Instramed DUALMAX User manual

User manual
Cardioverter/Biphasic Defibrillator Monitor

Instramed Indústria Médico Hospitalar Ltda.
Industrial unit:
Beco José Paris, 339 – Pavilhão 19
Postal code: 91140-310
Porto Alegre – RS, Brasil
Phone/fax number: + 55 (51) 3073 8200
E-mail: [email protected]
www.instramed.com.br
European representative
Obelis S.A.
Bd. Général Wahis 53, 1030, Brussels - Belgium
Tel. : + 32.2.732.59.54
Fax : + 32.2.732.60.03
E-mail: [email protected]
ATTENTION: Instramed assumes no responsibility for any damage caused to
individuals or property brought by failure to use this product in accordance
with the information, recommendations and warnings presented in the user
manual, alterations made in the device, attempts of repair not provided by
authorized technical assistance centers, operation by unqualified personnel,
use of defective device or use of accessories and parts not supplied by the
manufacturer.
For information about warranty or technical assistance, please contact
Instramed’s technical support.
Copyright © 2019 Instramed. The DualMax, Instramed and its respective logos are trademarks of Instramed Indústria Médico
Hospitalar Ltda. The internal software of this product is Instramed’s intellectual property, being protected under international
copyright laws. It is provided exclusively to be used with this present device, identified by the serial number, and may not be,
in whole or in part, evaluated, recompiled or altered in any way.
DualMax User Manual English R2.12 2019-08-30
ANVISA 10242950015
2460
II
Manufacturer

III
Battery use
ATTENTION: observe the battery charge maintenance instructions.
First use
Before using the DualMax for the first time, the equipment must receive a full
battery charge. In order to do this, the equipment needs to be connected to an
electric current for at least eught hours.
Occasional use
Even when disconnected (stand-by), the DualMax executes internal routines
checking the status of the equipment. In spite of this procedure entailing a low
power consumption, the battery charge may be consumed.
Therefore, whenever the device has not been connected to an electric current for
more than 20 days, it is advisable to execute a full battery charge. If this procedure
is not performed, there is a risk of draining the battery and consequently being
unable to use the DualMax in its portable configuration (not connected to the
electric current).
Storage
The battery must be removed from the equipment in case it is stored or not used.
Replacement
Every battery has a determined lifetime, which is the possible quantity of full charge
and discharge cycles, without loss of performance. When the appliance has a drop
in performance of the battery, with low autonomy, request a new unit from Instramed
technical assistance.
The battery can be replaced following the procedures described on the chapter
“Care and maintenance”.
Battery replacement is recommended every 02 (two) years or when the runtime is less
than 01 (one) hour.
ATTENTION: the equipment is capable of operating with only one battery
connected.
ATTENTION: when servicing the batteries, it is obligatory to change only
one battery at a time, leaving the other battery in the device, so that it can
continue to operate at that moment.

Included items
• 1 Dualmax and accessories listed in Accessories chapter.
Optional items
• Optional items listed in Accessories chapter.
Consult availability.
IV
Package contents

You can call Instramed for replacements of consumable items, parts and
accessories.
Consult Instramed for prices.
Shipping may apply.
.
To request parts and services, contact your local representative (the list can be found at
www.instramed.com.br) or directly contact Instramed by telephone at:
[phone].
The items already included may be acquired for replacement as extra
items.
V
Replacement parts

VI
Index
Introduction 20
Purpose and application........................................................................................... 20
Characteristics.......................................................................................................... 20
Optional items........................................................................................................... 21
About the manual ..................................................................................................... 21
Safety information 22
Warnings .................................................................................................................. 22
Adverse or side effects............................................................................................. 24
Classification and symbols ....................................................................................... 25
Standards ................................................................................................................. 26
Device care............................................................................................................... 27
Grounding................................................................................................................. 27
Electromagnetic compatibility................................................................................... 28
Disposing of the device ............................................................................................ 28
The equipment 29
Front panel ............................................................................................................... 29
Screen ...................................................................................................................... 30
e-Jog control............................................................................................................. 30
Selector switch ......................................................................................................... 30
Quick access buttons ............................................................................................... 31
Power and battery charging indications.................................................................... 31
Side view .................................................................................................................. 32
1 - Printer............................................................................................................. 32
2 - Pads............................................................................................................... 32
3 - Transport handle ............................................................................................ 32
4 - Temperature connector .................................................................................. 32
5 - Temperature connector .................................................................................. 33
6 - ECG connector............................................................................................... 33
7 - Capnography exhaust connector ................................................................... 33

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8 - Capnography connector................................................................................. 33
9 - NIBP connector.............................................................................................. 33
10 - SpO2connector ............................................................................................ 33
11 - CPR Maestro connector ............................................................................... 33
12 - P1 connector................................................................................................ 34
13 - P2 connector................................................................................................ 34
14 - Defibrillation electrodes (pads) connector: .................................................. 34
Rear panel................................................................................................................ 34
1 - Removable battery 1...................................................................................... 35
2 - Removable battery 2...................................................................................... 35
3 - Identification tags ........................................................................................... 35
4 - External DC socket ........................................................................................ 35
5 - 3-pin power connector.................................................................................... 35
6 - Grounding and potential equalizer ................................................................. 35
7 - USB connector............................................................................................... 36
8 - LAN connector ............................................................................................... 36
9 - USB host connector ....................................................................................... 36
Screen and operation 37
Turning on and operating ......................................................................................... 37
1 - Selector switch............................................................................................... 37
2 - Defibrillator mode........................................................................................... 37
3 - AED mode ...................................................................................................... 38
4 - Turns equipment off ....................................................................................... 38
5 - Pacemaker mode........................................................................................... 38
6 - Monitor mode ................................................................................................. 38
7 - Auto Seq mode............................................................................................... 38
Operating e-Jog control............................................................................................ 39
Information bar ......................................................................................................... 40
Quick access bar...................................................................................................... 40
Monitor mode screen – Variation A (with curves exhibition) ..................................... 41
Monitor mode screen – Variation B (without curves exhibition)................................ 42
AED mode screen - Variation A (without CPR)........................................................ 43

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AED mode screen - Variation B (with CPR) ............................................................ 44
Defibrillator mode screen – Variation A (with CPR) .................................................. 45
Defibrillator mode screen – Variation B (without CPR)............................................. 46
Pacemaker mode screen.......................................................................................... 47
Charge auto-sequencing mode screen – Variation A (with CPR)............................. 48
Charge auto-sequencing mode screen – Variation B (without CPR)........................ 49
Alarms and limits 50
Physiological alarm (high priority)............................................................................. 50
Technical alarm (medium priority)............................................................................. 51
Battery charge level.................................................................................................. 59
Pause audio.............................................................................................................. 59
Configuration of alarm limits..................................................................................... 59
Minimum / Maximum limits adjustment..................................................................... 61
Technical alarm test.................................................................................................. 62
Physiological alarm test............................................................................................ 63
Debrillator mode 64
Physics principle used.............................................................................................. 64
Warnings .................................................................................................................. 64
Use criteria ............................................................................................................... 65
Qualified users.......................................................................................................... 65
External pads use..................................................................................................... 66
About shock delivery ................................................................................................ 68
Child pads use.......................................................................................................... 69
Using multifunction pads .......................................................................................... 70
Defibrillation.............................................................................................................. 71
Synchronism - Synchronized discharge - Cardioversion.......................................... 72
Disarm key................................................................................................................ 73
Defibrillation display:................................................................................................. 73
1 - Elapsed time .................................................................................................. 73
2 - Number of shocks .......................................................................................... 73
3 - Defibrillation electrode type............................................................................ 73

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4 - Synchronism .................................................................................................. 73
5 - Selected and charged energy ........................................................................ 73
Charge Auto-Sequencing mode (Auto Seq) ............................................................. 74
Defibrillation setup.................................................................................................... 75
1 - Internal discharge time.................................................................................. 75
2 - Back/Exit ........................................................................................................ 75
Auto-sequencing configurations ............................................................................... 76
1 - First shock...................................................................................................... 76
2 - Second shock................................................................................................. 76
3 - Third shock..................................................................................................... 77
4 - Back/Exit ........................................................................................................ 77
AED mode 78
Introduction............................................................................................................... 78
Characteristics.......................................................................................................... 78
Physics principle used.............................................................................................. 79
Use criteria ............................................................................................................... 80
Qualified users.......................................................................................................... 80
Operation.................................................................................................................. 81
Applying CPR ........................................................................................................... 85
Using the DualMax on children under 8 years old.................................................... 87
Alarm system............................................................................................................ 88
Information signals ................................................................................................... 88
CPR Maestro 90
Using the CPR Maestro............................................................................................ 90
Feedback.................................................................................................................. 92
Messages ................................................................................................................. 94
CPR graphic ............................................................................................................. 94
Pacemaker mode 96
Physics principle used.............................................................................................. 96
Warnings .................................................................................................................. 96
Fixed mode............................................................................................................... 97

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Demand mode (synchronous) .................................................................................. 97
Operating in pacemaker mode ................................................................................. 98
Starting stimulation................................................................................................... 99
Fixed stimulation....................................................................................................... 99
Under demand stimulation...................................................................................... 100
Defibrillation............................................................................................................ 100
Monitor mode - ECG 101
Physics principle used............................................................................................ 101
Warnings ................................................................................................................ 101
Monitoring ECG...................................................................................................... 102
Leads...................................................................................................................... 103
Color patterns......................................................................................................... 103
Operating in monitor mode - ECG.......................................................................... 104
ECG Setup - Principal ............................................................................................ 105
1 - ECG response.............................................................................................. 105
2 - ECG cable.................................................................................................... 105
3 - Detect pacemaker........................................................................................ 106
4 - Amplitude ..................................................................................................... 106
5 - Frequency bandwidth selection.................................................................... 106
6 - Mains supply filter ........................................................................................ 106
7 - ST................................................................................................................. 106
8 - Sudden Death Prevention (SDP) ................................................................. 106
9 - Next page..................................................................................................... 106
10 - Back/Exit .................................................................................................... 106
ECG configurations - Alarm.................................................................................... 107
1 - Alarm sound ................................................................................................. 107
2 - Maximum limit .............................................................................................. 107
3 - Minimum limit ............................................................................................... 107
4 - Alarm sound ................................................................................................. 107
5 - Maximum limit .............................................................................................. 107
6 - Minimum limit ............................................................................................... 108
7 - Previous page .............................................................................................. 108

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8 - Back/Exit ...................................................................................................... 108
Monitor mode - NIBP 110
Physics principle used............................................................................................ 110
Warnings ................................................................................................................ 110
Monitoring Non-Invasive Pressure ..........................................................................111
Measurement modes.............................................................................................. 112
NIBP numeric indicator........................................................................................... 113
NIBP setup - Principal ............................................................................................ 113
1 - Manual measurement .................................................................................. 114
2 - NIBP On/Off ................................................................................................. 114
3 - Automatic measurement .............................................................................. 114
4 - Initial pressure.............................................................................................. 114
5 - Next page..................................................................................................... 114
6 - Back/Exit ...................................................................................................... 114
NIBP configurations - Alarm .................................................................................. 115
1 - Alarm............................................................................................................ 115
2 - Maximum limit - Systole ............................................................................... 115
3 - Minimum limit - Systole ................................................................................ 115
4 - Maximum limit - Diastole .............................................................................. 115
5 - Minimum limit - Diastole ............................................................................... 115
6 - Maximum limit – Average ............................................................................. 116
7 - Minimum limit – Average .............................................................................. 116
8 - Previous page .............................................................................................. 116
9 - Back/Exit ...................................................................................................... 116
Monitor mode - SpO2117
Physics principle used............................................................................................ 117
Factors which affect the SpO2measurement’s precision ....................................... 118
Sensor selection..................................................................................................... 118
Operating in monitor mode - SpO2....................................................................................................................................119
SpO2setup - Principal ............................................................................................ 120
1 - SpO2(On/Off)............................................................................................... 120

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2 - SpO2response ............................................................................................. 120
3 - Sensitivity..................................................................................................... 120
4 - Next page..................................................................................................... 120
5 - Back/Exit ...................................................................................................... 121
SpO2 configurations – Alarm.................................................................................. 121
1 - Alarm sound ................................................................................................. 121
2 - Maximum limit .............................................................................................. 121
3 - Minimum limit ............................................................................................... 121
4 - Previous page .............................................................................................. 121
5 - Back/Exit ...................................................................................................... 121
Monitor mode - Capnography 122
Physics principle used............................................................................................ 122
Warnings ................................................................................................................ 122
Capnography monitoring ........................................................................................ 123
EtCO2numeric indicator ......................................................................................... 124
EtCO2setup - Principal........................................................................................... 125
1 - CO2On/Off ................................................................................................... 125
2 - Units............................................................................................................. 125
3 - Scale ............................................................................................................ 125
4 - Calibration.................................................................................................... 126
5 - Calibration status ......................................................................................... 126
6 - Next page..................................................................................................... 126
7 - Back/Exit ...................................................................................................... 126
EtCO2 configurations – Alarm ................................................................................ 127
1 - Alarm sound ................................................................................................. 127
2 - Maximum limit .............................................................................................. 127
3 - Minimum limit ............................................................................................... 127
4 - Previous page .............................................................................................. 127
5 - Back/Exit ...................................................................................................... 127
Monitor mode - Respiration 128
Physics principle used............................................................................................ 128

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Warnings ................................................................................................................ 128
Respiration monitoring............................................................................................ 129
Respiration numeric indicator................................................................................. 130
Respiration setup.................................................................................................... 131
1 - Respiration monitoring On/Off...................................................................... 131
2 - Respiratory frequency.................................................................................. 131
3 - Respiration amplitude .................................................................................. 131
4 - Apnea alarm ................................................................................................. 131
5 - Next page..................................................................................................... 131
6 - Back/Exit ...................................................................................................... 132
Respiration configurations – Alarm......................................................................... 132
1 - Alarm............................................................................................................ 132
2 - Maximum limit .............................................................................................. 132
3 - Minimum limit ............................................................................................... 132
4 - Previous page .............................................................................................. 132
5 - Back/Exit ...................................................................................................... 132
Temperature monitoring 133
Physics principle used............................................................................................ 133
Monitoring temperature .......................................................................................... 134
Temperature numeric indicator............................................................................... 134
Temperature configuration...................................................................................... 134
Temperature configurations – Principal .................................................................. 135
1 - Temperature 1 .............................................................................................. 135
2 - Temperature 2 .............................................................................................. 135
3 - Unit............................................................................................................... 135
4 - Next page..................................................................................................... 135
5 - Back/Exit ...................................................................................................... 135
Temperature configurations – Alarms..................................................................... 136
1 - Temperature 1 alarm .................................................................................... 136
2 - Maximum limit (temperature 1) .................................................................... 136
3 - Minimum limit (temperature 1) ..................................................................... 136
4 - Temperature 2 alarm .................................................................................... 136

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5 - Maximum limit (temperature 2) .................................................................... 136
6 - Minimum limit (temperature 2) ..................................................................... 137
7 - Previous page .............................................................................................. 137
8 - Back/Exit ...................................................................................................... 137
Invasive pressure monitoring 138
Physics principle used............................................................................................ 138
IP numeric indicator................................................................................................ 139
Invasive pressure configuration.............................................................................. 139
IP configuration - Principal...................................................................................... 140
1 - 60 Hz filter.................................................................................................... 140
2 - Channel 1 On/Off ......................................................................................... 140
3 - Channel 1 scale ........................................................................................... 140
4 - Channel 1 clear transducer.......................................................................... 140
5 - Channel 1 reset status ................................................................................. 140
6 - Channel 2 On/Off ......................................................................................... 141
7 - Channel 1 scale ........................................................................................... 141
8 - Channel 1 clear transducer.......................................................................... 141
9 - Channel 1 reset status ................................................................................ 141
10 - Next page................................................................................................... 141
11 - Back/Exit .................................................................................................... 141
IP configurations – P1 alarms................................................................................. 143
1 - IP alarms 1................................................................................................... 143
2 - Maximum limit - Systole ............................................................................... 143
3 - Minimum limit - Systole ................................................................................ 143
4 - Maximum limit - Diastole .............................................................................. 143
5 - Minimum limit - Diastole ............................................................................... 143
6 - Maximum limit - Average.............................................................................. 143
7 - Minimum limit - Average............................................................................... 144
8 - Previous page .............................................................................................. 144
9 - Next page..................................................................................................... 144
10 - Back/Exit .................................................................................................... 144
IP configurations – P2 alarms................................................................................. 145

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1 - IP alarms 2................................................................................................... 145
2 - Maximum limit - Systole ............................................................................... 145
3 - Minimum limit - Systole ................................................................................ 145
4 - Maximum limit - Diastole .............................................................................. 145
5 - Minimum limit - Diastole ............................................................................... 145
6 - Maximum limit - Average.............................................................................. 145
7 - Minimum limit - Average............................................................................... 146
8 - Previous page .............................................................................................. 146
9 - Back/Exit ...................................................................................................... 146
Transducer connection and calibration accessories............................................... 147
ST segment 148
Relation between ST elevation and myocardial infarction...................................... 148
ST elevation characterization ................................................................................. 149
ST levels detection ................................................................................................. 150
ST segment configuration....................................................................................... 150
Turning ST segment on and off .............................................................................. 151
ST configurations – Alarms..................................................................................... 152
1 - ST alarms..................................................................................................... 152
2 - Maximum limit .............................................................................................. 152
3 - Minimum limit ............................................................................................... 152
4 - Previous page .............................................................................................. 152
5 - Back/Exit ...................................................................................................... 152
Event and data storage 153
Data storage........................................................................................................... 153
Events stored.......................................................................................................... 153
Patient configurations............................................................................................. 154
1 - Insert new patient......................................................................................... 154
2 - Patient number............................................................................................. 154
3 - Name............................................................................................................ 154
4 - Age............................................................................................................... 154
5 - Gender ......................................................................................................... 154

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6 - Register number........................................................................................... 155
7 - Back/Exit ...................................................................................................... 155
Mark events............................................................................................................ 155
1 - Patient selected............................................................................................ 157
2 - Transfer patient data .................................................................................... 157
3 - Print.............................................................................................................. 157
4 - Visualize curve associated with event.......................................................... 157
5 - Events list..................................................................................................... 157
6 - Roll list.......................................................................................................... 157
7 - Back/Exit ...................................................................................................... 157
Keyboards .............................................................................................................. 158
Printing 159
General................................................................................................................... 159
Instant printing........................................................................................................ 159
Continuous printing................................................................................................. 160
Stop printing ........................................................................................................... 160
Configurations ........................................................................................................ 161
1 - Alarm printing ............................................................................................... 161
2 - Shock printing .............................................................................................. 161
3 - Paper size .................................................................................................... 162
4 - Electrocardiograph function ......................................................................... 162
5 - Number of leads........................................................................................... 162
6 - Back/Exit ...................................................................................................... 162
Functional test 163
General................................................................................................................... 163
Performing the functional test................................................................................. 163
RTC - Real Time Check 165
General................................................................................................................... 165
RTC Operation on DualMax ................................................................................... 165
1 - Number of daily tests ................................................................................... 165
2 - Test 1 time.................................................................................................... 165

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3 - Test 2 time.................................................................................................... 166
4 - Test 3 time.................................................................................................... 166
5 - Perform manual test..................................................................................... 166
6 - Last test........................................................................................................ 166
7 - Show last test report .................................................................................... 166
8 - Print last test report...................................................................................... 166
9 - Back/Exit ...................................................................................................... 166
Automatic test......................................................................................................... 166
Manual test............................................................................................................. 167
Error BEEPS........................................................................................................... 167
PC connection 168
Introduction............................................................................................................. 168
Requirements ......................................................................................................... 168
SoftDEA installation................................................................................................ 169
Connecting the DualMax to a PC ........................................................................... 169
Startup screen ........................................................................................................ 170
1 - DualMax services initialization button .......................................................... 170
SoftDEA language selection screen ....................................................................... 171
1 - Buttons of SoftDEA language selection ....................................................... 171
Graphics generated by AED mode display screen ................................................. 172
1 - Download ..................................................................................................... 172
2 - Open ............................................................................................................ 172
3 - Print.............................................................................................................. 173
4 - PDF.............................................................................................................. 173
5 - Select all....................................................................................................... 173
6 - Event viewer window.................................................................................... 173
Events graphics display screen.............................................................................. 174
1 - Patient data window..................................................................................... 174
2 - Event view window....................................................................................... 174
RTC software installation........................................................................................ 175
RTC software operation.......................................................................................... 175
1 - E-mail configurations.................................................................................... 176

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2 - Reading log of the equipment ...................................................................... 179
3 - Options......................................................................................................... 181
4 - Backup ......................................................................................................... 183
5 - Information ................................................................................................... 183
Receiving data........................................................................................................ 184
Closing the application ........................................................................................... 184
Care and maintenance 185
Preventive maintenance......................................................................................... 185
Corrective maintenance.......................................................................................... 185
Cleaning ................................................................................................................. 185
Removable battery replacement............................................................................. 188
Replacing the thermal paper .................................................................................. 189
Repairs ................................................................................................................... 190
Precautions, restrictions and warnings................................................................... 190
1 - ECG ............................................................................................................. 190
2 - SpO2............................................................................................................ 190
3 - Electromagnetic compatibility....................................................................... 191
Electromagnetic immunity - General ...................................................................... 193
Electromagnetic immunity - Equipment with life support functions ........................ 194
Electromagnetic immunity - Equipment with life support functions......................... 195
Troubleshooting 197
Accessories 198
Included items ........................................................................................................ 198
Optional items......................................................................................................... 200
Specications and safety 201
General specifications ............................................................................................ 201
Display.................................................................................................................... 202
Environmental specifications.................................................................................. 203
Defibrillator ............................................................................................................. 203

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AED mode (optional) .............................................................................................. 204
ECG analysis algorithm.......................................................................................... 206
External pacemaker (optional)................................................................................ 210
ECG........................................................................................................................ 211
NIBP - Non-Invasive Arterial Pressure (optional) ................................................... 214
SpO2BCI (optional) ................................................................................................ 215
Respiration ............................................................................................................. 215
Capnography (optional).......................................................................................... 216
Printer (opcional) .................................................................................................... 216
CPR Maestro (optional).......................................................................................... 217
Temperature ........................................................................................................... 217
Invasive pressure (optional) ................................................................................... 217
Warranty certicate 218

Introduction 1
Purpose and application
The DualMax uses electrical defibrillation and cardioversion therapy to reverse
ventricular fibrillation arrhythmia or ventricular tachycardia without a pulse in adult
and pediatric patients. Cardioversion of arrhythmias is also used when necessary.
In the external pacemaker mode, the DualMax uses monophasic electrical
stimulation in order to reproduce or regulate the cardiac rhythm.
The equipment is also used for monitoring vital signs in adult, pediatric and natal
patients.
The ECG/Monitor mode shows the ECG signal and the heart rate value on the
screen.
The NIBP/Monitor mode indicates the blood pressure value measured by a
Non-Invasive method on the screen.
The SpO2 / Monitor mode measures the oxygen saturation of blood by a
Non-Invasive method.
The EtCO2/Monitor mode presents the partial pressure of exhaled CO2at the end of
expiration as well as inhaled value.
The RESP/Monitor mode displays the respiratory rate measured by ECG electrodes
or by the capnograph.
Characteristics
The DualMax is a modern, practical, lightweight, compact and portable device that
can be used in emergency situations.
The DualMax offers the following parameters and/or characteristics (some
parameters are optional):
• Biphasic Defibrillator (DEF).
• Automatic defibrillator mode (AED).
• Non-Invasive Pacemaker (NIP).
• ECG and cardiac frequency monitoring.
• Respiratory rate monitoring (RESP).
• Sudden Death Prevention Mode (SDP).
• ST segment value monitoring.
• Temperature (TEMP) monitoring.
• Functional artery oxygen saturation monitoring (SpO2).
• Pressure monitoring (Non-Invasive method - NIBP).
20