining which cable is defective.
Monitor cable (monitor connector to DSC box) is a 5-conductor cable that handles all
communications to/from the DSC. 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 DSC housing.
Therefore, failure in this cable is usually seen as failure to recognize the DSC (E01 “DSC Not
Connected” or E02 “DSC Overcurrent” messages).
Pigtail cable (DSC box to PIC connector) 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.
Please note that all of the Pigtail conductors are also continued through the PIC cable to the
sensor. It is important that the PIC cable be eliminated as a potential problem before opening the
DSC to change the pigtail cable. They both can generate the same types of faults!
Procedure: Once a problem is isolated to the DSC, use the following sequence to determine the
most probable cable:
1. With no sensor connected, run DSC Self test (see section 6.2.2):
• If test fails or will not start, or the DSC is not recognized, the Monitor cable is likely
suspect. This failure may also be related to a PCB problem in the DSC in which case the
DSC must be returned to Aspect for Service.
• If test indicates PASS, continue to step 2.
2. Connect Sensor Simulator or Test Simulator. Run Sensor Check (see section 6.2.3):
• If failure is noted, swap PIC with known good PIC cable and run again.
• If failure repeats, the Pigtail cable is likely suspect. This failure may also be related to a
PCB problem in the DSC in which case the DSC must be returned to Aspect for service.
Note:
A continuity test can be used to verify conductor integrity, use diagrams in
Appendix II
6-6
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
E04, E05, E06, E07, E08 1. Defective DSC 1. Replace the DSC.
DSC Error 2. Defective monitor. 2. Replace the monitor.
6-7
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
6-8
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
E17, E19, E20, E21, E22, Error in communication 1. Verify the software
E23, E24 between BIS Engine and level.
BIS Engine Comm. Error Host. 2. Replace the monitor.
6-9
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
Note: These messages relate to the condition of the EEG signal. This signal is often affected by
environmental conditions that cause artifact (non-EEG signal). The messages below do not
usually indicate a monitor system error; instead they serve as a notification of a patient or
environmental condition.
6-10
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
E29 The BIS has fallen below Take note of BIS at limit set
BIS < Low Alarm Limit the low alarm limit set by by user.
the user. The numeric
display flashes.
E30 The BIS has risen above Take note of BIS at limit set
BIS > High Alarm Limit the high alarm limit set by by user.
the user. The numeric
display flashes.
6-11
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
E32 Data memory has been re- 1. Turn the monitor off,
Review Data Lost initialized. then on again
2. If error persists, monitor
requires service.
E35 - E39, E43, E44, A software error has 1. Turn the monitor off,
E48 - E65, E69 – E73, E75, occurred. The monitor may then on again.
E78 – E80, E87- E89 stop operating. 2. Verify the software
Software Error level.
3. Replace monitor.
6-12
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
6-13
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
6-14
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
6-15
SECTION VI DIAGNOSTICS AND TROUBLESHOOTING
___________________________________________________________________________
6-16
SECTION VII SERVICING THE A-2000 SYSTEM
___________________________________________________________________________
SECTION VII
7 SERVICING THE A-2000 SYSTEM
INTRODUCTION
This section provides instructions for replacing the PIC, DSC, and the Monitor, and for removing
and replacing parts of the Digital Signal Converter (DSC). If a component needs to be serviced,
please consult sections 7.2 and 7.3 for instructions on packaging and shipping.
The A-2000 BIS Monitoring System is designed to be easily serviced by using the built in
diagnostic routines (see Section 6 of this Manual) and the major component swapping techniques
described below.
1. Unplug the PIC cable from the patient end of the DSC by grasping the connectors (NOT the
cable!) and firmly pulling the two sections apart. The restraining loop will need to be released
by clipping the nylon tie wrap to release the loop.
2. To attach the replacement PIC cable to the DSC pigtail, align and press PIC and DSC
connectors together firmly. Reconnect the restraining loop by fastening to cable strain relief
with the tie wrap.
1. While the PIC is connected to the DSC, place the loop strap over the strain relief as indicated.
2. Insert each cable tie through the hole at the end of the loop and secure the tie firmly by
pulling it through its own securing latch. Cut the excess tie so that the strap is flush to the
latch and no excess material is exposed.
3. Repeat for the other side of the PIC mated cable. If cable has to be removed, do not cut the
loop strap as it is intended to keep the system together. If the loop strap is cut for whatever
reason, please replace as soon as possible. Order number 675-0015.
7-1
SECTION VII SERVICING THE A-2000 SYSTEM
1. Disconnect the DSC from the front of the monitor. To do this, pull on the blue rubber overlay.
DO NOT twist or pull on the gray cable.
2. If necessary, unplug the PIC cable from the patient end of the DSC by grasping the
connectors (NOT the wires!) and firmly pulling the two sections apart. The restraining loop will
need to be released by clipping the nylon tie wrap to release the loop.
3. To install the replacement DSC, hold the cylindrical connector with the flat side up (at 12
o’clock position) and insert firmly into DSC port on front of monitor.
4. To re-attach the PIC cable, align the PIC and DSC connectors and press together firmly.
Reconnect the restraining loop by fastening to cable strain relief with the tie wrap.
1. Power down.
2. Remove power cable from its jack in the rear.
3. Disconnect the DSC from the front of the monitor. To do this, pull on the blue rubber overlay.
DO NOT twist or pull on the gray cable.
4. If required, 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 to jack on rear of monitor.
6. To install DSC, hold the cylindrical connector with flat side up (at 12 o’clock position) and
insert firmly into DSC port on front of monitor.
7. Re-mount pole clamp assembly.
The A-2000 contains two inline fuses (1.25A, 250V, 5x20mm Aspect P/N 430-0006) within the AC
power input module located at the rear of the monitor. To check or replace a fuse, one can
access these fuses as follows:
1. The fuse holder is part of the AC power input module on the rear of the monitor and is located
just above the power cord input connector.
2. Disconnect the AC power cord from the wall socket and from the rear of the monitor.
3. Locate the plastic locking tabs securing the fuse holder in place.
4. Insert the tip of a ball point pen or similar tool, into the slots provided to release the plastic
locking tabs allowing the fuse holder to spring out of its locked position.
5. Remove fuse holder.
6. Check fuses with an ohm meter. If replacement is needed, insert correct fuses (see below)
into fuse holder.
7. To re-install the fuse holder, simply insert the fuse holder and press in with finger until the
plastic locking tabs engage, securing the fuse holder in place.
WARNING!
REPLACE FUSES ONLY WITH ONE OF THE FOLLOWING PARTS:
Aspect P/N 430-0006, 1.25 Amps, 250V, 5x20mm
Littelfuse 217 Series, 1.25 Amps, 250V, 5x20mm
Wickmann 193 Series, 1.25 Amps, 250V, 5x20mm
7-2
SECTION VII SERVICING THE A-2000 SYSTEM
If it becomes necessary to return a major component to Aspect Medical Systems, follow the
procedure below:
• 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 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 customer.
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.
7-3
SECTION VII SERVICING THE A-2000 SYSTEM
This section provides instructions for removing and replacing parts of the Digital Signal Converter
(DSC). It describes:
• Required tools and supplies
• Opening and closing the DSC case
• Removing and installing DSC cables (monitor and pigtail),
• DSC Checkout and safety tests
Note that a fully functional A-2000 BIS Monitoring System and accessories (PIC cable, Sensor
Simulator or Test Sensor, and shorting bar) must be available to test any DSC that has been
opened. Do not attempt these repairs unless all required equipment and tools are available!
WARNING:
ANY PROCEDURES THAT REQUIRE THE REMOVAL OF THE DSC’s COVER
AND INTERNAL PARTS SHOULD BE PERFORMED BY A QUALIFIED
BIOMEDICAL ENGINEERING TECHNICIAN. POWER OFF THE UNIT BY
DISCONNECTING FROM THE MONITOR.
WARNING:
GROUND WIRE LEAKAGE CURRENT MUST BE CHECKED BY A
QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN WHENEVER THE
INSTRUMENT CASE IS OPENED FOR INSPECTION OR SERVICE.
Caution:
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 DSC assemblies.
Caution:
Use only the parts and tools specified. Use of any others may damage the
instrument.
7-4
SECTION VII SERVICING THE A-2000 SYSTEM
Caution:
Handle PCBs only by board edges to avoid contamination (moisture, skin
oils, etc.) on PCB and component surfaces!
Caution:
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 DSC assemblies.
Caution:
Handle PCBs only by board edges to avoid contamination (moisture, skin
oils, etc.) on PCB and component surfaces!
6. Carefully separate the two printed circuit boards to gain access to cable connections. Be
careful to not flex the PCBs or permanent damage to the connectors may result. See Figure
7-4.
7. Perform necessary service (e.g. replacement of cable, etc.).
7-5
SECTION VII SERVICING THE A-2000 SYSTEM
Monitor
Cable Ground shield
securing
screw
Pigtail
Shield cable
7-6
SECTION VII SERVICING THE A-2000 SYSTEM
Pigtail
Pre-amplifier cable
PCB
Monitor
cable
Communications
Locking tabs PCB
7-7
SECTION VII SERVICING THE A-2000 SYSTEM
Caution:
Handle PCBs only by board edges to avoid contamination (moisture, skin
oils, etc.) on PCB and component surfaces!
1. Re-connect communications and pre-amplifier PC boards together; carefully align pins and
jacks of the two printed circuit boards together, press pins firmly into jacks.
• Verify that no pins are bent or missing their respective jacks.
2. Orient and position shield around pigtail cable, fasten shield tabs to retain shield shape.
3. Carefully slide shield into position over PCB assembly and secure with ground shield
securing screw.
4. Prepare bottom case by inserting gasket into retaining groove. NOTE: If gasket is to be
reused, note that the cable passages have an access cut in them. For a new gasket, these
cable passages need to be carefully cut in one place to allow cable entry. See Figure 7-5.
5. Position and align PCB assembly with shield into bottom case assembly.
6. Align and position both cables into gasket cable passage and strain-reliefs into their cutouts.
See Figure 7-6.
7. Carefully place the top case and bottom case together.
• Verify that the sealing gasket is fully into its recess.
• Verify that no cables are trapped at the joint.
• Verify that both strain reliefs are fully secured in their recesses.
8. Install the two screws into the corners of the case and tighten.
9. Perform DSC Checkout and Safety tests. See section 7.5.4.
Figure 7-5 For a new gasket, cable passages need to be carefully cut
7-8
SECTION VII SERVICING THE A-2000 SYSTEM
Figure 7-6 Verify that the strain relief is fully secured in its recess.
Caution:
Handle PCBs only by board edges to avoid contamination (moisture, skin
oils, etc.) on PCB and component surfaces!
Caution:
Handle PCBs only by board edges to avoid contamination (moisture, skin
oils, etc.) on PCB and component surfaces!
1. Install cable by aligning the cable connector to jack and carefully pressing connector into
jack.
Verify that the locking tab engages.
2. Close case according to Closing the Case section 7.4.2.2. above.
7-9
SECTION VII SERVICING THE A-2000 SYSTEM
1. Perform DSC Self Test. See section 5.2.4. or refer to your monitor’s operating manual.
• Verify that all test sections PASS.
2. Install a known good PIC cable.
3. Connect a Sensor Simulator or Test Sensor tool as described in Appendix I
4. Perform a Patient Interface Cable (PIC) Checkout Procedure as described in section 5.2.5. of
this manual. For more detail, refer to your monitor’s Operating Manual.
5. Perform a leakage (electrical safety test) according to the appropriate institution
requirements.
6. If appropriate perform a Hipot test according to institution requirements.
End of Procedure.
7-10
SECTION VIII A-2000 SPECIFICATIONS
_____________________________________________________________________________
SECTION VIII
8 A-2000 SPECIFICATIONS
8.1 INTRODUCTION:
This section lists specifications for the Aspect A-2000 BIS Monitor.
GENERAL SPECIFICATIONS:
• Digital Output: RS232 serial port, printer port, isolated from ground
• Electrical Safety: Conforms to: UL 2601, CSA 22.2 No. 601-1 and
IEC 601-1
8-1
SECTION VIII A-2000 SPECIFICATIONS
_____________________________________________________________________________
EEG SPECIFICATIONS:
• User-defined Displays: TREND, DSA, BIS Log and real-time EEG waveforms
8-2
SECTION VIII A-2000 SPECIFICATIONS
_____________________________________________________________________________
BIS sensor
Patient Interface Cable - Plus (PIC Plus)
Pole Clamp for Monitor
Monitor Stand
Printer
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.
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 A-2000 system provides protection for the operator and patient during cardiac defibrillation.
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 2601-1, IEC601-2-26
CAN/CSA C22.2 NO. 601.1, CAN/CSA 601.2.26
42SA
8-3
SECTION VIII A-2000 SPECIFICATIONS
_____________________________________________________________________________
8.2 WARRANTY
Aspect warrants to the initial Purchaser that the A-2000 BIS monitor and the Digital Signal
Converter ("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.
8-4
SECTION VIII A-2000 SPECIFICATIONS
_____________________________________________________________________________
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.
8-5
SECTION VIII A-2000 SPECIFICATIONS
_____________________________________________________________________________
8-6
SECTION IX APPENDIX I
___________________________________________________________________________
SECTION IX
9 APPENDIX I
MAJOR COMPONENTS:
185-0070 A-2000 Monitor
185-0071 DSC-2 Assembly (serial number D3nnnnn)
186-0159-RFB DSC-XP (serial number DXnnnnn)
186-0067 PIC-S Cable
186-0107 PIC+, for DSC (serial number DXnnnnn, D4nnnnn)
186-0100 BIS Standard sensor
186-0106 BIS Quatro sensor
186-0110 BIS Pediatric sensor
186-0200 BIS Pediatric (XP) sensor
186-0160 BIS Extend sensor
175-0039 Power Cord 10’ North America
175-0038 Power Cord 15’ North America
150-0058 BIS Monitor Stand
ACCESSORIES:
186-0031 A-2000 Printer
186-0109 Paper, Printer
150-0037 Pole Clamp Assembly
PARTS:
675-0015 Restraining loop
430-0006 Fuse 1.25a 250V 5X20MM
175-0021-PI Monitor Cable (12’ length, monitor to DSC box)
175-0022 Pigtail Cable for DSC s/n D2…, D3….,(3’ length, DSC to PIC connector)
175-0045-PI Pigtail cable, for DSC S/N DX…, D4…(9” length, DSC to PIC connector)
150-0027 Shield
150-0026 Gasket
675-0004 Tie wrap
605-0024 Screw, case
605-0022 Screw, shield
800-0007 Hanging strap clip
675-0022 Cable wrap (Blue, Velcro)
MISCELLANEOUS
180-0006 Empty carton, with foam, A2000
186-0105 Sensor Simulator for DSC serial numbers D2nnnn, D3nnnn
186-0137 Sensor Simulator for DSC serial numbers DXnnnnn, D4nnnnn and PIC
Adaptor.
9-1
SECTION IX APPENDIX I
___________________________________________________________________________
Insert 2CH/4CH BIS Sensor Simulator service tool into patient interface cable. Impedance test
will be initiated by BIS Monitoring System when it detects that simulator has been inserted.
Note: This product is NOT intended for use with the DSC-2
Description of tool: The 2CH/4CH BIS Sensor Simulator is a service tool that allows for the
verification of proper impedance values being detected by the BIS Monitoring System during the
“Sensor check”. This test is part of the initial test that each monitor performs. The simulator also
allows for safety testing of BIS monitors in the field by allowing connection of the test equipment
to the monitor via the patient interface cable (PIC).
Input (-)
Input (+)
Figure 1: Schematic of the 2CH/4CH BIS Sensor Simulator circuitry. IO3 – IO6 connect to 4 input
signal pins on a 2 channel patient interface cable. IO1 – IO6 connect to 6 input signal pins on a 4
channel patient interface cable. The Inputs (+ and -) are where one connects the test signals to
test the BIS Monitor.
Electrode # 1 2 4 3
Acceptance Range in
4-6 8-17 3-5 2-4
Kohms
The monitor then proceeds to display the BIS screen. The BIS value is blanked and after a few
seconds, SQI=100.
9-2
SECTION IX APPENDIX I
___________________________________________________________________________
Simulator Cleaning
¾ Wipe simulator surfaces with a wet cloth soaked in lukewarm tap water containing bleach
solution of 10% by volume.
¾ Wipe simulator surfaces with a wet cloth of lukewarm tap water
¾ Dry with a clean cloth and allow to dry.
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.
9-3
SECTION IX APPENDIX I
___________________________________________________________________________
#1 #2 #4 #3
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.
6. The following chart shows expected Test Sensor values:
9-4
SECTION IX APPENDIX I
___________________________________________________________________________
This procedure describes a method to connect an A-2000 BIS Monitor 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 System.
A-2000
Monitor
DSC
9-5
SECTION IX APPENDIX I
___________________________________________________________________________
1. While the PIC is connected to the DSC, place the loop strap over the strain relief as
indicated.
2. Insert each cable tie through the hole at the end of the loop and secure the tie firmly by
pulling it through its own securing latch. Cut the excess tie so that the strap is flush to the
latch and no excess material is exposed.
3. Repeat for the other side of the PIC mated cable.
If cable has to be removed, do not cut the cable tie as it is intended to keep the system together.
If the loop strap is cut for whatever reason, please replace as soon as possible.
The PIC part number, 186-0107 (PIC with Loop Strap, Tiewraps and Label) includes the
following:
1 each 675-0015 – Tie (Loop strap)
2 each 675-0004 – Tie Wrap
1 each 194-0039 – Label, do not discard
1 each 071-0002 – Document, instructions
9-6
SECTION X APPENDIX II
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SECTION X
10 APPENDIX II
DSC
Monitor
10-1
SECTION X APPENDIX II
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DSC
Patient J1 PREAMP
J2 J3 J4
J4 J2 J3
COMM J1
BOARD
INTERCONNECT BOARD
J8 J1
KEYBOARD
These connectors are
internal to the board and DISPLAY
are mated as shown.
MONITOR
10-2
SECTION X APPENDIX II
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10-3
SECTION X APPENDIX II
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10-4
SECTION X APPENDIX II
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10-5
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