CARESCAPE B850, B650, B450 Supplemental Information Manual 2nd edition sw ver 3 (3.2)

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... 14 Safety precautions ... 15 Manual conventions ... 15 Monitor naming conventions ... 15 Acquisition module naming conventions ... 16 Other naming conventions ... 16 Related documents... 17 Ordering manuals ... 18 Product availability ... 18

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Compatible devices ...19 Compatibility ... 19 Compliant devices... 19 Acquisition platform compatibility ... 20 Acquisition module compatibility... 20 Identical acquisition modules... 20 PDM compatibility ... 21 E-module compatibility... 21 Frame compatibility ... 22 Input-output device compatibility... 23 Printing device compatibility ... 23 Remote alarm devices ... 23 Display devices... 23 Data collection software... 24 Input devices ... 24 CARESCAPE Network compatibility ... 24 Bedside monitors ... 24 Central stations ... 24

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Telemetry monitoring... 25 Other network devices ... 25 Unity Network ID compatibility ... 25 Additional information ... 25 12RL compatibility limitations ... 25 3

Compliance...27 Standards compliance... 27 IEC 60601-1 ... 27

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Design, environmental, and physical specifications...29 Design, environmental, and physical specifications... 29 CARESCAPE B850 specifications... 29 PRN 50–M+ specifications ... 30 F5 Frame specifications... 30 F7 Frame specifications... 31 CARESCAPE B650 specifications... 32 WLAN specifications, B650 ... 34 CARESCAPE B450 specifications... 34 WLAN specifications, B450 ... 36 Recorder specifications... 37 USB remote control specifications ... 37 PDM module specifications ... 38 PDM battery specifications... 38 E-PP and E-PT module specifications... 38 E-COP and E-COPSv module specifications... 39 E-PiCCO module specifications ... 39 CARESCAPE respiratory module specifications ... 39 E-miniC module specifications ... 40 E-EEGX module and N-EEGX headbox specifications ... 40 E-ENTROPY module specifications... 40 E-NMT module specifications ... 40 E-BIS module specifications ... 41 E-MASIMO module specifications... 41 E-NSATX module specifications... 41 E-musb module specifications ... 42

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D19KT VER01 (19 inch displays) specifications... 42 5

Alarm specifications...45 Alarm standards compliance ... 45 Auditory alarm volume, IEC tones... 45 Auditory alarm volume, legacy tones ... 46 Audio alarm sound tolerances ... 48 Legacy alarm tone sound patterns... 48 IEC alarm tone sound patterns ... 48 Remote alarm tone sound patterns... 49 Auditory information signal characteristics ... 49 Visual information signals ... 49 Alarm delay specifications ... 49 Time to alarm for tachycardia... 50 Physiological alarm delay specifications ... 50 Technical alarm delay specifications ... 62 Remote alarm delay specifications... 74 Alarm priorities and escalation times ... 74 Alarm priorities and escalation times for ECG... 74 Alarm priorities and escalation times for impedance respiration... 82 Alarm priorities and escalation times for SpO2 ... 83 Alarm priorities and escalation times for rSO2 ... 87 Alarm priorities and escalation times for NIBP... 89 Alarm priorities and escalation times for invasive pressures... 91 Alarm priorities and escalation times for temperature ... 99 Alarm priorities and escalation times for cardiac output ... 100 Alarm priorities and escalation times for CCO ... 102 Alarm priorities and escalation times for SvO2 and ScvO2 ... 102 Alarm priorities and escalation times for airway gases ... 104 Alarm priorities and escalation times for spirometry... 112 Alarm priorities and escalation times for gas exchange ... 114 Alarm priorities and escalation times for Entropy... 114 Alarm priorities and escalation times for NMT ... 115 Alarm priorities and escalation times for EEG and AEP ... 116 Alarm priorities and escalation times for BIS ... 118

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Alarm priorities and escalation times for TC... 119 Alarm priorities and escalation times for trends, snapshots, and laboratory data ... 119 Alarm priorities and escalation times for various situations ... 120 6

Parameter specifications...129 Parameter specifications... 129 ECG standards compliance ... 129 ECG performance specifications ... 129 Impedance respiration performance specifications... 132 SpO2 standards compliance ... 133 SpO2 displayed saturation values ... 133 SpO₂ summary of clinical studies used to establish accuracy claims... 133 SpO2 test methods used to establish accuracy claims during motion... 134 SpO₂ test methods used to establish accuracy claims during low perfusion... 135 SpO₂ test methods used to establish pulse rate accuracy... 135 SpO2 performance specifications ... 136 SpHb performance specifications... 139 rSO2 performance specifications ... 139 SPI performance specifications... 140 SPI calculations ... 140 NIBP standards compliance ... 140 NIBP performance specifications... 140 Invasive pressure standards compliance ... 141 Invasive pressure performance specifications... 141 Temperature standards compliance... 142 Temperature performance specifications ... 143 C.O. standards compliance... 144 Cardiac output (C.O.) performance specifications... 144 CCO performance specifications... 146 E-PiCCO calculation formulas... 148 SvO2 and ScvO2 performance specifications ... 149 Airway gases standards compliance... 149

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Airway gases normal conditions ... 150 Airway gases performance specifications ... 150 Airway gases calculations ... 155 Airway gases CO2 unit conversions ... 156 Spirometry normal conditions... 156 Spirometry performance specifications ... 156 Spirometry calculations ... 157 Gas exchange performance specifications... 158 Gas exchange calculation formulas ... 159 Entropy standards compliance ... 160 Entropy performance specifications... 160 NMT standards compliance... 161 NMT performance specifications ... 161 EEG standards compliance... 162 EEG performance specifications ... 162 BIS standards compliance ... 163 BIS performance specifications... 163 BIS calculations ... 164 7

Calculation specifications ...165 Drug calculation specifications... 165 Drug calculation formulas ... 165 Resuscitation medications calculations ... 166 Laboratory data calculations ... 166 Hemodynamic calculation specifications ... 167 Hemodynamic calculations input parameter specifications ... 167 Hemodynamic calculations calculated parameter specifications... 167 Hemodynamic calculations calculated parameter formulas... 168 Oxygenation calculation specifications... 169 Oxygenation calculations input parameter specifications... 169 Oxygenation calculations calculated parameter specifications... 170 Oxygenation calculations calculated parameter formulas... 171 Ventilation calculation specifications ... 172 Ventilation calculation input parameter specifications ... 172

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Ventilation calculations calculated parameter specifications ... 173 Ventilation calculations calculated parameter formulas ... 173 8

Default settings...175 Understanding your monitor configuration ... 175 Software packages ... 175 Software features... 175 Licensed software options... 175 Software profiles ... 176 Software settings ... 177 Care unit settings ... 177 DEMO MODE ... 178 Profile settings ... 178 Current patient settings ... 179 Configuring care unit settings ... 179 Alarm settings ... 179 Parameter alarms settings ... 181 Screen settings ... 184 Admit/discharge settings... 184 Unit of measure settings... 184 Parameter settings... 188 Drug list settings... 190 Standby site name settings ... 192 Show in Screen Setup settings ... 192 Roving settings ... 193 Telemetry settings... 193 Print settings... 193 Configuring profile settings ... 193 Absolute alarm limit settings ... 194 Alarm delay settings ... 198 V Tach Event Duration Criteria ... 198 Invasive pressures alarms settings ... 198 Invasive pressures colors settings for labels ... 203 Page settings ... 204 Trends and snapshot settings ... 218

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Care report settings ... 224 Configuring locking settings... 225 General locking settings ... 225 Parameter locking settings... 225 Alarm locking settings... 226 Configuring Time & Date settings ... 229 Time Format settings ... 230 Configuring current patient settings... 230 Alarm limits settings... 230 Alarm priority settings... 230 Arrhythmia alarm settings... 232 Audible and visual alarm settings ... 236 Monitor screen settings ... 237 Monitor brightness settings... 237 Invasive pressures color settings for channels ... 237 Other parameters color settings ... 238 Monitor sound settings ... 239 Monitor parameter settings... 239 Waveform printout settings ... 239 Report settings ... 240 Device settings ... 241 Drug calculator settings ... 242 Laboratory data settings ... 243 Calculation settings... 243 Other patients (remote alarm) settings... 243 Admit/discharge or start/end case settings... 244 Trend settings... 246 Parameter default settings... 251 ECG default settings... 251 ST default settings... 258 QT default settings ... 260 Impedance respiration default settings... 260 SpO2 default settings ... 261 rSO2 default settings ... 266

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SPI default settings... 266 NIBP default settings... 266 Invasive pressures default settings... 268 Temperature default settings ... 279 Cardiac output (C.O.) default settings... 282 CCO default settings ... 282 SvO2 and ScvO2 default settings ... 284 Airway gases default settings ... 285 Spirometry and gas exchange default settings ... 288 Entropy default settings... 290 NMT default settings ... 291 EEG default settings ... 292 BIS default settings ... 294 Transcutaneous CO2/O2 default settings... 295 9

Maintenance...297 Before any planned maintenance or regular checks ... 297 Planned maintenance for the monitor ... 297 Planned maintenance for the modules ... 297 Regular checks ... 297 Daily checks... 297 Check every two months ... 298 Check every six months ... 298 Check every 12 months ... 298 Check every 24 months ... 298

10 Supplies and accessories...299 About supplies and accessories... 299 Ordering information ... 299 A

SpO₂ supplemental analysis graphs ...301 Additional accuracy information for Nellcor sensors with E-NSATX and PDM (Nellcor) ... 301 Additional accuracy information for Masimo sensors... 302

B

Electromagnetic compatibility...307 IEC 60601-1-2... 307 Electromagnetic compatibility safety precautions ... 307

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Essential performance in EMC ... 308 Entropy accessories and electromagnetic compatibility ... 310 EEG accessories and electromagnetic compatibility... 310 BIS accessories and electromagnetic compatibility ... 311 Electromagnetic emissions ... 311 Electromagnetic immunity ... 312 Electromagnetic immunity for RF ... 313 Recommended separation distances... 314 Proximity field immunity compliance... 315

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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 CARESCAPE B850, CARESCAPE B650, or CARESCAPE B450. 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 B850, version MBC323

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CARESCAPE B650, version MBB323

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CARESCAPE B450, version MBA323

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CARESCAPE Software version 3 (3.2)

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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

CARESCAPE B850, B650, B450

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About this manual

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E-EEGX, version MJD101

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N-EEGX, version MJS101

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E-BIS-01

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E-BIS-01-JA

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E-musb, version MJU101

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Patient Data Module

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Patient Data Module GS

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PRN 50–M+

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Frame F5–01

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Frame F7–01

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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

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.

About these devices Refer to the user manual for important information about the CARESCAPE B850, CARESCAPE B650, and CARESCAPE B450, including intended use of these devices,

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About this manual

important safety information and detailed instructions for clinical use of these products.

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 B850, CARESCAPE B650 and CARESCAPE B450 are referred to as the monitor when a function or a feature applies to all three. For describing monitor-specific issues, the monitors are referred to as B850, B650 and B450, respectively. Where possible, the following icons are also used to help identify the monitor: Icon

Explanation

All Bx50 monitors: B850, B650, B450.

B850 and B650 only.

B650 and B450 only.

B850 and B450 only.

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Icon

Explanation

B850 only.

B650 only.

B450 only.

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

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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CARESCAPE Parameter interface module: E-musb

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:

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About this manual

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 regional oxygen saturation of blood (rSO2) in cerebral and somatic tissues with INVOS technology. Note that in the manual, the following name is used instead of the graphic: CARESCAPE rSO2. 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 - LoFlo. CARESCAPE Parameter for measuring end-tidal carbon dioxide (EtCO2), FiCO2, and respiration rate with Microstream technology. Note that in the manual, the following name is used instead of the graphic: CARESCAPE CO2 - Microstream. 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 rainbow 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 CO2 is used as a generic term when referring to all of the following products: CARESCAPE CO2 - LoFlo and CARESCAPE CO2 - Microstream. 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. In this manual, the following product names are used as generic terms: ●

D-lite when referring to D-lite, D-lite+, and D-lite++

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Pedi-lite when referring Pedi-lite and Pedi-lite+

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D-fend Pro when referring to D-fend Pro and D-fend Pro+

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D-lite(+) when referring to D-lite and D-lite+. Does not apply to D-lite++.

Related documents ●

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CARESCAPE B850, B650, B450 User Manual

CARESCAPE B850, B650, B450

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About this manual

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CARESCAPE ONE User Manual

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CARESCAPE B850 Service Manual

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CARESCAPE B650 Service Manual

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CARESCAPE B450 Service Manual

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Service manuals for acquisition modules and module frames

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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) User's Manual

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CARESCAPE Central Station User’s Manual

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Cleaning and Disinfecting Supplement

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Supplies and Accessories Supplement

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Instructions for use for CARESCAPE rSO2 - INVOS

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Instructions for use for CARESCAPE CO2 - Microstream

For a list of third-party or open-source software included in the device, please contact your GE service representative.

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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Compatible devices Compatibility

Devices and versions not specifically stated have not been verified and validated to comprise a conforming system with the CARESCAPE monitors. Devices and versions listed as supported only: refer to their original user and technical documentation.

Compliant devices The devices listed in the following table have been verified to be compliant with the standard 60601–1:2012, 3.1 edition: Acquisition platform

CARESCAPE ONE with software version 3.2

PDM

PDM (product code SPX) software v2.8 (Masimo and Nellcor).

E-modules

E-BIS-01

E-NSATX-00

E-BIS-01–JA

E-PP-00

E-COP-01 E-COPSv-01

E-PT-00 E-sCAiO-00 (product code SUA)

E-PiCCO-00

E-sCAiOE-00 (product code SUA)

E-EEGX MJD101, N-EEGX MJS101 E-ENTROPY-01

E-sCAiOV-00 (product code SUA) E-sCAiOVX-00 (product code SUA)

E-MASIMO-00

E-sCAiOVE-00 (product code SUA)

E-miniC-00 (product code SUB) E-musb MJU101, with:

E-sCO-00 (product code SUA) E-sCOV-00 (product code SUA)

● CARESCAPE rSO2

E-sCOVX-00 (product code SUA)

● CARESCAPE CO2 - Microstream

E-NMT-01

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Compatible devices

Frames

F0 docking station Frame F5-01 and Frame F7-01

Peripherals

PRN 50-M+ Digital Writer (DDW 2") v3A CARESCAPE RAD, version MBRA001 CARESCAPE D19KT VER01 2093421–001 USB Barcode Reader and Mount 2077698–001 USB Mouse 2077699–0xx USB Washable Keyboards 2039040-0xx USB Remote Unity Network ID v10A

Acquisition platform compatibility The monitor is compatible with CARESCAPE ONE with software version 3.2. The monitor supports the following devices: ● CARESCAPE ONE with software version 3.0

For more information, refer to the CARESCAPE ONE manuals.

Acquisition module compatibility Identical acquisition modules WARNING

PATIENT SAFETY. 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. In some cases, using identical modules may lead to misinterpretations and therefore compromise the patient safety.

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.

E-musb, CARESCAPE ONE

Only one per system.

E-musb

Only one per system.

CARESCAPE respiratory modules E-miniC

Only one per system.

E-COP E-COPSv

Only one per system.

E-PiCCO

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Exceptions

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.

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