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: +55 51- 3073 8200
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
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
Specications 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
Warrantycerticate 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
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