BIS VISTA Operating Manual Rev 3.0

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 2.5.1 2.5.2

Start Procedure / Standby Mode ... 2-12 Starting the Monitor for the First Time ... 2-12 Starting the Monitor from Standby Mode... 2-12

2.6 2.6.1 2.6.2 2.6.3

Initial Menu Settings... 2-12 Language Selection... 2-13 Date and Time ... 2-13 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 3.4.1 3.4.2

Main Screen Touch Keys... 3-11 Alarm Touch Keys ... 3-11 Menu, Home, Sensor Check and Review Touch Keys... 3-12

3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.8 3.5.9 3.5.10 3.5.11 3.5.12 3.5.13 3.5.14 3.5.15 3.5.16 3.5.17 3.5.18 3.5.19 3.5.20 3.5.21 3.5.22

Menu Selections ... 3-13 Target Range ... 3-13 Secondary Variable ... 3-15 Chart Data... 3-16 Alarm Volume... 3-17 BIS/EEG Display Modes... 3-18 View/Save Settings... 3-18 Help... 3-19 Snapshot... 3-20 Display Suppression Ratio (SR) ... 3-20 Monitor Mode ... 3-21 Export Data ... 3-22 BIS Smoothing Rate ... 3-24 Print (Snapshot)... 3-25 Configuration Information ... 3-26 EEG Channels ... 3-26 Date and Time... 3-27 Language ... 3-28 Filters... 3-28 Impedance Checking ... 3-29 Maintenance Menu... 3-30 Demo Case ... 3-30 Diagnostic Menu ... 3-30

3.6 3.6.1 3.6.2

Reviewing and Printing Stored Trend Data... 3-31 Review Mode Touch Keys ... 3-31 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 3.10.1 3.10.2 3.10.3 3.10.4 3.10.5 3.10.6

How the BIS VISTA Monitoring System Works... 3-36 Bispectral Index (BIS)... 3-37 Artifact Detection... 3-37 System Self-Checks... 3-37 Monitor Data Memory ... 3-38 BISx Data Memory ... 3-38 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 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6 5.2.7

Maintenance ... 5-2 Replace the PIC (Patient Interface Cable) ... 5-2 Checking Cable Integrity ... 5-3 System Checkout ... 5-3 Checking the Battery... 5-4 Replacing the Battery ... 5-4 Replacing the Power Supply... 5-5 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 6.1.1 6.1.2 6.1.3 6.1.4 6.1.5

Maintenance Menu... 6-1 Display BISx Connection History ... 6-1 Serial Protocol ... 6-1 Software Update... 6-2 Restore Default Settings for All Modes... 6-2 Calibrate Touch Screen ... 6-2

6.2 6.2.1 6.2.2

Diagnostic Menu ... 6-3 Diagnostic Codes ... 6-3 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 8.2.1 8.2.2

Electromagnetic Compatibility Specifications ... 8-5 Accessories... 8-5 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 (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.

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 CEXXXX Marking. Declarations of Conformity provided upon request where appropriate.

1-5

SECTION 1 SAFETY PRECAUTIONS ______________________________________________________________________

1.3

Key to Symbols Caution: Consult Accompanying Documents

USB-A

EC REP

Universal Serial Bus: Type A

Data I/O, RS-232 Serial Port 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

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 Recognized under the Component Recognition Program of Underwriters Laboratories Inc.

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 separate treatment from general waste at end of life *

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. **

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. 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)

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: • • • • • •

2.1

Installation checklist Proper environment Required equipment and supplies Cable connections Start and shutdown procedures Initial menu settings

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. 2-1

SECTION 2 INSTALLATION AND PREPARATION FOR USE ______________________________________________________________________ •

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 Humidity Pressure

-10°C to +60°C 15% to 95% (non-condensing) 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 Humidity Pressure

0°C to +40°C 15% to 95% (non-condensing) 800 mm Hg (1500 feet below sea level) to 360mm Hg (20,000 feet above sea level) 2-2