CARESCAPE ONE User Manual 2nd Edition Sw ver 3 Jan 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 ...23 Intended use of this manual... 23 Intended audience of this manual ... 23 Training requirements ... 23 Manual conventions ... 24 Monitor naming conventions ... 24 Other naming conventions ... 24 Illustrations and names ... 25 Related documents... 25 Ordering manuals ... 25 Revision history ... 25 Product availability ... 25 Trademarks ... 26 Third party trademarks ... 26 Manufacturer responsibility ... 26

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Safety ...27 Safety message signal words... 27 Safety symbols ... 27 System safety... 28 System warning safety messages ... 28 Accessories warnings ... 28 Cables warnings... 29 Defibrillation warnings... 29 Electrical warnings ... 30 System warnings... 31 Site requirement warnings ... 31 System caution safety messages ... 32 Loss of data ... 32 Electrical caution... 32 Site requirement caution ... 32 Notice safety messages ... 32

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Indications for use... 32 Contraindications for using the monitor... 32 CARESCAPE ONE indications for use ... 32 Indications for use safety precautions ... 33 Indications for use warnings ... 33 Indications for use cautions ... 34 Training requirements ... 34 Electromagnetic compatibility ... 34 EMC warnings... 34 EMC cautions ... 35 ESD safety precautions ... 35 3

System introduction ...37 System safety precautions ... 37 System warnings... 37 Operation warnings ... 37 CARESCAPE ONE installation points to note ... 37 Short description of the equipment ... 38 CARESCAPE ONE system components... 39 CARESCAPE ONE front and back views... 40 CARESCAPE ONE side view ... 41 CARESCAPE Parameters... 41 Power status indicator ... 41 Battery ... 42 Battery status indicator ... 42 Installing batteries... 42 Docks ... 45 Connecting the CARESCAPE ONE to a dock... 45 Disconnecting the CARESCAPE ONE from a dock ... 46 CARESCAPE Dock F0... 46 Mini Dock ... 48 Parameter Dock 1 and Parameter Dock 5... 48 Equipment symbols ... 48 Unique Device Identifier (UDI)... 53 CE marking application year ... 54

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Service requirements... 54 4

Monitoring basics ...55 Main screen layout... 55 Main keys... 56 An example of a menu... 56 Menu options... 57 Selecting menu options with a touchscreen ... 57 Data field entries ... 58 Entering data ... 58 About the user default settings... 58 About profiles ... 58 Selecting a profile... 58 Supply mains interruption ... 59 User interface indicators ... 59

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Setting up the monitor before use...61 Normal screen and other pages ... 61 Selecting the normal screen (main page) ... 61 Adjusting sound volumes ... 61 Brightness settings ... 61 Adjusting the display brightness ... 61 Adjusting the alarm light brightness... 62 Screen setup modifications... 62 Parameter windows ... 62 Normal screen pages... 63 Selecting parameters to the normal screen... 64 Waveform field safety precautions... 64 Locked alarm and parameter settings ... 64 Color selections ... 64 Parameter configurations... 65 Checking the battery status ... 65 Setting the touchscreen off ... 65 Other setup changes ... 65

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Starting and ending monitoring ...67 Software packages and terminology... 67

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Turning on the CARESCAPE ONE ... 67 Turning off the CARESCAPE ONE ... 67 Starting monitoring... 67 Pre-monitoring checklist... 68 Performance check... 69 Entering patient data... 69 Resetting a case/discharging a patient... 69 About continuing monitoring ... 69 About standby... 70 Starting standby... 70 End of standby... 71 7

Alarms ...73 Alarm safety precautions ... 73 Alarm warnings ... 73 Alarm overview ... 74 Alarm types... 74 Alarm conditions ... 75 Alarms in dual monitoring ... 75 Checking alarm function... 75 Visual alarm indications ... 76 Alarm icons on the screen ... 76 Description of alarm and information messages... 76 Visual alarm signals and priority levels... 77 Setting the alarm light brightness... 77 Audible alarm indications... 78 Audible alarm signals... 78 Audible alarm signals and priority levels ... 78 Auditory information signals ... 79 Parameter alarms ... 79 Alarm locks ... 79 Setting parameter alarm limits ... 79 Setting alarm limits automatically ... 79 Returning the default alarm limits ... 80 Alarm priorities and escalation ... 81

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Alarm priority levels... 81 Alarm priority escalation... 81 Selecting parameter alarm priority levels... 81 Setting arrhythmia alarms... 82 Pausing and silencing alarms ... 83 Audible alarms off behavior ... 83 Pause audio behaviors ... 83 Pausing alarms for 5 minutes... 84 Activating all audible alarms ... 84 Technical alarms’ deactivation with the pause audio key... 85 Apnea alarms’ deactivation with the pause audio key... 85 Breakthrough alarms ... 85 Latched alarms ... 85 Alarm settings after a power loss ... 85 Alarm data stored in Clinical logs ... 86 Stored alarm data during a power cycle or power loss... 86 8

Transport use ...87 Transport monitoring... 87 Dual monitoring and transport ... 87 Preparing to transport a patient ... 88 Returning a patient from transport ... 88 Transport transfer settings... 89 Transport settings ... 89 Transport troubleshooting... 95

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ECG ...97 ECG compatibility limitations... 97 ECG safety precautions ... 97 ECG warnings ... 97 ECG cautions ... 99 ECG measurement limitations... 99 ECG points to note ... 99 ECG measurement setup... 99 ECG equipment to patient connection with CARESCAPE ONE... 99 Preparing the patient’s electrode sites ... 100

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Applying the electrodes to the patient... 100 3- lead or 5-lead ECG electrode placement ... 101 6-lead ECG electrode placement ... 101 10–lead ECG electrode placement for cardiac monitoring ... 102 Standard resting 10–lead ECG electrode placement ... 103 Checking the ECG measurement ... 104 About the ECG analog output signal... 104 Using the ECG measurement ... 104 The first three displayed ECG leads... 104 Selecting the Va ECG lead... 105 Selecting the Vb ECG lead... 105 Changing to an ECG cable with fewer leadwires ... 105 Deactivating the ECG leads off alarm ... 105 Setting the beat volume... 106 Selecting the beat source ... 106 Setting the beep tone during bradycardia alarms... 106 Selecting the ECG waveform size ... 106 Selecting the hemodynamic waveform sweep speed... 107 Selecting the ECG waveform filter... 107 Setting the QRS width ... 107 Selecting the leads for ECG analysis ... 108 Relearning the patient’s QRS pattern... 108 Setting the primary HR source ... 108 Selecting HR alarm range... 109 Showing another value in the HR parameter window... 109 Displaying the ECG grid... 110 ECG alarm limits ... 110 ECG alarm priorities ... 111 ECG measurement practicalities... 111 Alternate pulse rate source ... 111 IntelliRate algorithm... 111 Auto algorithm... 112 ECG troubleshooting ... 112 About the 12RL™ feature ... 112

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Pacemaker detection... 113 Pacemaker detection warnings ... 113 Pacemaker detection points to note... 113 Selecting the pacemaker detection ... 114 Pacemaker detection troubleshooting ... 114 Arrhythmia monitoring ... 115 Arrhythmia monitoring warnings... 115 Arrhythmia measurement limitations... 116 Setting the arrhythmia category to alarm... 117 Setting arrhythmia alarms... 117 Setting HR for V Tach ... 117 Setting the pause interval... 117 Setting the SVT length... 118 Setting HR for SVT ... 118 Arrhythmia alarm messages ... 118 About the arrhythmia detection... 120 Arrhythmia troubleshooting ... 120 ST detection... 122 About the ST analysis... 122 ST detection measurement limitations ... 122 ST detection points to note... 122 Starting the ST detection ... 122 ST alarm limits ... 122 10 Impedance respiration...123 Impedance respiration compatibility limitations ... 123 Respiration safety precautions ... 123 Respiration warnings ... 123 Respiration cautions ... 124 Respiration measurement limitations... 124 Respiration points to note ... 124 Respiration measurement setup... 125 Respiration equipment to patient connection with CARESCAPE ONE ... 125 Preparing the patient’s respiration electrode sites ... 125

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Respiration lead and breath detection ... 125 Respiration lead I electrode placement ... 126 Respiration lead II electrode placement ... 126 Respiration lead RL-LL electrode placement... 127 Respiration measurement checks... 127 Respiration measurement on the monitor screen... 127 Using the respiration measurement ... 128 Turning on the respiration measurement... 128 Selecting the respiration lead... 128 Selecting the respiration waveform size automatically... 128 Selecting the respiration waveform size manually ... 128 Selecting the waveform sensitivity ... 128 Enabling respiration smoothing ... 128 Turning inspiration and expiration markers on or off ... 129 Selecting the waveform speed... 129 Relearning the respiration pattern... 129 Turning on or off the respiration rate alarm... 129 Setting the respiration alarm limits... 129 Apnea alarms’ deactivation with the pause audio key... 130 Setting the apnea alarm delay ... 130 Enabling the respiration cardiac artifact alarm ... 130 Respiration alarm priorities ... 130 Turning off the respiration measurement ... 130 Respiration measurement description ... 131 How to interpret the respiration values... 131 Respiration troubleshooting ... 131 11 SpO₂ ...133 SpO2 compatibility limitations ... 133 SpO2 safety precautions ... 133 SpO2 warnings... 133 SpO2 cautions ... 136 SpO2 measurement limitations ... 137 SpO2 points to note ... 137 Masimo safety precautions ... 137

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Masimo warnings... 137 Masimo cautions ... 139 Masimo points to note ... 140 SpO₂ measurement guidelines... 141 GE TruSignal technology and sensor measurement guidelines... 141 Masimo SET technology and sensor measurement guidelines... 141 Nellcor™ sensors with OxiMax™ technology and sensor measurement guidelines... 142 SpO₂ measurement setup ... 143 SpO2 equipment to patient connection with CARESCAPE ONE ... 143 Preparing the SpO2 connection... 143 Checking the SpO2 measurement ... 143 Using the SpO₂ measurement... 144 Changing the SpO2 waveform scale ... 144 Changing the SpO2 waveform size... 144 Selecting the SpO2 hemodynamic sweep speed... 144 Selecting the SpO2 as the primary heart rate source ... 144 Showing the SpO2 pulse rate... 145 Adjusting the SpO2 pulse beep volume... 145 Selecting the beat source ... 145 Setting the variable beat tone ... 145 Masimo SET data averaging and updating ... 145 Selecting the SpO2 averaging time ... 145 Selecting the Masimo SpO2 sensor sensitivity level ... 146 Nellcor™ sensors with OxiMax™ technology data averaging and updating... 146 Selecting the SpO2 response time ... 146 Nellcor™ OxiMax™ SatSeconds™ alarm management ... 147 Setting the SpO2 alarms and alarm limits... 148 Deactivating the SpO2 probe off alarm ... 148 SpO2 alarm priorities ... 148 Stopping the SpO2 measurement ... 149 How to interpret the SpO₂ values... 149 SpO2 signal strength ... 149

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SpO2 waveform quality ... 149 SpO2 waveform stability ... 150 SpO2 wavelengths and optical output power ... 150 SpO2 measurement and interference... 150 SpO2 troubleshooting... 151 12 Non-invasive blood pressure...153 NIBP compatibility limitations ... 153 NIBP safety precautions ... 153 NIBP warnings ... 153 NIBP cautions ... 154 NIBP measurement limitations ... 155 NIBP points to note ... 155 NIBP measurement setup... 156 NIBP equipment to patient connection with CARESCAPE ONE... 156 Preparing the NIBP patient connection ... 156 Checking the NIBP measurement ... 156 NIBP measurement on screen ... 157 Manual NIBP measurements... 157 Starting or stopping a single NIBP measurement from the main menu ... 157 Starting or stopping a single NIBP measurement from the NIBP setup menu ... 157 Automatic NIBP measurements... 157 NIBP Auto mode ... 157 Setting the cycle time between NIBP measurements... 158 Automatic NIBP measurements and monitor clock synchronization ... 158 STAT mode ... 158 NIBP cuffs ... 159 NIBP cuff selection and placement ... 159 Selecting NIBP cuff size... 159 Initial NIBP cuff inflation pressure ... 159 NIBP volume and display settings... 160 Adjusting the NIBP measurement completion tone volume ... 160 Setting the NIBP display format ... 160

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NIBP alarms... 160 Setting NIBP alarms ... 160 NIBP alarms’ deactivation with pause audio key ... 161 NIBP recheck after alarm violation (control measurement) ... 161 NIBP measurement description ... 161 NIBP measurement technologies ... 162 DINAMAP SuperSTAT NIBP technology... 162 DINAMAP Step Deflation technology ... 162 NIBP calibration... 163 NIBP troubleshooting... 164 13 Invasive pressures ...165 Invasive pressures compatibility limitations ... 165 Invasive pressure safety precautions ... 165 Invasive pressure warnings ... 165 Invasive pressure points to note ... 166 Invasive pressure measurement setup ... 166 Invasive pressure equipment to patient connection with CARESCAPE ONE ... 166 Connecting the invasive pressure transducer and cable ... 166 Checking the invasive pressure measurement ... 166 Invasive pressure measurement on the monitor screen... 167 Using the invasive pressure measurement ... 167 Invasive pressure analog output... 167 About zeroing the invasive pressure transducers... 167 Zeroing the invasive pressure transducers ... 168 Selecting an invasive pressure channel label... 168 Selecting the size of the invasive pressure waveform ... 168 Optimizing the invasive pressure waveform scale... 168 Selecting the hemodynamic waveform sweep speed... 169 Selecting the displayed invasive pressure format... 169 Selecting invasive pressure as the primary heart rate source ... 169 Showing the pulse rate in the invasive pressure parameter window ... 170 Showing the CPP value in the ICP parameter window... 170

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Using the IP channel standby... 170 Selecting the invasive pressure noise reduction filter... 170 Selecting the primary arterial source ... 171 Selecting Smart BP... 171 Compensating for intra-aortic balloon pump (IABP) waveform irregularities... 171 Setting an arterial invasive pressure disconnection alarm ... 172 Setting invasive pressure alarm limits ... 172 Invasive pressures alarm priorities ... 172 Invasive pressure practicalities ... 173 Invasive pressure parameters... 173 Intra-aortic balloon pump ... 173 Invasive pressure troubleshooting... 176 14 Temperature...179 Temperature compatibility limitations... 179 Temperature safety precautions... 179 Temperature warnings ... 179 Temperature cautions... 179 Temperature points to note... 180 Temperature measurement setup... 180 Temperature equipment to patient connection with CARESCAPE ONE ... 180 Preparing the patient for temperature measurement... 180 Checking the temperature measurement ... 181 Temperature measurement on screen... 181 Using the temperature measurement... 181 Temperature mappings ... 181 Starting the temperature measurement ... 181 Changing the temperature site label ... 181 Setting temperature alarms ... 181 Stopping the temperature measurement... 182 Temperature practicalities ... 182 Temperature troubleshooting ... 182 15 CO₂...185

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CO2 safety precautions ... 185 CO2 warnings... 185 CO2 cautions ... 186 CO2 points to note ... 186 CO₂ measurement setup ... 187 Equipment connection with CARESCAPE CO2 ... 187 Preparing the setup for CARESCAPE CO2 ... 187 About sidestream kits ... 188 Using the CO₂ measurement... 188 Pump on or off with CARESCAPE CO2 ... 188 Selecting the CO2 scale ... 188 Selecting the CO2 sweep speed... 188 Setting CO2 limit alarms ... 189 Deactivating the apnea alarm ... 189 Apnea alarm deactivation with the pause audio key ... 189 Selecting CO2 average ... 190 Selecting the FiO2 level... 190 Selecting the N2O level... 190 Selecting the apnea alarm limit ... 190 Zeroing the LoFlo Sidestream Module ... 190 Preventing care area pollution ... 191 Connecting to scavenging systems ... 191 Stopping the CO2 measurement ... 191 Basics of CO₂ measurement... 191 Normal CO2 waveform... 191 The origin of the CO2 waveform ... 192 Dips in capnogram... 192 CO₂ measurement practicalities ... 193 Ventilation management ... 193 Prevention of the breathing system contamination ... 194 How to prevent effects of humidity... 194 CO2 troubleshooting... 195 16 Trends...197 Viewing numeric trends... 197

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Changing the time interval of numeric trends ... 197 About snapshots and graphic trends ... 197 17 Cleaning and care...199 Cleaning and care overview... 199 Cleaning... 199 Cleaning safety precautions... 199 Permitted detergents ... 200 Cleaning points to note... 200 Setting the touchscreen off for cleaning ... 200 General cleaning instructions... 200 Other manufacturer cleaning instructions ... 201 Disinfection... 204 Disinfection cleaning precautions... 204 Disinfection points to note... 204 Permitted disinfectants... 204 Disinfection and sterilization of accessories ... 206 Care... 207 Care safety precautions... 207 Care schedules ... 207 Regular calibration checks ... 208 18 Messages ...209 Messages related to ECG measurement ... 209 Messages related to impedance respiration measurement with CARESCAPE ONE... 213 Messages related to SpO2 measurement with CARESCAPE ONE... 214 Messages related to NIBP measurement ... 218 Messages related to invasive pressures measurement ... 219 Messages related to temperature measurement ... 225 Messages related to CO2 measurement... 226 Messages related to various technical issues... 229 19 Abbreviations ...233 List of abbreviations... 233 A

Skills checklist ...239 System introduction... 239

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Starting and ending ... 239 Monitoring basics... 240 Alarms... 240 Transport ... 241 ECG... 241 Impedance respiration ... 243 Pulse oximetry (SpO2) ... 243 Non-invasive blood pressure... 244 Invasive pressures... 245 Temperature... 245 CO2 ... 246 Trends ... 246 B

Compatibility ...247 Compatibility ... 247 Measurement device compatibility... 247 Identical measurement devices ... 247 Measurement device compatibility... 248 Host monitor compatibility... 248 Dock compatibility ... 248

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Compliance...249 Standards compliance... 249 IEC 60601-1 ... 249

D

Design, environmental, and physical specifications...251 CARESCAPE ONE specifications... 251 CARESCAPE Dock F0 specifications ... 253 Mini Dock, Parameter Dock 1, and Parameter Dock 5 specifications ... 254 CARESCAPE ECG specifications ... 255 CARESCAPE SpO2 specifications... 255 CARESCAPE Pressure specifications ... 257 CARESCAPE Temperature specifications ... 258 CARESCAPE CO2 specifications... 258

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Alarm specifications...261 Alarm standards compliance ... 261

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Auditory alarm volume, IEC tones... 261 Auditory alarm volume, legacy tones ... 261 Audio alarm sound tolerances ... 262 IEC alarm tone sound patterns ... 262 Legacy alarm tone sound patterns... 263 Auditory information signal characteristics ... 263 Visual information signals ... 263 Alarm delay specifications ... 263 Time to alarm for tachycardia... 264 Physiological alarm delay specifications ... 264 Technical alarm delay specifications... 269 Alarm priorities and escalation times ... 273 Alarm priorities and escalation times for ECG... 273 Alarm priorities and escalation times for impedance respiration ... 278 Alarm priorities and escalation times for SpO2 ... 279 Alarm priorities and escalation times for NIBP... 283 Alarm priorities and escalation times for invasive pressures... 284 Alarm priorities and escalation times for temperature ... 291 Alarm priorities and escalation times for CO2 ... 292 Alarm priorities and escalation times for various situations ... 294 F

Parameter specifications...297 Parameter specifications... 297 ECG standards compliance ... 297 ECG performance specifications... 297 Impedance respiration standards compliance ... 300 Impedance respiration performance specifications... 300 SpO2 standards compliance... 300 SpO2 displayed saturation values ... 301 SpO₂ summary of clinical studies used to establish accuracy claims... 301 Accuracy of Nellcor™ sensors with Oximax™ technology ... 301 Accuracy of Masimo SET technology with Masimo SET sensors... 301 Accuracy of GE TruSignal technology with TruSignal sensors ... 302

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SpO2 test methods used to establish accuracy claims during motion... 302 SpO₂ test methods used to establish accuracy claims during low perfusion... 303 Low perfusion accuracy of Nellcor Oximax technology with Oximax sensors... 303 Low perfusion accuracy of Masimo SET technology ... 303 Low perfusion accuracy of GE TruSignal technology with TruSignal sensors... 303 SpO₂ test methods used to establish pulse rate accuracy ... 303 Pulse rate accuracy of Nellcor Oximax technology with Oximax sensors... 303 Pulse rate accuracy of Masimo SET technology with Masimo sensors... 304 Pulse rate accuracy of GE TruSignal technology with TruSignal sensors... 304 SpO2 performance specifications ... 304 SpO₂ supplemental analysis graphs... 307 Additional accuracy information for Nellcor™ sensors ... 307 Additional accuracy information for Masimo sensors... 309 Additional accuracy information for GE TruSignal sensors ... 313 NIBP standards compliance ... 318 NIBP performance specifications... 318 Invasive pressure standards compliance... 319 Invasive pressure performance specifications ... 319 Temperature standards compliance ... 320 Temperature performance specifications... 320 CO2 standards compliance... 321 CO2 performance specifications ... 321 G

Default settings...323 Understanding your monitor configuration ... 323 Software packages ... 323 Licensed software options... 323 Software profiles ... 324 Software settings ... 324 Care unit settings ... 324

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DEMO MODE ... 325 Profile settings ... 325 Current patient settings ... 326 Configuring care unit settings ... 326 Alarm settings ... 326 Parameter alarms settings ... 327 Admit/discharge settings... 330 Unit of measure settings... 330 Parameter settings... 330 Configuring profile settings ... 331 Alarm delay settings ... 332 Invasive pressures alarms settings ... 332 Invasive pressures settings for labels ... 337 Configuring locking settings... 339 Parameter locking settings... 339 Alarm locking settings... 339 Configuring Time & Date settings ... 341 Time Format settings ... 341 Configuring current patient settings... 341 Alarm limits settings... 342 Alarm priority settings... 342 Arrhythmia alarm settings... 343 Audible and visual alarm settings ... 346 Monitor screen settings ... 346 Invasive pressures color settings for channels ... 347 Other parameters color settings ... 347 Monitor sound settings ... 347 Monitor parameter settings... 348 Admit/discharge or start/end case settings... 348 Trend settings... 349 Parameter default settings... 350 ECG default settings... 350 ST default settings... 354 Impedance respiration default settings... 355

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