Aspect BIS VIsta User manual

BIS VISTA™ 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 0123
(Tel) 617-559-7000 Tel: [phone]
(Tel) 888-BIS INDE(X) (U.S. only) Fax: [phone]
(Fax) 617-559-7400 [e-mail]
[e-mail]
www.aspectmedical.com
070-0069 3.00

EC REP

BIS VISTA™ Monitoring System

OPERATING MANUAL

© Copyright, 2008, 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 VISTA 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 VISTA 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 INSTALLATION AND PREPARATION FOR USE ................................ 2-1

2.1 BIS VISTA Monitor Installation 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.................................................................................... 2-3

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 VISTA Monitoring System – Equipment and Supplies ............................. 2-6

2.3.1 BIS VISTA Monitor .................................................................................................................................. 2-7

2.3.1.1 Front Panel...................................................................................................................................... 2-7

2.3.1.2 Touch Screen ................................................................................................................................. 2-7

2.3.1.3 ON/Standby button ...................................................................................................................... 2-7

2.3.1.4 Rear Panel....................................................................................................................................... 2-7

2.3.1.5 Integral Battery .............................................................................................................................. 2-9

2.3.2 BISx ........................................................................................................................................................... 2-10

2.3.3 Patient Interface Cable (PIC)............................................................................................................... 2-11

2.3.4 BIS Sensors .............................................................................................................................................. 2-11

2.4 Cable Connections..................................................................................................... 2-11

2.5 Start Procedure / Standby Mode ............................................................................. 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.................................................................................................. 2-12

2.6.1 Language Selection ................................................................................................................................. 2-13

2.6.2 Date and Time ........................................................................................................................................ 2-13

2.6.3 View/Save Settings.................................................................................................................................. 2-13

3 OPERATING THE BIS VISTA MONITORING SYSTEM....................... 3-1

3.1 Preparing for Operation ............................................................................................. 3-1

3.2 Sensor Check................................................................................................................ 3-3

3.3 BIS Trend Data Screen ............................................................................................... 3-6

3.3.1 BIS (Bispectral Index) Value ................................................................................................................... 3-6

3.3.2 Signal Quality Indicator ........................................................................................................................... 3-6

3.3.3 Electromyograph (EMG) Indicator ....................................................................................................... 3-7

3.3.4 EEG Waveform Display .......................................................................................................................... 3-7

3.3.5 Message Region ........................................................................................................................................ 3-7

3.3.6 BIS Trend Graph ...................................................................................................................................... 3-8

3.3.7 Additional Screen Information .............................................................................................................. 3-9

3.3.7.1 Battery Icon.................................................................................................................................... 3-9

3.3.7.2 USB Export Icon............................................................................................................................ 3-9

3.3.7.3 Print Icon....................................................................................................................................... 3-10

3.3.7.4 Extend Mode................................................................................................................................ 3-10

3.3.7.5 Suppression Ratio (SR) Number.............................................................................................. 3-10

3.3.7.6 Burst Count (Bursts/Minute).................................................................................................... 3-10

3.4 Main Screen Touch Keys........................................................................................... 3-11

3.4.1 Alarm Touch Keys ................................................................................................................................. 3-11

3.4.2 Menu, Home, Sensor Check and Review Touch Keys................................................................... 3-12

3.5 Menu Selections ......................................................................................................... 3-13

3.5.1 Target Range ........................................................................................................................................... 3-13

3.5.2 Secondary Variable ................................................................................................................................ 3-15

3.5.3 Chart Data............................................................................................................................................... 3-16

3.5.4 Alarm Volume......................................................................................................................................... 3-17

3.5.5 BIS/EEG Display Modes.........................................................................................................................3-18

3.5.6 View/Save Settings.................................................................................................................................. 3-18

3.5.7 Help........................................................................................................................................................... 3-19

3.5.8 Snapshot................................................................................................................................................... 3-20

3.5.9 Display Suppression Ratio (SR) ...........................................................................................................3-20

3.5.10 Monitor Mode ................................................................................................................................... 3-21

3.5.11 Export Data ....................................................................................................................................... 3-22

3.5.12 BIS Smoothing Rate.......................................................................................................................... 3-24

3.5.13 Print (Snapshot)................................................................................................................................. 3-25

3.5.14 Configuration Information.............................................................................................................. 3-26

3.5.15 EEG Channels.................................................................................................................................... 3-26

3.5.16 Date and Time................................................................................................................................... 3-27

3.5.17 Language ............................................................................................................................................. 3-28

3.5.18 Filters................................................................................................................................................... 3-28

3.5.19 Impedance Checking........................................................................................................................ 3-29

3.5.20 Maintenance Menu............................................................................................................................ 3-30

3.5.21 Demo Case ........................................................................................................................................ 3-30

3.5.22 Diagnostic Menu ............................................................................................................................... 3-30

3.6 Reviewing and Printing Stored Trend Data............................................................ 3-31

3.6.1 Review Mode Touch Keys ................................................................................................................... 3-31

3.6.2 Printing Stored Data.............................................................................................................................. 3-33

3.7 EEG Display ................................................................................................................ 3-34

3.8 Ending a Case ............................................................................................................. 3-34

3.9 Data Transfer ............................................................................................................. 3-35

3.10 How the BIS VISTA Monitoring System Works.................................................... 3-36

3.10.1 Bispectral Index (BIS).......................................................................................................................3-37

3.10.2 Artifact Detection............................................................................................................................. 3-37

3.10.3 System Self-Checks........................................................................................................................... 3-37

3.10.4 Monitor Data Memory ....................................................................................................................3-38

3.10.5 BISx Data Memory ........................................................................................................................... 3-38

3.10.6 Battery Operation ............................................................................................................................ 3-39

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 Replace the PIC (Patient Interface Cable) .......................................................................................... 5-2

5.2.2 Checking Cable Integrity ........................................................................................................................ 5-3

5.2.3 System Checkout ..................................................................................................................................... 5-3

5.2.4 Checking the Battery............................................................................................................................... 5-4

5.2.5 Replacing the Battery .............................................................................................................................. 5-4

5.2.6 Replacing the Power Supply................................................................................................................... 5-5

5.2.7 Checking Leakage Current..................................................................................................................... 5-6

5.3 Technical Documentation .......................................................................................... 5-7

5.4 Instrument Identification............................................................................................ 5-7

6 DIAGNOSTICS AND TROUBLESHOOTING ........................................ 6-1

6.1 Maintenance Menu....................................................................................................... 6-1

6.1.1 Display BISx Connection History ......................................................................................................... 6-1

6.1.2 Serial Protocol .......................................................................................................................................... 6-1

6.1.3 Software Update....................................................................................................................................... 6-2

6.1.4 Restore Default Settings for All Modes............................................................................................... 6-2

6.1.5 Calibrate Touch Screen .......................................................................................................................... 6-2

6.2 Diagnostic Menu .......................................................................................................... 6-3

6.2.1 Diagnostic Codes ..................................................................................................................................... 6-3

6.2.2 DSC Self Test............................................................................................................................................ 6-3

6.3 BIS VISTA System Messages and Corrective Actions ............................................ 6-4

6.4 Using the Reset button ............................................................................................. 6-11

6.5 What to do if the BIS VISTA 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 ............................................................................................ 7-4

7.4 Glossary......................................................................................................................... 7-5

8 APPENDIX II: SPECIFICATIONS, WARRANTY AND SOFTWARE

LICENSE AGREEMENT..................................................................................... 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

TABLE OF FIGURES

Figure 1 - Symbol Key (page 1 of 3) .............................................................................................1-6

Figure 2 - Pole Clamp...................................................................................................................... 2-4

Figure 3 - The BIS VISTA 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 (Values not Shown).................................................. 3-4

Figure 8 - Sensor Check Graphic Screen with Values Shown................................................... 3-5

Figure 9 - Screen Features – BIS Trend Data Screen................................................................. 3-6

Figure 10 - BIS Trend Data Screen with Battery Icon, Target Range, SR, and Burst Count3-9

Figure 11 - Alarm Touch Keys ....................................................................................................3-11

Figure 12 - Menu, Home, Sensor Check and Review Mode Touch Keys............................. 3-12

Figure 13 - Target Range............................................................................................................... 3-13

Figure 14 - Secondary Variable .................................................................................................... 3-15

Figure 15 - Chart Data...................................................................................................................3-16

Figure 16 - Alarm Volume............................................................................................................3-17

Figure 17 - BIS/EEG Display Modes ........................................................................................ 3-18

Figure 18 - View/Save Settings.................................................................................................... 3-18

Figure 19 - Help ............................................................................................................................. 3-19

Figure 20 - Snapshot...................................................................................................................... 3-20

Figure 21 - Display SR................................................................................................................... 3-20

Figure 22 - Monitor Mode Settings ............................................................................................. 3-21

Figure 23 - Export Data................................................................................................................3-22

Figure 24 - Smoothing Rate.......................................................................................................... 3-24

Figure 25 - “Print” Touch Key ....................................................................................................3-25

Figure 26 - Configuration Information....................................................................................... 3-26

Figure 27 - EEG Channels ........................................................................................................... 3-26

Figure 28 - Date and Time............................................................................................................ 3-27

Figure 29 - Language Menu..........................................................................................................3-28

Figure 30 - Filters........................................................................................................................... 3-28

Figure 31 - Impedance Checking ON/OFF.............................................................................. 3-29

Figure 32 - Review Screen (Case Mode)..................................................................................... 3-31

Figure 33 - Review Screen (Cursor Mode)................................................................................. 3-32

Figure 34 - EEG Display .............................................................................................................. 3-34

Figure 35 - BIS Range Guidelines ............................................................................................... 3-36

Figure 36 - Replacing the Power Supply....................................................................................... 5-5

Figure 37 - Diagnostic Codes ON/OFF...................................................................................... 6-3

Figure 38 - BIS VISTA 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 VISTA™ Monitoring System. 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 VISTA 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 VISTA system, please familiarize yourself
with the safety information provided in this section.

i

INTRODUCING THE BIS VISTA MONITORING SYSTEM

Introduction

The BIS VISTA 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 VISTA 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 VISTA monitor display consists of:

• The current BIS number

• Trend graphs of processed EEG parameters

• Raw EEG waveforms in real time

• Various signal quality indicators (EMG, SQI)

• Suppression Ratio (if requested by the user)

• Burst Count number (when a BIS Extend Sensor is in use)

• 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. Touch screen menus allow the user to change the data display and review stored data.

ii

Important Information about Using BIS Monitoring

The BIS EEG VISTA Monitor System is intended for use under the direct supervision of a
licensed healthcare practitioner or by personnel trained in its 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 VISTA Monitor 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 BIS in conjunction
with other available clinical signs. Reliance on 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 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 that may appear on the BIS VISTA system appears at the end of this
section.

1.1 Warnings

EXPLOSION HAZARD: DO NOT USE THE BIS VISTA SYSTEM IN A
FLAMMABLE ATMOSPHERE OR WHERE CONCENTRATIONS OF
FLAMMABLE ANESTHETICS MAY OCCUR.

MONITOR IS NOT DESIGNED FOR USE IN MRI ENVIRONMENT.

USE ONLY THE POWER CORD SUPPLIED BY THE MANUFACTURER.
NEVER ADAPT THE PLUG FROM THE MONITOR TO FIT A NON­STANDARD 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 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.

1-1

SECTION 1 SAFETY PRECAUTIONS

______________________________________________________________________

IF THE INTEGRITY OF THE EXTERNAL PROTECTIVE EARTH GROUND
IS IN DOUBT, THE BIS VISTA SYSTEM SHALL BE OPERATED FROM ITS
INTERNAL BATTERY POWER SOURCE ONLY.

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.

TO REDUCE THE HAZARD OF BURNS DURING USE OF BRAIN­STIMULATING 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 VISTA SYSTEM.

TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT
INTERFACE CABLE (PIC) MUST BE CAREFULLY PLACED AND SECURED.

1-2

SECTION 1 SAFETY PRECAUTIONS

______________________________________________________________________

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 GROUND LEAKAGE CURRENT BEFORE FURTHER
USE.

LEAKAGE CURRENT MUST BE CHECKED BY A QUALIFIED BIOMEDICAL
ENGINEERING TECHNICIAN WHENEVER INSTRUMENT CASE IS
OPENED.

POWER SUPPLY IS INTERNALLY FUSED. REPLACE POWER SUPPLY
ONLY WITH ASPECT MEDICAL SYSTEMS BIS VISTA 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 BISx for any reason. The seal to prevent liquids from entering the BISx
may be damaged if opened.

Service or repairs must be performed only by qualified biomedical technicians.

1-3

SECTION 1 SAFETY PRECAUTIONS

______________________________________________________________________

The BIS VISTA system has been designed to operate with a BIS sensor. The sensor
is a silver/silver chloride electrode array that utilizes Aspect's patented Zipprep™

technology and uses a proprietary connector. Use of other electrodes is not
recommended.

To completely remove power from the unit: put the monitor in Standby mode,
disconnect power cord from the power 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).

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 VISTA monitor that has been
disconnected from the wall socket and that has been charged to full capacity (at least
6 hours of charge time). After long periods of storage, charge the battery for 6 hours
to assure full capacity. If the BIS VISTA monitor fails to operate reliably from the
battery for approximately 45 minutes, battery replacement is required.

The BIS VISTA monitor contains an internal Lithium ion battery. The battery must
be removed by a qualified service technician and disposed of or recycled in
accordance with the national laws of the country. Contact Aspect Medical Systems,
Inc. or the local distributor for a replacement battery: Aspect part number 186-0208.

Avoid liquid ingress to the Patient Interface Cable. Contact of fluids with the PIC
sensor connector can interfere with PIC performance.

Service or repairs must be performed only by qualified biomedical technicians.

The BIS VISTA 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.

1-4

SECTION 1 SAFETY PRECAUTIONS

______________________________________________________________________

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 VISTA Monitoring
System.

The BIS VISTA Monitor should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the BIS VISTA Monitor should
be observed to verify normal operation in the configuration in which it will be used.

Important:
The BIS VISTA systems comply with the European Medical Device Directive
(MDD) and applicable regulatory requirements of the country distributed to and
carry the CE

Marking. Declarations of Conformity provided upon request where

XXXX

appropriate.

1-5

SECTION 1 SAFETY PRECAUTIONS

______________________________________________________________________

1.3 Key to Symbols

USB-A

Caution: Consult
Accompanying Documents

Universal Serial Bus:
Type A

Caution: Hot Surface

Type BF Equipment

USB-B

Data I/O, RS-232 Serial Port

Universal Serial Bus:
Type B

Storage Temperature Limits

Type BF Equipment
Defibrillator-proof

EC REP

Alternating Current (A/C)

Battery Location

Monitor Power ON

Do not Reuse

Latex-free product

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

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 3)

1-6

SECTION 1 SAFETY PRECAUTIONS

______________________________________________________________________

Crossed out wheelie bin indicates

Recyclable

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. **

*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.

** Refer to www.aspectmedical.com for Material Declaration Data Sheets.

Figure 1 - Symbol Key (Page 2 of 3)

separate treatment from general
waste at end of life *

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. **

1-7

SECTION 1 SAFETY PRECAUTIONS

______________________________________________________________________

Operating on Battery

No Battery is Installed in Monitor

USB Drive: Data Export is in Progress

A Printable File Is Being Transferred to the USB Drive

Ringing Bell Icon - High Priority Alarm Sounding

Green Bell Icon - Alarms Active

Yellow Bell with Countdown Timer - Alarms Paused

Red Bell with ‘X’ - Alarms Silenced

A green box denotes ON or active condition.

A red box with an ‘X’ denotes OFF or cancel.

Figure 1 - Symbol Key (page 3 of 3)

1-8

SECTION 2 INSTALLATION AND PREPARATION FOR USE

______________________________________________________________________

2 INSTALLATION AND PREPARATION

FOR USE

____________________________________________________

INTRODUCTION

This section provides installation instructions for the BIS VISTA Monitor, BISx, and
accessories. It includes:

• Installation checklist

• Proper environment

• Required equipment and supplies

• Cable connections

• Start and shutdown procedures

• Initial menu settings

2.1 BIS VISTA Monitor Installation and Checkout

1. Open packages and inspect for all components:

• Monitor (P/N 185-0151)

• Power cord

• Pole clamp

• BISx (P/N 185-0145-AMS)

• PIC (Patient interface cable, connects BISx to patient) (P/N 186-0107)

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.

• Verify next screen says “Connect BISx.”

4. Connect BISx with PIC to monitor.

• Verify screen says, “BISx Initialization Complete.”

• Verify screen says “Connect sensor or cable.”

5. Connect PIC and sensor.

• Verify SENSOR CHECK begins.

6. Disconnect power cord from monitor.

• Verify ‘OPERATING ON BATTERY BACKUP’ is displayed.

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• Verify battery icon displays below BIS number.

7. Reconnect power cord.

• Verify battery icon is not displayed below BIS banner.

• Verify “OPERATING ON BATTERY BACKUP” is not displayed.

8. End of install.

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 -10°C to +60°C
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 VISTA Monitoring System is not designed for use in areas containing flammable
gases or vapors.

WARNING:
EXPLOSION HAZARD: DO NOT USE THE BIS VISTA SYSTEM
IN A FLAMMABLE ATMOSPHERE OR WHERE
CONCENTRATIONS OF FLAMMABLE ANESTHETICS MAY
OCCUR.

MONITOR IS NOT DESIGNED FOR USE IN MRI
ENVIRONMENT.

The BIS VISTA monitor is designed to operate safely under the following conditions.
Conditions outside these ranges could affect reliability.

Temperature 0°C to +40°C
Humidity 15% to 95% (non-condensing)
Pressure 800 mm Hg (1500 feet below sea level) to 360mm Hg (20,000 feet

above sea level)

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2.2.3 Power Requirements and System Grounding

The BIS VISTA Monitoring System requires a power source of 100-240 VAC, 50-60Hz.
Current consumption is 0.7 ampere maximum.

To protect operating personnel and patients, the monitor must be properly grounded.
Accordingly, the monitor is equipped with a hospital grade line cord. The power cord
grounds the system to the power line ground when plugged into an appropriate three-wire
receptacle.

WARNING:
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 VISTA MONITOR
SHALL BE OPERATED FROM ITS INTERNAL BATTERY
POWER SOURCE ONLY.

2.2.4 Electromagnetic Compatibility Requirements

The BIS VISTA Monitoring System should be used only with the power cord and
accessories recommended and supplied by Aspect Medical Systems, Inc. The system must be
installed and put into use according to the specifications described in Section 8.2
“Electromagnetic Compatibility Specifications.”

Caution:
The BIS VISTA 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.”

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2.2.5 Site Preparation: Mounting the Monitor

Aspect Medical Systems, Inc. strongly recommends permanent mounting of the BIS VISTA
monitor to the anesthesia machine to enhance safety and facilitate ease-of-use. Please
contact your local representative or Aspect to discuss mounting options.

WARNING:
BE SURE THE MONITOR IS MOUNTED SECURELY IN PLACE
TO AVOID PERSONAL OR PATIENT INJURY.

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.

Figure 2 - Pole Clamp

To remove the monitor, press tab on top of clamp shoe before sliding monitor up.

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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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2.3 The BIS VISTA Monitoring System –

Equipment and Supplies

The BIS VISTA Monitoring System consists of the following basic components:

• BIS VISTA Monitor (P/N 185-0151)

• BISx (P/N 185-0145-AMS)

• Patient Interface Cable (PIC) (P/N 186-0107)

• 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 VISTA Monitor

BIS Sensor

Patient Interface
Cable (PIC)

Monitor
Interface
Cable

ON/Standby
Button

BISx

Figure 3 - The BIS VISTA Monitoring System

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2.3.1 BIS VISTA Monitor

2.3.1.1 Front Panel

The front panel of the BIS VISTA monitor contains the Touch Screen, BISx port and the
ON/Standby button. See Figure 3.

2.3.1.2 Touch Screen

The BIS VISTA monitor is designed so that all controls (with the exception of the
ON/Standby button) are accessible by touching a designated area on the monitor screen.
This area is called a touch key. The touch keys are designed to function even when the user
is wearing examination gloves.

2.3.1.3 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.

2.3.1.4 Rear Panel

The rear panel components are pictured in Figure 4. They include: two USB ports (Type A
and B), the clamp shoe, an RS-232 port, the Reset button, the Battery/Power Supply cover,
and the power cord receptacle.

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USB Port
(Type A)

Reset Button

USB Port
(Type B)

Battery/Power
Supply

Cover

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 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.

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

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• 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 VISTA 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 VISTA Monitoring 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”.

2.3.1.5 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.

Caution:
Check the battery periodically by operating a BIS VISTA monitor that
has been disconnected from the wall socket and that has been charged
to full capacity (at least 6 hours of charge time). After long periods of
storage, charge the battery for 6 hours to assure full capacity. If the
BIS VISTA monitor fails to operate reliably from the battery for
approximately 45 minutes, battery replacement is required.

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The BIS VISTA monitor contains an internal lithium ion battery. The
battery must be removed by a qualified service technician and
disposed of or recycled in accordance with the national laws of the
country. Contact Aspect Medical Systems, Inc. or the local distributor
for a replacement battery: Aspect part number 186-0208.

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.

The attachment clip on the BISx is used to secure it in a convenient location near the
patient's head.

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