CARESCAPE B850, B650, B450 User Manual 1 st edition sw ver 3(3.2)

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.

2

CARESCAPE B850, B650, B450

5815925 2021-02-05

Contents 1

About this manual ...41 Intended use of this manual... 41 Intended markets of this manual ... 42 Intended audience of this manual ... 42 Training requirements ... 42 Manual conventions ... 43 Monitor naming conventions ... 43 Acquisition module naming conventions ... 44 Other naming conventions ... 44 Illustrations and names ... 45 Related documents... 46 Ordering manuals ... 46 Product availability ... 46 Trademarks ... 46 Third party trademarks ... 46 Manufacturer responsibility ... 47

2

Safety ...49 Safety message signal words... 49 Safety symbols ... 49 System safety... 50 Reporting of serious incidents... 50 System warning safety messages ... 51 Accessories warnings ... 51 Cables warnings... 51 Defibrillation warnings... 52 Electrical warnings ... 52 System warnings... 53 Site requirement warnings ... 54 System caution safety messages ... 54 Loss of data ... 54 Electrical caution... 55

5815925

CARESCAPE B850, B650, B450

3

Site requirement caution ... 55 Notice safety messages ... 55 Indications for use... 55 B850 indications for use ... 55 B650 indications for use ... 56 B450 indications for use ... 56 Contraindications for using the monitor... 57 Clinical benefits of using the monitor ... 57 E-MASIMO indications for use ... 57 E-NSATX indications for use... 57 E-PP and E-PT indications for use ... 57 E-COP–01 and E-COPSv–01 indications for use ... 57 E-PiCCO indications for use ... 58 CARESCAPE respiratory modules’ indications for use... 58 E-miniC indications for use ... 58 Entropy indications for use ... 58 E-NMT indications for use... 59 EEG indications for use ... 59 BIS indications for use... 59 E-musb indications for use ... 59 Indications for use safety precautions ... 60 Indications for use warnings ... 60 Indications for use cautions ... 60 Training requirements ... 60 Electromagnetic compatibility ... 60 EMC warnings... 60 ESD safety precautions ... 62 3

System introduction ...63 System safety precautions ... 63 System warnings... 63 System caution... 65 Operation warnings ... 65 Monitor installation points to note... 66 Short description of the equipment ... 66

4

CARESCAPE B850, B650, B450

5815925

B850 system components... 67 B850 processing unit front view... 69 B850 processing unit back view... 69 B850 module frames F7 and F5 ... 70 B650 system components... 70 B650 monitor front panel ... 72 B650 monitor side views... 72 B650 monitor back panel ... 73 B650 pivoting module frame ... 74 B450 system components... 75 B450 monitor front panel ... 77 B450 monitor side views... 77 B450 monitor back panel ... 78 Monitor battery ... 79 Inserting and removing the B650 monitor battery ... 80 Inserting and removing the B450 monitor battery ... 80 Checking the battery charge with monitor software... 81 Monitor battery charge indicators on screen... 81 Battery test button ... 81 CARESCAPE ONE... 82 CARESCAPE Parameters... 82 Acquisition modules... 83 Module compatibility limitations ... 83 Identical acquisition modules... 83 E-modules... 84 Connecting E-modules... 84 Removing E-modules ... 84 E-COP, E-COPSv, and E-PiCCO parameters ... 85 E-PP and E-PT parameters... 85 E-module gas parameters... 85 E-MASIMO and E-NSATX parameters... 86 Specialty E-module parameters... 86 E-musb... 86 E-musb front view ... 86

5815925

CARESCAPE B850, B650, B450

5

E-musb parameters ... 87 PDM... 87 Connecting a PDM... 87 Removing a PDM ... 87 PDM front view ... 88 PDM parameters ... 88 Displays... 89 Other system components ... 90 Access to external applications ... 91 InSite RSvP ... 92 Equipment markings... 92 Unique Device Identifier (UDI)... 99 CE marking application year ... 100 4

Monitoring basics ...101 Main screen layout... 101 Main keys... 102 An example of a menu... 103 Menu options... 104 Selecting menu options with a touchscreen ... 104 Selecting menu options with the Trim Knob control... 104 Selecting menu options with a mouse... 104 Data field entries ... 104 Entering data ... 104 About the user default settings... 105 About profiles ... 105 Selecting a profile... 105 Supply mains interruption ... 105 User interface indicators ... 106

5

Setting up the monitor before use...113 Normal screen and other pages ... 113 Selecting the normal screen (main page) ... 113 Selecting pages ... 113 Adjusting sound volumes ... 114 Brightness settings ... 114

6

CARESCAPE B850, B650, B450

5815925

B850 display brightness... 114 Adjusting the display brightness automatically ... 114 Adjusting the display brightness manually... 114 Adjusting the alarm light brightness... 115 Screen setup modifications... 115 Parameter windows ... 115 Selecting parameters to the normal screen... 116 Waveform field safety precautions... 116 Selecting the display mode for IP waveforms ... 117 Setting up a split screen... 117 Locked alarm and parameter settings ... 117 Color selections ... 118 Parameter configurations... 118 Setting up printing options ... 118 Checking the CARESCAPE ONE battery status ... 118 Checking the PDM battery status ... 118 Checking the monitor battery status... 119 Setting the touchscreen off ... 119 B850 with two screens... 119 Other setup changes ... 119 6

Starting and ending monitoring ...121 Software packages and terminology... 121 Turning on the monitor... 121 Turning off the monitor... 121 Starting monitoring... 122 Pre-monitoring checklist... 123 Performance check... 124 Entering patient data... 124 Patient data privacy protection... 124 Entering patient data with the monitor ... 124 Entering patient data with a barcode reader... 124 Loading patient information from the CARESCAPE Network ... 125 Entering administrative information... 125 About case reset/patient discharge ... 125

5815925

CARESCAPE B850, B650, B450

7

Pending software or setting activation... 126 Residual physiological data... 126 Resetting a case/discharging a patient... 126 Resetting a case/discharging a patient in combination monitoring mode ... 126 Time change during a patient case ... 127 About continuing monitoring ... 127 About Continue menu ... 128 About Select Patient and Data menu... 129 How to continue monitoring with patient case on the monitor... 130 How to continue monitoring with patient case on the acquisition device... 130 How to continue monitoring by combining patient cases ... 131 About standby... 131 Starting standby... 131 End of standby... 132 About the roving functionality... 132 Roving between units... 133 Roving between beds... 133 Adding new units and beds (manual roving) ... 133 7

Alarms ...135 Alarm safety precautions ... 135 Alarm warnings ... 135 Alarm overview ... 138 Alarm types... 138 Alarm conditions ... 139 Broadcast only alarms... 139 Broadcasted limit alarms... 144 Arrhythmia alarm mapping ... 144 Alarms in dual monitoring ... 145 Checking alarm function... 145 Visual alarm indications ... 146 Alarm icons on the screen ... 146 Description of alarm and information messages... 147

8

CARESCAPE B850, B650, B450

5815925

Visual alarm signals and priority levels... 148 Setting the alarm light brightness... 148 Audible alarm indications... 148 Audible alarm signals... 148 Audible alarm signals and priority levels ... 149 Auditory information signals ... 150 Parameter alarms ... 150 Alarm locks ... 150 Absolute alarm limits ... 150 About critical alarms ... 150 Setting parameter alarm limits ... 151 Setting alarm limits automatically ... 151 Returning the default alarm limits ... 152 Alarm priorities and escalation ... 152 Alarm priority levels... 152 Alarm priority escalation... 153 Selecting parameter alarm priority levels... 153 Setting arrhythmia alarms... 154 Pausing and silencing alarms ... 155 Audible alarms off behavior ... 155 Pause audio behaviors ... 156 Pausing alarms for 5 minutes... 157 Activating all audible alarms ... 157 Technical alarms’ deactivation with the pause audio key... 157 Apnea alarms’ deactivation with the pause audio key... 158 Alarms’ deactivation from the parameter menu ... 158 Pause audio with combination monitoring ... 158 Breakthrough alarms ... 158 Latched alarms ... 159 Pause monitoring... 159 Safety considerations when using pause monitoring ... 159 Turning off all local alarm indicators (sleep mode) ... 159 Selecting Pause Monitor & Central... 160 Remote management of alarms... 160

5815925

CARESCAPE B850, B650, B450

9

Alarm settings after a power loss ... 161 Alarm data stored in Clinical logs ... 161 Stored alarm data during a power cycle or power loss... 161 8

ECG ...163 About this measurement with CARESCAPE ONE ... 163 ECG compatibility limitations... 163 ECG safety precautions ... 163 ECG warnings ... 163 ECG cautions ... 165 ECG measurement limitations... 166 ECG points to note ... 166 ECG measurement setup... 166 ECG equipment to patient connection with the PDM ... 166 ECG equipment to patient connection with CARESCAPE ONE... 167 Preparing the patient’s electrode sites ... 168 Applying the electrodes to the patient... 168 3- lead or 5-lead ECG electrode placement ... 168 6-lead ECG electrode placement ... 169 10–lead ECG electrode placement for cardiac monitoring ... 170 Standard resting 10–lead ECG electrode placement ... 171 Checking the ECG measurement ... 172 About the ECG analog output signal... 172 About the combination monitoring mode... 172 About V Tach criteria and combination monitoring... 174 About enhanced Asystole detection and combination monitoring ... 174 About the ECG analog output signal... 174 Selecting the ECG source... 175 Using the ECG measurement ... 175 The first three displayed ECG leads... 175 Selecting the Va ECG lead... 176 Selecting the Vb ECG lead... 176 Changing to an ECG cable with fewer leadwires ... 176 Deactivating the ECG leads off alarm ... 177

10

CARESCAPE B850, B650, B450

5815925

Setting the beat volume... 177 Selecting the beat source ... 177 Setting the beep tone during bradycardia alarms... 177 Aspect ratio and different display sizes ... 178 Selecting the ECG waveform size ... 178 Selecting the hemodynamic waveform sweep speed... 178 Printing all ECG waveforms ... 178 Selecting the ECG waveform filter... 178 Setting the QRS width ... 179 Selecting the leads for ECG analysis ... 179 Relearning the patient’s QRS pattern... 180 Setting the primary HR source ... 180 Selecting HR alarm range... 181 Showing a second HR value in the HR parameter window ... 181 Showing ST in the HR parameter window ... 181 Showing PVC in the HR parameter window ... 181 Showing QT in the HR parameter window... 182 Displaying the ECG grid... 182 ECG alarm limits ... 182 Configurable PR alarm delays ... 184 ECG alarm priorities ... 184 Checking alarm delays and priorities information... 184 ECG measurement practicalities... 184 Alternate pulse rate source ... 184 IntelliRate algorithm... 185 Auto algorithm... 185 ECG troubleshooting ... 185 12 lead analysis... 186 Intended use of 12RL™ Interpolated 12 lead ECG analysis... 186 Intended use of 12SL ECG analysis ... 186 Intended use of ACI-TIPI... 186 12 lead ECG analysis points to note... 187 Entering data for a 12 lead ECG analysis ... 187 Entering data for an ACI-TIPI 12 lead ECG analysis ... 187

5815925

CARESCAPE B850, B650, B450

11

Enabling and disabling the 12SL ACS... 188 Setting automatic 12 lead ECG analysis measurements... 188 Generating a 12 lead ECG analysis report during an ST alarm condition ... 188 Setting the 12 lead ECG analysis display format... 188 Including or excluding 12SL statements in printed reports... 189 Entering the Location ID for 12SL... 189 Selecting the 12 lead print speed... 189 Selecting the 12SL baseline stabilization... 189 Performing a 12 lead ECG analysis ... 190 A 12 lead report and the MUSE database ... 190 Sending a 12 lead ECG report to the MUSE database ... 190 Selecting the low-pass 12 lead waveform filter ... 190 Viewing or printing saved 12 lead ECG reports ... 191 About the 12 lead ECG analysis program ... 191 About the 12RL™ ECG analysis feature ... 192 12 lead ECG analysis troubleshooting ... 193 Pacemaker detection... 193 Pacemaker detection warnings ... 193 Pacemaker detection points to note... 193 Selecting the pacemaker detection ... 194 Pacemaker detection troubleshooting ... 194 Arrhythmia monitoring ... 196 Arrhythmia monitoring warnings... 196 Arrhythmia measurement limitations... 197 Setting the arrhythmia category to alarm... 197 Setting arrhythmia alarms... 198 Selecting V Tach criteria ... 198 Setting minimum HR for V Tach ... 199 Setting V Tach event duration ... 199 Setting the pause interval... 199 Setting the SVT length... 199 Setting HR for SVT ... 200 Arrhythmia alarm messages ... 200

12

CARESCAPE B850, B650, B450

5815925

About the arrhythmia detection... 202 Arrhythmia troubleshooting ... 203 ST detection... 204 About the ST analysis... 204 ST detection measurement limitations ... 204 ST detection points to note... 205 Starting the ST detection ... 205 Selecting leads to the ST window... 205 Changing the displayed ST leads ... 205 Adjusting the ST point manually... 205 Adjusting the isoelectric measurement (ISO) point ... 206 Adjusting the J point ... 206 About the realtime QRS/ST complexes ... 206 About the reference QRS ... 206 Saving a reference QRS manually... 206 Selecting a saved reference QRS complex for display... 206 Erasing a reference QRS ... 207 Printing a realtime QRS/ST report ... 207 Viewing QRS and ST in a split screen ... 207 Selecting the ST time scale ... 207 ST trend display ... 208 Displaying QRS complexes and ST trends for other leads ... 208 Reviewing ST trends ... 208 Printing an ST trend report ... 208 Ischemic burden... 208 ST alarm limits ... 209 QT detection ... 210 9

Impedance respiration...213 About this measurement with CARESCAPE ONE ... 213 Impedance respiration compatibility limitations ... 213 Respiration safety precautions ... 213 Respiration warnings ... 213 Respiration cautions ... 214 Respiration measurement limitations... 214

5815925

CARESCAPE B850, B650, B450

13

Respiration points to note ... 214 Respiration measurement setup... 215 Respiration equipment to patient connection with PDM... 215 Respiration equipment to patient connection with CARESCAPE ONE ... 216 Preparing the patient’s respiration electrode sites ... 216 Respiration lead and breath detection ... 216 How to interpret the respiration values ... 217 Respiration lead I electrode placement ... 217 Respiration lead II electrode placement ... 218 Respiration lead RL-LL electrode placement... 218 Respiration measurement checks... 218 Respiration measurement on the monitor screen... 219 Using the respiration measurement ... 219 Turning on the respiration measurement... 219 Selecting the respiration lead... 219 Selecting the respiration waveform size automatically... 219 Selecting the respiration waveform size manually ... 219 Selecting the waveform sensitivity ... 219 Enabling respiration smoothing ... 220 Turning inspiration and expiration markers on or off ... 220 Selecting the waveform speed... 220 Relearning the respiration pattern... 220 Turning on or off the respiration rate alarm... 220 Setting the respiration alarm limits... 221 Apnea alarms’ deactivation with the pause audio key... 221 Setting the apnea alarm delay ... 221 Configurable respiration alarm delays ... 221 Enabling the respiration cardiac artifact alarm ... 221 Respiration alarm priorities ... 222 Checking alarm delays and priorities information... 222 Turning off the respiration measurement ... 222 Respiration measurement description ... 222 Respiration troubleshooting ... 223

14

CARESCAPE B850, B650, B450

5815925

10 Pulse oximetry...225 About this measurement with CARESCAPE ONE ... 225 SpO2 compatibility limitations ... 225 SpO2 safety precautions ... 225 SpO2 warnings... 225 SpO2 cautions ... 229 SpO2 measurement limitations ... 229 SpO2 points to note ... 229 Masimo safety precautions ... 230 Masimo warnings... 230 Masimo cautions ... 233 Masimo points to note ... 234 SpO₂ measurement guidelines... 235 Masimo SET technology and sensor measurement guidelines... 235 Pulse CO-Oximetry measurement with Masimo rainbow SET ... 235 Additional information for MASIMO technology... 236 Nellcor™ sensors with OxiMax™ technology and sensor measurement guidelines... 236 SpO₂ measurement setup ... 237 SpO2 equipment to patient connection with PDM ... 237 SpO2 equipment to patient connection with CARESCAPE ONE ... 237 Preparing the SpO2 connection... 238 Checking the SpO2 measurement ... 238 Using the SpO₂ measurement... 238 SpO2 measurement source channels ... 238 Changing the SpO2 waveform size... 238 Selecting the SpO2 hemodynamic sweep speed... 239 Selecting the SpO2 as the primary heart rate source ... 239 Showing the SpO2 pulse rate... 239 Adjusting the SpO2 pulse beep volume... 240 Selecting the beat source ... 240 Setting the variable beat tone ... 240 Masimo SET data averaging and updating ... 240 Selecting the SpO2 averaging time ... 240

5815925

CARESCAPE B850, B650, B450

15

Selecting the Masimo SpO2 sensor sensitivity level ... 241 Additional Masimo parameters... 241 Nellcor™ sensors with OxiMax™ technology data averaging and updating... 242 Selecting the SpO2 response time ... 243 Nellcor™ OxiMax™ SatSeconds™ alarm management ... 243 Setting the SpO2 alarms and alarm limits... 244 Deactivating the SpO2 probe off alarm ... 244 Configurable SpO2 alarm delays ... 245 Configurable PR alarm delays ... 245 SpO2 alarm priorities ... 245 Checking alarm delays and priorities information... 246 Stopping the SpO2 measurement ... 246 Using the SpHb measurement ... 246 Setting the SpHb alarms and alarm limits... 246 SpHb alarm priorities ... 247 Selecting the SpHb averaging time... 247 Selecting the SpHb rounding precision... 247 Selecting the SpHb measurement location ... 247 Stopping the SpHb measurement... 248 How to interpret the SpO₂ values... 248 SpO2 signal strength ... 248 SpO2 waveform quality ... 248 SpO2 waveform stability ... 249 SpO2 wavelengths and optical output power ... 249 SpO2 measurement and interference... 249 SpO2 troubleshooting... 250 11 Regional oxygen saturation (rSO₂)...253 rSO2 compatibility ... 253 rSO2 safety precautions... 253 rSO2 warnings... 253 rSO2 measurement limitations ... 253 rSO2 points to note... 253 rSO₂ measurement setup ... 254

16

CARESCAPE B850, B650, B450

5815925

rSO2 equipment to patient connection with CARESCAPE ONE ... 254 rSO2 equipment to patient connection with E-musb ... 254 Preparing the rSO2 connection... 255 Starting the rSO2 measurement ... 255 Checking the rSO2 measurement... 255 Using the rSO₂ measurement ... 255 rSO2 measurement channels ... 255 rSO2 measurement description ... 255 Storing rSO2 sensor information... 256 Identifying the rSO2 sensors ... 256 Changing the rSO2 channel labels ... 257 Setting the rSO2 alarms and alarm limits ... 257 rSO2 alarm priorities... 257 Using rSO2 baselines ... 257 Setting the rSO2 microtrend length ... 258 Stopping the rSO2 measurement ... 258 rSO2 troubleshooting ... 258 12 Surgical pleth index (SPI)...261 SPI compatibility... 261 Surgical Pleth Index (SPI)... 261 SPI indications for use... 261 SPI safety statements ... 261 SPI warnings ... 261 SPI cautions ... 264 SPI points to note ... 264 Using the SPI measurement ... 265 Patient connections and preparing the patient ... 265 SPI measurement on the monitor screen ... 265 Stopping the SPI and SpO2 measurement ... 265 Basics of SPI measurement... 266 SPI clinical implications... 266 SPI measurement description ... 266 How to interpret the SPI values... 267 SPI in typical general anesthesia... 267

5815925

CARESCAPE B850, B650, B450

17

Common surgical events ... 267 SPI practicalities ... 268 AoA split screen and the BalView... 268 SPI and NIBP measurement... 269 Physiological and technical issues affecting SPI... 270 SPI calculations ... 270 SPI troubleshooting... 271 Basic SPI troubleshooting ... 271 Advanced SPI troubleshooting ... 271 13 Non-invasive blood pressure...273 About this measurement with CARESCAPE ONE ... 273 NIBP compatibility limitations ... 273 NIBP safety precautions ... 273 NIBP warnings ... 273 NIBP cautions ... 275 NIBP measurement limitations ... 275 NIBP points to note ... 275 NIBP measurement setup... 276 NIBP equipment to patient connection with PDM... 276 NIBP equipment to patient connection with CARESCAPE ONE... 276 Preparing the NIBP patient connection ... 277 Checking the NIBP measurement ... 277 NIBP measurement on screen ... 277 Manual NIBP measurements... 278 Starting or stopping a single NIBP measurement from the main menu ... 278 Starting or stopping a single NIBP measurement from the NIBP setup menu ... 278 Automatic NIBP measurements... 278 NIBP Auto mode ... 278 Setting the cycle time between NIBP measurements... 278 Automatic NIBP measurements and monitor clock synchronization ... 278 STAT mode ... 279 NIBP cuffs ... 279

18

CARESCAPE B850, B650, B450

5815925

NIBP cuff selection and placement ... 279 Selecting NIBP cuff size... 280 Initial NIBP cuff inflation pressure ... 280 NIBP volume and display settings... 281 Adjusting the NIBP measurement completion tone volume ... 281 Setting the NIBP display format ... 281 NIBP alarms... 281 Setting NIBP alarms ... 281 NIBP alarms’ deactivation with pause audio key ... 281 NIBP recheck after alarm violation (control measurement) ... 281 NIBP measurement description ... 282 NIBP measurement technologies ... 282 DINAMAP Classic NIBP technology... 282 DINAMAP SuperSTAT NIBP technology... 283 DINAMAP Step Deflation technology ... 283 NIBP calibration... 284 NIBP troubleshooting... 285 14 Invasive pressures ...287 About this measurement with CARESCAPE ONE ... 287 Invasive pressures compatibility limitations ... 287 Invasive pressure safety precautions ... 287 Invasive pressure warnings ... 287 Invasive pressure measurement limitations ... 288 Invasive pressure points to note ... 288 Invasive pressure measurement setup ... 289 Invasive pressure equipment to patient connection with PDM... 289 Invasive pressure equipment to patient connection with CARESCAPE ONE ... 289 Invasive pressure module keys ... 290 Connecting the invasive pressure transducer and cable ... 290 Checking the invasive pressure measurement ... 290 Invasive pressure measurement on the monitor screen... 290 Selecting the display mode for IP waveforms ... 291 Using the invasive pressure measurement ... 291

5815925

CARESCAPE B850, B650, B450

19

Invasive pressure measurement mapping ... 291 Invasive pressure analog output... 291 About zeroing the invasive pressure transducers... 292 Zeroing the invasive pressure transducers ... 292 Selecting an invasive pressure channel label... 293 Selecting the size of the invasive pressure waveform ... 293 Optimizing the invasive pressure waveform scale... 293 Selecting the hemodynamic waveform sweep speed... 293 Selecting the displayed invasive pressure format... 294 Using the invasive pressure waveform cursor ... 294 Selecting invasive pressure as the primary heart rate source ... 294 Selecting the ventilation mode... 295 Showing the pulse rate in the invasive pressure parameter window ... 295 Showing the CPP value in the ICP parameter window... 295 Using the IP channel standby... 295 Selecting the invasive pressure noise reduction filter... 295 Selecting the primary arterial source ... 296 Selecting Smart BP... 296 Compensating for intra-aortic balloon pump (IABP) waveform irregularities... 296 Selecting the invasive pressure response time ... 297 Setting an arterial invasive pressure disconnection alarm ... 297 Setting invasive pressure alarm limits ... 297 Configurable PR alarm delays ... 298 Invasive pressures alarm priorities ... 298 Checking alarm delays and priorities information... 298 Systolic pressure variation and pulse pressure variation... 298 Changing the SPV source ... 299 Measuring SPV manually ... 299 PA catheter insertion ... 299 Selecting the PA catheter insertion mode ... 299 Pulmonary capillary wedge pressure (PCWP) measurement... 300 Showing the PCWP value in the PA window ... 300

20

CARESCAPE B850, B650, B450

5815925