Instramed CardioMax User manual

Quick start guide
Cardioverter/Biphasic Defibrillator Monitor

Instramed Indústria Médico Hospitalar Ltda.
Industrial unity:
Beco José Paris, 339 – Pavilhão 19
Postal code: 91140-310
Porto Alegre – RS, Brazil
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 © 2017 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-quick-start-guide-eng-r11-2019-02-01
ANVISA
10242950009
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Manufacturer

III
Attention - 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 eight hours.
Attention - 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.
More information on this topic is available in the CardioMax User Manual
present on the CD which accompanies the product.
Battery use

IV
Index
Presentation 08
Optional items........................................................................................................... 08
Safety information 09
About this guide........................................................................................................ 09
Device care............................................................................................................... 09
Grounding................................................................................................................. 09
ECG misinterpretation .............................................................................................. 09
Warnings .................................................................................................................. 09
The equipment 11
Front panel ............................................................................................................... 11
Side view .................................................................................................................. 12
Rear connectors ....................................................................................................... 13
Screen and operation 14
Turning and operating .............................................................................................. 14
Operating the e-Jog Control ..................................................................................... 15
Quick access buttons ............................................................................................... 15
Parameters visualization screen............................................................................... 16
Access icons for events and configuration functions................................................ 17
Alarms 18
Debrillator mode 19
External pads use..................................................................................................... 19

V
Quick start guide | Index
V
Child pads use.......................................................................................................... 20
Defibrillation.............................................................................................................. 21
Step 1 - Select energy......................................................................................... 21
Step 2 - Charge................................................................................................... 21
Step 3 - Shock..................................................................................................... 21
Disarm key................................................................................................................ 22
Synchronism - Synchronized discharge - Cardioversion.......................................... 22
Defibrillation Display................................................................................................. 22
Charge Auto-Sequencing Mode (Auto Seq) ............................................................. 23
Functional test .......................................................................................................... 23
AED mode 24
Step 1 - Connect pads......................................................................................... 24
Step 2 - Apply pads to patient ............................................................................. 24
Step 3 - Select AED............................................................................................. 24
Step 4 - Deliver shock ......................................................................................... 25
Step 5 - Start CPR............................................................................................... 25
Using the CardioMax on children under 8 years old................................................. 25
Pacemaker mode 26
Operating in pacemaker mode ................................................................................. 26
Starting stimulation................................................................................................... 26
Monitor mode - ECG 28
Monitoring ECG........................................................................................................ 28
Operating in monitor mode - ECG............................................................................ 29

VI
Quick start guide | Index
VI
NIPB monitoring 31
Monitoring Non-Invasive Pressure ........................................................................... 31
Placing the armband................................................................................................. 31
Measurement modes................................................................................................ 31
NIBP numeric indicator............................................................................................. 32
Monitor mode - SpO233
Monitor mode - Capnography
Capnography monitoring .......................................................................................... 34
EtCO2numeric indicator ........................................................................................... 34
Monitor mode - Respiration 35
Respiration monitoring.............................................................................................. 35
Respiration numeric indicator................................................................................... 35
Event and data storage 36
Data storage............................................................................................................. 36
Viewing and managing events.................................................................................. 36
Printing 37
1 - Instant printing..................................................................................................... 37
2 - Continuous printing ............................................................................................. 38
3 - Stop printing ........................................................................................................ 38
RTC - Real Time Check 39
General..................................................................................................................... 39
ST Segment 30
4- Alarm printing ...................................................................................................... 38
5- Shock printing...................................................................................................... 38

VII
Quick start guide | Index
VII
CPR Maestro 40
Using the CPR Maestro............................................................................................ 40
PC connection 41
Requirements ........................................................................................................... 41
SoftDEA Installation.................................................................................................. 41
Connecting the CardioMax to a PC.......................................................................... 41
RTC Installation........................................................................................................ 42
Battery use 43
Power and battery charging indications.................................................................... 43
First use.................................................................................................................... 43
Occasional use......................................................................................................... 43
Replacement ............................................................................................................ 43
Care and maintenance 45
Preventive maintenance........................................................................................... 45
Corrective maintenance............................................................................................ 45
Cleaning and disinfection ......................................................................................... 45
Warranty Certicate 46

Presentation 1
The CardioMax is a modern, practical, lightweight and compact device that
can be used in emergency situations and transported within hospitals or in
ambulances.
The CardioMax offers the following parameters and/or characteristics (some
parameters are optional):
•Exhaled carbon dioxide (EtCO2) 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).
•Sudden Death Prevention Mode (SDP).
•Charge Auto-Sequencing mode (CAS).
•Printer.
•Feedback on the frequency and depth of chest compressions
(CPR Maestro).
•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.
More information on this topic is available in the CardioMax User Manual
present on the CD which accompanies the product.
08

Safety information 2
About this guide
This guide does not substitute the user manual. Its function is to familiarize the
user with the main functions and ways of operating the equipment. For detailed
information on the functioning of the CardioMax, please consult the user manual on
the CD which accompanies the product.
Device care
• Do not place the equipment where it may fall on the patient. Do not lift the
equipment by its cables or connections.
• Place cables connected to the patient in order to restrict the possibility of
strangulation.
• Keep the defibrillator in a dry environment, avoiding places that allow liquids to
spill over the monitor. Do not use the defibrillator if it is wet or excessively humid.
• Always keep the equipment and its accessories clean and well maintained.
• If you suspect a fall or external damage, do not use the equipment.
Grounding
Grounding is essential to protect the operator and patient against electrical
discharge accidents.
ECG misinterpretation
ATTENTION: The following factors can cause ECG misinterpretation:
• Wrongly placed pads.
• Patient’s movements.
• Pacemaker (it may lessen the precision of the cardiac arrest detector).
• Radio frequency interference, including mobile phones.
• Excessive hair or wet skin in the application area of the electrodes.
• Pieces of clothing between skin and pads.
Warnings
Before installing the equipment verify if there are any abnormalities or
damage caused by mishandling during transportation.
09

Quick start guide | Safety information
10
WARNING: The use of the CardioMax is restricted to one patient at a time.
IMPORTANT: This device must only be operated by qualified technical personnel.
Before using, read the manual attentively.
NOTICE: the applied parts intended to come into contact with the patient have
been evaluated and comply with the directives and principles of ISO 10993-1.
WARNING: CardioMax should not be used too close to or over other equipment. If
this is necessary, it is recommended that the equipment or system be observed to
verify the normal operation in the configuration in which it will be used.
WARNING: risk of explosion if the equipment is operated in the presence of
flammable liquids or gases.
Electrical shock hazard: never open the device. Each and every repair must be
performed by instramed’s authorized technical centers.
ATTENTION: Do not use CardioMax or its accessories in the presence of MRI
equipment.
This equipment was projected to offer resistance to electromagnetic interferences.
However, the functioning of this device can be affected in the presence of strong
sources of electromagnetic-interference or radio-frequency, such as mobile phones,
communicator radios, etc.
WARNING: always check the general state of the equipment, the battery and the
accessories before using it.
NOTICE: the applied parts (electrodes, sensors, cuffs, etc.) are protected against
defibrillation discharge; during discharge there may be baseline variation.
WARNING: when the CardioMax is operated in monitor mode, it can be used with
other electromedical equipment simultaneously connected to the patient, provided
that the other equipment are in compliance with the safety standards.
WARNING: the conductive parts of the electrodes and connectors associated with
the applied parts, including the neutral electrode, must not come into contact with
other conductive parts, including the ground wire.
NOTICE: avoid connecting the patient to several items of equipment at the same
time. The limits of current leakage may be exceeded.
WARNING: the patient must be placed on non conductive surfaces.
WARNING: do not touch the patient, the equipment, the accessories nor any
metallic or conductive surface which is in contact with the patient during the
defibrillation.
WARNING: the patient must be completely still during the cardiac rhythm analysis
phase (AED mode). Do not give cardiac massage at this point.
If the precision of measurements seems to be incorrect, first check the vital signs of
the patient and then check the functioning of the CardioMax.
More information on this topic is available in the CardioMax User Manual
present on the CD which accompanies the product.

The equipment 3
Front panel
11
1. Transport handle.
2. LCD screen.
3. Selector switch: turns the equipment on and o󰀨. Selects the operation mode
(see following chapters).
4. Quick access buttons (see “quick access buttons”).
5. E-Jog Control: equipment general configuration.
6. Power and battery charging indicators.
1
3
2
4 5
6

Quick start guide | The equipment
12
Side view
7 8
9
1. Printer: printer for thermosensitive paper. It prints electrocardiograms and
events. For more information view the “Printing” chapter.
2. SpO2connector: BCI standard oximetry connector. Adult and child oximetry
sensors.
3. USB connector: USB connector for access to data stored by the AED mode.
4. NIBP connector: Connector for direct use with the cuff.
5. ECG connector: Connector for ECG cables.
6. CPR connector: connector for use of the CPR MAESTRO accessory.
7. Connector for defibrillation electrodes (pads): adult/child external pads,
internal and multifunctional pads.
8. Capnography exhaust connector: connector used for the removal of the gas-
es collected by capnography.
9. Capnography connector: connector for the capnography sampling line.
1
3
2
5
4
6



15A
Quick start guide | The equipment
13
Rear connectors
More information on this topic is available in the CardioMax User Manual
present on the CD which accompanies the product.
1 2 3 4
1. 3-pin power connector: input of 100 to 220 VAC, with central pin for grounding.
5A fuse (20mm 20AG F5A GLASS FUSE).
2. External DC socket: for battery connection or external DC source connection in
a range of 11 to 16 VDC.
3. Grounding and potential equalizer: potential equalization and general ground-
ing connector.
4. RS-232 output: cable socket for updating software (reserved for authorized
technical personnel).

Screen and operation 4
Turning and operating
Use selector switch for turning CardioMax on and off. When turning on, the operator
must immediately select an operation mode.
14
1. Selector switch: selects the operation mode.
2. Defibrillator mode: selects shock energy (1 to 360 J scale).
3. Auto Seq. mode: shock delivery in a sequence mode.
4. Monitor mode: multiparametric monitor mode.
5. Turns equipment o󰀨.
6. Pacemaker mode: enables the external pacemaker.
7. AED mode: enables the Automated External Defibrillator (AED).
Monitor
Energy
OFF
Seq.
Auto
Pacemaker
1
2
3
4
567

Quick start guide | Screen and operation
15
Operating the e-Jog Control
The e-Jog Control is used to access many functions and menus of the CardioMax,
such as configuring alarms, defining the information displayed on the screen,
altering parameters, etc.
Fast Lead Change: enables quick
access to change ECG leads.
Fast Sensitivity Change: enables
quick change of ECG sensitivity.
Print: press once to print a quick
report. For continuous printing,
simply press the button for 3
seconds. For further information,
see the “Printing” section.
Events: when used with the
e-Jog Control, it allows to mark an
important event and store it in the
equipment’s memory.
Pause audio: press the button
quickly to deactivate ALL sound
alarms for a previously programmed
period of time. Press for 3 seconds
to deactivate ALL sound alarms for
an INDETERMINATE period.
NIBP (when available): starts
or suspends the functionality of
the Non-Invasive Blood Pressure
Measurement. When the NIBP
(optional) parameter is not present
in the device, this button has no
function.
Freeze: Freezes graphic screen
signals for a closer examination
(same Cancel button).
Quick access buttons

Quick start guide | Screen and operation
16
Parameters visualization screen
1. ECG: ECG measurements and ECG alarms.
2. Pacemaker or defibrillation modes: area for the defibrillation or pacemaker modes.
3. SpO2: Oximetry measurements and oximetry alarms.
4. Graph area for oximetry, ECG and EtCO2 waveforms. Also used for configura-
tions.
5. Time, date, battery and mode status.
6. Infocenter: Information on the equipmentand its operation. This is how the
device communicates with the user.
7. Access icons for event and configuration functions.
PPM mA
70 30
Modo: Adult
07/10/12
80
dII
95
13
4
5 7
Connect
Multifunctional Paddles
6
5 leads
PAUSE DEMAND
2

Quick start guide | Screen and operation
17
Access icons for events and configuration functions
1. Events menu: views events
stored in the CardioMax.
2. Configuration menu:
configuration of all the
parameters of the equipment.
3. Printer menu shortcut: prints
and configures the printing
parameters.
4. Alarms menu shortcut: direct
access to the menu which
configures the alarms.
1 2
3 4
More information on this topic is available in the CardioMax User Manual
present on the CD which accompanies the product.

Alarms 5
Physiological alarm: there are two ways to enable the physiological alarm
indications: Asistoly and Violation of MAXIMUM or MINIMUM limits.
Technical alarm: sound and visual signals indicate that the CardioMax is not able
to accurately monitor the patient’s status.
More information on this topic is available in the CardioMax User Manual
present on the CD which accompanies the product.
18

Debrillator mode 6
Warnings
The CardioMax has a patient impedance meter that delivers shocks in 25 to 300
ohms impedances.
If a cable or conductor is suspected of being ruptured, avoid using the equipment.
Ensure that the defibrillation electrodes of the CardioMax are at an appropriate
distance from other electrodes so that the power applied does not flow through
these electrodes.
Disconnect all equipment devoid of protection against the discharge of defibrillators.
Ensure that the patient does not come into contact with any metallic parts.
External pads use
1-Connect the defibrillation cable to the pads socket
located on the equipment’s side.
2- Take both pads from their base pulling them up and out.
3- Apply the conductive material to the pads’ electrodes.
4- Place pads as shown in the image below. The
electrodes must be placed in a position which will
maximize the current that passes through the myocardium,
as indicated below:
A. Electrode identified as
“STERNUM” on the right
second intercostal space,
mid-clavicular line.
B. Electrode identified as
“APEX” positioned on the
left sixth intercostal space,
midaxillary line.
A
B
ENSURE that the electrodes are away from each other. DO NOT apply paste
or gel to the thorax between the pads or the current may follow a superficial
route along the thorax wall and not reach the heart.
5- Check contact with the patient.
19

Quick start guide | Debrillator mode
20
The STERNUM pad has a
patient contact indicator.
The indicator goes from BAD
contact (red ashing LED) to
GOOD contact (at least one
LED on).
GOOD BAD
When all LEDs blink simultaneously the pads have a short circuit, and shock
delivery will not be permitted.
When only the red LED is blinking, shock delivery will not be allowed.
Child pads use
1 2 3
1-Fasten the lock in the front of the adult external pads.
2- Pull the pads base forward to remove them.
3- This exposes the smaller electrode for children.
A. Adult pad (w/ the base).
B. Child pad (w/o the base).
A B
The CardioMax will automatically identify that it is operating in pediatric
mode. Energy is limited to 50 Joules in the pediatric mode.