BIS Complete Monitoring System Operators Manual Rev A

COVIDIEN, COVIDIEN with logo, and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ©2013 Covidien.

Table of Contents 1 Introduction... 1-1 1.1 About This Manual... 1-1 1.2 Introducing the BIS™ Complete Monitoring System... 1-1 2 Safety Precautions... 2-1 2.1 Introduction ... 2-1 2.2 Key to Symbols... 2-1 2.3 Safety Symbol Definitions... 2-1 2.4 Warnings... 2-2 2.5 Cautions... 2-5 2.6 Key to Symbols... 2-8 3 Installation and Preparation for Use... 3-1 3.1 Introduction ... 3-1 3.2 BIS Complete Monitor Installation and Checkout... 3-1 3.3 Environment... 3-3 3.3.1 Shipping and Storage Environment... 3-3 3.3.2 Operating Environment... 3-3 3.3.3 Power Requirements and System Grounding... 3-4 3.3.4 Electromagnetic Compatibility Requirements... 3-5 3.3.5 Site Preparation: Mounting the Monitor... 3-5 3.4 The BIS™ Complete Monitoring System – Equipment and Supplies... 3-7 3.4.1 BIS™ Complete Monitor ... 3-8 3.4.2 BISX™... 3-11 3.4.3 Patient Interface Cable (PIC)... 3-12 3.4.4 BIS Sensors... 3-12 3.5 Cable Connections... 3-12 3.6 Start Procedure / Standby Mode... 3-13 3.6.1 Starting the Monitor for the First Time... 3-13 3.6.2 Starting the Monitor from Standby Mode... 3-13 3.6.3 Power-Up Messages... 3-14 3.7 Initial Menu Settings... 3-14 3.7.1 Language Selection... 3-14 3.7.2 Date and Time... 3-15 3.7.3 View/Save Settings... 3-16

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4 Operating the BIS™ Complete Monitoring System... 4-1 4.1 Introduction ... 4-1 4.2 Preparing for Operation... 4-1 4.3 Sensor Check ... 4-3 4.4 BIS™ Trend Data Screen... 4-6 4.4.1 BIS (Bispectral Index) Value... 4-6 4.4.2 Signal Quality Indicator... 4-6 4.4.3 Electromyograph (EMG) Indicator... 4-7 4.4.4 EEG Waveform Display... 4-7 4.4.5 Message Region... 4-7 4.4.6 BIS™ Trend Graph... 4-8 4.4.7 Additional Screen Information... 4-9 4.5 Main Screen Touch Keys... 4-11 4.5.1 Alarm Touch Keys ... 4-11 4.5.2 Menu, Home, Sensor Check and Review Touch Keys... 4-12 4.6 Menu Selections... 4-12 4.6.1 Target Range... 4-13 4.6.2 Secondary Variable... 4-14 4.6.3 Chart Data... 4-16 4.6.4 Alarm Volume... 4-17 4.6.5 BIS™/EEG Display Modes... 4-18 4.6.6 View/Save Settings... 4-18 4.6.7 Help... 4-20 4.6.8 Snapshot... 4-20 4.6.9 Display Suppression Ratio (SR)... 4-21 4.6.10 Monitor Mode... 4-22 4.6.11 Export Data... 4-23 4.6.12 BIS Smoothing Rate... 4-26 4.6.13 Print (Snapshot)... 4-27 4.6.14 Configuration Information... 4-28 4.6.15 EEG Channels... 4-29 4.6.16 Date and Time... 4-29 4.6.17 Language... 4-31 4.6.18 Filters... 4-32 4.6.19 Impedance Checking... 4-32 4.6.20 Maintenance Menu... 4-33 4.6.21 Demo Case ... 4-34 4.6.22 Diagnostic Menu... 4-34 4.7 Reviewing and Printing Stored Trend Data... 4-35 4.7.1 Review Mode Touch Keys... 4-35 4.7.2 Printing Stored Data... 4-37

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4.8 EEG Display... 4-38 4.9 Ending a Case... 4-38 4.10 Data Transfer... 4-39 4.11 How the BIS™ Complete Monitoring System Works... 4-40 4.11.1 Bispectral Index (BIS™)... 4-41 4.11.2 Artifact Detection... 4-41 4.11.3 System Self-Checks ... 4-41 4.11.4 Monitor Data Memory... 4-43 4.11.5 BISX Data Memory... 4-43 4.11.6 Battery Operation... 4-43 5 Quick Reference Guide... 5-1 5.1 Introduction ... 5-1 5.2 Basic Operation... 5-1 6 Preventive Maintenance, Care and Cleaning... 6-1 6.1 Introduction ... 6-1 6.2 Care and Cleaning... 6-1 6.2.1 Cleaning the Monitor and BISX™ ... 6-1 6.2.2 Disinfecting the Monitor and BISX™ ... 6-2 6.2.3 Cleaning the Monitor Display ... 6-2 6.3 Maintenance... 6-3 6.3.1 Replace the PIC (Patient Interface Cable) ... 6-3 6.3.2 Checking Cable Integrity... 6-3 6.3.3 System Checkout... 6-4 6.3.4 Checking the Battery... 6-5 6.3.5 Replacing the Battery... 6-6 6.3.6 Replacing the Power Supply... 6-6 6.3.7 Checking Leakage Current... 6-7 6.4 Technical Documentation... 6-9 6.5 Instrument Identification... 6-9 6.5.1 BIS™ Complete Monitor ... 6-9 6.5.2 BISX™... 6-9 6.5.3 Software Revision Numbers... 6-9 7 Diagnostics and Troubleshooting... 7-1 7.1 Introduction ... 7-1 7.2 Maintenance Menu... 7-1 7.2.1 Display BISX Connection History... 7-1 7.2.2 Serial Protocol... 7-2 7.2.3 Software Update... 7-2

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7.2.4 Restore Default Settings for All Modes... 7-3 7.2.5 Audio Off Reminder... 7-3 7.2.6 Calibrate Touch Screen... 7-4 7.3 Diagnostic Menu... 7-4 7.3.1 Diagnostic Codes... 7-4 7.3.2 DSC Self Test... 7-5 7.4 BIS™ Complete System Messages and Corrective Actions... 7-5 7.5 Using the Reset button... 7-14 7.6 What to do if the BIS™ Complete Monitoring System Requires Service... 7-14 A Menus, Processed Variables and Glossary... A-1 A.1 Menu Map... A-1 A.2 Menu Listing... A-2 A.3 Processed EEG Variables... A-4 A.4 Glossary... A-5 B Specifications, Warranty and Software License Agreement... B-1 B.1 Specifications ... B-1 B.2 Electromagnetic Compatibility Specifications... B-4 B.2.1 Accessories... B-4 B.2.2 IEC 60601-1-2:2001 Electromagnetic Compatibility Guidance B5 B.3 Warranty... B-9 B.4 Software License Agreement... B-10

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Figures 3 Installation and Preparation for Use Figure 3-1 Pole Clamp... 3-6 Figure 3-2 The BIS Complete Monitoring System... 3-7 Figure 3-3 Rear Panel... 3-9 Figure 3-4 BISX and PIC... 3-11 4 Operating the BIS™ Complete Monitoring System Figure 4-1 Connecting the PIC... 4-3 Figure 4-2 Sensor Check Graphic Screen (Values not Shown)... 4-4 Figure 4-3 Sensor Check Graphic Screen with Values Shown... 4-5 Figure 4-4 Screen Features – BIS Trend Data Screen... 4-6 Figure 4-5 BIS™ Trend Data Screen with Battery Icon, Target Range, SR, and Burst Count... 4-9 Figure 4-6 Target Range... 4-13 Figure 4-7 Secondary Variable... 4-15 Figure 4-8 Chart Data... 4-16 Figure 4-9 Alarm Volume... 4-17 Figure 4-10 BIS/EEG Display Modes... 4-18 Figure 4-11 View/Save Settings... 4-18 Figure 4-12 Passkey Entry Screen... 4-19 Figure 4-13 Help... 4-20 Figure 4-14 Snapshot... 4-20 Figure 4-15 Display SR... 4-21 Figure 4-16 Export Data... 4-24 Figure 4-17 Smoothing Rate... 4-26 Figure 4-18 “Print” Touch Key... 4-27 Figure 4-19 Configuration Information... 4-28 Figure 4-20 EEG Channels... 4-29 Figure 4-21 Date and Time... 4-30 Figure 4-22 Language Menu... 4-31 Figure 4-23 Filters... 4-32 Figure 4-24 Impedance Checking ON/OFF... 4-33 Figure 4-25 Review Screen (Case Mode)... 4-35 Figure 4-26 Review Screen (Cursor Mode)... 4-36 Figure 4-27 EEG Display... 4-38 Figure 4-28 BIS Range Guidelines... 4-40

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6 Preventive Maintenance, Care and Cleaning Figure 6-1 Replacing the Power Supply... 6-6 7 Diagnostics and Troubleshooting Figure 7-1 Audio Off Reminder ON/OFF... 7-3 Figure 7-2 Diagnostic Codes ON/OFF... 7-4 A Menus, Processed Variables and Glossary Figure A-1 BIS™ Complete Menu Map... A-1

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Operator’s Manual

1 Introduction

1.1

About This Manual This Operator’s Manual contains all of the information you need to set up and operate the Covidien BIS™ Complete 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 Operator’s Manual with the BIS Complete 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 Complete system, please familiarize yourself with the safety information provided in this chapter.

1.2

Introducing the BIS™ Complete Monitoring System The BIS Complete 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 Complete 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 Complete monitor display consists of: •

The current BIS number

•

Raw EEG waveforms in real time

•

Various signal quality indicators (EMG, SQI)

•

Trend graphs of processed EEG parameters

1-1

Introduction

•

Suppression Ratio (if requested by the user)

•

Alarm Indicator and Messages

•

Burst Count number (when a BIS Extended Use Sensor is in use)

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. Important Information about Using BIS™ Monitoring The BIS EEG Complete 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 Complete 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 Covidien Representative. For more information, please contact Covidien at (800) 442-2051. If you require additional information on the use of BIS, please contact Covidien at 800-442-8655 or 617-559-7655 if calling from outside of the USA.

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Operator’s Manual

2 Safety Precautions

2.1

Introduction Carefully read this entire manual before using the monitor in a clinical setting.

2.2

Key to Symbols A key to the symbols that may appear on the BIS™ Complete system appears at the end of this chapter.

2.3

Safety Symbol Definitions Table 2-1. Safety Symbol Definitions Symbol

Definition WARNING Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient, user, or environment. Caution Cautions alert users to exercise appropriate care for safe and effective use of the product. Note Notes provide additional guidelines or information.

2-1

Safety Precautions

2.4

      

2-2

Warnings WARNING: Explosion hazard: do not use the BIS™ Complete system in a flammable atmosphere or where concentrations of flammable anesthetics may occur. WARNING: Monitor is not designed for use in MRI environment. WARNING: Use only the power cord supplied by the manufacturer. Never adapt the plug from the monitor to fit a non-standard outlet. WARNING: 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. WARNING: If the integrity of the external protective earth ground is in doubt, the BIS Complete system shall be operated from its internal battery power source only. WARNING: Be sure the monitor is mounted securely in place to avoid personal or patient injury. WARNING: When connecting external equipment (e.g., data capture computer), the system leakage current must be checked and must be less than the IEC 606011-1 limit.

Operator’s Manual

Warnings



WARNING: 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.

WARNING: Due to elevated surface temperature, do not place BISX™ in prolonged direct contact with patient’s skin, as it may cause discomfort. WARNING: The conductive parts of electrodes or sensor and connectors should not contact other conductive parts, including earth. WARNING: To reduce the hazard of burns during use of high-frequency surgical equipment, the sensor or electrodes should not be located between the surgical site and the electro-surgical unit return electrode. WARNING: To reduce the hazard of burns during use of brain-stimulating devices (e.g., transcranial electrical motor evoked potential), place stimulating electrodes as far as possible from the BIS sensor and make certain that sensor is placed according to package instructions. The sensor must not be located between defibrillator pads when a defibrillator is used on a patient connected to the BIS™ Complete system. WARNING: To minimize the risk of patient strangulation, the patient interface cable (pic) must be carefully placed and secured. WARNING: 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.

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Safety Precautions

      

2-4

WARNING: Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Place contaminated materials in regulated waste container. WARNING: Do not mix disinfecting solutions (e.g., bleach and ammonia), as hazardous gases may result. WARNING: Electrical Shock Hazard: Do not remove monitor covers during operation or while power is connected to monitor. WARNING: 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. WARNING: Whenever an event such as spillage of blood or solutions occurs, re-test ground leakage current before further use. WARNING: Leakage current must be checked by a qualified biomedical engineering technician whenever instrument case is opened. WARNING: Power supply is internally fused. Replace power supply only with Covidien BIS Complete power supply.

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Cautions

2.5

       

Cautions Caution: 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. Caution: Do not block ventilation inlet holes on the underside of monitor. Caution: Do not open BISX for any reason. The seal to prevent liquids from entering the BISX may be damaged if opened. Caution: Service or repairs must be performed only by qualified biomedical technicians. Caution: The BIS™ Complete system has been designed to operate with a BIS sensor. The sensor is a silver/silver chloride electrode array that utilizes Covidien's patented Zipprep™ technology and uses a proprietary connector. Use of other electrodes is not recommended. Caution: 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. Caution: 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). Caution: 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

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Safety Precautions

interfere with the proper function of the BIS monitoring system. Check for compatibility of equipment during patient setup.

   



2-6

Caution: Check the battery periodically by operating a BIS Complete 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 Complete monitor fails to operate reliably from the battery for approximately 45 minutes, battery replacement is required. Caution: The BIS Complete 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 Covidien or the local distributor for a replacement battery: Covidien part number 186-0208. Caution: 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. Caution: The BIS™ Complete 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.

•

Reference Electromagnetic Compatibility Specifications, p. B-4.

Caution: Do not disconnect the BISX™ during the software update.

Operator’s Manual

Cautions

  

Caution: When connecting or disconnecting BISX, take care not to touch the exposed contacts of either connector. Damage due to electrostatic discharge may result. Caution: Using accessories other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the BIS Complete Monitoring System. Caution: The BIS Complete Monitor should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the BIS Complete Monitor should be observed to verify normal operation in the configuration in which it will be used.

Important: The BIS Complete 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.

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Safety Precautions

2.6

Key to Symbols Table 2-2. Symbol Key Symbol

Description Latex Free product

Do Not Reuse

Single use Caution: Consult Accompanying Documents

Caution, consult accompanying documents

Storage Temperature Limits

Packaging Labeling: Fragile, Do Not Get Wet, and This Side Up Fragile

This side up

Recyclable

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. 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.

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Key to Symbols

Table 2-2. Symbol Key (Continued) Symbol

Description Crossed out wheelie bin indicates separate treatment from general waste at end of life1

Type BF Equipment

Type BF Equipment Defibrillator-proof

Alternating Current

Direct Current (D/C) Caution: Hot Surface

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

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. Authorized Representative in the European Community

Catalog Number

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Safety Precautions

Table 2-2. Symbol Key (Continued) Symbol

Description Manufacturer

Manufacturer Date

Use by YYYY-MM-DD or YYYY-MM

Batch Code Serial Number

Data I/O, RS-232 Serial Port

USB-A

Universal Serial Bus: Type A

USB-B

Universal Serial Bus: Type B Battery Location

Reset Button

Monitor Power ON

Monitor Power OFF or Standby Mode

PVC-free product

Operating on Battery

No Battery is Installed in Monitor

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