CARESCAPE Central Station Model MAI700 and MAS700 Users Manual Sw ver 2 Nov 2018.pdf

The information in this manual applies to the software version and product models on the first page of the manual. Due to continuing innovation, specifications in this manual are subject to change without notice. For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies, Inc., and GE Healthcare Finland Oy.

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Contents 1

About this manual ...13 Manual intended use ... 13 Manual conventions ... 13 Illustrations and names ... 13 Common terms ... 14 Ordering manuals ... 14 Trademarks ... 14 Related manual ... 14 Additional resources ... 15 Revision history ... 15

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Safety precautions...17 Safety message signal words... 17 Danger safety messages... 17 Warning safety messages... 17 Caution safety messages ... 27 Notice safety messages ... 30 Safety symbols ... 30 Safety tests... 30 Verifying proper operation ... 31 Safely turning off the device... 32

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About this system ...33 Intended use... 33 Contraindications... 33 User profile ... 33 Required training and skills ... 34 CE marking information... 34 Manufacturer responsibility ... 34 Integrated processing unit (MAI700) ... 34 Desktop processing unit (MAS700)... 35 Primary display... 35 Secondary display... 36

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Mirrored central displays ... 36 Enhanced display... 36 Remote display... 37 Keyboard and mouse ... 37 Writer ... 38 Laser printer ... 38 Controls, indicators, and connections ... 39 Device symbols ... 40 4

About this software ...45 Configuration levels ... 45 Multi-Viewer overview ... 46 Patient Multi-Viewer window overview ... 47 Single Viewer overview... 49 User interface symbols ... 49 Multi-Viewer user-level defaults overview ... 54 Adjusting Auto Display user-level defaults ... 54 Adjusting parameter color and size user-level defaults ... 54 Patient Multi-Viewer window control settings... 55 Adjusting displayed waveform control settings ... 55 Adjusting waveform color control settings... 55 Adjusting Real-time Trend Graph control settings ... 56 Parameter control settings overview... 56 ECG control settings overview... 58 Adjusting SPO2 control settings ... 61 Adjusting Respiration control settings ... 61 Adjusting CO2 control settings ... 62 Pressures control settings... 63

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Managing patients...67 Monitoring modes overview... 67 Adjusting patient Multi-Viewer windows overview... 70 Adding patient Multi-Viewer windows ... 71 Using Auto Display ... 71 Rearranging patient Multi-Viewer windows ... 71 Swapping patient Multi-Viewer windows ... 72

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Removing unlocked patient Multi-Viewer windows... 72 Admitting patients overview ... 73 Admitting Standard monitoring patients... 74 Admitting Combination monitoring patients... 76 Changing patient information ... 78 Discharging patients overview... 79 Discharging patients ... 80 Breaking Combination monitoring by discharging the bedside monitor ... 80 Breaking Combination monitoring by discharging the telemetry monitoring device ... 80 Admitting new telemetry patients... 81 Moving telemetry patients to another in-unit bed... 82 Replacing telemetry monitoring devices... 82 Viewing other patients... 82 6

Alarms ...85 Alarm safety precautions ... 85 Alarm conditions ... 88 Alarm system diagram ... 89 Alarm priority levels ... 90 Audio alarm tones... 92 Visual alarm indicators ... 93 Testing alarm function... 96 Adjusting alarm volume... 96 Pausing audio alarms ... 97 Adjusting alarm control settings overview... 99 Adjusting bedside monitor alarm control settings... 101 Adjusting telemetry monitoring device alarm control settings ... 103 Reviewing and acknowledging alarm control settings... 105

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Data review tools...107 Time focus ... 107 Full Disclosure overview ... 107 Adjusting Full Disclosure user-level defaults ... 108 Using FD Strip ... 110

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Using FD Page ... 111 Printing FD Page... 112 Using Data Sessions ... 113 Events overview ... 114 Selecting Event Source ... 114 Viewing events ... 115 Reviewing events ... 117 Deleting events... 118 Annotating events ... 118 Printing events... 119 Creating event reports ... 119 Trends overview ... 120 Using Graphic Trends... 121 Using Numeric Trends... 123 Using Calipers... 124 Enabling ST Monitoring Status indicator... 127 Using ST Review ... 128 Using Browser ... 132 8

Printing...135 Adjusting printer control settings... 135 Manually printing ECG strips ... 136 Printing all parameter alarm limits and waveforms ... 136 Automatic alarm printouts ... 137 Stop printing ... 137 Supported printouts... 138

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Maintenance...143 Maintenance overview ... 143 Cleaning, disinfection and care overview... 143 Cleaning... 143 Cleaning safety precautions... 143 Permitted detergents ... 144 Cleaning points to note... 144 General cleaning instructions... 145 Other manufacturer cleaning instructions ... 145

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Disinfection... 145 Disinfection points to note... 145 Permitted disinfectants... 146 Disinfecting external surfaces... 147 Touchscreen display guidelines ... 148 Writer maintenance... 148 Changing writer paper... 148 Storing writer paper ... 149 10 Technical specifications...151 Overview... 151 General specifications ... 151 Alarm specifications... 156 Software platform specifications ... 157 Display specifications ... 157 Processing unit specifications... 157 Power requirements... 157 Physical specifications... 158 Integrated processing unit (MAI700) ... 158 Desktop processing unit (MAS700) ... 158 Standalone display (MD22) ... 159 Environmental specifications ... 159 Device classification ... 159 Compliance... 160 11 Compatible devices ...161 Overview... 161 Compatible central stations ... 161 Compatible monitoring devices ... 162 Compatible telemetry monitoring devices ... 162 Compatible bedside monitors for ST record acquisition and storage into Full Disclosure ... 163 Other compatible systems ... 163 Compatible printers ... 163 12 Supported accessories...165 Overview... 165

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GE accessories ... 165 Displays – touchscreen ... 165 Mousepad ... 166 Other accessories ... 166 DisplayPort cables... 166 Displays – non-touchscreen ... 166 Displays – remote... 167 Displays – touchscreen ... 168 Extenders/splitters ... 168 External speakers... 169 HDMI cables... 169 Keyboards... 169 Keyboard and mouse cable extender... 170 Laser printers... 170 Mounts ... 170 Mouse... 170 Power cords... 170 Strip printer (writer) ... 171 Strip printer cables and adapters... 171 Touchscreen cables ... 172 A

Alarm characteristics...173 Audio alarm tone characteristics... 173 IEC HIGH audio alarm tone characteristics ... 173 IEC MEDIUM audio alarm tone characteristics... 173 IEC LOW audio alarm tone characteristics... 173 Legacy CRISIS audio alarm tone characteristics... 174 Legacy WARNING audio alarm tone characteristics ... 174 Legacy SYSTEM WARNING audio alarm tone characteristics ... 174 Legacy ADVISORY audio alarm tone characteristics ... 174 Legacy SYSTEM ADVISORY audio alarm tone characteristics ... 174 Alarm Audio Off Reminder alarm tone characteristics ... 174 Audio alarm tone sound pressure ranges overview... 174 IEC audio alarm tone sound pressure ranges ... 175 Legacy audio alarm tones sound pressure ranges... 175

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Visual alarm indicator characteristics ... 175 B

Supported parameters...177 Supported parameters overview ... 177 Arterial Blood Gas (ABG/POC) supported parameters ... 179 Arterial (AR/ART) pressure supported parameters ... 181 Bispectral Index (BIS/BISm) supported parameters... 182 Carbon Dioxide (CO2) supported parameters ... 183 Cardiac Calculations (CC) supported parameters... 184 Cardiac Output (CO) supported parameters ... 186 Central Venous pressure (CV/CVP) supported parameters ... 187 Continuous Cardiac Output (CCO) supported parameters ... 188 Electrocardiograph (ECG) supported parameters... 189 Electroencephalograph (EEG) supported parameters ... 192 Entropy (ENT) supported parameters ... 193 Femoral (FE/FEM) pressure supported parameters ... 194 Impedance Cardiography (ICG) supported parameters ... 195 Intra-Cranial Pressure (ICP) supported parameters... 196 Left Atrial (LA) pressure supported parameters ... 197 Mass Spectrometry (Gas) supported parameters ... 198 Non-Invasive Blood Pressure (NBP) supported parameters... 201 Non-Invasive Cardiac Output (NICO) supported parameters... 202 Neuromuscular Transmission (NMT) supported parameters ... 203 Pulmonary Artery (PA) pressure supported parameters... 204 Pulmonary Calculations (PC/estPC) supported parameters... 205 Right Atrial (RA) pressure supported parameters... 208 Respiration (RESP) supported parameters... 209 Respiratory Mechanics (RM) supported parameters ... 210 Central Venous Oxygen Saturation (ScvO2) supported parameters... 212 Special (SP) pressure supported parameters ... 213 Surgical Pleth Index (SPI) supported parameters... 214 SPO2 (SPO2m/SPO2x) supported parameters ... 215 Systolic Pressure Variation (SPV) supported parameters ... 217 SVO2 supported parameters... 218

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Temperature (TP/TEMP) supported parameters... 219 Transcutaneous CO2 (TC/TCm) supported parameters... 221 Umbilical Artery (UA/UAC) pressure supported parameters ... 222 Umbilical Venous (UV/UVC) pressure supported parameters ... 223 Ventilator (VENT) supported parameters... 224 Ventilator calculations (VC) supported parameters ... 230 C

Messages ...231 Monitoring device messages... 231 Central station system status messages... 241

D

Presets...243 Presets overview ... 243 Central Defaults presets ... 243 Telemetry presets... 244 Telemetry Unit Defaults presets ... 244 Telemetry Parameter Limits and Alarm Levels presets ... 245 Telemetry Arrhythmia Alarm Levels presets... 246 Telemetry Technical Alarm Priorities presets... 246 Display Configuration presets ... 247 Full Disclosure Defaults presets ... 247 FD Page presets ... 248 Graphic Trends Groups presets... 248 Numeric Trends Groups presets... 250 Caliper Page presets ... 252 ST Review presets ... 252

E

Custom defaults and settings ...253 Custom defaults and settings overview ... 253 Central Defaults settings ... 253 Telemetry custom defaults overview... 254 Telemetry Unit Defaults custom defaults ... 254 Telemetry Parameter Limits and Alarm Levels custom defaults... 255 Telemetry Arrhythmia Alarm Levels custom defaults... 256 Telemetry Technical Alarm Priorities custom defaults... 257 Caliper Page settings ... 258 Display Configuration settings ... 258

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Full Disclosure Defaults settings ... 259 FD Page settings ... 260 Graphic Trends Groups settings... 260 Numeric Trends Groups settings... 263 ST Review settings ... 265 Save As Favorites settings... 266 F

Known issues...269 Alarm AUDIO PAUSE known issue ... 269 Calipers events known issue ... 269 Combination monitoring known issue... 270 ECG events known issue... 270 Non-ECG events known issue ... 271 72 hours trending known issue... 271

G

Glossary ...273 Glossary ... 273

H

Abbreviations and symbols ...281 Abbreviations ... 281 Symbols ... 293

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About this manual

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Manual intended use This manual is an integral part of the system. It should always be kept in a place accessible to users, and information indicating that place should be available close to the equipment. Observance of the manual is a prerequisite for proper performance and correct operation and ensures patient and user safety. The list below indicates the compatible products (brands, models and descriptions as applicable) with which this manual is to be used. Other products are covered by the manuals that were delivered with those products or with the CARESCAPE Central Station with software versions earlier than version 2.1. Refer to those manuals for proper performance and correct operation to ensure patient and user safety. ●

CARESCAPE Central Station running software version 2.1

Manual conventions This manual uses the following styles to emphasize text or indicate action. Item

Description

bold

Indicates hardware terms.

bold italic

Indicates software terms.

italic

Indicates terms for emphasis.

+

Indicates keyboard keys to select simultaneously.

>

Indicates menu options to select consecutively.

X

supported

-

not supported

(7)

Indicates page number.

Illustrations and names This manual uses illustrations as examples only. Illustrations in this manual may not necessarily reflect all settings, features, configurations, or displayed data. Names of persons, institutions, and places and related information are fictitious; any similarity to actual persons, entities, or places is purely coincidental.

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About this manual

Common terms This manual uses the following terms to simplify common terms: Item

Description

acquisition device

Refers to acquisition modules or other acquisition devices used to acquire and process parameter data.

bedside monitor

Refers to bedside monitors, including patient monitors, transport monitors, or wireless monitors on the network.

central station

Refers to the CARESCAPE Central Station.

monitoring device

Refers to bedside monitors or telemetry monitoring devices.

printer

Refers to direct digital writers or laser printers.

network

Refers to the CARESCAPE Network. The Unity Network has been renamed to the CARESCAPE Network. Not all references to the Unity Network will be changed immediately; Unity may display in some places and CARESCAPE in others. It is important to understand that while the CARESCAPE Network replaces the Unity Network name, they refer to the same GE monitoring network.

remote device

Refers to remote devices like the central station that can be used to view patient data and modify some control settings on primary monitoring devices.

telemetry monitoring device

Refers to telemetry monitoring devices, including transmitters, transceivers, and the established telemetry system.

writer

Refers to direct digital writers (DDW).

Ordering manuals A paper copy of this manual will be provided upon request. Contact your local GE representative and request the paper manual part number on the first page of the manual.

Trademarks GE, GE Monogram, APEX, APEXPRO, and CARESCAPE are trademarks of General Electric Company. 12RL, Aware, CIC Pro, DASH, DINAMAP, MARS, MUSE, SOLAR, TRAM, and UNITY NETWORK are trademarks of GE Medical Systems Information Technologies, Inc. Mobile Viewer is a trademark of GE Healthcare Finland Oy. Java Powered. Java and all Java based trademarks and logos are trademarks or registered trademarks of Oracle America, Inc. in the U.S. and other countries. All third party trademarks are the property of their respective owners.

Related manual The technical manual provides installation instructions and contact information for persons qualified to perform the installation.

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About this manual

Additional resources For white papers, guides, and other instructive materials about our clinical measurements, technologies, and applications, please visit: http://clinicalview.gehealthcare.com

Revision history

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Revision

Description

2nd edition

Initial release.

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Safety precautions

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Safety message signal words Safety message signal words designate the severity of a potential hazard. The signal words danger, warning, caution, and notice are used throughout this manual to point out hazards and to designate a degree or level of seriousness. A hazard is defined as a source of potential injury to a person. Learn their definitions and significance. DANGER

Indicates a hazardous situation that, if not avoided, will result in death or serious injury.

WARNING

Indicates a hazardous situation that, if not avoided, could result in death or serious injury.

CAUTION

Indicates a hazardous situation that, if not avoided, could result in minor or moderate injury.

NOTICE

Indicates a hazardous situation not related to personal injury that, if not avoided, could result in property damage.

The order in which safety messages are presented in no way implies the order of importance. The following safety messages apply to the system. Safety messages specific to parts of the system are found in the relevant section of this manual.

Danger safety messages No danger safety messages apply to this system.

Warning safety messages The following warning safety messages apply to this system:

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WARNING

ACCESSORIES (SUPPLIES) - To ensure patient safety, use only parts and accessories manufactured or recommended by GE.

WARNING

ACCIDENTAL SPILLS - To avoid electric shock or device malfunction, liquids must not be allowed to enter the device. If liquids have entered a device, take it out of service and have it checked by authorized service personnel before it is used again.

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Safety precautions

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WARNING

ACCURACY - If the accuracy of any value displayed or printed is questionable, first determine the patient's vital signs by alternative means. Then, verify the monitoring devices and printers are working correctly.

WARNING

ACCURACY - Regardless of the units of measurement used to display the values at the monitoring device, the monitoring device sends CO2 values in mmHg, an absolute pressure, to the central station. If the central station is configured to display CO2 in relative values (i.e., percent), a conversion including barometric pressure is used to display relative values. If the accuracy of any value displayed or printed is questionable, refer to the values displayed on the monitoring device.

WARNING

ACCURACY - Regardless of the units of measurement used to display the values at the monitoring device, the monitoring device sends O2 and Gas values in percent, a relative pressure, to the central station. If the central station is configured to display either O2 or Gas in absolute values (i.e., mmHg or kPa), a conversion including barometric pressure is used to display absolute values. If the accuracy of any value displayed or printed is questionable, refer to the values displayed on the monitoring device.

WARNING

ADJUSTING WAVEFORM COLORS - For a locked patient Multi-Viewer window, the color changes remain in effect until a user manually changes the colors. Depending on the bedside monitor and acquisition device, waveform colors may change when removing a parameter from the bedside monitor and then adding it back again (e.g., removing and then re-inserting a TRAM module).

WARNING

ADJUSTING WAVEFORM COLORS - For an unlocked patient Multi-Viewer window, the waveform color changes remain in effect until the patient is removed from the Multi-Viewer, discharged, or the patient is moved to another patient Multi-Viewer window. Depending on the bedside monitor and acquisition device, waveform colors may change when removing a parameter from the bedside monitor and then adding it back again (e.g., removing and then re-inserting a TRAM module).

WARNING

ALARM ACTIVATION - Audio alarms do not sound and visual alarm indicators do not display at the central station until a patient is admitted. The central station will not provide alarm notification if an unadmitted patient enters an alarm condition. You must admit the patient to activate the alarm notification, automatic alarm printing, and events storage.

WARNING

ALARM CONTROL SETTINGS - Parameter alarm limits or alarm priority levels adjusted at the central station are also implemented at the bedside monitor, unless the settings are locked. Always notify the bedside clinician when parameter alarm limits or alarm priority levels are adjusted.

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Safety precautions

WARNING

ALARM LIMITS - Always make sure that necessary alarm limits are active and set according to the patient’s clinical condition when you start monitoring a patient. Setting alarm limits lower than clinically relevant for a patient may result in reduced awareness of patient critical conditions (i.e., alarms).

WARNING

ALARM NOTIFICATION - HIGH (CRISIS) priority level alarms will continue to audibly and visually alarm until the alarm AUDIO PAUSE button or alarm AUDIO PAUSE keyboard key is manually selected.

WARNING

ALARM PRIORITY LEVEL - The CARESCAPE Central Station has different Telemetry Alarm Setup Defaults > Technical Alarm Priorities custom default options than the CIC Pro Clinical Information Center for telemetry monitoring devices. Use the latest version CARESCAPE Central Station in the unit when making changes to the Technical Alarm Priorities custom defaults. Failure to use the latest version CARESCAPE Central Station in the unit will render some options unavailable (e.g., HIGH (CRISIS) alarm priority level). For more information, see the technical manual.

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WARNING

ALARM VOLUME - Adjustment of the minimum alarm volume (Volume Minimum) to a low level or OFF allows the actual volume (Volume Current) to be adjusted to a low level or OFF during monitoring, which may result in a hazard to patients.

WARNING

ALARM VOLUME - Setting the LOW (ADVISORY) priority level audio alarm (Low Priority Alarm Audio OFF) to OFF during monitoring may result in a hazard to the patient.

WARNING

ALARM VOLUME LEVEL - Adjustment of alarm volume to a low level or to a level less than ambient volume levels or off during monitoring may result in a hazard to the patient.

WARNING

ALARMS OFF - The telemetry monitoring device alarms remain off until you manually select On.

WARNING

ARRHYTHMIA DETECTION - Manually changing the arrhythmia detection level to Lethal may result in a missed arrhythmia or adverse patient outcome, as only lethal arrhythmia alarms will be detected. Do not rely exclusively on the audio arrhythmia alarms. Always keep patients under close observation and notify the bedside clinician whenever arrhythmia detection settings are changed. Before changing the setting, assess the patient condition to ensure the change is appropriate for the patient.

WARNING

ARRHYTHMIA DETECTION - Manually changing the arrhythmia detection level to Off may result in a missed arrhythmia or adverse patient outcome, as no arrhythmia alarms will be detected. Always keep patients under close observation and notify the bedside clinician whenever arrhythmia detection settings are changed. Before changing the setting, assess the patient condition to ensure the change is appropriate for the patient.

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Safety precautions

WARNING

AUDIO ALARM PAUSE - Do not continuously try to pause audio alarms. New alarms could be inadvertently paused.

WARNING

AUDIO ALARM PAUSE - Do not rely exclusively on the alarm pause breakthrough feature for alarm notification during an audio alarm pause. This may result in a hazard to the patient as only HIGH (CRISIS) priority alarms break through.

WARNING

AUDIO ALARMS - Some bedside monitors (e.g., CARESCAPE Monitor B850) provide the ability to turn off alarm notifications at the bedside monitor (e.g., sleep mode, display off/alarm off). In the event that a network disconnection occurs, and the central station NO COMM alarm was set to Enable Audio Breakthrough during AUDIO OFF before clinical use, then audio alarm annunciates at the previously set volume along with visual NO COMM notification at the central station for that bedside monitor. For additional information on turning off alarm notifications at the bedside monitors, see the documentation accompanying the bedside monitor. For more information, see the technical manual.

WARNING

AUDIO ALARMS - Some bedside monitors (e.g., CARESCAPE Monitor B850) provide the ability to turn off alarm notifications at the bedside monitor (e.g., sleep mode, display off/alarm off). In the event that a network disconnection occurs, and the central station NO COMM alarm was set to Status Message only or Disable Audio Breakthrough during AUDIO OFF before clinical use, then only a visual NO COMM notification displays at the central station for that bedside monitor. For additional information on turning off alarm notifications at the bedside monitors, see the documentation accompanying the bedside monitor. For more information, see the technical manual.

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WARNING

AUDIO ALARM TONES - To comply with international specifications for alarming (e.g., IEC 60601-1-8), newer devices like the CARESCAPE Central Station and CARESCAPE Monitor B850 use a slightly different order for alarm priorities than older devices like the CIC Pro Clinical Information Center and Dash 3000 patient monitor. This results in occasional differences between audio and/or visual annunciation of alarms between the newer and older devices. Different audio alarm tones may occur from a CARESCAPE Central Station versus a CIC Pro Clinical Information Center for certain combinations of alarms. Across multiple older devices displayed by the same central station, when the two highest alarms are SYSTEM WARNING and physiological LOW (ADVISORY), then CARESCAPE Central Station sounds the MEDIUM (WARNING) audio alarm tone while the CIC Pro Clinical Information Center sounds the LOW (ADVISORY) audio alarm tone.

WARNING

AUDIO ALARM TONES - Use the same audio alarm tones for all monitoring devices within the same unit to reduce the chance of difficulty differentiating between alarm priority levels based on audio alarm tones which could result in missed higher priority alarm.

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