Mediana HeartOn A16 Series User manual

OPERATOR’S MANUAL
HeartOn A16
Automated External Defibrillator
EU representative
OBELIS S.A
Bd. Général Wahis, 53, 1030 Brussels, Belgium
Manufacturer
Mediana Co., Ltd.
132, Donghwagongdan-ro,
Munmak-eup, Wonju-si, Gangwon-do, Korea
Tel: [phone] (82) 33 742 5400
Fax:[phone] (82) 33 742 5483
Revised Date: 2020-01
Part Number-Revision: A7659-0
Copyright © 2020 All rights reserved.
MEDIANA
HEARTON
AED A16
Automated External Defibrillator
OPERATORS
MANUAL

MEDIANA
HEARTON
AED A16
Automated External Defibrillator
Directive
Copyright law allows no part of this instruction manual to be reproduced without
permission.
The contents of this manual are subject to change without notice.
The contents of this manual should be correct. If, for some reason, there are any
questionable points, please do not hesitate to contact our service center.
The manual will be replaced if any pages are missing or collation is incorrect.
Warranty
Device failure or damage related to the following situations during the guarantee period
is not covered by this warranty:
Installation, transfer installation, maintenance and repairs by any person other than
an authorized Mediana. employee or technician specified by Mediana.
Damage sustained to the Mediana product(s) caused by product(s) from another
company excluding products delivered by Mediana.
Damage –caused by mishandling and/or misuse –is the responsibility of the user.
Maintenance and repairs utilizing maintenance components that are not specified
by Mediana.
Device modifications or use of accessories not recommended by Mediana.
Damage caused by accidents or natural disasters (earthquakes, flooding, etc.).
Damage resulting from usage where caution statements and operating instructions
shown in this manual have not been followed.
Damage due to neglect of specified maintenance checks.
This warranty only covers the hardware of the HeartOn A16. The warranty does not
cover the following selections:
Whatever damage or loss results from the attachment of accessories or their
operation.
In the event of a defect in the product, contact our sales outlet or EU representative
as noted on the back cover.
The HeartOn A16 conforms to the EMC standard IEC60601-1-2.
Note: It is possible that using in the vicinity of mobile phone may result in disruption in
the AED operation.
Revision History
The documentation part number and revision number indicate its current edition. The revision
number changes when a new edition is printed in accordance with the revision history of the
documentation. Minor corrections and updates which are incorporated at reprint do not cause
the revision number to change. The document part number changes when extensive
technical changes are incorporated.
Trademark
Product brand names shown in this manual are likely to be the trademark or registered
trademark of the company concerned.

MEDIANA
HEARTON
AED A16
Automated External Defibrillator
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CONTENTS
CONTENTS.................................................................................................................................................... i
SAFETY INFORMATION .............................................................................................................................. 1
General Safety Information ................................................................................................................... 1
Warning .................................................................................................................................................1
Cautions ................................................................................................................................................ 3
INTRODUCTION...........................................................................................................................................5
Intended Use for the AED...................................................................................................................... 5
Where can it be used? .......................................................................................................................... 5
Who can use it?..................................................................................................................................... 5
Local Requirements............................................................................................................................... 5
Device Tracking .....................................................................................................................................5
About This Manual.................................................................................................................................6
Education............................................................................................................................................... 6
Identifying the AED Configurations........................................................................................................7
DESCRIPTION OF THE AED .......................................................................................................................9
Top and Right Panel Components.........................................................................................................9
Rear Panel Components .....................................................................................................................10
Symbols and Labels ............................................................................................................................ 11
SETTING UP THE AED .............................................................................................................................. 13
Unpacking and Inspection ...................................................................................................................13
List of Components.............................................................................................................................. 13
Soft Carry Case ...................................................................................................................................14
SD card................................................................................................................................................14
Event Data...........................................................................................................................................14
Infrared communication port................................................................................................................15
Setting up the AED ..............................................................................................................................16
Temperature status.............................................................................................................................. 16
Pads status..........................................................................................................................................16
BATTERY OPERATION..............................................................................................................................19
Operating the AED on Battery Power..................................................................................................19
Battery Status Indication...................................................................................................................... 21
Self Test...............................................................................................................................................22
CPR FEEDBACK MODULE OPERATION .................................................................................................25
Operating the CPR Feedback Module ................................................................................................25
USING THE AED ........................................................................................................................................27
AHA/ERC guidelines (Rescue protocol).............................................................................................. 27
Pre Defibrillation Action ....................................................................................................................... 29
Operating the AED............................................................................................................................... 29
Operation of HeartOn A16................................................................................................................... 32
Performing CPR ..................................................................................................................................36
Note User and Bystander Safety......................................................................................................... 38
MAINTENANCE ..........................................................................................................................................39
Recycling and Disposal .......................................................................................................................40
Returning the AED and System Components .....................................................................................40
Service.................................................................................................................................................40
Periodic Safety Checks .......................................................................................................................40
Cleaning ..............................................................................................................................................41
Battery Maintenance............................................................................................................................ 41
Pads Maintenance...............................................................................................................................41
CPR Feedback Module Maintenance..................................................................................................42
The AED Maintenance ........................................................................................................................ 43
TROUBLESHOOTING................................................................................................................................45
General................................................................................................................................................ 45
Corrective Action .................................................................................................................................45
EMI (Electromagnetic Interference).....................................................................................................46
Obtaining Technical Assistance ...........................................................................................................46
GLOSSARY ................................................................................................................................................47
SPECIFICATION .........................................................................................................................................49
Defibrillation Electric Shock................................................................................................................. 49

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HEARTON
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Automated External Defibrillator
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ECG .....................................................................................................................................................49
Indication .............................................................................................................................................49
Physical ...............................................................................................................................................49
Environmental Conditions.................................................................................................................... 50
Self Test...............................................................................................................................................50
Data Backup and Communication.......................................................................................................50
Expected Service Life..........................................................................................................................50
Accessories Specifications .................................................................................................................. 51
Defibrillation waveform ........................................................................................................................52
ECG Analysis Performance.................................................................................................................54
Compliance..........................................................................................................................................55
Manufacturer’s Declaration .................................................................................................................56
Figures
Figure 1. HeartOn A16: Top and Right Panel Components..........................................................................9
Figure 2. HeartOn A16: Rear Panel Components.......................................................................................10
Figure 3. Removing the battery ...................................................................................................................19
Figure 4. Inserting the battery .....................................................................................................................20
Figure 5. Removing the battery protection sticker.......................................................................................20
Figure 6. Place the Adhesive Pad ...............................................................................................................25
Figure 7. Replacing the CPR Feedback Module.........................................................................................26
Figure 8. Patient mode switch Button .........................................................................................................30
Figure 9. Pads disconnect icon (Chest type∙A16-DS, A16-DF) ..................................................................31
Figure 10. Pads disconnect icon (Icon type∙A16-GS, A16-GF) ..................................................................31
Figure 11. Action Icon –Step 1
(Left: Chest type∙A16-DS, A16-DF(
ⓑ ), Right: Icon type∙A16-GS, A16-GF( ⓑ )............................32
Figure 12. Pads Placement .........................................................................................................................32
Figure 13. Action Icon –Step 2
(Left: Chest type∙A16-DS, A16-DF(
ⓒ ), Right: Icon type∙A16-GS, A16-GF ( ⓒ ) ...........................33
Figure 14. Action Icon –Step 3
(Left: Chest type∙A16-DS, A16-DF (
ⓒ , ⓔ ), Right: Icon type∙A16-GS, A16-GF( ⓒ , ⓔ ) .................34
Figure 15. Action Icon –Step 4
(Left: Chest type∙A16-DS, A16-DF(
ⓓ) , Right: Icon type∙A16-GS, A16-GF( ⓓ )............................35
Figure 16. Pads status icon.........................................................................................................................41
Figure 17. Use by date of Pads...................................................................................................................43
Tables
Table 1. HeartOn A16 Panel Components ..................................................................................................10
Table 2. Panel and Label Symbols.............................................................................................................. 11
Table 3. Accessories....................................................................................................................................13
Table 4. The battery Status Icon..................................................................................................................21
Table 5. Electromagnetic Emissions (IEC60601-1-2) .................................................................................56
Table 6. Electromagnetic Immunity (IEC60601-1-2) ...................................................................................56
Table 7. Electromagnetic Immunity (IEC60601-1-2) (continued)................................................................57
Table 8. Recommended Separation Distances...........................................................................................58
Table 9. Immunity to proximity fields from RF wireless communications equipment (IEC 60601-1-2).......59
Table 10. Cables (IEC60601-1-2) ...............................................................................................................59

MEDIANA
HEARTON
AED A16
Automated External Defibrillator
1
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SAFETY INFORMATION
General Safety Information
This section contains important safety information related to general use of the HeartOn
A16. Other important safety information appears throughout the manual. The HeartOn
A16will be referred to as the AED throughout this manual.
Before use, carefully read operator’s manual, accessory directions for use, all
precautionary information and specifications.
Warning
Warnings alert you to potential serious outcomes (death, injury, or adverse events)
to the patient or user.
As a user of an AED it is essential that you inform Mediana of any
incident where your AED is suspected to have caused a death, serious
injury or illness. If you have any suspicions that this is the case inform
Mediana directly or through your local distributor.
The AED must be used by a person trained in CPR and the use of AED.
The qualification for the usage of AED should follow the local laws.
The AED has the capability to deliver therapeutic electrical shocks. The
shock can cause serious harm to either operators or bystanders. Caution
must be taken to ensure that neither the operators nor bystanders touch
the patient when a shock is to be delivered.
The AED has not been evaluated or approved for use in hazardous
locations as defined in the National Electrical Code (Articles 500-503). In
accordance with the IEC/EN 60601-1 Classifications, the AED is not to be
used in the presence of flammable substance/air mixtures.
The AED has been designed to work on unresponsive, non-breathing and
pulseless* patients. If the patient is conscious or breathing and regain a
pulse, do not use the AED to provide treatment.
(*checking pulse
corresponds to health care provider)
Touching the patient during the analysis phase of treatment can cause
interference with the diagnostic process. Avoid contact with the patient
and keep the patient as motionless as possible while ECG analysis is
being carried out. The AED will instruct you when it is safe to touch the
patient.
Always stand clear of patient when delivering treatment. Defibrillation
energy delivered to the patient may be conducted through the patient’s
body and cause a lethal chock to those touching the patient.
It has been determined that the AED is safe to use in conjunction with
oxygen mask delivery systems. However, due to the danger of explosion
it is strongly advised that the AED should not be used in the vicinity of
explosive gases. This includes flammable anesthetics, concentrated
oxygen and gasoline.
The identical pad is used for both Adult and Pediatric. The Adult mode
must be used on patients older than 8 years old. The Pediatric mode
must be used on patients between 1 and 8 years or less than 25 kg (55lb).
Do not use the AED on patient younger than 1 year old.

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Proper placement of the pads is critical. Strict observance of pad
positioning instructions, as indicated on the labeling and in training, is
essential. Care must be taken to ensure pads are adhered to the patients'
skin properly. Air pockets between the adhesive pad and skin must be
eliminated. Failure in pad adhesion may hinder effectiveness of therapy
or cause excessive skin burns to the patient if a shock is applied.
Reddening of the skin may appear after use, this is normal.
The battery of AED is not rechargeable. Do not try to recharge, open,
crush, or burn the battery, or it may explode or catch fire.
Do not allow the pads to contact other electrodes or metal parts that are
in contact with the patient. Such contact can cause patient skin burns
during defibrillation and may divert defibrillating current away from the
heart.
Pay attention to possibility of contact with conduction part of electrode,
lead line, cable connector, other patient installation part for patient
safety.
Do not use this AED near or within puddles of water.
Do not reuse electrodes to many patients.
Use the AED or accessories only as described in this manual. Improper
use of the AED can cause death or injury.
Do not use or place the AED in service if the status indicator of AED
displays “X”. Contact your local distributor or Mediana service team.
Keep batteries dry and away from any heat sources (including direct
sunlight). If you see any damage or leakage, do not allow the liquid to
come in contact with your skin or eyes. If contact has been made, wash
the affected area with plenty
of water and seek medical advice
immediately.
The AED contains an automatic disarm of the stored energy. If the
operator has not delivered the energy to a patient, an internal timer will
disarm the stored energy. This stored electrical energy can potentially
cause death or injury if discharged improperly. Follow all instructions in
this manual.
Check the status Indicator periodically. If the status Indicator displays
“X”, a problem has been detected. Manage it for no problem in case of
emergency.
As with any medical equipment, carefully route patient cabling to reduce
the possibility of patient entanglement or strangulation.

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Automated External Defibrillator
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Cautions
Caution statements identify conditions or practices that could result in damage to
the equipment or other property.
The AED may not operate properly if it is operated or stored at conditions
outside the ranges stated in this manual.
The AED was designed to be sturdy and reliable for many different use
conditions. However, handling the AED too roughly can damage it or its
accessories and will invalidate the warranty. Check the AED and
accessories regularly for damage, according to directions.
Before delivering a shock, it is important to disconnect the patient from
non-defibrillation protected electronic devices, such as blood-flow
meters, that may not incorporate defibrillation protection. In addition,
make sure the pads are not in contact with metal objects such as a bed
frame or stretcher.
The pads pouch shall not be opened until immediately prior to use.
Do not use or place the AED in service until you have read the AED
Operator’s manual.
Do not use or stack the AED with other equipment. If the AED is used or
stacked with other equipment, verify proper operation prior to use.
Handling or transporting the patient during ECG analysis can cause
incorrect or delayed diagnosis. If the AED
gives a SHOCK ADVISED
prompt during such handling or transport, stop the vehicle and keep the
patient as still as possible for at least 15 seconds before pressing the
Shock button, to allow the AED to reconfirm the rhythm analysis.
Periodic checks of this AED must be undertaken to ensure among other
things that the AED is not damaged in any way.
The pads are a single use item and must be replaced after each use or if
pouch that seals pads has been broken/compromised in any way. If
damage is suspected the pads must be replaced immediately.
Do not use training pads with this AED.
Carefully observe pacemaker patients. Patient history and physical
examinati
on are important in determining the presence of implanted
pacemaker. Patient pacemakers may reduce the sensitivity of the AED
analysis and errors in detecting shockable rhythms.
If the pads are attached to the chest firmly, the AED can analyze the exact
ECG and prevent the skin burns. But if the pads are overlapped on the
patient chest, the pads will not deliver defibrillation energy properly.
If the voice recording option is applied, the HeartOn A16records the
surrounding sound. The voice prompt, “Audio recording in progress”, is
played.

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HEARTON
AED A16
Automated External Defibrillator
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HEARTON
AED A16
Automated External Defibrillator
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INTRODUCTION
Mediana provides you with a fully configurable AED system to allow you to comply with
your chosen SCA treatment protocol. Our current AED is configured to be compliant with
the 2015 version of the AHA/ERC guidelines on Cardiopulmonary Resuscitation (CPR)
and Emergency Cardiovascular Care (ECC). It is recommended to be trained in the
appropriate version of the AHA/ERC guidelines and the use of your AED configuration.
Contact Mediana or your authorized Mediana distributor for further information.
Intended Use for the AED
The AED is intended to be used to treat someone who is unresponsive, non-breathing
and pulseless for the adult and pediatric in all area of a hospital, pre-hospital, public
access, alternate care and home healthcare environment. AED is designed to easy to use.
Note: The intended patient populations are adult and pediatric (between 1 and 8 years or
less than 25 kg (55lb)) can be treated with the appropriate pads.
Note: If you have concerns about your health or an existing medical condition, talk to
your doctor. A defibrillator is not a replacement for seeking medical care.
Where can it be used?
The intended environment to use the AED includes home healthcare, public space and
hospital. The public space is a social space that is generally open and accessible to
people. Roads (including the pavement), public squares, parks, subway station,
government buildings, beaches, public libraries, privately owned buildings or property
opened to public/visible from sidewalks and any shared spaces of automobiles and other
vehicles are typically considered public space. Hospital use typically includes areas such
as general care floors, operating rooms, special procedure areas, intensive and critical
care areas within the hospital. Hospital-type facilities include physician office-based
facilities, sleep labs, skilled nursing facilities, surgical centers, and sub-acute care centers.
Who can use it?
You cannot use the AED to treat yourself. The AED talks the user through each step of
treating someone who is in SCA. However, anyone who might use the AED should review
the training materials that come with it or contact your local authorized supplier or Medical
technical support, and should be trained in cardiopulmonary resuscitation (CPR).
Responding to SCA may require the user to kneel.
Local Requirements
Check with your state health department to see if there are any local or state
requirements about owning and using an AED. You can find contact local supplier or
Mediana technical support for learning about your country or state.
Device Tracking
This AED may be subject to tracking requirements by the manufacturer and distributors
per local regulation. If there are tracking requirements in your local, please notify your
local distributor when the AED has been sold, donated, lost, stolen, exported, or
destroyed.

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Automated External Defibrillator
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About This Manual
This manual explains how to set up and use the AED.
Read the entire manual including the Safety Information section, before you operate the
AED.
Education
An acute heart attack is an emergency situation that requires an emergency treatment.
First-aid measures can be performed without physician action due to the nature of acute
heart attack. We encourage potential users who are expected to use AEDs to be trained
in CPR and AED usage for accurate diagnosis. It is also recommended that user be
educated or retrained with the latest content in accordance with general retraining or the
recommendation of the training institution. If the person expecting to use the AED is not
trained in the above, please contact your local distributor or Mediana who can provide the
training. Information on authorized local training organizations can also be found in
relevant departments of the government.
Note: Check the surrounding environment to make sure it conforms to the environmental
conditions mentioned in this manual. If the AED is used in an environment other
than the environment mentioned in this manual, there may be a problem with
stability.

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Automated External Defibrillator
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Identifying the AED Configurations
The following table identifies the AED configurations and how they are indicated. The
Reference number and serial number are located on the bottom of the AED.
Model Name
Reference No.
Description
HeartOn A16-DS
A16M-DS-0E
A16-DS Standard
A16M-DS-VQ-0E
A16-DS Standard + Voice recording + Pads
quality
A16M-DS-CQ-0E
A16-DS Standard + Pads quality + CPR
feedback
A16M-DS-VCQ-0E
A16-DS Standard + Voice recording + Pads
quality + CPR feedback
HeartOn A16-DF
A16M-DF-0E
A16-DF Standard
A16M-DF-VQ-0E
A16-DF Standard + Voice recording + Pads
quality
A16M-DF-CQ-0E
A16-DF Standard + Pads quality + CPR
feedback
A16M-DF-VCQ-0E
A16-DF Standard + Voice recording + Pads
quality + CPR feedback
HeartOn A16-GS
A16M-GS-0E
A16-GS Standard
A16M-GS-VQ-0E
A16-GS Standard + Voice recording + Pads
quality
A16M-GS-CQ-0E
A16-GS Standard + Pads quality
HeartOn A16-GF
A16M-GF-0E
A16-GF Standard
A16M-GF-VQ-0E
A16-GF Standard + Voice recording + Pads
quality
A16M-GF-CQ-0E
A16-GF Standard + Pads quality
Note: A16-DS Standard = A16 (Semi auto) + Multilingual voice prompt + Chest type
A16-DF Standard = A16 (Fully auto) + Multilingual voice prompt + Chest type
A16-GS Standard = A16 (Semi auto) + Multilingual voice prompt + Icon type
A16-GF Standard = A16 (Fully auto) + Multilingual voice prompt + Icon type
Note: The alphabet “E”can be added as the last digit of reference number in accordance
with the region.

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Automated External Defibrillator
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Features for the AED
Physical/Mechanical
The AED is an automated external defibrillator (AED) used for the fast delivery of
defibrillation electric shock therapy which can be battery-operated.
Electrical
The AED has a battery which is detachable and non-rechargeable.
Display
The indication is LED indicator that flashes red LED under the relevant action icon.
Auxiliary Input/Output(s)
The AED provides Infrared communication port, SD card ports.

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DESCRIPTION OF THE AED
Top and Right Panel Components
<Chest Type ∙ A16-DS, A16-DF>
<Icon Type ∙ A16-GS, A16-GF>
Figure 1. HeartOn A16: Top and Right Panel Components
3
2
8
7
9
1
4
5
6
3
2
8
7
9
1
4
5
6

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Rear Panel Components
Figure 2. HeartOn A16: Rear Panel Components
Table 1. HeartOn A16Panel Components
1 Select language
button
User can select the desired language among three different
languages by pushing the select language button.
2
Pad connector
Pad connector links the pads.
3 Cover
Cover is used to protect the action icon, the patient mode switch
button, the power button, the select language button
and the
shock button.
4 Patient mode switch
button
After user distinguish the patient according to patient type, select
the patient mode between adult and pediatric patient mode by
pushing the patient mode switch button.
5
Indicator LED
The indicator LED flashes red LED near the relevant action icon.
6 Infrared
communication port
Infrared communication
port is used to communicate with the
PC.
7 Shock button
(Semi-Auto Only)
When preparation
for electric shock is completed, the shock
button will flash. Push the Shock
button and then the AED
delivers the shock.
8 Status indicator Status indicator displays the AED status, the temperature status,
the battery status and the PADS status.
9
Power button
Power button is used to On/Off the power.
10
Battery
User can remove or reseat the battery.
11
SD card port
SD card is used to save the data and update the AED software.
<
With a Battery>
<
Without a Battery>
1
1
10

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Automated External Defibrillator
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Symbols and Labels
The following symbols may be used in this manual, related documentation, or appear on
system components or packaging.
Table 2. Panel and Label Symbols
Symbols
Description
Symbols
Description
Ready to use Do not reuse
Not ready to use
CE mark
Battery status
Environmental
shipping/storage
atmospheric pressure
limitations
Tem perature status
Environmental
shipping/storage
humidity limitations
Contains no latex
Environmental
shipping/storage
temperature limitations
Use by date
Fragile-handle with care
Follow instructions for use This way up
Manufacturer
Keep dry
Date of manufacture
Type CF –Defibrillator
proof
Reference number Dust and water resistance
Serial number
Disposal instructions
Pads status
.

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Automated External Defibrillator
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SETTING UP THE AED
To ensure accurate performance and prevent AED failure, do not expose
the AED
to extreme moisture, including direct exposure to rain. Such
exposure may cause inaccurate performance or AED
failure. Refer to
Specification section.
Using damaged or expired AED or accessories may cause the AED to
perform improperly, and/or injury the patient or the user.
Unpacking and Inspection
The AED is shipped in one carton. Examine the AED including the accessories carefully
for evidence of damage. Do not use damaged equipment. Refer to the Maintenance
section for instructions on returning damaged items. Ensure all potential users are
suitably trained.
Note: Inspect the packaging of accessories to ensure integrity of seals and validity of use
by date.
List of Components
The following items are accessories in the package. Optional accessories may be
ordered if needed. Contact qualified service personnel or your local supplier for pricing
and ordering information.
Table 3. Accessories
Standard Accessories
Qty
HeartOn A16
1
Operator’s manual
1
Automated External Defibrillator Pads (1.8m)
1
Non-rechargeable LiMnO2Battery (15V, 3000mAh)
1
Optional Accessories
Qty
HeartOn AED Event Review Software
-
HeartOn AED Event Review Software - User Guide
-
Infrared communication adaptor
-
Mini USB cable
-
Soft Carry Case
1
Micro SD card
1
CPR Feedback Module *Only when CPR feedback option is installed.
1
Adhesive Pad *Only when CPR feedback option is installed.
5
Automated External Defibrillator Pads (1.8m / for pads quality)
*Only when Pads quality option is installed.
1
Automated External Defibrillator Pads
(1.8m / for pads quality + CPR Feedback)
*Only when CPR feedback option is installed.
1
Recommended Accessories
Qty
Scissors –for cutting the victim’s clothed if needed
-
Disposable gloves –to protect the user
-
A disposable razor –to shave the chest if hair prevents good pads contact
-
A pocket mask or face shield –to protect the user
-
A towel or absorbent wipes –to dry the victim’s skin for good pads contact
-

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Soft Carry Case
The AED should be protected by the soft carry case during the move.
The soft carry case has been designed to allow the AED not to move in the soft carry
case by using the AED own handle. The user can check the status indicator of AED
without having to open the carry case. The paper with contact information of the nearest
emergency medical services can be inserted to the clear cover. The soft carry case has
the pocket on the rear side of the carry case for the manual and spare pads, spare
battery and the CPR Feedback module (option).
SD card
The SD card is inserted into the SD card port on the AED’s bottom panel as described
below. The SD card is used to record the history of the AED performance and to update
the AED firmware. The recorded history in the SD card can be checked by the HeartOn
AED Event Review Software. If you want to use the SD card to use the HeartOn AED
Event Review Software or to update the AED firmware, please contact qualified service
personnel or your local supplier.
1. When the AED is turned on, turn off the AED by pushing the power button.
2. Remove the battery from the bottom of the AED.
3. Check the proper orientation of the SD card and insert the SD card into the SD card
port.
4. Reseat the battery in the bottom of the AED.
5. If necessary to update the AED through SD card, turn on the AED by pushing the
power button.
6. After complete the update, automatically turn off itself. Close the cover again.
Note: Only micro SD cards supplied by Mediana should be used.
Event Data
The event data are stored in the SD card. The event data can be read by HeartOn AED
Event Review Software.
Note: When the AED does not have an SD card in it or your SD card is unreadable,
corrupted, damaged or has some error, the event data are stored in the internal
memory as the LED indicator and buzzer sound will go on.
In case the SD card has a problem, buzzer will sound 4 times after the CPR Action
Icon LED lights up. {Repeat twice}
AED records up to 4 times (1 time: from power ON to power OFF) of operation data in
the flash memory. From the fifth operation data will be stored after the oldest data is
deleted.
The maximum data that can be stored at one time is ECG (6488 sec), HR (37 times of
shock advised, 74 times of no shock advised), Trend (37 times of shock advised, 74
times of no shock advised), and Temperature (36 times). If any of the above four data is
full during a progress once, the operation data is no longer stored.

MEDIANA
HEARTON
AED A16
Automated External Defibrillator
15
15
The event data which are stored in internal memory can be viewed after downloading via
SD card in accordance with the following procedure.
1. Run the Notepad in Windows. The Notepad window appears with a blank document
open.
2. Save this empty file in Notepad and name it ‘Import Internal Data.txt’.
3. Open the SD card on PC.
4. In the SD card, create the directory folder and name it ‘Update’.
5. Copy the carried out ‘Import Internal Data.txt’ file into the ‘Update’ directory folder.
6. Remove the battery from the AED and insert the SD card supplied by Mediana to SD
card port which is located at bottom side of the AED.
7. Reseat the battery and the AED is turned on, the event data are downloaded to SD
card automatically.
8. The downloaded event data can be viewed via the HeartOn AED Event Review
Software.
Note: When downloading the stored event data in internal memory to SD card, the event
data which are stored in internal memory will be deleted.
Note: If the SD card has some error, the AED can recognize that the SD card is not
inserted.
Note: Event data in SD card could be used for further clinical assessment. Please make
sure that event data are securely saved in any of storage format when event data
is accessed by the HeartOn AED Event Review Software or is uploaded to PC.
Note: It is strongly recommended that the event data in SD card should be uploaded to
PC and should be reset before the event data reach 10000 events in SD card by
periodically checking the HeartOn AED Event Review Software, in order to avoid
losing any of event data because the device is designed to stop saving event data
when it reaches 10000 events in SD card and there is no indication in the device of
reaching 10000 events in SD card.
Note: If you require any additional information, please refer to HeartOn AED Event
Software User guide.
Infrared communication port
Infrared communication port provides wireless communications from the AED to a PC
through the Infrared communication data download cable and IR communication adaptor
which is connected to PC. The Infrared communication is used to transfer information
and to connect to service mode. If you want to use Infrared communication port, please
contact qualified service personnel or your local supplier.

MEDIANA
HEARTON
AED A16
Automated External Defibrillator
16
16
Setting up the AED
Use only Mediana-approved and specified parts, accessories, optional
parts, consumables, and components. Use of unauthorized accessories
may cause the
AED to operate improperly and provide false
measurements. Follow all labeling instructions on the defibrillation pads
and the battery.
Always follow your facility’s infection control procedures and applicable
regulations when disposing of anything that has been used on patients.
Do not open the pads from packaging previously until the time of
emergency use when pads are used for patient.
The pads should be connected to the AED as preparation for emergency
circumstances.
The AED should not be used or loaded with other equipment. If it is
necessary, the AED should be observed to verify normal operation before
using.
Do not use the expired pads.
Do not reuse the pads. Reuse can lead to potential cross infection,
improper performance of the device, inadequate delivery of therapy,
and/or injury to the patient or operator.
Temperature status
Temperature status displays the following description.
If the self-test is implemented in out-of-range for environmental operation condition,
the status indicator ‘O’will be displayed.
If the self-test is implemented in out-of-range for environmental operation condition
above 5 times, the status indicator ‘X’will be displayed.
When the AED with displaying status indicator ‘O’is turned on in out-of-range for
environmental operation condition.
Note: When the AED with displaying status indicator ‘X’and temperature status is turned
on in specified environmental operation condition, will operate properly.
Note: When the AED is turned on in the inappropriate environmental operation condition,
temperature status will be blink.
Note: If the AED is placed in out-of-range value for environmental operation condition for
long time, it will be longer than usual to recognize the temperature. It is
recommended that AED should be stored in environmental operation condition
described in this manual.
Pads status
Pads status displays the following description.
If the pads are disconnected with the AED, the pads status will be displayed.
For the AED with the pads quality feature, the pads status will be displayed if there is
a problem with the pad connected to the AED. (expiration of the pads, expired pads,
damaged pads or recommended replacement of the pads)
Note: If the pads are normally connected to the pads quality enabled AED but the pad
status indicator is showing, the pads need to be replaced.
Note: If user replaces the pad connected to the pads quality enabled AED and perform a
self test, the pads status indicator will be displayed or not according to the pads
status.