CARESCAPE B450 User Manual 1st edition sw ver 3 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 ...39 Intended use of this manual... 39 Intended markets of this manual ... 40 Intended audience of this manual ... 40 Training requirements ... 41 Manual conventions ... 41 Monitor naming conventions ... 41 Acquisition module naming conventions ... 41 Other naming conventions ... 41 Illustrations and names ... 42 Related documents... 42 Ordering manuals ... 43 Product availability ... 43 Trademarks ... 43 Third party trademarks ... 43 Manufacturer responsibility ... 43

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Safety ...45 Safety message signal words... 45 Safety symbols ... 45 System safety... 46 System warning safety messages ... 46 Accessories warnings ... 46 Cables warnings... 47 Defibrillation warnings... 47 Electrical warnings ... 48 System warnings... 49 Site requirement warnings ... 50 System caution safety messages ... 50 Loss of data ... 50 Electrical caution... 50 Site requirement caution ... 50

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Notice safety messages ... 50 Indications for use... 51 B450 indications for use ... 51 Contraindications for using the monitor... 51 E-MASIMO indications for use ... 51 E-NSATX indications for use... 51 E-PP and E-PT indications for use ... 51 E-COP–01 and E-COPSv–01 indications for use ... 52 E-PiCCO indications for use ... 52 CARESCAPE respiratory modules’ indications for use... 52 E-miniC indications for use ... 53 Entropy indications for use ... 53 E-NMT indications for use... 53 EEG indications for use ... 53 BIS indications for use... 53 Indications for use safety precautions ... 54 Indications for use warnings ... 54 Indications for use cautions ... 54 Training requirements ... 54 Electromagnetic compatibility ... 54 EMC warnings... 54 EMC cautions ... 55 ESD safety precautions ... 55 3

System introduction ...57 System safety precautions ... 57 System warnings... 57 System caution... 58 Operation warnings ... 58 Monitor installation points to note... 59 Short description of the equipment ... 59 B450 system components... 60 B450 monitor front panel ... 61 B450 monitor side views... 62 B450 monitor back panel ... 62

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Monitor battery ... 63 Inserting and removing the B450 monitor battery ... 64 Checking the battery charge with monitor software... 64 Monitor battery charge indicators on screen... 65 Battery test button ... 65 CARESCAPE ONE... 65 CARESCAPE Parameters... 66 Acquisition modules... 67 Module compatibility limitations ... 67 Identical acquisition modules... 67 E-modules... 67 Connecting E-modules... 67 Removing E-modules ... 68 E-COP, E-COPSv, and E-PiCCO parameters ... 68 E-PP and E-PT parameters... 68 E-module gas parameters... 68 E-MASIMO and E-NSATX parameters... 69 Specialty E-module parameters... 69 PDM... 70 Connecting a PDM... 70 Removing a PDM ... 70 PDM front view ... 71 PDM parameters ... 71 Displays... 72 Other system components ... 73 Access to external applications ... 74 InSite RSvP ... 75 Equipment markings... 75 Unique Device Identifier (UDI)... 81 CE marking application year ... 82 4

Monitoring basics ...83 Main screen layout... 83 Main keys... 84 An example of a menu... 85

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Menu options... 86 Selecting menu options with a touchscreen ... 86 Selecting menu options with the Trim Knob control... 86 Selecting menu options with a mouse... 86 Data field entries ... 86 Entering data ... 86 About the user default settings... 87 About profiles ... 87 Selecting a profile... 87 Supply mains interruption ... 87 User interface indicators ... 88 5

Setting up the monitor before use...93 Normal screen and other pages ... 93 Selecting the normal screen (main page) ... 93 Selecting pages ... 93 Adjusting sound volumes ... 94 Brightness settings ... 94 Adjusting the display brightness automatically ... 94 Adjusting the display brightness manually... 94 Adjusting the alarm light brightness... 94 Screen setup modifications... 95 Parameter windows ... 95 Selecting parameters to the normal screen... 95 Waveform field safety precautions... 96 Selecting the display mode for IP waveforms ... 96 Setting up a split screen... 96 Locked alarm and parameter settings ... 97 Color selections ... 97 Parameter configurations... 97 Setting up printing options ... 98 Checking the PDM battery status ... 98 Checking the monitor battery status... 98 Setting the touchscreen off ... 98 Other setup changes ... 98

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Starting and ending monitoring ...99 Software packages and terminology... 99 Turning on the monitor... 99 Turning off the monitor... 99 Starting monitoring... 100 Pre-monitoring checklist... 101 Performance check... 101 Entering patient data... 101 Patient data privacy protection... 101 Entering patient data with the monitor ... 101 Entering patient data with a barcode reader... 102 Loading patient information from the CARESCAPE Network ... 102 Entering administrative information... 103 About case reset/patient discharge ... 103 Pending software or setting activation... 103 Residual physiological data... 103 Resetting a case/discharging a patient... 104 Resetting a case/discharging a patient in combination monitoring mode ... 104 Time change during a patient case ... 104 About continuing monitoring ... 105 About Continue menu ... 106 About Select Patient and Data menu... 107 How to continue monitoring with patient case on the monitor... 107 How to continue monitoring with patient case on the acquisition device... 108 How to continue monitoring by combining patient cases ... 108 About standby... 109 Starting standby... 109 End of standby... 109 About the roving functionality... 110 Roving between units... 110 Roving between beds... 110 Adding new units and beds (manual roving) ... 111

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Alarms ...113 Alarm safety precautions ... 113 Alarm warnings ... 113 Alarm overview ... 116 Alarm types... 116 Alarm conditions ... 116 Broadcast only alarms... 116 Broadcasted limit alarms... 120 Arrhythmia alarm mapping ... 121 Alarms in dual monitoring ... 121 Checking alarm function... 122 Visual alarm indications ... 122 Alarm icons on the screen ... 122 Description of alarm and information messages... 123 Visual alarm signals and priority levels... 124 Setting the alarm light brightness... 124 Audible alarm indications... 125 Audible alarm signals... 125 Audible alarm signals and priority levels ... 125 Auditory information signals ... 126 Parameter alarms ... 126 Alarm locks ... 126 Absolute alarm limits ... 126 About critical alarms ... 126 Setting parameter alarm limits ... 127 Setting alarm limits automatically ... 127 Returning the default alarm limits ... 128 Alarm priorities and escalation ... 129 Alarm priority levels... 129 Alarm priority escalation... 129 Selecting parameter alarm priority levels... 129 Setting arrhythmia alarms... 131 Pausing and silencing alarms ... 131 Audible alarms off behavior ... 131

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Pause audio behaviors ... 132 Pausing alarms for 5 minutes... 133 Activating all audible alarms ... 133 Technical alarms’ deactivation with the pause audio key... 133 Apnea alarms’ deactivation with the pause audio key... 134 Pause audio with combination monitoring ... 134 Breakthrough alarms ... 134 Latched alarms ... 134 Pause monitoring... 135 Safety considerations when using pause monitoring ... 135 Turning off all local alarm indicators (sleep mode) ... 135 Selecting Pause Monitor & Central... 136 Remote management of alarms... 136 Alarm settings after a power loss ... 137 Alarm data stored in Clinical logs ... 137 Stored alarm data during a power cycle or power loss... 137 8

ECG ...139 About this measurement with CARESCAPE ONE ... 139 ECG compatibility limitations... 139 ECG safety precautions ... 139 ECG warnings ... 139 ECG cautions ... 141 ECG measurement limitations... 141 ECG points to note ... 141 ECG measurement setup... 142 ECG equipment to patient connection with the PDM ... 142 ECG equipment to patient connection with CARESCAPE ONE... 143 Preparing the patient’s electrode sites ... 143 Applying the electrodes to the patient... 143 3- lead or 5-lead ECG electrode placement ... 144 6-lead ECG electrode placement ... 144 10–lead ECG electrode placement for cardiac monitoring ... 145 Standard resting 10–lead ECG electrode placement ... 146 Checking the ECG measurement ... 147

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About the ECG analog output signal... 147 About the combination monitoring mode... 148 About V Tach criteria and combination monitoring... 149 About enhanced Asystole detection and combination monitoring ... 149 About the ECG analog output signal... 150 Selecting the ECG source... 150 Using the ECG measurement ... 150 The first three displayed ECG leads... 150 Selecting the Va ECG lead... 151 Selecting the Vb ECG lead... 151 Changing to an ECG cable with fewer leadwires ... 152 Deactivating the ECG leads off alarm ... 152 Setting the beat volume... 152 Selecting the beat source ... 152 Setting the beep tone during bradycardia alarms... 152 Aspect ratio and different display sizes ... 153 Selecting the ECG waveform size ... 153 Selecting the hemodynamic waveform sweep speed... 153 Printing all ECG waveforms ... 153 Selecting the ECG waveform filter... 154 Setting the QRS width ... 154 Selecting the leads for ECG analysis ... 154 Relearning the patient’s QRS pattern... 155 Setting the primary HR source ... 155 Selecting HR alarm range... 156 Showing a second HR value in the HR parameter window ... 156 Showing ST in the HR parameter window ... 156 Showing PVC in the HR parameter window ... 157 Showing QT in the HR parameter window... 157 Displaying the ECG grid... 157 ECG alarm limits ... 157 Configurable PR alarm delays ... 159 ECG alarm priorities ... 159

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Checking alarm delays and priorities information... 159 ECG measurement practicalities... 160 Alternate pulse rate source ... 160 IntelliRate algorithm... 160 Auto algorithm... 160 ECG troubleshooting ... 160 12 lead analysis... 161 Intended use of 12RL™ Interpolated 12 lead ECG analysis... 161 Intended use of 12SL ECG analysis ... 161 Intended use of ACI-TIPI... 161 12 lead ECG analysis points to note... 162 Entering data for a 12 lead ECG analysis ... 162 Entering data for an ACI-TIPI 12 lead ECG analysis ... 162 Enabling and disabling the 12SL ACS... 163 Setting automatic 12 lead ECG analysis measurements... 163 Generating a 12 lead ECG analysis report during an ST alarm condition ... 163 Setting the 12 lead ECG analysis display format... 164 Including or excluding 12SL statements in printed reports... 164 Entering the Location ID for 12SL... 164 Selecting the 12 lead print speed... 164 Selecting the 12SL baseline stabilization... 164 Performing a 12 lead ECG analysis ... 165 A 12 lead report and the MUSE database ... 165 Sending a 12 lead ECG report to the MUSE database ... 165 Selecting the low-pass 12 lead waveform filter ... 166 Viewing or printing saved 12 lead ECG reports ... 166 About the 12 lead ECG analysis program ... 167 About the 12RL™ ECG analysis feature ... 167 12 lead ECG analysis troubleshooting ... 168 Pacemaker detection... 168 Pacemaker detection warnings ... 168 Pacemaker detection points to note... 169 Selecting the pacemaker detection ... 169

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Pacemaker detection troubleshooting ... 169 Arrhythmia monitoring ... 171 Arrhythmia monitoring warnings... 171 Arrhythmia measurement limitations... 172 Setting the arrhythmia category to alarm... 172 Setting arrhythmia alarms... 173 Selecting V Tach criteria ... 173 Setting minimum HR for V Tach ... 174 Setting V Tach event duration ... 174 Setting the pause interval... 174 Setting the SVT length... 174 Setting HR for SVT ... 175 Arrhythmia alarm messages ... 175 About the arrhythmia detection... 177 Arrhythmia troubleshooting ... 178 ST detection... 179 About the ST analysis... 179 ST detection measurement limitations ... 179 ST detection points to note... 180 Starting the ST detection ... 180 Selecting leads to the ST window... 180 Changing the displayed ST leads ... 180 Adjusting the ST point manually... 180 Adjusting the isoelectric measurement (ISO) point ... 181 Adjusting the J point ... 181 About the realtime QRS/ST complexes ... 181 About the reference QRS ... 181 Saving a reference QRS manually... 181 Selecting a saved reference QRS complex for display... 181 Erasing a reference QRS ... 182 Printing a realtime QRS/ST report ... 182 Viewing QRS and ST in a split screen ... 182 Selecting the ST time scale ... 182 ST trend display ... 183

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Displaying QRS complexes and ST trends for other leads ... 183 Reviewing ST trends ... 183 Printing an ST trend report ... 183 Ischemic burden... 183 ST alarm limits ... 184 QT detection ... 185 9

Impedance respiration...187 About this measurement with CARESCAPE ONE ... 187 Impedance respiration compatibility limitations ... 187 Respiration safety precautions ... 187 Respiration warnings ... 187 Respiration cautions ... 188 Respiration measurement limitations... 188 Respiration points to note ... 188 Respiration measurement setup... 189 Respiration equipment to patient connection with PDM... 189 Respiration equipment to patient connection with CARESCAPE ONE ... 189 Preparing the patient’s respiration electrode sites ... 190 Respiration lead and breath detection ... 190 How to interpret the respiration values ... 190 Respiration lead I electrode placement ... 191 Respiration lead II electrode placement ... 191 Respiration lead RL-LL electrode placement... 191 Respiration measurement checks... 192 Respiration measurement on the monitor screen... 192 Using the respiration measurement ... 192 Turning on the respiration measurement... 192 Selecting the respiration lead... 192 Selecting the respiration waveform size automatically... 193 Selecting the respiration waveform size manually ... 193 Selecting the waveform sensitivity ... 193 Enabling respiration smoothing ... 193 Turning inspiration and expiration markers on or off ... 193

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Selecting the waveform speed... 193 Relearning the respiration pattern... 194 Turning on or off the respiration rate alarm... 194 Setting the respiration alarm limits... 194 Apnea alarms’ deactivation with the pause audio key... 194 Setting the apnea alarm delay ... 194 Configurable respiration alarm delays ... 195 Enabling the respiration cardiac artifact alarm ... 195 Respiration alarm priorities ... 195 Checking alarm delays and priorities information... 195 Turning off the respiration measurement ... 195 Respiration measurement description ... 196 Respiration troubleshooting ... 196 10 Pulse oximetry...199 About this measurement with CARESCAPE ONE ... 199 SpO2 compatibility limitations ... 199 SpO2 safety precautions ... 199 SpO2 warnings... 199 SpO2 cautions ... 202 SpO2 measurement limitations ... 203 SpO2 points to note ... 203 Masimo safety precautions ... 204 Masimo warnings... 204 Masimo cautions ... 206 Masimo points to note ... 207 SpO₂ measurement guidelines... 208 Masimo SET technology and sensor measurement guidelines... 208 Nellcor™ sensors with OxiMax™ technology and sensor measurement guidelines... 209 SpO₂ measurement setup ... 209 SpO2 equipment to patient connection with PDM ... 209 SpO2 equipment to patient connection with CARESCAPE ONE ... 210 Preparing the SpO2 connection... 210 Checking the SpO2 measurement ... 210

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Using the SpO₂ measurement... 211 SpO2 measurement source channels ... 211 Changing the SpO2 waveform size... 211 Selecting the SpO2 hemodynamic sweep speed... 211 Selecting the SpO2 as the primary heart rate source ... 211 Showing the SpO2 pulse rate... 212 Adjusting the SpO2 pulse beep volume... 212 Selecting the beat source ... 212 Setting the variable beat tone ... 212 Masimo SET data averaging and updating ... 212 Selecting the SpO2 averaging time ... 212 Selecting the Masimo SpO2 sensor sensitivity level ... 213 Nellcor™ sensors with OxiMax™ technology data averaging and updating... 213 Selecting the SpO2 response time ... 213 Nellcor™ OxiMax™ SatSeconds™ alarm management ... 214 Setting the SpO2 alarms and alarm limits... 215 Deactivating the SpO2 probe off alarm ... 215 Configurable SpO2 alarm delays ... 216 Configurable PR alarm delays ... 216 SpO2 alarm priorities ... 216 Checking alarm delays and priorities information... 216 Stopping the SpO2 measurement ... 217 How to interpret the SpO₂ values... 217 SpO2 signal strength ... 217 SpO2 waveform quality ... 217 SpO2 waveform stability ... 218 SpO2 wavelengths and optical output power ... 218 SpO2 measurement and interference... 218 SpO2 troubleshooting... 219 11 Surgical pleth index (SPI)...221 SPI compatibility... 221 Surgical Pleth Index (SPI)... 221 SPI indications for use... 221

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SPI safety statements ... 221 SPI warnings ... 221 SPI cautions ... 223 SPI points to note ... 224 Using the SPI measurement ... 225 Patient connections and preparing the patient ... 225 SPI measurement on the monitor screen ... 225 Stopping the SPI and SpO2 measurement ... 225 Basics of SPI measurement... 225 SPI clinical implications... 225 SPI measurement description ... 225 How to interpret the SPI values... 226 SPI in typical general anesthesia... 226 Common surgical events ... 227 SPI practicalities ... 228 AoA split screen and the BalView... 228 SPI and NIBP measurement... 229 Physiological and technical issues affecting SPI... 229 SPI calculations ... 230 SPI troubleshooting... 230 Basic SPI troubleshooting ... 230 Advanced SPI troubleshooting ... 231 12 Non-invasive blood pressure...233 About this measurement with CARESCAPE ONE ... 233 NIBP compatibility limitations ... 233 NIBP safety precautions ... 233 NIBP warnings ... 233 NIBP cautions ... 235 NIBP measurement limitations ... 235 NIBP points to note ... 235 NIBP measurement setup... 236 NIBP equipment to patient connection with PDM... 236 NIBP equipment to patient connection with CARESCAPE ONE... 236 Preparing the NIBP patient connection ... 237

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Checking the NIBP measurement ... 237 NIBP measurement on screen ... 237 Manual NIBP measurements... 237 Starting or stopping a single NIBP measurement from the main menu ... 237 Starting or stopping a single NIBP measurement from the NIBP setup menu ... 238 Automatic NIBP measurements... 238 NIBP Auto mode ... 238 Setting the cycle time between NIBP measurements... 238 Automatic NIBP measurements and monitor clock synchronization ... 238 STAT mode ... 239 NIBP cuffs ... 239 NIBP cuff selection and placement ... 239 Selecting NIBP cuff size... 240 Initial NIBP cuff inflation pressure ... 240 NIBP volume and display settings... 240 Adjusting the NIBP measurement completion tone volume ... 240 Setting the NIBP display format ... 241 NIBP alarms... 241 Setting NIBP alarms ... 241 NIBP alarms’ deactivation with pause audio key ... 241 NIBP recheck after alarm violation (control measurement) ... 241 NIBP measurement description ... 241 NIBP measurement technologies ... 242 DINAMAP Classic NIBP technology... 242 DINAMAP SuperSTAT NIBP technology... 242 DINAMAP Step Deflation technology ... 243 NIBP calibration... 244 NIBP troubleshooting... 245 13 Invasive pressures ...247 About this measurement with CARESCAPE ONE ... 247 Invasive pressures compatibility limitations ... 247 Invasive pressure safety precautions ... 247

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Invasive pressure warnings ... 247 Invasive pressure measurement limitations ... 248 Invasive pressure points to note ... 248 Invasive pressure measurement setup ... 249 Invasive pressure equipment to patient connection with PDM... 249 Invasive pressure equipment to patient connection with CARESCAPE ONE ... 249 Invasive pressure module keys ... 250 Connecting the invasive pressure transducer and cable ... 250 Checking the invasive pressure measurement ... 250 Invasive pressure measurement on the monitor screen... 250 Selecting the display mode for IP waveforms ... 251 Using the invasive pressure measurement ... 251 Invasive pressure measurement mapping ... 251 Invasive pressure analog output... 251 About zeroing the invasive pressure transducers... 252 Zeroing the invasive pressure transducers ... 252 Selecting an invasive pressure channel label... 252 Selecting the size of the invasive pressure waveform ... 253 Optimizing the invasive pressure waveform scale... 253 Selecting the hemodynamic waveform sweep speed... 253 Selecting the displayed invasive pressure format... 253 Using the invasive pressure waveform cursor ... 254 Selecting invasive pressure as the primary heart rate source ... 254 Selecting the ventilation mode... 254 Showing the pulse rate in the invasive pressure parameter window ... 255 Showing the CPP value in the ICP parameter window... 255 Using the IP channel standby... 255 Selecting the invasive pressure noise reduction filter... 255 Selecting the primary arterial source ... 255 Selecting Smart BP... 256 Compensating for intra-aortic balloon pump (IABP) waveform irregularities... 256 Selecting the invasive pressure response time ... 257

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Setting an arterial invasive pressure disconnection alarm ... 257 Setting invasive pressure alarm limits ... 257 Configurable PR alarm delays ... 257 Invasive pressures alarm priorities ... 258 Checking alarm delays and priorities information... 258 Systolic pressure variation and pulse pressure variation... 258 Changing the SPV source ... 258 Measuring SPV manually ... 259 PA catheter insertion ... 259 Selecting the PA catheter insertion mode ... 259 Pulmonary capillary wedge pressure (PCWP) measurement... 260 Showing the PCWP value in the PA window ... 260 Taking a manual PA wedge measurement... 260 Taking an automated PA wedge measurement... 261 Starting a new PA wedge measurement ... 261 Other selections in the Wedge menu... 262 Calibrating the invasive pressure transducer with PDM... 262 Invasive pressure calibration with E-modules ... 262 Invasive pressure practicalities ... 262 Invasive pressure parameters... 262 Intra-aortic balloon pump ... 264 Invasive pressure troubleshooting... 266 14 Temperature...269 About this measurement with CARESCAPE ONE ... 269 Temperature compatibility limitations... 269 Temperature safety precautions... 269 Temperature warnings ... 269 Temperature measurement limitations... 269 Temperature points to note... 270 Temperature measurement setup... 270 Temperature equipment to patient connection with PDM ... 270 Temperature equipment to patient connection with CARESCAPE ONE ... 271 Preparing the patient for temperature measurement... 271

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Checking the temperature measurement ... 271 Temperature measurement on screen... 271 Using the temperature measurement... 272 Temperature mappings ... 272 Starting the temperature measurement ... 272 Changing the temperature site label ... 272 Displaying the delta value between two temperature channels ... 272 Setting temperature alarms ... 272 Stopping the temperature measurement... 273 Temperature practicalities ... 273 Temperature troubleshooting ... 273 15 Cardiac output ...275 Cardiac output measurement... 275 Cardiac output compatibility limitations... 275 C.O. safety precautions ... 275 C.O. measurement limitations ... 276 C.O. points to note ... 276 C.O. measurement setup ... 276 Using the C.O. measurement... 279 C.O. practicalities ... 284 C.O. troubleshooting... 285 Continuous cardiac output (CCO) measurement ... 287 Continuous cardiac output compatibility limitations... 287 CCO safety precautions ... 287 E-PiCCO indications for use ... 289 Feature availability... 289 CCO measurement limitations ... 289 CCO points to note ... 290 CCO measurement setup... 291 Using the CCO measurement ... 292 How to improve the CCO accuracy... 300 CCO troubleshooting... 300 16 Venous oxygenation (SvO₂ and ScvO₂) ...303 SvO₂ measurement... 303

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