Aspect Medical Systems BIS VIEW User Manual
BIS VIEW Monitoring System
OPERATING MANUAL
Rx only
Aspect Medical Systems, Inc. Aspect Medical Systems International B.V.
One Upland Road Rijnzathe 7d2
Norwood, MA 02062 3454 PV De Meern
U.S.A. The Netherlands
(Tel) 617-559-7000 Tel: +31.30.662.9140 0123
(Tel) 888-BIS INDE(X) (U.S. only) Fax: +31.30.662.9150
(Fax) 617-559-7400 amsint@aspectms.com
bis_info@aspectms.com
www.aspectmedical.com 070-0089 1.01
EC REP
BIS VIEW Monitoring System
OPERATING MANUAL
Copyright, 2007, Aspect Medical Systems, Inc. All rights reserved. Copying or other
reproduction of this document is prohibited without prior written consent of Aspect
Medical Systems, Inc.
BIS VIEW is a trademark of Aspect Medical Systems, Inc.
Aspect, Bispectral Index, BIS, the BIS logo, BISx, the BISx logo and Zipprep are trademarks
of Aspect Medical Systems, Inc. and are registered in the U.S.A., E.U. and other countries.
TABLE OF CONTENTS
ABOUT THIS MANUAL........................................................................................ i
INTRODUCING THE BIS VIEW MONITORING SYSTEM............................. ii
1 SAFETY PRECAUTIONS........................................................................... 1-1
1.1 Warnings....................................................................................................................... 1-1
1.2 Cautions........................................................................................................................1-3
1.3 Key to Symbols ............................................................................................................ 1-6
2 SYSTEM SETUP AND PREPARATION FOR USE ................................. 2-1
2.1 BIS VIEW Monitor Setup and Checkout .................................................................. 2-1
2.2 Environment................................................................................................................. 2-2
2.2.1 Shipping and Storage Environment....................................................................................................... 2-2
2.2.2 Operating Environment .......................................................................................................................... 2-2
2.2.3 Power Requirements and System Grounding.................................................................................... 2-3
2.2.4 Electromagnetic Compatibility Requirements.................................................................................... 2-4
2.2.5 Site Preparation: Mounting the Monitor............................................................................................. 2-4
2.2.5.1 Mounting the Monitor using the Pole Clamp.......................................................................... 2-4
2.2.5.2 Optional Mounting Accessories................................................................................................. 2-5
2.3 The BIS VIEW Monitoring System – Equipment and Supplies .............................. 2-6
2.3.1 The BIS VIEW Monitor........................................................................................................................... 2-7
2.3.1.1 Front Panel...................................................................................................................................... 2-7
2.3.1.2 Soft Keys ......................................................................................................................................... 2-7
2.3.1.3 Alarm Key....................................................................................................................................... 2-7
2.3.1.4 ON/Standby button ...................................................................................................................... 2-7
2.3.1.5 Rear Panel....................................................................................................................................... 2-8
2.3.1.6 Integral Battery .............................................................................................................................. 2-9
2.3.2 BISx ........................................................................................................................................................... 2-10
2.3.3 Patient Interface Cable (PIC)............................................................................................................... 2-11
2.3.4 BIS Sensor................................................................................................................................................ 2-11
2.4 Cable Connections..................................................................................................... 2-11
2.5 Start Procedure ......................................................................................................... 2-12
2.5.1 Starting the Monitor for the First Time ............................................................................................ 2-12
2.5.2 Starting the Monitor from Standby Mode......................................................................................... 2-12
2.6 Initial Menu Settings.................................................................................................. 2-13
2.6.1 Language Selection................................................................................................................................. 2-13
2.6.2 Date and Time........................................................................................................................................ 2-13
2.6.3 Save Settings............................................................................................................................................ 2-14
3 OPERATING THE BIS VIEW MONITORING SYSTEM........................ 3-1
3.1 Preparing for Operation ............................................................................................. 3-1
3.2 Sensor Check................................................................................................................ 3-4
3.3 BIS Number Display Screen....................................................................................... 3-6
3.3.1 BIS (Bispectral Index) Value................................................................................................................... 3-6
3.3.2 Battery Icon............................................................................................................................................... 3-7
3.3.3 Alarm Icon................................................................................................................................................. 3-7
3.3.4 Signal Quality Indicator........................................................................................................................... 3-8
3.3.5 Electromyograph (EMG) Indicator ....................................................................................................... 3-8
3.3.6 Case ID....................................................................................................................................................... 3-8
3.3.7 Message Region ........................................................................................................................................ 3-8
3.3.8 Soft Key Screen Selections..................................................................................................................... 3-9
3.4 BIS Trend Display Screen with Sensor Status.......................................................... 3-9
3.4.1 BIS Trend Graph .................................................................................................................................... 3-10
3.4.2 Target Range ........................................................................................................................................... 3-10
3.5 BIS Trend Display Screen with EEG........................................................................ 3-10
3.6 Menu Selections ......................................................................................................... 3-11
3.6.1 Chart Data............................................................................................................................................... 3-11
3.6.2 Export Data............................................................................................................................................. 3-12
3.6.3 Setup......................................................................................................................................................... 3-13
3.6.3.1 Screen Options............................................................................................................................ 3-13
3.6.3.2 Alarms: The Alarms Menu.........................................................................................................3-14
3.6.3.2.1 Target Range ..................................................................................................................... 3-15
3.6.3.2.2 Alarm Volume Menu / Test Alarm Volume................................................................ 3-16
3.6.3.3 Smoothing Rate: The Smoothing Rate Menu......................................................................... 3-16
3.6.3.4 Date/Time..................................................................................................................................... 3-17
3.6.3.5 Settings: Active and Saved Monitor Settings..........................................................................3-17
3.6.4 Maintenance ............................................................................................................................................ 3-18
3.6.5 Diagnostics .............................................................................................................................................. 3-18
3.6.6 Demo Case.............................................................................................................................................. 3-18
3.7 Ending a Case ............................................................................................................. 3-19
3.8 Data Transfer ............................................................................................................. 3-19
3.9 How the BIS VIEW Monitoring System Works..................................................... 3-20
3.9.1 Bispectral Index (BIS) ............................................................................................................................ 3-21
3.9.2 System Self-Checks................................................................................................................................ 3-22
3.9.3 Data Memory.......................................................................................................................................... 3-23
3.9.4 Battery Operation.................................................................................................................................. 3-23
4 QUICK REFERENCE GUIDE..................................................................... 4-1
5 PREVENTIVE MAINTENANCE, CARE AND CLEANING.................... 5-1
5.1 Care and Cleaning ....................................................................................................... 5-1
5.2 Maintenance ................................................................................................................. 5-2
5.2.1 Checking Cable Integrity ........................................................................................................................ 5-2
5.2.2 System Checkout ..................................................................................................................................... 5-2
5.2.3 Checking the Battery............................................................................................................................... 5-3
5.2.4 Replacing the Battery .............................................................................................................................. 5-4
5.2.5 Replacing the Power Supply................................................................................................................... 5-4
5.2.6 Checking Leakage Current..................................................................................................................... 5-5
5.3 Technical Documentation .......................................................................................... 5-6
5.4 Instrument Identification............................................................................................ 5-7
6 DIAGNOSTICS AND TROUBLESHOOTING ........................................ 6-1
6.1 Maintenance ................................................................................................................. 6-1
6.1.1 Software Update....................................................................................................................................... 6-1
6.1.2 Default Settings......................................................................................................................................... 6-2
6.1.3 Language..................................................................................................................................................... 6-2
6.2 Diagnostics.................................................................................................................... 6-3
6.2.1 Impedance Checking................................................................................................................................ 6-3
6.2.2 Diagnostic Codes..................................................................................................................................... 6-4
6.2.3 System Configuration Information ....................................................................................................... 6-4
6.2.4 Advanced Diagnostics ............................................................................................................................. 6-4
6.3 BIS VIEW System Messages and Corrective Actions.............................................. 6-5
6.4 Using the Reset button ............................................................................................. 6-11
6.5 What to do if the BIS VIEW Monitoring System Requires Service..................... 6-11
7 APPENDIX I: MENUS, PROCESSED VARIABLES AND GLOSSARY. 7-1
7.1 Menu Map ..................................................................................................................... 7-1
7.2 Menu Listing ................................................................................................................. 7-2
7.3 Processed EEG Variables ............................................................................................ 7-3
7.4 Glossary......................................................................................................................... 7-4
8 APPENDIX II: SPECIFICATIONS, WARRANTY, SOFTWARE
LICENSE AGREEMENT AND PATENTS ....................................................... 8-1
8.1 Specifications................................................................................................................ 8-1
8.2 Electromagnetic Compatibility Specifications ......................................................... 8-5
8.2.1 Accessories................................................................................................................................................ 8-5
8.2.2 IEC 60601-1-2:2001 Electromagnetic Compatibility Guidance ...................................................... 8-6
8.3 Warranty .................................................................................................................... 8-11
8.4 Software License Agreement................................................................................... 8-13
8.5 List of Patents ............................................................................................................ 8-15
TABLE OF FIGURES
Figure 1 - Symbol Key (page 1 of 2) .............................................................................................1-6
Figure 2 - Pole Clamp...................................................................................................................... 2-5
Figure 3 - The BIS VIEW Monitoring System............................................................................ 2-6
Figure 4 - Rear Panel ....................................................................................................................... 2-8
Figure 5 - BISx and PIC................................................................................................................ 2-10
Figure 6 - Connecting the PIC....................................................................................................... 3-3
Figure 7 - Sensor Check Graphic Screen...................................................................................... 3-4
Figure 8 - BIS Number Display..................................................................................................... 3-6
Figure 9 - Screen Features – BIS Trend Display Screen with Sensor Status........................... 3-9
Figure 10 - BIS Trend Display Screen with EEG..................................................................... 3-10
Figure 11 - Trend Display with Target Range ........................................................................... 3-14
Figure 12 - BIS Range Guidelines ...............................................................................................3-21
Figure 13 - Replacing the Power Supply....................................................................................... 5-4
Figure 14 - BIS VIEW Menu Map ................................................................................................ 7-1
ABOUT THIS MANUAL
This Operating Manual contains all of the information you need to set up and operate the
Aspect Medical Systems’ BIS VIEW Monitoring System (Figure 3). It also includes
specific cleaning and test procedures you may occasionally be required to perform. Although
this manual is intended for trained medical personnel, it does not assume prior knowledge or
experience with operator-programmable medical electronics devices.
Keep this Operating Manual with the BIS VIEW monitor for use by the operator. This
manual is also intended to be a service information manual for service technicians or
biomedical engineering personnel.
Before attempting to set up or use the BIS VIEW system, please familiarize yourself
with the safety information provided in this section.
i
INTRODUCING THE BIS VIEW MONITORING SYSTEM
Introduction
The BIS VIEW Monitoring System is a user-configurable patient monitoring system
designed to monitor the hypnotic state of the brain based on acquisition and processing of
EEG signals. The BIS VIEW system processes raw EEG signals to produce a single
number, called the Bispectral Index, or BIS, which correlates with the patient's level of
hypnosis.
The BIS VIEW monitor display consists of:
The current BIS number
Trend graph of BIS values over time
Raw EEG waveforms in real time
Various signal quality indicators (EMG, SQI, SR)
Alarm Indicator and Messages
The system performs self-tests to ensure that the monitor and its components are
functioning properly and that impedance levels of patient sensors are within acceptable
limits. Easy-to-use menus allow the user to change the data display and review stored data.
ii
Important Information about Using BIS Monitoring
BIS monitoring systems are intended for use under the direct supervision of a licensed
healthcare practitioner or by personnel trained in their proper use. They are 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;
and its usage with certain anesthetic agents may be associated with a reduction in primary
anesthetic use and a reduction in emergence and recovery time.
Use of BIS monitoring to help guide anesthetic administration may be associated with the
reduction of incidence of awareness with recall in adults during general anesthesia and
sedation.
BIS is a complex monitoring technology intended for use as an adjunct to clinical judgment
and training. Clinical judgment should always be used when interpreting the BIS in
conjunction with other available clinical signs. Reliance on the BIS alone for
intraoperative anesthetic management is not recommended. As with any monitored
parameter, artifacts and poor signal quality may lead to inappropriate BIS values. Potential
artifacts may be caused by poor skin contact (high impedance), muscle activity or rigidity,
head and body motion, sustained eye movements, improper sensor placement and unusual
or excessive electrical interference. BIS values should also be interpreted cautiously with
certain anesthetic combinations, such as those relying primarily on either ketamine or nitrous
oxide/narcotics to produce unconsciousness. Due to limited clinical experience in the
following applications, BIS values should be interpreted cautiously in patients with known
neurological disorders and those taking other psychoactive medications.
The BIS education site, www.biseducation.com
articles on the clinical use of BIS. In addition, there is a “Monitoring Consciousness Using
the Bispectral Index During Anesthesia” Clinician’s Pocket Guide available on the website
and through your local Aspect Representative.
For more information, please contact Aspect Medical Systems at (800) 442-2051. If you
require additional information on the use of BIS, please contact Aspect Medical Systems
Clinical Support at 800-442-8655 or 617-559-7655 if calling from outside of the USA.
, offers relevant information and published
iii
SECTION 1 SAFETY PRECAUTIONS
______________________________________________________________________
SECTION 1
1 SAFETY PRECAUTIONS
INTRODUCTION
Caution:
Carefully read this entire manual 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 VIEW system appears at the end of this section.
1.1 Warnings
EXPLOSION HAZARD: DO NOT USE THE BIS VIEW SYSTEM IN A
FLAMMABLE ATMOSPHERE OR WHERE CONCENTRATIONS OF
FLAMMABLE ANESTHETICS MAY OCCUR.
MONITOR IS NOT DESIGNED FOR USE IN MRI ENVIRONMENT.
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.
USE ONLY THE POWER CORD SUPPLIED BY THE MANUFACTURER.
NEVER ADAPT THE PLUG FROM THE MONITOR TO FIT A NONSTANDARD OUTLET.
1-1
SECTION 1 SAFETY PRECAUTIONS
______________________________________________________________________
U.S.A. REQUIREMENT: 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 VIEW SYSTEM SHALL BE OPERATED FROM ITS
INTERNAL BATTERY POWER SOURCE ONLY.
BE SURE THE MONITOR IS MOUNTED SECURELY IN PLACE TO AVOID
PERSONAL OR PATIENT INJURY.
WHEN CONNECTING EXTERNAL EQUIPMENT (e.g., DATA CAPTURE
COMPUTER), THE SYSTEM LEAKAGE CURRENT MUST BE CHECKED
AND MUST BE LESS THAN THE IEC 60601-1-1 LIMIT.
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 60601-1-1 HARMONIZED
NATIONAL STANDARD.
DUE TO ELEVATED SURFACE TEMPERATURE, DO NOT PLACE BISx IN
PROLONGED DIRECT CONTACT WITH PATIENT’S SKIN, AS IT MAY
CAUSE DISCOMFORT.
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSOR AND
CONNECTORS SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS,
INCLUDING EARTH.
TO REDUCE THE HAZARD OF BURNS DURING USE OF HIGHFREQUENCY SURGICAL EQUIPMENT, 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 VIEW SYSTEM.
1-2
SECTION 1 SAFETY PRECAUTIONS
______________________________________________________________________
TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT
INTERFACE CABLE (PIC) MUST BE CAREFULLY PLACED AND SECURED.
DO NOT EXPORT BISx HISTORY DATA WHILE A CASE IS IN PROGRESS.
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.
UNIVERSAL PRECAUTIONS SHALL BE OBSERVED TO PREVENT
CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS
MATERIALS. PLACE CONTAMINATED MATERIALS IN REGULATED
WASTE CONTAINER.
DO NOT MIX DISINFECTING SOLUTIONS (e.g., BLEACH AND AMMONIA),
AS HAZARDOUS GASES MAY RESULT.
ELECTRICAL SHOCK HAZARD: DO NOT REMOVE MONITOR COVERS
DURING OPERATION OR WHILE POWER IS CONNECTED TO MONITOR.
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 LEAKAGE CURRENT BEFORE FURTHER USE.
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 VIEW POWER SUPPLY.
1.2 Cautions
Read this entire manual carefully before using the monitor in a clinical setting.
Do not autoclave the BISx or Monitor. Autoclaving will seriously damage both
components.
Do not block ventilation inlet holes on the underside of monitor.
Do not open the BISx for any reason. The seal to prevent liquids from entering the
BISx may be damaged if opened.
1-3
SECTION 1 SAFETY PRECAUTIONS
______________________________________________________________________
The BIS VIEW 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 remove drive while export is in progress.
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).
Check the battery periodically by operating a BIS VIEW 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 VIEW monitor fails to operate reliably from the battery
for approximately 45 minutes, battery replacement is required.
The BIS VIEW 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.
Avoid liquid ingress to the Patient Interface Cable. Contact of fluids with the PIC
sensor connector can interfere with PIC performance.
The BIS VIEW system complies with the electromagnetic compatibility
requirements of IEC 60601-1-2. 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 8.2 “Electromagnetic Compatibility Specifications.”
Do not disconnect the BISx during the software update.
When connecting or disconnecting BISx, take care not to touch the exposed contacts
of either connector. Damage due to electrostatic discharge may result.
Using accessories other than those specified may result in increased electromagnetic
emissions or decreased electromagnetic immunity of the BIS VIEW Monitoring
System.
1-4
SECTION 1 SAFETY PRECAUTIONS
______________________________________________________________________
The BIS VIEW Monitor should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the BIS VIEW Monitor should be
observed to verify normal operation in the configuration in which it will be used.
To completely remove power from the unit: put the monitor in standby mode,
disconnect power cord from the power cord receptacle of the monitor, then remove
the battery from the monitor.
The BIS VIEW 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 6.4 “Using the Reset Button”).
Service or repairs must be performed only by qualified biomedical technicians.
Important:
The BIS VIEW systems comply with the European Medical Device Directive (MDD)
and applicable regulatory requirements of the country distributed to and carry the
CE
Marking. Declarations of Conformity provided upon request where
XXXX
appropriate.
1-5
SECTION 1 SAFETY PRECAUTIONS
______________________________________________________________________
1.3 Key to Symbols
USB-B
Data I/O, RS-232 Serial Port
Universal Serial Bus:
Type B
Storage Temperature Limits
Type BF Equipment
Defibrillator-proof
USB-A
Caution, Consult
Accompanying Documents
Universal Serial Bus:
Type A
Caution: Hot Surface
Type BF Equipment
EC REP
Alternating Current (A/C)
Battery Location
Monitor Power ON
Do not Reuse
Latex-free product
Recyclable
Manufacturer
Authorized Representative
in the European
Community
Batch Code
Conformité Européenne
(CE) Marking of
Conformity to European
Medical Device Directive.
CE
represents the
XXXX
Notified Body number
Recognized under the
Component Recognition
Program of Underwriters
Laboratories Inc.
Direct Current (D/C)
Reset Button
Monitor Power OFF or Standby
Mode
Use by
YYYY-MM-DD or
YYYY-MM
PVC-free product
Crossed out wheelie bin indicates
separate treatment from general
waste at end of life
Date of Manufacture
Catalog Number
Serial 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
Packaging Labeling:
Fragile, Do Not Get Wet, and
This Side Up
Figure 1 - Symbol Key (page 1 of 2)
1-6
SECTION 1 SAFETY PRECAUTIONS
______________________________________________________________________
Operating on Battery
No Battery is Installed in Monitor
Ringing Bell Icon – High Priority Alarm Condition exists. The alarm
sounds unless the alarm key has been pressed to silence it.
Yellow Bell with dotted ‘X’ - Alarms Paused
Red Bell with ‘X’ - Alarms Silenced
Figure 1 - Symbol Key (page 2 of 2)
1-7
SECTION 1 SAFETY PRECAUTIONS
______________________________________________________________________
1-8
SECTION 2 SYSTEM SETUP AND PREPARATION FOR USE
______________________________________________________________________
SECTION 2
2 SYSTEM SETUP AND PREPARATION
FOR USE
____________________________________________________
INTRODUCTION
This section provides setup instructions for the Aspect BIS VIEW Monitor, BISx, and
accessories. It includes:
Setup checklist
Proper environment
Required equipment and supplies
Cable connections
Start and shutdown procedures
Initial menu settings
2.1 BIS VIEW Monitor Setup and Checkout
1. Open packages and inspect for all components:
Monitor (P/N 185-0205)
Power cord
Pole clamp
BISx (P/N 185-0145-AMS)
PIC (Patient interface cable, connects BISx to patient)
Sensors are sold separately. For a list of available sensors please contact Aspect Medical
Systems, Inc. or your local distributor.
2. Connect power cable to monitor, plug power plug into appropriate wall outlet.
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. (Do not connect or disconnect equipment,
or press keys until the monitor has completed its tests.)
Verify next screen says “Connect BISx.”
4. Connect BISx with PIC to monitor.
Verify that screen says “Connect sensor or cable.”
5. Connect PIC and sensor.
Verify SENSOR CHECK begins.
6. Disconnect power cord from monitor.
2-1
SECTION 2 SYSTEM SETUP AND PREPARATION FOR USE
______________________________________________________________________
Verify ‘OPERATING ON BATTERY BACKUP’ is displayed
Verify battery icon displays.
7. Reconnect power cord.
Verify battery icon is not displayed.
Verify “OPERATING ON BATTERY BACKUP” is not displayed.
8. End of checkout.
2.2 Environment
2.2.1 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 -10C to +60C
Humidity 15% to 95% (non-condensing)
Pressure 800 mm Hg (1500 feet below sea level) to 360mm Hg (20,000 feet
above sea level)
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.
2.2.2 Operating Environment
The BIS VIEW Monitoring System is not designed for use in areas containing flammable
gases or vapors.
WARNING:
EXPLOSION HAZARD: DO NOT USE THE BIS VIEW SYSTEM
IN A FLAMMABLE ATMOSPHERE OR WHERE
CONCENTRATIONS OF FLAMMABLE ANESTHETICS MAY
OCCUR.
MONITOR IS NOT DESIGNED FOR USE IN MRI
ENVIRONMENT.
The BIS VIEW monitor is designed to operate safely under the following conditions.
Conditions outside these ranges could affect reliability.
Temperature 0C to +40C
Humidity 15% to 95% (non-condensing)
2-2
SECTION 2 SYSTEM SETUP AND PREPARATION FOR USE
______________________________________________________________________
Pressure 800 mm Hg (1500 feet below sea level) to 360mm Hg (20,000 feet
above sea level)
2.2.3 Power Requirements and System Grounding
The BIS VIEW Monitoring System requires a power source of 100-240 VAC, 50-60Hz.
Current consumption is 0.7 ampere maximum.
To protect operating personnel and patients, the monitor must be properly grounded.
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:
USE ONLY THE POWER CORD SUPPLIED BY THE
MANUFACTURER. NEVER ADAPT THE PLUG FROM THE
MONITOR TO FIT A NON-STANDARD OUTLET.
U.S.A. REQUIREMENT: 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 VIEW MONITOR
SHALL BE OPERATED FROM ITS INTERNAL BATTERY
POWER SOURCE ONLY.
The BIS VIEW Monitoring unit does not contain a
Since the exposed metal parts on the rear of the BIS VIEW 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 VIEW Monitor that are
connected to protective earth are contained within its enclosure and are not accessible to the
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 VIEW 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 can be measured by
Protective Earth Stud (GND Stud)
.
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connecting the patient connection terminals of a safety tester to the patient input connection
(the PIC) of the BISx.
The BIS VIEW Monitor has been certified by Underwriters Laboratories to comply with
IEC 60601-1, as indicated on the labeling on the rear of the monitor.
2.2.4 Electromagnetic Compatibility Requirements
The BIS VIEW Monitoring System should be used only with the power cord and accessories
recommended and supplied by Aspect Medical Systems, Inc. The system must be set up and
put into use according to the specifications described in Section8.2 “Electromagnetic
Compatibility Specifications.”
Caution:
The BIS VIEW system complies with the electromagnetic
compatibility requirements of IEC 60601-1-2. 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 8.2 “Electromagnetic Compatibility Specifications.”
2.2.5 Site Preparation: Mounting the Monitor
Aspect Medical Systems, Inc. strongly recommends permanent mounting of the BIS VIEW
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.
2.2.5.1 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.
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SECTION 2 SYSTEM SETUP AND PREPARATION FOR USE
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Figure 2 - 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. 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.
2.2.5.2 Optional Mounting Accessories
For information on optional mounting accessories, request Aspect’s “Monitor Mounting
Solutions” booklet (part number 070-0031).
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SECTION 2 SYSTEM SETUP AND PREPARATION FOR USE
(
______________________________________________________________________
2.3 The BIS VIEW Monitoring System –
Equipment and Supplies
The BIS VIEW Monitoring System consists of the following basic components:
BIS VIEW Monitor (P/N 185-0205)
BISx (P/N 185-0145-AMS)
Patient Interface Cable (PIC)
BIS Sensor
Detachable Power Cord
Sensors are sold separately. For a list of available sensors please contact Aspect Medical
Systems, Inc. or your local distributor.
A pole clamp is also included; however its use is optional. Contact Aspect or your local
representative for information on additional equipment and accessories.
BIS Sensor
BIS VIEW Monitor
Patient
Interface Cable
PIC)
Monitor Interface
Cable
BISx
Figure 3 - The BIS VIEW Monitoring System
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SECTION 2 SYSTEM SETUP AND PREPARATION FOR USE
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2.3.1 The BIS VIEW Monitor
2.3.1.1 Front Panel
The front panel of the BIS VIEW monitor contains four soft keys, an alarm key, the BISx
port and the ON/Standby button. See Figure 3.
2.3.1.2 Soft Keys
The four white “soft” keys directly under the BIS VIEW screen are used to make all
selections. These keys are designed to function even when the user is wearing examination
gloves.
2.3.1.3 Alarm Key
The Alarm Key is used to pause, silence, or reinstate audible alarms.
2.3.1.4 ON/Standby button
The ON/Standby button is located in the lower right corner of the monitor and indicates
whether the monitor is 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.
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2.3.1.5 Rear Panel
The rear panel components are pictured in Figure 4. They include: two USB ports (Type A
and B), the Reset button, an RS-232 port, the Battery/Power Supply cover, and the clamp
shoe.
USB Port
(Type A)
USB Port
(Type B)
Battery/Power
Supply
Cover
Reset Button
Serial Port
Power Cord
Receptacle
Clamp Shoe
Figure 4 - Rear Panel
There are two USB ports on the rear of the monitor. The Type A port is used to export
data to a removable drive. It is also used to update monitor and BISx software. The USB
(Type B) port is for manufacturer’s use only.
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.
The RS-232 serial port can be used to transfer data from the monitor.
WARNING:
WHEN CONNECTING EXTERNAL EQUIPMENT (e.g., DATA
CAPTURE COMPUTER), THE SYSTEM LEAKAGE CURRENT
MUST BE CHECKED AND MUST BE LESS THAN THE IEC
60601-1-1 LIMIT.
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SECTION 2 SYSTEM SETUP AND PREPARATION FOR USE
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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 60601-1-1 HARMONIZED NATIONAL
STANDARD.
Under normal operation, power is cycled through the ON/Standby button. The Reset
button can be used to reset the software functions of the BIS monitor (and the BISx if it is
attached) in the unlikely case that it is required. See Section 6.4 “Using the Reset Button.”
The Battery/Power Supply cover contains the BIS VIEW monitor’s power supply and
allows access to its battery.
The power cord receptacle, located on the side of the Battery/Power Supply cover, is used
to plug in the power cord provided by the manufacturer. It provides power to the monitor
and to the BISx when it is attached.
Caution:
The BIS VIEW Monitoring System complies with the electromagnetic
compatibility requirements of IEC60601-1-2. 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 8.2 “Electromagnetic Compatibility Specifications.”
2.3.1.6 Integral Battery
A rechargeable lithium ion battery inside the monitor provides approximately 45 minutes of
back-up power when power cannot be supplied via the power cord. Recharge time is
approximately 6 hours. The battery charges continually as long as the unit is plugged into
A/C power.
When the system is running on battery, a battery icon displays indicating the battery status. A
battery icon with four green bars indicates that the battery is fully charged. When the battery
reaches a low power condition, the monitor beeps and the battery symbol displayed on the
screen changes color. In addition, a “Battery Voltage Low” message blinks in the Message
area of the screen.
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Caution:
Check the battery periodically by operating a BIS VIEW 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 VIEW monitor fails to operate reliably from the battery for
approximately 45 minutes, battery replacement is required.
The BIS VIEW 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.
2.3.2 BISx
Patient Interface Cable (PIC)
Monitor Interface Cable
Figure 5 - BISx and 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.
The BISx is shown in Figure 5. 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.
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