CARESCAPE B450 Supplemental Infomation Manual 1st edition June 2018

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

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Contents 1

About this manual ...13 Intended use of this manual... 13 Intended markets of this manual ... 14 Intended audience of this manual ... 14 About these devices... 15 Safety precautions ... 15 Manual conventions ... 15 Monitor naming conventions ... 15 Acquisition module naming conventions ... 15 Other naming conventions ... 16 Related documents... 16 Ordering manuals ... 17 Product availability ... 17

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Compatible devices ...19 Compatibility ... 19 Acquisition platform compatibility ... 19 Acquisition module compatibility... 19 Identical acquisition modules... 19 PDM compatibility ... 20 E-module compatibility... 20 Frame compatibility ... 21 Input-output device compatibility... 21 Printing device compatibility ... 21 Remote alarm devices ... 22 Display devices... 22 Data collection software... 22 Input devices ... 22 CARESCAPE Network compatibility ... 22 Bedside monitors ... 23 Central stations ... 23 Telemetry monitoring... 23

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Miscellaneous network devices... 23 Unity Network ID compatibility ... 24 Additional information ... 24 12RL compatibility limitations ... 24 3

Compliance...25 Standards compliance... 25 IEC 60601-1 ... 25

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Design, environmental, and physical specifications...27 Design, environmental, and physical specifications... 27 CARESCAPE B450 specifications... 27 WLAN specifications, B450 ... 29 Recorder specifications... 30 USB remote control specifications ... 30 PDM module specifications ... 30 PDM battery specifications... 31 E-PP and E-PT module specifications... 31 E-COP and E-COPSv module specifications... 31 E-PiCCO module specifications ... 32 CARESCAPE respiratory module specifications ... 32 E-miniC module specifications ... 32 E-EEGX module and N-EEGX headbox specifications ... 33 E-ENTROPY module specifications... 33 E-NMT module specifications ... 33 E-BIS module specifications ... 33 E-MASIMO module specifications... 34 E-NSATX module specifications... 34 D19KT VER01 (19 inch displays) specifications... 34

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Alarm specifications...37 Alarm standards compliance ... 37 Auditory alarm volume, IEC tones... 37 Auditory alarm volume, legacy tones ... 38 Audio alarm sound tolerances ... 38 Legacy alarm tone sound patterns... 39 IEC alarm tone sound patterns ... 39

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Remote alarm tone sound patterns... 39 Auditory information signal characteristics ... 39 Visual information signals ... 40 Alarm delay specifications ... 40 Time to alarm for tachycardia... 40 Physiological alarm delay specifications ... 41 Technical alarm delay specifications ... 52 Remote alarm delay specifications... 60 Alarm priorities and escalation times ... 61 Alarm priorities and escalation times for ECG... 61 Alarm priorities and escalation times for impedance respiration... 71 Alarm priorities and escalation times for SpO2 ... 73 Alarm priorities and escalation times for NIBP... 77 Alarm priorities and escalation times for invasive pressures... 78 Alarm priorities and escalation times for temperature ... 87 Alarm priorities and escalation times for cardiac output ... 89 Alarm priorities and escalation times for CCO ... 90 Alarm priorities and escalation times for SvO2 and ScvO2 ... 90 Alarm priorities and escalation times for airway gases ... 92 Alarm priorities and escalation times for spirometry... 98 Alarm priorities and escalation times for gas exchange ... 100 Alarm priorities and escalation times for Entropy... 100 Alarm priorities and escalation times for NMT ... 102 Alarm priorities and escalation times for EEG and AEP ... 103 Alarm priorities and escalation times for BIS ... 104 Alarm priorities and escalation times for TC... 105 Alarm priorities and escalation times for trends, snapshots, and laboratory data ... 106 Alarm priorities and escalation times for various situations ... 107 6

Parameter specifications...113 Parameter specifications... 113 ECG standards compliance ... 113 ECG performance specifications ... 113 Impedance respiration performance specifications... 116

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SpO2 standards compliance ... 117 SpO2 displayed saturation values ... 117 SpO₂ summary of clinical studies used to establish accuracy claims... 117 SpO2 test methods used to establish accuracy claims during motion... 118 SpO₂ test methods used to establish accuracy claims during low perfusion... 119 SpO₂ test methods used to establish pulse rate accuracy... 119 SpO2 performance specifications ... 120 SPI performance specifications... 123 SPI calculations ... 123 NIBP standards compliance ... 123 NIBP performance specifications... 123 Invasive pressure standards compliance ... 124 Invasive pressure performance specifications... 124 Temperature standards compliance... 125 Temperature performance specifications ... 125 C.O. standards compliance... 127 Cardiac output (C.O.) performance specifications... 127 CCO performance specifications... 128 E-PiCCO calculation formulas... 130 SvO2 and ScvO2 performance specifications ... 131 Airway gases standards compliance... 131 Airway gases normal conditions ... 131 Airway gases performance specifications ... 132 Airway gases calculations ... 136 Airway gases CO2 unit conversions ... 137 Spirometry normal conditions... 138 Spirometry performance specifications ... 138 Spirometry calculations ... 139 Gas exchange performance specifications... 140 Gas exchange calculation formulas ... 140 Entropy standards compliance ... 141 Entropy performance specifications... 141

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NMT standards compliance... 142 NMT performance specifications ... 142 EEG standards compliance... 143 EEG performance specifications ... 144 BIS standards compliance ... 145 BIS performance specifications... 145 BIS calculations ... 145 7

Calculation specifications ...147 Drug calculation specifications... 147 Drug calculation formulas ... 147 Resuscitation medications calculations ... 148 Laboratory data calculations ... 148 Hemodynamic calculation specifications ... 149 Hemodynamic calculations input parameter specifications ... 149 Hemodynamic calculations calculated parameter specifications... 149 Hemodynamic calculations calculated parameter formulas... 150 Oxygenation calculation specifications... 151 Oxygenation calculations input parameter specifications... 151 Oxygenation calculations calculated parameter specifications... 152 Oxygenation calculations calculated parameter formulas... 153 Ventilation calculation specifications ... 154 Ventilation calculation input parameter specifications ... 154 Ventilation calculations calculated parameter specifications ... 155 Ventilation calculations calculated parameter formulas ... 155

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Default settings...157 Understanding your monitor configuration ... 157 Software packages ... 157 Software features... 157 Licensed software options... 157 Software profiles ... 158 Software settings ... 159 Care unit settings ... 159 DEMO MODE ... 160

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Profile settings ... 160 Current patient settings ... 160 Configuring care unit settings ... 161 Alarm settings ... 161 Parameter alarms settings ... 163 Screen settings ... 166 Admit/discharge settings... 166 Unit of measure settings... 166 Parameter settings... 170 Drug list settings... 172 Standby site name settings ... 174 Show in Screen Setup settings ... 174 Roving settings ... 175 Telemetry settings... 175 Print settings... 175 Configuring profile settings ... 175 Absolute alarm limit settings ... 176 Alarm delay settings ... 179 V Tach Event Duration Criteria ... 180 Invasive pressures alarms settings ... 180 Invasive pressures colors settings for labels ... 185 Page settings ... 186 Trends and snapshot settings ... 200 Care report settings ... 205 Configuring locking settings... 207 General locking settings ... 207 Parameter locking settings... 207 Alarm locking settings... 208 Configuring Time & Date settings ... 211 Time Format settings ... 212 Configuring current patient settings... 212 Alarm limits settings... 212 Alarm priority settings... 212 Arrhythmia alarm settings... 214

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Audible and visual alarm settings ... 218 Monitor screen settings ... 219 Monitor brightness settings... 219 Invasive pressures color settings for channels ... 219 Other parameters color settings ... 219 Monitor sound settings ... 220 Monitor parameter settings... 221 Waveform printout settings ... 221 Report settings ... 222 Device settings ... 223 Drug calculator settings ... 224 Laboratory data settings ... 224 Calculation settings... 225 Other patients (remote alarm) settings... 225 Admit/discharge or start/end case settings... 226 Trend settings... 227 Parameter default settings... 233 ECG default settings... 233 ST default settings... 239 QT default settings ... 241 Impedance respiration default settings... 242 SpO2 default settings ... 243 SPI default settings... 246 NIBP default settings... 247 Invasive pressures default settings... 249 Temperature default settings ... 258 Cardiac output (C.O.) default settings... 261 CCO default settings ... 262 SvO2 and ScvO2 default settings ... 264 Airway gases default settings ... 264 Spirometry and gas exchange default settings ... 267 Entropy default settings... 269 NMT default settings ... 270 EEG default settings ... 271

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BIS default settings ... 274 Transcutaneous CO2/O2 default settings... 274 9

Maintenance...275 Before any planned maintenance or regular checks ... 275 Planned maintenance for the monitor ... 275 Planned maintenance for the modules ... 275 Recommended regular checks ... 275 Daily checks... 275 Monthly checks... 276 Check every two months ... 276 Check every six months ... 276 Check every 12 months ... 276 Check every 24 months ... 276

10 Supplies and accessories...277 About this list... 277 Ordering information ... 278 Parameter accessories ... 278 ECG accessories ... 278 SpO₂ accessories... 284 Non-invasive blood pressure accessories ... 288 Invasive pressure accessories... 296 Temperature accessories ... 298 Cardiac output accessories ... 299 Continuous cardiac output accessories ... 299 SvO2 and ScvO2 accessories... 300 Gas accessories... 300 Spirometry accessories... 303 Entropy accessories ... 304 NMT accessories ... 305 EEG accessories ... 305 BIS accessories... 306 Non-medical parameter accessories ... 306 Other accessories ... 307 Power cords... 307

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Cables, adapters and accessories ... 307 Recorder paper... 308 Supplies ... 308 Calibration gases and regulators... 308 Cables and cable management supplies ... 308 Mounts ... 310 A

SpO₂ supplemental analysis graphs ...313 Additional accuracy information for Nellcor sensors with E-NSATX and PDM (Nellcor) ... 313 Additional accuracy information for Masimo sensors with PDM (Masimo) and E-MASIMO... 314

B

Electromagnetic compatibility...315 IEC 60601-1-2... 315 Electromagnetic compatibility safety precautions ... 315 Essential performance in EMC ... 316 Electromagnetic emissions ... 317 Electromagnetic immunity ... 318 Electromagnetic immunity for RF ... 318 Recommended separation distances... 320

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About this manual

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Intended use of this manual This manual must be used in conjunction with the user manual for important safety information and detailed instructions for clinical use of these products. Devices and versions not specifically stated are not supported and should not be used with the monitor. The list below indicates the compatible products (brands, models and descriptions as applicable) with which this manual is to be used. Supported products are covered by the manuals that were delivered with those products.

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CARESCAPE B450 MBA313

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CARESCAPE B450–LI MBA313

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CARESCAPE D19KT VER01

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E-COP-01

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E-COPSv-01

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E-PiCCO-00

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E-sCAiO-00

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E-sCAiOV-00

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E-sCAiOVX-00

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E-sCO-00

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E-sCOV-00

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E-sCOVX-00

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E-sCAiOE-00

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E-sCAiOVE-00

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E-miniC-00

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E-MASIMO-00

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E-NSATX-00

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E-PP-00

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E-PT-00

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E-ENTROPY-01

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E-NMT-01

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E-EEGX MJD101

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N-EEGX MJS101

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E-BIS-01

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E-BIS-01-JA

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Patient Data Module

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Patient Data Module GS

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2069156–001 Bedrail Hook Unit, B450

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2017098-001 E-PORT PDM to Host 5 ft

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2017098-003 E-PORT PDM to Host 15 ft

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2017098-005 E-PORT PDM to Host 25 ft

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2017098-007 E-PORT PDM to Host 45 ft

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2087716-002 Cable Assembly EPORT CARESCAPE ONE to Host 1.5 m (5 ft)

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2087716-003 Cable Assembly EPORT CARESCAPE ONE to Host 4.5 m (15 ft)

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2097197-001 Cable Assembly EPORT ETHERNET CARESCAPE ONE to Host 30 m (98.5 ft)

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USB Remote Control

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USB Remote Control GER

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USB Remote Control FRE

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USB Remote Control SWE

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USB Remote Control SPA

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USB Remote Control ITA

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USB Remote Control DUT

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USB Remote Control DAN

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USB Remote Control NOR

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USB Remote Control POR

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USB Remote Control POL

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USB Remote Control CZE

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USB Remote Control FIN

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CARESCAPE RAD, Remote Alarm Device, version MBRA001

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2017842–001 DS1 Sync to Unterm 15 ft Cable

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2024696-001 DS1 Field Termination Kit

Intended markets of this manual This manual is not intended for U.S. FDA-regulated markets because the modules E-sCAiOE, E-sCAiOVE, the Surgical Pleth Index (SPI) measurement, Full PiCCO license, and certain supplies and accessories are not cleared for use by the U.S. FDA.

Intended audience of this manual This manual is intended for clinical professionals. Clinical professionals are expected to have a working knowledge of medical procedures, practices and terminology required to provide patient care. Using the system should never replace nor impede the human intervention and required patient care provided by clinical professionals. This manual is also intended for service representatives and technical personnel who install, maintain, troubleshoot, or repair this device.

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About this manual

About these devices Refer to the user manual for important information about the monitor, including intended use of the device, important safety information and detailed instructions for clinical use of the product.

Safety precautions Refer to the user manual for important system safety messages. Safety messages specific to parts of the system are found in the relevant section. Read all the safety information before using the monitor for the first time.

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

Description

bold

Indicates hardware keys and connectors.

bold italic

Indicates software terms.

italic

Indicates terms for emphasis.

>

Indicates menu options to select consecutively.

select

The word select means choosing and confirming.

acquisition device

A generic term when referring to both the acquisition modules (PDM, E-modules) and the acquisition platform (CARESCAPE ONE).

NOTE

Note statements provide application tips or other useful information.

Monitor naming conventions In this manual, the CARESCAPE B450 is referred to as the monitor. It may also be referred to as B450.

Acquisition module naming conventions In this manual, the following naming conventions are used to refer to different modules and module categories:

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PDM: Patient Data Module

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E-modules: All modules with the prefix E-.

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E-COP, E-COPSv

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E-PiCCO

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Pressure E-modules: E-PP, E-PT

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CARESCAPE respiratory modules: E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE

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E-miniC

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Specialty E-modules: E-NMT, E-EEGX, E-BIS, E-ENTROPY

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SpO2 E-modules: E-NSATX, E-MASIMO

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About this manual

Other naming conventions For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies, Inc., and GE Healthcare Finland Oy. In this manual, CARESCAPE Network is used to refer to both the IX Network and MC Network except where they need to be differentiated. Then they are referred to as IX Network and MC Network. In this manual, the CARESCAPE ONE acquisition platform may also be referred to as CS ONE. In this manual, CARESCAPE Parameters is used as a generic term when referring to all of the following products: Graphic on the CARESCAPE Parameter

Explanation CARESCAPE Parameter for measuring ECG. Note that in the manual, the following name is used instead of the graphic: CARESCAPE ECG. CARESCAPE Parameter for measuring invasive pressures. Note that in the manual, the following name is used instead of the graphic: CARESCAPE Pressure. CARESCAPE Parameter for measuring temperature. Note that in the manual, the following name is used instead of the graphic: CARESCAPE Temperature. CARESCAPE Parameter for measuring CO2 with Respironics LoFlo technology. Note that in the manual, the following name is used instead of the graphic: CARESCAPE CO2. CARESCAPE Parameter for measuring SpO2 with GE TruSignal technology. Note that in the manual, the following name is used instead of the graphic: CARESCAPE SpO2. CARESCAPE Parameter for measuring SpO2 with Masimo SET technology. Note that in the manual, the following name is used instead of the graphic: CARESCAPE SpO2 - Masimo. CARESCAPE Parameter for measuring SpO2 with Nellcor™ sensors with OxiMax™ technology. Note that in the manual, the following name is used instead of the graphic: CARESCAPE SpO2 - Nellcor.

In this manual, CARESCAPE SpO2 device is used as a generic term when referring to all of the following products: CARESCAPE SpO2, CARESCAPE SpO2 - Nellcor, and CARESCAPE SpO2 - Masimo. In this manual, acquisition platform refers to the CARESCAPE ONE.

Related documents

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CARESCAPE B450 User Manual

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CARESCAPE ONE User Manual

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CARESCAPE B450 Service Manual

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Service manuals for acquisition modules

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CARESCAPE Network Configuration Guide

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Marquette 12SL ECG Analysis Program Physician’s Guide

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CARESCAPE Modular Monitors Mounting Solutions

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User documentation for displays

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Service documentation for displays

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Unity Network Interface Device (ID) Operator’s Manual

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CIC Pro Clinical Information Center Operator’s Manual

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CARESCAPE Central Station User’s Manual

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

Product availability NOTE

Due to continual product innovation, design and specifications for these products are subject to change without notice.

Some of the products mentioned in this manual may not be available in all countries. Please consult your local representative for the availability.

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About this manual

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Compatible devices Compatibility

Devices and versions not specifically stated have not been verified and validated to comprise a conforming system with the CARESCAPE B450. In the following sections, compatible devices refer to devices that have been verified to be compliant with the standard 60601–1:2012, 3.1 edition. Supported devices refer to devices that are compatible with the system, but have not been verified to meet the recent standard requirements. Devices and versions listed as supported only: refer to their original user and technical documentation.

Acquisition platform compatibility The monitor is compatible with CARESCAPE ONE with software version 3. For more information, refer to the CARESCAPE ONE manuals.

Acquisition module compatibility Identical acquisition modules WARNING

Do not use identical acquisition modules or modules that map a measurement to the same channel or parameter window. If such modules have been connected, remove the module that has been most recently connected. You can also remove both modules and reconnect the new module after five seconds.

The following modules are considered identical and should not be used simultaneously in the same monitoring system. Module

Simultaneous use

PDM, CARESCAPE ONE

Only one per system.

CARESCAPE respiratory modules E-miniC

Only one per system.

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Compatible devices

Module

Simultaneous use

Exceptions

Only one per system.

E-PiCCO and E-COPSv-01 can be used simultaneously if E-PiCCO measures CCO and E-COPSv-01 measures ScvO2 with only the optical module connected.

E-COP E-COPSv E-PiCCO E-NSATX

Only one per system.

E-MASIMO E-PP

Only one per system.

E-PT

Only one per system.

E-ENTROPY

Only one per system.

E-NMT

Only one per system.

E-EEGX

Only one per system.

E-BIS

Only one per system.

PDM compatibility The monitor is compatible with PDM (product code SPX) software v2.7 (Masimo and Nellcor). In addition, the following modules are supported: PDM (product code SA3) with software v2.3, v2.4, v2.5, and v2.7 (Masimo and Nellcor). Product codes and serial numbers can be found on the device label. SPX and SA3 listed above refer to the first three characters in the serial number on the device label.

E-module compatibility The monitor is compatible with the following modules: ● E-BIS-01 ● E-BIS-01–JA ● E-COP-01 ● E-COPSv-01 ● E-PiCCO-00 ● E-EEGX MJD101, N-EEGX MJS101 ● E-ENTROPY-01 ● E-MASIMO-00 ● E-miniC-00 ● E-NMT-01 ● E-NSATX-00 ● E-PP-00 ● E-PT-00 ● E-sCAiO-00 ● E-sCAiOE-00 ● E-sCAiOV-00 ● E-sCAiOVX-00

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