BIS VISTA Operating Manual Rev 1.01

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 The 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 ... 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

The Sensor Check... 3-3

3.3 The BIS Trend Data Screen ... 3-5 3.3.1 The BIS (Bispectral Index) Value... 3-5 3.3.2 Signal Quality Indicator ... 3-6 3.3.3 The Electromyograph (EMG) Indicator... 3-6 3.3.4 The EEG Waveform Display... 3-6 3.3.5 The Message Region ... 3-6 3.3.6 The BIS Trend Graph ... 3-6 3.3.7 Additional Screen Information ... 3-8 3.3.7.1 The Battery Icon... 3-8 3.3.7.2 Extend Mode ... 3-8 3.3.7.3 The Suppression Ratio (SR) Number... 3-8 3.3.7.4 The Burst Count (Bursts/Minute) – Extend Mode Only ... 3-8 3.4

BIS Trend Data Screen Touch Keys ... 3-9

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

Menu Selections ... 3-11 Target Range ... 3-11 Secondary Variable ... 3-12 Chart Data... 3-13 Alarm Volume... 3-14 BIS/EEG Display Modes... 3-15 View/Save Settings... 3-15 Snapshot... 3-16 Display Suppression Ratio (SR) ... 3-17 Monitor Mode... 3-17 Export Data ... 3-18 BIS Smoothing Rate ... 3-19 Configuration Information ... 3-20 EEG Channels ... 3-20 Date and Time... 3-21 Language ... 3-22 Filters... 3-23 Impedance Checking ... 3-23 Maintenance Menu... 3-24 Demo Case ... 3-24 Diagnostic Menu ... 3-24

3.6

Reviewing Stored Trend Data... 3-25

3.7

The EEG Display ... 3-26

3.8

Ending a Case ... 3-26

3.9

Data Transfer ... 3-26

4

QUICK REFERENCE GUIDE ... 4-1

5

FEATURES AND CAPABILITIES ... 5-1

5.1

How the BIS VISTA Monitoring System Works... 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 5.2.8 5.2.9 5.2.10 5.2.11 5.2.12 5.2.13 5.2.14 5.2.15 5.2.16 5.2.17 5.2.18 5.2.19 5.2.20 5.2.21 5.2.22 5.2.23 5.2.24 5.2.25 5.2.26 5.2.27 5.2.28

System Features ... 5-2 Bispectral Index (BIS) ... 5-2 Signal Quality Indicator (SQI) ... 5-3 Electromyograph (EMG) Indicator ... 5-3 Suppression Ratio (SR)... 5-3 Burst Count (Bursts/Minute) ... 5-3 BIS Trend and Secondary Trend Graph ... 5-3 Electroencephalogram (EEG) Waveform Display ... 5-4 EEG Channels... 5-4 Filters ... 5-4 Artifact Detection... 5-4 Chart Data ... 5-4 Target Range... 5-4 BIS Trend Smoothing ... 5-5 Snapshot ... 5-5 Demo Case ... 5-5 Languages... 5-5 Time/Date ... 5-5 Review Mode ... 5-5 Standby Mode... 5-6 Monitor Mode ... 5-6 Saved Settings ... 5-7 System Alarms... 5-7 System Messages... 5-7 System Self-Checks... 5-7 Data Memory... 5-8 Battery Operation ... 5-9 Data Transfer ... 5-9 Software Upgrades ... 5-10

6

PREVENTIVE MAINTENANCE, CARE AND CLEANING... 6-1

6.1

Care and Cleaning ... 6-1

6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5 6.2.6

Maintenance ... 6-2 Checking Cable Integrity ... 6-2 System Checkout ... 6-2 Checking the Battery... 6-3 Replacing the Battery ... 6-4 Replacing the Power Supply... 6-4 Checking Leakage Current... 6-5

6.3

Technical Documentation ... 6-6

6.4

Instrument Identification ... 6-6

7

DIAGNOSTICS AND TROUBLESHOOTING ... 7-1

7.1 7.1.1 7.1.2 7.1.3 7.1.4

Maintenance Menu... 7-1 Display BISx Connection History ... 7-1 Software Upgrade ... 7-1 Restore Default Settings for All Modes... 7-2 Calibrate Touch Screen ... 7-2

7.2 7.2.1 7.2.2

The Diagnostic Menu... 7-2 Diagnostic Codes ... 7-2 DSC Self Test... 7-2

7.3

BIS VISTA System Messages and Corrective Actions ... 7-3

7.4

Using the Reset button ... 7-7

7.5

What to do if the BIS VISTA Monitoring System Requires Service... 7-7

8

APPENDIX i: MENUS, PROCESSED VARIABLES AND GLOSSARY. 8-1

8.1

Menu Map ... 8-1

8.2

Menu Listing ... 8-2

8.3

Processed EEG Variables ... 8-5

8.4

Glossary... 8-6

9

APPENDIX ... 9-1

9.1

Specifications... 9-1

9.2 9.2.1 9.2.2

Electromagnetic Compatibility Specifications ... 9-5 Accessories... 9-5 IEC 60601-1-2:2001 Electromagnetic Compatibility Guidance ... 9-6

9.3

Warranty ... 9-11

9.4

Software License Agreement... 9-13

9.5

List of Patents ... 9-15

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 – The BISx... 2-10 Figure 6 - Connecting the PIC... 3-3 Figure 7 - The Sensor Check Graphic Screen with Impedance Values and Results... 3-4 Figure 8 - Screen Features – The BIS Trend Data Screen... 3-5 Figure 9 - BIS Trend Data Screen with Battery Icon, Target Range, SR, and Burst Count . 3-7 Figure 10 - The Alarm Touch Keys ... 3-9 Figure 11 – The Menu, Home, Sensor Check and Review Mode Touch Keys... 3-10 Figure 12 - Target Range... 3-11 Figure 13 - Secondary Variable ... 3-12 Figure 14 - Chart Data... 3-13 Figure 15 - Alarm Volume... 3-14 Figure 16 - BIS/EEG Display Modes ... 3-15 Figure 17 - View/Save Settings... 3-15 Figure 18 - Snapshot... 3-16 Figure 19 – Display SR... 3-17 Figure 20 - Export Data... 3-18 Figure 21 - Smoothing Rate... 3-19 Figure 22 - Configuration Information... 3-20 Figure 23 - EEG Channels ... 3-20 Figure 24 - Date and Time... 3-21 Figure 25 - Language Menu... 3-22 Figure 26 - Filters ... 3-23 Figure 27 - Impedance Checking ON/OFF... 3-23 Figure 28 - Review Mode... 3-25 Figure 29 - BIS Range Guidelines ... 5-2 Figure 30 - Monitor Mode Settings ... 5-6 Figure 31 - Replacing the Power Supply... 6-4 Figure 32 - Diagnostic Codes ON/OFF... 7-2 Figure 33 - BIS VISTA Menu Map ... 8-1

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 (Figure 3). It also includes specific cleaning and test procedures you may occasionally be required to perform. Although this manual is intended for trained medical personnel, it does not assume prior knowledge or experience with operator-programmable medical electronics devices. Keep this Operating Manual with the BIS 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 Indications for Use The BIS VISTA Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS VISTA Monitor 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 may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

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. Easy-to-use menus allow the user to change the data display and review stored data.

ii

Important Information about Using BIS Monitoring 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. Due to limited clinical experience in the following applications, BIS values should be interpreted cautiously in patients with known neurological disorders, those taking other psychoactive medications and in children below the age of one.

iii

SECTION 1 SAFETY PRECAUTIONS ______________________________________________________________________ SECTION 1

1 SAFETY PRECAUTIONS INTRODUCTION Caution: Carefully read this entire manual before using the monitor in a clinical setting.

WARNINGS, CAUTIONS, AND NOTES The terms warning, caution, and note have specific meanings in this manual. • • •

A WARNING advises against certain actions or situations that could result in personal injury or death. A CAUTION advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure, although personal injury is unlikely. A NOTE provides useful information regarding a function or procedure.

KEY TO SYMBOLS A key to the symbols used on the BIS 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. CONSIDERATIONS WHEN USING ELECTRO CONVULSIVE THERAPY (ECT) EQUIPMENT DURING BIS MONITORING: • SEPARATE ECT ELECTRODES FROM THE BIS SENSOR AS MUCH AS POSSIBLE TO MINIMIZE THE EFFECT OF INTERFERENCE. • CERTAIN ECT EQUIPMENT MAY INTERFERE WITH THE PROPER FUNCTION OF THE BIS MONITORING SYSTEM. CHECK FOR COMPATIBILITY OF EQUIPMENT DURING PATIENT SETUP. FOR PROPER GROUNDING, THE POWER RECEPTACLE MUST BE A THREE-WIRE GROUNDED OUTLET. A HOSPITAL GRADE OUTLET IS 1-1

SECTION 1 SAFETY PRECAUTIONS ______________________________________________________________________ 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 SYSTEM SHALL BE OPERATED FROM ITS INTERNAL BATTERY POWER SOURCE ONLY. FOR BIS VISTA SYSTEMS USED OUTSIDE OF NORTH AMERICA: A HARMONIZED LINE CORD WITH CONDUCTORS HAVING A CROSS SECTIONAL AREA GREATER THAN 0.75 mm2 MUST BE USED. 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. ENSURE THAT THE BISx DOES NOT COME INTO PROLONGED CONTACT WITH PATIENT’S SKIN, AS IT MAY GENERATE HEAT AND CAUSE DISCOMFORT. 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. THE SENSOR MUST NOT BE LOCATED BETWEEN DEFIBRILLATOR PADS WHEN A DEFIBRILLATOR IS USED ON A PATIENT CONNECTED TO THE BIS VISTA SYSTEM.

1-2

SECTION 1 SAFETY PRECAUTIONS ______________________________________________________________________ TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT INTERFACE CABLE (PIC) MUST BE CAREFULLY PLACED AND SECURED. 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 BEFORE FURTHER USE. GROUND WIRE LEAKAGE CURRENT MUST BE CHECKED WHENEVER INSTRUMENT CASE IS OPENED BY A QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN. POWER SUPPLY IS INTERNALLY FUSED. REPLACE POWER SUPPLY ONLY WITH ASPECT MEDICAL SYSTEMS BIS 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. Continuous impedance checking may need to be disabled if the 1 nanoampere 128 Hz impedance check signal interferes with other equipment (e.g., evoked potential monitors). Check the battery periodically by operating a BIS 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 (e.g., more than 1 month) it may be necessary to cycle (charge, then discharge) the battery a few times to get full charge capacity. If the BIS 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. The BIS VISTA system complies with the electromagnetic compatibility requirements of EN60601-1-2. 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”. Do not disconnect the BISx during the software upgrade. 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.

1-4

SECTION 1 SAFETY PRECAUTIONS ______________________________________________________________________ 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.

BIS VISTA, 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 U.S.A., E.U. and other countries.

1-5

SECTION 1 SAFETY PRECAUTIONS ______________________________________________________________________

1.3

Key to Symbols Manufacturer

EC REP

Authorized Representative in the European Community 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. Latex-free product

Type BF Equipment

Type BF Equipment Defibrillator-proof

Crossed out wheelie bin indicates separate treatment from general waste at end of life Attention, Consult Accompanying Documents

Attention, Data I/O, RS-232 Serial Port, Consult Accompanying Documents

Figure 1 - Symbol Key (page 1 of 3)

1-6

SECTION 1 SAFETY PRECAUTIONS ______________________________________________________________________

Attention, USB-A, Host. Consult Accompanying Documents USB-A

Attention, USB-B function. Consult Accompanying Documents USB-B

Caution: Hot Surface

Alternating Current D/C Current

Battery Location

Reset Button

Storage Temperature Limits

Monitor Power ON

Monitor Power OFF or Standby Mode

Figure 1 - Symbol Key (page 2 of 3)

1-7

SECTION 1 SAFETY PRECAUTIONS ______________________________________________________________________

Operating on Battery

No Battery is Installed in Monitor

Ringing Bell Icon - 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 ______________________________________________________________________ SECTION 2

2 INSTALLATION AND PREPARATION FOR USE ____________________________________________________

INTRODUCTION This section provides installation instructions for the Aspect 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) 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 beep tone as power switch is activated. • 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 to PIC and sensor. • Verify screen says, “BISx Initialization Complete.” • Verify SENSOR CHECK begins. 5. Disconnect power cord from rear of monitor.

2-1

SECTION 2 INSTALLATION AND PREPARATION FOR USE ______________________________________________________________________ • •

Verify ‘OPERATING ON BATTERY BACKUP’ is displayed. Verify battery icon displays below BIS number.

6. Reconnect power cord. • Verify battery icon is not displayed below BIS banner. • Verify “OPERATING ON BATTERY BACKUP” is not displayed. 7. 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) 360 mmHg to 800 mmHg

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. Temperature: The BIS VISTA monitor is designed to operate safely at a room temperature of 0°C to 40°C. Conditions that exceed these limits could affect reliability. Humidity: The monitor is designed to operate within specifications at a relative noncondensing humidity of 15% to 95%.

2-2

SECTION 2 INSTALLATION AND PREPARATION FOR USE ______________________________________________________________________ Pressure: The monitor will operate satisfactorily at or above sea level, and is unaffected by extremes or changes in altitude within atmospheric pressures of 360 mmHg to 800 mmHg.

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! FOR PROPER GROUNDING, THE POWER RECEPTACLE MUST BE A THREE-WIRE GROUNDED OUTLET. A HOSPITAL GRADE OUTLET IS REQUIRED. NEVER ADAPT THE THREEPRONG PLUG FROM THE MONITOR TO FIT A TWO-SLOT OUTLET. IF THE OUTLET HAS ONLY TWO SLOTS, MAKE SURE THAT IT IS REPLACED WITH A THREE-SLOT GROUNDED OUTLET BEFORE ATTEMPTING TO OPERATE THE MONITOR. IF THE INTEGRITY OF THE EXTERNAL PROTECTIVE EARTH GROUND IS IN DOUBT, THE BIS VISTA MONITOR SHALL BE OPERATED FROM ITS INTERNAL BATTERY POWER SOURCE ONLY. FOR BIS VISTA SYSTEMS USED OUTSIDE OF NORTH AMERICA - A HARMONIZED LINE CORD WITH CONDUCTORS HAVING A CROSS SECTIONAL AREA GREATER THAN 0.75 mm2 MUST BE USED.

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 9.2 “Electromagnetic Compatibility Specifications.” Caution: The BIS VISTA system complies with the electromagnetic compatibility requirements of EN60601-1-2. 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

2-3