Aspect BIS VIEW Operating and installation instructions

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

BIS VIEWMonitoring
System
SERVICE INFORMATION MANUAL
Aspect Medical Systems, Inc.
Bispectral Index(BIS) Monitoring System
©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.
BIS VIEW, BISx and the BISx logo are trademarks of Aspect Medical Systems, Inc.
Aspect, Bispectral Index, BIS, the BIS logo, and Zipprep are trademarks of Aspect Medical
Systems, Inc. and are registered in the USA., EU and other countries.

v
TABLE OF CONTENTS
ABOUT THIS MANUAL.................................................................................................................. I
1SAFETY PRECAUTIONS.................................................................................................... 1-1
1.1 WARNINGS ................................................................................................................................................. 1-1
1.2 CAUTIONS................................................................................................................................................... 1-3
1.3 KEY TO SYMBOLS........................................................................................................................................ 1-6
2BIS VIEW MONITORING SYSTEM OVERVIEW ............................................................ 2-1
2.1 INTRODUCING THE BIS VIEW MONITORING SYSTEM ........................................................................... 2-1
2.2 PRINCIPAL COMPONENTS.......................................................................................................................... 2-2
2.2.1 The BIS VIEW Monitor ........................................................................................................................................ 2-2
2.2.2 The BISx and Patient Interface Cable (PIC) ................................................................................................... 2-4
2.3 INSTRUMENT IDENTIFICATION .................................................................................................................. 2-4
2.4 PROPRIETARY INFORMATION AND DEVICES ............................................................................................ 2-5
3PRINCIPLES OF OPERATION .......................................................................................... 3-1
3.1 HOW THE BIS VIEW MONITORING SYSTEM WORKS............................................................................ 3-1
3.2 SYSTEM ARCHITECTURE ............................................................................................................................. 3-1
3.2.1 The BISx................................................................................................................................................................... 3-3
3.2.2 The BIS VIEW Monitor ........................................................................................................................................ 3-6
3.3 SYSTEM FEATURES ....................................................................................................................................... 3-7
3.3.1 System Self Checks ............................................................................................................................................... 3-7
3.3.2 Diagnostic Codes ................................................................................................................................................... 3-8
3.3.3 Monitor Data Memory......................................................................................................................................... 3-8
3.3.4 BISx Data Memory ............................................................................................................................................... 3-9
3.3.5 Saved Settings......................................................................................................................................................... 3-9
3.3.6 Battery Operation.................................................................................................................................................. 3-9
3.3.7 Data Transfer and Software Updates ...........................................................................................................3-10
4PREPARATION FOR USE AND INSTALLATION ......................................................... 4-1
4.1 ENVIRONMENT............................................................................................................................................ 4-1
4.1.1 Shipping and Storage Environment .................................................................................................................. 4-1
4.1.2 Operating Environment........................................................................................................................................ 4-1
4.1.3 Power Requirements and System Grounding................................................................................................. 4-2
4.1.4 Site Preparation: Mounting the Monitor ......................................................................................................... 4-2
4.2 INSTRUMENT CONNECTIONS.................................................................................................................... 4-4
4.2.1 Connecting the BISx.............................................................................................................................................. 4-4
4.2.2 Power Cord Connections...................................................................................................................................... 4-4
4.3 INSTALLATION AND VERIFICATION PROCEDURE .................................................................................... 4-4
5CARE AND CLEANING...................................................................................................... 5-1
5.1 CARE AND CLEANING................................................................................................................................5-1
5.1.1 Cleaning the Monitor and BISx.......................................................................................................................... 5-1
5.1.2 Disinfecting the Monitor and BISx.................................................................................................................... 5-1
5.1.3 Cleaning the Monitor Display............................................................................................................................. 5-2
6PREVENTIVE MAINTENANCE ......................................................................................... 6-1
6.1 PHYSICAL INTEGRITY INSPECTION ............................................................................................................ 6-1
6.2 REPLACING THE PIC (PATIENT INTERFACE CABLE) ................................................................................ 6-1
6.3 SYSTEM CHECKOUT ................................................................................................................................... 6-2

vi
6.3.1 Monitor Checkout Procedure.............................................................................................................................. 6-2
6.3.2 BISx Checkout Procedure .................................................................................................................................... 6-3
6.3.3 Patient Interface Cable (PIC) Checkout Procedure....................................................................................... 6-4
6.4 CHECKING THE BATTERY .......................................................................................................................... 6-6
6.5 CHECKING LEAKAGE CURRENT................................................................................................................ 6-7
7DIAGNOSTICS AND TROUBLESHOOTING ................................................................. 7-1
7.1 GENERAL TROUBLESHOOTING ................................................................................................................. 7-1
7.2 BIS VIEW MONITORING SYSTEM TROUBLESHOOTING PROCEDURE ................................................... 7-2
7.3 BIS VIEW SYSTEM MESSAGES AND CORRECTIVE ACTIONS ................................................................... 7-4
8SERVICING THE BIS VIEW SYSTEM............................................................................... 8-1
8.1 REPLACING THE PIC................................................................................................................................... 8-1
8.2 REPLACING THE BISX................................................................................................................................. 8-1
8.3 REPLACING THE MONITOR........................................................................................................................ 8-2
8.4 REPLACING THE BATTERY.......................................................................................................................... 8-3
8.5 REPLACING THE POWER SUPPLY ............................................................................................................... 8-4
8.6 REPLACING THE CLAMP SHOE................................................................................................................... 8-5
8.7 REPLACING THE BISX MONITOR INTERFACE CABLE............................................................................... 8-6
8.7.1 Parts and Tools Required .................................................................................................................................... 8-6
8.7.2 Procedure:................................................................................................................................................................ 8-6
8.8 REPLACING THE BISX BULKHEAD CONNECTOR..................................................................................... 8-9
8.8.1 Parts and Tools Required .................................................................................................................................... 8-9
8.8.2 Procedure:..............................................................................................................................................................8-10
8.9 USING THE RESET BUTTON ..................................................................................................................... 8-13
8.10 BISX CHECKOUT AND SAFETY TESTS..................................................................................................... 8-13
8.11 PERFORMING A SOFTWARE UPDATE....................................................................................................... 8-14
8.12 WHAT TO DO WITH A COMPONENT THAT REQUIRES SERVICE .......................................................... 8-15
8.13 REPACKAGING FOR SHIPPING AND STORAGE........................................................................................ 8-15
9SPECIFICATIONS AND WARRANTY............................................................................. 9-1
9.1 GENERAL SPECIFICATIONS ......................................................................................................................... 9-1
9.2 ELECTROMAGNETIC COMPATIBILITY SPECIFICATIONS ............................................................................ 9-5
9.2.1 Accessories............................................................................................................................................................... 9-5
9.2.2 IEC 60601-1-2:2001 Electromagnetic Compatibility Guidance............................................................... 9-6
9.3 WARRANTY .............................................................................................................................................. 9-11
10 APPENDIX I........................................................................................................................ 10-1
10.1 ACCESSORIES AND SPARE PARTS LIST..................................................................................................... 10-1
10.2 SENSOR SIMULATOR:P/N: 186-0137................................................................................................... 10-2
10.3 TEST SENSOR............................................................................................................................................. 10-3
10.4 SAFETY TESTER CONNECTION WITH PIC.............................................................................................. 10-6
11 APPENDIX II ...................................................................................................................... 11-1
11.1 DATA FLOW DIAGRAM............................................................................................................................ 11-1
11.2 BLOCK DIAGRAM ..................................................................................................................................... 11-2

vii
TABLE OF FIGURES
Figure 1 - Symbol Key (page 1 of 3)................................................................................1-6
Figure 2- The BIS VIEW Monitoring System................................................................... 2-1
Figure 3 - Rear Panel ...................................................................................................... 2-3
Figure 4 - The BISx and PIC ...........................................................................................2-4
Figure 5 - The BIS VIEW System Block Diagram ...........................................................3-2
Figure 6 - The BIS VIEW Data Flow Diagram ...............................................................3-3
Figure 7 - Pole Clamp ..................................................................................................... 4-3
Figure 8 - Schematic of the BIS Sensor Simulator ........................................................ 10-2
Figure 9 - BIS Sensor Simulator individual electrode impedance range ...................... 10-3
Figure 10 - BIS Sensor................................................................................................... 10-4
Figure 11 - Connecting electrodes #2 and #4. ..............................................................10-4
Figure 12 - Connecting electrode #3 with #4, and #1 with #2. .................................... 10-4
Figure 13 - Safety Tester Contact Points.......................................................................10-6

i
ABOUT THIS MANUAL
This manual contains information necessary for the customer to install, maintain, service,
identify and prepare for use Aspect Medical Systems’ BIS VIEWMonitoring System. Also
included are directions to diagnose, troubleshoot, and repair the system. A spare parts and
accessories list and system specifications are included.
This manual is intended to be used in combination with the BIS VIEW Monitoring System
Operating Manual.
The BIS VIEW Monitoring System is designed and manufactured using state-of-the-art
components and manufacturing processes. Field repair or customer repairs are therefore
limited by design to replacement of major component assemblies such as the Patient
Interface Cable (PIC), BISx™, the BIS VIEW monitor, or the monitor’s power supply and
battery.
This manual, in conjunction with the BIS VIEW Monitoring System Operating Manual,
contains the maintenance and diagnostic troubleshooting information necessary for
customer qualified technical personnel to test and replace those parts of the equipment that
are replaceable by the customer. Aspect does not authorize nor provide information to
service or repair the internal components of the BIS VIEW monitor, with the exception of
the power supply and battery.
Before attempting to set up or service the BIS VIEW Monitoring System, please familiarize
yourself with the safety information provided in Section 1 of this manual.

ii
Important Information about Using BIS Monitoring
The BIS VIEW Monitoring System is intended for use under the direct supervision of a
licensed healthcare practitioner or by personnel trained in their proper use. The system, and
all its associated parameters, is intended for use on adult and pediatric patients within a
hospital or medical facility providing patient care to monitor the state of the brain by data
acquisition of EEG signals.
The BIS Index, one of the BIS VIEW monitor’s output parameters, 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 the BIS Index for 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, offers relevant information and published
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 [phone]. 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.

iii

SECTION 1 SAFETY PRECAUTIONS
________________________________________________________________________
1-1
1SAFETY PRECAUTIONS
INTRODUCTION:
Caution:
Carefully read the BIS VIEW Monitoring System Operating Manual
entirely before using the monitor in a clinical setting.
WARNINGS, CAUTIONS, AND NOTES
The terms warning, caution, and note have specific meanings in this manual.
•A WARNING advises against certain actions or situations that could result in
personal injury or death.
•A CAUTION advises against actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure, although personal injury is
unlikely.
•A NOTE provides useful information regarding a function or procedure.
KEY TO SYMBOLS
A key to the symbols that may appear on the BIS VIEW Monitoring System appears at the
end of this section.
1.1 Warnings
GROUND WIRE LEAKAGE CURRENT MUST BE CHECKED BY A
QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN WHENEVER
INSTRUMENT CASE IS OPENED.
EXPLOSION HAZARD: DO NOT USE THE BIS VIEW SYSTEM IN A
FLAMMABLE ATMOSPHERE OR WHERE CONCENTRATIONS OF
FLAMMABLE ANESTHETICS MAY OCCUR.
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.
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.

SECTION 1 SAFETY PRECAUTIONS
________________________________________________________________________
1-2
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 SHALL BE OPERATED FROM ITS INTERNAL
BATTERY POWER SOURCE ONLY.
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSOR AND
CONNECTORS, INCLUDING THE NEUTRAL ELECTRODE, SHOULD NOT
CONTACT OTHER CONDUCTIVE PARTS, INCLUDING EARTH.
TO REDUCE THE HAZARD OF BURNS IN THE HIGH-FREQUENCY
SURGICAL NEUTRAL ELECTRODE CONNECTION, THE SENSOR OR
ELECTRODES SHOULD NOT BE LOCATED BETWEEN THE SURGICAL
SITE AND THE ELECTRO-SURGICAL UNIT RETURN ELECTRODE.
TO REDUCE THE HAZARD OF BURNS DURING USE OF BRAIN-
STIMULATING DEVICES (e.g., TRANSCRANIAL ELECTRICAL MOTOR
EVOKED POTENTIAL), PLACE STIMULATING ELECTRODES AS FAR AS
POSSIBLE FROM THE BIS™ SENSOR AND MAKE CERTAIN THAT SENSOR
IS PLACED ACCORDING TO PACKAGE INSTRUCTIONS.
THE SENSOR MUST NOT BE LOCATED BETWEEN DEFIBRILLATOR
PADS WHEN A DEFIBRILLATOR IS USED ON A PATIENT CONNECTED
TO THE BIS VIEW SYSTEM.
TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT
INTERFACE CABLE (PIC) MUST BE CAREFULLY PLACED AND SECURED.
WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR SOLUTIONS
OCCURS, RE-TEST GROUND LEAKAGE CURRENT BEFORE FURTHER
USE.
BE SURE THE MONITOR IS MOUNTED SECURELY IN PLACE TO AVOID
PERSONAL INJURY.
MONITOR IS NOT DESIGNED FOR USE IN MRI ENVIRONMENT.

SECTION 1 SAFETY PRECAUTIONS
________________________________________________________________________
1-3
DUE TO ELEVATED SURFACE TEMPERATURE, DO NOT PLACE BISx IN
PROLONGED DIRECT CONTACT WITH PATIENT’S SKIN, AS IT MAY
CAUSE DISCOMFORT.
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.
WHEN CONNECTING EXTERNAL EQUIPMENT (e.g., DATA CAPTURE
COMPUTER), THE SYSTEM LEAKAGE CURRENT MUST BE CHECKED
AND MUST BE LESS THAN THE IEC601-1-1 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 60601-2-26 HARMONIZED
NATIONAL STANDARD.
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.
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.
Continuous impedance checking may need to be disabled if the 1 nanoampere 128
Hz impedance check signal interferes with other equipment (e.g., evoked potential
monitors).
Do not autoclave the BISx or Monitor. Autoclaving will seriously damage both
components.

SECTION 1 SAFETY PRECAUTIONS
________________________________________________________________________
1-4
Avoid liquid ingress to the Patient Interface Cable. Contact of fluids with the PIC
sensor connector can interfere with PIC performance.
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.
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, charge the battery for 6 hours
to assure full capacity. If the BIS VIEW monitor fails to operate reliably from the
battery for approximately 45 minutes, battery replacement is required.
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, P/N 186-0208.
All repairs to the BIS VIEW Monitoring System should be made only by a qualified
Biomedical Engineering Technician or other authorized personnel.
Use only the parts and tools specified. Use of any others may damage the
instrument.
Using accessories other than those specified may result in increased electromagnetic
emissions or decreased electromagnetic immunity of the BIS VIEW Monitoring
System.
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.
Do not block ventilation inlet holes on the underside of monitor.
Do not open the BISx. The seal to prevent liquids from entering the BISx may be
damaged if opened. Service or repairs must be performed only by qualified
biomedical technicians.
The BIS 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 disconnect the BISx during a BISx software upgrade.

SECTION 1 SAFETY PRECAUTIONS
________________________________________________________________________
1-5
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 9.2 “Electromagnetic Compatibility Specifications.”
When connecting or disconnecting BISx, take care not to touch the exposed contacts
of either connector. Damage due to electrostatic discharge may result.
All work involving opening the instrument case must be performed in a static-safe
environment to prevent damage to electronic components and assemblies. This
environment includes the operator, work area and tools, and any other test or storage
items that might touch the monitor or BISx assemblies.
Exposed metal parts are double insulated from live parts of the monitor and are not
wired for safety current. A ground continuity test is not recommended.
Important:
The BIS VIEW systems comply with the European Medical Device Directive (MDD)
and applicable regulatory requirements of the country distributed to and carry the
CEXXXX Marking. Declarations of Conformity provided upon request where
appropriate.

SECTION 1 SAFETY PRECAUTIONS
________________________________________________________________________
1-6
1.3 Key to Symbols
Caution: Consult
Accompanying Documents Data I/O, RS-232 Serial Port
USB-A
Universal Serial Bus:
Type A USB-B Universal Serial Bus: Type B
Caution: Hot Surface Storage Temperature Limits
Type BF Equipment
Type BF Equipment
Defibrillator-proof
Alternating Current (A/C)
Direct Current (D/C)
Battery Location
Reset Button
Monitor Power ON
Monitor Power OFF or Standby
Mode
Do not Reuse
Use by
YYYY-MM-DD or
YYYY-MM
Latex-free product PVC-free product
Manufacturer Date of Manufacture
EC REP
Authorized Representative
in the European Community Catalog Number
Batch Code Serial Number
Conformité Européenne
(CE) Marking of
Conformity to European
Medical Device Directive.
CEXXXX represents the
Notified Body number
Classified by Underwriters
Laboratories Inc.with respect
to electric shock, fire and
mechanical hazards only, in
accordance with
UL 60601-1 and IEC60601-2-26
Recognized under the
Component Recognition
Program of Underwriters
Laboratories Inc.
Packaging Labeling:
Fragile, Do Not Get Wet, and
This Side Up
Figure 1 - Symbol Key (page 1 of 3)

SECTION 1 SAFETY PRECAUTIONS
________________________________________________________________________
1-7
Recyclable
Crossed out wheelie bin indicates
separate treatment from general
waste at end of life *
Product marked with a
number contains certain
toxic or hazardous
substances or elements, and
can be used safely during its
Environment-Friendly Use
Period (EFUP). The
product should be recycled.
The Environment-Friendly
Use Period is valid only
when the product is
operated under the
conditions defined in the
product manual. **
Product marked with the “e”
does not contain any toxic or
hazardous substances or
elements, and is green and
environmental. The product can
be recycled. **
*Contact Aspect Medical Systems International B.V. for a Return Materials
Authorization (RMA) number or contact your municipality or the nearest collection site
to dispose of waste equipment. 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 from ‘normal’ household waste and make sure that it
is treated at an electronics recycler.
** Refer to www.aspectmedical.com for Material Declaration Data Sheets.
Figure 1 - Symbol Key (page 2 of 3)

SECTION 1 SAFETY PRECAUTIONS
________________________________________________________________________
1-8
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 3 of 3)

SECTION 2 BIS VIEW MONITORING SYSTEM OVERVIEW
_______________________________________________________________________
2-1
2BIS VIEW MONITORING SYSTEM
OVERVIEW
2.1 Introducing the BIS VIEW Monitoring
System
The BIS VIEW Monitoring System processes raw EEG signals to produce a single number,
called the Bispectral Index, or BIS, which correlates to the patient’s level of hypnosis. It
operates from an AC power source of 100V to 240V, 50/60Hz, and provides approximately
45 minutes of automatic back-up battery power.
The monitor is menu-driven. A detailed description of how the BIS VIEW Monitoring
System works is included in the BIS VIEW Operating Manual. Please refer to the BIS VIEW
Operating Manual for additional information.
Figure 2- The BIS VIEW Monitoring System
BIS Sensor
BIS VIEW Monitor
Monitor Interface
Cable
BISx
Pat
i
ent
Interface Cable
(
PIC)

SECTION 2 BIS VIEW MONITORING SYSTEM OVERVIEW
_______________________________________________________________________
2-2
2.2 Principal Components
The system is composed of a monitor, a BISx, a Patient Interface Cable (PIC), and BIS
sensor.
2.2.1 The BIS VIEW Monitor
The front panel of the BIS VIEW monitor contains four soft keys, an alarm key, the BISx
port and the ON/Standby button. See Figure 2.
Soft Keys
The four white “soft” 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.
Alarm Key
The Alarm Key is used to pause, silence, or reinstate audible alarms.
ON/Standby button
The ON/Standby button is located in the lower right corner of the monitor and is used to
put the monitor in ON or in Standby mode. When the small LED light to the right of the
ON/Standby button is green, the unit is running and providing power to the BISx. When it
is yellow, the battery is charging and the system is in Standby mode. When it is not lit, no
A/C power is available to the unit; pressing the ON/Standby button will start up the
monitor using the battery.