CARESCAPE Central Station MP100 Users Manual Sw Ver 1 July 2014

The information in this manual applies to the software and hardware version listed 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. 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.

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CARESCAPE Central Station

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Contents 1

About this manual ...11 Manual intended use ... 11 Manual conventions ... 11 Illustrations and names ... 11 Common terms ... 11 Ordering manuals ... 12 Related manuals ... 12 Additional resources ... 12 Revision history ... 13

2

Safety precautions...15 Safety message signal words... 15 Danger safety messages... 15 Warning safety messages... 15 Caution safety messages ... 25 Notice safety messages ... 27 Safety symbols ... 27 Safety tests... 28 Verifying proper operation ... 28 Safely turning off the device... 30

3

About this system ...31 Intended use... 31 User profile ... 31 Required training and skills ... 32 CE marking information... 32 Device classification ... 32 Manufacturer responsibility ... 33 System components ... 33 Processing unit ... 33 Primary display... 34 Secondary display ... 34 Mirrored central displays ... 34

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Remote display... 35 Keyboard and mouse... 35 External speakers... 36 Laser printer ... 36 Writer ... 36 Device symbols ... 36 4

About this software ...41 Configuration levels ... 41 Multi-Viewer overview ... 42 Patient Multi-Viewer window overview ... 43 Single Viewer overview... 44 User interface symbols ... 45 Multi-Viewer user-level defaults overview ... 49 Adjusting Auto Display user-level defaults ... 49 Adjusting parameter color and size user-level defaults ... 50 Patient Multi-Viewer window control settings... 51 Adjusting displayed waveform control settings ... 51 Adjusting waveform color control settings... 52 Adjusting Real-time Trend Graph control settings ... 53 Parameter control settings overview... 54 ECG control settings overview... 55 Adjusting SPO2 control settings ... 59 Adjusting Respiration control settings ... 60 Adjusting CO2 control settings ... 61 Pressures control settings... 62

5

Managing patients...67 Monitoring modes overview... 67 Adjusting patient Multi-Viewer windows overview... 70 Adding patient Multi-Viewer windows ... 70 Using Auto Display ... 71 Rearranging patient Multi-Viewer windows ... 72 Swapping patient Multi-Viewer windows ... 72 Removing unlocked patient Multi-Viewer windows... 73 Admitting patients overview ... 73

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Admitting Standard monitoring patients... 75 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 ... 81 Admitting new telemetry patients... 81 Moving telemetry patients to another in-unit bed... 82 Replacing telemetry monitoring devices... 83 Viewing other patients... 83 6

Alarms ...85 Alarm safety precautions ... 85 Alarm conditions ... 88 Alarm system diagram ... 88 Alarm priority levels ... 89 Audio alarm tones... 91 Visual alarm indicators ... 92 Adjusting alarm volume... 95 Pausing audio alarms ... 96 Adjusting alarm control settings overview... 98 Adjusting bedside monitor alarm control settings... 100 Adjusting telemetry monitoring device alarm control settings ... 101

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Data review tools...105 Time focus ... 105 Full Disclosure overview ... 105 Adjusting Full Disclosure user-level defaults ... 106 Using FD Strip ... 108 Using FD Page ... 110 Printing FD Page... 112 Using Data Sessions ... 113 Events overview ... 116

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Selecting Event Source ... 116 Viewing events ... 117 Reviewing events ... 120 Deleting events... 120 Annotating events ... 121 Printing events... 122 Creating event reports ... 122 Trends overview ... 123 Using Graphic Trends... 124 Using Numeric Trends... 126 Using Calipers... 127 Enabling ST Monitoring Status indicator... 131 Using ST Review ... 132 Using Browser ... 137 8

Printing...139 Adjusting printer control settings... 139 Manually printing ECG strips ... 140 Printing all parameter alarm limits and waveforms ... 140 Automatic alarm printouts ... 141 Stop printing ... 141 Supported printouts... 142

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Maintenance...147 Maintenance overview ... 147 Cleaning safety precautions... 147 Permitted cleaning agents ... 148 Harmful cleaning agents ... 148 Results of improper cleaning... 149 Cleaning external surfaces... 149 Cleaning displays and touchscreens ... 150 Disinfecting external surfaces... 150 Touchscreen display guidelines ... 151 Writer maintenance... 151 Changing writer paper... 151 Storing writer paper ... 152

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A

Alarm characteristics...153 Audio alarm tone characteristics... 153 IEC HIGH audio alarm tone characteristics ... 153 IEC MEDIUM audio alarm tone characteristics... 153 IEC LOW audio alarm tone characteristics... 153 Legacy CRISIS audio alarm tone characteristics... 154 Legacy WARNING audio alarm tone characteristics ... 154 Legacy SYSTEM WARNING audio alarm tone characteristics ... 154 Legacy ADVISORY audio alarm tone characteristics ... 154 Legacy SYSTEM ADVISORY audio alarm tone characteristics ... 154 Alarm Audio Off Reminder alarm tone characteristics ... 154 Audio alarm tone sound pressure ranges overview... 154 IEC audio alarm tone sound pressure ranges ... 155 Legacy audio alarm tones sound pressure ranges... 155 Visual alarm indicator characteristics ... 155

B

Supported parameters...157 Supported parameters overview ... 157 Arterial Blood Gas (ABG/POC) supported parameters ... 159 Arterial (AR/ART) pressure supported parameters ... 161 Bispectral Index (BIS/BISm) supported parameters... 162 Carbon Dioxide (CO2) supported parameters ... 163 Cardiac Calculations (CC) supported parameters... 164 Cardiac Output (CO) supported parameters ... 165 Central Venous pressure (CV/CVP) supported parameters ... 166 Continuous Cardiac Output (CCO) supported parameters ... 167 Electrocardiograph (ECG) supported parameters... 168 Electroencephalograph (EEG) supported parameters ... 172 Femoral (FE/FEM) pressure supported parameters ... 173 Impedance Cardiography (ICG) supported parameters ... 174 Intra-Cranial Pressure (ICP) supported parameters... 175 Left Atrial (LA) pressure supported parameters ... 176 Mass Spectrometry (Gas) supported parameters ... 177 Non-Invasive Blood Pressure (NBP) supported parameters... 180 Non-Invasive Cardiac Output (NICO) supported parameters... 181

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Pulmonary Artery (PA) pressure supported parameters... 182 Pulmonary Calculations (PC/estPC) supported parameters... 183 Right Atrial (RA) pressure supported parameters... 186 Respiration (RESP) supported parameters... 187 Respiratory Mechanics (RM) supported parameters ... 188 Special (SP) pressure supported parameters ... 190 SPO2 (SPO2m/SPO2x) supported parameters ... 191 SVO2 supported parameters... 193 Temperature (TP/TEMP) supported parameters... 194 Transcutaneous CO2 (TC/TCm) supported parameters... 196 Umbilical Artery (UA/UAC) pressure supported parameters ... 197 Umbilical Venous (UV/UVC) pressure supported parameters ... 198 Ventilator (VENT) supported parameters... 199 C

Messages ...205 Monitoring device messages... 205 Central station system status messages... 214

D

Factory presets ...217 Factory presets overview ... 217 Central Defaults factory presets ... 217 Telemetry factory presets... 218 Telemetry Unit Defaults factory presets ... 218 Telemetry Parameter Limits and Alarm Levels factory presets... 219 Telemetry Arrhythmia Alarm Levels factory presets... 220 Telemetry Technical Alarm Priorities factory presets... 220 Display Configuration factory presets ... 221 Full Disclosure Defaults factory presets ... 222 FD Page factory presets ... 222 Graphic Trends Groups factory presets... 222 Numeric Trends Groups factory presets... 224 ST Review factory presets ... 226

E

Custom defaults and settings ...227 Custom defaults and settings overview ... 227 Central Defaults settings ... 227 Telemetry custom defaults overview... 228

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Telemetry Unit Defaults custom defaults ... 228 Telemetry Parameter Limits and Alarm Levels custom defaults... 229 Telemetry Arrhythmia Alarm Levels custom defaults... 230 Telemetry Technical Alarm Priorities custom defaults... 231 Display Configuration settings ... 232 Full Disclosure Defaults settings ... 233 FD Page settings ... 233 Graphic Trends Groups settings... 234 Numeric Trends Groups settings... 236 ST Review settings ... 239 Save As Favorites settings... 240 F

Additional information...243 Alarm AUDIO PAUSE known issue ... 243 Combination monitoring known issue... 243 ST segment deviation values known issue... 244 Manual Full Disclosure data collection known issue ... 244

G

Glossary ...245 Glossary ... 245

H

Abbreviations and symbols ...253 Abbreviations ... 253 Symbols ... 264

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About this manual

1

Manual intended use This manual is an integral part of the system. It should always be kept close to the system. Observance of the manual is a prerequisite for proper performance and correct operation and ensures patient and user safety. This publication conforms with the specifications and applicable IEC publications on safety and essential performance, as well as applicable UL and CSA requirements and AHA recommendations.

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.

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

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About this manual

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 appear 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.

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.

Related manuals The release notes supplement is created on an as needed basis. If provided, this supplement should be read prior to reading the documents listed below. Release notes provide one or more of the following: updates to this document and/or the document(s) below, additional information, and workarounds. The technical manual provides installation instructions and contact information for persons qualified to perform the installation. The supplies and accessories supplement provides information on supplies and accessories approved for use with this system. The compatible devices supplement provides information on compatible devices approved for use with this system. The technical specifications supplement provides information on the physical and design characteristics of this system.

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

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About this manual

Revision history The part number and revision letter for this manual are at the bottom of each page. The revision letter changes whenever the manual is revised. The first letter shown in the following table is the first customer-released version of this manual.

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Revision

Description

E

Initial release.

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About this manual

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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

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.

WARNING

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

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Safety precautions

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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 on the screen 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 on the screen 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.

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).

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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 accompanying the central station.

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WARNING

ALARM VOLUME - Adjustment of the minimum alarm volume to a low level or off may allow the actual volume to be adjusted to a low level or off during monitoring, which may result in a hazard to patients.

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.

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.

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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 AUDIO was set to Disable before clinical use, then only a visual NO COMM notification appears 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 additional information about NO COMM AUDIO configuration, see the central station technical manual.

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 verses 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 - GE recommends using 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.

WARNING

AUDIO ALARMS - Do not rely exclusively on the audio alarm system for monitoring. Remember that the most reliable method of monitoring combines close personal surveillance with correct operation of monitoring devices.

WARNING

AUDIO ALARMS - Audio alarms will not sound at the central station when a bedside monitor is configured for use in operating rooms.

WARNING

AUDIO ALARMS - The functions of the alarm system must be verified at regular intervals. Check speaker volume of all connected speakers periodically to ensure audio alarm functionality.

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Safety precautions

WARNING

BEFORE INSTALLATION - Compatibility is critical to safe and effective use of this device. Only external devices specifically designed to be connected to the CARESCAPE Central Station, or approved by GE for use with the CARESCAPE Central Station, should be connected, as specified in this manual or as otherwise specified by the manufacturer. To avoid possible reduced system performance, please contact your local GE representative prior to installation to verify equipment compatibility.

WARNING

BEFORE USE - Before putting the system into operation, visually inspect all connecting cables for signs of damage. Damaged cables and connections must be replaced immediately. Before using the system, the user must verify that it is in correct working order and operating condition. Periodically, and whenever the integrity of the product is in doubt, test all functions. Consult the technical manual for information related to installation of this device prior to clinical use.

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WARNING

DISCONNECTION FROM MAINS - When disconnecting the system from the power line, remove the plug from the wall outlet first. Then you may disconnect the power cord from the device. If you do not observe this sequence, there is a risk of coming into contact with line voltage by inserting metal objects, such as the pins of leadwires, into the sockets of the power cord by mistake.

WARNING

EXCESSIVE LEAKAGE CURRENT - Do not place non-medical grade devices (e.g., laser printers, remote displays) within the patient environment without an additional isolating or separating transformer providing basic isolation to avoid unacceptable enclosure leakage current.

WARNING

EXCESSIVE LEAKAGE CURRENT - Do not use a multiple socket outlet or extension cord.

WARNING

EXCESSIVE LEAKAGE CURRENT - Do not plug the CARESCAPE Central Station into a power strip used by other non-medical grade devices, such as a laser printer. Laser printers are UL 60950/IEC 60950 certified equipment, which may not meet the leakage current requirements of patient care equipment. This equipment must not be located in the patient environment unless the medical system standard EN 60601-1-1 is followed. Do not connect a laser printer to a multiple socket outlet supplying patient care equipment. The use of multiple socket outlet for a system will result in an enclosure leakage current equal to the sum of all the individual earth leakage currents of the system if there is an interruption of the multiple socket outlet protective earth conductor. Consult authorized service personnel before installing a laser printer.

WARNING

EXPLOSION HAZARD - Do not use this device in the presence of flammable anesthetics, vapors, or liquids, or in an oxygen-rich environment.

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Safety precautions

WARNING

INCORRECT ALGORITHMS, ARRHYTHMIA PROCESSING, AND CALCULATIONS BASED ON PATIENT AGE - After manually updating or automatically retrieving patient information from a network database, always confirm that the entered patient's date of birth matches the patient's actual date of birth. Otherwise the appropriate age-related algorithms, arrhythmia detection, and calculations will not be applied.

WARNING

INSTRUCTIONS FOR USE - For continued safe use of this device, it is necessary that the listed instructions are followed. However, instructions listed in this manual in no way supersede established medical practices concerning patient care.

WARNING

INTENDED USE - This device is for use by qualified medical personnel only.

WARNING

INTERFACING OTHER DEVICES - Devices may only be interconnected with each other or to parts of the system when it has been determined by authorized service personnel that there is no danger to the patient, the user, or the environment as a result. In those instances where there is any element of doubt concerning the safety of connected devices, the user must contact the manufacturers concerned (or other informed experts) for proper use. In all cases, safe and proper operation should be verified with the applicable manufacturer's instructions for use and system standards IEC 60601-1-1/EN 60601-1-1 must be complied with.

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WARNING

LOSS OF DATA - If the bedside monitor does not automatically resume operation after 60 seconds, power cycle the monitor using the power on/off switch. Use alternative monitoring devices or close patient observation until monitoring at the central station is restored. Once monitoring at the central station has been restored, check the monitoring state and alarm system function. If monitoring is not restored, contact authorized service personnel.

WARNING

LOSS OF MONITORING - Do not use viewing Other Patients as a substitute for having enough patient Multi-Viewer windows configured to display in the Multi-Viewer to support all patients monitored in a care unit. Loss of monitoring at the central station may result.

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