Instramed I.ON Pro User manual

User manual
AUTOMATED EXTERNAL
DEFIBRILLATOR
AUTOMATED EXTERNAL
DEFIBRILLATOR
WITH MANUAL FUNCTION

Manufacturer
Instramed Indústria Médico Hospitalar Ltda.
Industrial unit:
Beco José Paris, 339 – Pavilhões 18 e 19
Postal code: 91140-310
Porto Alegre – RS, Brazil
Phone/Fax number: [phone]
Email: [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 I.on/I.on PRO, 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.
I.on/I.on PRO User Manual R1.10 English 2020-08-09
ANVISA
10242950016
2460
II

Battery use
ATTENTION: observe the battery charge maintenance instructions.
Rechargeable batteries first use
The batteries of the I.on or I.on PRO are rechargeable Lithium-Ion (Li-Ion) batteries.
Before the first use, the equipment must receive a full battery charge. For this, it
needs to be connected to the electric current for at least 8 hours.
To charge the battery, disconnect it from the I.on/I.on PRO and connect the charger
at the back of the battery and then connect it to the mains supply.
Time to battery full charge = 5 hours.
The device blocks any operation on the patient when connected to the electric
current.
Occasional use
Even when disconnected (stand-by), the I.on/I.on PRO executes internal routines
checking the status of the equipment. Despite of this procedure entailing a low power
consumption, the battery charge may be consumed.
Therefore, whenever the device is not connected to the mains for 8 months, it is
recommended to fully charge the battery (only for rechargeable batteries).If this
procedure is not performed, there is a risk of draining the battery and consequently
being unable to use the I.on/I.on PRO in its portable configuration (not connected to
the electric current).
Rechargeable batteries replacement
Every battery has a determined shelf life, which is the possible quantity of
full charge and discharge cycles, without loss of performance (see battery
specifications in chapter 8). When the device presents a drop in battery
performance, with low autonomy, please request a new unit from Instramed’s
technical assistance.
The battery can be withdrawn through the rear opening through a quick-release
system. Remove the old battery and replace the new battery, observing the correct
docking position.
Battery replacement is recommended every 02 (two) years or when the runtime is less
than 01 (one) hour.
III

Package contents
Included items
When opening the package, please check whether all items below are present:
• An I.on/I.on PRO automated defibrillator.
• A pair of disposable adult size adhesive pads.
• One first-aid kit containing 1 pair of surgical gloves, 1 scissor and 1 CPR mask.
• A transport bag.
• A USB cable.
• CD with instructions manual and SOFTDEA management PC software.
Optional items
• A power supply for charging internal battery.
• A cable for connecting the power supply to the electric current.
• A pair of disposable child size adhesive pads.
• 3 Lead ECG cable.
• Accessory for chest compression (CPR Maestro).
Replacement parts
You can ask Instramed for replacements of the following items (consult Instramed
for prices. Shipping costs may be applied):
• Batteries replacement.
• Adult/child adhesive pads replacement.
To request pieces and services, please contact Instramed.
IV

V
Index
Introduction 10
Characteristics.......................................................................................................... 10
Purpose .................................................................................................................... 11
Principle.................................................................................................................... 11
Use criteria ............................................................................................................... 12
Qualified users.......................................................................................................... 12
About the manual ..................................................................................................... 12
Safety information 13
Attention ................................................................................................................... 13
Warnings .................................................................................................................. 13
Adverse events or side-effects ................................................................................. 14
Standards ................................................................................................................. 15
Device care............................................................................................................... 15
Cleaning ................................................................................................................... 16
Connection to other equipment ................................................................................ 17
Disposing of the device ............................................................................................ 17
Precautions............................................................................................................... 17
Classification and symbols ....................................................................................... 18
The equipment 20
Front Panel - Models I.on and I.on PRO with LCD screen....................................... 20
1 - Touch screen.................................................................................................. 21
Front panel - Model I.on without LCD screen........................................................... 24
1 - Indicative LEDs of the care stage. ................................................................. 25
2 - Operational status indicator ........................................................................... 26
3 - Speaker.......................................................................................................... 27
4 - Start button..................................................................................................... 28
5 - Microphone (optional) .................................................................................... 28

VI
User manual | Index
VI
Side connectors........................................................................................................ 29
1 - ECG connector............................................................................................... 30
2 - CPR Maestro connector................................................................................. 30
3 - Disposable pads connector. .......................................................................... 30
Rear connectors ....................................................................................................... 31
1 - Battery compartment...................................................................................... 31
2 - USB Connector .............................................................................................. 31
Charging the battery................................................................................................. 32
Operating in AED mode 33
Step 1.................................................................................................................. 34
Step 2.................................................................................................................. 35
Step 3.................................................................................................................. 36
Step 4.................................................................................................................. 37
Step 5.................................................................................................................. 37
Simplified diagram of procedure in adults ................................................................ 38
Operating in manual mode 40
Step 1.................................................................................................................. 41
Step 2.................................................................................................................. 42
Step 3.................................................................................................................. 43
Step 4.................................................................................................................. 44
Step 5.................................................................................................................. 44
Simplified diagram of procedure in adults ................................................................ 45
Applying CPR 47
Use in children 49
Using the I.on/I.on PRO on children under 8 years old ............................................ 49
ECG monitoring 50
Using ECG................................................................................................................ 51

VII
User manual | Index
VII
CPR Maestro 52
Using the CPR Maestro............................................................................................ 52
Feedback.................................................................................................................. 54
Messages ................................................................................................................. 54
CPR graphic ............................................................................................................. 55
PC connection 57
Introduction............................................................................................................... 57
Requirements ........................................................................................................... 57
SoftDEA Installation.................................................................................................. 58
Installing the SoftDEA using the website.................................................................. 58
Connecting the I.on/I.on PRO to a PC...................................................................... 58
Operating SoftDEA 59
Initial screen ............................................................................................................. 59
1 – Close button ...................................................................................................... 59
2 – Minimize button .................................................................................................. 59
Adjusts screen.......................................................................................................... 60
1 – Options bar.................................................................................................... 60
2 – Back button ................................................................................................... 60
3 – Clock button .................................................................................................. 60
4 – Volume level.................................................................................................. 61
Languages screen.................................................................................................... 62
1 – On the application............................................................................................... 62
2 – On the equipment............................................................................................... 62
Recordings screen.................................................................................................... 63
1 - Download ....................................................................................................... 63
2 - Open .............................................................................................................. 63
3 – List of audios ................................................................................................. 63
4 – Player ............................................................................................................ 64

VIII
User manual | Index
VIII
Shocks screen.......................................................................................................... 64
1 – Define shock sequence ...................................................................................... 64
2 – Previous sequence............................................................................................. 64
AED screen .............................................................................................................. 65
1 – Download............................................................................................................ 65
2 – Open................................................................................................................... 65
3 – Print .................................................................................................................... 65
4 – Generate PDF .................................................................................................... 66
5 – Select events...................................................................................................... 66
6 – List of events ...................................................................................................... 66
7 – Curves area........................................................................................................ 66
Definition of events displayed in AED mode............................................................. 67
Precautions, restrictions and warnings 68
Electromagnetic compatibility................................................................................... 68
Attention ................................................................................................................... 68
Warnings .................................................................................................................. 68
Electromagnetic emissions....................................................................................... 69
Electromagnetic immunity - General ........................................................................ 70
Electromagnetic immunity - Equipment with life support functions........................... 71
ECG analysis algorithm............................................................................................ 74
Types of arrhythmia analyzed................................................................................... 76
Specications 77
General specifications .............................................................................................. 77
Environmental specifications.................................................................................... 79
Defibrillator ............................................................................................................... 79
CPR Maestro............................................................................................................ 81
Precision of applied energy ...................................................................................... 81
Patient’s impedance response table......................................................................... 81

IX
User manual | Index
IX
ECG rhythm recognition and detector table ............................................................. 82
ECG.......................................................................................................................... 85
ECG electrodes (adult and child).............................................................................. 86
Alarm system............................................................................................................ 87
Information signals ................................................................................................... 88
Care and maintenance 90
Preventive Maintenance........................................................................................... 90
Corrective Maintenance............................................................................................ 90
Accessories 91
Included.................................................................................................................... 91
Optional .................................................................................................................... 92
Warrantycerticate 93

Introduction 1
The I.on/I.on PRO is a new generation semi-automatic external defibrillator
(AED), which, through a care protocol, guides by voice, performs the diagnosis,
considers the clinical variables and applies the treatment safely with the touch of
only button.
Designed for emergency care, it is compact, light, resistant and easy to use.
I.on PRO
In its PRO version, the equipment offers the flexibility of the manual mode, which
allows the health care professional to select the parameters of shock delivery
treatment, such as selecting charge up to 360 Joules.
Through a touch screen with excellent contrast and visualization area, the user
selects the operation mode and charge, while visualizing the ECG curve. The
interface is simple and self-explanatory.
Characteristics
• Semi-automated.
• Artificial Intelligence: accurate diagnosis of the patient’s conditions, indicating
shock delivery or not.
• Safety precautions: prevents accidental use in cases in which shock treatment is
not advisable or in healthy people.
• Operation with just one button.
• Orientation by voice and indicator lights.
• Internal recording of events.
• Audio recording (optional).
• PC connection via USB.
• Software for connection, download and data management via PC.
• Biphasic shock.
• Automatic self-diagnosis of functions and battery.
• Easy access to pads for use and replacement.
• ECG Monitoring (optional).
• Chest compression performance feedback, with the use CPR Maestro
(optional).
10
only
I.on PRO

User manual | Introduction
11
Purpose
The defibrillator is a device used for treating cardiac arrhythmias, situations in which
the heart loses the ability of keeping steady heartbeats, blood stops being pumped
and oxygen and nutrients do not get to the organs, starting a degenerative process
known as biological death.
Among the most common cases of cardiorespiratory arrest are ventricular fibrillation
(VF) and ventricular tachycardia (VT), and the most efficient treatment for these
kinds of cardiac dysrhythmia are electrical defibrillation, a technique by which
electrical shocks are applied to the anterior thoracic wall.
Obviously, the success of defibrillation depends on the metabolic conditions of the
myocardium. The more the ventricular fibrillation lasts, the greater the metabolic
deterioration is and, consequently, the fewer chances of the electrical shock
converting it into a steady rhythm.
However, if it lasts shortly, as in the cases of quickly assisted cardiac arrests, shock
response is almost always positive.
Therefore, the most important factor in survival is how fast treatment is delivered.
Ideally, treatment should not be delayed for more than four minutes from the
beginning of the defibrillation.
Principle
Defibrillation is the electrical shock therapy responsible for reversing cardiac arrest
caused by ventricular fibrillation or ventricular tachycardia without a pulse.
The I.on/I.on PRO uses the BIPHASIC SHOCK technology, which is characterized
by a current which is released in a direction and, after a very short time, reverts in
the opposite direction.
During the defibrillation the whole myocardium is briefly depolarized by a strong
positive impulse and a negative one, of adjustable intensity (Biphasic Truncated
Exponential Shock). This impulse is used for eliminating atrial and ventricular
fibrillation and ventricular disturbances.
Compared to monophasic shock, the following advantages can be mentioned
regarding biphasic technology:
• Greater efficiency at ending ventricular fibrillation.
• Lesser damage to the myocardium, through the use of lesser energy intensity,
with attenuation of subsequent myocardial dysfunction.
• Fewer incidence of defibrillation.
Source: Sociedade de Cardiologia do Estado de São Paulo – SOCESP, Revista
Socesp V.11, no 2.

User manual | Introduction
12
Use criteria
The I.on/I.on PRO, as well as any other Automated External Defibrillator, must only
be used if the following circumstances, as a whole, are presented:
• Unconscious victim.
• Not breathing.
• No pulse (for professionals).
Other important considerations regarding the use of the I.on/I.on PRO:
• Not recommended for children under one year old.
• Pacemakers may affect the device’s efficiency.
• Medicines in adhesive form must be removed before starting defibrillation.
• Hypothermic patients may not respond well to defibrillation.
• Once the removal of the patient is started, the defibrillation must be interrupted.
Qualified users
Shall be considered qualified users those who have had training in a recognized
institution in the use of automated defibrillators and CPR techniques -
Cardiopulmonary Resuscitation.
About the manual
The function of this guide is to explain how the I.on/I.on PRO Automated
Defibrillator series works, alerting the user to safety risks.
The information contained in this manual belongs to Instramed and cannot be used
fully, or in part, without expressed written consent.
Instramed has the right to make any changes to improve this guide and the product
without prior notice.
This guide is a part of the I.on/I.on PRO and must be kept for further reference.

Safety information 2
Attention
The following factors may 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.
I.on/I.on PRO ONLY works with battery.
Warnings
IMPORTANT: this equipment may only be operated by qualified technical
personnel. Read this guide carefully before using the equipment.
WARNING: not recommended for patients younger than one (01) year old.
ATTENTION: the patient’s movements can confuse the correct detection of
rhythm and delay therapy. Do not perform maneuvers with the patient and
keep him still during rhythm analysis.
WARNING: I.on/I.on PRO can be used by patients over 01 (one) year old,
regardless of their weight.
WARNING: the patient must be placed on non-conductive surfaces. Do not
use wet or metallic surfaces and, if necessary, dry the chest before applying
the shock.
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. Do not give cardiac massage at this point.
WARNING: risk of explosion if the equipment is operated in the presence of
flammable liquids or gases.
WARNING: always check the general state of the equipment, the battery and
the accessories before using it.
NOTICE: each and every repair to the equipment can only be done by
instramed’s authorized technical assistance centers.
13

User manual | Safety information
14
NOTICE: the use of the I.on/I.on PRO is restricted to one patient at a time.
NOTICE: the applied parts are protected against defibrillation discharge;
during discharge there may be baseline variation.
NOTICE: avoid connecting the patient to several items of equipment at the
same time. The limits of current leakage may be exceeded.
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.
NOTICE: when removing the equipment from the package, carefully verify if
there is any abnormality or visible damage in the device or its accessories,
caused by impact or mishandling during transportation. In case of
irregularities, please contact instramed.
NOTICE: disposable accessories and any other components must be
disposed of according to the norms of hospital waste disposal.
NOTICE: do not modify this equipment without authorization from instramed.
ATTENTION: the adhesive pads cannot be in contact with the patient while
Ion/Ion pro is connected to the AC/DC external source.
The pads should not be placed on the patient while I.on/I.on PRO is
connected to the mains via its AC/DC external source. The same way
I.on/I.on PRO should not be connected to the mains via its AC/DC external
source, while the pads are positioned on the patient. Under these conditions
the leakage current limits defined in EN 60601-1 and EN 60601-2-4 for this
class of equipment, may be exceeded.
ATTENTION: I.on/I.on PRO should not be connected to the AC/DC external
source when in use.
I.on/I.on PRO was designed to operate only from its internal battery and when
disconnected from its AC/DC external source, that is designated only to feed
the charger’s internal battery I.on/I.on PRO. I.on/I.on PRO does not work while
connected to your AC/DC external source, turning itself off automatically
when it detects this condition.
Adverse events or side-effects
Superficial burns may occur to the patient’s skin on the area in contact with the
electrodes. To minimize this effect, apply the pads soon after removing their
protective envelope and press them firmly to the patient’s skin.
Possibility of superficial skin burns. To minimize the effect, in the case of adhesive
pads, apply them immediately after removal of the protective envelope and securely
attach to the patient’s skin. The patient’s skin must be dry.
Possibility of reduction of treatment efficiency. The patient’s skin must be dry,
otherwise the electric discharge may leak. Never apply conductive gel.

User manual | Safety information
15
Possibility of reddish and/or bruised skin at the application place (thorax) by the use
of CPR MAESTRO. It is recommended for cases of resuscitation maneuvers of long
duration, the use of a gauze between the skin and the CPR MAESTRO.
Possible BURNED/REDNESS SKIN, due to the HIGH VOLTAGE and HIGH
CURRENT delivered. But it becomes more severe damaged as the progressive
counting of the delivered shocks. These side-effects depends also on the quantity of
delivered shocks.
ECZEMAS on the skin, due to a bad biocompatibility of the adhesive pads or ECG
electrodes. The accessories supplied with the product are biocompatible according
the ISO 10993 standard.
Standards
I.on/I.on PRO was designed following performance and safety national and
international standards. Among them are:
• IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance.
• IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirement for
basic safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and test.
• IEC 60601-1-6 - Medical Electrical Equipment - Part 1-6: General requirements
for basic safety - Collateral Standard: Usability.
• IEC 60601-1-8 - Medical electrical equipment - Part 1-8: General requirements
for basic safety and essential performance - Collateral standards: General
requirements, testes and guidance for alarm systems in medical electrical
equipment and medical electrical systems.
• IEC 60601-2-4 - Medical electrical equipment Part 2-4: Particular requirements
for the basic safety and essential performance of cardiac defibrillators.
Or equivalent IECs.
The current versions of technical standards can be verified on the Product
Conformity Certificate, available at www.instramed.com.br.
All instramed equipments that has AED mode are manufacture with current
AHA protocol.
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.
Always keep the equipment and its accessories clean and well maintained.
If you suspect a fall or external damage, do not use the equipment.

User manual | Safety information
16
Cleaning
Instramed recommends cleaning the equipment monthly and its accessories at
each patient exchange, or in shorter periods whenever the existence of dirt or
contamination is evident.
CLEANING THE EQUIPMENT
• Disconnect the equipment from the mains supply before cleaning it.
• Wipe the external part of the device with a cloth moistened with water (almost
dry) and neutral liquid soap until the entire surface is free of dirt. Never allow
cleaning agents or water to enter the cabinet slits, display, and openings for
connectors.
• Repeat the procedure only with the cloth moistened with water (almost dry) to
remove soap residue.
• Dry the equipment with a clean and dry cloth.
• Perform the procedure in room temperature.
CLEANING THE ACCESSORIES
For the ECG cable:
• Clean the cable, the connection box and the surfaces of contact with the patient
with a soft cloth moistened with water or neutral disinfection solution, dry the
cable to use again.
• The cleaning must be periodic.
• Keep the plugs dry.
For the CPR MAESTRO:
• Moisten a cloth with clean water and neutral detergent and clean the device until
all dirty is removed.
• Use a second dry cloth to remove excess of liquid and/or foam.
• Moisten a third cloth with Alcohol 70º and pass lightly on the product.
IMPORTANT RECOMMENDATIONS
• Never immerse in liquid and never spill liquid of any kind on any part of the
equipment.
• Do not use any other cleaning products not recommended by this manual.
NEVER sterilize any parts of the equipment, regardless of the sterilization
method, as this would damage the mechanical structure and compromise
the product’s operation.

User manual | Safety information
17
The above recommendations ensure that the device will support, without
damage or deterioration of safety factors, the cleaning and disinfection
process necessary.
Connection to other equipment
When connecting the I.on/I.on PRO to any device, ensure that the equipment is
operating correctly before clinical use.
Disposing of the device
As provided in Brazilian environmental legislation, equipment and parts that do not
have more use conditions should be referred to the manufacturer for proper final
destination, thus preserving natural resources and contributing to the conservation
of the environment.
For the disposal of Instramed products, contact us through the telephones available
on the website “www. instramed.com.br” or by e-mail “[email protected]”.
Avoid contamination of the environment, humans, or other equipment by make sure
to properly decontaminate the equipment before disposing of it.
Refer to local regulations for the proper disposal of trash in your area. For countries
that follow European Guidelines, refer to 2002/96/CE.
Precautions
Danger of EXPLOSION: do not use the I.on/I.on PRO in the presence of
flammable anesthetics.
Risk of ELECTRICAL SHOCK: never open the equipment. When necessary,
this must be done by authorized individuals.
Do not use the equipment in the presence of magnetic resonance devices.
This equipment was designed to be resistant to electromagnetic interference.
However, equipment performance can be affected if in the presence of strong
sources of electromagnetic interference or radio frequencies, such as mobile
phones, radio communicators, etc.

User manual | Safety information
18
Classification and symbols
Symbol Description
Follow the instructions for use
ATTENTION
General WARNING symbol
WARNING: dangerous voltage
Power supply connector
Non-ionizing radiation
USB connector
This side up
Fragile equipment
Maximum stacking of 4 units
Keep away from rain
Storage temperature limits
Operation temperature limits
Minimum and maximum atmospheric pressure
Minimum and maximum relative humidity
Recyclable paper
Remains of electrical and electronic equipment - Dispose of separately from other disposables
2460
Mark of conformity according to the European Community.
“2460” stands for the number of the Notified Body.
Internal exclusive use
Direct current
CF applied part - defibrillation proof

User manual | Safety information
19
On/Off (push-push)
Manufacturer
European representative
Serial Number
Electric polarity of the rechargeable battery power supply
Does not contain natural rubber LATEX
Do not reuse
Non-sterile
Do not use if the packaging is damaged.
Keep away from sunlight
Adhesive pads operation temperature limits
Check instructions for use
LOT
Lot code
REF
Catalog number
Date after which the product cannot be used
The norms EN 60601-1 and ISO 15223 are used as reference to the symbols.

The equipment 3
Front Panel - Models I.on and I.on PRO with LCD screen
2
3
4
5
1
1. Touch screen: presents operational
information and allows for manual
interaction with the device.
2. Operational status indicator.
3. Speaker.
4. Start button.
5. Microphone (optional).
On the next pages you will find the detailed description of each component of the
front panel.
20