CARESCAPE ONE User Manual sw ver 3.2 3rd edition

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 ...23 Intended use of this manual... 23 Intended audience of this manual ... 23 Training requirements ... 24 Manual conventions ... 24 Monitor naming conventions ... 24 Other naming conventions ... 24 Illustrations and names ... 25 Related documents... 25 Ordering manuals ... 26 Revision history ... 26 Product availability ... 26 Trademarks ... 26 Third party trademarks ... 26 Manufacturer information... 26 Manufacturer responsibility ... 27

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Safety ...29 Safety message signal words... 29 Safety symbols ... 29 System safety... 30 Reporting of serious incidents... 30 System warning safety messages ... 31 Accessories warnings ... 31 Battery warnings... 31 Cables warnings... 32 Care warnings ... 32 Cleaning warnings ... 33 Defibrillation warnings... 33 Dock warnings... 34 Electrical warnings ... 34 Monitoring warnings ... 36

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Operation warnings ... 37 Service warnings ... 37 Site requirement warnings ... 37 System warnings... 37 System caution safety messages ... 38 Battery cautions ... 38 Cleaning cautions... 38 Disinfection cautions... 38 Disposal cautions ... 38 Electrical caution... 38 Loss of data ... 39 Monitoring cautions ... 39 Site requirement caution ... 39 Touchscreen caution... 39 Notice safety messages ... 39 Safety messages for parts of the system ... 39 Alarm warnings ... 40 ECG warnings ... 42 ECG cautions ... 43 Pacemaker detection warnings ... 44 Arrhythmia monitoring warnings... 44 Respiration warnings ... 45 Respiration cautions ... 46 SpO2 warnings... 46 SpO2 cautions... 50 NIBP warnings ... 50 Invasive pressure warnings... 52 Invasive pressure cautions ... 53 Temperature warnings ... 53 Temperature cautions ... 53 CO2 warnings... 53 CO2 cautions... 55 Indications for use... 55 CARESCAPE ONE indications for use ... 55

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Contraindications for using CARESCAPE ONE ... 56 Clinical benefits of using the monitor ... 56 Indications for use safety precautions ... 57 Indications for use warnings ... 57 Indications for use cautions ... 57 Electromagnetic compatibility ... 57 EMC warnings... 57 Electromagnetic compatibility cautions ... 58 ESD safety precautions ... 58 3

System introduction ...61 System safety precautions ... 61 System warnings... 61 Operation warnings ... 61 CARESCAPE ONE installation points to note ... 62 Short description of the equipment ... 62 CARESCAPE ONE system components... 63 CARESCAPE ONE front and back views... 65 CARESCAPE ONE side view ... 66 CARESCAPE Parameters... 66 Power status indicator ... 67 Battery ... 67 Battery status indicator ... 67 Installing batteries... 68 Docks ... 70 Connecting the CARESCAPE ONE to a dock... 70 Disconnecting the CARESCAPE ONE from a dock ... 71 CARESCAPE Dock F0... 71 Mini Dock ... 73 Parameter docks ... 73 Equipment symbols ... 74 Unique Device Identifier (UDI)... 81 CE marking application year ... 81 Service requirements... 81

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Monitoring basics ...83

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Main screen layout... 83 Main keys... 84 An example of a menu... 84 Menu options... 85 Selecting menu options with the touchscreen... 85 Data field entries ... 86 Entering data ... 86 About the user default settings... 86 About profiles ... 86 Selecting a profile... 86 Supply mains interruption ... 87 User interface indicators ... 87 5

Setting up the monitor before use...91 Normal screen and other pages ... 91 Selecting the normal screen (main page) ... 91 Adjusting sound volumes ... 91 Brightness settings ... 91 Adjusting the display brightness ... 91 Adjusting the alarm light brightness... 92 Screen setup modifications... 92 Parameter windows ... 92 Normal screen pages... 93 Selecting parameters to the normal screen... 94 Waveform field safety precautions... 94 Locked alarm and parameter settings ... 95 Color selections ... 95 Parameter configurations... 95 Checking the battery status ... 95 Setting the touchscreen off ... 95 Other setup changes ... 96

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Starting and ending monitoring ...97 Software packages and terminology... 97 Turning on the CARESCAPE ONE ... 97 Turning off the CARESCAPE ONE ... 97

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Starting monitoring... 97 Pre-monitoring checklist... 98 Performance check... 99 Entering patient data... 99 Adding or removing parameters during an active patient case... 99 Resetting a case/discharging a patient... 100 About standby... 100 Starting standby... 100 End of standby... 101 7

Alarms ...103 Alarm safety precautions ... 103 Alarm warnings ... 103 Alarm overview ... 105 Alarm types... 105 Alarm conditions ... 105 Alarms in dual monitoring ... 106 Checking alarm function... 106 Visual alarm indications ... 106 Alarm icons on the screen ... 106 Description of alarm and information messages... 107 Visual alarm signals and priority levels... 108 Setting the alarm light brightness... 108 Audible alarm indications... 109 Audible alarm signals... 109 Audible alarm signals and priority levels ... 109 Auditory information signals ... 110 Parameter alarms ... 110 Alarm locks ... 110 About critical alarms ... 110 Setting parameter alarm limits ... 111 Setting alarm limits automatically ... 111 Returning the default alarm limits ... 112 Alarm priorities and escalation ... 112 Alarm priority levels... 112

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Alarm priority escalation... 112 Selecting parameter alarm priority levels... 113 Setting arrhythmia alarms... 113 Pausing and silencing alarms ... 114 Audible alarms off behavior ... 114 Pause audio behaviors ... 115 Pausing alarms for 5 minutes... 116 Activating all audible alarms ... 116 Technical alarm deactivation with the pause audio key ... 116 Apnea alarm deactivation with the pause audio key ... 117 Breakthrough alarms ... 117 Latched alarms ... 117 Alarm settings after a power loss ... 117 Alarm data stored in Clinical logs ... 117 Stored alarm data during a power cycle or power loss... 118 8

Intra-hospital transport use ...119 Transport monitoring... 119 Dual monitoring and transport ... 119 Preparing to transport a patient ... 119 Returning a patient from transport ... 120 Transport patient settings ... 121 Transport care unit settings ... 126 Transport troubleshooting... 127

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ECG ...129 ECG compatibility limitations... 129 ECG safety precautions ... 129 ECG warnings ... 129 ECG cautions ... 131 ECG measurement limitations... 131 ECG points to note ... 131 ECG measurement setup... 131 ECG equipment to patient connection with CARESCAPE ONE... 131 Preparing the patient’s electrode sites ... 132 Applying the electrodes to the patient... 132

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3- lead or 5-lead ECG electrode placement ... 133 6-lead ECG electrode placement ... 133 10-lead ECG electrode placement for cardiac monitoring... 134 Standard resting 10-lead ECG electrode placement ... 135 Checking the ECG measurement ... 136 About the ECG analog output signal... 136 Using the ECG measurement ... 136 The first three displayed ECG leads... 136 Selecting the Va ECG lead... 137 Selecting the Vb ECG lead... 137 Changing to an ECG cable with fewer leadwires ... 137 Deactivating the ECG leads off alarm ... 137 Setting the beat volume... 138 Selecting the beat source ... 138 Setting the beep tone during bradycardia alarms... 138 Selecting the ECG waveform size ... 138 Selecting the hemodynamic waveform sweep speed... 139 Selecting the ECG waveform filter... 139 Setting the QRS width ... 139 Selecting the leads for ECG analysis ... 139 Relearning the patient’s QRS pattern... 140 Setting the primary HR source ... 140 Selecting the HR alarm range ... 141 Showing another value in the HR parameter window... 141 Displaying the ECG grid... 141 ECG alarm limits ... 142 Configurable PR alarm delays ... 143 ECG alarm priorities ... 143 Checking alarm delays and priorities information... 143 ECG measurement practicalities... 144 Alternate pulse rate source ... 144 IntelliRate algorithm... 144 Auto algorithm... 144 ECG troubleshooting ... 145

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About the 12RL™ feature ... 145 Pacemaker detection... 146 Pacemaker detection warnings ... 146 Pacemaker detection points to note... 146 Selecting pacemaker detection... 146 Pacemaker detection troubleshooting ... 147 Arrhythmia monitoring ... 148 Arrhythmia monitoring warnings... 148 Arrhythmia measurement limitations... 149 Setting the arrhythmia category to alarm... 149 Setting arrhythmia alarms... 150 Selecting V Tach criteria ... 150 Setting minimum HR for V Tach ... 150 Setting V Tach event duration ... 151 Setting the pause interval... 151 Setting the SVT length... 151 Setting HR for SVT ... 151 Arrhythmia alarm messages ... 152 About the arrhythmia detection... 153 Arrhythmia troubleshooting ... 154 ST detection... 155 About ST analysis ... 155 ST detection measurement limitations ... 155 ST detection points to note... 156 Starting ST detection... 156 ST alarm limits ... 156 10 Impedance respiration...157 Impedance respiration compatibility limitations ... 157 Respiration safety precautions ... 157 Respiration warnings ... 157 Respiration cautions ... 158 Respiration measurement limitations... 158 Respiration points to note ... 158 Respiration measurement setup... 159

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Respiration equipment to patient connection with CARESCAPE ONE ... 159 Preparing the patient’s respiration electrode sites ... 159 Respiration lead and breath detection ... 159 How to interpret the respiration values ... 160 Respiration lead I electrode placement ... 160 Respiration lead II electrode placement ... 161 Respiration lead RL-LL electrode placement... 161 Respiration measurement checks... 161 Respiration measurement on the monitor screen... 162 Using the respiration measurement ... 162 Turning on the respiration measurement... 162 Selecting the respiration lead... 162 Selecting the respiration waveform size automatically... 162 Selecting the respiration waveform size manually ... 162 Selecting the waveform sensitivity ... 163 Enabling respiration smoothing ... 163 Turning inspiration and expiration markers on or off ... 163 Selecting the waveform speed... 163 Relearning the respiration pattern... 163 Turning on or off the respiration rate alarm... 164 Setting the respiration alarm limits... 164 Apnea alarm deactivation with the pause audio key ... 164 Setting the apnea alarm delay ... 164 Configurable respiration alarm delays ... 164 Enabling the respiration cardiac artifact alarm ... 164 Respiration alarm priorities ... 165 Checking alarm delays and priorities information... 165 Turning off the respiration measurement ... 165 Respiration measurement description ... 165 Respiration troubleshooting ... 166 11 SpO₂ ...167 SpO2 compatibility limitations ... 167 SpO₂ safety precautions ... 167

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SpO2 warnings... 167 SpO2 cautions ... 170 SpO2 measurement limitations ... 171 SpO2 points to note ... 171 Masimo safety precautions ... 171 Masimo warnings... 171 Masimo cautions ... 173 Masimo points to note ... 174 SpO₂ measurement guidelines... 175 GE TruSignal technology and sensor measurement guidelines... 175 Masimo SET technology and sensor measurement guidelines... 175 Nellcor™ sensors with OxiMax™ technology and sensor measurement guidelines... 176 SpO₂ measurement setup ... 177 SpO2 equipment to patient connection with CARESCAPE ONE ... 177 Preparing the SpO2 connection... 177 Checking the SpO2 measurement ... 178 Using the SpO₂ measurement... 178 Changing the SpO2 waveform scale ... 178 Changing the SpO2 waveform size... 178 Selecting the SpO2 hemodynamic sweep speed... 178 Selecting SpO2 as the primary heart rate source... 178 Showing the SpO2 pulse rate... 179 Adjusting the SpO2 pulse beep volume... 179 Selecting the beat source ... 179 Setting the variable beat tone ... 179 Masimo SET data averaging and updating ... 179 Selecting the SpO2 averaging time ... 180 Selecting the Masimo SpO2 sensor sensitivity level ... 180 Nellcor™ sensors with OxiMax™ technology data averaging and updating... 180 Selecting the SpO2 response time ... 181 Nellcor™ OxiMax™ SatSeconds™ alarm management ... 181 Setting the SpO2 alarms and alarm limits... 182

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Deactivating the SpO2 probe off alarm ... 182 Configurable SpO2 alarm delays ... 183 Configurable PR alarm delays ... 183 SpO2 alarm priorities ... 183 Checking alarm delays and priorities information... 183 Stopping the SpO2 measurement ... 183 How to interpret the SpO₂ values... 184 SpO2 signal strength ... 184 SpO2 waveform quality ... 184 SpO2 waveform stability ... 184 SpO2 wavelengths and optical output power ... 184 SpO2 measurement and interference... 185 SpO2 troubleshooting... 186 12 Non-invasive blood pressure...189 NIBP compatibility limitations ... 189 NIBP safety precautions ... 189 NIBP warnings ... 189 NIBP measurement limitations ... 191 NIBP points to note ... 191 NIBP measurement setup... 192 NIBP equipment to patient connection with CARESCAPE ONE... 192 Preparing the NIBP patient connection ... 192 Checking the NIBP measurement ... 192 NIBP measurement on screen ... 193 Manual NIBP measurements... 193 Starting or stopping a single NIBP measurement from the main menu ... 193 Starting or stopping a single NIBP measurement from the NIBP setup menu ... 193 Automatic NIBP measurements... 193 NIBP Auto mode ... 193 Setting the cycle time between NIBP measurements... 194 Automatic NIBP measurements and monitor clock synchronization ... 194 STAT mode ... 194

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NIBP cuffs ... 195 NIBP cuff selection and placement ... 195 Selecting NIBP cuff size... 195 Initial NIBP cuff inflation pressure ... 196 NIBP volume and display settings... 196 Adjusting the NIBP measurement completion tone volume ... 196 Setting the NIBP display format ... 196 NIBP alarms... 197 Setting NIBP alarms ... 197 NIBP alarms’ deactivation with pause audio key ... 197 NIBP recheck after alarm violation (control measurement) ... 197 NIBP measurement description ... 197 NIBP measurement technologies ... 198 DINAMAP SuperSTAT NIBP technology... 198 DINAMAP Step Deflation technology ... 199 NIBP calibration... 200 NIBP troubleshooting... 200 13 Invasive pressures ...203 Invasive pressures compatibility limitations ... 203 Invasive pressure safety precautions ... 203 Invasive pressure warnings ... 203 Invasive pressure points to note ... 204 Invasive pressure measurement setup ... 204 Invasive pressure equipment to patient connection with CARESCAPE ONE ... 204 Connecting the invasive pressure transducer and cable ... 204 Checking the invasive pressure measurement ... 205 Invasive pressure measurement on the monitor screen... 205 Using the invasive pressure measurement ... 206 Invasive pressure analog output... 206 About zeroing the invasive pressure transducers... 206 Zeroing the invasive pressure transducers ... 206 Selecting an invasive pressure channel label... 207 Selecting the size of the invasive pressure waveform ... 207

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Optimizing the invasive pressure waveform scale... 207 Selecting the hemodynamic waveform sweep speed... 208 Selecting the displayed invasive pressure format... 208 Selecting invasive pressure as the primary heart rate source ... 208 Showing the pulse rate in the invasive pressure parameter window ... 209 Showing the CPP value in the ICP parameter window... 209 Using the IP channel standby... 209 Selecting the invasive pressure noise reduction filter... 209 Selecting the primary arterial source ... 209 Selecting Smart BP... 210 Compensating for intra-aortic balloon pump (IABP) waveform irregularities... 210 Setting an arterial invasive pressure disconnection alarm ... 211 Setting invasive pressure alarm limits ... 211 Configurable PR alarm delays ... 211 Invasive pressures alarm priorities ... 211 Checking alarm delays and priorities information... 212 Invasive pressure practicalities ... 212 Invasive pressure parameters... 212 Intra-aortic balloon pump ... 213 Invasive pressure troubleshooting... 215 14 Temperature...219 Temperature compatibility limitations... 219 Temperature safety precautions... 219 Temperature warnings ... 219 Temperature cautions... 219 Temperature points to note... 220 Temperature measurement setup... 220 Temperature equipment to patient connection with CARESCAPE ONE ... 220 Preparing the patient for temperature measurement... 220 Checking the temperature measurement ... 221 Temperature measurement on screen... 221 Using the temperature measurement... 221

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Temperature mappings ... 221 Starting the temperature measurement ... 221 Changing the temperature site label ... 221 Setting temperature alarms ... 221 Stopping the temperature measurement... 222 Temperature practicalities ... 222 Temperature troubleshooting ... 222 15 CO₂...225 CO2 compatibility limitations ... 225 CO₂ safety precautions... 225 CO2 warnings... 225 CO2 cautions ... 227 CO2 points to note ... 227 CO₂ measurement setup ... 227 Equipment connection with CARESCAPE CO2 - LoFlo... 227 Preparing the setup for CARESCAPE CO2 - LoFlo ... 228 Equipment connection with CARESCAPE CO2 - Microstream... 228 Preparing the setup for CARESCAPE CO2 - Microstream... 229 About sidestream kits ... 229 Using the CO₂ measurement... 230 Pump on or off with CARESCAPE CO2 - LoFlo... 230 Selecting the age range... 230 Selecting the CO2 scale ... 230 Selecting the CO2 sweep speed... 230 Setting CO2 limit alarms ... 231 Deactivating the apnea alarm ... 231 Apnea alarm deactivation with the pause audio key ... 231 Selecting CO2 average ... 231 Selecting the FiO2 level... 232 Selecting the N2O level... 232 Selecting the apnea alarm limit ... 232 Zeroing the LoFlo Sidestream Module ... 232 Preventing care area pollution ... 233 Connecting to scavenging systems ... 233

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Stopping the CO2 measurement ... 233 Basics of CO₂ measurement... 233 Normal CO2 waveform... 233 The origin of the CO2 waveform ... 233 Dips in capnogram... 234 CO₂ measurement practicalities ... 235 Ventilation management ... 235 Prevention of breathing system contamination... 236 How to prevent effects of humidity... 236 CO2 troubleshooting... 237 16 Trends...239 Viewing numeric trends... 239 Changing the time interval of numeric trends ... 239 About snapshots and graphic trends ... 239 17 Cleaning, disinfection, and care ...241 About cleaning, disinfection, and care instructions... 241 Care... 241 Care safety precautions... 241 Care schedules ... 242 18 Messages ...243 Messages related to ECG measurement ... 243 Messages related to impedance respiration measurement with CARESCAPE ONE... 247 Messages related to SpO2 measurement with CARESCAPE ONE... 248 Messages related to NIBP measurement ... 252 Messages related to invasive pressures measurement ... 254 Messages related to temperature measurement ... 258 Messages related to CO2 measurement... 260 Messages related to various technical issues... 264 19 Abbreviations ...269 List of abbreviations... 269 A

Symbols glossary ...275 Symbols glossary ... 275

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Skills checklist ...283

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System introduction... 283 Starting and ending ... 283 Monitoring basics... 284 Alarms... 284 Transport ... 285 ECG... 285 Impedance respiration ... 287 Pulse oximetry (SpO2) ... 287 Non-invasive blood pressure... 288 Invasive pressures... 289 Temperature... 289 CO2 ... 290 Trends ... 290 C

Compliance...293 Standards compliance... 293 IEC 60601-1 ... 293

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Design, environmental, and physical specifications...295 CARESCAPE ONE specifications... 295 CARESCAPE Dock F0 specifications ... 297 Mini Dock and Parameter docks specifications ... 298 CARESCAPE ECG specifications ... 299 CARESCAPE SpO2 specifications... 300 CARESCAPE Pressure specifications ... 301 CARESCAPE Temperature specifications ... 302 CARESCAPE CO2 specifications... 303

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Alarm specifications...305 Alarm standards compliance ... 305 Auditory alarm volume, IEC tones... 305 Auditory alarm volume, legacy tones ... 305 Audio alarm sound tolerances ... 306 IEC alarm tone sound patterns ... 306 Legacy alarm tone sound patterns... 307 Auditory information signal characteristics ... 307 Visual information signals ... 307

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Alarm delay specifications ... 307 Time to alarm for tachycardia... 308 Physiological alarm delay specifications ... 308 Technical alarm delay specifications... 313 Alarm priorities and escalation times ... 318 Alarm priorities and escalation times for ECG... 318 Alarm priorities and escalation times for impedance respiration ... 326 Alarm priorities and escalation times for SpO2 ... 327 Alarm priorities and escalation times for NIBP... 331 Alarm priorities and escalation times for invasive pressures... 332 Alarm priorities and escalation times for temperature ... 339 Alarm priorities and escalation times for CO2 ... 340 Alarm priorities and escalation times for various situations ... 342 F

Parameter specifications...345 Parameter specifications... 345 ECG standards compliance ... 345 ECG performance specifications... 345 Impedance respiration standards compliance ... 348 Impedance respiration performance specifications... 348 SpO2 standards compliance... 348 SpO2 displayed saturation values ... 349 SpO₂ summary of clinical studies used to establish accuracy claims... 349 Accuracy of Nellcor™ sensors with Oximax™ technology ... 349 Accuracy of Masimo SET technology with Masimo SET sensors... 349 Accuracy of GE TruSignal technology with TruSignal sensors ... 350 Neonatal clinical performance of GE TruSignal technology with TruSignal sensors ... 350 SpO2 test methods used to establish accuracy claims during motion... 350 SpO₂ test methods used to establish accuracy claims during low perfusion... 351 Low perfusion accuracy of Nellcor Oximax technology with Oximax sensors... 351 Low perfusion accuracy of Masimo SET technology ... 351

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Low perfusion accuracy of GE TruSignal technology with TruSignal sensors... 351 SpO₂ test methods used to establish pulse rate accuracy ... 352 Pulse rate accuracy of Nellcor Oximax technology with Oximax sensors... 352 Pulse rate accuracy of Masimo SET technology with Masimo sensors... 352 Pulse rate accuracy of GE TruSignal technology with TruSignal sensors... 352 SpO2 performance specifications ... 353 SpO₂ supplemental analysis graphs... 356 Additional accuracy information for Nellcor™ sensors ... 356 Additional accuracy information for Masimo sensors... 362 Additional accuracy information for GE TruSignal sensors ... 371 rSO2 performance specifications ... 379 NIBP standards compliance ... 379 NIBP performance specifications... 380 Invasive pressure standards compliance... 380 Invasive pressure performance specifications ... 381 Temperature standards compliance ... 382 Temperature performance specifications... 382 CO2 standards compliance... 383 CO2 performance specifications ... 383 G

Default settings...385 Understanding your monitor configuration ... 385 Software packages ... 385 Licensed software options... 385 Software profiles ... 386 Software settings ... 386 Care unit settings ... 386 DEMO MODE ... 387 Profile settings ... 387 Current patient settings ... 388 Configuring care unit settings ... 388 Alarm settings ... 388

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