Instramed APOLUS Manual de usuario
User Manual
Biphasic Defibrillator
Instramed Indústria Médico Hospitalar Ltda.
CNPJ: 90.909.631/0001-10
I.E.: 096/0642048
Industrial unity:
Beco José Paris, 339 – Pavilhões 18 e 19
CEP: 91140-310
Porto Alegre – RS, Brasil
Phone/Fax: +55 51 3073 8200
www.instramed.com.br
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 © 2016 Instramed. Apolus, 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, copied, evaluated, recompiled or altered in any way.
Apolus User Manual R2.0 2022-06-06
ANVISA 10242950011
II
Manufacturer
ATTENTION: observe the instructions of the maintenance of the battery charge.
First use
The batteries are rechargeable Nickel-Metal Hydride (Ni-MH). 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 the electric current for at least eight hours.
Occasional use
Even when disconnected (stand-by), the Apolus 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, except when the rear power
switch is turned off.
Therefore, whenever the device has not been connected to an electric current for
more than 20 days, and with the power switch at the position on, 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 Apolus in its portable
configuration (not connected to the electric current).
Replacement
Every battery has a determined lifetime, which is the possible quantity of full charge
and discharge cycles, without loss of performance. When the equipment presents
a decrease in battery performance, with low autonomy, request a new unit from
Instramed’s technical assistance.
The lifetime of the battery is of at least 500 cycles (full charges and discharges).
III
Battery use
Included items
When opening the package, please check whether all items below are
present:
• Apolus Biphasic Defibrillator
• Instructions manual
• 3-pin professional power cable
• External defibrillation pads set – adult and child
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 the representative of your region (the list
may be found on www.instramed.com.br ) or directly Instramed by the telephone
+55 51 3073-8200.
IV
Package contents
V
Index
Introduction 08
Purpose and application........................................................................................... 08
Characteristics.......................................................................................................... 08
About the Manual ..................................................................................................... 08
Safety Information 09
Attention ................................................................................................................... 09
Warnings .................................................................................................................. 09
Adverse effects......................................................................................................... 10
Classification and symbols ....................................................................................... 11
Standards ................................................................................................................. 12
Device care............................................................................................................... 12
Connection to other equipment ................................................................................ 12
Grounding................................................................................................................. 13
Electromagnetic compatibility................................................................................... 13
Disposing of the device ............................................................................................ 13
The equipment 14
Front panel ............................................................................................................... 14
1 - Selector switch............................................................................................... 15
2 - LCD Display ................................................................................................... 15
3 - Power, battery charge and QRS indications .................................................. 16
4 - Operation buttons........................................................................................... 16
Side view .................................................................................................................. 17
1 - Connector for defibrillation electrodes (pads) ................................................ 17
Rear pannel.............................................................................................................. 18
Debrillation operation 19
Physics principle used.............................................................................................. 19
VI
User manual | Index
VI
Warnings .................................................................................................................. 20
Use criteria ............................................................................................................... 20
Qualified users.......................................................................................................... 20
External pads use..................................................................................................... 21
Considerations for shock delivery............................................................................. 23
Child pads use.......................................................................................................... 24
Defibrillation.............................................................................................................. 25
Synchronism - Synchronized discharge - Cardioversion.......................................... 26
Disarm key................................................................................................................ 27
Pantalla de desfibrilación.......................................................................................... 27
Functional test 28
Step 1 ....................................................................................................................... 28
Step 2 ....................................................................................................................... 28
Step 3 ....................................................................................................................... 28
Step 4 ....................................................................................................................... 28
Step 5 ....................................................................................................................... 28
Indication of the functional tests results.................................................................... 29
Care and maintenance 30
Preventive maintenance........................................................................................... 30
Corrective maintenance............................................................................................ 30
Cleaning and disinfection ......................................................................................... 30
Sterilization............................................................................................................... 30
Battery ...................................................................................................................... 31
Returning componentes ........................................................................................... 31
Precautions, restrictions and warnings..................................................................... 31
Electromagnetic compatibility................................................................................... 31
Electromagnetic emissions....................................................................................... 33
Electromagnetic immunity - General ........................................................................ 34
Electromagnetic immunity - Equipment with life support functions........................... 35
VII
User manual | Index
VII
Troubleshooting 39
Accessories 40
List of basic accessories........................................................................................... 40
List of optional accessories ...................................................................................... 40
Specications and safety 41
General specifications .............................................................................................. 41
Environmental specifications.................................................................................... 42
Defibrillator ............................................................................................................... 42
Warranty Certicate 48
Introduction 1
Purpose and application
The Apolus uses electrical defibrillation and cardioversion therapy to reverse
ventricular fibrillation arrhythmia or ventricular tachycardia without a pulse in adult
and pediatric patients, as well as cardioversion of arrhythmias when necessary.
Characteristics
The Apolus is a lightweight and compact biphasic defibrillator with a modern
design. It has an internal battery, therefore it is practical and suitable for emergency
situations and transport within hospitals or in ambulances.
WARNING: The Apolus must be used by qualified personnel on patients who
need defibrillation therapy or as a complement in assessing the patient’s
physiological conditions. The use must happen in conjunction with the
patient’s clinical signs and symptoms.
About the Manual
This manual explains the functioning of the Apolus defibrillators series, alerting the
user to safety risks. This manual is part of the Apolus 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 manual as well as the
product without prior notice.
08
Safety Information 2
Attention
The following factors can cause bad contact, causing burns on the patient.
• Misplaced pads;
• Excessive hair or wet skin in the area of the electrodes application;
• Pieces of clothing between skin and pads.
Warnings
CAUTION: To perform a direct defibrillation (not synchronized), the
synchronized defibrillation indicator LED must be off. Otherwise the
defibrillator will not apply the energy discharge on the patient due to absence
of ECG signal or electrical connection between the defibrillator and a cardiac
monitor for acquisition of the ECG signal.
For synchronized (cardioversion) discharge, the device must detect the ECG
signal with QRS.
IMPORTANT: This device must only be operated by qualified technical
personnel. Before using it, read the user manual attentively.
ATTENTION: 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: THE PATIENT MUST BE PLACED ON NON CONDUCTIVE
SURFACES. DO NOT USE WET OR METALLIC SURFACES AND, IF
NECESSARY, DRY THE PATIENT’S CHEST BEFORE SHOCK DELIVERY.
ATTENTION: DURING THE DEFIBRILLATION, DO NOT TOUCH THE PATIENT,
THE EQUIPMENT, THE ACCESSORIES NOR ANY METALLIC OR CONDUCTIVE
SURFACE IN CONTACT WITH THE PATIENT.
Do not use Apolus 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.
ATTENTION: always check the general state of the equipment and its
accessories before using it.
Before installing the equipment verify if there are any abnormalities or
damage caused by mishandling during transportation.
WARNING: The use of the Apolus is restricted to one patient at a time.
09
User manual | Safety information
10
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.
WARNING: avoid connecting the patient to several equipments at the same
time, because the limits of current leakage may be exceeded.
WARNING: In general, the parts of the EQUIPMENT and ACCESSORIES of
the Apolus defibrillator intended to come into contact with biological tissues,
cells or fluids are tested and analyzed according to the directives and
principles of ISO 10993-1, which deals exclusively with the biocompatibility
test of the applied parts.
WARNING: When removing the equipment from its 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.
WARNING: disposable accessories and any other components must be
disposed according to the hospital waste disposal norms.
Adverse effects
Superficial burns may occur on the patient’s skin in the area in contact with the
electrodes. To minimize the effect of the disposable paddles, apply them directly
after removal from the protection envelope and attach them firmly to the patient’s
skin.
The skin must be dry, or electric current leakage may occur, increasing the burn’s
area and reducing the efficiency of the treatment.
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