BIS™ Advance Monitor Operator’s Manual DRAFT PN: PT00117631 Rev A 0123
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Introduction Table of Contents 1. Introduction 13 1.1. Introduction 13 Safety Symbol Definitions 13 Safety Information 13 1.2.1. General 13 1.2.2. Electrical Issues 15 1.2.3. Battery Cautions 16 1.2.4. Burn Hazards 18 1.2.5. EMC Issues 18 1.2.6. Alarms 19 1.2.7. Sensors 19 1.2.8. Cautions 20 1.2.9. Notes 21 1.3. Device Description 23 1.4. Intended Purpose 25 1.4.1. BIS™ Monitor 25 1.4.2. BISx and BISx4 Modules 25 1.4.3. BIS™ Sensors 25 1.4.4.
Introduction 2. The BIS™ Advance Monitor — Equipment and Supplies 40 2.1. The BIS™ Advance System 40 2.2. Parts of the System 43 2.2.1. BIS™ Monitor 43 2.2.2. Adapter Cable 48 2.2.3. Docking Station 51 2.2.4. BISx Module 54 2.2.5. BIS Sensors 56 2.2.6. The BIS™ Sensor Simulator 59 3. Installation and Preparation for Use 60 3.1. Operating Environment 60 3.2. Power Requirements and Battery Use 60 3.3. Battery Operation 60 3.3.1. Battery Pack General Information 60 3.
Introduction 3.9.3. EEG Display 98 3.9.4. DSA Display 100 3.9.5. ASYM Graph 102 3.10. Home Screen Numeric Section 104 3.10.1. BIS™ Number 106 3.10.2. EMG 107 3.10.3. SQI (Signal Quality Indicator) 108 3.10.4. Burst Count 109 3.10.5. SR (Suppression Ratio) 110 3.10.6. ST (Suppression Time) 111 3.10.7. SEF (Spectral Edge Frequency) 112 3.10.8. MF (Median Frequency) 113 3.10.9. Home Screen Indicators and Messages 114 Home Screen Menus 115 3.11.1.
Introduction 4.2.1. Case Storage 138 4.2.2. Case Review 139 Alarms and Messages 143 4.3. 4.3.1. Alarm and Message Types 143 4.3.2. Alarms 145 4.3.3. Messages 152 4.3.4. Alarm Display 162 4.3.5. Alarm Limits 166 4.3.6. Audio Alarms Pause and Silence 167 4.3.7. Changing Alarms Settings 168 4.4. Chart Data 173 4.5. Menu Map 176 4.6. Institutional Settings 180 5. Data Storage, Transfer, and Export 186 5.1. Cybersecurity and Data Integrity 186 5.2.
Introduction 6.1. Introduction 206 6.2. Servicing the BIS™ Advance Monitor 206 6.3. Battery Handling 206 6.4. Cleaning the BIS™ Advance Monitor 208 6.4.1. Cleaning the BIS™ Advance Monitor and BISx Module 208 6.4.2. Disinfecting the BIS™ Advance System 209 6.4.3. Cleaning the Monitor Display 210 Instrument Identification 210 6.5. 6.5.1. Permanent Identification Marking 210 6.5.2. Configuration Data on Monitor 210 7. Diagnostics and Troubleshooting 212 7.1.
Introduction 7.6.8. Sound Pressure Data 234 7.6.9. BIS Specifications 234 7.6.10. EEG Specifications 235 7.6.11. BISx Module Specifications 236 7.6.12. Software/GUI Specifications 237 7.7. Electromagnetic Compatibility Specifications 237 7.8. Product Compliance 249 7.9. BIS™ Advance Components, Accessories, and Documentation 251 7.10. Warranty 260 7.11.
Introduction List of Figures Figure 1. BIS Range Guidelines Figure 2. BIS™ Advance Monitor Components Figure 3. The BIS™ Monitor Figure 4. BIS Monitor Connectors Figure 5. BIS Tablet LEDs Figure 6. BIS™ Advance Adapter Cable Figure 7. Attaching the Adapter Cable to the Monitor Figure 8. Detaching the Adapter Cable from the Monitor Figure 9. BIS™ Advance Docking Station, Front View Figure 10. BIS™ Advance Docking Station, Back View Figure 11. BIS™ Advance Docking Station Connectors Figure 12.
Introduction Figure 36. BIS Numeric Figure 37. EMG Display on Home Screen Figure 38. SQI Indicator Figure 39. Burst Count Numeric Figure 40. SR Display on Home Screen Figure 41. ST Display on Home Screen Figure 42. SEF Display on Home Screen Figure 43. MF Numeric Figure 44. Main Menu Icon Figure 45. Main Menu on Home Screen Figure 46. Left Bar Menu Figure 47. Display Settings Selection Figure 48. Secondary Trend Selection Figure 49. Alarm Control Figure 50.
Introduction List of Tables Table 1. The BIS™ Advance Monitor Parameters 31 Table 2. Symbols that Appear on the Monitor and its Packaging 34 Table 3. BIS™ Advance Monitor Components 42 Table 4. Sensor/BISx/Use Case Matrix 78 Table 5. Home Screen Indicators 114 Table 6. Main Menu Selections 116 Table 7. Home Screen Left Menu Bar Icons 119 Table 8. Home Screen Display Settings Options 122 Table 9. Expanded Alarm Control Icons 127 Table 10. EEG Display Scale Options 132 Table 11.
Introduction Table 33. BIS™ Advance Monitor Components and Sensors Table 34.
1. Introduction 1.1. Introduction Carefully read this operator’s manual and the Directions for Use that accompany the BIS™ sensors in order to use the BIS™ Advance Monitor (henceforth referred to as the monitor) and the BIS™ BISx module or BIS™ BISx4 module (henceforth the term BISx will refer to both modules) correctly and safely. Use of the monitor requires full understanding and strict observance of these instructions, the precautionary information, and the specifications. 1.1.1.
Safety Information WARNING: Be sure the monitor is mounted securely in place to avoid personal or patient injury. WARNING: The BIS™ Advance monitor should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the monitor should be observed to verify normal operation in the configuration in which it will be used.
Safety Information 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. Caution: Do not autoclave the BISx module or monitor. Autoclaving will seriously damage both components.
Safety Information WARNING: Whenever an event such as spillage of blood or solutions occurs, retest ground leakage current before further use. WARNING: Power supply is internally fused. Replace power supply only with the power supply designated for this monitor, Medtronic PN PMB4000PWS. 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.
Safety Information WARNING: Do not place the battery near any heat source. WARNING: Do not try to disassemble or short circuit the battery. WARNING: Only the battery pack provided with this monitor should be used for the monitor. Use of another battery or a refurbished battery may cause damage to the monitor or endanger the user. Reference Table 34. BIS™ Advance Accessories on page 252 regarding the battery pack. WARNING: The BIS™ Advance monitor contains an internal lithium ion battery.
Safety Information 1.2.4. Burn Hazards WARNING: Due to elevated surface temperature, do not place the BISx module in prolonged direct contact with patient’s skin, as it may cause discomfort. WARNING: The conductive parts of electrodes or sensor and connectors should not contact other conductive parts, including earth.
Safety Information 1.2.6. Alarms 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. WARNING: If you plan to monitor the patient using alarms, do not set the Target Range alarm limits to extreme values that render the monitoring system ineffective. Ensure Target Range alarm limits are appropriate for each patient.
Safety Information WARNING: Use of the host system with sensor during electroconvulsive therapy (ECT) may result in a corrupted EEG signal. Caution: Dispose of the sensor in accordance with current medical standards and applicable national regulations for biologically hazardous waste. 1.2.8. Cautions Caution: Do not block inlet holes on the monitor as this may prevent ventilation constriction or affect the audio output of the monitor. Caution: Do not open the BISx unit for any reason.
Safety Information equipment may interfere with the proper function of the BIS™ Advance monitor. Check for compatibility of equipment during patient setup. Caution: The BIS™ Advance monitor complies with the electromagnetic compatibility requirements of IEC 60601-1-2. Operation of this device may affect or be affected by other equipment in the vicinity due to electromagnetic interference (EMI). If this occurs: • Increase separation between devices. • Re-orient device cabling.
Safety Information Note: Please select the date and time format in common use in your locality to enhance clarity for users of the monitor. Note: Medtronic recommends use of the 24-hour clock option in all clinical settings, to avoid situations in which the current time may be misunderstood by users. Note: The screenshots seen in this manual do not represent actual patient data and are provided for illustrative purposes only.
Device Description Note: Canada, avis d'Industry Canada (IC) Cet appareil est conforme avec Industrie Canada exemptes de licence RSS standard(s). Son fonctionnement est soumis aux deux conditions suivantes : (1) cet appareil ne doit pas causer d'interférence et (2) cet appareil doit accepter toute interférence, notamment les interférences qui peuvent affecter son fonctionnement.
Device Description patient's level of hypnosis. The device is for use by medical personnel only. The monitor and the BISx unit are designed for use for multiple patients, multiple uses.
BIS™ Advance Monitor System Indications and Contraindications For both the 2-channel and the 4-channel systems, BIS™ monitoring is implemented as follows: A sensor placed on the patient’s head transmits EEG signals to the BISx module. The BISx module filters the data, analyzes it for artifacts and processes it using digital signal processing techniques, then sends the data to the monitor for display.
Intended Users The BIS™ Advance 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.
Essential Performance For more information and technical support, contact BISTechnicalsupport@medtronic.com. 1.8. Essential Performance The essential performance of the monitor is the display of the BIS™ index and EEG in order to monitor a patient's level of consciousness. In addition, the monitor meets the essential performance requirements per IEC 80601-2-26:2019, as listed below. Requirement Subclause Results Accuracy of signal reproduction 201.12.1.
Essential Performance Frequency response 201.12.1.105 The output at 0.5 Hz and 50 Hz is within 71 % to 110 % of the output obtained with a 5 Hz sine wave input signal: 4-channel: 101.7% at 0.5 Hz; 95.8% at 50 Hz 2-channel: 104.8% at 0.5 Hz; 90.4% at 50 Hz Common mode rejection 201.12.1.106 4-channel: max output signal is 39 µv pv (peak to valley) 2-channel: max output signal is 47 µv pv (peak to valley) 1.8.1.
The BIS™ Advance Parameters • Disconnecting the Monitor Interface Cable of the BISx module from the BIS™ Advance monitor and then immediately reconnecting back to the BIS™ Advance monitor 1.9. Adverse Events (Residual Risks) Any serious incident that occurs in relation to the device or its accessories should be reported to Medtronic and to the national competent authority. Covidien is a Medtronic company. 1.10.
The BIS™ Advance Parameters Figure 1. BIS Range Guidelines This chart reflects a general association between clinical state and BIS™ values. Ranges are based on results from a multi-center study of the BIS™ monitor involving the administration of specific anesthetic agents. BIS™ values and ranges assume that the EEG is free of artifacts that can affect its performance. Titration of anesthetics to BIS™ range should be dependent upon the individual goals established for each patient.
The BIS™ Advance Parameters Table 1. The BIS™ Advance Monitor Parameters Processed Parameter Description Bispectral Index (BIS™ number) The BIS™ number is a processed EEG value representing the depth of sedation. It is a continuously processed EEG parameter that correlates to the patient's level of hypnosis, where 100 = awake and 0 = flat line EEG. BIS™ was designed to correlate with "hypnotic" clinical endpoints and to track changes in the effects of anesthetics of the brain.
The BIS™ Advance Parameters smoothing rate provides a smoother trend with decreased variability and sensitivity to artifact. EEG (Electroencephalogram) A visual representation of the rhythmic fluctuations of electric potential between parts of the brain (brain waves). EEG (Electroencephalogram) Amplitude The maximum absolute voltage of the waveform. The EEG waveform amplitude is typically conveyed in microvolts (µV).
The BIS™ Advance Parameters factors such as general anesthesia, coma, or hypothermia. Burst count is activated by connection of an Extend Sensor or Bilateral Sensor. Thus, the burst count parameter will appear on the screen only when an Extend and Bilateral sensor is used. SR (Suppression Ratio) The percentage of time during the last 63 seconds in a state of isoelectric EEG. For example, SR=10% represents 6.3 seconds of the last 63 seconds.
Symbols ASYM (Asymmetry) The difference in EEG power between the left and right hemispheres of the brain over time. ASYM is displayed as a value between 20% and 100%. It represents the ratio of EEG power present in one hemisphere to the total EEG power (total power = left power + right power). ASYM is displayed only during four-channel monitoring. 1.11. Symbols The following symbols appear on the body of the monitor and on its packaging (including labels). Table 2.
Symbols Packaging Caution, consult accompanying documents for warnings and precautions Follow Instructions for Use (in blue on device) Packaging Packaging MR Unsafe Atmospheric pressure limit for storage and transport for monitor and docking station; values for BISx unit seen in 7.6.
Symbols Packaging Fragile China ROHS CB symbol (for BISx unit only) Packaging China RoHS symbol (indicating no hazardous substances above restriction limits) Packaging China RoHS symbol (indicating Environment Friendly Use Period of 50 years) Packaging Packaging Directive on waste from electrical and electronic equipment UL recognized component certification symbol for Canada and the USA (on BISx unit and adapter cable) Packaging Defibrillation-proof type BF applied part (on BISx unit) 36 Packa
Symbols Caution, hot surface (on BISx unit) Latex free (on BISx unit only) Packaging Packaging Packaging Medical Device UL registration mark. Complies with 21CFR 1040.10 and 10410.11 except for deviation pursuant to Laser Notice No.50, dated June 24 2007. Packaging MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 6061-1 (2005) + AMD (2012) and CAN/CSAC22.2 No.
Symbols Packaging CE mark Authorized representative in the European Community Packaging Catalog number Packaging Manufacturer Packaging Packaging Importer Serial number Packaging Date of manufacture Packaging Device Battery charging icon Device USB port indicator on docking station and monitor Device Network port indicator on docking station On/Off button and On/Off indicator 38 Device BIS™ Advance Monitor
Symbols Battery compartment cover locked Device Battery compartment cover unlocked Device Home button Function button Earphones/microphone port indicator on monitor BIS™ Advance Monitor Device Device Device Reset button on monitor (Not for user/operator use) Device HDMI port indicator on monitor (Not for user/operator use) Device DC power port indicator on monitor Device RS-232 port indicator on docking station Device VGA port indicator on docking station Device 39
2. The BIS™ Advance Monitor — Equipment and Supplies 2.1. The BIS™ Advance System All of the items listed below are required in order to operate the BIS™ system: BIS™ monitor: The monitor processes collected data and provides an interface for the user, in which results are displayed, settings are inputted, and data is recorded for download. The monitor is supplied with a removable battery. Docking station: The docking station provides power and communication for the monitor.
The BIS™ Advance System Patient Interface Cable (PIC): Connects between the BISx module and the sensor. The patient interface cable is an integral part of the BISx module. BIS™ sensor: The appropriate BIS™ sensor is used to connect the system to the patient and acquire patient data for analysis. Figure 2.
The BIS™ Advance System Number Component 1 Monitor 2 Docking station 3 Adapter cable 4 GCX mounting accessory (the selected accessory will depend on the use case) 5 MIC 6 Sensor 7 PIC 8 BISx module/BISx4 module For a list of these parts and their part numbers, reference Table 3. BIS™ Advance Monitor Components, below. A list of sensors for use with the BIS™ Advance monitor appears in Table 34. BIS™ Advance Accessories on page 252. Table 3.
Parts of the System Product Name Legacy Product Name Description or Application Part Number of BIS Advance Product BIS™ Advance Adaptor cable NA Adapter cable used to connect monitor to BISx module PMB4000ACBL BISx module LoC 2 Channel Processes 2 channels of EEG information (one brain hemisphere) to work with BIS™ Advance Monitor. The MIC (monitor interface cable) and PIC (patient interface cable) are integral to this module.
Parts of the System It includes three hard keys, three LEDs, a brightness sensor, a touch screen for display and interface, a camera (which is disabled), and a series of connectors as described below. The BIS™ monitor does not have wireless functionality. Figure 3. The BIS™ Monitor 1 2 3 4 5 6 7 8 Number Item Description 1 Camera The camera is disabled and is not used for BIS™ monitor functionality.
Parts of the System Number Item Description monitor’s right edge, not seen) earphones, USB, mini USB, reset button, HDMI. Only the USB port is intended for end-user use. 5 Docking station connector (on monitor’s bottom edge, not seen) Used to connect the monitor to the docking station in order to provide power and connectivity to the monitor via the docking station.
Parts of the System Figure 4.
Parts of the System Figure 5. BIS Tablet LEDs 2 1 3 4 Number LED Description Functioning 1 Brightness Brightness sensor Detects ambient brightness 2 Wireless reception Green LED Wireless reception detected; as the BIS™ Advance monitor does not have wireless functionality, this will always be off. 3 Charging Yellow/green LED Will appear yellow when the monitor is attached to mains power and the tablet battery pack is charging, will appear green when battery pack is fully charged.
Parts of the System The monitor can be viewed from any viewing angle up to 140 degrees from either side and up to 120 degrees from above or below the tablet. The BIS value is visible at up to 4 meters from the monitor, the EMG data at up to one meter, and graphs and status data at up to 45 cm from the monitor. 2.2.2. Adapter Cable The adapter cable is seen in Figure 6. BIS™ Advance Adapter Cable, below. Figure 6.
Parts of the System Place the adapter cable in place at the back of the monitor, lining up the arrow on the cable port and the red dot on the adapter cable. Push the cable into the port. Reference Figure 7. Attaching the Adapter Cable to the Monitor on page 49. Once this connection is made, the adapter cable can stay connected to the monitor, whether the monitor remains on or is turned off between uses.
Parts of the System 3 Adapter cable connector to monitor 4 Adapter cable marking (appears on metal part of adapter cable) Figure 8.
Parts of the System 2.2.3. Docking Station A docking station is provided in order to permit the mounting of the monitor on a variety of surfaces, as required by user preference. For a list of operating configurations, reference 7.6.2 Operating Environments on page 229. The docking station is provided with the monitor and is also sold separately. It uses the power supply and power cord supplied with the monitor. WARNING: Use only the power cord and power supply supplied by the manufacturer.
Parts of the System Figure 9.
Parts of the System Figure 10.
Parts of the System Figure 11. BIS™ Advance Docking Station Connectors 2 1 3 4 5 Number Feature Description 1 Power For connecting docking station to AC power 2 USB For data download only 3 RS-232 (serial) port For connection to monitoring systems, including hospital data systems. Only approved medical devices may be connected. 4 VGA For connection to display data on an additional screen 5 Network For development, production and service use only 2.2.4.
Parts of the System The BISx module 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. Its integral Monitor Interface Cable (MIC) connects to the interface cable which should be attached to the monitor. Its integral Patient Interface Cable (PIC) connects the BIS™ sensor to the BISx module.
Parts of the System Number Feature Description 3 BISx module Unit which collects, processes and stores data as part of the functionality of the BIS™ Advance monitoring system. 4 PIC cable Connects between the BISx module and the patient sensor 5 Sensor connector This end of the PIC cable connects to the sensor. Note the button on the connector; when connected, press this button to release the sensor.
Parts of the System defibrillation to be ineffective. In emergency use when defibrillation is required to save a patient's life, ineffective defibrillation may result in death. WARNING: The sensor is not intended to collect EEG, ECG, or other electrophysiological signals for interpretation; the signals collected are intended for use solely for calculating the BIS™ parameter. WARNING: Use of the host system with sensor during electroconvulsive therapy (ECT) may result in a corrupted EEG signal.
Parts of the System Figure 13.
Parts of the System 2.2.6. The BIS™ Sensor Simulator In addition to patient sensors, the BIS™ Sensor Simulator is also available. It is a service tool that allows for the verification of proper impedance values being detected by the BIS™ Advance monitor during the sensor check. This sensor is used for testing purposes only. If the sensor does not pass the sensor check process, check the following: 1.
3. Installation and Preparation for Use 3.1. Operating Environment The system is designed for use in operating rooms and in transit following procedures. For more details regarding specific operating environments and the recommended mounting options, reference 7.6.2 Operating Environments on page 229. 3.2. Power Requirements and Battery Use The BIS™ Advance monitor should always be operated with a battery installed, to permit for continued use following interruption of supply mains.
Battery Operation WARNING: Charge the monitor fully before your first use of the monitor, by attaching the monitor to AC power with the battery installed. See 3.3 Battery Operation on page 60 for more information. WARNING: The monitor should always be operated with the battery installed in order to provide back-up power in the event of a momentary or temporary power outage. WARNING: Improper operation may cause damage to the battery or endanger the user.
Battery Operation 2. To remove or switch the battery pack (#2 in Figure 14, below) , open the battery pack compartment of the monitor as follows: 3. Pushing the lower lock lever at the back of the tablet (#5 in Figure 14, below) towards the lower edge of the tablet. Note that this lock lever is indicated by locked and unlocked symbols above the lever. The lower lock will remain in the open position until moved again to the center of the tablet to close the lock. 4.
Battery Operation Label Function Description 1 Connector pins area Battery connector pins are located under this panel 2 Battery pack Removable battery pack 3 Upper Battery pack lock This lock must be held in the open position while removing the battery. 4 Tab to open battery pack Pull this tab out to remove the battery pack 5 Lower Battery pack lock Slide this lock to the open position; it will remain in the open position until moved again to the center of the tablet to close the lock.
Mounting the Docking Station Therefore, ensure that a battery is always installed in the device, to ensure that the monitor maintains power and can continue to function when disconnected from an AC power source. A low priority battery alarm (BATTERY LOW) will be triggered when the battery reaches a level below 30% state of charge (state of charge is current capacity/maximum capacity) and the battery is not charging (that is, if the monitor is not connected with a cable to AC power or charging is faulty).
Mounting the Docking Station GCX desktop mount) before or after you place the monitor in the docking station. 2. GCX clamp mount or GCX desktop mount with required screws (screws are packaged with the mount) 3. If desired, IV pole, anesthesia mount, or other hardware for mounting medical devices for use To set up the monitor with the GCX clamp mount: 1. Place the docking station on a stable surface. 2.
Mounting the Docking Station Figure 15. Setup with GCX Clamp Mount 1 2 3 Label Description 1 Docking station 2 Screw holes for attaching clamp mount to docking station 3 Clamp mount To set up the monitor with the GCX desktop mount: 1. Stand the GCX desktop mount on a stable surface. 2. Prepare the docking station. If your docking station has four round black supports attached to its back (to the four screw holes seen in Figure 16.
Mounting the Docking Station them aside in case you need them in the future for other mounting solutions. 3. Locate the four screws supplied with the desktop mount. Using a standard screwdriver, attach the GCX desktop mount to the back of the docking station using these four screws, by inserting the screws through the four holes or indentations in the desktop mount and into the four screwholes on the back of the docking station (from which the four supports were removed). Reference Figure 16.
Preparing the Docking Station 3.5. Preparing the Docking Station Follow the instructions below to place the monitor in the docking station: 1. Place the monitor in the docking station so that the connectors on the monitor’s bottom edge fit into the connectors in the groove at the inside of the bottom of the docking station (#3 in Figure 17). Reference Figure 17. Docking Station Installation Step 1 on page 68. Figure 17.
Preparing the Docking Station 3 Connector pins in docking station groove 4 Docking station groove to hold monitor 2. Push the top edge of the monitor inwards to fit it into the docking station. Reference Figure 18. Docking Station Installation Step 2 on page 69. Figure 18. Docking Station Installation Step 2 1 2 3 Number Description 1 Top edge clasp 2 Monitor 3 Docking station 3. The top edge clasp will now click into place and hold the monitor in place inside the docking station.
Preparing the Docking Station 4. If required, use the four supports connected to the back of the docking station to attach the docking station to the required mounting solution. For more information, reference 3.4 Mounting the Docking Station on page 64. 5. Attach the power supply connector to the power port on the docking station and to mains AC power. Attach your selected communications cable to provide communication with the docking station.
Preparing the Monitor Figure 19. Docking Station Removal 1 2 3 Number Description 1 Top edge clasp 2 Monitor 3 Docking station 3.6. Preparing the Monitor Follow the steps described below to prepare the monitor for use. 3.6.1. Connecting the Monitor Ensure that you have all of the required components, as described in 2.1 The BIS™ Advance System on page 40.
Preparing the Monitor The adapter cable should already be connected to the monitor, as described in 2.2.2 Adapter Cable on page 48. If you want to mount the docking station, do so now. Follow the instructions in 3.4 Mounting the Docking Station on page 64. Connect the docking station and the monitor as described in 3.5 Preparing the Docking Station on page 68.
Preparing the Monitor Figure 20. Attaching the BISx Module to the BIS Advance Monitor 1 2 3 4 5 Label Description 1 Monitor 2 Adapter cable 3 MIC push button (used to disconnect MIC and adapter cable) 4 MIC (monitor interface cable, an integral part of the BISx module) 5 BISx module If the BIS™ Advance initialization is completed before the BISx or BISx4 module is connected, an on-screen message will indicate Connect BISx to start monitoring.
Preparing the Monitor If the BISx or BISx4 module is connected but no sensor is connected, an on-screen message will indicate Connect sensor to start monitoring. Ensure that you are using a BISx module or a BISx4 module with a Quatro, Extend or Pediatric sensor to conduct two-channel monitoring, or a BISx4 module with a Bilateral sensor to conduct four-channel monitoring. Connect the appropriate sensor (reference Figure 21.
Preparing the Monitor Figure 22. Disconnecting the sensor from the BISx module 1 2 Label Description 1 PIC (patient interface cable, connected to BISx module) connector 2 Sensor connector To begin monitoring, connect the sensor to the patient; reference 3.6.2 Connecting a Sensor to a Patient, below.
Preparing the Monitor The automatic sensor check is described in 3.6.3 Sensor Check on page 82. The BIS Advance monitor setup should now appear as seen in Figure 23. BIS Advance Monitor Setup and Figure 24. BIS Advance Monitor Setup - Back, both below. Figure 23.
Preparing the Monitor Label Description 6 PIC (patient interface cable, attached to BISx module) 7 BIS™ sensor Figure 24.
Preparing the Monitor Number Description 1 Sensor 2 PIC 3 BISx module 4 MIC 5 Adapter cable 6 Monitor 7 Docking station 8 GCX mounting accessory (the selected accessory will depend on the use case) 3.6.2. Connecting a Sensor to a Patient Select the appropriate sensor. A list of sensors appears in Table 34. BIS™ Advance Accessories on page 252. It is important to use the correct sensor for your current patient and monitoring situation, as follows: Table 4.
Preparing the Monitor Before applying the sensor to the patient, view the sensor application animation video. To open the video, click Sensor Application Guide on the Connect sensor to begin monitoring screen. Apply the sensor to the patient as described in the video. Please note that this video, the instructions, and the sketch below describe applying the sensor to the left side of the patient’s head; the sensor may also be applied to the right side of the patient’s head.
Preparing the Monitor 6. Sketches displaying sensor placement for both two-channel monitoring and four-channel monitoring appear below. Figure 25.
Preparing the Monitor Figure 26.
Preparing the Monitor 3.6.3. Sensor Check Ensure that the BISx or BISx4 module is connected to the monitor, as described in 3.6.1 Connecting the Monitor on page 71. Attach the selected sensor to the BISx or BISx4 module. Please note that the sensors are consumable products with a defined lifetime and expiry date.
Preparing the Monitor The system will display the sensor check test result for each electrode as follows: Value color in sensor check screen Description PASS Green An electrode PASSES the sensor check if the impedance for that electrode is less than 7.5 kiloohms. The ground electrode (electrode 2 for a two-channel sensor and electrode G for a fourchannel sensor) must be less than 30 kiloohms to pass. HIGH Red An electrode is labeled HIGH if its impedance value is above 7.
Preparing the Monitor patient’s skin may help the electrode pass the sensor check. The sensor check will determine if the sensor will pass the sensor check based on the impedance of the electrodes and the ground electrode. If the sensor passes the sensor check, monitoring will begin automatically. If the sensor fails, monitoring will not begin. If the sensor does not pass the sensor check process, check the functionality of the PIC cable by running a sensor check using a Sensor Simulator.
Preparing the Monitor Figure 27. Sensor Check Window: In progress and Completed Manual Sensor Check The user can start a sensor check manually when a sensor is already connected to the monitor, if desired, perhaps because the user is actively monitoring a patient, but no BIS™ value is displayed, or if the clinician suspects that the BIS™ value does not align with the clinical assessment of the patient.
Preparing the Monitor Ground Check and Combined Sensor Check The monitor automatically performs a ground check every ten minutes during monitoring, to ensure that the sensor is positioned correctly on the patient. During the ground check (duration approximately 5 seconds), EEG values will not be collected, but the BIS™ value will continue to be displayed.
Preparing the Monitor 3.6.5. Start Procedure To start the monitor, press and hold the ON/OFF button at the lower right side of the monitor for up to 3 seconds. The system will indicate that it is initializing. If no BISx module is connected to the monitor, the monitor will indicate Connect BISx to start monitoring. In this case, the operator can enter Demo mode or review recorded case data in Case Review mode. Monitoring cannot take place without a BISx module.
Home Screen Click Shutdown to shut down the monitor. If you press the ON/OFF button for 4 seconds, the monitor will shut down without requiring a response in the dialog box. 3.7. Home Screen The BIS™ standard graphical home screen includes four main screen sections, as follows: 1. Trend Section: The screen may display one trend that covers most of the screen, or display two or three trends on the screen at the same time.
Home Screen is more than one message, they will appear in succession, and a message count will appear at the right side of the message bar. To view the next message more quickly, click the NEXT button on the right side of the message bar. For a list of messages that may appear in this section of the screen, reference Table 13. Information Messages on page 153.
Home Screen 11 10 9 8 7 6 Figure 29.
Home Screen Label Function Description 1 Left menu bar Reference 3.11.2 Left Bar Menu on page 118 2 BIS™ graph Reference 3.9.1 BIS Trend Graph on page 96 3 Audio alarm indicators area Reference 3.14 Home Screen Audio Alarm Settings on page 126 4 Case ID information Reference 4.2 Cases on page 138 5 Indicators area Reference 3.10.9 Home Screen Indicators and Messages on page 114 6 EMG numeric Reference 3.10.2 EMG on page 107 7 SQI indicator Reference 3.10.
Four-Channel Monitoring Label Function Description using an Extend sensor or monitoring with four-channel monitoring) 3.8. Four-Channel Monitoring The monitor provides the option of monitoring both hemispheres of the brain, using a Bilateral sensor. This is known as four-channel or bilateral monitoring. The option may provide useful information to the clinician.
Four-Channel Monitoring The BIS graph will display the left hemisphere by default; if the right hemisphere is selected with the L/R button, it will display the right hemisphere. If selected, the ASYM graph will display the left side at the top of the graph and the right side at the bottom of the graph. The EEG graph will display the left side at the top of the graph and the right side at the bottom of the graph. The upper numeric panel (BIS, EMG, SR and ST) will display data from the left hemisphere.
Four-Channel Monitoring 9 8 7 1 12 2 11 10 3 4 5 6 Figure 30.
Four-Channel Monitoring Label Function Description 1 Left menu bar Reference 3.11.2 Left Bar Menu on page 118. Note the L/R icon at the top of the menu bar, just under the Main Menu icon. 2 BIS™ graph Reference 3.9.1 BIS Trend Graph on page 96 3 Audio alarm indicators area Reference 3.14 Home Screen Audio Alarm Settings on page 126 4 Case ID information Reference 4.2 Cases on page 138 5 Indicators area Reference 3.10.
Home Screen Trend Graphs 3.9. Home Screen Trend Graphs 3.9.1. BIS Trend Graph The BIS trend graph is provided as a default graph on the monitor main screen, both in the 2-channel and 4-channel systems. This graph enables the user to view changes in the BIS value for the patient over time, which is useful in patient monitoring. This information provides added value for the caregiver, beyond the BIS number that appears on right side of the screen. Figure 31.
Home Screen Trend Graphs Label Function Description 4 Secondary variable drop-down arrow Selection drop-down arrow to select secondary variable to appear on BIS graph (will open the same window as the Display Settings>BIS graphs> Secondary section opens); see description below 5 Secondary variable scale Right side vertical Y axis indicating the scale of the secondary variable, in this case EMG in orange 6 Display time scale selection Indication of time scale in current use and drop-down arrow fo
Home Screen Trend Graphs • EMG • Suppression ratio (SR) • Signal quality (SQI) • Burst count (for bilateral and Extend sensors only) (BURST) • BIS number of the non-selected hemisphere (for 4-channel mode only) The user can also choose NONE for the secondary variable; in this case, no secondary variable will be shown on the BIS™ trend graph, and no secondary variable scale will be seen on the right Y axis of the graph. Reference Figure 48. Secondary Trend Selection on page 126.
Home Screen Trend Graphs On the home screen, the user can select one of the following EEG scales: 2, 5, and 10 [µV/mm]. When a 2 µV/mm scale is used, only one EEG channel is seen on the graph; with other scales, 2 channels are seen. Not all scales are available in all screen layouts.
Home Screen Trend Graphs Label Function Description 4 Y axis Y axis showing the EEG amplitude 5 EEG trend line/s One EEG trend line is seen if scale is 2µV/mm; with other scales, one graph will be displayed for each channel 3.9.4. DSA Display To display DSA on the home screen, select a display option that includes DSA as described in 3.12 Home Screen Options on page 121.
Home Screen Trend Graphs Figure 33. DSA Trend Display 1 2 3 7 4 5 6 7 8 Label Function Description 1 Y vertical axis frequency The vertical axis indicates the frequency of the EEG signal in Hz. 2 Power legend Legend explaining the colors demonstrating the level of power; blue indicates lower power and red lighter power. 3 Spectral Edge Frequency (SEF) The white line on the graph indicates the SEF, the line under which 95% of the EEG power lies.
Home Screen Trend Graphs Label Function Description The EEG display is not affected by a time scale change. 5 Case start indicator The small grey triangle on the horizontal axis time line indicates the case start, if the case start occurred during the period seen on the screen 6 Median Frequency (MF) The purple line on the graph indicates the MF, the line under which 50% of the EEG power lies.
Home Screen Trend Graphs ASYM is displayed only for four-channel monitoring. Two examples are show in Figure 34. ASYM Graph on page 103: • A value of 60 LEFT for ASYM at a certain point in time would mean that the EEG power in the left hemisphere is 60% higher than it is in the right hemisphere at that point in time.
Home Screen Numeric Section 3 Time scale drop-down menu Use the small arrow next to the time scale indicator to change the time scale of the graph. Options are 1 hours, 6 hours, 12 hours, and 24 hours. When the time scale is changed, this affects all graphs on the screen (for example, BIS, DSA and ASYM). The EEG display is not affected by a time scale change.
Home Screen Numeric Section The home screen numeric section, seen in Figure 35. Home Screen Numeric Section, below, displays the parameters listed in this section. Figure 35.
Home Screen Numeric Section Label Function Description 1 SQI data Reference 3.10.3 SQI (Signal Quality Indicator) on page 108 2 EMG data Reference 3.10.2 EMG on page 107 3 BIS data Reference 3.10.1 BIS™ Number on page 106 4 SR data Reference 3.10.5 SR (Suppression Ratio) on page 110 5 ST data Reference 3.10.6 ST (Suppression Time) on page 111 6 SEF data Reference 3.10.7 SEF on page 112 7 MF data Reference 3.10.
Home Screen Numeric Section If measuring with a 4-channel system, the BIS display will appear for each hemisphere. Figure 36. BIS Numeric 22 1 3 Label Function Description 1 BIS disabled icon If range alarm is disabled, the Alarm Disabled icon will be displayed 2 BIS range Current BIS range; this will be displayed only if BIS range alarm has been enabled 3 BIS numeric Current BIS value of patient 3.10.2.
Home Screen Numeric Section Figure 37. EMG Display on Home Screen 2 3 1 Label Function Description 1 EMG numeric EMG numeric 2 EMG bar Displays EMG in graphic format 3 EMG units Units in which EMG is measured If measuring with a 4-channel system, the EEG display, including both the numeric and the bar, will appear for each hemisphere. 3.10.3.
Home Screen Numeric Section Figure 38. SQI Indicator A high SQI will be indicated by five complete green bars, as seen in the figure above. Lower values will be indicated by fewer green bars, two orange bars (denoting excessive artifacts in the EEG signal), or one red bar only (denoting a very low SQI value). If measuring with a 4-channel system, the SQI display will appear for each hemisphere. 3.10.4.
Home Screen Numeric Section Label Function Description 1 Burst Count numeric Burst Count numeric 2 Burst units Units in which Burst Count is displayed 3.10.5. SR (Suppression Ratio) SR is displayed as a numeric in percent units, and, if selected as a secondary trend on the BIS trend graph, also as a solid purple line on the BIS trend graph (0-100%).
Home Screen Numeric Section Label Function Description 1 SR alarm disabled indicator When the SR alarm is disabled, the alarm disabled icon will be displayed 2 SR alarm level When the SR alarm is enabled, its level will be displayed 3 SR numeric SR numeric 4 SR units Units for SR (percent) 3.10.6. ST (Suppression Time) ST is displayed as a time value in units of seconds and minutes (or sec, min, hr if ST time exceeds 59 minutes and 59 seconds).
Home Screen Numeric Section Label Function Description 1 ST numeric ST numeric in minutes and seconds (and hours, if required) 2 ST unit markers If ST is over 59 minutes and 59 seconds, an hour section will appear as well 3.10.7. SEF (Spectral Edge Frequency) SEF, the Spectral Edge Frequency (indicated in Hz) , is displayed as a numeric in the numeric section and as a white line on the DSA graph.
Home Screen Numeric Section Label Function Description 1 Alarm disabled icon Since no alarm is set, an alarm disabled icon will appear 2 SEF alarm range Alarm range will display when an alarm is set 3 SEF numeric SEF numeric in Hz 4 SEF units SEF unit is Hz 3.10.8. MF (Median Frequency) MF (Median Frequency) (indicated in Hz) represents the frequency below which 50% of the total EEG power lies. It is displayed as a purple line on the DSA graph.
Home Screen Numeric Section Label Function Description 1 MF numeric MF numeric in Hz 2 MF units MF unit is Hz 3.10.9. Home Screen Indicators and Messages The monitor provides a number of power and connectivity indicators on the top bar of the home screen, as described in Table 5. Home Screen Indicators, below. At the bottom of the home screen, monitor messages are displayed.
Home Screen Menus Power cable is connected Current battery capacity Battery is charging Battery is installed, but not charging; charge is over 50% Battery is installed, but not charging; charge is 25% to 50% Battery is installed, but not charging; charge is under 25% The monitor is currently recording a live case Icons on message bar at the bottom of the screen Message active (in this case, 2 messages are active) 3.11. Home Screen Menus 3.11.1.
Home Screen Menus Figure 44. Main Menu Icon The main menu will open a drop-down menu, with options as described in Table 6. Main Menu Selections, below. Using the touch screen, select the desired sub-menu. Table 6. Main Menu Selections Menu Button Description ALARMS Set alarm settings, including alarm enabling and disabling, alarm limits, alarm volume, and audio off reminder. For a description of alarms options, reference 4.3.7 Changing Alarms Settings on page 168.
Home Screen Menus Figure 45. Main Menu on Home Screen If no sensor is connected to the BISx module connected to the monitor, or if no BISx module is connected, all of these options are available. In monitoring mode, that is, when a BISx module and a sensor are attached to the system, the Alarms and Case Review sub-menus are disabled. In Demo Mode, the Download and Case Review sub-menus are disabled.
Home Screen Menus 3.11.2. Left Bar Menu The left menu bar provides quick access to some important features directly from the home screen. It includes the options listed in Table 7. Home Screen Left Menu Bar Icons, below: Figure 46.
Home Screen Menus Table 7. Home Screen Left Menu Bar Icons Label Function Description 1 Main Menu button Opens the main menu, described in 3.11.1 Main Menu Settings on page 115 2 Trend view toggle button Toggles the screen view from graph view to a data chart view 3 ALARMS Opens the Alarm setting window; for more information, reference 4.3.7 Changing Alarms Settings on page 168. 4 SNAPSHOT Enables recording of a Snapshot; for more information, reference 5.7 Recording a Snapshot on page 195.
Home Screen Menus Parameter Indicator Meaning BIS target range BIS target range seen in numeric section. Message shown when alarm range exceeded. BIS target range alarm is enabled; target range is as shown; target range stripe seen on BIS graph; message indicates that the alarm has been triggered SR parameter Alarm limit seen in numeric section. Message shown when alarm range exceeded.
Home Screen Options Parameter Indicator Meaning SEF Alarm Disabled icon seen in numeric section SEF alarm is disabled 3.12. Home Screen Options By default, the home screen will appear as seen in Figure 29. Sample 2-channel BIS™ Screen on page 90 or as seen in Figure 30. Sample 4-channel BIS™ Screen on page 94, depending on the selected type of monitoring (two-channel or four-channel).
Home Screen Options Table 8.
Home Screen Options Symbol Display Icon Description DSA, EEG The DSA and EEG trends occupy the graph/trend area, with each occupying half of the area DSA only The DSA trend occupies the whole graph/trend area EEG only The EEG trend occupies the whole graph/trend area; sometimes referred to as full screen EEG layout Layouts for 4-channel mode: BIS, EEG BIS™ Advance Monitor The BIS and EEG trends occupy the graph/trend area, with each occupying half of the area.
Home Screen Options Symbol Display Icon Description BIS only The BIS trend occupies the whole graph/trend area. The BIS L (left) trend will be shown by default; this can be changed to show the BIS R (right) trend. BIS, ASYM, EEG The BIS, ASYM and EEG trends occupy the graph/trend area, with each occupying a third of the area. The BIS and EEG L (left) trends will be shown by default; this can be changed to show the R (right) trends.
Secondary Trend Selection Symbol Display Icon Description EEG only The EEG trend occupies the whole graph/trend area. Both EEG L (left) and EEG R (right) trends are shown. DSA,ASYM Two DSA graphs, one for each hemisphere, and the ASYM trend occupies the graph/trend area, with each occupying approximately one third of the area 3.13.
Home Screen Audio Alarm Settings Figure 48. Secondary Trend Selection The options for the secondary trend on the BIS trend graph are None, SR, EMG, SQI or Burst Count (the latter only when using an Extend Sensor). For four-channel monitoring, the BIS value for the hemisphere not shown on the graph (R or L) or Burst Count can also be selected as a secondary trend.
Home Screen Audio Alarm Settings Figure 49. Alarm Control To open the expanded alarm control window, click the drop-down arrow on the right side of the window in Figure 49. Alarm Control, above. The options seen in Figure 50. Expanded Alarm Control with Alarm Volume, below, will appear. Select your desired option and click to activate. With both methods of setting alarm silence, alarms will still continue to occur during temporary and permanent alarm silence, but an audible alarm indicator will not sound.
Settings and Maintenance Alarm Pause (Temporary Alarm Silence) Pauses the audio alarm for default time of 120 seconds, with countdown Alarm Off (Permanent Alarm Silence) Turns off the audio alarm, until it is turned on again or device is restarted Alarm Volume adjustment Opens window in which alarm volume can be adjusted For more information about alarm settings, reference 4.3 Alarms on page 143. 3.15.
Settings and Maintenance administrator) is re-attached, the monitor will apply the settings that were in place when that sensor was used last time. Please note that all display settings will affect the display only, and will not affect the resolution of the patient data saved in the monitor. 3.15.1. Setting up Language, Date and Time Enter Main Menu>Settings and Maintenance>Settings>Global>Time and Language.
Settings and Maintenance Date format DD MMM YYYY, MMM DD YYYY MMM DD YYYY Time format 24 hours, 12 hours (AM/PM) 24 hours Medtronic recommends use of the 24-hour clock option in all clinical settings, to avoid situations in which the current time may be misunderstood by users. Select the desired choice for each option and click Apply. Please select the date and time format in common use in your locality to enhance clarity for users of the monitor.
Settings and Maintenance If MPM configuration is changed during a case to a configuration which is different from the factory default setting, the change will be valid only for the current active case. The factory default setting is Binary. MPM Configuration cannot be adjusted during Demo Mode.. 3.15.3. Advanced User Settings The advanced user settings are described in the section below. BIS Smoothing Rate Setup This option permits the user to adjust the BIS Smoothing Rate.
Settings and Maintenance Trends graphical display, make the desired changes on this screen and click APPLY to apply the changes. The EEG Trends Graphical Display may be changed only when a sensor is attached to the monitor and the current display settings include an EEG waveform display. Parameter Options Default EEG Amplitude +/- 50 [µV] +/- 50 [µV] +/- 100 [µV] (only when full screen EEG layout is selected as described in 3.12 Home Screen Options on page 121) EEG Scale See Table 10.
Settings and Maintenance Display Scale Full Screen (1:1) Half Screen (1:2) One Third Screen (1:3) 10 µV/mm 1,2 1,2 1,2 4 Channel Display Scale 2 µV/mm 1,2 1 NA 5 µV/mm 1,2,4 1,2 1 10 µV/mm 1,2,4 1,2,4 1,2 When the user applies a change to the EEG scale from the Home Screen, the same change will be displayed in the EEG scale as accessed from the Settings menu. If filters are set, the values will be as follows: • 2 (2.
Settings and Maintenance the user resets the monitor to Institutional Defaults (using the RESET SETTINGS button as described in 4.6 Institutional Settings on page 180) or an administrator resets the monitor to Factory Defaults (using the RESET SETTINGS button as described in 4.6 Institutional Settings on page 180). To enter the screen, click Main Menu>Settings and Maintenance> Settings>Advanced>Impedance.
Info Options When a BIS™ trend is selected, the default secondary variable (EMG) will appear in all layouts. For more information about secondary variables, reference 3.12 Home Screen Options on page 121. If enabled in Administrator mode (reference 7.3.2 Administrator Mode Actions on page 221), EEG Test layout will be an additional option available for display. This will display two EEG trends on the screen at the same time in 2-channel mode and four EEG trends in four-channel mode.
Quick Reference Checklist The INFO button on the main menu and the INFO button on the left menu bar both open the same window, which provides the options listed in Table 11. Info Window Options, below. Table 11. Info Window Options Button Description Demo Mode Opens Two-channel or Four-channel Demo Mode, per user selection. For more information about Demo Mode, reference 7.3.2.2 7.4 Demo Mode on page 223.
Quick Reference Checklist Press the button in the bottom right corner of the monitor to turn the monitor and BISx module on. The system will initiate a self-test to ensure that all equipment is operating properly. The monitor home screen will appear. Step 3: Attach sensor to patient • Prepare sensor site and place BIS™ sensor on the patient in accordance with the sensor instructions.
4. Operating the BIS™ Advance Monitoring System 4.1. Preparing for Operation Ensure that the system, including the monitor, docking station, BISx module, sensor, and all connecting cables are set up as described in 3.5 Preparing the Docking Station on page 68 and 3.6 Preparing the Monitor on page 71. If you want to mount the monitor, do so before operation, following the instructions in 3.4 Mounting the Docking Station on page 64. The BIS™ parameters and their meaning appears in Table 1.
Cases Note: Since the case storage capacity of the monitor is limited, it is recommended to download case data when a case ends, to avoid accidental erasure of case data. 4.2.2. Case Review Case Review is available only when no sensor is attached to the monitor. If a sensor is connected, the option is greyed out. A BISx module may be connected during Case Review. To select a case for review, click Main Menu>Case Review.
Cases Label Function Description 1 Case Start Date and time of case start 2 Case ID Case ID assigned by system 3 Filter Cases may be filtered by Case ID; when a valid Case ID is inputted, only cases with that Case ID will appear on the case list 4 Blue arrow Clicking on the blue arrow will open the selected case 5 Duration Duration of case in hours and minutes Select a case and open the case review screen by clicking on its Case ID or on the blue arrow at the right side of each row.
Cases 8 7 1 6 2 3 4 5 Figure 52.
Cases Label Function Description 1 Case data Indicates date, start time, duration and Case ID of displayed case 2 Cursor Red line indicates point on graph for which numerical data is displayed at the right side of the screen 3 Cursor time indicator Indicates time at cursor location 4 Graphical data Graphical data for displayed case 5 Numeric Data Numeric data of case in review, at the point in time represented by the cursor 6 Case start time indicator Small grey triangle indicator indic
Alarms and Messages During Case Review, the user can scroll through the trend in the displayed Trend window through a specific case time, by swiping the monitor's touch screen left or right to scroll through the available data. A cursor indicates the point in time on the graph for which the data appears in the numeric window. During Case Review, Alarms which were active during the specific case being reviewed will not be displayed and will not sound.
Alarms and Messages Alarm/Message Categories 1. Periodic alarms will sound and be displayed continuously as long as the alarm condition continues to exist. If the alarm condition is cleared, the alarms will cease to sound and display. All alarms are periodic. 2. Once information messages will sound and display once for approximately 5 seconds, whether or not the condition continues to exist. Message Area Display Categories 1.
Alarms and Messages 4.3.2. Alarms The monitor’s alarm messages are listed in Table 12. Alarm Messages, below. All alarms listed in this table are Periodic and Non-latching. Table 12. Alarm Messages Alarm Message Possible Causes Corrective Actions Alarm Priority BIS ALARM The BIS has fallen below the target range set by the user. 1. Check patient. HIGH BIS below defined range BIS ALARM BIS above defined range ISOELECTRIC EEG The BIS has risen above the target range set by the user.
Alarms and Messages Alarm Message Possible Causes Corrective Actions user of a flatline EEG. This is a normal condition when sensor simulator is connected. 2. Check leads for proper Alarm Priority connection and possible shorts. 3. Verify Sensor Check passes. 4. Verify DSC Self-test passes. 5. Verify PIC, using the sensor simulator and Sensor Check. RIGHT ISOELECTRIC EEG No discernible EEG activity is detected for sixty-three seconds; SR = 100. Note: This message notifies user of a flatline EEG.
Alarms and Messages Alarm Message Possible Causes Corrective Actions Alarm Priority SENSOR GROUND FAULT Problem is detected relating to sensor ground element. A continuous ground fault has occurred for longer than 8 seconds. 1. Disconnect and examine sensor connection. Clean any contamination present. HIGH Monitor temperature limit has been exceeded. If the problem persists, the monitor may need to be replaced. Contact technical support.
Alarms and Messages Alarm Message Possible Causes Corrective Actions Alarm Priority SENSOR DISCONNECTED o Disconnected sensor. 1. Connect the sensor. LOW Connect sensor or cable o Poor or contaminated connection between sensor and PIC. o Disconnected PIC. 2. Connect/clean connection between sensor and PIC. 3. Connect the PIC. 4. Replace the PIC. 5. Replace the BISx. o Defective PIC. o Defective BISx.
Alarms and Messages Alarm Message Possible Causes Replace the sensor system for more than 24 hours. UNRECOVERABLE MONITOR ERROR A system error has occurred. The monitor may stop operating. Restart the monitor Corrective Actions Alarm Priority 1. Follow on-screen instructions (if any). LOW 2. Turn the monitor off, then on again. 3. Replace monitor. BISx UNRECOVERABLE ERROR Disconnect and reconnect BISx o Poor connection between BISx module monitor cable and monitor. 1.
Alarms and Messages Alarm Message Possible Causes Corrective Actions Alarm Priority BATTERY LOW There is only a short amount of battery usage time remaining. Restore AC power to avoid automatic shutdown. LOW The DSC Self-Test process failed. Replace the BISx module. LOW o Poor connection between BISx module monitor cable (MIC) and monitor. 1. Disconnect and LOW Connect to power supply DSC SELF-TEST FAILED Replace BISx BISx INITIALIZATION ERROR Disconnect and reconnect BISx o Defective BISx.
Alarms and Messages Alarm Message Possible Causes Corrective Actions Alarm Priority PRESS CENTER OF ELECTRODES {0} TO ENABLE MONITORING One (or more) of the sensor electrodes is not in contact. The relevant electrode number will appear instead of the parentheses. Press the center of the electrode listed on the BIS sensor to initiate contact and enable monitoring.
Alarms and Messages 4.3.3. Messages All information messages will sound once and be displayed in the information message section at the bottom of the home screen. For an example of this display, reference Figure 54. Home Screen with Active Alarm on page 165. The information messages displayed on the message bar at the bottom of the screen are described in Table 13. Information Messages on page 153. Figure 53.
Alarms and Messages Table 13. Information Messages Message Meaning Message Display Type Suggested Action This is the last time this sensor can be used The sensor attached to the monitor has already been used, and the current use is the last use for this sensor. Nonlatching Replace the sensor AC power disconnected The monitor is not connected to AC power and therefore is running on battery power Nonlatching The AC power has been lost and the monitor is running on the battery.
Alarms and Messages Message Meaning Message Display Type Suggested Action Smoothing rate changed to 15 seconds Smoothing rate was changed to 15 seconds, based upon the type of sensor connected, or the user changed the smoothing rate. Once None. Informational message only. Smoothing rate changed to 30 seconds Smoothing rate was changed to 30 seconds, based upon the type of sensor connected, or the user changed the smoothing rate. Once None. Informational message only.
Alarms and Messages Message Meaning Message Display Type Suggested Action Alarm Silent Mode On Audio Alarm Silent Mode is on Once None. Informational message only. Alarm Silent Mode Off Audio Alarm Silent Mode is off Once None. Informational message only. Audio Reminder is On Audio Off alarm reminder signal is on Once None. Informational message only. Audio Reminder is Off Audio Off alarm reminder signal is off Nonlatching None. Informational message only.
Alarms and Messages Message Meaning Message Display Type Suggested Action EEG Filtering On EEG filters are on Once None. Informational message only. EEG Filtering Off EEG filter are off Latching None. Informational message only. Live data export in progress Live data export is in progress Nonlatching None. Informational message only. Live data export stopped Live data export has been stopped Once None. Informational message only.
Alarms and Messages Message Meaning Message Display Type properly to USB port. Suggested Action 3. Replace drive. . • Drive “write protect” is locked. • Drive is incompatible or defective. • Drive is full. BISx connection history export completed BISx module connection history export has been completed Once USB flash drive may be removed. BISx connection history export failed BISx module connection history export was not successful. Latching 1. Check connection. 2.
Alarms and Messages Message Meaning Message Display Type Suggested Action Sensor connection history export completed Sensor connection history export has been completed Once USB flash drive may be removed. Sensor connection history export failed Sensor connection history export was not successful. Latching 1. Check connection. 2. Verify “write protect” switch on the drive is set to “unlock” position. • Removable drive is not connected properly to USB port. 3. Replace drive.
Alarms and Messages Message Meaning Message Display Type Suggested Action • Drive “write protect” is locked. • Drive is incompatible or defective. • Drive is full. System log export completed System log export has been completed Once USB flash drive may be removed. System log export in progress System log export is in progress Nonlatching None. Informational message only. System log export failed System log export was not successful. Latching 1. Check connection. 2.
Alarms and Messages Message Meaning Message Display Type Suggested Action Factory settings restored Factory settings have been restored Latching Message appears at each power-up after a normal shutdown. No action, informational message. Impedance Checking Off User has disabled impedance checking. Nonlatching None. Informational message only. Last case resumed - User settings restored Case resumed settings previously set for that case have been restored Once None. Informational message only.
Alarms and Messages Message Meaning Message Display Type Suggested Action Institutional settings restored Institutional settings have been restored Once None. Informational message only. Monitor software update failed Monitor software update has failed Latching Contact technical support Monitor software update complete Monitor software update is complete Latching USB flash drive may be removed. BIS alarm enabled BIS alarm has been enabled by user Once None. Informational message only.
Alarms and Messages Message Meaning Message Display Type Suggested Action Fan malfunction - replace docking station Fan malfunction has occurred. Nonlatching Replace the docking station. Battery not installed Battery is not installed. Nonlatching Install a battery in the monitor. System is in Demo Mode The monitor is currently running a demo case. Nonlatching None. Informational message only. Monitor Overheat Recovered The monitor has recovered from an overheat scenario. Latching None.
Alarms and Messages Table 14.
Alarms and Messages Indicator Meaning Medium Priority alarm is enabled and will provide audible and visual indicators. If all alarms are silenced, an enabled alarm will still show visual indicators and be recorded in the case records, but will not provide an audible indicator. Medium Priority alarm is disabled. There will be no record of alarms in case records, and neither audible nor visual indicators will be provided.
Alarms and Messages 3 2 1 Figure 54.
Alarms and Messages Label Function Description 1 Alarm message BIS range alarm in alarm message bar 2 Alarm numeric BIS range alarm as seen in numeric section 3 Information message Information message in information message area Figure 55. Alarms List 4.3.5. Alarm Limits An alarm limit is a target level or target range within which the patient’s value for that parameter should ideally remain at all points during monitoring.
Alarms and Messages The proposed BIS™ target range is as follows: Parameter Recommended Target Range BIS 40-60 For other alarms, there is no recommended target range, but the user can set the limit in the available range, as follows: Parameter Available Range SR SR High: 1 to 100, in increments of 1 SEF 0 to 29 for Low SEF limit, 1 to 30 for High SEF limit (there must be a gap of at least 1 between the Low and High limits) In order to verify operator-set alarm limits, attach a sensor to the syste
Alarms and Messages In both cases, alarm paused or off affects only the audible alarms. Visual alarms are not affected. Temporary audio alarm paused may be set for the device using the alarm keys. Temporary alarm silence will be for a period of 120 seconds; a countdown until the return of the alarm will appear in the Alarm area on the Home screen. Audio volume can be set in the Alarm window, accessible using Main Menu>ALARMS or Left Menu bar>ALARMS on the home screen. Reference 3.11.
Alarms and Messages 1. Main Menu>Alarm Settings 2. Left Menu bar>Alarms button 3. Alarm Settings button that appears when a BISx module but not a sensor is connected to the monitor, on the Connect sensor to start monitoring window 4. The BIS target range can also be set using Home Screen>BIS Graph, Set Range>BIS Range In the first three cases, the same Alarm Settings window will open. The BIS range setting choice will open a window that shows BIS range choices only. Table 16.
Alarms and Messages 3. Open the Alarms Settings screen. The Alarm Settings screen can be reached via the options described above. 4. To enable an alarm, select a parameter at the left. Set limit by dragging alarm setting handle to the desired level. Once you make any change to the limit, the alarm will become enabled. Alternatively, you can slide the Alarm Disabled slider from the left side (Alarm Disabled) to the right side (Alarm Enabled) and then change the limit.
Alarms and Messages Figure 56. Alarm Settings Screen 1 2 3 4 5 6 7 8 9 10 Label Function Description 1 Parameters Parameters for which alarms can be set; if an alarm limit has been set (even if it has been set in the past and is not currently enabled, but the Reset to Default button has not yet been pressed) that limit will appear on this line.
Alarms and Messages 3 BIS RANGE text and icon Indicates the alarm which is currently displayed in this window 4 Alarm Enabled text Indicates if the alarm is currently enabled; if the alarm being displayed is disabled, this text will indicate Alarm Disabled. 5 Alarm Disabled icon If black, indicates that the alarm highlighted with a white background on the list at left and displayed at the top of the screen is disabled. If grey, indicates that the alarm is enabled.
Chart Data An example of the alarm settings screen is seen in Figure 56. Alarm Settings Screen on page 171. The other alarms are set using the same procedure. If an alarm is enabled, its range will display on the numeric panel of the home screen, next to the parameter name. If an alarm is disabled, the disabled icon will show on the numeric panel of the home screen, next to the parameter name. Reference Figure 36. BIS Numeric on page 107 for an example. Audio alarm options are as seen in Table 17.
Chart Data Chart data can be seen at a selection of intervals: 1 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes. The default interval is 15 minutes. To adjust the interval, click the CHANGE button next to the Interval text at the top of the chart and select the desired interval. If there is no active case and the system is not in Case Review mode, chart data will not be available. The information available on the Chart Data screen is listed below. Table 18.
Chart Data 7 6 5 4 3 2 1 Figure 58.
Menu Map Label Function Description 1 Case ID display Click to see Case ID of current case 2 Interval display and selection Displays interval used for table, or click to change interval displayed 3 Table headings Displays headings of each column in table 4 Current numeric data Numeric data at current point in time 5 Scroll bar Scroll up or down to see other lines of data 6 Table data Table data for displayed case 7 Start case icon Icon indicating start date and time of current case
Menu Map 2. Map of the menu items available upon pressing the main menu button (at the top left of the main screen) 3. Map of the menu items available in the Administrator Mode (which is password-protected) All three are seen in Figure 59, Figure 60, and Figure 61.
Menu Map Figure 59. Home Screen Main Section Menu Map Figure 60.
Menu Map BIS™ Advance Monitor 179
Institutional Settings Figure 61. Administrator Section Menu Map 4.6. Institutional Settings The monitor is provided to the users with a defined set of factory defaults for various settings and alarms. These defaults will remain in force unless: 1. The user adjusts one or more settings for the current use of the monitor; in this case the new adjusted settings will remain in force until a new case is started, or the monitor is shut down and then restarted. 2.
Institutional Settings settings, and they shall appear as default settings to the regular (nonAdministrator) user. If the user clicks Reset to Default in any Alarm Settings screen, the settings will return to the Institutional Default settings, not the Factory Default settings. The institutional default settings will remain in force even after the monitor is shut down and then restarted.
Institutional Settings Norwegian, Polish, Portuguese, Romanian, Russian, Serbian, Slovak, Slovenian, Spanish Swedish Date Selection via calendar (October 26 2020 to October 26 2099) (but not before the monitor manufacture date). Available only when a BISx module is not connected.
Institutional Settings EEG Sweep speed 6.25 mm/sec, 12.
Institutional Settings 2-Channel Default Layout BIS, EEG; BIS, EEG BIS; BIS, DSA; BIS, DSA, EEG; DSA, EEG; DSA; EEG 4-Channel Default Layout BIS, EEG; BIS, ASYM, EEG BIS; BIS, ASYM, EEG; BIS, DSA, ASYM; DSA, ASYM, EEG; EEG; DSA, ASYM; Alarms Settings (accessible from ALARMS window) Alarm Limits BIS Target Range Alarm Enable Enabled, Disabled Disabled BIS Target Range Low – 5 to 95 40-60 High – 10-100 SR Limit Alarm Enable Enabled, Disabled Disabled SR Limit 1 - 100 NA SEF Target Range A
Institutional Settings High – 2 to 30 Audio Alarm Volume 1-7 Level 4 of 7 Audio Off Reminder Access On/Off Enabled, Disabled (OFF) Off (can be changed only in Administrator Mode) Live Data recording (accessible on DOWNLOAD window) On, Off On Chart Data time interval (accessible on Home Screen) 1, 5, 10, 15, 30, 60 minutes 15 minutes BIS graph display scale (accessible on Home Screen) 1 hour, 6 hours, 12 h, 24 hours 1 hour Other Settings BIS™ Advance Monitor 185
5. Data Storage, Transfer, and Export 5.1. Cybersecurity and Data Integrity Caution: Do not connect any device to RS-232 (serial) port on the docking station (reference 2.2.3 Docking Station on page 51) other than an approved RS-232 cable. RS-232 cable is supplied by the customer. Caution: Do not connect any USB cables to the USB port on the monitor (reference 2.2.1 BIS™ Monitor on page 43) or to the USB port on the docking station (reference 2.2.3 Docking Station on page 51).
BISx Data Memory 1. Alarm Messages (messages displayed in alarm bar) 2. Modal Messages (messages displayed in message windows, i.e., Connect BISx to start monitoring) 3. Information messages (messages displayed in message bar) 4. User Event Marking 5. System Events 6. BISx module Errors 7. Monitor Errors 8. User GUI Events (events in which user performed a GUI-related action) The system log can hold up to 1,000,000 records or up to 50 cases, whichever is smaller.
Live Case Export When the BISx memory is full, the oldest data are automatically erased as new data are saved. Memory will be retained even if the monitor battery has been discharged and will be retained when the monitor and BISx are powered off. 5.4. Types of Exported Data The types of data that can be exported from the monitor include the following: 1. Live Case Data 2. Saved Cases on the monitor 3. Saved Data on the BISx module 4.
Live Case Export Download of Live Case data cannot commence unless a USB flash drive is connected to the monitor or the docking station. 2. Live Case data can be exported during monitoring only, only when a USB flash drive is connected to the monitor (either directly to the monitor or via the docking station). Commence monitoring. 3. Click Main Menu>DOWNLOAD. Select Live Case. The left button in the middle of the screen will display a grey circle.
Live Case Export 9. To terminate Live Case Recording, best practice is to first terminate the case by removing the sensor from the patient, and then to remove the USB flash drive from USB flash drive port on the monitor or the docking station. Figure 62. Live Case Recording Screen 1 2 3 4 5 Label Function Description 1 Download Options List of download options.
Live Case Export 3 Live Case main recording indicator The Live Case icon in the middle of the screen indicates that Live Case recording is going on 4 Not-recording indicator Click this icon to turn off Live Case recording 5 CLOSE button Click this button to close this window. Closing this window will not affect downloading. Upon Live Case download, a folder with the name LMMDDHHMM (for description of file name, reference Table 20.
Saved Cases Export The Live Data Export file will include the information described in Table 22. Data Export Files on page 197. 5.6. Saved Cases Export Both the monitor and the BISx module will contain saved data, and both types of saved data may be downloaded. To download either type of data, monitoring must not be taking place. Thus, to download data from the monitor, remove the sensor from the BISx unit or remove the BISx unit from the monitor.
Saved Cases Export 7. To download BISx module saved cases, attach a BISx module to the monitor, but do not attach a sensor. Select the BISx SAVED CASES option. Click DOWNLOAD to download all data on the BISx module. 8. When the download is complete, the Monitor Saved Cases or BISx Saved Cases window will display a message indicating that the download has been successfully completed. 9. At this point the USB flash drive may be removed from the USB flash drive port on the monitor or the docking station.
Saved Cases Export XXXXXXX = serial number of BISx module Table 21. Monitor Saved Cases Export Options Option Description Folder Name Case History data A folder containing 9 files with case history data. The types of files are described in Table 22. Data Export Files on page 197. (For a better understanding of the files, consult the BIS™ Advance Monitor Export Data Technical Specification document, available via BISTechnicalsupport@medtronic. com.
Recording a Snapshot Event DSA Report A DSA report in pdf format showing DSA chart data and BIS data for the period covered in the export. The data included in this report include: DSA_CCCC_DDMMYYYY_N-M.pdf (CCCC is a 4-character case ID, DD is a day [1-31], MM is a month [0112], YYYY is a four digit year, N is the first page [1], M is the last page [2]) 1. SEF, MF 2. Frequency band scale labels 3. For 2-channel monitoring: DSA and BIS Trend 4.
Recording a Snapshot Event available only during a currently running case. A Snapshot cannot be recorded during Demo Mode. If a snapshot is recorded as described in this section, the snapshot files will become part of the record for that case. Thus, if you download case data for a case for which a Snapshot has been recorded as described, the downloaded case data will include a Snapshot folder. To create a Snapshot event: 1.
BIS™ Saved Data Files The records are written from the earliest time to the latest time. 5.8. BIS™ Saved Data Files Each type of export will create a folder with a series of files on the USB flash drive to which the data has been exported. The folders will include pdf files (described in the relevant sections) and a series of data files. For a more detailed explanation, consult the BIS™ Advance Monitor Export Data Technical Specification document, available via BISTechnicalsupport@medtronic.com. Table 22.
BIS™ Saved Data Files • Date - Month Day Year • Time - HH:MM:SS - in 24-hour format • Log type - ALARM or CLEAR • Name of Event • User Initialed event unique ID Marker file m The Marker file will include the following data: BIS R2 Revision Information, BIS R2 Serial Number, Application revision, Platform revision, Serial protocol revision, Hardware revision, BISx module Revision Information, BISx module serial number, BISx module Software revision, BISx module Hardware revision, BISx module Ser
Logs Export count, and, for 4-channel monitoring, ASYM, Standard BIS, and Standard EMG. Time t The Time File includes current monitor time. 5.9. Logs Export The user can download various logs to aid in troubleshooting and other analysis. The logs that are available for download are listed in the sections below. The BISx module Connection, Sensor connection, and System logs are provided in English only. The Monitor log will be in the current monitor GUI language.
Logs Export • "Demo Case," if this display was display of a demo case The file name of the BISx connection history file will be as follows: nx_bisxcDDMMYYYYHHMMSS_SNNNNNNNNN.log, on the basis of the same variables used in the system log file name, except that “nx_bisxc” for “BISx Connection” will replace “s.” 5.9.2. Sensor Connection History The sensor connection history log provides information about all sensors that have been connected to the BISx module.
Logs Export 5.9.3. Monitor Log The Monitor Log includes the serial number of the monitor, SW Revision Number, and all saved events on the monitor, displayed in tabular format. The listed events include: 1. Alarm Messages (messages displayed in alarm bar) 2. Modal Messages (messages displayed in message windows, i.e., Connect BISx to start monitoring) 3. Information messages (messages displayed in message bar) 4. User Event Marking For each line, the following data is provided: 1.
Logs Export • SS – Download seconds • SN – preset, denotes serial number • NNNNNNNNNN – monitor serial number The data in the Monitor Log is included in the System Log. 5.9.4. System Log The System Log include identifying data (serial number of monitor and software revision number), as well as the records listed below. It differs from the monitor log in that it includes data about the system as well as data about the patient. The System Log includes the following data: 1.
Viewing and Printing Saved Data in PDF Format 5.10. Viewing and Printing Saved Data in PDF Format Some of the reports downloaded in the process described in 5.5 Live Case Export on page 188 and 5.6 Saved Cases Export on page 192 can be viewed in pdf format (with no need for additional processing). For a better understanding of the files that cannot be viewed with a pdf viewer, consult the BIS™ Advance Monitor Export Data Technical Specification document, available via BISTechnicalsupport@medtronic.com.
Viewing and Printing Saved Data in PDF Format Option Description Download Options digit day (1-31), N is the first page (1), M is the last page(2). EEG sub-graphs for 4channel monitoring mode. created during monitoring Each 2-channel EEG PDF page includes 3 EEG graphs with different time slots, all of which will display time labels at 1 second spacing.
Viewing and Printing Saved Data in PDF Format Option Description Download Options generated, Case ID, Case start - date and time, Case end - date and time, Serial number of the monitor, Monitor software version, Copyright data and copyright symbol , BISx module software version. DSA Report The DSA report is named “DSA_CCCC_YYYYMMDD_NM.pdf” A DSA report in pdf format showing DSA chart data and BIS data for the period covered in the export.
6. Service and Maintenance 6.1. Introduction This section describes the steps required for service and maintenance of the monitor. 6.2. Servicing the BIS™ Advance Monitor Any type of service other than battery replacement may be performed only by authorized service technicians. Information regarding service is provided to service technicians in a separate service manual. For more information regarding servicing the monitor, contact BISTechnicalsupport@medtronic.com. For battery replacement, reference 6.
Battery Handling After storage for three months or longer, charge the battery until it reaches at least an 80% charge level; battery charge will be indicated by the battery indicators. Battery capacity indicators are described in 3.3.3 Battery and Power Usage on page 63. If the monitor fails to operate reliably from the battery for at least one hour when fully charged, battery replacement is required. To charge the battery, place the battery in the monitor battery compartment as seen in 3.3.
Cleaning the BIS™ Advance Monitor endanger the user. Reference Table 34. BIS™ Advance Accessories on page 252 regarding the battery pack. Caution: Check the battery annually by operating a BIS™ Advance monitor that has been disconnected from the wall socket and that has been charged for 4 hours when the monitor is powered off or 8 hours when the monitor is functioning. The monitor should function for at least one hour on battery power only.
Cleaning the BIS™ Advance Monitor Clean any spillage of blood or solutions on the surfaces of the monitor, docking station, adapter cable or BISx module as soon as possible. Dried blood is very difficult to remove. Use lint-free absorbent towels for spill cleanups. Dampen the towel with detergent and lukewarm water to aid in cleaning. After cleaning, wipe the PIC connector ends with alcohol and allow to dry completely. Residual moisture inside the connector may affect BISx module performance.
Instrument Identification 6.4.3. Cleaning the Monitor Display Clean the monitor display screen with a mild solution of detergent and warm water or a commercial display screen cleaner, available through personal computer dealers. To avoid scratching the screen, never use abrasive cleaning materials. 6.5. Instrument Identification 6.5.1. Permanent Identification Marking The BIS™ Advance monitor identification information is permanently marked on the rear panel of the monitor.
Instrument Identification Table 24. Monitor Configuration Data Configuration Type Available Data Monitor Configuration Monitor software, BIOS, OS, OS image version, Monitor serial no.
Diagnostics 7. Diagnostics and Troubleshooting 7.1. Diagnostics 7.1.1. DSC Self-Test The Digital Signal Conversion (DSC) Self-Test verifies the signal acquisition and conversion functions of the BISx module, and tests the entire signal processing chain inside the BISx module. It does not test the PIC or the sensor. The BISx module must be connected to perform DSC self-test; a sensor may be connected but is not required.
Diagnostics monitor fails the DSC Self-Test, consult BISTechnicalsupport@medtronic.com for the next steps to take to continue working with the monitor. 7.1.2. EEG Filters The monitor automatically turns on EEG filters in order to filter out undesirable interference from the raw EEG signals. The notch filter handles both 50 and 60 Hz interference. The EEG filters for the display support the following modes: ON: 2 - 70 [Hz]; OFF: 0.25-100 [Hz]. The EEG filters also include high and low pass filters.
Troubleshooting 7.2. Troubleshooting In order to perform troubleshooting for issues that occur with use of the monitor, the following steps are recommended: 1. If a message appears on the monitor screen, locate that message in 4.3 Alarms and Messages on page 143, and follow the relevant instructions in that section. 2. Check the list of issues in Table 25.
Troubleshooting placed in docking station. Monitor is not monitoring even though all components are connected. Pins may need cleaning. Do not attempt to clean the pins. If needed, contact BISTechnicalsupport@medtronic.com. Sensor may not be compatible with the BIS™ Advance monitor and the BISx module. Use only sensors supplied by Medtronic. Use the correct sensor for the specific patient and BISx module. For more information about sensors, reference 2.2.5 BIS Sensors on page 56.
Troubleshooting Adapter cable does not connect to monitor The connection may have been performed incorrectly. Arrow on monitor and red dot on adapter cable must be lined up in order to connect. Reference Figure 7. Attaching the Adapter Cable to the Monitor on page 49. Touch screen not functioning properly: Screen does not respond at all; discernable delay in use of touch screen; touch screen is mis-aligned. Touch screen problem. Clean the touch screen with an approved cleaning solution.
Troubleshooting Sensor check fails, even after the sensor has been replaced Sensor check fails, even after the sensor has been replaced EMC interference Read EMC guidance in manual (reference 7.7 Electromagnetic Compatibility Specifications on page 237) and readjust monitor and nearby appliances. 1. Ascertain if the PIC cable is functioning properly by running the sensor check with the sensor simulator attached to the patient end of the PIC cable instead of a sensor. Faulty PIC 2.
Administrator Mode Audio output is not clear Software update failed Stickers may be covering the device speakers. Flash drive not connected correctly, flash drive not readable by monitor, incorrect file on flash drive Remove any stickers covering the device speakers. Stickers should be placed only on the battery area at the back of the monitor or on the docking station. If needed, contact BISTechnicalsupport@medtronic.com.
Administrator Mode Record the selected password in a safe place. Input the selected password twice as requested by the software. Click SET PASSWORD and then CLOSE. The new password has now been set. Use this password for future entry to the Administrator section of the software. Record the selected password in a safe place; reset of the Administrator password will require a service technician. For more information, contact BISTechnicalsupport@medtronic.com.
Administrator Mode Figure 64. Administrator Mode Login Screen 1 2 3 4 Label Function Description 1 Administrator Mode Select Main Menu>Settings and Maintenance>Administrator Mode to enter this screen 2 Set Password field Input desired unique password into this field 3 Verify Password field Re-input desired unique password into this field 4 Close button Select Close (or select the X at the top right of the window) to close this window and work in Administrator Mode.
Administrator Mode 7.3.2. Administrator Mode Actions After the user enters a valid password and applies it, the software shall open the Administrator Settings and Maintenance menu and enable the Administrator user to perform the functions listed in this section. Administrator Mode Settings The user can modify defaults for the parameters listed in Table 19. Institutional Settings on page 181 while in Administrator Mode (except for those items listed in that table as not available in Administrator Mode).
Administrator Mode sensor is disconnected) Table 27. Administrator Mode Actions Screen Text Action Result Erase Case Data Erase Data: Cancel/Erase Data Will permanently clear all previous case data Factory Defaults Reset Settings: Cancel/Apply Will reset all settings to factory defaults Audio Off Reminder (in ALARM SETTINGS screen if entered while in Administrator Mode) Checkbox: check the checkbox to Allow users to disable/enable this reminder for their own sessions.
Glossary 4. Click NEXT and follow the instructions on the screen to update your monitor software. Caution: Do not disconnect the BISX™ unit during a software update. For more information regarding software updates, contact BISTechnicalsupport@medtronic.com. 7.4. Demo Mode The user can view either a 2-channel or a 4-channel Demo case. Demo cases can be viewed only if there is no BISx module connected to the monitor. In addition, please note that Demo Mode cannot be accessed while in Administration Mode.
Glossary would cause severe or intolerable pain to an unanesthetized patient. Asymmetry The percentage of total EEG power that resides in the left hemisphere of the brain. Available only with BISx4 and Bilateral Sensor. Calculated by BISx4 as: (Total Power Left / (Total Power Left + Total Power Right)) * 1000. The same calculation is performed for the right side of the brain, with (Total Power Right / (Total Power Right + Total Power Left)) * 1000.
Glossary BIS™ Sensor A single patient use, disposable, pre-gelled 4electrode array that is applied directly to the patient’s forehead to record electrophysiological signals. The BIS sensor tab contains an electric smart card memory device that stores configuration and Identification information. BIS Complete Monitor, BIS Vista Monitor Previous versions of the BIS™ Advance monitor Extend Sensor The brand name for the 2-channel (unilateral) sensor for use in the ICU.
Glossary >240 msecs during which the electroencephalographic voltage did not exceed 5 µV. Level of Consciousness (LoC) Level of consciousness (LoC) is a measurement of a person's ability to be aroused and responsiveness to stimuli from the environment. Monitor Interface Cable (MIC) The portion of the cable the connects the BISx module to the Monitor. It is integral to the BISx module. Patient Interface Cable (PIC) The cable that connects the BIS™ sensor to the BISx module.
Specifications 7.6. Specifications Specifications listed below are current for the time of manual printing. To obtain the most recent specifications, consult BISTechnicalsupport@medtronic.com. In case of any discrepancy, the data in the product specification to be supplied by BISTechnicalsupport@medtronic.com is considered authoritative. 7.6.1. General Specifications Item Value Unit Dimensions Monitor: 27.6cm (w) x 20.1cm (h) x 4.6cm (d) Docking station: 28.4 cm (w) x 23.8 cm (h) x 7.
Specifications Item Value 800 mm Hg (-457 [1500ft] below sea level) to 360mm Hg (6100 [20,000ft] above sea level) for BISx module Operating Humidity 10% to 95%, non-condensing for monitor, docking station, adapter cable, power supply and removable battery Storage and Transport Temperature -20 ºC to +60 ºC (-4 ºF to 140 ºF) for monitor, docking station and adapter cable -10 ºC to +60 ºC (14 ºF to 14 ºF) for BISx module Storage and Transport Pressure and Altitude 107kPa (430m [1410ft] below sea level)
Specifications Item Value Protection Type Internally powered when operating on internal battery Class II with isolated functional earth when operating on AC power Degree of Protection Type BF (defibrillator-proof) Mode of Operation Continuous Isolation The system includes 2MOPP isolation in its power supply (PMB4000PWS), as well as 1MOPP isolation in the BISx module. Electromagnetic Compatibility IEC 60601-1-2 (3rd and 4th Edition) 7.6.2.
Specifications 2 - OR Anesthesia Machine Mounted to the post using a clamp mount Clamped to the IV pole / Clamped to a handle on the anesthesia machine / Attached to the bed frame One of the below, depending on requirements: GCX clamp mount (PMB4000PMT) Channel mount (standard mount to be purchased separately) Pivot arm (standard mount to be purchased separately) Post (standard mount to be purchased separately) 3 – OR Desk Top Mounting Mounted to the tablet desktop mount Clamped to the IV pole / Atta
Specifications 7.6.3. Power Supply Item Value Input 100-240 VAC, ±10% 50-60 Hz, 1.5A Output Voltage and Power 19V DC, 3.15A ~ 4.73A Maximum System Power consumption Up to 25W Power supplied to system 60W 7.6.4. Battery Specifications Item Value Battery Type 2S1P -Lithium-ion Polymer Battery pack nominal voltage and energy Nominal Voltage -7.4V Battery Operational Temperature During battery charging (when connected to AC power): 0° to 45° C Nominal energy -38.
Specifications For time periods over three months, batteries should be stored at 25±3° C If the monitor is to be stored for three months or more, store the battery outside the monitor. 7.6.5.
Specifications Low Priority Alarm Single beep repeated every 17 ± 1 seconds Yellow square under alarming parameter Messages Single beep None 7.6.7. Display Item Value Display size 10.1 Inch IPS Display with LED Backlight Active Display Area: 216.81 (horizontal) 135.50 (vertical) mm Display characteristics Multi-touch projected capacitive display Contrast Ratio 800:1 Brightness 600 nits TYP. Screen resolution 1920 (horizontal) x 1200 (vertical) pixels PPI (pixels per inch) 224.
Specifications 7.6.8. Sound Pressure Data Sound pressure values when measured at a microphone positioned in a distance of 1 m, behind the monitor, are as follows (higher value is when used with a docking station): Item Minimum Volume Setting Maximum Volume Setting High priority alarms 60-63 dB(A) 81-84 dB(A) Medium priority alarms 53-56 dB(A) 75-78 dB(A) Low priority alarms 47-50 dB(A) 68-71 dB(A) Info messages 47-50 dB(A) 68-71 dB(A) 7.6.9.
Specifications SEF 1 Hz-30 Hz Frequency - [Hz] units DSA NA (graphic representation) NA (graphic representation) EEG µV/mm Display gain 2, 5, or 10 [µV/mm] Burst Count Bursts/Minute 0 - 30 7.6.10.
Specifications Default 6.25 mm/sec Computed Parameters Bispectral Index, Suppression Ratio, Suppression Time, EMG, Signal Quality Indicator, and Burst Count User-defined Displays Trend and real-time EEG waveforms Update Rate 1 second for BIS™ number, 10 seconds for Trend Alarms Auditory and visual, user adjustable limits Filters ON (2-70 Hz with notch) or OFF (0.25-100 Hz) Mode Sensor Automatically selects mode two-channel or 4-channel) 7.6.11.
Electromagnetic Compatibility Specifications 0.25 Hz to 50 Hz Common Mode Rejection 110 dB at 50/60 Hz to earth ground (Isolation mode) 0.16–100 Hz 7.6.12.
Electromagnetic Compatibility Specifications Docking Station Connectors on page 54. These ports are for use with a USB flash drive only. WARNING: Using accessories other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the BIS™ Advance monitor system. WARNING: The BIS™ Advance monitor should not be used adjacent to or stacked with other equipment.
Electromagnetic Compatibility Specifications Table 29. Guidance and Manufacturer's Declaration - Electromagnetic Emissions The BIS™ Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS™ Advance monitor should assure that it is used in such an environment. Emissions test Compliance Electromagnetic Environment – Guidance RF Emissions CISPR 11 Group 1 The BIS™ Advance monitor uses RF energy only for its internal function.
Electromagnetic Compatibility Specifications Table 30. Guidance and Manufacturer's Declaration - Electromagnetic Immunity The BIS™ Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS™ Advance monitor should assure that it is used in such an environment.
Electromagnetic Compatibility Specifications The BIS™ Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS™ Advance monitor should assure that it is used in such an environment.
Electromagnetic Compatibility Specifications The BIS™ Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS™ Advance monitor should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Note: UT is the AC mains voltage prior to the application of the test level.
Electromagnetic Compatibility Specifications The BIS™ Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS™ Advance monitor should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Field strengths from fixed RF transmitters, as determined by electromagnetic site surveya, should be less than the compliance level in each frequency range.
Electromagnetic Compatibility Specifications The BIS™ Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS™ Advance monitor should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Over the frequency ranges 150kHz to 80 MHz field strength should be less than 3 V/m.
Electromagnetic Compatibility Specifications Rated maximum output power of equipment Separation distance according to frequency of transmitter W m 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Electromagnetic Compatibility Specifications Table 32. Proximity Field Immunity Compliance Guidance and Manufacturer’s Declaration—Electromagnetic Immunity (IEC/EN 60601-1-2, 4th Edition) Test Frequ ency (MHz) Ban d (MH z) Service Modulati on Max . Po wer (W) Dist anc e (m) Immuni ty Compli ance Level (V/m) Immu nity Test Level (V/m) 385 380 to 390 TETRA 400 Pulse Modulatio n 18 Hz 1.8 0.3 27 27 450 430 to 470 GMRS 460, FRS 460 FM ± 5kHz deviation 1 kHz sine 2 0.
Electromagnetic Compatibility Specifications Guidance and Manufacturer’s Declaration—Electromagnetic Immunity (IEC/EN 60601-1-2, 4th Edition) Test Frequ ency (MHz) Ban d (MH z) Service Modulati on Max . Po wer (W) Dist anc e (m) Immuni ty Compli ance Level (V/m) Immu nity Test Level (V/m) iDEN 820, CDMA 850, LTE Band 5 870 800 to 960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse Modulatio n 18 Hz 2 0.
Electromagnetic Compatibility Specifications Guidance and Manufacturer’s Declaration—Electromagnetic Immunity (IEC/EN 60601-1-2, 4th Edition) Test Frequ ency (MHz) Ban d (MH z) Service Modulati on Max . Po wer (W) Dist anc e (m) Immuni ty Compli ance Level (V/m) Immu nity Test Level (V/m) 1845 1700 to 1990 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS Pulse Modulatio n 217 Hz 2 0.
Product Compliance Guidance and Manufacturer’s Declaration—Electromagnetic Immunity (IEC/EN 60601-1-2, 4th Edition) Test Frequ ency (MHz) Ban d (MH z) Service Modulati on Max . Po wer (W) Dist anc e (m) Immuni ty Compli ance Level (V/m) Immu nity Test Level (V/m) 5500 5100 to 5800 WLAN 802.11 a/n Pulse Modulatio n 217 Hz 0.2 0.3 9 9 5785 5100 to 5800 WLAN 802.11 a/n Pulse Modulatio n 217 Hz 0.2 0.
Product Compliance PSE Marking for power supply FCC ID, FCC CFR 47 Part 15 Directive 2006/66/EC UL 2054, 2nd edition (batteries) IEC 62133-2 2017-02. (batteries) UN 38.3 EU 2017/999 (REACH) IEC 60601-1:1988 +A1/A2 & EN 60601-1:1990 +A11/A12/A13 Medical Electrical Equipment Part 1: General Requirements for Safety (China) IEC 60601-1:2005 + A1:2012 (medical devices in general) 2012.
BIS™ Advance Components, Accessories, and Documentation EN/IEC 60601-1-6: 2010 +A1: 2015 - Medical Electrical Equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability.
BIS™ Advance Components, Accessories, and Documentation Table 33.
BIS™ Advance Components, Accessories, and Documentation Product Name Description or Application GCX desktop mount Desktop mount for docking station with monitor. For purchase directly from GCX. GCX mount for anesthesia machine Mounting accessories for mounting monitor with docking station to anesthesia machine. The clamp mount can be purchased from Medtronic. The other parts are for purchase directly from GCX.
BIS™ Advance Components, Accessories, and Documentation Product Name Description or Application Part Number AC power in continental Europe UK power cord Power cord used with monitor for connection to AC power in the United Kingdom PT00059578 Israel power cord Power cord used with monitor for connection to AC power in Israel PT00059579 Australia power cord Power cord used with monitor for connection to AC power in Australia PT00059581 China power cord Power cord used with monitor for connection
BIS™ Advance Components, Accessories, and Documentation Product Name Description or Application Part Number South Africa power cord Power cord used with monitor for connection to AC power in South Africa PT00059588 BISx (previously known as LoC 2 Channel) Processes 2 channels of EEG information (one brain hemisphere) to work with BIS™ Advance Monitor.
BIS™ Advance Components, Accessories, and Documentation Configurations on page 229 and determine which solution is best for the specific environment. To purchase accessories, please contact BISTechnicalsupport@medtronic.com. The BIS™ Advance monitor is packaged with a manual and clinical quick guide cards in English and other languages in soft copy on a flash drive. A list of documentation available in multiple languages in hard copy is listed below.
BIS™ Advance Components, Accessories, and Documentation Item Language Part Number Operator’s Manual Hungarian PT00136176 Operator’s Manual Japanese PT00136177 Operator’s Manual Kazak PT00136178 Operator’s Manual Korean PT00136180 Operator’s Manual Latvian PT00136181 Operator’s Manual Lithuanian PT00136182 Operator’s Manual Macedonian PT00136183 Operator’s Manual Norwegian PT00136184 Operator’s Manual Polish PT00136185 Operator’s Manual Portuguese PT00136186 Operator’s Manua
BIS™ Advance Components, Accessories, and Documentation Item Language Clinical quick guide cards Brazilian Portuguese Clinical quick guide cards Bulgarian Clinical quick guide cards Chinese (simplified) Clinical quick guide cards Croatian Clinical quick guide cards Czech Clinical quick guide cards Danish Clinical quick guide cards Dutch Clinical quick guide cards English Clinical quick guide cards Estonian Clinical quick guide cards Finnish Clinical quick guide cards French Clinical
BIS™ Advance Components, Accessories, and Documentation Item Language Clinical quick guide cards Italian Clinical quick guide cards Hungarian Clinical quick guide cards Japanese Clinical quick guide cards Kazak Clinical quick guide cards Korean Clinical quick guide cards Latvian Clinical quick guide cards Lithuanian Clinical quick guide cards Macedonian Clinical quick guide cards Norwegian Clinical quick guide cards Polish Clinical quick guide cards Portuguese Clinical quick guide c
Warranty Item Language Clinical quick guide cards Serbian Clinical quick guide cards Slovak Clinical quick guide cards Slovene Clinical quick guide cards Spanish Clinical quick guide cards Swedish Clinical quick guide cards Turkish Clinical quick guide cards Ukrainian 7.10.
Warranty To request repair or replacement under this warranty, Purchaser should contact Covidien directly (see contact information on the back cover of this manual). Covidien will authorize Purchaser to return the Warranted Product (or part thereof) to Covidien. Covidien shall determine whether to repair or replace Products and parts covered by this warranty and all Products or parts replaced shall become Covidien’s property.
Software License Agreement HEREIN, ALL PRODUCTS ARE SUPPLIED “AS IS” WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED. 7.11. Software License Agreement The computer software (“Licensed Software”) loaded on the BIS™ Complete monitor (“System”) is licensed, not sold, to you for use only under the terms of this license. Covidien (“Covidien”) reserves any rights not expressly granted to you. You own the System, but Covidien retains all ownership rights and title to the Licensed Software itself. 1.
Software License Agreement 5. LIMITATION OF REMEDIES AND DAMAGES: COVIDIEN’S ENTIRE LIABILITY TO YOU FOR ACTUAL DAMAGES FOR ANY CAUSE WHATSOEVER, AND REGARDLESS OF THE FORM OF THE ACTION, AND YOUR EXCLUSIVE REMEDY SHALL BE LIMITED TO THE MONEY PAID FOR THE SYSTEM, WHICH INCLUDED THE LICENSED SOFTWARE.
Software License Agreement 7. GENERAL: This License Agreement will be construed under the laws of the Commonwealth of Massachusetts. If any provision of this License Agreement shall be held by a court of competent jurisdiction to be contrary to law, that provision will be enforced to the maximum extent permissible, and the remaining provisions of this Agreement will remain in full force and effect.
Covidien IIc, 15 Hampshire Street, Mansfield, MA, 02048 USA Medtronic BV, Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands BIS™ Advance Monitor 265
