Instramed Isis Manual de usuario
Quick start guide
AUTOMATED EXTERNAL DEFIBRILLATOR
00:0080
Shocks: 0 00:00:20
0,25
mV
CPR
FOLLOW THE INSTRUCTIONS
Place the pads on
the patient.
Manufacturer
Instramed Indústria Médico Hospitalar Ltda.
Industrial Unity:
Beco José Paris, 339 – Pavilhão 19
Postal code: 91140-310
Porto Alegre – RS, Brazil
Phone/Fax number: +55 51- 3073 8200
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
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 Isis, 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.
isis-quick-start-guide-eng-R4-2019-01-11
ANVISA
10242950010
2460
II
Battery use
Attention - first use
The batteries are rechargeable Lithium-Ion (Li-ion). Before using it for the first time
the device 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.
To charge the battery connect the charger to the lateral connector in the device
and then to the electric current.
Time for full battery charge = 5 hours.
The device blocks any operation on the patient when connected to the electric
current.
Attention - occasional use
Even when disconnected (stand-by), the Isis 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, as long as the device remains for 12 months without being connected
to the electric current, it is advisable to carry out a full charge of the battery. If this
procedure is not carried out, there is a risk of depletion of the battery and
consequent impossibility of using the Isis in its portable configuration (not
connected to the electrical network).
More information on this topic is available in the ISIS User Manual present on
the CD which accompanies the product.
III
IV
Index
Presentation 06
Characteristics.......................................................................................................... 06
Safety Information 07
About this guide........................................................................................................ 07
Use criteria ............................................................................................................... 07
Qualified users.......................................................................................................... 07
ECG misinterpretation .............................................................................................. 07
Warnings .................................................................................................................. 08
Adverse effects......................................................................................................... 08
Precautions............................................................................................................... 09
Electromagnetic Compatibility .................................................................................. 09
The Equipment 10
Front panel ............................................................................................................... 10
Sides......................................................................................................................... 10
Function of the front panel elements ........................................................................ 11
1 - Screen............................................................................................................ 11
2 - Operational status indicator ........................................................................... 12
3 - Start button..................................................................................................... 13
Operation 14
Operation cycle of the Isis ........................................................................................ 14
V
Quick start guide | Index
V
Adhesive pads placement ....................................................................................... 15
1 - adults.............................................................................................................. 15
2 - children under 8 years old.............................................................................. 16
Simplified diagram of procedure in adults ................................................................ 17
ECG Monitoring 19
CPR Maestro 20
Using the CPR Maestro............................................................................................ 21
PC Connection 22
Requirements ........................................................................................................... 22
SoftDEA Installation.................................................................................................. 22
Connecting the Isis to a PC...................................................................................... 22
Inspection and Maintenance 23
Device care............................................................................................................... 23
Cleaning and disinfection ......................................................................................... 23
Preventive Maintenance........................................................................................... 23
Corrective Maintenance............................................................................................ 23
Warranty Certicate 24
Presentation 1
Given the complexity of the clinical variables involved, for many years only doctors
and experienced paramedics could use defibrillators to reverse a cardiac arrest.
Nowadays, however, with the evolution of artificial intelligence (AI), the Isis, using
its Neural Network Technology, is capable of analyzing the state of the patient,
considering the clinical variables and applying, automatically, the most suitable
shock therapy.
This allows any individual with proper training to perform assistance to a victim in
the process of fibrillation, multiplying and making life-saving possibilities easier.
Characteristics
06
• Semi-automatic.
• 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 (when available).
• PC connection via USB.
• Software for connection, download and data management via PC.
• Biphasic shock.
• Automatic self-diagnosis of functions and battery.
•Use in a hospital or extra-hospital environment.
•ECG Monitoring (optional).
•Feedback of the compression performance of the thorax, with the use of the
Maestro CPR (optional).
Safety Information 2
07
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 Isis, please consult the user manual on the CD
which accompanies the product.
Use criteria
The Isis, as well as any other Automated External Defibrillator, must only be
used if the following circumstances, as a whole, are presented:
•Unconscious victim or unresponsive to verbal or physical stimulus
•Not breathing
•No pulse (for professionals)
Other important considerations regarding the use of the Isis:
• Not recommended for children under one year old
• Pacemaker 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.
ECG misinterpretation
WARNING: 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.
Quick start guide | Safety Information
08
Warnings
IMPORTANT: this equipment may only be operated by qualified technical
personnel. Read this guide carefully before using the equipment.
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.
ATTENTION: ADHESIVE PADS SHOULD NOT BE POSITIONED ON THE
PATIENT WHILE ISIS IS CONNECTED TO THE ELECTRICAL NETWORK,
THROUGH ITS EXTERNAL AC/DC SOURCE. IN THE SAME WAY, IT MUST
NOT BE CONNECTED TO THE ELECTRICAL NETWORK, THROUGH ITS
EXTERNAL AC/DC SOURCE, WHILE ADHESIVE PADS ARE POSITIONED ON
THE PATIENT.
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.
NOTICE: the use of the Isis 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.
Adverse 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.
The skin should be dry, or electrical current leakage may happen, enlarging burn
area and reducing treatment efficiency.
Quick start guide | Safety Information
09
Precautions
Danger of EXPLOSION: Do not use the Isis 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.
Electromagnetic Compatibility
The Isis is a device built according to NBR and IEC standards and therefore is
completely safe for the patient and the user. However, all safety precautions
described below must be followed
The operation of the Isis may be affected by the presence of electromagnetic
power supplies, such as electrosurgical equipment and computer
tomography (CT).
WARNING: Using the Isis requires special precautions concerning Electromagnetic
Compatibility in compliance with the information contained in this manual..
Mobile and portable RF communications equipment, such as a cellphones, may
affect the functioning of the Isis.
Maximum length of accessory cables in order to comply with the requirements of
Electromagnetic Compatibility is 2,5 m.
All parts and accessories, listed below, follow the requirements for Electromagnetic
compatibility.
• Pair of disposable adhesive pads, adult size
• Pair of disposable adhesive pads, child size (optional)
• Power supply for charging internal battery
• USB cable
WARNING: using cables and accessories different from the ones specified above,
except for cables and accessories sold by Instramed as replacement pieces, may
result in emission gain or immunity decrease of the equipment.
The Isis must not be used too close to or piled over other equipment.
More information on this topic is available in the ISIS User Manual present on
the CD which accompanies the product.
The Equipment 3
Front panel
Sides
10
1. Screen indicating the stages
of the de-fibrillation.
procedure and ECG curve.
2. Microphone.
3. Operational status indicator.
4. Start button.
1. Speaker.
2. Connector for ECG cable
(optional).
3. Connector for CPR Maestro
(optional).
4. Battery power supply connector.
5. Battery compartment.
6. USB connector.
7. Disposable pads compartment.
8. Disposable pads connector.
9. Cabinet recess.
3
4
2
00:0080
Shocks: 0 00:00:20
0,25
mV
1
CPR
FOLLOW THE INSTRUCTIONS
Place the pads
on the patient.
AUTOMATED EXTERNAL DEFIBRILLATOR
1
3
2
4
7
5
4
2
1
8
9
6
3
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