Medtronic 186-1046 Operator's Manual

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BIS™ Complete
0123
Monitoring System
Operator’s Manual
PN: PT00087175B
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BIS™ Complete Monitor
Copyright Information
©2020 – 07 Medtronic. All rights reserved.
COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG.™* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company. Covidien is a Medtronic company.
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About this Manual
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Table of Contents
1. Introduction 11
1.1. About this Manual 11
1.2. Introducing the BIS™ Complete Monitoring System 11
2. Safety Precautions 15
2.1. Introduction 15
2.2. Safety Symbol Definitions 15
2.3. Warnings 16
2.4. Cautions 20
2.5. Key to Symbols 23
3. Installation and Preparation for Use 31
3.1. Introduction 31
3.2. BIS™ Complete Monitor Installation and Checkout 31
3.3. Environment 33
3.3.1. Shipping and Storage Environment 33
3.3.2. Operating Environment 34
3.3.3. Power Requirements and System Grounding 35
3.3.4. Electromagnetic Compatibility Requirements 35
3.3.5. Site Preparation: Mounting the Monitor 36
3.4. The BIS™ Complete Monitoring System—Equipment and
Supplies 38
3.5. Cable Connections 50
3.6. Start Procedure / Standby Mode 51
3.7. Initial Menu Settings 54
3.4.1. BIS™ Complete Monitor 44
3.4.2. BISX™ Unit 48
3.4.3. Patient Interface Cable (PIC) 49
3.4.4. BIS Sensors 49
3.6.1. Starting the Monitor for the First Time 51
3.6.2. Starting the Monitor from Standby Mode 51
3.6.3. Power-Up Messages 52
3.7.1. Language Selection 54
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Date and Time 55
3.7.2.
3.7.3. View/Save Settings 55
4. Operating the BIS™ Complete Monitoring System 57
4.1. Introduction 57
4.2. Preparing for Operation 57
4.3. Sensor Check 61
4.4. BIS™ Trend Data Screen 64
4.4.1. BIS™ (Bispectral Index) Value 66
4.4.2. Signal Quality Indicator 66
4.4.3. Electromyograph (EMG) Indicator 67
4.4.4. EEG Waveform Display 67
4.4.5. Message Region 67
4.4.6. BIS™ Trend Graph 68
4.4.7. Additional Screen Information 71
4.5. Main Screen Touch Keys 76
4.5.1. Alarm Touch Keys 76
4.5.2. Menu, Home, Sensor Check and Review Touch Keys
77
4.6. Menu Selections 78
4.6.1. Target Range 79
4.6.2. Secondary Variable 81
4.6.3. Chart Data 83
4.6.4. Alarm Volume 84
4.6.5. Display Modes 86
4.6.6. View/Save Settings 87
4.6.7. Help 90
4.6.8. Snapshot 90
4.6.9. Display Suppression Ratio (SR) 91
4.6.10. Monitor Mode 92
4.6.11. Export Data 95
4.6.12. BIS™ Smoothing Rate 99
4.6.13. Print (Snapshot) 100
4.6.14. Configuration Information 102
4.6.15. EEG Channels 102
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Date and Time 103
4.6.16.
4.6.17. Language 105
4.6.18. Filters 106
4.6.19. Impedance Checking 107
4.6.20. Maintenance Menu 108
4.6.21. Demo Case 108
4.6.22. Diagnostic Menu 109
4.7. Reviewing and Printing Stored Trend Data 109
4.7.1. Review Mode Touch Keys 110
4.7.2. Printing Stored Data 112
4.8. EEG Display 113
4.9. DSA Display 114
4.10. Ending a Case 116
4.11. Data Transfer 117
4.12. How the BIS™ Complete Monitoring System Works 118
4.12.1. Bispectral Index (BIS™) 120
4.12.2. Artifact Detection 120
4.12.3. System Self-Checks 120
4.12.4. Monitor Data Memory 122
4.12.5. BISX™ Data Memory 122
4.12.6. Battery Operation 123
4.12.7. The BIS™ Bilateral System 124
5. Quick Reference Guide 141
5.1. Introduction 141
5.2. Basic Operation 141
6. Preventive Maintenance, Care and Cleaning 143
6.1. Introduction 143
6.2. Care and Cleaning 143
6.3. Maintenance 145
6.2.1. Cleaning the Monitor and BISX™ 144
6.2.2. Disinfecting the Monitor and BISX™ 144
6.2.3. Cleaning the Monitor Display 145
6.3.1. Replace the PIC (Patient Interface Cable) 145
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Checking Cable Integrity 146
6.3.2.
6.3.3. System Checkout 146
6.3.4. Checking the Battery 147
6.3.5. Checking Battery Expiry Date 149
6.3.6. Replacing the Battery 149
6.3.7. Replacing the Power Supply 150
6.3.8. Checking Leakage Current 151
6.4. Technical Documentation 153
6.5. Instrument Identification 153
6.5.1. BIS™ Complete Monitor 153
6.5.2. BISX™ 153
6.5.3. Software Revision Numbers 153
7. Diagnostics and Troubleshooting 155
7.1. Introduction 155
7.2. Maintenance Menu 155
7.2.1. Display BISX™ Connection History 156
7.2.2. Serial Protocol 156
7.2.3. Software Update 157
7.2.4. Restore Default Settings for All Modes 158
7.2.5. Audio Off Reminder 158
7.2.6. Calibrate Touch Screen 159
7.3. Diagnostics Menu 159
7.3.1. Diagnostic Codes 159
7.3.2. DSC Self Test 160
7.4. BIS™ Complete System Messages and Corrective Actions 160
7.5. Using the Reset button 174
7.6. What to do if the BIS™ Complete Monitoring System
Requires Service 175
8. Menus, Processed Variables and Glossary 177
8.1. Menu Map 177
8.2. Menu Listing 178
8.3. Processed EEG Variables 183
8.4. Glossary 186
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9. Specifications, Warranty and Software License Agreement 189
9.1. Specifications 189
9.2. Electromagnetic Compatibility Specifications 195
Guidance 196
9.3. Warranty 210
9.4. Software License Agreement 212
10. Password Protected Features 215
9.1.1. General Specifications 189
9.1.2. EEG Specifications 190
9.1.3. BISX™ Unit Specifications 192
9.1.4. Product Compliance 193
9.1.5. Essential Performance 194
9.1.6. Classification 195
9.2.1. Accessories 196
9.2.2. IEC 60601-1-2:2001 Electromagnetic Compatibility
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List of Figures
Figure 1. Pole Clamp 37 Figure 2. The BIS™ Complete Monitoring System 43 Figure 3. Rear Panel 45 Figure 4. BISX™ Unit and PIC 48 Figure 5. Connecting the PIC 60 Figure 6. Sensor Check Graphic Screen (Values not Shown) 62 Figure 7. Sensor Check Graphic Screen with Values Shown 63 Figure 8. Screen Features – BIS™ Trend Data Screen 65 Figure 9. BIS™ Trend Data Screen with Battery Icon, Target Range,
SR, and Burst Count 70 Figure 10. BIS™ Main Screen on 2-Channel BIS™ System 74 Figure 11. BIS™ Main Screen on Bilateral (4-Channel) BIS™ System
74 Figure 12. Target Range 79 Figure 13. Secondary Variable for 2-Channel System 81 Figure 14. Secondary Variables for Bilateral (4-Channel) System 82 Figure 15. Chart Data 84 Figure 16. Alarm Volume 85 Figure 17. BIS™ Display Modes for the 2-Channel System 86 Figure 18. BIS™ Display Modes for the Bilateral (4-channel)
System 86 Figure 19. View/Save Settings 88 Figure 20. Passkey Entry Screen 89 Figure 21. Help 90 Figure 22. Snapshot 90 Figure 23. Display SR 91 Figure 24. Export Data 95 Figure 25. Smoothing Rate 99 Figure 26. Print Touch Key 100 Figure 27. Configuration Information 102 Figure 28. EEG Channels 103 Figure 29. Date and Time 104 Figure 30. Language Menu 105 Figure 31. Filters 106 Figure 32. Impendance Checkin ON/OFF 107
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Figure 33. Review Screen (Case Mode) 110 Figure 34. Review Screen (Cursor Mode) 111 Figure 35. EEG Display 114 Figure 36. DSA Display (DSA + Amplitude) on 2-Channel BIS™
System 116 Figure 37. DSA+BIS Display on 2-Channel BIS™ System 116 Figure 38. BIS™ Range Guidelines 119 Figure 39. The BIS™ Complete Bilateral Monitoring System 125 Figure 40. Sensor Check (Values not Shown) 127 Figure 41.Sensor Check with Values Shown 128 Figure 42. BIS™ Number Display/Bilateral Touch Key 129 Figure 43. Main Display (DSA) and Small Display (BIS™ Trend) 130 Figure 44. DSA Display 131 Figure 45. DSA Vertical Display on Bilateral (4-Channel) BIS™
System 132 Figure 46. DSA Horizontal Display on Bilateral (4-Channel) BIS™
System 133 Figure 47. BIS™ Trend Display 133 Figure 48. Four-channel EEG with ASYM Display 134 Figure 49. Bilateral Display Menu 136 Figure 50. Secondary Variables Menu (Bilateral) 138 Figure 51. Chart Data Screen 139 Figure 52. Demo Case 140 Figure 53. Replacing the Power Supply 150 Figure 54. Audio Off Reminder ON/OFF 158 Figure 55. Diagnostic Codes ON/OFF 159 Figure 56. BISTM Complete Menu Map for 2-Channel System 177 Figure 57. BISTM Complete Menu Map for Bilateral (4-Channel)
System 178
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List of Tables
Table 1. Safety Symbol Definitions 15 Table 2. Symbol Key 23 Table 3. Shipping and Storage Environment 33 Table 4. Operating Environment 34 Table 5. Current vs. Legacy BIS Complete Monitoring System
Product Names 39 Table 6. Summary of Cables used with the BIS Complete
Monitoring System 42 Table 7. Summary of Settings Restored after System Start 52 Table 8. Alarm Touch Keys 76 Table 9. Menu, Home, Sensor Check and Review Mode Touch
Keys 77 Table 10. Monitor Mode Settings 93 Table 11. High-Priority Alarm Conditions - Messages and
Corrective Actions 160 Table 12. Low-Priority Alarm Conditions - Messages and
Corrective Actions 162 Table 13. Other System Messages and Corrective Actions 172 Table 14. Essential Performance 194 Table 15. Guidance and Manufacturer's Declaration -
Electromagnetic Emissions 197 Table 16. Guidance and Manufacturer's Declaration -
Electrommagnetic Immunity 199 Table 17. Recommended Separation Distances between Portable
and Mobile RF Communications Equipment and the BIS™
Complete Monitor 204 Table 18. Proximity Field Immunity Compliance 206
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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.
Within this manual the terms BISX™ and BIS™ LoC 2 Channel are used interchangeably. For additional information, see Table 5.
Current vs. Legacy BIS Complete Monitoring System Product Names on page 39.
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
Note:
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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 (including various
options)
Suppression Ratio (SR, displayed upon activation by the user)
Suppression Time (ST, a new feature, displayed upon
activation by the user, available for SW revision 3.50 and higher)
Alarm Indicator and Messages
Burst Count number (when a 4-channel BIS™ system and a BIS™
bilateral sensor are 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.
The BIS™ system also includes a number of methods for downloading data from the system.
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Introducing the BIS™ Complete Monitoring System
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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. Rel iance on BI S™ alone for intraoperative anestheti c 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.
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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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2. Safety Precautions
2.1. Introduction
Carefully read this entire manual before using the monitor in a clinical setting.
2.2. Safety Symbol Definitions
Table 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.
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2.3. 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:
The BIS™ complete monitor should not be used adjacent to or
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Warnings
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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.
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.
WARNING
Using accessories other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the BIS™ complete monitoring System.
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:
o 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 the BISX™ unit 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.
WARNING:
WARNING:
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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.
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.
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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.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the BIS™ complete monitoring system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Check Target Range alarm limits to ensure they are appropriate
WARNING:
WARNING:
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for the patient being monitored with each use. Ensure Target Range alarm limits do not exceed the standard thresholds set by the institution.
WARNING:
Do not decrease the adjustable alarm volume below ambient sound levels. Decreasing the alarm volume below ambient levels may compromise patient safety.
2.4. Cautions
Caution:
Read this entire manual carefully before using the monitor in a clinical setting. Do not autoclave the BISX™ unit or monitor. Autoclaving will seriously damage both components.
Caution:
Do not set the Target Range alarm limits to extreme values that render the monitoring system useless. Ensure Target Range alarm limits are appropriate for each patient.
Caution:
Do not block ventilation inlet holes on the underside of monitor.
Caution:
Do not open BISX™ unit for any reason. The seal to prevent liquids from entering the BISX™ unit may be damaged if opened.
Caution:
Service or repairs must be performed only by qualified biomedical technicians.
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Cautions
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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 interfere with the proper function of the BIS™ monitoring system. Check for compatibility of equipment during patient setup.
Caution:
Check the battery annually 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 3 hours (or 2 hours with BISX™ or BISX4™ unit attached), battery replacement is required.
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Caution:
Check the battery pack annually to ensure that the expiration date listed on the battery pack is not exceeded. If the expiration date is exceeded, then dispose of the battery. Reference 6.3.5 Checking Battery Expiry Date on page 149, for instructions on how to access battery and expiration date.
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:
o Increase separation between devices.
Re-orient device cabling. Plug devices into separate outlet circuit branches. Reference 9.2 Electromagnetic Compatibility Specifications on page 195.
Caution:
Do not disconnect the BISX™ unit during the software update.
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Key to Symbols
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Caution:
When connecting or disconnecting BISX™ unit, take care not to touch the exposed contacts of either connector. Damage due to electrostatic discharge may result.
Important: The BIS™ complete system complies 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.
2.5. Key to Symbols
A key to the symbols that may appear on the BIS™ Complete system appears below.
Table 2. Symbol Key
Symbol
Description
Latex Free product
Do Not Reuse
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Symbol
Description
Caution: Consult Accompanying Documents
Follow Instructions for Use
Consult Instructions for Use
Storage Temperature Limits
Packaging Labeling: Fragile
Packaging Labeling: Do Not Get Wet
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Key to Symbols
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Symbol
Description
Packaging Labeling: 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.
1
In regards to European Union Directive 2006/66/EC on batteries and accumulators and waste
batteries and accumulators: The Batteries Directive, 2006/66/EC, introduced new
Crossed out wheelie bin indicates separate treatment from general waste at end of life
1
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Symbol
Description
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
requirements, effective September 26, 2008, regarding removability of batteries from waste equipment in EU Member States. To comply with this Directive, this device has been designed for safe removal of the batteries at end-of-life by a qualified service technician. Infected units should be de-contaminated before they are sent for recycling, in accordance with Ca Directive 2002/96/EC on waste electrical and electronic equipment (WEEE). All waste electrical and electronic equipment (WEEE) should be disposed of and collected separately. This product is Electrical and Electronic Equipment and should be disposed of in accordance with national and local legislation and requirements.
re and Clea ning (6.2) o
f this manual. In regards to European Union
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Key to Symbols
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Symbol
Description
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
Not connected to protective earth
Manufacturer
Manufacturer Date
Use by YYYY-MM-DD or YYYY-MM
Batch Code
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Symbol
USB-A
USB-B
Description
Serial Number
Data I/O, RS-232 Serial Port
Universal Serial Bus: Type A
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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Key to Symbols
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Symbol
Description
USB Drive: Data Export is in Progress
A Printable File Is Being Transferred to the USB Drive
Green Bell Icon – Alarms Active
Yellow Bell with Countdown Timer – Alarms Paused
Red Bell with ‘X’ – Alarms Silenced
NOTE: When alarms are silenced, an audible reminder sounds at 3-minute intervals. This reminder can be disabled via the Maintenance Menu (passkey protected).
A green box denotes ON or active condition.
A red box with an ‘X’ denotes OFF or cancel.
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3. Installation and Preparation for Use
3.1. Introduction
This chapter provides installation instructions for the BIS™ complete monitor, BISX™ unit, and accessories. It includes:
Installation checklist
Proper environment
Required equipment and supplies
Cable connections
Start and shutdown procedures
Initial menu settings
The system is seen in Figure 2. The BIS™ Complete Monitoring System on page 43.
3.2. BIS™ Complete Monitor Installation and Checkout
1. Open packages and inspect for all components:
Monitor
Power cord
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Pole clamp
BISX™ unit
PIC (Patient interface cable, connects BISX™ unit to patient)
Sensors are sold separately. For a list of available sensors please contact Covidien or your local distributor.
2. Connect power cable to monitor, plug power plug into appropriate wall outlet. Ensure that the outlet used for the monitor is easily accessible; disconnection from the outlet is the only way to completely remove AC power to the monitor.
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.
Verify battery icon displays below BIS™ number.
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7. Reconnect power cord.
Item
Value
Temperature
-20°C to +60°C (-4°F to 140°F)
Humidity
15% to 95% (non-condensing)
Pressure
800 mm Hg (1500 feet below sea level) to
Verify battery icon is not displayed below BIS™ banner.
Verify “OPERATING ON BATTERY BACKUP” is not displayed.
8. End of install.
3.3. Environment
3.3.1. 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 non­operational storage and shipping situations.
Table 3. Shipping and Storage Environment
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
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Item
Value
Temperature
0°C to +40°C (32°F to 104°F)
Humidity
15% to 95% (non-condensing)
Pressure
800 mm Hg (1500 feet below sea level) to
placing into service. Before operation, wipe down all visible condensation and allow the system to reach equilibrium at room temperature.
3.3.2. Operating Environment
The BIS™ complete monitoring system is not designed for use in areas containing flammable gases or vapors.
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.
The BIS™ complete monitor is designed to operate safely under the following conditions. Conditions outside these ranges could affect reliability.
Table 4. Operating Environment
360mm Hg (20,000 feet above sea level)
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Environment
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35
3.3.3. Power Requirements and System
Grounding
The BIS™ complete 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.
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.
If the integrity of the external protective earth ground is in doubt, the BIS™ complete monitor shall be operated from its internal battery power source only.
3.3.4. Electromagnetic Compatibility
The BIS™ complete monitoring system should be used only with the power cord and accessories recommended and supplied by Covidien. The system must be installed and put into use according to the
WARNING:
Requirements
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BIS™ Complete Monitor
specifications described in
.
(B.2)
Electromagnetic Compatibility Specifications
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:
o Increase separation between devices.
Re-orient device cabling. Plug devices into separate outlet circuit branches. Refer to 9.2 Electromagnetic Compatibility Specifications on page 195.
3.3.5. Site Preparation: Mounting the
Monitor
Covidien strongly recommends permanent mounting of the BIS™ complete monitor to the anesthesia machine to enhance safety and facilitate ease-of-use. Please contact your local representative or Covidien to discuss mounting options.
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
WARNING:
Be sure the monitor is mounted securely in place to avoid personal or patient injury.
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.
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Environment
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37
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 1. Pole Clamp
To remove the monitor, press tab on top of clamp shoe before sliding monitor up.
The pole clamp may be locked onto the monitor so that the two do not get separated. To do this:
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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.
3.4. The BIS™ Complete Monitoring System— Equipment and Supplies
The BIS™ complete monitoring system consists of the following basic components:
BIS™ complete monitor
BISX™ unit
Patient Interface Cable (PIC)
BIS™ sensor
Detachable Power Cord
Sensors are sold separately. For a list of available sensors please contact Covidien or your local distributor.
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A pole clamp is also included; however, its use is optional. Contact Covidien or your local representative for information on additional equipment and accessories.
Product names for some components of the BIS™ complete monitoring system have changed. For current vs. legacy product names, refer to
Table 5. Current vs. Legacy BIS Complete Monitoring System Product Names, below.
Table 5. Current vs. Legacy BIS Complete Monitoring System
Product Names
Current Product Name
BIS™ complete monitor
Legacy Product Name
BIS™ Vista monitor
LoC 2 Channel BISX™
Description or Application
BIS™ monitor that can be used with either a 2 or 4 Channel LoC device.
Monitor is connected to the LoC device by a BIS Host Cable which is packaged with the LoC device.
Processes 2 channels of EEG information (one side of the brain) and calculates an index (0-100) that provides a direct measure
Part Number
185-0151
186-1100
185-1014-
xxx
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of the patient's
Current Product Name
Legacy Product Name
LoC 4 Channel BISX4™
Description or Application
level of consciousness.
Connects to a BIS sensor by the 10-pin Patient Interface Cable (PIC) which is packaged with the LoC device.
Processes 4 channels of EEG information (both sides of the brain) and calculates an index (0-100) that provides a direct measure of the patient's level of consciousness.
Part Number
185-1016-
xxx
Connects to a BIS sensor by the 12-pin Patient Interface Cable (PIC) which is packaged with the LoC device.
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Current
of the LoC 4
Product Name
BIS™ Sensors
Legacy Product Name
Description or Application
Part Number
Quatro Quatro
Extend Extend
Pediatric Pediatric
Bilateral Bilateral
Sensor for adult patients undergoing general anesthesia or sedation.
Sensor for adult patients undergoing general anesthesia or sedation in environments such as the ICU.
Sensor for pediatric patients ages four and up.
Sensor that detects hemispheric differences in the brain (for advanced monitoring applications).
Requires use
186-0106
186-0160
186-0200
186-0212
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Channel
Current Product Name
Legacy Product Name
Description or Application
Part Number
device.
Table 6. Summary of Cables used with the BIS Complete
Monitoring System
Cable Location Comment
AC Power Back of Monitor
Provided by Manufacturer
USB (Type A)2 Back of Monitor Provided by Customer
USB (Type A) Port is used with removable drive only
RS-232 Back of Monitor Provided by Customer
(1m < Length < 3m)
Monitor Interface Cable
Front of Monitor ­Side of LoC
Provided by Manufacturer
(see
Specifications
192)
2
USB (Type B) Port is for manufacturing use only. See 4.11 Data Transfer 106
9.1.3 BISX™ Unit
on page
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43
Cable Location Comment
1
Monitor Interface Cable
4
Patient Interface Cable 2
BIS™ complete monitor
5
BISX™
3
BIS™ sensor
Patient Interface Cable
Figure 2. The BIS™ Complete Monitoring System
Side of LoC – BIS™ Sensor
Provided by Manufacturer
(see
9.1.3 BISX™ Unit
Specifications
192)
on page
(PIC)
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3.4.1. BIS™ Complete Monitor
Front Panel
The front panel of the BIS™ complete monitor contains the Touch Screen, BISX™ port and the ON/Standby button. See Figure 2. The BIS™ Complete
Monitoring System on page 43.
Touch Screen
The BIS™ complete 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.
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™ unit. 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.
Rear Panel
The rear panel components are pictured in Figure 3. Rear Panel on page
45. They include: two USB ports (Type A and B), the clamp shoe, an RS-
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232 port, the Reset button, the Battery/Power Supply cover, and the
1
Battery/Power Supply Cover
5
Serial Port
power cord receptacle.
Note:
Do not touch the patient and the RS-232 or USB ports at the same time.
Figure 3. Rear Panel
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2
USB Port (Type B)
6
Power Cord Receptacle 3
USB Port (Type A)
7
Clamp Shoe
4
Reset Button
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.
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:
o 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.
Under normal operation, power is cycled through the ON/Standby button. The Reset button can be used to reset the software functions of
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the BIS™ monitor (and the BISX™ unit if it is attached) in the unlikely case that it is required. See 2.5 Key to Symbols on page 23.
The Battery/Power Supply cover contains the BIS™ complete 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™ unit when it is attached.
Caution:
The BIS™ complete 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:
o Increase separation between devices.
Re-orient device cabling. Plug devices into separate outlet circuit branches. Refer to 9.2 Electromagnetic Compatibility Specifications on page 195.
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.
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1
Monitor Interface Cable
2
Patient Interface Cable
Caution:
Check the battery annually 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.
3.4.2. BISX™ Unit
Figure 4. BISX™ Unit and PIC
(PIC)
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The BISX™ unit 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™ unit is shown in Figure 4. BISX™ Unit and PIC on page 48. 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™ unit.
The attachment clip on the BISX™ unit is used to secure it in a convenient location near the patient's head.
WARNING:
Due to elevated surface temperature, do not place BISX™ unit in prolonged direct contact with patient’s skin, as it may cause discomfort.
Caution:
Do not open BISX™ unit for any reason. The seal to prevent liquids from entering the BISX™ unit may be damaged if opened. Service or repairs must be performed only by qualified biomedical technicians.
3.4.3. Patient Interface Cable (PIC)
Covidien BIS™ sensor patient interface cable (PIC) (see Figure 2. The BIS™
Complete Monitoring System on page 43) connects the BISX™ unit to the
BIS™ sensor.
3.4.4. BIS Sensors
The sensor is the single use component of the BIS™ monitoring system and should be replaced after each use. For details on how to apply the sensor to the patient and how to connect to the BIS™ monitoring system,
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refer to the BIS™ sensor instructions for use. All sensors, including the BIS™ extended use sensor, utilize the monitor’s saved settings (such as smoothing rate).
3.5. Cable Connections
After you have familiarized yourself with the safety information in the introductory section of this manual and have prepared a suitable environment, follow these steps to prepare the BIS™ complete system for operation.
1. Connect the BISX™ unit to the monitor
Holding the cylindrical connector with the flat side up, plug the BISX™ monitor interface cable into the BISX™ port on the front of the monitor.
Once connected, the BISX™ unit need not be disconnected again. However, if you wish to disconnect the BISX™ cable from the monitor, carefully grasp the connector and pull. DO NOT pull on the cable.
2. Connect the PIC to the BISX™ unit.
Attach the gray connector of the Patient Interface Cable to the BISX™ unit.
Note:
Connect with the BIS™ logo facing up for proper pin alignment. To disconnect the PIC, grasp the connector housing and pull firmly. DO NOT pull apart by the cable wire.
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Start Procedure / Standby Mode
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3.6. Start Procedure / Standby Mode
3.6.1. Starting the Monitor for the First Time
To start the instrument for the first time, after it has been reset with the RESET button, or after battery replacement:
1. Attach one end of the power cord to the receptacle on the left side of the monitor.
2. Plug the other end of the power cord into a properly grounded hospital-grade AC power outlet. A yellow light illuminates to the right of the ON/Standby button.
3. Press the ON/Standby button. The light changes to green and diagnostics tests run to verify that the system is operating properly. A beep indicates that the tests are complete. If there is a problem, the system halts and an error message appears. Error messages are explained in the Troubleshooting section of this manual.
When not in use, the monitor should be placed in Standby mode. To put the system in Standby mode, press and hold the ON/Standby button for two seconds before releasing. The light will change from green to yellow. If the monitor is running on battery, the light will go off completely.
3.6.2. Starting the Monitor from Standby
When the monitor is in Standby mode (yellow light), you may start it by pressing the ON/Standby button. The light will change to green.
Mode
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Setting
Description
Alarm volume
Saved alarm volume setting will be restored
Charting
Saved charting interval setting will be restored
Device will restore date and time based on the last Diagnostic
Saved diagnostic codes setting will be restored
When not in use, the monitor should be placed in Standby mode. To put the system in Standby mode, press and hold the ON/Standby button for two seconds before releasing. The light will change from green to yellow. If the monitor is not connected to A/C power, the light will go off completely.
3.6.3. Power-Up Messages
At power-up, the following message will appear in the Message Region of the screen:
“Saved settings restored”
This message appears at each power-up, both after normal shutdown and after an unexpected shutdown. See Table 7. Summary of Settings
Restored after System Start, below for the list of settings restored.
After an unexpected shutdown, such as a power failure, a black screen with a Hardware Timer error message will be shown, with a [Continue] button.
Table 7. Summary of Settings Restored after System Start
interval
Date and time
time saved on the monitor and elapsed time since that time
codes
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Display SR
Saved SR setting will be restored
Filters
Saved EEG Filters setting will be restored
Impedance
Checking
Saved Impedance Checking setting will be Language
User selected language will be restored
Monitor Mode
User Selected Mode will be restored
DSA graph
Saved DSA graph direction (vertical or horizontal)
Secondary
Saved secondary variable displayed in the BIS
Sensor Check
Saved Sensor Check Values setting will be Serial Protocol
Saved Serial Protocol setting will be restored
Target High
Target Low
restored
Orientation
Variable
Values
will be restored
trend display will be restored
restored
Limit Saved target high alarm limit will be restored
Limit Saved target low alarm limit will be restored
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For all other user-adjustable settings, the manufacturer recommends that the user re-check these settings after a system restart, to ensure that the settings meet user requirements.
3.7. Initial Menu Settings
Before using the BIS™ complete monitor for the first time, you may need to select the proper language and set the current date and time. Other setting options are discussed in detail in
Monitoring System (4)
The BIS™ complete monitor utilizes a touch screen. To access the Menus, press the [MENU] icon on the left side of the screen. Press the [Next] or [Previous] touch keys to scroll through the menu options. At any time, you may press the [HOME] touch key to return to the main display screen.
.
3.7.1. Language Selection
The BIS™ complete monitor is designed to support multiple languages. If the screen does not display the desired language, follow these steps:
Opera ting the BIS™ Complete
To change the language:
1. Press [MENU].
2. Press [Next] to go to the second menu, then [Next] again to go
3. Press [Language]. The current language is displayed.
4. Use the [+] or [-] keys to scroll through the list of languages
5. Press [HOME] to return to the main screen.
to the third menu.
until the desired language appears. All screens will now display in the selected language.
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Initial Menu Settings
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3.7.2. Date and Time
To set the current date and time:
1. Press [MENU].
2. Press [Next] to go to the second menu, then [Next] again to go to the third menu.
3. Press [Date and Time]. A new screen displays the current date and time. “Day” is displayed in blue letters.
4. Use the up and down arrows to set the day of the month.
5. Press [Month]. “Month” is displayed in blue letters.
6. Use the up and down arrows to set the month.
7. Repeat this process for the “Year,” “Hour,” “Minute” and “Second” displays.
8. Press [Apply Changes] to apply the changes that you have just made.
9. When you have finished, you may press [Return to Previous Menu] or press [HOME] to return to the main screen.
The time/date is initially set for the Eastern Standard or Eastern Daylight Time zone (USA). It will be necessary for you to change the time twice per year using the Time/Date feature if you are located in a time zone that alters its clocks at the beginning or end of Daylight Savings Time.
3.7.3. View/Save Settings
The BIS™ complete monitor will always start up configured to settings that have been saved in memory.
Note:
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To save the current configuration settings,
1. Press [MENU].
2. Press [View/Save Settings]. The current settings display.
3. Press [Save Active]. A passkey is required to save the settings
3.7.3 View/Save Settings
(see entering the passkey). The message, “Settings Saved” appears. The settings displayed will be saved except as noted below.
4. Press [Previous] or [HOME] to exit.
on page 55 for information about
Note:
The “Save Active” option is disabled when in Battery Backup­Low Power condition. Monitor Mode in current use is also saved when the “Save Active” button is pressed. The following settings are not saved by the “Save Active” option: Impedance Checking (always returns to ON), Filters (returns to ON), and Display Type (returns to BIS™).
Settings are set and saved for the current Monitor Mode only. See 4.6.10
Monitor Mode on page 92.
See 3.7.3 View/Save Settings on page 55 for instructions on restoring factory default values.
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4. Operating the BIS™
Complete Monitoring System
4.1. Introduction
This chapter covers:
Preparing for operation
The sensor check
The monitor screen display
Software menus and menu selections
Reviewing stored data
The EEG display
Ending a case
Read this chapter before operating the monitor in a clinical setting.
4.2. Preparing for Operation
After you have familiarized yourself with the safety information in the introductory section of this manual, prepared a suitable environment, properly connected the BISX™ unit and PIC cables, and completed the initial settings described in 3.7 Initial Menu Settings on page 54, follow
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these steps to prepare the BIS™ complete monitoring system for operation.
1. Startup and System Check
Press the ON/Standby button on the lower right corner of the monitor to start the monitor. The light changes from yellow to green, and the system initiates a self-test to make sure that all equipment is operating properly.
2. Attach BIS™ Sensor to Patient
Prepare sensor site and place the BIS™ sensor on the patient in accordance with the instructions included on the sensor packaging.
Caution:
The BIS™ complete monitoring 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.
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 high-frequency surgical equipment, 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
WARNING:
WARNING:
WARNING:
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Preparing for Operation
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59
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:
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the BIS™ complete monitoring system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
3. Secure the BISX™ unit
Using the attachment clip, secure the BISX™ unit to a convenient location near the patient's head.
4. Attach the BIS™ sensor to the PIC
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1
PIC Sensor Connector
3
Sensor Tab
2
Release Button
Figure 5. Connecting the PIC
To insert the sensor into the PIC, line up as shown and insert the sensor tab into the PIC sensor connector without pausing, until an audible “click” is heard. The blank side of the sensor tab (i.e. the side without the computer chip) should be facing up.
When disconnecting the sensor, press the release button on the PIC.
Note:
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Sensor Check
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The Sensor Integrity Check is initiated each time that a sensor is connected to the PIC to make certain that a valid, unexpired sensor is in use.
4.3. Sensor Check
The Sensor Check tests the impedance of each electrode on the BIS™ sensor to verify that it is within an acceptable range for monitoring. A Sensor Check is initiated automatically when the sensor and PIC are connected to the BISX™ unit. It may also be initiated by the user by pressing the [Sensor Check] touch key.
The message, “Sensor Check in Progress” appears. When the sensor successfully passes the test, the Main Screen displays and monitoring begins.
If the sensor does not immediately pass the test, or if the user has manually initiated the test, the Sensor Check Graphic Screen displays. This screen shows the sensor with each electrode numbered. Colors indicate the status of each electrode:
Hollow circle – No status is available. The electrode label will appear after a few seconds.
Green circle with Checkmark – The electrode impedance is within the acceptable range. When all circles are green, monitoring can begin.
Red blinking circle with ‘X’ – The electrode impedance is not within the acceptable range. Press the edges of the sensor to ensure adhesion and then press each circle for 5 seconds to ensure proper contact. Check all connections. If the problem persists, remove sensor, clean skin thoroughly, and reapply sensor or apply new sensor in accordance with instructions on the sensor packaging.
Gray circle with Question Mark – The electrode impedance cannot be determined due to electrical interference (noise)
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from another source. Monitoring will not commence until the source of the noise has been removed and all electrodes have passed the sensor check.
If the user has requested the Sensor Check and all electrodes pass the test, the circles return to their original display color (blue) and the label, “PASS” displays at the bottom of the screen.
Figure 6. Sensor Check Graphic Screen (Values not Shown)
If user action is required, messages in the message region of the screen issue instructions.
The monitor continues updating the values until all impedance values are acceptable. The [EXIT] touch key allows the user to exit the screen before the test has completed, however, the Sensor Check impedance test must be successfully completed before normal processing resumes.
For more detailed impedance information, press the [Show Values] touch key.
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Sensor Check
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Figure 7. Sensor Check Graphic Screen with Values Shown
In this display, the impedance value for each electrode, in kilo ohms (a measure of electrical resistance), appears on the screen along with its status:
PASS - An electrode passes if the impedance for that electrode is less than 7.5 kilo ohms. The ground electrode (electrode #2) must be less than 30 kilo ohms to pass.
HIGH - An electrode is labeled “HIGH” if its impedance value is above 7.5 kilo ohms (30 kilo ohms for the ground electrode). As long as the combined impedance of electrodes #1 and #3 and the combined impedance of electrodes #1 and #4 are less than 15 kilo ohms, and the ground electrode is less than 30 kilo ohms, the sensor check will be considered successful.
NOISE - If the signal from the electrode goes beyond the measurable range, the label “NOISE” displays.
POOR CONTACT - If the impedance check indicates that the electrode is not in contact with the patient, the label “POOR CONTACT” displays.
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To return to the previous display, press the [Hide Values] touch key.
To save this screen as the default screen, return to the menu system, press the [View/Save Settings] touch key, then press [Save Active].
4.4. BIS™ Trend Data Screen
Once the sensor check has successfully completed, monitoring begins and the corresponding information appears on the screen.
Note that the figures below display the screen as seen for SW Revision
3.50 and higher. There will be slight differences for earlier versions of the device.
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Figure 8. Screen Features – BIS™ Trend Data Screen
1
Sensor Check Touch Key
11
Secondary Variable
2
Menu/Home Touch Key
12
Current Time and Date
3
Alarm Pause/Silence Touch
13
Target Range
4
BIS™ Trend Unit Labels
14
Secondary Variable
7 8 9
20
19
18
17
16
15
14
13
12
11
10
1
2
3
4 5 6
Key
Unit Labels
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5
Primary Variable Name
15
Trend Time Scale
6
BIS™ Value
16
Secondary Trend
7
Signal Quality Indicator
17
Snapshot Event Marker
8
EMG Indicator
18
BIS™ Trend
9
EEG Waveform(s)
19
Artifact Bar
10
Case ID
20
Review Arrow
4.4.1. BIS™ (Bispectral Index) Value
The current numeric value of the BIS™ is displayed in the upper left corner of the screen. The BIS™ number is displayed and continuously updated during all display modes as long as signal quality is sufficient.
4.4.2. Signal Quality Indicator
The Signal Quality Indicator (SQI) is a measure of the signal quality for the EEG channel source and is calculated based on impedance data, artifact, and other variables. It is displayed in the upper left corner of the screen, to the right of the “BIS” label. Signal quality is optimal when all five bars of the SQI icon are green. When signal quality is too low to accurately calculate a BIS™ value, the BIS™ value and other trend variables that are adversely affected by artifact will not be displayed on the screen.
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4.4.3. Electromyograph (EMG) Indicator
Message Priority
Background Color
The EMG bar graph displays the power (in decibels) in the frequency range 70–110 Hz. This frequency range contains power from muscle activity (i.e., electromyography or “EMG”) as well as power from other high-frequency artifacts. When the indicator is low, it indicates that EMG activity is low. BIS™ monitoring conditions are optimal when the bar is empty.
1 bar represents power in the 30–38 range 2 bars represent power in the 39–47 range 3 bars represent power in the 48–55 range 4 bars represent power greater than 55.
4.4.4. EEG Waveform Display
Filtered electroencephalogram (EEG) waveforms are displayed above the BIS™ trend graph with a sweep rate of 25 millimeters per second and a scale of 25 microvolts (1 channel) or 50 microvolts (2 channels) per division. One or two channels of EEG may be displayed in this area. For the bilateral display, 4 channels of EEG can also be displayed. EEG filters can be turned off, if desired.
An alternate screen display is available to view the waveforms in a larger format. Refer to 4.8 EEG Display on page 113 for information.
4.4.5. Message Region
The Message Region is a space reserved for status and error messages. These messages are prioritized so that a high priority message displays before a lower priority message.
The BIS™ complete monitor has two alarm priorities (High and Low) and information messages. The background color of the message indicates its priority:
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High
Red (Flashing)
Low
Yellow (Solid)
Information only
Dark Blue or Grey
Diagnostic codes may be displayed above the messages by activating them in the Diagnostic Menu. Specific error messages are explained in the Troubleshooting section of this manual (7 Diagnostics and Troubleshooting on page 155).
4.4.6. BIS™ Trend Graph
The BIS™ trend graph plots the values of the Bispectral Index over time. The BIS™ trend is indicated with a thick yellow line for 2-channel systems and, in 4-channel systems, as a thick yellow line for the left hemisphere and a thick blue line for the right hemisphere. Its unit labels appear on the left axis. The name BIS™ is displayed above the left corner of the graph (in a color that matches the BIS™ trend line) and the current date and time display in the center. (See Figure 8. Screen Features – BIS™ Trend
Data Screen on page 65 and Figure 9. BIS™ Trend Data Screen with Battery Icon, Target Range, SR, and Burst Count on page 70)
On the right, a unique Case ID number is displayed. A new case number is assigned when a new sensor is attached to the PIC and passes the Sensor Check.
If a target range for BIS™ has been set, the target area displays as either a colored bar or two horizontal lines showing the upper and lower target ranges (depending on the user setting). If the BIS™ value falls outside of the target range, a message displays in the Message Region of the screen, and if an audible alarm was requested in the target range setup screen, the alarm sounds (unless alarms have been silenced). The alarm continues to sound until the BIS value returns to the target range or the
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alarm is silenced by pressing the alarm touch key. See 4.6.1 Target Range on page 79 for more information.
A secondary variable may be added to the display by selecting one of the available choices as a secondary variable in the menu system. See
4.6.2 Secondary Variable on page 81 for instructions. The secondary
trend is shown with a thin line and its unit labels appear on the right axis. The secondary trend name is displayed above the right corner of the graph. Note that Burst Count is only available as a secondary variable when a BIS™ extend sensor is in use.
During periods of poor signal quality, an artifact bar appears along the horizontal axis at the bottom of the graph. When signal quality is considered too low to calculate a BIS value, the bar becomes bright yellow and any trend variables that are adversely affected by artifact will not be displayed.
A Data Snapshot may be taken to save up to 10 minutes of data leading up to a significant event. A Data Snapshot Marker (a camera icon) displays at the bottom of the BIS™ trend graph at the time the snapshot was taken. Only one set of data is saved in memory at a time. When a second snapshot is taken, the snapshot marker from the first snapshot changes from a camera to a diamond and its data are overwritten. Snapshot data may be saved to a removable drive. To export snapshot data, see 4.6.11 Export Data on page 95. To save snapshot data in a printable (PDF) format, see 4.6.13 Print (Snapshot) on page 100.
If desired, EEG may be displayed in place of the BIS™ trend graph by selecting the EEG display mode in the menu system. See 4.6.5 Display
Modes on page 86 for details. During the sensor check procedure, this
area of the screen is used to issue instructions and report current status.
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1
Battery Icon
4
Suppression Ratio
2
Extend Mode Indicator
5
Target Range
3
Burst Count
1 2 5 3 4
Figure 9. BIS™ Trend Data Screen with Battery Icon, Target
Range, SR, and Burst Count
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4.4.7. Additional Screen Information
Battery Icon
The battery icon is displayed below the BIS™ number when the monitor and BISX™ unit are running on battery power. When the battery icon contains four green bars, the battery is fully charged. When the icon turns orange, the battery is nearly depleted.
If an empty battery icon displays on the screen with a slash across it, there is no battery in the monitor.
USB Export Icon
The USB Export icon is displayed below the BIS™ number during data export to a removable USB drive inserted in the rear of the monitor.
Print Icon
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The Print icon is displayed below the BIS™ number while printable files are being written to a removable USB drive inserted in the rear of the monitor.
Extend Mode
The message, “EXTEND MODE ON,” displays below the BIS™ number when a BIS™ extended use sensor is in use. Note that the monitor automatically changes to the smoothing rate that was set in Mode II (ICU) when a BIS™ extend sensor is attached.
Suppression Ratio (SR) Number
The Suppression Ratio (SR) is displayed in the upper right corner of the screen only when it has been requested by the user. Suppression ratio is a calculated parameter designed to indicate when an isoelectric (flatline) condition may exist. Suppression ratio is the percentage of time over the last 63-second period that the signal is considered to be in the suppressed state. For example: SR=11 (isoelectric over 11% of the last 63 second review).
When SR reaches 100%, the message “Isoelectric EEG Detected” will notify the user. Suppression ratio can be plotted over time as a secondary trend on the BIS™ Trend Graph.
Suppression Time (ST)
ST is a new feature, displaying the cumulative time spent in suppressed (isoelectric) state, and is displayed in hours:minutes:seconds format as a numeric and in hours:minutes format on the graph. This feature is available for SW revision 3.50 and higher. Suppression Time (ST) is a secondary variable available in both 2-channel and 4-channel BIS™ systems. It is displayed at the top of the main screen as a numeric value, and on the BIS™ trend graph by a trend line, when selected by the user as described below.
SR and ST can be selected for display at the top of the main monitoring screen, where SR is displayed as a percent and ST as a number in h:mm:ss
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(hours:minutes:seconds) format. For an example of this display, see
Figure 10. BIS™ Main Screen on 2-Channel BIS™ System Figure 11. BIS™ Main Screen on Bilateral (4-Channel) BIS™ System
on page 74 and
on page
74.
The ST trend can also be selected to be displayed on the BIS™ trend graph through the Secondary Variables menu. For an example of this display, see
System
Figure 11. BIS™ Main Screen on Bilateral (4-Channel) BIS™
on page 74. The ST is displayed as an additional line, in purple, on
the graph.
The ST is seen on the right-side Y axis on the BIS™ trend graph in h:mm format in a scale of 0-2 hours (in increments of 20 minutes) for the first 2 hours of display; for an additional two hours, ST data is displayed in a smaller scale of 0-4 hours, in increments of 40 minutes.
ST is seen only for a maximum of 4 hours; after 4 hours of measurement, the ST will be displayed on the top part of the graph as a dashed line, for both 2-channel and 4-channel BIS™ systems. The exact time that exceeds the 4 hours limit of the graph is displayed as follows:
In the 2-channel BIS™ system, the time that exceeds the 4-hour limit will be seen in the ST numeric value on top of the screen.
In the 4-channel BIS™ system, the time that exceeds the 4-hour limit will be displayed alternately with the SR numeric value at the top right side of the screen.
For both systems, after 10 hours of measurement, the numeric display will be displayed as a dash.
SR and ST can be displayed as numeric values or as trends on the BIS™ graph; neither, just one, or both forms of data can be selected and displayed. In below, ST is shown both as a numeric value in hours:minutes:seconds format at the top of the screen and as the purple line on the graph. The right side Y axis of the graph indicates ST time in an hours:minutes format. The numeric value shows the cumulative ST, while the graph
Figure 10. BIS™ Main Screen on 2-Channel BIS™ System
,
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ST Trend
ST in
format
SR in %
ST and SR
ST Trend Line;
axis
shows the cumulative ST as a trend. In
Bilateral (4-Channel) BIS™ System
Figure 11. BIS™ Main Screen on
, below, only the graph is shown.
Figure 10. BIS™ Main Screen on 2-Channel BIS™ System
Figure 11. BIS™ Main Screen on Bilateral (4-Channel) BIS™
System
format
h:mm:ss
ST shown in
h:mm format
on right side Y
alternately,
ST in h:mm:ss
(as seen in
Figure 10) and
SR in %
Line; ST
shown in
h:mm
format on
right side Y
axis
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The user may choose whether to display the Suppression Ratio (SR) and Suppression Time (ST) at the top of the main monitoring screen.
To display ST:
1. Navigate to and select [MENU].
2. Navigate to and select [Next].
3. Navigate to and select [Display SR].
4. The grey square at the bottom left of the button will turn green, indicating that SR is being displayed at the top of the main screen. When SR is displayed, ST will be displayed as well.
5. To turn off SR Display, select [MENU]>[Next]>[Display SR]>[X] will appear at bottom right of Display SR window.)
The user may choose whether to display the Suppression Time (ST) on the screen as part of the BIS™ trend graph. The ST trend line can be displayed as a secondary variable on the BIS™ graph only.
To display ST on the BIS™ graph:
1. Navigate to and select [MENU].
2. Navigate to and select [Secondary Variable].
3. Navigate to and select [ST]
4. Navigate to and select [Home} to return to the Home screen.
5. If ST already appears in the graph and the user wants to turn it off, navigate to and select another option or [None] in the same screen. Navigate to and select [Home} to return to the Home screen.
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A green bell icon indicates that the alarms are
It is recommended to display ST in both numeric and
graphic format for clarity.
Burst Count (Bursts/Minute)
When a 4-channel BIS™ system and a BIS™ bilateral sensor are in use, the Burst Count is displayed above the EEG waveform display. Burst Count is an alternative method of quantifying suppression, reported as the number of EEG bursts per minute. The system defines a “burst” as a short period of EEG activity, preceded and followed by periods of inactivity. When the signal quality is low or when the Suppression Ratio is less than 5, the Burst Count is not displayed.
The Burst Count may also be graphed as a secondary variable on the BIS™ trend graph.
4.5. Main Screen Touch Keys
4.5.1. Alarm Touch Keys
Alarms sound to alert the user to possible problems with the patient or the equipment. Alarm conditions are prioritized so that high priority alarms take precedence over lower priority alarms. The user may silence all alarms. Alarm volume may be set in the menu system.
Table 8. Alarm Touch Keys
active and will sound if activated. Pressing this icon changes the alarm status to “Alarms Paused” and the yellow bell icon displays.
Alarms Active
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Alarms Paused
A yellow bell indicates that all alarms have been
The red bell with a solid “X” over it indicates that
The MENU/HOME touch key:
Alarms Silenced
4.5.2. Menu, Home, Sensor Check and
silenced for two minutes. A countdown timer counts down the seconds until the alarm sounds again. Pressing this icon changes the alarm status to “Alarms Silenced” and the red bell icon displays.
all alarms have been silenced indefinitely. Pressing this icon restores the active alarms and the green bell icon displays.
NOTE: When alarms are silenced, an audible reminder sounds at 3-minute intervals. This reminder can be disabled via the Maintenance Menu (passkey protected).
Review Touch Keys
Table 9. Menu, Home, Sensor Check and Review Mode Touch Keys
The [MENU] touch key is used to enter the Menu system.
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When a menu displays, the [MENU] touch key
The SENSOR CHECK touch key:
The Review Mode Arrow
becomes the [HOME] touch key.
The [HOME] touch key is used to return to the main display screen.
This touch key is used to begin a sensor impedance check. Sensor Check is initiated automatically when the PIC and sensor are attached to the BISX™ unit. You may initiate another check at any time by selecting this option.
When an automatic check has been completed successfully, the screen will exit automatically. Otherwise, the user may press the [EXIT] key at any time to exit. For details on the sensor check procedure, refer to
4.3 Sensor Check
on page 61.
This touch key is used to enter Review Mode
4.6. Menu Selections
Before using the BIS™ complete monitor for the first time, you may want to update the monitor with your desired screen settings and the current date and time. You should also familiarize yourself with the various menu options available. This section describes the menu options available and how they work. These menu options are discussed below. For more detail on what the settings mean, refer to 4.4 BIS™ Trend Data
Screen on page 64.
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4.6.1. Target Range
To access the Target Range, press [MENU].
Figure 12. Target Range
To aid in patient management, a target range of desired BIS™ values may be set. When the Target Range is activated, the selected range displays on the BIS™ trend graph. The BIS™ complete monitor will notify the user when the patient’s BIS value is outside of the intended range. The Target Range menu has four components:
1. Activating the Target Range feature so that the range displays on the BIS™ trend graph.
2. Setting the Target Range display format (colored band or two horizontal lines).
3. Setting the audible alarm to sound when a BIS™ value falls outside of the range.
4. Setting a Target Range of desired BIS™ values.
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Caution:
Do not set the Target Range alarm limits to extreme values that render the monitoring system useless. Ensure Target Range alarm limits are appropriate for each patient.
To set the Target Range options, press [Target Range]. The Target Range Screen displays.
1. To activate the Target Range so that it displays on the BIS™ trend graph, or deactivate it so that it does not, press [Target Range Active].
When the Target Range is active, a green box displays.
When the Target Range is inactive, a red box with an ‘X’ displays.
2. To change the Target Range display format, press the [Target Range Format] touch key. When the left side of the [Target Range Format] key is illuminated, the Target Range will display as a colored band. When the right side of the [Target Range Format] touch key is illuminated, the Target Range displays as a pair of horizontal lines denoting the upper and lower limits.
3. To activate or deactivate the target alarm, press [Target
A green bell indicates that the Target Alarm is active. Alarms will sound
when the BIS value falls outside of the Target Range, unless the alarms have been silenced on the main screen.
A red bell with an ‘X’ indicates that the Target Alarm is inactive. Audible
Target Alarms will not sound.
4. The Target Range upper (High) and lower (Low) limits are
Alarm].
displayed between minus and plus signs. To change the Target Range, use the [+] and [-] touch keys to increase or decrease the Target Range limits. Each key press will change the limit by a factor of 5. The system will not allow the difference between
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the upper and lower limits to be less than 5. A high value of 100 = none, and a low of 0 = none.
To permanently save this change, press the [View/Save Settings] touch key in the menu system, then press [Save Active].
Note:
A passkey is required to save settings. See 4.6.6 View/Save
Settings on page 87.
4.6.2. Secondary Variable
To access Secondary Variable, press [MENU].
Figure 13. Secondary Variable for 2-Channel System
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Figure 14. Secondary Variables for Bilateral (4-Channel) System
This option allows the user to add a secondary trend variable to the Trend Graph:
Selecting “Suppression Ratio” will plot the suppression ratio.
Selecting “EMG” will plot electromyograph or high frequency signal detection.
Selecting “Signal Quality” will plot a number (0–100) that indicates the quality of the EEG signal received and processed.
Selecting ST will display ST as a secondary variable (only on the BIS™ trend graph).
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Selecting “Bursts/Minute” will plot the burst count in number of bursts per minute. Note that this is available only when a BIS™ extend sensor is attached to the PIC. If a BIS™ extend sensor is not connected, this menu option does not appear.
Selecting “None” removes the secondary variable from the graph.
To specify a secondary variable:
1. Press [MENU] to access menu options.
2. The [Secondary Variable] touch key displays the options available. The current setting displays in green.
3. Press the desired touch key (Suppression Ratio, EMG, Signal Quality, Bursts/Minute, or None).
4. When the desired setting is displayed in green letters, press [Return to Previous Menu] or [HOME] to exit.
To permanently save this change, press the [View/Save Settings] touch key in the menu system, then press [Save Active].
A passkey is required to save settings. See 4.6.6 View/Save
Settings on page 87.
4.6.3. Chart Data
To access Chart Data press [MENU].
Note:
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Figure 15. Chart Data
When selected, this option provides a listing of BIS™, SQI and EMG values at a selected interval, so that they can be recorded on the patient chart. The charting interval can be changed by the user. Available intervals are 1, 5, 10, 15, 30, and 60 minutes. If a data snapshot was taken during the case, the snapshot icon appears on the chart at the corresponding time.
To chart data:
1. Press [MENU] to enter the menu system.
2. Press the [Chart Data] touch key. The Chart display appears.
3. To change the charting interval, use the [+] and [-] touch keys.
4. Use the [
5. Press [Return to Previous Menu] or [HOME] to exit.
To access Alarm Volume, press [MENU] and select [Alarm Volume].
Available intervals are 1, 5, 10, 15, 30 and 60 minutes.
] and [] arrows to scroll through the data.
4.6.4. Alarm Volume
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Figure 16. Alarm Volume
The alarm volume can be set within a range, from low to high. The user may listen to the loudness of the current alarm by pressing the “Test” button.
WARNING:
Do not decrease the adjustable alarm volume below ambient sound levels. Decreasing the alarm volume below ambient levels may compromise patient safety.
To change the Alarm Volume:
1. Press [Alarm Volume]. The Alarm Volume screen appears.
2. Press a number from 1-5 on the touch screen to select the desired volume.
3. Press and hold the “Test” key to listen to the alarm volume you have set.
4. When the volume is set to the desired level, press [Return to Previous Menu] or press [HOME] to exit.
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To permanently save this change, press the [View/Save Settings] touch key in the menu system, then press [Save Active].
Note:
A passkey is required to save settings. See 4.6.6 View/Save
Settings on page 87.
4.6.5. Display Modes
To access Display, press the [MENU] touch key and then the {Display} touch key.
Figure 17. BIS™ Display Modes for the 2-Channel System
Figure 18. BIS™ Display Modes for the Bilateral (4-channel)
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System
For the 2-channel system, starting with SW revision 3.50 and higher, the main display area of the BIS™ complete monitor can display either BIS™ trend graph, EEG, DSA, or DSA+ BIS. (For earlier devices, less options are available.) For the 4-channel system, the main display area can show BIS, EEG, or DSA. In the 4-channel system, the desired BIS™ side (right or left) and orientation (horizontal or vertical) can also be selected.
Select the desired display by pressing the Main display button until the desired display option appears in green. The Top display can show one of the display options not seen in the Main display. Select the desired Top display by pressing the Top display button until the desired display option appears in green. Select the desired DSA Layout (horizontal or vertical) and the desired BIS™ side (right or left) in the same manner.
Press [HOME] to exit.
The system defaults to the BIS Trend Data Screen display.
4.6.6. View/Save Settings
To access the View/Save Settings function, press [MENU].
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Figure 19. View/Save Settings
Whenever the monitor is started up from Standby mode, it reverts to user settings that have been set up and then saved using the [Save Active] touch key on the View/Save Settings screen. Settings are saved to the current Monitor Mode (I, II, III, or IV).
Operating settings may be changed for an individual use. However, to save settings, a passkey is required. Only qualified personnel (as determined by hospital administration) are authorized to save changes to system operating parameters. Passkey information is available in the
Service Manua l
To view or save the current configuration settings, press [View/Save Settings]. The current settings display on the screen. Settings that are active but have not been saved are displayed in yellow.
WARNING:
Check Target Range alarm limits to ensure they are appropriate for the patient being monitored with each use. Ensure Target Range alarm limits do not exceed the standard thresholds set by the institution.
.
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Save Active: Press this touch key to save the settings on display (the “Active” Settings) to the current Monitor Mode.
Enter the passkey using the numerical buttons provided, then press [OK].
Figure 20. Passkey Entry Screen
The message “Settings Saved” appears.
The settings displayed will be saved except as noted below:
The “Save Active” option is disabled when in Battery Backup­Low Power condition.
The following settings are not saved by the “Save Active” option: Impedance Checking (always returns to ON), Filters (returns to ON), and Display Type (returns to BIS™).
Settings are set and saved for the current Monitor Mode only. See 4.6.10
Monitor Mode on page 92.
Restore Saved: Press this touch key to return the current settings to the previously saved settings. This applies to the current Monitor Mode only.
Restore Default: Press this touch key to restore the factory default settings. This applies to the current Monitor Mode only. This restores the default values until the next time the monitor is re-started. To permanently restore the default settings for the selected monitor mode, press [Restore Default] and then press [Save Active].
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To restore the factory settings to all Monitor Modes, go to the Maintenance Menu and press [Restore Default Settings for All Modes].
To save settings for all monitor modes, each mode must be selected and saved separately.
Press [Previous] or [HOME] to exit.
4.6.7. Help
To access Help, press [MENU].
Figure 21. Help
The [Help] touch key allows the user access to information on use of the BIS™ complete monitoring system including: sensor placement, BIS guidelines, troubleshooting and system features. Press the [Help] key, then follow the on-screen instructions.
To access the Snapshot function, press [MENU].
This option is used during operation to mark a significant event on the trend screen display and to save the previous 10 minutes of data leading up to the event. Snapshot data is saved in memory until another snapshot is taken.
4.6.8. Snapshot
Figure 22. Snapshot
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To take a data Snapshot, press [MENU] and then[Snapshot]. The event is immediately marked with a snapshot marker (a camera icon) on the time scale of the BIS™ trend graph. If a snapshot is already in memory, the message “Warning: Snapshot in memory will be erased. Press ‘Save Snapshot’ button to save new snapshot” notifies the user. If the new snapshot is saved, the previous snapshot marker displayed on the time scale changes to a diamond, and the new snapshot marker displays as the camera icon.
Snapshot data may be sent to a removable drive. To export snapshot data, see 4.6.11 Export Data on page 95. For snapshot data in a printable (PDF) format, see 4.6.13 Print (Snapshot) on page 100.
4.6.9. Display Suppression Ratio (SR)
To access Display SR:
1. Press [MENU].
2. Press [Next]. Select [Display SR].
Figure 23. Display SR
The user may choose whether or not to display the Suppression Ratio (SR) on the main screen.
To change the setting, press [Display SR].
When the key shows a green box, the Suppression Ratio will display on the main screen.
When the key shows a red box with an ‘X’, the Suppression Ratio will not be displayed.
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To permanently save this change for the current Monitor Mode, press the [View/Save Settings] touch key in the menu system, then press [Save Active].
Note:
A passkey is required to save settings. See 4.6.6 View/Save
Settings on page 87.
4.6.10. Monitor Mode
To access Monitor Mode:
1. Press [MENU].
2. Press [Next]. Select [Monitor Mode].
The BIS™ complete monitor has four preset configurations (I, II, III, and IV) for use in different types of cases. Each mode has its own settings, which are set up during installation.
The default settings for each mode are shown in Table 10. Monitor Mode Settings, below.
WARNING:
Check Target Range alarm limits to ensure they are appropriate for the patient being monitored with each use. Ensure Target Range alarm limits do not exceed the standard thresholds set by the institution.
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Table 10. Monitor Mode Settings
Variable Default Value
I II III IV
Trend Time
1 1 1 1
Scale (hours)
Alarm
3 3 3 3
Volume
Target Range Inactive Inactive Inactive Inactive
Target
On On On On Alarms Audible
Target Range
Color Bar Color Bar Color Bar Color Bar Display Format
BIS™
15 30 10 15 Smoothing Rate
Display SR on
No Yes No No Main Screen
Secondary Variable
EMG EMG EMG EMG
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Variable Default Value
I II III IV
Maximum
1 1 1 4
3
Number of EEG Channels
Charting Interval
Sensor Check
15
minutes
15 minutes
15 minutes 15 minutes
Hide Hide Hide Hide Values
Settings may be changed for the current mode. When the settings are saved using the “View/Save Settings” function, they are saved for the current mode only.
Factory settings for the current mode may be restored using the “View/Save Settings” function. To restore factory settings for all modes, use “Restore Default Settings for All Modes” in the Maintenance Menu.
To change the monitor mode:
1. Press [MENU] to access menu options.
2. Press [Monitor Mode].
3. Press the desired Mode.
3
Only two channels display unless a BIS Bilateral Sensor and BISX4™ unit are in use.
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4. Press [Return to Previous Menu] or press [HOME] to exit.
To permanently restore the default settings, press [Restore Default] and then press [Save Active].
Note:
A passkey is required to save settings. See 4.6.6 View/Save
Settings on page 87.
4.6.11. Export Data
To access the Export Data function:
1. Press [MENU].
2. Press [Next].
Figure 24. Export Data
This selection allows the user to send data to a removable drive via the USB port (Type A) at the rear of the monitor, or to a device connected to the monitor’s serial port. For a list of acceptable USB drives, please contact Covidien. (Contact information is listed on the back cover of this manual.)
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The various types of data that may be exported are listed below.
Live Data: When this option is selected, live case data (BIS™ values, SQI, EMG and unfiltered EEG waveforms) are exported. Live data files are named using the format LMMDDHHMM, where ‘L’ stands for Live Data, MM is the two-digit month, DD the two-digit day, HH is the two-digit hour and MM the two­digit minute that the data were exported.
History Data: When this option is selected, case data stored in the BISX™ unit are exported. BIS™ values, SQI and EMG are reported at one-minute intervals. History data files are named using the format HMMDDHHMM, where the initial ‘H’ stands for History data, followed by the two-digit month, day, hour, and minute that the data were exported.
BISX™ Connection History: This option reports which BISX™ units were connected to the monitor. The BISX™ serial number and the date and time of each connect and disconnect are noted. Files are named using the format nx_bisxcDDMMYYYYHHMMSS_SNxxxxxxx.log, where ‘nx_bisxc’ stands for BISX™ connection, followed by the two­digit day and month, four-digit year, and two-digit hour, minute, and second that the data file was created and xxxxxxx is the monitor serial number.
Monitor Error Log: This option reports all system errors, including those related to the monitor, BISX™ unit, PIC or sensor. The monitor error log contains monitor critical events, as well as any monitor errors. Files are named using the format:
nx_error
DDMMYYYYHHMMSS
_SN
XXXXXXXX
.log
DDMMYYYYHHMMSS
where
is the time stamp (day, month,
year, hour, minute, second) reflecting the first error in the file.
XXXXXXXX
is the monitor serial number, which may be up to 8
alpha-numeric characters.
Examples of entries in the error log are:
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29 Mar 2015 14:58:23,[ 29 Mar 2015 14:58:18,[
NNNN
],Sensor Disconnected
NNNN
],Sensor Invalid
NNNN
where [
] is a unique error number.
The log is maintained when system power is cycled and/or lost, but time of power event is not necessarily captured. The last 5000 event entries are downloaded to a single file. Events are downloaded in reverse time order (latest event first).
Sensor Data: This option lists sensor information stored in the BISX™ unit. Files are named using the format SDMMDDHHMM where ‘SD’ indicates Sensor Data, followed by the two-digit month, day, hour and minute that the data were exported.
Snapshot: This option sends the most recent snapshot data. Files are named using the format SMMDDHHMM where ‘S’ stands for Snapshot, followed by the two-digit month, day, hour and minute that the data were exported.
History Raw Data (a new feature, available for SW revision 3.50 and higher): During monitoring, case data is continuously internally recorded in the background. The recorded data can be downloaded to an external USB storage device.
The History Data option presents processed BIS™ values (average BIS™ value and other parameters) every minute. A new option for download of raw history data (History Raw Data) is available; this provides the raw EEG data used to compile the BIS™ values, in a format similar to that provided during Live Data Export. This option is useful for detailed analysis and study.
To access these and other export options, navigate to and select [Menu]>[Next]>[Export Data]>[History Raw Data].select desired export option>[Begin Export].
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The monitor provides the following options for downloading History Raw Data:
o The entire data contents stored on the monitor
o Data from the last recorded 72 hours
o Data from the last recorded 24 hours
o Data from the last recorded 12 hours
History Raw Data is useful for researchers for analysis purposes.
Information on the data file format may be obtained by contacting Covidien. (See back cover for contact information.)
The BIS™ value is not processed during History Data or Sensor Data Exports. For all other exports, when a case is in process, the BIS™ number will continue to update and display during the export process.
In order to export data, the system must be powered ON and the BISX™ unit must be connected to the monitor. If the removable drive has a “write protect” switch, it must be set to the “unlock” position. Plug the removable drive into the USB-A port on the back of the monitor. To export data:
1. Press the [Export Data] touch key. The display shows the data
2. Press the desired data type, then press [Begin Export].
3. Export begins. If you press [Return to Home Menu] the export
4. During Export, the USB Export icon displays on the screen
types available for export.
process will continue to run in the background. The status of the export can be viewed at any time by selecting [Export] from the Menu system.
below the BIS™ number. (See
USB Export Icon
on page 71.)
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5. When the export status screen displays “100% complete,” the drive may be removed from the back of the monitor. To stop Live Export, press [Stop Export] before removing the drive.
To exit while the export is still running, press [HOME]. To stop the export, press [Stop Export].
Caution:
Do not remove drive while export is in progress.
4.6.12. BIS™ Smoothing Rate
To access the BIS™ Smoothing Rate:
1. Press [MENU].
2. Press [Next].
Figure 25. Smoothing Rate
The BIS™ complete system offers three choices of smoothing rates over which the BIS™ value is averaged:
10 seconds: Provides increased responsiveness to state changes, such as induction or awakening. This is the default setting for Monitor Mode III.
15 seconds: This is the default setting for Monitor Modes I and IV.
30 seconds: Provides a smoother trend with decreased variability and sensitivity to artifact. This is the default setting for Monitor Mode II.
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To change the Smoothing Rate, press the [BIS™ Smoothing Rate] touch key. The current Smoothing Rate displays in green letters. Press the key until the desired rate displays in green. Press [HOME] to exit.
To permanently save this change, press the [View/Save Settings] touch key in the menu system, then press [Save Active].
Note:
A passkey is required to save settings. See 4.6.6 View/Save
Settings on page 87.
4.6.13. Print (Snapshot)
Snapshot and Review data may be printed to PDF and saved using the BIS™ complete monitor. To print Review data, see 4.7 Reviewing and
Printing Stored Trend Data on page 109. To print Snapshot data, use the
Print menu selection. To access Print:
1. Press [MENU].
2. Press [Next].
This Print option allows the user to create a PDF file of the most recent Snapshot data or DSA data and send it to a removable drive on the USB­A port. The removable drive can then be used to transfer the data to a personal computer for viewing or printing.
To “Print” Snapshot (send a printable file to a removable drive):
1. Attach the removable drive to the USB-A port.
2. Press [MENU], then [Next] to get to the second menu.
Figure 26. Print Touch Key
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