CARESCAPE B850 User Manual Sw ver 3

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 ... 41 Intended audience of this manual ... 41 Training requirements ... 41 Manual conventions ... 41 Monitor naming conventions ... 41 Acquisition module naming conventions ... 41 Other naming conventions ... 42 Illustrations and names ... 43 Related documents... 43 Ordering manuals ... 43 Product availability ... 43 Trademarks ... 43 Third party trademarks ... 43 Manufacturer responsibility ... 44

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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 B850 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 Operation warnings ... 58 Monitor installation points to note... 59 Short description of the equipment ... 60 B850 system components... 60 B850 processing unit front view... 62 B850 processing unit back view... 62 B850 module frames F7 and F5 ... 63 CARESCAPE ONE... 63

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CARESCAPE Parameters... 64 Acquisition modules... 64 Module compatibility limitations ... 64 Identical acquisition modules... 64 E-modules... 65 Connecting E-modules... 65 Removing E-modules ... 65 E-COP, E-COPSv, and E-PiCCO parameters ... 65 E-PP and E-PT parameters... 66 E-module gas parameters... 66 E-MASIMO and E-NSATX parameters... 67 Specialty E-module parameters... 67 PDM... 67 Connecting a PDM... 67 Removing a PDM ... 68 PDM front view ... 68 PDM parameters ... 69 Displays... 69 Other system components ... 70 Access to external applications ... 72 InSite RSvP ... 72 Equipment markings... 72 Unique Device Identifier (UDI)... 78 CE marking application year ... 79 4

Monitoring basics ...81 Main screen layout... 81 Main keys... 82 An example of a menu... 83 Menu options... 84 Selecting menu options with a touchscreen ... 84 Selecting menu options with the Trim Knob control... 84 Selecting menu options with a mouse... 84 Data field entries ... 84 Entering data ... 84

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About the user default settings... 85 About profiles ... 85 Selecting a profile... 85 Supply mains interruption ... 85 User interface indicators ... 85 5

Setting up the monitor before use...91 Normal screen and other pages ... 91 Selecting the normal screen (main page) ... 91 Selecting pages ... 91 Adjusting sound volumes ... 92 B850 display brightness ... 92 Screen setup modifications... 92 Parameter windows ... 92 Selecting parameters to the normal screen... 93 Waveform field safety precautions... 93 Selecting the display mode for IP waveforms ... 94 Setting up a split screen... 94 Locked alarm and parameter settings ... 95 Color selections ... 95 Parameter configurations... 95 Setting up printing options ... 95 Checking the PDM battery status ... 95 Setting the touchscreen off ... 96 B850 with two screens... 96 Other setup changes ... 96

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Starting and ending monitoring ...97 Software packages and terminology... 97 Turning on the monitor... 97 Turning off the monitor... 97 Starting monitoring... 98 Pre-monitoring checklist... 99 Performance check... 99 Entering patient data... 100 Patient data privacy protection... 100

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Entering patient data with the monitor ... 100 Entering patient data with a barcode reader... 100 Loading patient information from the CARESCAPE Network ... 101 Entering administrative information... 101 About case reset/patient discharge ... 101 Pending software or setting activation... 102 Residual physiological data... 102 Resetting a case/discharging a patient... 102 Resetting a case/discharging a patient in combination monitoring mode ... 102 Time change during a patient case ... 103 About continuing monitoring ... 103 About Continue menu ... 104 About Select Patient and Data menu... 105 How to continue monitoring with patient case on the monitor... 106 How to continue monitoring with patient case on the acquisition device... 106 How to continue monitoring by combining patient cases ... 107 About standby... 107 Starting standby... 107 End of standby... 108 About the roving functionality... 108 Roving between units... 109 Roving between beds... 109 Adding new units and beds (manual roving) ... 109 7

Alarms ...111 Alarm safety precautions ... 111 Alarm warnings ... 111 Alarm overview ... 114 Alarm types... 114 Alarm conditions ... 114 Broadcast only alarms... 114 Broadcasted limit alarms... 118 Arrhythmia alarm mapping ... 119

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Alarms in dual monitoring ... 120 Checking alarm function... 120 Visual alarm indications ... 120 Alarm icons on the screen ... 120 Description of alarm and information messages... 121 Visual alarm signals and priority levels... 122 Setting the alarm light brightness... 122 Audible alarm indications... 123 Audible alarm signals... 123 Audible alarm signals and priority levels ... 123 Auditory information signals ... 124 Parameter alarms ... 124 Alarm locks ... 124 Absolute alarm limits ... 124 About critical alarms ... 124 Setting parameter alarm limits ... 125 Setting alarm limits automatically ... 125 Returning the default alarm limits ... 126 Alarm priorities and escalation ... 127 Alarm priority levels... 127 Alarm priority escalation... 127 Selecting parameter alarm priority levels... 127 Setting arrhythmia alarms... 129 Pausing and silencing alarms ... 129 Audible alarms off behavior ... 129 Pause audio behaviors ... 130 Pausing alarms for 5 minutes... 131 Activating all audible alarms ... 131 Technical alarms’ deactivation with the pause audio key... 131 Apnea alarms’ deactivation with the pause audio key... 132 Pause audio with combination monitoring ... 132 Breakthrough alarms ... 132 Latched alarms ... 132 Pause monitoring... 133

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Safety considerations when using pause monitoring ... 133 Turning off all local alarm indicators (sleep mode) ... 133 Selecting Pause Monitor & Central... 134 Remote management of alarms... 134 Alarm settings after a power loss ... 135 Alarm data stored in Clinical logs ... 135 Stored alarm data during a power cycle or power loss... 135 8

ECG ...137 About this measurement with CARESCAPE ONE ... 137 ECG compatibility limitations... 137 ECG safety precautions ... 137 ECG warnings ... 137 ECG cautions ... 139 ECG measurement limitations... 139 ECG points to note ... 139 ECG measurement setup... 140 ECG equipment to patient connection with the PDM ... 140 ECG equipment to patient connection with CARESCAPE ONE... 141 Preparing the patient’s electrode sites ... 141 Applying the electrodes to the patient... 141 3- lead or 5-lead ECG electrode placement ... 142 6-lead ECG electrode placement ... 142 10–lead ECG electrode placement for cardiac monitoring ... 143 Standard resting 10–lead ECG electrode placement ... 144 Checking the ECG measurement ... 145 About the ECG analog output signal... 145 About the combination monitoring mode... 146 About V Tach criteria and combination monitoring... 147 About enhanced Asystole detection and combination monitoring ... 147 About the ECG analog output signal... 148 Selecting the ECG source... 148 Using the ECG measurement ... 148 The first three displayed ECG leads... 148

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Selecting the Va ECG lead... 149 Selecting the Vb ECG lead... 149 Changing to an ECG cable with fewer leadwires ... 150 Deactivating the ECG leads off alarm ... 150 Setting the beat volume... 150 Selecting the beat source ... 150 Setting the beep tone during bradycardia alarms... 150 Aspect ratio and different display sizes ... 151 Selecting the ECG waveform size ... 151 Selecting the hemodynamic waveform sweep speed... 151 Printing all ECG waveforms ... 151 Selecting the ECG waveform filter... 152 Setting the QRS width ... 152 Selecting the leads for ECG analysis ... 152 Relearning the patient’s QRS pattern... 153 Setting the primary HR source ... 153 Selecting HR alarm range... 154 Showing a second HR value in the HR parameter window ... 154 Showing ST in the HR parameter window ... 154 Showing PVC in the HR parameter window ... 155 Showing QT in the HR parameter window... 155 Displaying the ECG grid... 155 ECG alarm limits ... 155 Configurable PR alarm delays ... 157 ECG alarm priorities ... 157 Checking alarm delays and priorities information... 157 ECG measurement practicalities... 158 Alternate pulse rate source ... 158 IntelliRate algorithm... 158 Auto algorithm... 158 ECG troubleshooting ... 158 12 lead analysis... 159 Intended use of 12RL™ Interpolated 12 lead ECG analysis... 159 Intended use of 12SL ECG analysis ... 159

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Intended use of ACI-TIPI... 159 12 lead ECG analysis points to note... 160 Entering data for a 12 lead ECG analysis ... 160 Entering data for an ACI-TIPI 12 lead ECG analysis ... 160 Enabling and disabling the 12SL ACS... 161 Setting automatic 12 lead ECG analysis measurements... 161 Generating a 12 lead ECG analysis report during an ST alarm condition ... 161 Setting the 12 lead ECG analysis display format... 162 Including or excluding 12SL statements in printed reports... 162 Entering the Location ID for 12SL... 162 Selecting the 12 lead print speed... 162 Selecting the 12SL baseline stabilization... 162 Performing a 12 lead ECG analysis ... 163 A 12 lead report and the MUSE database ... 163 Sending a 12 lead ECG report to the MUSE database ... 163 Selecting the low-pass 12 lead waveform filter ... 164 Viewing or printing saved 12 lead ECG reports ... 164 About the 12 lead ECG analysis program ... 165 About the 12RL™ ECG analysis feature ... 165 12 lead ECG analysis troubleshooting ... 166 Pacemaker detection... 166 Pacemaker detection warnings ... 166 Pacemaker detection points to note... 167 Selecting the pacemaker detection ... 167 Pacemaker detection troubleshooting ... 167 Arrhythmia monitoring ... 169 Arrhythmia monitoring warnings... 169 Arrhythmia measurement limitations... 170 Setting the arrhythmia category to alarm... 170 Setting arrhythmia alarms... 171 Selecting V Tach criteria ... 171 Setting minimum HR for V Tach ... 172 Setting V Tach event duration ... 172

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Setting the pause interval... 172 Setting the SVT length... 172 Setting HR for SVT ... 173 Arrhythmia alarm messages ... 173 About the arrhythmia detection... 175 Arrhythmia troubleshooting ... 176 ST detection... 177 About the ST analysis... 177 ST detection measurement limitations ... 177 ST detection points to note... 178 Starting the ST detection ... 178 Selecting leads to the ST window... 178 Changing the displayed ST leads ... 178 Adjusting the ST point manually... 178 Adjusting the isoelectric measurement (ISO) point ... 179 Adjusting the J point ... 179 About the realtime QRS/ST complexes ... 179 About the reference QRS ... 179 Saving a reference QRS manually... 179 Selecting a saved reference QRS complex for display... 179 Erasing a reference QRS ... 180 Printing a realtime QRS/ST report ... 180 Viewing QRS and ST in a split screen ... 180 Selecting the ST time scale ... 180 ST trend display ... 181 Displaying QRS complexes and ST trends for other leads ... 181 Reviewing ST trends ... 181 Printing an ST trend report ... 181 Ischemic burden... 181 ST alarm limits ... 182 QT detection ... 183 9

Impedance respiration...185 About this measurement with CARESCAPE ONE ... 185 Impedance respiration compatibility limitations ... 185

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Respiration safety precautions ... 185 Respiration warnings ... 185 Respiration cautions ... 186 Respiration measurement limitations... 186 Respiration points to note ... 186 Respiration measurement setup... 187 Respiration equipment to patient connection with PDM... 187 Respiration equipment to patient connection with CARESCAPE ONE ... 187 Preparing the patient’s respiration electrode sites ... 188 Respiration lead and breath detection ... 188 How to interpret the respiration values ... 188 Respiration lead I electrode placement ... 189 Respiration lead II electrode placement ... 189 Respiration lead RL-LL electrode placement... 189 Respiration measurement checks... 190 Respiration measurement on the monitor screen... 190 Using the respiration measurement ... 190 Turning on the respiration measurement... 190 Selecting the respiration lead... 190 Selecting the respiration waveform size automatically... 191 Selecting the respiration waveform size manually ... 191 Selecting the waveform sensitivity ... 191 Enabling respiration smoothing ... 191 Turning inspiration and expiration markers on or off ... 191 Selecting the waveform speed... 192 Relearning the respiration pattern... 192 Turning on or off the respiration rate alarm... 192 Setting the respiration alarm limits... 192 Apnea alarms’ deactivation with the pause audio key... 192 Setting the apnea alarm delay ... 192 Configurable respiration alarm delays ... 193 Enabling the respiration cardiac artifact alarm ... 193 Respiration alarm priorities ... 193

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Checking alarm delays and priorities information... 193 Turning off the respiration measurement ... 194 Respiration measurement description ... 194 Respiration troubleshooting ... 194 10 Pulse oximetry...197 About this measurement with CARESCAPE ONE ... 197 SpO2 compatibility limitations ... 197 SpO2 safety precautions ... 197 SpO2 warnings... 197 SpO2 cautions ... 200 SpO2 measurement limitations ... 201 SpO2 points to note ... 201 Masimo safety precautions ... 202 Masimo warnings... 202 Masimo cautions ... 204 Masimo points to note ... 205 SpO₂ measurement guidelines... 206 Masimo SET technology and sensor measurement guidelines... 206 Nellcor™ sensors with OxiMax™ technology and sensor measurement guidelines... 207 SpO₂ measurement setup ... 207 SpO2 equipment to patient connection with PDM ... 207 SpO2 equipment to patient connection with CARESCAPE ONE ... 208 Preparing the SpO2 connection... 208 Checking the SpO2 measurement ... 208 Using the SpO₂ measurement... 209 SpO2 measurement source channels ... 209 Changing the SpO2 waveform size... 209 Selecting the SpO2 hemodynamic sweep speed... 209 Selecting the SpO2 as the primary heart rate source ... 209 Showing the SpO2 pulse rate... 210 Adjusting the SpO2 pulse beep volume... 210 Selecting the beat source ... 210 Setting the variable beat tone ... 210

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Masimo SET data averaging and updating ... 210 Selecting the SpO2 averaging time ... 210 Selecting the Masimo SpO2 sensor sensitivity level ... 211 Nellcor™ sensors with OxiMax™ technology data averaging and updating... 211 Selecting the SpO2 response time ... 211 Nellcor™ OxiMax™ SatSeconds™ alarm management ... 212 Setting the SpO2 alarms and alarm limits... 213 Deactivating the SpO2 probe off alarm ... 213 Configurable SpO2 alarm delays ... 214 Configurable PR alarm delays ... 214 SpO2 alarm priorities ... 214 Checking alarm delays and priorities information... 214 Stopping the SpO2 measurement ... 215 How to interpret the SpO₂ values... 215 SpO2 signal strength ... 215 SpO2 waveform quality ... 215 SpO2 waveform stability ... 216 SpO2 wavelengths and optical output power ... 216 SpO2 measurement and interference... 216 SpO2 troubleshooting... 217 11 Surgical pleth index (SPI)...219 SPI compatibility... 219 Surgical Pleth Index (SPI)... 219 SPI indications for use... 219 SPI safety statements ... 219 SPI warnings ... 219 SPI cautions ... 221 SPI points to note ... 222 Using the SPI measurement ... 223 Patient connections and preparing the patient ... 223 SPI measurement on the monitor screen ... 223 Stopping the SPI and SpO2 measurement ... 223 Basics of SPI measurement... 223

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SPI clinical implications... 223 SPI measurement description ... 223 How to interpret the SPI values... 224 SPI in typical general anesthesia... 224 Common surgical events ... 225 SPI practicalities ... 226 AoA split screen and the BalView... 226 SPI and NIBP measurement... 227 Physiological and technical issues affecting SPI... 227 SPI calculations ... 228 SPI troubleshooting... 228 Basic SPI troubleshooting ... 228 Advanced SPI troubleshooting ... 229 12 Non-invasive blood pressure...231 About this measurement with CARESCAPE ONE ... 231 NIBP compatibility limitations ... 231 NIBP safety precautions ... 231 NIBP warnings ... 231 NIBP cautions ... 233 NIBP measurement limitations ... 233 NIBP points to note ... 233 NIBP measurement setup... 234 NIBP equipment to patient connection with PDM... 234 NIBP equipment to patient connection with CARESCAPE ONE... 234 Preparing the NIBP patient connection ... 235 Checking the NIBP measurement ... 235 NIBP measurement on screen ... 235 Manual NIBP measurements... 235 Starting or stopping a single NIBP measurement from the main menu ... 235 Starting or stopping a single NIBP measurement from the NIBP setup menu ... 236 Automatic NIBP measurements... 236 NIBP Auto mode ... 236

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Setting the cycle time between NIBP measurements... 236 Automatic NIBP measurements and monitor clock synchronization ... 236 STAT mode ... 237 NIBP cuffs ... 237 NIBP cuff selection and placement ... 237 Selecting NIBP cuff size... 238 Initial NIBP cuff inflation pressure ... 238 NIBP volume and display settings... 238 Adjusting the NIBP measurement completion tone volume ... 238 Setting the NIBP display format ... 239 NIBP alarms... 239 Setting NIBP alarms ... 239 NIBP alarms’ deactivation with pause audio key ... 239 NIBP recheck after alarm violation (control measurement) ... 239 NIBP measurement description ... 239 NIBP measurement technologies ... 240 DINAMAP Classic NIBP technology... 240 DINAMAP SuperSTAT NIBP technology... 240 DINAMAP Step Deflation technology ... 241 NIBP calibration... 242 NIBP troubleshooting... 243 13 Invasive pressures ...245 About this measurement with CARESCAPE ONE ... 245 Invasive pressures compatibility limitations ... 245 Invasive pressure safety precautions ... 245 Invasive pressure warnings ... 245 Invasive pressure measurement limitations ... 246 Invasive pressure points to note ... 246 Invasive pressure measurement setup ... 247 Invasive pressure equipment to patient connection with PDM... 247 Invasive pressure equipment to patient connection with CARESCAPE ONE ... 247 Invasive pressure module keys ... 248

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Connecting the invasive pressure transducer and cable ... 248 Checking the invasive pressure measurement ... 248 Invasive pressure measurement on the monitor screen... 248 Selecting the display mode for IP waveforms ... 249 Using the invasive pressure measurement ... 249 Invasive pressure measurement mapping ... 249 Invasive pressure analog output... 249 About zeroing the invasive pressure transducers... 250 Zeroing the invasive pressure transducers ... 250 Selecting an invasive pressure channel label... 250 Selecting the size of the invasive pressure waveform ... 251 Optimizing the invasive pressure waveform scale... 251 Selecting the hemodynamic waveform sweep speed... 251 Selecting the displayed invasive pressure format... 251 Using the invasive pressure waveform cursor ... 252 Selecting invasive pressure as the primary heart rate source ... 252 Selecting the ventilation mode... 252 Showing the pulse rate in the invasive pressure parameter window ... 253 Showing the CPP value in the ICP parameter window... 253 Using the IP channel standby... 253 Selecting the invasive pressure noise reduction filter... 253 Selecting the primary arterial source ... 253 Selecting Smart BP... 254 Compensating for intra-aortic balloon pump (IABP) waveform irregularities... 254 Selecting the invasive pressure response time ... 255 Setting an arterial invasive pressure disconnection alarm ... 255 Setting invasive pressure alarm limits ... 255 Configurable PR alarm delays ... 255 Invasive pressures alarm priorities ... 256 Checking alarm delays and priorities information... 256 Systolic pressure variation and pulse pressure variation... 256 Changing the SPV source ... 256

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Measuring SPV manually ... 257 PA catheter insertion ... 257 Selecting the PA catheter insertion mode ... 257 Pulmonary capillary wedge pressure (PCWP) measurement... 258 Showing the PCWP value in the PA window ... 258 Taking a manual PA wedge measurement... 258 Taking an automated PA wedge measurement... 259 Starting a new PA wedge measurement ... 259 Other selections in the Wedge menu... 260 Calibrating the invasive pressure transducer with PDM... 260 Invasive pressure calibration with E-modules ... 260 Invasive pressure practicalities ... 260 Invasive pressure parameters... 260 Intra-aortic balloon pump ... 262 Invasive pressure troubleshooting... 264 14 Temperature...267 About this measurement with CARESCAPE ONE ... 267 Temperature compatibility limitations... 267 Temperature safety precautions... 267 Temperature warnings ... 267 Temperature measurement limitations... 267 Temperature points to note... 268 Temperature measurement setup... 268 Temperature equipment to patient connection with PDM ... 268 Temperature equipment to patient connection with CARESCAPE ONE ... 269 Preparing the patient for temperature measurement... 269 Checking the temperature measurement ... 269 Temperature measurement on screen... 269 Using the temperature measurement... 270 Temperature mappings ... 270 Starting the temperature measurement ... 270 Changing the temperature site label ... 270 Displaying the delta value between two temperature channels ... 270

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Setting temperature alarms ... 270 Stopping the temperature measurement... 271 Temperature practicalities ... 271 Temperature troubleshooting ... 271 15 Cardiac output ...273 Cardiac output measurement... 273 Cardiac output compatibility limitations... 273 C.O. safety precautions ... 273 C.O. measurement limitations ... 274 C.O. points to note ... 274 C.O. measurement setup ... 274 Using the C.O. measurement... 277 C.O. practicalities ... 282 C.O. troubleshooting... 283 Continuous cardiac output (CCO) measurement ... 285 Continuous cardiac output compatibility limitations... 285 CCO safety precautions ... 285 E-PiCCO indications for use ... 287 Feature availability... 287 CCO measurement limitations ... 287 CCO points to note ... 288 CCO measurement setup... 289 Using the CCO measurement ... 290 How to improve the CCO accuracy... 298 CCO troubleshooting... 298 16 Venous oxygenation (SvO₂ and ScvO₂) ...301 SvO₂ measurement... 301 SvO2 compatibility limitations... 301 SvO₂ safety precautions ... 301 SvO2 measurement limitations... 302 SvO2 points to note ... 302 SvO₂ measurement setup... 302 Using the SvO₂ measurement ... 303 SvO2 measurement description ... 305

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