CARESCAPE Modular Monitors Supplemental Information Manual rev 2 Dec 2012

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

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Compatible devices ...17 Compatibility ... 17 Parameter measurement modules compatibility ... 17 PDM compatibility ... 17 TRAM module compatibility... 18 PSM compatibility... 18 Hemodynamic E-module and M-module compatibility... 18 Other E-module compatibility ... 18 TRAM-Rac module compatibility ... 19 TRAM-Rac and Frame compatibility ... 20 TRAM serial interface compatibility ... 20 Input-output device compatibility... 21 Printing device compatibility ... 21 Remote alarm devices ... 21 Display devices... 21 Data collection software... 22 Input devices ... 22 CARESCAPE Network compatibility ... 22 Bedside monitors ... 22

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Central stations ... 23 Telemetry monitoring... 23 Miscellaneous network devices... 23 Unity Network ID compatibility ... 23 S/5 Network 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 Monitor B850 CPU (C1-CPU) specifications ... 27 M-Port keypad specifications ... 28 PRN 50–M specifications... 29 F5 Frame specifications... 29 F7 Frame specifications... 30 CARESCAPE Monitor B650 specifications... 30 WLAN specifications, B650 ... 32 CARESCAPE Monitor B450 specifications... 33 WLAN specifications, B450 ... 35 Recorder specifications... 36 E-PSM, E-PSMW, E-PSMP and E-PSMPW module specifications ... 36 PDM specifications ... 37 PDM battery specifications... 37 E-P, E-PP, and E-PT module specifications ... 38 E-sCAiO, E-sCAiOV, E-sCO, and E-sCOV module specifications... 38 E-CAiO, E-CAiOV, E-CAiOVX, E-CO, E-COV, and E-COVX module specifications... 38 E-COP and E-COPSv module specifications... 39 E-miniC module specifications ... 39 CapnoFlex LF CO2 module specifications ... 39 E-EEG module specifications ... 40 E-ENTROPY module specifications... 40

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E-NMT module specifications ... 40 E-BIS module specifications ... 40 E-MASIMO module specifications... 41 E-NSATX module specifications... 41 D15K (15 inch display) specifications ... 41 D19KT (19 inch display) specifications ... 43 5

Alarm specifications...45 Alarm standards compliance ... 45 Auditory alarm volume ... 45 Audio alarm sound tolerances ... 47 Legacy alarm tone sound patterns... 47 IEC alarm tone sound patterns ... 47 Remote alarm tone sound patterns... 48 Auditory information signal characteristics ... 48 Visual information signals ... 48 Remote alarm light ... 48 Alarm delay specifications ... 49 Time to alarm for tachycardia... 49 Physiological alarm delay specifications ... 51 Technical alarm delay specifications ... 60 Remote alarm delay specifications... 67 Alarm priorities and escalation times ... 67 Alarm priorities and escalation times for ECG... 67 Alarm priorities and escalation times for impedance respiration... 78 Alarm priorities and escalation times for SpO2 ... 79 Alarm priorities and escalation times for NIBP... 84 Alarm priorities and escalation times for invasive pressures... 86 Alarm priorities and escalation times for temperature ... 92 Alarm priorities and escalation times for cardiac output ... 94 Alarm priorities and escalation times for SvO2 ... 95 Alarm priorities and escalation times for airway gases ... 96 Alarm priorities and escalation times for Patient Spirometry ... 102 Alarm priorities and escalation times for gas exchange ... 104 Alarm priorities and escalation times for Entropy... 104

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Alarm priorities and escalation times for NMT ... 105 Alarm priorities and escalation times for EEG and AEP ... 106 Alarm priorities and escalation times for BIS ... 107 Alarm priorities and escalation times for TC... 108 Alarm priorities and escalation times for trends, snapshots, and laboratory data ... 109 Alarm priorities and escalation times for various situations ... 110 6

Parameter specifications...117 Parameter specifications... 117 ECG standards compliance ... 117 ECG performance specifications ... 117 Impedance respiration performance specifications... 122 SpO2 standards compliance ... 122 SpO2 displayed saturation values ... 123 SpO2 summary of clinical studies used to establish accuracy claims... 123 SpO2 test methods used to establish accuracy claims during motion... 124 SpO2 test methods used to establish accuracy claims during low perfusion... 125 SpO2 test methods used to establish pulse rate accuracy ... 125 SpO2 performance specifications ... 126 NIBP standards compliance ... 130 NIBP performance specifications... 130 Invasive pressure standards compliance ... 132 Invasive pressure performance specifications... 132 Temperature standards compliance... 134 Temperature performance specifications ... 134 Cardiac output (C.O.) performance specifications... 135 SvO2 performance specifications... 136 Airway gases standards compliance... 136 Airway gases performance specifications ... 137 Airway gases calculations ... 143 Airway gases CO2 unit conversions ... 144 Patient Spirometry performance specifications... 144

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Patient Spirometry calculations ... 147 Gas exchange performance specifications... 147 Gas exchange calculation formulas ... 148 Entropy standards compliance ... 149 Entropy performance specifications... 149 NMT standards compliance... 151 NMT performance specifications ... 151 EEG standards compliance... 152 EEG performance specifications ... 152 BIS standards compliance ... 154 BIS performance specifications... 154 BIS calculations ... 154 7

Calculation specifications ...157 Drug calculation specifications... 157 Drug calculation formulas ... 157 Resuscitation medications calculations ... 158 Laboratory data calculations ... 158 Hemodynamic calculation specifications ... 159 Hemodynamic calculations input parameter specifications ... 159 Hemodynamic calculations calculated parameter specifications... 159 Hemodynamic calculations calculated parameter formulas... 160 Oxygenation calculation specifications... 161 Oxygenation calculations input parameter specifications... 161 Oxygenation calculations calculated parameter specifications... 162 Oxygenation calculations calculated parameter formulas... 163 Ventilation calculation specifications ... 164 Ventilation calculation input parameter specifications ... 164 Ventilation calculations calculated parameter specifications ... 165 Ventilation calculations calculated parameter formulas ... 165

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Default settings...167 Understanding your monitor configuration ... 167 Software packages ... 167 Software features... 167

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Licensed software options... 167 Software profiles ... 168 Software settings ... 169 Care unit settings ... 169 Profile settings ... 170 Current patient settings ... 170 Configuring care unit settings ... 170 Alarm settings ... 171 Screen settings ... 173 Admit/discharge settings... 173 Unit of measure settings... 173 Parameter settings... 177 Drug list settings... 180 Standby site name settings ... 182 Print settings... 182 Configuring profile settings ... 182 Absolute alarm limit settings ... 183 Page settings ... 187 Trends and snapshot settings ... 201 Care report settings ... 207 Configuring locking settings... 208 General locking settings ... 208 Parameter locking settings... 208 Alarm locking settings... 209 Configuring current patient settings... 213 Alarm limits settings... 213 Alarm priority settings... 213 Arrhythmia alarm settings... 215 Audible and visual alarm settings ... 223 Monitor screen settings ... 224 Monitor brightness settings... 224 Invasive pressures color settings ... 224 Other parameters color settings ... 225 Monitor sound settings ... 226

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Monitor parameter settings... 227 Waveform printout settings ... 227 Report settings ... 227 Device settings ... 228 Drug calculator settings ... 229 Laboratory data settings ... 230 Calculation settings... 230 Other patients (remote alarm) settings... 230 Admit/discharge or start/end case settings... 231 Trend settings... 233 Parameter default settings... 236 ECG default settings... 236 ST default settings... 241 QT default settings ... 243 Impedance respiration default settings... 244 SpO2 default settings ... 245 NIBP default settings... 247 Invasive pressures default settings... 249 Temperature default settings ... 261 Cardiac Output (C.O.) default settings ... 264 SvO2 default settings... 264 Airway gases default settings ... 265 Patient Spirometry and gas exchange default settings ... 268 Entropy default settings... 270 NMT default settings ... 271 EEG default settings ... 272 BIS default settings ... 275 Transcutaneous CO2/O2 default settings... 275 9

Maintenance...277 Planned maintenance for the monitor ... 277 Planned maintenance for the modules ... 277 Recommended regular checks ... 277 Daily checks... 277 Monthly checks... 277

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Check every two months ... 278 Check every six months ... 278 Once a year checks... 278 10 Supplies and accessories...279 About this chapter ... 279 Ordering information ... 279 Accessories... 279 ECG accessories ... 280 SpO2 accessories... 290 TruSignal SpO2 accessories ... 290 Masimo SpO2 accessories ... 291 Nellcor OxiMax accessories... 293 Non-invasive blood pressure accessories ... 295 Invasive pressure accessories... 303 Temperature accessories ... 304 Cardiac output accessories... 306 SvO2 accessories... 306 Gas accessories ... 306 Patient Spirometry accessories... 312 Entropy accessories... 314 NMT accessories ... 315 EEG accessories ... 315 BIS accessories... 316 Cables and cable management accessories ... 317 Power cords... 319 Mounting solutions ... 321 B850 CPU mounts ... 321 Display mounts... 321 Arm, wall, and ceiling mounts ... 321 Frame mounts ... 322 PDM mounts ... 322 PSM mounts... 322 Input device mounts ... 323 PRN–50 recorder mounts ... 323

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Unity Network Interface Device (ID) mounts ... 323 Roll stands ... 323 Other mounts ... 323 Other accessories ... 324 A

Electromagnetic compatibility...325 IEC 60601-1-2... 325 Electromagnetic compatibility safety precautions ... 325 Electromagnetic emissions ... 326 Electromagnetic immunity ... 326 Recommended separation distances... 328

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About this manual

1

Intended use of this manual This manual must be used in conjunction with the CARESCAPE Modular Monitors User's 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 Monitor B850, CARESCAPE Monitor B650, or CARESCAPE Monitor B450.

Intended markets of this manual This manual is not intended for U.S. FDA-regulated markets because the modules E-PSMW and E-PSMPW and the Surgical Pleth Index (SPI) measurement are not cleared for use in those countries.

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 device should never replace nor impede the human intervention and required patient care provided by clinical professionals.

About these devices Refer to the CARESCAPE Modular Monitors User's Manual for important information about the CARESCAPE Monitor B850, CARESCAPE Monitor B650, and CARESCAPE Monitor B450, including intended use of these devices, important safety information and detailed instructions for clinical use of these products.

Safety precautions Refer to the CARESCAPE Modular Monitors User's 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 action.

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Item

Description

bold

Indicates hardware terms.

bold italic

Indicates software terms.

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About this manual

Item

Description

italic

Indicates terms for emphasis.

>

Indicates menu options to select consecutively.

GE

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.

select

The word select means choosing and confirming.

NOTE

Note statements provide application tips or other useful information.

Monitor naming conventions In this manual, the CARESCAPE Monitor B850, CARESCAPE Monitor B650 and CARESCAPE Monitor 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.

B850 only.

B650 only.

B450 only.

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About this manual

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 ● PSM: Patient Side Module, E-PSM, E-PSMP, E-PSMW, and E-PSMPW ● E-modules: All modules with the prefix E-. In parameter chapters, E-modules refers to those modules that measure the parameter(s) in question. ● Hemodynamic E-modules: E-PRESTN, E-PRETN, E-RESTN. These modules can be used with the B850 and B650 only. ● Cardiac output and SvO2 E-modules: E-COP, E-COPSv ● Pressure E-modules: E-P, E-PP, E-PT ● CARESCAPE respiratory modules: E-sCO, E-sCOV, E-sCAiO, E-sCAiOV ● Compact airway modules: E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX. These modules can be used with the B850 and B650 only. ● Single-width airway module: E-miniC ● Specialty E-modules: E-NMT, E-EEG, E-BIS, and E-ENTROPY ● SpO2 E-modules: E-NSATX, E-MASIMO ● TRAM: TRAM modules 451, 451M, 451N, 451N5, 851, 851M, 851N, 851N5. These modules can be used with the B850 only. ● Tram-Rac: Single-parameter Tram-Rac modules measuring BP, SpO2, SpO2 Masimo, Capnostat CO2, Dual CO2. These modules can be used with the B850 only.

Related documents ● ● ● ● ● ● ● ● ● ● ● ● ● ●

CARESCAPE Modular Monitors User's Manual CARESCAPE Monitor B850 Technical Manual CARESCAPE Monitor B650 Technical Manual CARESCAPE Monitor B450 Technical Manual Module Frames and Modules Technical Manual TRAM and Tram-Rac Modules Supplemental Information for CARESCAPE Monitor B850 CARESCAPE Network Configuration Guide Marquette 12SL ECG Analysis Program Physician's Guide CARESCAPE Modular Monitors Mounting Solutions User documentation for displays Unity Network Interface Device (ID) Operator's Manual iCentral and iCentral Client User's Reference Manual CIC Pro Clinical Information Center Operator's Manual 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.

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About this 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

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Compatibility Devices and versions not specifically stated have not been verified and validated to comprise a conforming system with the CARESCAPE Modular Monitors.

Parameter measurement modules compatibility ● Only one TRAM can be used at a time (B850 only). ● Only one PDM (CARESCAPE Patient Data Module), E-PSM (Patient Side Module), E-PSMW,

E-PSMPW, or hemodynamic E-module (B850 and B650 only) can be used at a time. NOTE

E-PSMW and E-PSMPW modules can only be purchased with the B30 monitor.

● Only one E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (these six modules with B850

and B650 only), E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-miniC, CAPNOSTAT Mainstream (B850 only), or CapnoFlex LF (B850 only) module can be used at a time. ● Do not use E-COP and E-COPSv modules simultaneously in the same system. ● Do not use E-P and E-PT modules simultaneously in the same system. ● Do not use E-NSATX and E-MASIMO modules simultaneously in the same system. ● The monitor detects and prevents the use of M-modules and E-modules when the NICU

software package is enabled, except for the E-NSATX and E-MASIMO modules. NOTE

In the following sections, compatible modules refer to modules which are compatible with the system and currently in production. Supported modules refer to modules which are compatible with the system, but no longer in production. Supported modules are not verified to meet the recent standard requirements.

PDM compatibility The monitor is compatible with PDM v2.1 (Masimo and Nellcor). In addition, the following modules are supported: PDM v1.3 and v1.4 (Masimo and Nellcor).

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Compatible devices

TRAM module compatibility B850 only. The monitor supports the following modules: ● TRAM 451 v11A, v11C, v11D, and v12A ● TRAM 451M v11A, v11C, v11D, and v12A ● TRAM 451N v11A, v11C, v11D, and v12A ● TRAM 451N5 v12A ● TRAM 851 v11A, v11C, v11D, and v12A ● TRAM 851M v11A, v11C, v11D, and v12A ● TRAM 851N v11A, v11C, v11D, and v12A ● TRAM 851N5 v12A

PSM compatibility The monitor is compatible with E-PSM-01, E-PSMP-01, E-PSMW-00, and E-PSMPW-00. In addition, the following modules are supported: E-PSM-00 and E-PSMP-00.

Hemodynamic E-module and M-module compatibility B850 and B650 only. The monitor supports the following modules: ● E-PRESTN-00 ● E-PRETN-00 ● E-RESTN-00 ● M-PRESTN..01 ● M-PRETN..01 ● M-RESTN..01

Other E-module compatibility The monitor is compatible with the following modules: ● E-BIS-01 ● E-CAiO-00 (B850 and B650 only) ● E-CAiOV-00 (B850 and B650 only) ● E-CAiOVX-00 (B850 and B650 only) ● E-CO-00 (B850 and B650 only) ● E-COP-01

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● E-COPSv-01 ● E-COVX-00 (B850 and B650 only) ● E-COV-00 (B850 and B650 only) ● E-EEG-00 ● E-ENTROPY-01 ● E-MASIMO-00 ● E-miniC-00 ● E-NMT-01 ● E-NSATX-00 ● E-P-00 ● E-PP-00 ● E-PT-00 ● E-sCAiO-00 ● E-sCAiOV-00 ● E-sCO-00 ● E-sCOV-00

In addition, the following modules are supported: ● E-BIS-00 (B850 and B650 only) ● E-COP-00 ● E-COPSv-00 ● E-NSAT-00 ● E-ENTROPY-00 ● E-NMT-00

TRAM-Rac module compatibility B850 only. The monitor is compatible with the following modules: ● CapnoFlex LF CO2 Module (PN 2013427-001) ● CapnoFlex Adapter (PN 2027759-001)

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Compatible devices

In addition, the following modules are supported: ● BP Module ● BP/CO Module (IP parameter only) ● BP/Dual Temp Module (IP parameter only) ● CAPNOSTAT Mainstream EtCO2 Module v1.2 and v1.4 ● CAPNOSTAT Dual CO2 Module v1.2 and v1.4 ● Dual BP Module ● GE SpO2 Module v1A ● Masimo SpO2 Module v1A (MS-3 v4.3.1.0, v3.1.1.2, v3.0.3.2, and v3.0.0.8)

TRAM-Rac and Frame compatibility B850 only. The monitor is compatible with the following devices: ● F5 and F7 Frames ● Tram-Rac 2 housing

In addition, the following device is supported: ● Tram-Rac 4A housing v6C

The monitor supports the following connections: ● Up to two Tram-Rac housings can be connected to the monitor at the same time if one

Tram-Rac is AC mains powered. ● Up to two F5 Frames can be connected to the monitor at the same time. ● Only one F7 Frame can be connected to the monitor at a time. ● One AC mains powered Tram-Rac and one F5 Frame can be connected at the same time.

TRAM serial interface compatibility B850 only. The monitor is compatible with the Transport Pro Patient Monitor v2.1D when it is connected to the TRAM through the TRAM serial interface.

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Input-output device compatibility Printing device compatibility NOTE

The list below contains the printers supported at the time of this document’s release. Additional compatible printers may be available. Contact your sales representative or technical support for more information.

The monitor is compatible with the following devices: ● HP2430 network laser printer1 ● HP4000 network laser printer1 ● HP4050 network laser printer1 ● HP4100 network laser printer1 ● HP4200 network laser printer1 ● HP4250 network laser printer1 ● HP Laserjet P3015DN network laser printer (manufacturer PN: CE528A) ● HP Laserjet P3005 network laser printer 2

● Kyocera FS-2020D ● Kyocera LS-3830N

● OKI Printing Solutions B430dn network laser printer (manufacturer PN 91643003) ● Brother HL-5370DW monochrome laser printer ● PRN 50-M Digital Writer (DDW 2") v2B and v3A (B850 only)

Remote alarm devices The monitor is compatible with the following devices: ● Remote Alarm Light (RALRM-CA through RALRM-CN)(B850 only) ● Remote Nurse Call (RALRM-AA through RALRM-AO)(B850 only)

Display devices WARNING

B650, B450: Secondary displays do not sound audible alarms. Keep the patient under close surveillance.

WARNING

B850: Using other displays than the B850 system specific ones may result in loss of visual alarms and patient monitoring.

NOTE

Display for B850 system: CARESCAPE D19KT 19-inch, medical grade display with touchscreen.

The monitor is compatible with the following devices: 1. 2.

When configured with the HP Jetdirect 620n fast ethernet print server. The HP Jetdirect 620n ethernet print server must be installed in the HP network laser printer. In some cases this may require an upgrade to the version of HP Jetdirect ethernet print server that was originally provided with the laser printer. When configured with the SEH printer server model PS1109 and KYOMulticode 1.0.

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