Instramed CardioMax 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: (51) 3073 8200
E-mail: [email protected]
Website: www.instramed.com.br
European representative:
Obelis S.A.
Bd. Général Wahis 53, 1030, Brussels - Belgium
Phone. : + 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 CardioMax, 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.
Cardiomax User Manual Eng R13.5 2019-06-17
ANVISA
10242950009
2460
II
Manufacturer

ATTENTION: Observe the battery charge maintenance instructions
First use:
Before using the CardioMax 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 four and a half hours.
Occasional use:
Even when disconnected (stand-by), the CardioMax 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 CardioMax 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 (check out the specifications of
the battery on page 171). 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.
III
Battery use

Included items:
When opening the package, please check whether all items below are
present:
• The CardioMax Monitor Cardioverter/Biphasic Defibrillator.
• Instruction Manual.
• 3-pin professional power cable.
• Removable battery.
• External defibrillation pads - adult and child.
• 5-lead ECG cable.
When the NIBP optional parameter is present:
• Adult armband.
• Armband extensor.
When the Oximetry optional parameter is present:
• Oximetry sensor.
• Oxymetry sensor extensor.
When the Printer optional parameter is present:
• Paper bobbin for the printer.
When the CO2optional parameter is present:
• Sampling line.
When the Pacemaker/AED parameter is present:
• MP trunk cable.
• Multifunction adhesive pads.
• SoftDEA installation CD.
When the Central RTC optional parameter is present:
• USB cable.
IV
Package contents

V
Replacement parts
You can call Instramed for replacements of consumable items, parts and
accessories.
Consult Instramed for prices.
Shipping may apply.
To request pieces and services please contact Instramed.

VI
Index
Introduction 19
Purpose and application........................................................................................... 19
Characteristics.......................................................................................................... 19
Optional items........................................................................................................... 20
About the Manual ..................................................................................................... 20
Safety information 21
Warnings .................................................................................................................. 21
Adverse or side effects............................................................................................. 23
Classification and symbols ....................................................................................... 24
Standards ................................................................................................................. 25
Device care............................................................................................................... 26
Connection to other equipment ................................................................................ 27
Disposing of the device ............................................................................................ 27
The equipment 28
Front panel ............................................................................................................... 28
Screen ...................................................................................................................... 29
e-Jog Control............................................................................................................ 29
Selector switch ......................................................................................................... 29
Quick access buttons ............................................................................................... 30
Power and battery charging indications.................................................................... 30
Side view .................................................................................................................. 31
1 - SpO2connector .............................................................................................. 31
2 - USB connector............................................................................................... 31
3 - NIBP connector.............................................................................................. 31

VII
User manual | Index
VII
4 - ECG connector............................................................................................... 31
5 - Printer............................................................................................................. 32
6 - CPR Maestro connector................................................................................. 32
7 - Connector for defibrillation electrodes (pads) ................................................ 32
8 - Capnography exhaust connector ................................................................... 32
9 - Capnography connector................................................................................. 32
Rear panel................................................................................................................ 33
1 - Pads............................................................................................................... 33
2 - Removable battery......................................................................................... 33
3 - Identification tags ........................................................................................... 33
4 - Ventilation....................................................................................................... 33
Rear connectors ....................................................................................................... 34
1 - 3-pin power connector.................................................................................... 34
2 - External DC socket ........................................................................................ 34
3 - Grounding and potential equalizer ................................................................. 34
4 - RS-232 output................................................................................................ 34
Screen and operation 35
Turning on and operating ......................................................................................... 35
1 - Selector switch............................................................................................... 35
2 - Defibrillator mode........................................................................................... 35
3 - Auto Seq. mode.............................................................................................. 36
4 - Monitor mode ................................................................................................. 36
5 - Turns equipment off ....................................................................................... 36
6 - AED mode ...................................................................................................... 36
7 - Pacemaker mode........................................................................................... 36
Operating the e-Jog Control ..................................................................................... 37

VIII
User manual | Index
VIII
Startup screen .......................................................................................................... 38
Parameters visualization screen............................................................................... 39
Access icons for events and configuration functions................................................ 40
Monitor mode screen – variation A (ECG and SpO2present)................................... 41
Monitor mode Screen – variation B (ECG, SpO2, and NIBP present) ...................... 42
Monitor mode screen – variation C (all parameters present) ................................... 43
Pacemaker mode screen.......................................................................................... 44
AED mode screen .................................................................................................... 45
Defibrillator mode - variation A (ECG, SpO2and NIBP present)............................... 46
Defibrillator mode - variation B (ECG, SPO2and EtCO2present) ............................ 47
Configuration menu .................................................................................................. 48
1 - ECG ............................................................................................................... 48
2 - SpO2.............................................................................................................. 48
3 - NIBP............................................................................................................... 49
4 - CO2................................................................................................................ 49
5 - Defibrillator mode........................................................................................... 49
6 - RESP ............................................................................................................. 49
7 - Functional test................................................................................................ 49
Configuration menu .................................................................................................. 50
1 - Physiological Alarm ........................................................................................ 50
2 - Technical Alarm .............................................................................................. 50
2 - Time and date ................................................................................................ 51
3 - General setup................................................................................................. 51
4 - Printer............................................................................................................. 52
5 - Events ............................................................................................................ 52
6 - Waveforms ..................................................................................................... 52

IX
User manual | Index
IX
8 - RTC................................................................................................................ 53
Alarms and limits 54
Physiological Alarm .................................................................................................. 54
Technical Alarm ........................................................................................................ 55
Bad contact............................................................................................................... 61
Battery charge level:................................................................................................. 62
Pause audio.............................................................................................................. 64
Configuration of alarm limits..................................................................................... 64
Auto set .................................................................................................................... 65
Silence...................................................................................................................... 65
Minimum/maximum limit........................................................................................... 66
Technical alarms settings ......................................................................................... 67
Technical alarm test.................................................................................................. 67
Physiological alarm test............................................................................................ 68
Debrillator mode 69
Physics principle used.............................................................................................. 69
Use criteria ............................................................................................................... 70
Qualified users.......................................................................................................... 70
External pads use..................................................................................................... 71
About shock delivery ................................................................................................ 73
Child pads use.......................................................................................................... 74
Using multifunction pads .......................................................................................... 75
Defibrillation.............................................................................................................. 76
Synchronism - Synchronized discharge - Cardioversion.......................................... 77
Disarm key................................................................................................................ 78

X
User manual | Index
X
Defibrillation display.................................................................................................. 78
1 - Synchronism .................................................................................................. 78
2 - Elapsed time .................................................................................................. 78
3 - Defibrillation electrode type............................................................................ 78
4 - Number of shocks .......................................................................................... 79
5 - Selected and charged energy ........................................................................ 79
Charge Auto-Sequencing mode (Auto Seq) ............................................................. 80
Defibrillation setup.................................................................................................... 81
1 - Internal discharge time................................................................................... 81
2 - Sudden Death Prevention (SDP) ................................................................... 81
3 - Charge Auto-Sequencing ............................................................................... 81
4 - Back/Exit ........................................................................................................ 82
Functional test .......................................................................................................... 82
Result screens for functional tests............................................................................ 83
AED mode 84
Introduction............................................................................................................... 84
Characteristics.......................................................................................................... 84
Physics principle used.............................................................................................. 85
Use criteria ............................................................................................................... 86
Qualified users.......................................................................................................... 86
Operation.................................................................................................................. 87
Applying CPR ........................................................................................................... 91
Using the CardioMax on children under 8 years old................................................. 93
Alarm system............................................................................................................ 94
Information signals ................................................................................................... 94

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User manual | Index
XI
Pacemaker mode 96
Physics principle used.............................................................................................. 96
Warnings .................................................................................................................. 96
Fixed mode............................................................................................................... 97
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 ............................................................................................................. 105
1 - ECG response.............................................................................................. 105
2 - ECG cable.................................................................................................... 105
3 - Sensitivity..................................................................................................... 106
4 - Frequency bandwidth selection.................................................................... 106
5 - Mains supply filter ........................................................................................ 106
6 - Detect pacemaker........................................................................................ 106
7 - ST segment.................................................................................................. 106
8 - Alarm ............................................................................................................ 106

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User manual | Index
XII
9 - Back/Exit ...................................................................................................... 106
ST segment 107
Relation between ST elevation and myocardial
infarction................................................................................................................. 107
ST elevation characterization ................................................................................. 108
ST segment configuration....................................................................................... 109
1 - ST segment.................................................................................................. 109
2 - Alarm ............................................................................................................ 109
NIPB monitoring 110
Physics principle used............................................................................................ 110
Warnings ................................................................................................................ 110
Monitoring Non-Invasive Pressure ......................................................................... 112
Measurement modes.............................................................................................. 113
NIBP numeric indicator........................................................................................... 114
NIBP setup ............................................................................................................. 114
1 - Manual measurement .................................................................................. 115
2 - NIBP ON/OFF .............................................................................................. 115
3 - Automatic measurement .............................................................................. 115
4 - Initial pressure.............................................................................................. 115
5 - Alarm ............................................................................................................ 115
6 - Back/Exit ...................................................................................................... 115
Monitor mode - SpO2 116
Physics principle used............................................................................................ 116
Factors which affect the SpO2measurement’s precision ....................................... 117
Sensor selection..................................................................................................... 117

XIII
User manual | Index
XIII
Operating in monitor mode - SpO2........................................................................ 118
SpO2setup ............................................................................................................ 119
1 - SpO2response ............................................................................................. 119
2 - Alarm ............................................................................................................ 119
3 - Back/Exit ...................................................................................................... 119
Monitor mode - Capnography 120
Physics principle used............................................................................................ 120
Warnings ................................................................................................................ 120
Capnography monitoring ........................................................................................ 121
EtCO2numeric indicator ......................................................................................... 123
EtCO2setup............................................................................................................ 124
1 - CO2ON/OFF ................................................................................................ 124
2 - Units............................................................................................................. 124
3 - Scale ............................................................................................................ 124
4 - Calibration.................................................................................................... 125
5 - EtCO2alarm ................................................................................................. 125
6 - Back/Exit ...................................................................................................... 125
Monitor mode - Respiration 126
Physics principle used............................................................................................ 126
Warnings ................................................................................................................ 126
Respiration monitoring............................................................................................ 127
Respiration numeric indicator................................................................................. 128
Respiration setup.................................................................................................... 129
1 - Respiration monitoring On/Off...................................................................... 129
2 - Respiratory frequency.................................................................................. 129

XIV
User manual | Index
XIV
3 - Apnea alarm ................................................................................................. 129
4 - Respiration sensitivity .................................................................................. 129
5 - Back/Exit ...................................................................................................... 130
Event and data storage 131
Data storage........................................................................................................... 131
Events stored.......................................................................................................... 131
Viewing and managing events................................................................................ 132
1 - Patient.......................................................................................................... 133
2 - Print list ........................................................................................................ 133
3 - Delete memory/used memory ...................................................................... 133
4 - New patient .................................................................................................. 134
5 - Events list..................................................................................................... 134
6 - Printing icon ................................................................................................. 134
Printing 135
General................................................................................................................... 135
Instant printing........................................................................................................ 135
Continuous printing................................................................................................. 136
Stop printing ........................................................................................................... 137
Configurations ........................................................................................................ 137
1 - Alarm printing ............................................................................................... 137
2 - Shock printing .............................................................................................. 138
3 - Paper size .................................................................................................... 139
4 - Electrocardiograph function ......................................................................... 139
5 - Number of leads........................................................................................... 139
6 - Back/Exit ...................................................................................................... 139

XV
User manual | Index
XV
RTC - Real Time Check 140
General................................................................................................................... 140
RTC Operation on the CardioMax 8 with transmitter.............................................. 140
Automatic test......................................................................................................... 141
Manual test............................................................................................................. 143
Status of the last test.............................................................................................. 144
Error BIPS .............................................................................................................. 144
RTC Operation on the CardioMax 8 without transmitter......................................... 145
CPR Maestro 146
Using the CPR Maestro.......................................................................................... 146
Feedback................................................................................................................ 148
Messages ............................................................................................................... 149
CPR Graphic .......................................................................................................... 149
PC connection 151
Introduction............................................................................................................. 151
Requirements ......................................................................................................... 151
SoftDEA Installation................................................................................................ 152
Connecting the CardioMax to a PC........................................................................ 152
Startup Screen........................................................................................................ 153
1 - Graphic display button ................................................................................. 153
Graphic display screen........................................................................................... 154
1 - Download ..................................................................................................... 154
2 - Open ............................................................................................................ 154
3 - Print.............................................................................................................. 155
4 - PDF.............................................................................................................. 155

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User manual | Index
XVI
5 - Amplitude selection ...................................................................................... 155
6 - Time frame ................................................................................................... 155
7 - Time frame scroll.......................................................................................... 155
8 - Amplitude scroll ............................................................................................ 155
9 - Event viewer window.................................................................................... 155
Settings................................................................................................................... 156
Changing languages............................................................................................... 157
Other buttons.......................................................................................................... 157
1 - Back ............................................................................................................. 157
2 - Exit ............................................................................................................... 158
RTC software installation........................................................................................ 158
RTC software operation.......................................................................................... 158
1 - E-mail configurations.................................................................................... 159
2 - Reading log of the equipment ...................................................................... 162
3 - Options......................................................................................................... 164
4 - Backup ......................................................................................................... 166
5 - Information ................................................................................................... 166
Warning .................................................................................................................. 167
Receiving data........................................................................................................ 167
Closing the application ........................................................................................... 167
Care and maintenance 168
Preventive maintenance......................................................................................... 168
Corrective maintenance.......................................................................................... 168
Cleaning ................................................................................................................. 168
Removable battery replacement............................................................................. 171
Replacing the thermal paper of the GSI Printer...................................................... 172

XVII
User manual | Index
XVII
Replacing the Thermal Paper of the Bixolon Printer .............................................. 173
Returning components ........................................................................................... 174
Repairs ................................................................................................................... 174
Precautions, Restrictions and Warnings................................................................. 175
1 - ECG ............................................................................................................. 175
2 - SpO2............................................................................................................ 175
3 - Electromagnetic compatibility....................................................................... 175
Electromagnetic emissions..................................................................................... 176
Electromagnetic immunity - General .............................................................................. 178
Electromagnetic immunity - Equipment with life support functions ................................. 179
Troubleshooting 182
Accessories 183
Basic....................................................................................................................... 183
Defibrillator ............................................................................................................. 183
ECG........................................................................................................................ 183
NIBP ....................................................................................................................... 183
SpO2...................................................................................................................... 183
Pacemaker ............................................................................................................. 184
List of optional accessories .................................................................................... 184
Parts ....................................................................................................................... 184
Specications and safety 185
General specifications ............................................................................................ 185
Environmental specifications.................................................................................. 187
Defibrillator ............................................................................................................. 187
AED mode .............................................................................................................. 188

XVIII
User manual | Index
XVIII
ECG analysis algorithm.......................................................................................... 190
Pacemaker ............................................................................................................. 196
ECG........................................................................................................................ 197
NIBP - Non-Invasive Arterial Pressure ................................................................... 199
SpO2...................................................................................................................... 200
CPR Maestro.......................................................................................................... 201
GSI Printer.............................................................................................................. 201
Bixolon Printer ........................................................................................................ 202
Respiration ............................................................................................................. 202
Capnography.......................................................................................................... 202
Warranty Certicate 204

Introduction 1
Purpose and application
The CardioMax 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 CardioMax 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 CardioMax is a modern, practical, lightweight, compact and portable device
that can be used in emergency situations.
The CardioMax offers the following parameters and/or characteristics (some
parameters are optional):
• Exhaled carbon dioxide (CO2) monitoring.
• Respiratory rate monitoring (RESP).
• ECG and cardiac frequency monitoring.
• Functional artery oxygen saturation monitoring (SpO2).
• Non-Invasive pacemaker.
• Pressure monitoring (Non-Invasive method - NIBP).
• Biphasic Defibrillator.
• Automatic defibrillator mode (AED).
19

User manual | Introduction
20
• Sudden Death Prevention Mode (SDP).
• Charge Auto-Sequencing mode (CAS).
• Printer.
• Removable battery.
Optional items
This manual refers to all of CardioMax’s functions, however, some of them are
optional and may not be present in your equipment. The icon beside will appear
next to the text, whenever an optional characteristic is mentioned.
WARNING: the CardioMax must be used by qualified professionals on
patients who need defibrillation therapy or as a complement in assessing
the patient’s physiological conditions. It must be accompanied by constant
analysis of the patient’s clinical status and symptoms.
About the Manual
This guide explains the functioning of the CardioMax defibrillator/monitor series ,
alerting the user to possible safety risks. This manual is part of the CardioMax and
must be kept for further reference.
The information contained in this manual belongs to Instramed and cannot be
copied fully, or in part, without expressed written consent.
Instramed has the right to make any changes to improve this guide as well as the
product without prior notice.