Instramed Isis User manual

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: [phone]
Email: [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 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 Certicate 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

Quick start guide | The Equipment
11
Function of the front panel elements
1 - Screen
The Isis presents the following items on the screen when connected to the patient:
1. Shock counter: Shows total of defibrillations performed with success.
2. Orientation message.
3. ECG curve.
4. General chronometer: Shows the total time of the equipment turned on.
5. Icon indicating the defibrillation stage.
6. Battery status.
7. Heart beats per minute.
8. CPR interval counter: counts the interval between discharge delivery, helping in the
CPR (Cardiopulmonary resuscitation) massage.
0,25
mV
2 31
ANALYSING...
Do not touch
the patient.
80
Shocks: 0
CPR 00:00
00:00:20
8
4 65
7

Quick start guide | The Equipment
12
2 - Operational status indicator
• Shows that the device is operating and ready for use.
• Shows that the device DOES NOT HAVE ENOUGH BATTERY CHARGE TO
OPERATE or has another internal defect. Charge battery immediately. If the
indicator remains red, please call technical assistance.
• Mains supply LED on means device is connected to the electric current. Mains
supply LED blinking when in normal use means the battery needs charging.In
this state, Isis guarantees at least 3 discharges at maximum energy.
• Battery LED on means internal battery is being charged. A blinking LED beside
this symbol means full charge.
EVEN WHEN THE BATTERY HAS BEEN FULLY CHARGED, THE OPERA-
TIONAL STATUS INDICATOR WILL STILL BE SHOWING .
The display will only change from to when the Isis performs the au-
to-test routine or if the device is turned on/of by the user.

Quick start guide | The Equipment
13
3 - Start button
Switch on
1st press
Analyze Deliver shock
2nd press
StartInício
The Isis offers exclusive technology which allows to operate the device completely
safely with a single button.
The start button has the functions of:
• Turning on the device
• Starting the automatic process of the patient’s clinical analysis
• Applying shock therapy (active only when the automatic clinical analysis of the
patient indicates the need for it).
NOTE: it is not necessary to switch the Isis off. Fifteen seconds after the re-
moval of pads from the patient or disconnection of pads from the equipment,
the device switches itself off, saving battery charge. In this moment the follow-
ing message will be heard: “The device is being turned off. Press the button in
order to turn the machine back on”.
More information on this topic is available in the ISIS User Manual present on
the CD which accompanies the product.

Operation 4
Operation cycle of the Isis
The Isis is an advanced and fully automated cardiac resuscitation equipment
(defibrillator). See below a simplified introduction of its operation.
Start
Início
3
2 4
1 5
6
Shock delivered: start CPR
(cardiopulmonary resuscitation)
The energy delivered is preset. The user cannot change this protocol.
For adult electrodes: 1st shock: 150J, the following: 200J.
For child electrodes: 50 J.
More information on this topic is available in the ISIS User Manual present on
the CD which accompanies the product.
14
Equipment analyzes patient’s
condition
Place
pads on
patient
Analysis is
concluded:
shock is
recommended!
Press button to
start cycle
Press button to
deliver shock

Quick start guide | Operation
15
1 - adults
Remove pads from their wrapping and peel off the film protecting the adhesive.
Place pads on the patient according to the picture above, keeping adhesive area in
contact with the skin.
ATTENTION: The area in contact with the pads must be dry.
ATTENTION: The presence of too much hair in the contact area may affect
scanning. In this case, shave hair.
ATTENTION: The pads must be applied directly over the skin. DO NOT place
pads over clothes.
ATTENTION: The pads are disposable and for single-use, cannot be reused
under any circumstances.
ATTENTION: After opening the wrapping, the pads should be used within 24
hours.
ATTENTION: In case of use for long periods, the pads should be replaced every
24 hours.
Adhesive pads placement
1

Quick start guide | Operation
16
2 - children under 8 years old
The Isis can be used on children from the age of one year onwards. However, on
patients from one year of age to eight years of age or patients who weigh less than
25kg, some precautions must be taken:
• Use child pads;
• If the pads cannot be placed within the minimal distance of 4 centimeters
between them, place one of them on the child’s chest and another on his
back.
More information on this topic is available in the ISIS User Manual present on
the CD which accompanies the product.
2

Quick start guide | Operation
17
Unconscious
Call emergency
service
- Conscious
- Panting
Wait for emergency
team
Not breathing
No pulse
Recovers
pulse
+ breathing
Recovers
pulse
+ breathing
Restarts the cycle Restarts the cycle
CPR for 2 minutes
No pulse, no breathing
recovery
Shock
recommended
Shock delivered
Check patient’s condition
Place victim on a dry, flat
and steady area
The Isis analyzes
patient’s condition
Shock NOT
recommended
Move away from the patient
Activate AED
CPR for 2 minutes
Wait for emergency
team
Wait for emergency
team
- Place pads
- Activate the Isis
Simplified diagram of procedure in adults
Healthcare professional

Quick start guide | Operation
18
It recovers
breath and/or
movements
Restarts the cycle Restarts the cycle
Unconscious
Call emergency
service
Check patient’s condition
Not breathing
Place victim in a dry flat
steady area
- Place pads
- Activate the Isis
The Isis analyzes
patient’s condition
Shock NOT
recommended
CPR for 2 minutes
It doesn’t recover breath
and/or movements
Shock
recommended
Move away from the patient
Activate AED
Shock applied
CPR for 2 minutes
Wait for emergency
team
Wait for emergency
team
Wait for emergency
team
- Conscious
- Panting
It recovers
breath and/or
movements
Simplified diagram of procedure in adults
User without graduation in medicine, with training in the use of automatic
defibrillators and CPR techniques.

ECG Monitoring 5
The ECG monitoring is available with the use of the 3 lead
ECG cable (optional). The Isis monitors only the ECG DII derivation.
The device may operate in three different ways.
19
•Only adhesive pads connected: the device works as an external automated
defibrillator, using the AHA protocol.
•ECG cable and adhesive pads connected: the device will give priority to the
adhesive pads utilization, operating as an external automated defibrillato, using
the AHA protocol.
•Only ECG cable connected: the equipment monitors the patient’s ECG silently
(always on DII derivation) and alarms when detects a situation of cardiac arrest.
In this situation, and in shock indicated situation, the adhesive pads should be
connected.
Using the ECG: Connect the ECG patient cable to the Isis, using the connector
indicated below, located on the side of the device.

CPR Maestro 6
The CPR Maestro is an accessory from Isis, created
to help rescuers perform compressions in accordance with the latest CPR
recommendations. Its sensors measure the frequency and depth of chest
compressions, providing the user with real-time feedback. These information are
displayed on CPR Maestro and Isis screens and through sound recommendations.
20
Note: Because it is an accessory, it can not be used by itself. Only con-
nected to Isis.
To turn off the equipment, simply press the ON/OFF button for 3 seconds.