Saadat SHOOKA User manual

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User Manual
SHOOKA
Electroshock
D00983-V7
SAADAT Co.

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POOYANDEGAN RAH SAADAT CO.
No. 4, 1st East St., Ettehad Blvd., Damavand St., TEHRAN,
IRAN.
Post box: 1658916599
Tel: [phone]
Fax: [phone]
Customer Services:
Tel: [phone]
Cell: [phone]
Fax: [phone]
Legal responsible:
Address: Trionara Technologies AB
Polygonvägen 21. 18766. Täby. Sweden
E-Mail: [e-mail]
Tel: [phone]
Web site: www.saadatco.com
Email: [e-mail]

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Manual Purpose
This manual provides the necessary instructions to operate Automated External Defibrillator (AED)
system based on its intended use. It also describes all adjustable and measurable parameters by the
system, defined maneuvers, alarms and briefly all capabilities of the SHOOKA AED.
Observance of this manual is a prerequisite for proper operation and assures patient and operator’s
safety. If you have any questions about the AED, please contact our customer service department.
This manual is an essential part of the AED system and should always be kept close to it, so that it
can be obtained conveniently when necessary.
Intended Audience
This unit is intended to be used by trained rescuers to provide emergency defibrillation.
Version Information
This manual has a version number. The version number changes whenever the manual is revised
due to software or technical specification changes. The version information of this manual is as
below:
Version number
Release date
D00983-V7
April 2022

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Contents
1INTRODUCTION................................................................................................................................................5
1-1 DESCRIPTION..........................................................................................................................................................5
1-2 INTENDED USE ........................................................................................................................................................5
1-3 WARNINGS AND SAFETY INFORMATION........................................................................................................................ 6
1-4 DEVICE LABELS AND SYMBOLS....................................................................................................................................7
1-5 GUARANTEE AND RESPONSIBILITIES .............................................................................................................................8
2OVERVIEW OF SHOOKA AED ............................................................................................................................9
2-1 DEFIBRILLATION ......................................................................................................................................................9
2-2 DEVICE VIEWS.........................................................................................................................................................9
3ACCESSORIES .................................................................................................................................................12
3-1 BATTERY..............................................................................................................................................................12
3-2 PADS ..................................................................................................................................................................14
4OPERATION....................................................................................................................................................16
4-1 USE OF THE AED................................................................................................................................................... 16
5AED MANAGEMENT MODE............................................................................................................................20
5-1 PREPARING SHOOKA FOR MANAGEMENT MODE.......................................................................................................20
5-2 SETTINGS.............................................................................................................................................................20
6MAINTENANCE AND TROUBLESHOOTING......................................................................................................22
6-1 PHYSICAL AND ACCESSORIES....................................................................................................................................22
6-2 SELF-TEST...........................................................................................................................................................22
6-3 TROUBLESHOOTING ...............................................................................................................................................23
6-4 PERIODIC INSPECTION.............................................................................................................................................24
7CLEANING AND DISINFECTING .......................................................................................................................25
8TECHNICAL SPECIFICATIONS...........................................................................................................................26
APPENDIX 1_ RECTILINEAR BIPHASIC WAVEFORM.................................................................................................28
APPENDIX 2_ ECG ANALYSIS ALGORITHM ACCURACY ............................................................................................31
APPENDIX 3_EMC...................................................................................................................................................35

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1Introduction
1-1 Description
SHOOKA is an easy to use, battery operated, automated external defibrillator (AED).
SHOOKA automatically analyses patient’s ECG signal and identifies sudden cardiac arrest
(SCA) and advises if the electrical shock is needed. SHOOKA provides audible and visual
prompts during operation which simplify system usage. SHOOKA is manufactured based on
CPR guideline of AHA revised in 2010.
SHOOKA provides an internal automated self-test and indicates the device is ready to use or
not. SHOOKA operates with disposable battery and detects low battery condition and produces
related prompts for battery exchanging.
SHOOKA is designed to operate in two different modes: Adult and child.
1-2 Intended use
SHOOKA is designed to use in clinical environments and public places and used by trained
user with appropriate technical and clinical trainings.
SHOOKA automated external defibrillator (AED) are indicated for use on victims of sudden
cardiac arrest who are:
•Unconsciousness
•Absence of breathing
•Absence of pulse and other sign of circulation
When the victim is less than 8 years old or less than 25 Kg weight (newborns and under 1 year
old are not included), use child pad. Do not delay therapy to determine exact age or weight. If
child pads are not available, apply adult pads in the position as shown for a child and set AED
on child mode and use the AED.
Contraindications
Never use the SHOOKA Automated External Defibrillators (AED) if the victim
•Is responsive or conscious,
•Is breathing, or
•Has a detectable pulse or other sign of circulation.
SHOOKA is not intended for resuscitation of newborns and under 1-year-old patients.
Also, resuscitation of pregnant women should be done provided that it is under an expert
(including an obstetrician and neonatologist) supervision.

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1-3 Warnings and safety information
Warning
➢Read User manual carefully before operating the AED system.
➢The system function can be affected by using unapproved accessories.
➢The AED should only be operated and maintained by trained person.
➢Use only standard pads.
➢The device maintenance should always be accomplished in conformity with
safety regulations.
➢The AED must be repaired, assembled, and used by trained personnel.
➢There will be some risks to the environment pollution associated with the disposal
of the device accessories and parts (e.g., pads). The device and accessories shall be
disposed in compliance with relevant regulations. Contact your municipality to
check where you can safely dispose the pads.
➢Do not use this equipment in presence of electro-surgery.
➢Maintenance of the device should be conducted due to the manufacturer
recommendations in the user manual.
➢Do not connect the AED to a PC or other devices while the device is connected to
patient.
➢Check the expiration date of electrodes.
➢Check the expiration date of battery pack.
➢Remove patient from strongly wet environment and conductive (metal) surface
because it may lead to disfunction and burn.
➢Remove any sharp object from the treatment area such as rock and knife.
➢Make sure there is no direct contact between user and patient during shock.
➢Do not use SHOOKA AED in the presence of flammable gases or anesthetics. Turn
off gas source or move source away from patient during defibrillation. Do not
defibrillate in an oxygen-enriched atmosphere.
➢For pregnant patients, call for expert help (including an obstetrician and
neonatologist) and start basic life support, ensure good quality chest compressions
with minimal interruptions.

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1-4 Device Labels and Symbols
Table 1: Symbols
Waste equipment is disposed of in
compliance with environmental
requirements
Compliance with CE standard requirements
IP22
Under 12.5 mm diameter protection from
particles and vertically dripping water have
no harmful effect when the enclosure is
tilted at an angle up to 15° from its normal
position
Serial Number
Caution
Consult instructions for use
General warning
Address of manufacturer
20XX
Date of manufacture

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BF-type applied parts
European representative
Dangerous voltage
1-5 Guarantee and responsibilities
The manufacturer will not take any responsibility if operator:
•Misuses the device
•Fails to follow operating instructions
•Disregards any warning or technical information
•Modifies the device in any way
•Uses accessories that are not approved or recommended by manufacturer

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2Overview of SHOOKA AED
SHOOKA provides two operation modes:
1- Rescue mode: This is default operation mode of the device when it turns ON. In this
mode AED provides rescue measures. SHOOKA could be configured as fully
automated or semi-automated which could be decided by customer requirement.
2- Management mode: This mode is intended for service and troubleshooting of the
device.
2-1 Defibrillation
SHOOKA uses rectilinear biphasic waveform for defibrillation. SHOOKA automatically
applies shock energy according to the table below:
Table 2: shock energy
First shock
Second shock
Third shock
Adult
120
150
200
Child
50
70
85
2-2 Device views
Front View
Status indicator
PAD Connector
Child key
Touch Screen Display
Shock Key
On/OFF key

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Back view
Top View
Battery Pack
Table 3: Controls
Title
Description
1
Status indicator
Indicate the last self-test status
2
ON/OFF key
Used for turning device on or off
3
Child key
This button set AED for child mode.
4
Shock key
In semi-automatic versions, this button is used to deliver
shock to patient after hearing appropriate voice alarm. When
device is ready to deliver energy to patient, the LED
indicator beneath this button turns on.
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5” TFT Display and
Touch screen
In rescue mode operation, LCD shows information below:
•CPR help guide according to rescue situation
•Displays child or adult mode is selected
•Elapsed time
Pad Storage Area
USB Port
Speaker

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In management mode, touch screen provides required control
menu for configuration of the device.
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PAD connector
PAD connection
7
Battery placement
Battery placement
8
USB Connector
USB connection for export data

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3Accessories
Only use manufacturer recommended accessories. These accessories are listed in the
below table.
Table 4: Accessories
Manufacturer Part
Number
Manufacturer
Accessory
F7958W
FIAB
Adult PAD
F7958P
FIAB
Child PAD
P41021
SAADAT
Battery Pack
3-1 Battery
SHOOKA uses non-chargeable lithium-ion manganese Dioxide battery (LiMnO2) pack for
operation. Install battery pack according to below steps:
1.

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2.
3.
Warning
➢Lithium manganese dioxide battery packs are non-rechargeable. Do not attempt to
recharge the battery pack, it may result in fire or explosion.
➢Do not immerse battery pack in water or other liquids It may result in fire or
explosion.
➢To avoid fire and explosion hazard, do not burn or incinerate the battery pack.
➢Do not use the battery after its expiration date. A depleted battery shall be removed
and replaced as soon as possible.
➢Disposal of the battery shall be in compliance with relevant regulations.
➢Extract the battery if the device is not to be used for a long period of time.

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3-2 Pads
SKOOKA AED always has a connected pad. If the pad is not compatible with patient
(Adult/child) change the pad with suitable pad according to below steps:
•Adult
Connect adult pad as picture below:
Figure 2: Adult pad placement
•Child
Connect child pad as picture below:
Figure 3: Child pad placement

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Warning
➢To prevent possible cross-contamination and inappropriate shock delivery, single-use
accessories (such as pads) should not be reused.
➢Pay attention to expiration date of the accessories and avoid using outdated
accessories.
➢When using Child pad, the Child mode will be selected automatically.
➢When using Adult pad for a child patient, the rescuer must press
the Child button.
➢For men with hairy chest, after removing clothes, shaving is required. Make sure to
remove any water and air bubble between pads and patient.
➢Do not connect two pads to each other, it will result in electrical arcing.

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4Operation
4-1 Use of the AED
Warning
➢The AED must be operated by trained rescuers.
➢Be sure battery is installed and pad’s cable is connected.
When SHOOKA is turned on in rescue mode, operators should follow below sequences:
Table 5: AED mode user prompts
Step
Action
Result
1
Turn ON AED by Press and
release ON/OFF button.
AED turns ON and applies a self-test and
visually shows:
SELF TEST…
If self-test result is true, AED visually shows:
UNIT OK
and plays audio prompt as below:
UNIT OK
CALL EMS
PRESS CHILD BUTTON IF NEEDED
3
Apply pads to the patient’s
body according to visual
prompts
ATTACH DEFIBRILLATOR PADS TO
PATIENT’S BARE CHEST
(Audio prompt)
4
Wait until ANALYZING is
completed
If AED detects connected PAD, displays and
plays this prompt:
DON’T TOUCH PATIENT,
ANALYZING HEART RHYTHM
(Audio prompt)
ANALYZING HEART RHYTHM

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Step
Action
Result
(Audio prompt will be repeated after 4 seconds)
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After ANALYZING, AED
decides whether a shock is
needed
AED determines that patient has a shockable
rhythm or not:
If rhythm is shockable plays:
SHOCK ADVISED
DON’T TOUCH PATIENT
If rhythm is not shockable Plays:
SHOCK NOT ADVISED
6
According to previous step:
If shock advised, AED
automatically go to next step
If no shock advised, AED
automatically go to CPR help
step 10
AED goes to charging mode or CPR help
mode according to previous step.
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Wait until charging is
completed
Charging is started and AED displays:
CHARGING…“x” J
while charging is completed, then AED
display this prompt
CHARGE COMPLETED
STAND CLEAR
8
In semi-automated mode
press the shock button,
unless go to step 9
PRESS SHOCK BUTTON
(Audio prompt)
9
Stay away from the patient
because the shock is
delivering
AED delivers the shock and update the shock
counter on display and following voice prompt
will be heard:
SHOCK DELIVERED
10
Apply CPR for 1 minute and
30 seconds, until the next
prompt is played
Help prompts of the CPR is displayed until
AED’s next prompt
Perform CPR
(Audio prompt)

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Step
Action
Result
Perform CPR
(Audio prompt will be repeated each 30
seconds)
CPR Remaining Time MINUTE: SECOND
After 30 Pushes, Give Two Breaths
(Visual prompt GIVE 2 RESCUE
BREATHS
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Wait until AED determines
next step
ANALYZING HEART RHYTHM,
DON’T TOUCH PATIENT
(Audio prompt)
AED determine next action according to
analysis and specify continue with step 7 or 10
Warning
➢The defibrillator deliversup to 200 J of electrical energy.When discharging the AED,
do not touch the disposable pads.
➢If a person is touching the patient, bed, or any other conductive material in contact
with the patient during defibrillation, the delivered energy may be partially discharged
through that person. Clear everyone away from contact with the patient, bed, and other
conductive material before shock delivery.
➢During defibrillation, air pockets between the skin pads may cause skin burns for the
patent. Apply pads so that entire electrode adheres to skin. Do not reposition the
electrodes once applied. If the position must be changed, remove and replace with
new pads.
➢Pads that are dried out or damaged may cause patient skin burns during defibrillation.
Do not use pads that have been removed from foil package for more than 24 hours.
Also, pads should not be in continuous contact with the patient’s skin for more than
24 hours. Do not use electrodes beyond expiration date. Check that electrode adhesive
is intact and undamaged. Replace pads after 50 shocks.
➢Defibrillation may cause implanted devices to malfunction. Place pads away from
implanted devices if possible. Check implanted device function after defibrillation, if
possible.
➢Do not analyze in a moving vehicle. Motion artifact may affect the ECG signal
resulting in an incorrect shock or no shock advised message. Stop vehicle and stand
clear of the patient during analysis.

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➢Do not move the AED during analysis. Moving the AED during analysis may affect
the ECG signal resulting in an inappropriate shock or no shock advised decision. Do
not touch the patient or the AED during analysis.
➢Before using this defibrillator, disconnect all equipment that is not defibrillator-
protected from the patient.
➢If malfunctions could not be solved with the help of the user manual during the
resuscitation, do use an alternative AED device.

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5AED Management Mode
SHOOKA provides management mode for device configuration, self-test, data transferring
and updates.
Warning
➢Approved supplier must change the AED setting.
➢In case the cross symbol is pressed in management mode, the device will autosave the
data and changes and AED will be turn off.
5-1 Preparing SHOOKA for Management Mode
1- Check battery is available
2- Hold ON/OFF key for at least 5 seconds.
5-2 Settings
The below parameters could be set in management mode:
Figure 4: System setting menu
In this page, subsequent settings can be applied:
- Date/Time: user can adjust date or time by moving to Date/Time. Date/Time page is
depicted in Figure 5